Download Minutes of 246th meeting of Registration Board

Minutes for 246th Meeting of Registration Board held on
10-11th December, 2014.
Item No.
Detail of Item
Page No(s)
Item No.I
Confirmation of minutes of 245th meeting Registration Board
06-08
Item No.II
Agenda points referred by Members, Registration Board
08-10
Item No.III
Cases for conduction of Clinical Trials – Pharmacy Services Division
11-15
Item No.IV
Matters referred for deliberation by Registration Board
16-56
Item No.V
Registration of drugs - Pharmaceutical Evaluation Cell
57-272
Item No.VI
Miscellaneous cases - Pharmaceutical Evaluation & Registration Division
273-385
Item No.VII
Registration of Biological Drugs – Biological Evaluation & Research Division
386-410
Item No.VIII
Quality Control Cases – Quality Assurance & Lab Testing Division
411-461
Item No.IX
Registration of Medical Devices – Medical Devices Division
462-472
Item No.X
Local Manufacturing of Biological Drugs.
473-480
Item No.XI
Applications for transfer of registrations
481-496
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246th meeting of Registration Board was held on 10-11th December, 2014 in the
Committee Room, M/o National Health Regulation Services and Coordination, Islamabad. The
meeting was chaired by Mr. Ghulam Rasool Dutani, Director, Pharmaceutical Evaluation &
Registration Division. The meeting started with the recitation of Holy Verses. The meeting was
attended by the following:1.
Lt General (R) Karamat Ahmed Karamat.
Member
2.
Prof.Dr.Rafi uz Zaman Saeedul Haq
Assocaite Dean, Faculty of Pharmacy, University of
Lahore, Islamabad
Member
3.
Brig (R). Dr. Muzammil Hasan Najmi,
Associate Dean, Basic Sciences Division,
Foundation Medical University, Rawalpindi.
Member
4.
Brig.Dr.Aslam Khan,
Professor of Medicine, Military Hospital Rawalpindi.
Member
5.
Dr. Muhammad Arshad,
President, Pakistan Veterinary Medical Council
Member
6.
Abdul Razak
Director Drugs Testing Laboratory
Government of Sind, Karachi.
Dr.Muhammad Khalid Khan
Director Drugs Testing Laboratory
Government of Khyber Pakhtunkhwa, Peshawar.
Dr.Amanullah Khan
Director Drugs Testing Laboratory
Government of Baluchistan, Quetta.
Shaikh Ansar Ahmad
Director Biological Drugs, DRAP
Member
10.
Dr.Noor Muhammad Shah
Director MD&MC, DRAP
Member
11.
A.Q.Javed Iqbal
Director QA &LT, DRAP
Member
12.
Dr. Obaidullah, Deputy Director General (Reg.I).
7.
8.
9.
Minutes246thMeetingRegistrationBoard
Member
Member
Member
Secretary/Member
Page2
Dr. Muhammad Arshad did not attend the meeting on 10.12.2014 and Dr. Muhammad
Khalid Khan did not attend the meeting on 11.12.2014. Both days, meeting started at 09:30 AM
and continued till 08:00 PM.
Dr.Masud ur Rehman DDG (Biological), Dr. Abdur Rasheed DDG (Pharmacovigilance),
Dr. Tariq Siddique (DDG R.II), Muhammad Arif (DDC R.I), Muhammad Amin (DDC R.V),
Babar Khan (Incharge, PEC), Muneeb Ahmad Cheema ADC (PEC), Ammad Zaka ADC (PEC),
Atiq ul Bari ADC (PEC), Tehreem Sara (DDC MD&MC), Asif Jalil (ADC MD&MC) and
Khalid Mehmood (DDC QC) assisted relevant Directors and Secretary of the Board with agenda.
Mr.Shamim Ahmad and Abuzar Faizy, Mr.Nadeem Alamgeer and Muhammad Farooq
Memon attended the meeting as observer on behalf of PPMA, Pharma Beauru and PCDA
respectively.
In addition to routine agenda, the Board discussed and decided various other matters, as
follows:
1. In future agenda will be circulated about 07 days before the meeting.
2. Registration Board deliberated on agenda point referred by Director DTL, Quetta
regarding attending the meeting by observers (PPMA, Pharma Bureau and PCDA). The
Board decided that respective observer will leave the meeting by ownself, when agenda
related to its company will be discussed. All observers also consented to the decision
3. Registration Board authorized its Chairman for grant of registration for export purpose on
contract manufacturing basis excluding controlled drugs and new drug as per contract
manufacting policy.
4. Dr.Aslam Khan Director Malaria Control Program and Dr.Qutub-ud-Din Kakar, WHO
National Professional Officer briefed the Board about irrational use of antimalarial drugs
in the country particularly injectable anti-malarial therapy and development of emerging
artemisinin resistance. Keeping in view briefing by experts, Registration Board decided
that Malaria Control Program will hold a consultative meeting of all the stakeholders
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including DRAP, prescribers, provincial governments, pharmaceutical manufacturers etc
for framing recommendations on the matter.
5.
Registration Board discuused comments of its members, stakeholders and international
practices and agreed that for all topical preparations viz. eye / ear preparations, external
preparations (cream / ointment / gel / lotion / spary) and aerosols, steroid manufacturing
may be permitted on campaign manufacturing basis in general manufacturing areas for
these dosage forms provided that manufacturer has segregated dispensing booths,
validation and controls studies for processes and adequate system to minimize any
potential risk of cross contamination. Registration Board decided to forward above
recommendation to Licensing Division for ultimate decision by Central Licensing Board.
6. Registration Board deliberated on the storage requirement for Misoprostol and keeping in
view EMA’s assessment report decided that Misoprostol 1% HMPC dispersion
(processed material) will be permitted for use in tablet dosage form with storage
condition of 5+3 °C.
7. Registration Board discussed matter regarding non-availability of finished drugs in
country of origin and advised stake holders (PPMA, Pharma Bureau and PCDA) to
forward their comments till 15.01.2015 to already constituted committee for framing its
recommendations for considerartion by Registration Board.
8. Registration Board advised stake holders (PPMA, Pharma Bureau and PCDA) to forward
their comments on case of re-registration of drugs till 15.01.2015 for considerartion by
Registration Board.
9. While discussing case for grant of registration for export purpose, Mr.A Q Javed Iqbal,
Director QA &LT opined that for export purpose only those formulations should be
registered, which are already registered in Pakistan. For new fornulations (which are not
registered in Pakistan), manufacturers should first conduct stability studies and then
registration for export purpose be granted. Prof. Muzammil H Najmi also endorsed it.
Registration Board after deliberation decided that inorder to facilitate export of quality
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drugs (non-me too drugs), export registration will be granted and manufacturer will
comply following conditions before export of drug:


Manufacturer will export the product after complying all the conditions as required under
Drug Act, 1976 including No objection certificate from concerned DRAP office.
Moreover, Federal Inspector of drugs will take sample from each consignemnet for
analysis from CDL, Karachi.
Manufacturer will also furnish export documents endorsed from custom authorities in
order to ensure the export of the product.
These conditions will also be applicable to products approved for exports
(Sofosbuvir) by Chairman, registration Board.
10.
Chairman again advised all members, PPMA and Pharma Bureau to forward their
scientific comments and relevant references on manufacturing requirements till
15.01.2015 for following classes of drugs:
a.
b.
c.
d.
11.
Immunosuppresants.
Clomiphene and letrozole
Prostaglandins and its analogues.
Vancomycin
On the direction of the Honorable Ombudsman, the case for local manufacturing of
biological drugs was re-examined by Registration Board. Representatives of local
manufacturers (Hilton, Getz, Nextar and Macter) were also heard and the Board then
decided the matter in light of directions of Ombudsman.
12.
Registration Board discussed the matter regarding issuance of registration letter of
products for which product specific inspections have been conducted and recommended
by the panel of inspectors or cases where product specific inspections are not required /
exempted as per Import Policy for Finished Drugs. The Board authorized its Chairman
for issuance of registration letter in both aforementioned cases. In cases where there is
any ambiguity in inspection reports or products not recommended by panel of inspectors
then such cases will be placed before Regisrtration Board for decision.
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Item No I:
Confirmation of minutes of 245th meeting Registration Board.
245th meeting of Registration Board was held on 28-29th September, 2014 and minutes
were circulated to all members through e-mail. Two members forwarded following comments, as
follows:

Dr. Amanullah Khan (Director, DTL, Quetta):
Agenda Item No II:
The following comments may be added as discussed in the 245th Registration Board Meeting regarding
Registration of Sofosbuvier which is very important drug and very badly required for the country man.
“The stability study shall be conducted by the manufacturer and accordingly stability data must be
submitted to the Registration Board before the launch of their product into the market, my point is this
that registration may be granted to the firms with the undertaking that they will provide stability study
before the launch of their product into the market as per previous practice.”
Case No. 50. Cases deferred by Registration Board.
M/s Ideal Pharma, Lahore- Product Specific InspectionThere is typographic error and needs correction for record purpose, the inspection for product specific
inspection was carried out by two members only that is Director DTL, Quetta and area FID.

Mr.A.Q.Javed Iqbal, Director QA & LT, DRAP.
g. Import of raw materials for experimental purpose and stability studies etc.
Director QA stated that any such Import for trial batch is not discouraged subject to meet all
codal formalities required for the production of commercial batch as per defined policy
Change in company name from M/s.
Bayer Schering Pharma AG to M/s. Bayer Pharma AG.
Item No.VII:
Miscellenous cases. Case No.15.
Company also informed that German authorities have confirmed the GMP of manufacturer of this
product & product is available in Switzerland and UK which is part of EMA/ SRA.
Minutes were approved after incorporation of above points.
Registration Board in 245th meeting discussed and approved following case but erroneously
decision was not recorded in minutes. However, later on Chairman, Registration Board approved
correction in minutes as decided by the Board.
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Registration of Drugs for export purpose-Not me too Drugs.
Case No.30
Following firms have requested for registration of following drugs for export purpose
only which are not me-too. Details are as under:S.
No.
1.
Name of
Company
M/s
PharmEvo
Karachi
Name of product(s)
Procoxam Forte 1500mg
Tablet
Each tablet contains:Glucosamine HCl ....1500mg
2.
-do-
Procoxam 625mg Tablet
Each tablet contains:Glucosamine HCl …..625mg
3.
M/s
Medisure
Labs,
Karachi
Calvita Syrup
Each 5ml contains:Calcium lacatate
Gluconate…………..40mg
Vitamin A ………….1200IU
Vitamin D3 ………….100IU
Vitamin B1 HCl …….1mg
Vitamin B2 5-sodium
phosphate …….. …….1mg
Vitamin B5 HCl.. …0.5mg
Nicotinamide ………..5mg
Dexpanthenol ……….2mg
Vitamin C…….. …….50mg
Vitamin E acetate ……1mg
4.
M/s
Kaizen
Pharma,
Karachi
Vitacal Syrup
Calcium lacatate
Gluconate…………..40mg
Vitamin A ………….1200IU
Vitamin D3 ………….100IU
Vitamin B1 HCl …….1mg
Vitamin B2 5-sodium
phosphate …….. …….1mg
Vitamin B5 HCl.. …0.5mg
Nicotinamide ………..5mg
Dexpanthenol ……….2mg
Minutes246thMeetingRegistrationBoard
Date of application,
Diary No. & Form
13-05-2014
688
Rs.20,000/13-05-2014
686
Rs.20,000/15-04-2014
668
Rs.20,000/-
26-06-2014
701
Rs.20,000/-
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Vitamin C…….. …….50mg
Vitamin E acetate ……1mg
Decision:
5.
M/s
Genix
Pharma,
Karachi
6.
-do-
7.
-do-
Apitonic Syrup
Each 5ml contains:Cyproheptadine HCl
(anhydrous) BP ……..2mg
Thiamine HCl (B-1) ...2mg
Riboflavin BP (as 5phosphate sodium)…2mg
Pyridoxine HCl ….0.75mg
D-Panthenol BP ….2.5mg
Nicotinamide BP ….22.5mg
Calceg Injection 100mg/ml
Each ml contains:Calcium gluconate
(10%)……. …….10mg
Tyca Tablet 90
Each tablet contains:Ticagrelor ………90mg
27-08-2014
719
Rs.20,000/-
27-08-2014
720
Rs.20,000/27-08-2014
726
Rs.20,000/-
Registration Board approved minutes of 245th meeting with above correction
/ amendment in already approved minutes.
Item No II: Agenda points referred by Members, Registration Board.

Dr. Amanullah Khan, Director DTL, Quetta:
a. PPMA Representation from North zone.
Reference to the above , it is submitted that for the last few DRB Meetings it is observed
that PPMA from North Zone/Region nominates that member for to attend the DRB Meetings
whose case is part of the agenda and in my opinion its a matter of conflict of interest. Therefore
it is requested that in the forthcoming meeting of DRB , this matter may be placed as agenda
item before the DRB and take decision whether such conflict of interest nomination may be
allowed or otherwise. Furthermore it is expected that PPMA from both the regions may
nominate(s) a member for DRB for a specified period.
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Decision:
Registration Board deliberated on the point and it was decided that
respective observer will leave the meeting by ownself, when agenda related to its company
will be discussed. All observers also consented to the decision.
b. Registration of drugs under Drugs Act, 1976.
Reference DRAP letter No. F.1-20/2000-Reg-I(Pt) dated 23rd April 2014 on the subject cited
above, in this regard it is submitted that DRAP has constituted a panel to carryout inspection
abroad at Argentina, the panel comprised of the following officials,
(I)
(II)
Dr. Amanullah Khan, Director Drugs Testing Laboratory Government of
Balochistan, Quetta/ Member Drug Registration Board DRAP.
Ms Sara Naeem, Assistant Drugs Controller, DRAP Lahore.
As per said letter there were four (04) importers / firms who have requested for the
import of their products from Argentina and accordingly on the request of the importers/firms the
panel was constituted to carry out inspections of their Principals abroad for the purpose of
registration of drugs under Drugs Act, 1976. The following is the list of firms/importers who had
requested for registration of drugs under the Drugs Act 1976.
i.
ii.
iii.
iv.
M/s Pine International Lahore.
M/s Atco Pharma International (Pvt) Ltd Karachi.
M/s Oncogene Pharmaceuticals Karachi.
M/s Nawab Sons, Karachi.
As per procedure of the DRAP the letter for inspection is issued only when all the
prerequisite documents/information for the Registration of the Drugs is completed and
accordingly the said letter is also issued on the same grounds by the competent authority,
however regret to mention that M/s Pine International Lahore has declined to carryout
inspection of their Principal abroad so there is need that the Firm has to clear their position and
explain their position for refusing inspection abroad and why action may not be taken against
them in wasting the time of the officials/inspectors and by enlarge of the DRAP.
Regret to mention that M/s Oncogene Pharmaceuticals Karachi as per DRAP, changed
their principal without approval from the DRAP which is not accepted ethically and officially.
They kept the inspection in grey and at any stage never accepted their mistake of change of
Principal and ultimately on 16th October 2014 the coordinator of the inspection team from Atco
Pharma has forwarded an e-mail from Mr Zubair Khalil owner of M/s Oncogene
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Pharmaceuticals Karachi, and explained that DRAP has refused our request for change of
Principal and further added that i will be obliged if Atco Pharma etc takes my case to DRAP for
not carryout inspection abroad. As a Member Drug Registration Board i am not comfortable with
such offensive statement issued from M/s Oncogene Pharmaceuticals Karachi and there is need
to ask them explain their position on such offended statement.
M/s Atco Pharma International (Pvt) Ltd Karachi and M/s Nawab Sons, Karachi also
declined to carry out their inspection abroad by giving no reason.
Keeping in view an exercise of more than six months wherein the Inspectors from time to
time has to reschedule their official activities for the purpose to carryout inspection abroad
smoothly , but regret to say that the inspectors have been kept in dark by the firms/importers and
there was nobody who could come up with truth that we are not in position to carryout
inspection , as from the beginning it was apparent that the importers/firms were not interested to
carryout inspection abroad and it was also apparent that among the firms/importers blame game
has started which was not a good sign for inspection.
I would like that the case may be kept as Agenda Point in the forthcoming meeting of
DRB and a decision may be taken against the firm/importers who are responsible for this Act.
The cases may be dealt as per Drug Act and as per Policy of DRAP to stop such practices in
future and the offenders may be treated as per policy/Drug Act and I also request for the
cancellation of their requested products.
Decision:
Registration Board advised pharmaceutical Evaluation & Registration
Division to present update status of these cases in its forthcoming meeting.

c.
Mr.A.Q.Javed Iqbal, Director QA & LT, DRAP.
This point should be brought into discussion of next meeting that Board should define
uniform guidelines to scrutinize variations if it is related to API / quality of Drug substance in
light of ICH guidelines (Q 8, Q9 & Q10) for all originators and for generic products as well.
Moreover the all respective change should be assessed under the scope of applied variations.
Decision:
Registration Board discussed the matter and it was decided that QA & LT
Division will develop guidelines for this purpose in consultation with PPMA and Pharma
Bureau.
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Item No.III
Cases for conduction of Clinical Trials – Pharmacy Services Division
Case No.01. Polio End-game strategies-Poliovirus Type 2 challenge study. A Five Arm
Community Based Randomized Trial, Karachi. Pakistan.
Aga Khan University has applied for the clinical trial to be conducted in collaboration
with WHO in assistance with EPI Programme.
The key feature of the trial is as under:
Title
Phase
Background
Objective
Participating
Country/Sites.
Number of
participants
Duration of
Trial.
Study
Interventions.
Study
Outcomes
Quantity of
Drug to be
Imported.
Registration
Status of drugs
in Pakistan.
Polio End-game strategies-Poliovirus Type 2 challenge study. A Five Arm
Community Based Randomized Trial, Karachi. Pakistan.
III
Polio disease is present in only three countries including Pakistan. Since the
injectable polio vaccine has better results, WHO “Polio Endgame Strategy ”
is to slowly withdraw the current vaccines replace all oral polio vaccine with
injectable polio vaccine.
The over all purpose of this study is to compare the suggested five different
polio vaccine strategies to see which produces the best immunity for Pakistani
Children and prevents the spread of polio.
Pakistan
Outreach Primary clinics in Karachi at Rehri Goth, Ali Akber Shah Goth,
Ibrahim Hyderi and Bhains Colony.
1000 children each study group (arm) will have 200 children.
One year (June 2014-15)






Oral Bivalent vaccine – Available from EPI
Oral Trivalent Vaccine – Available from EPI
Inactivated Polio Vaccine (IPV) – To be imported
Inactivated Polio Vaccine2 (IPV2) – To be imported
Oral Monovalent Vaccine2 (mOPV2) – To be imported at a later stage
in the study. An amendment and request will be sent to DRA at that
time.
To determine which vaccine best protects the children from polio



IPV= 1510 Doses
IPV= 230 Doses
Other vaccines are already registered and standard of care. These will
be purchased from EPI.
Oral Bivalent, trivalent polio vaccine is provided to EPI by WHO.
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Monitor of the
Trial.
Sponsor


Dr. Maha Mohamed Saadeldine Salama
Head Clinical Research Sector/VACSERA, Cairo Egypt.
World Health Organization (Geneva)
Bilthoven Biologicals BV (BBIO) has been a manufacturer of IPV and monovalent bulk
components since 1994. The company has now developed an investigational monovalent high
dose inactivated poliovirus vaccine (m-IPV2 HD) in alignment with the Global Polio Eradication
Initiative (GPEI) and World Health Organization (WHO)’s strategic advisory group of experts
(SAGE) recommendation for the eradication of polio. The m-IPV2 HD vaccine contains 32 Dantigen (D-Ag) units of inactivated type 2 poliovirus, which is four times the current dose of type
2 polioviirus in the trivalent inactivated poliovirus vaccine (t-IPV). This high dose of antigen
should permit the one step immunization of children against type 2 polioviirus while avoiding
the safety issues associated with the attenuated type 2 poliovirus used in the oral poliovirus
vaccine (OPV).
Bulk virus was initially produced in monkey kidney cells and is now produced in Vero
cell line. Full nonclinical toxicology testing was performed on the trivalent polio vaccine.
Manufactured using bulk viruses produced in monkey kidney cells. Extensive clinical data were
also obtained for this formulation. When production of IPV was switched from sub cultured
monkey kidney cells to Vero cells, a limited number of preclinical and clinical studies were
conducted to compare the safety and the efficacy of IPV produced in Vero cells (IPV-Vero) to
the safety and the efficacy of IPV produced in subculture monkey kidney cells (IPV-MK). A
nonclinical toxicology study in rats showed no unexpected toxicological findings.
There are currently no clinical data with the m-IPV-HD. However, clinical studies
showed that t-IPV-Vero is a safe, well-tolerated vaccine that induces as effective immune
response similar to that of IPV-MK. The safety and effectiveness of IPV-Vero is further
supported by post-marketing surveillance bases on a 15-year follow-up of more than 90 million
IPV-Vero vaccine doses distributed worldwide in close to 60 countries.
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As per procedure in vogue the submitted trial was referred to three experts for expert
opinion to facilitate the decision making process by the Registration Board. The same is
summarized as under:
S.No.
Expert Name
Opinion
1.
Syed Sohail Zahoor
Zaidi, Chief Scientist
(Virology) Head of
Department of Virology
It is hereby informed that the subject study is well planned to
determine the improved effect of vaccination with combined
formulations i.e bivalent OPV + IPV vaccines to fill-in the
gaps in immunity type 2 polioviruses among Pakistani
Children.
The study will be conducted with the financial and technical
support of WHO Head Quarters, Geneva and does not pose
any apparent burden on the GoP/National or international stake
holders providing assistance for the Polio Eradication program
in the country.
I hope that the findings and outcomes of this interventional
study will improve our understanding and help to devise
progressive recommendations for vaccination to achieve the
goal of Polio eradication.
2.
Mr.Mazharullah
Memon,
Principal
Scientific
Officer/Manager
Quality
Control
Laboratory.
Dr. Haider Sherazi,
Neonatology,
PIMS,
Islamabad.
The five arms plan for End Game Polio Virus, the pattern of
dosing as described are suitable for the subject study and the
subject clinical trial is suggested in my opinion and there is no
financial burden on the Government of Pakistan.
3.
Comments are still awaited in spite of reminders
The institution has also requested for import of the following trial material to supplied by the WHO
through EPI:
Decision:
Drug Name
Quantity required
Inj IPV
1510 Doses
Inj IPV2
230 Doses
Registration Board discussed trial for its all prons and cons keeping in view
the prevalence of polio in the country. Dr.Abdur Rasheed, DDG (Pharmacovigilance)
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informed that Dr. Haider Sherazi has also given his expert views in favor of the trial.
However, after thorough deliberation the Board deferred the case for presentation by
Principal Investigator of the trial.
Case No.02. Phase III (b) Clinical Trial for use of Buprenorphine for treatment and
detoxification of injectable drug users in Pakistan.
Pakistan is signatory to the Millennium Development Goals (MDGs). Goal 6 state that
Pakistan will halt and begin to reverse the spread of HIV/AIDs Globally the most
recommendation intervention to halt the spread of HIV/AIDs infections among the group of
injectable drug users is Buprenorphine which is being used by the drug users for Detoxification,
treatment or at lease substitute the other injectable drugs with oral dosage form.
National AIDs Control Programme, Ministry of National Health Services, Regulation &
Coordination Islamabad has submitted a project proposal to the subject cited above. It is
hypothesized that Buprenorphine has challenges of misuse considering the non regulated
environment if produced and made available in higher doses.. Safety, as reflected by Adverse
Events (AEs) and severe Adverse Events (SAEs), withdrawal severity, stabilization dose and
treatment retention during the study will also be explored.
This is an open-label study, 1,000 (One Thousand) IDU’s seeking treatment for opiate
dependence will be enrolled in 5 centers across Pakistan. Participants are expected to be
predominantly males and non-pregnant and non-lactating females who are at least 18 years-ofage at the time of enrollment. Following screening, there will be a 28 day stabilization period on
Buprenorphine. All participants will be inducted onto the drug over a period of 3 days with doses
not to exceed 8mg on the first day, 12 mg on the second day and 16mg of third day. Until the end
of the third week doses may be adjusted in 4 or 8mg increments to a total dose of 8, 16, 24mg
based on clinical need, as judged by the treating physician/investigator. The duration of study
participation for each participant will be a maximum of approximately 6 months, including
screening, stabilization, tapering, post-tapering and follow-up, results from this study will add to
the knowledge bases of the clinical use of Buprenorphine in Pakistani population and provide
clinicians/regulatory bodies with data to guide the process of Buprenorphine treatment.
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Principal investigator has submitted ethical approval issued by the National Bioethics
Committee (NBC Pakistan) on 5.11.2014. The trial material is proposed to be arranged from two
following sources if approved by the Registration Board:-
Decision:
S.No Name of Firms
2mg tablets
8mg tablets
1.
M/s. Valor Pharmaceutical, Islamabad
1,80,000 tabs
1,80,000 tabs
2.
M/s. Wilshire Labs, Lahore
1,80,000 tabs
1,80,000 tabs
Dr.Basir Achakzai, Director National AIDS Control Programme and his
team presented in detail background of the case with special refrenece to Pakistan scenario.
The Board also discussed that internationally such therapies are available in combination
with Naloxone for patients admitted in hospital. After detailed deliberation, registration
Board deferred the case dor following:

National AIDs Control Programme will revise its protocol in line With International
Best Practices recommended / adopted for this purpose.

Pharmacy Services Division, DRAP will forward revised protocols to Narcotic
Control Division anf following expert for their views:
o Prof.Dr.Rizwan Taj, PIMS, Islamabad.
o Maj.Gen.Saleem Jehangeer, AFIMH, Pawalpindi.
o Prof.Dr.Ghulam Rasool, Quetta.
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Item No.IV
Matters referred for deliberation by Registration Board
a. Comments of Director Malaria Control, Islamabad regarding injectable antimalarial therapy.
Registration Board in 245th meeting discussed following comments of Director Malaria
Control, Islamabad.
“The matter has been discussed with the National Professional Officer, MCE, WHO Pakisan
and technical team of this Directorate. Due to emerging Artemisinin resistance in the South East
Asia, which also threatened Pakistan, because of uncontrolled / irrational use of parental
Artemisinin Monotherapy derivatives including Artemether in uncomplicated P. Falciparium
case and also in clinical Malaria cases by the unregulated Private Sector. During the recent 6th
Inter Country Meeting of National Malaria Control Managers held at Cairo, Egypt on 13th – 14th
August, 2014 WHO EMRO Region showed their serious concern on production of Artemisinin
monotherapy and injectable chloroquine in Pakistan. According to the approved National AntiMalaria Drug Policy only Injection Artesunate is recommended for confirmed severe
Falciparium Malaria cases in hospital settings and as pre-referral treatment in RHCs /BHUs.
Directorate of Malaria Control intends to convene a meeting with Drug Regulatory Authority of
Pakistan along-with other stake holders to share the views on emerging artemisinin resistance
and irrational use of antimalarial drugs in the country. It is also requested to halt further
registration Antimalarial Drugs”.
Registration Board in 245th meeting deferred all injectable anti-malarial drugs and invited
Director Malaria Control, Islamabad in forthcoming meeting for detailed discussion.
Discussion:
Dr.Aslam Khan Director Malaria Control Program and Dr.Qutub-ud-Din Kakar,
WHO National Professional Officer briefed the Board about irrational use of antimalarial drugs
in the country particularly injectable anti-malarial therapy and development of emerging
artemisinin resistance. Crux of the briefing is as follows:
a. Resistance to antimalarial drugs is the biggest challenge to malaria control in the country
resulting from “increased drug pressure” due to irrational use of antimalarial drugs
particularly the “monotherapies”.
Minutes246thMeetingRegistrationBoard
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b. Malaria is re-emerging due to “failure” of control interventions particularly the low coverage
of “effective treatment” and vector control.
c. Effective treatment is the “Foundation stone” of malaria control today which is dependent on
correct lab diagnosis and effective medicines. Effective treatment is the most effective tool to
reduce transmission potential due to reduction in parasite reservoir in human hosts.
d. Malaria Control programmes have been left with limited choices of treatment for confirmed
cases and there has been no development made in the development of new effective and safe
drugs in near future. This calls for rational and restricted use of available regimens where the
mainstay of treatment is Artemesinin Combination Therapies.
e. In Pakistan the positivity rate in suspected cases has been lower than 5% in highly endemic
areas and <1% in low endemic province of Punjab, treatment of malaria cases on clinical
grounds is mostly wrong in 98% of suspected cases, which is the major reason of misuse of
these drugs. No antimalarial drug should be dispensed in Pakistan without confirmatory test,
is the national policy and promotion of produced “anti-malarial” molecules by the industry
has led to the indiscriminate prescriptions by the untrained physicians, paramedics and
kwakes.
f. As per policy injectable quinine and Artesunate only can be sued in the treatment of
complicated and severe malaria cases, which are only seen in a fraction malaria cases due to
falciparum species only. The total estimated number of confirmed cased due to falciparum
malaria in the country are not >200,000 cases and the number of true severe malaria cases
will not be more than 20,000 warranting treatment with injectable quinine and Artesunate.
g. Treatment of severe cases of malaria is a medical emergency requiring intravenous
medication with above mentioned drugs and can only be dealt in at Secondary or tertiary care
hospitals only.
h. Huge quantities of Artesunate injections have been provided by the Global Fund from WHO
Pre-Qualified manufacturer (Guillin Pharma) sufficient to cover all the country needs of
dealing with severe cases.
i. Resistance is rapidly developing against artemisinin group and within short time the care
delivery system will be unable to treat the complicated cases at hospitals.
Minutes246thMeetingRegistrationBoard
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Decision:
Registration Board appreciated the concern raised during the briefing. It
was then decided that Malaria Control Program will hold a consultative meeting of all the
stakeholders including DRAP, prescribers, provincial governments, pharmaceutical
manufacturers etc for framing recommendations on the matter.
b. Transfer of registered drugs.
Under Rule 27 of Drugs (Licensing, Registering & Advertisement) Rules 1976, a
certificate for registration is issued for a period of five years unless earlier suspended or
cancelled. As per practice in vogue, if a firm applies for transfer of registration, such cases are
transferred according to the following provisions incorporated in schedule F vide SRO
877(I)/2000 dated 09th December, 2000:An application for:(i)
transfer of registration from one importer or manufacturer to another,
(ii)
transfer from import to local manufacture,
(iii) import in bulk and repacking locally, and
(iv)
change of name of registered drug, shall be considered as for grant of a new
registration and shall be made as per rule 26(1).
Registration Board in its 240th meeting also approved the following SOPs to stream line
the transfer of registrations and delegated its powers to the Chairman Registration Board to
approve such cases:Transfer of registration:
i) With change in manufacturing site:
a.
Application with Form-5 and required fee as per relevant SRO.
b.
Copy of registration letter and renewal status.
c.
NOC for CRF clearance.
d.
Copy of approved section by Central Licensing Board.
e.
Copy of last inspection report.
f.
NOC from existing manufacturer / registration holder permitting for transfer of
product.
g.
Statement / undertaking that applicant do not have registration of same products.
If so, it has to apply for cancellation of product.
h.
Accelerated stability studies of 6 months with to conduct real time stability
studies up to assigned shelf life & report if any result falls outside shelf life
specifications with proposed action).
Minutes246thMeetingRegistrationBoard
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i.
Validated method of analysis, master formula and product development data
ii) Change in name / title of manufacturer (site of manufacturing remains the same)
a.
Application on Form-5 with required fee as per relevant SRO.
b.
Copy of registration letter and renewal status.
c.
NOC for CRF clearance.
d.
Approval of new name / title from CLB.
e.
Undertaking that the formulation, API source & Specifications, manufacturing
process, analytical test methods, release & shelf life specifications have not
changed.
However, schedule F was amended as per SRO 1117(I)/2012 dated 10th September, 2012
and above provisions defined for transfer of registration vide SRO 877(I)/2000 dated 09th
December, 2000 have been omitted now.
In view of above, directions /guidance of Registration Board is solicited to process cases
of transfer of registration of drugs.
Decision:
Registration Board deliberated on the matter and it was decided that
following procedure will be adopted for these cases.

Registration will be cancelled from name of existing registration holder. The
applicant will comply all requiremenrs for grant of registration and then
registration Board will decide the case for grant of registration keeping in view
safety, efficacy and quality parameters.

For imported drugs, Import Policy for Finished Drugs will be followed.

A reference will be sent to Cost & Pricing Division whether such cases for grant of
registration shall be considered at existing MRP or otherwise.

Cases will be divided into any of following category and requisite documents will be
as follows:
o Registration of drug for local manufacturing.
a. Application with Form-5 and required fee as per relevant SRO.
b. Copy of registration letter and renewal status.
c. NOC for CRF clearance.
d. Copy of approved section by Central Licensing Board.
e. Copy of last inspection report.
Minutes246thMeetingRegistrationBoard
Page19
f. NOC from existing manufacturer / registration holder permitting for cancellation
of product from its name and grant to new registration holder / manufacturer.
g. Statement / undertaking that applicant do not have registration of same products.
If so, it has to apply for cancellation of product.
o Registration of drug for import (Change of authorized agent in Pakistan only).
a. Application on Form 5A with required fee as per relevant SRO.
b. Copy of registration letter and last renewal status.
c. Notorized termination letter (original) from manufacturer for previous importer.
d. Notorized authority letter/sole agent letter (original) from manufacturer.
e. NOC from existing importer / registration holder permitting for cancellation of
product from its name and grant to new importer / registration holder.
o Registration of drug when title of firm has been changed by firm and approved
by Central Licensing Board (manufacturing site remains the same).
Registration Board discussed that in this case registration will not be cancelled from
previous name as there is no change in manufacturing site and only title of registration
holder has been changed. Thus case will be processed for change of title of the firm and
firm will submit following documents.
a. Application on Form-5 with required fee as per relevant SRO.
b. Copy of registration letter and renewal status.
c. NOC for CRF clearance.
d. Approval of new name / title from CLB.
e. Undertaking that the formulation, API source & Specifications, manufacturing
process, analytical test methods, release & shelf life specifications have not been
changed.
c. Re-registration of drugs.
Under Rule 27 of Drug (Licensing Registration and Advertising) rule, 1976, a certificate
of registration, shall unless earlier suspended or cancelled, be in force for a period of five
years from the date of registration of the drug and may thereafter be renewed for periods not
exceeding five years. Provided that an application for the renewal of registration shall not be
entertained unless it has been made within sixty days after the expiry of the registration and
when and application has been made as aforesaid the registration shall subject to the orders
passed on the application for renewal continue in force for the next period of five years.
Minutes246thMeetingRegistrationBoard
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Previously, in case a firm applies for re-registration of drug i.e after expiry of renewal
of registration of a drug, such cases were processed for re-registration on payment of full
registration fee and submission of form-5. Chairman Registration Board was authorized to
approve such cases on file.
Decision:
Registration Board advised stake holders (PPMA, Pharma Bureau and
PCDA) to forward their comments till 15.01.2015 for considerartion by Registration Board.
d. Registration of 10 Products per section for New Drug Manufacturing Licence/
Additional Section.
Registration Board in 245th meeting constituted following committee to review policy of
registration of 10 products per section to new manufacturers/ additional sections.
-
Prof. Muzamil Hassan Najmi, Member Registration Board
Mr. A Q Javed, Director QA, DRAP.
Mr. Arif Chowdhry, DDC Reg-I
The Committee forwarded following recommendations:

To achieve the standards as laid down in GMP, the present practice of granting
registrations of ten products in a section to the new licensees may be continued.

The operational status of the manufacturer may be assessed by a panel inspection after 60
days of commencement of manufacturing activity.

Subject to compliance of GMP, as determined by the inspection panel, another ten
products per section may be granted to the new licensees on priority.
Decision: Registration Board was informed that DRAP’s Policy Board has also
discussed and deferred instant matter for further deliberation. The Board decided that
above points will be forwarded to DRAP’s Policy Board as recommendation from
Registration Board.
Minutes246thMeetingRegistrationBoard
Page21
e. Non-Availability of finished drugs in country of origin.
Registration Board in 245th meeting discussed that in some cases, finished drug of a
manufacturing site is neither available / authorized for sale in country of origin / manufacture
nor approved by any of regulatory authority of USFDA, Australian TGA, Japan or EMA, but
applicant intend to import finished product from that site. The Board constituted following
committee to look into the matter keeping in view international practices in such cases and
frame its recommendations.
‐
‐
‐
Prof. Muzamil Hassan Najmi, Member Registration Board.
Mr. A Q Javed, Director QA & LT
Mrs. Sara Mahreen ADC, PEC
Mrs. Sara Mahreen could not join the committee due to her posting in DRAP, Lahore and
Mr.Ammad Zaka, ADC was assigned the task.
The Committee forwarded following recommendations:

If any such drug which is not available in country of origin and not approved by reference
regulatory authorities i.e., USFDA, Australian TGA, Japan or EMA, it may be considered
for registration or approval of post registration variation, provided:
o Its registration has not been cancelled / withdrawn by any ICH member countries,
which are considered SRA, for safetyreasons.
o There is no new toxicity data reported about the drug requiring re-evaluation of its
status.
o It is available in atleast threeSRAcountries as notified by International Conference
onHarmonization of Technical Requirements for Registration of Pharmaceuticals
for Human use (ICH) on www.ich.org.
Decision:
Registration Board advised stake holders (PPMA, Pharma Bureau and
PCDA) to forward their comments till 15.01.2015 to already constituted committee for
framing its recommendations for considerartion by Registration Board.
Minutes246thMeetingRegistrationBoard
Page22
f. Export of drugs with same brand name of different manufacturers
M/s Ambrosia Pharmaceuticals, Islamabad has informed that they have exported
following drug:Name of product
Util Capsule 40mg
(Esomeprazole)
Regn No. for M/s Regn No. for M/s
Ambrosia
in Ambrosia in Kingdom
Pakistan
of Combodia
046889
CAM 0279-10
Firm has submitted that they were surprise and shock that M/s Medisure Labs, Karachi
exporting their same molecule “Esomeprazole” with same brand name “Util” to Kingdom of
Combodia with printed same registration number granted to them in Cambodia. This kind of act
is not only hurting their marketing and market share and image in Kingdom of Combodia as their
product are more effective and superior quality but more importantly damaging the image of
DRAP. At this time their distributor in Combodia has refused to place any further orders or
accept shipments of above products till such time they receive letter from DRAP stating that
DRAP will cancel these EX registrations of M/s Medisure and also confirmed that this brand
name will not be issued to any other manufacturers / companies in Pakistan by DRAP for export
purposes in the future.
Decision:
Registration Board was informed that M/s Ambrosia Pharmaceuticals,
Islamabad has also submitted similar type of complaint against M/s English Pharma,
Lahore. Thus the Board decided to call these three manufacturers in forthcoming
Registration Board meeting with relevant record for presentation of their case.
g. Registration of generic Nilotinib
Advocate Mr. Kazim Hasan, Barrister-at-Law of M/s Novartis Pharma Limited has informed
that they have been instructed by Novartis to advise the Drug Registration Board of the DRAP
that the intellectual property rights to Nilotinib vests in Novartis globally. Nilotinib is a
breakthrough treatment of Lukemia and it has been developed by Novartis. M/s Novartis has
come to know that M/s Genix Pharma has applied for generic registration of Nilotinib under the
trade name Lukopenil. Being intellectual property rights to Nilotinib vests in Novartis globally a
generic Nilotinib would be a violation intellectual property rights.
Minutes246thMeetingRegistrationBoard
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Advocate Mr. Kazim Hasan has further submitted that such registration would also constitute
a sovereign breach, as Pakistan is a signatory to international treaties which guarantee protection
of intellectual property rights. He requested that application filed by Genix Pharma for generic
registration of a Novartis product may be rejected and Drug Registration Board should not even
entertain any application for generic registration Nilotinib under any trade name.
Decision:
Registration Board decided to forward instant letter to IPO, Pakistan for its
comments for consideration by the Board.
h.
Recommendation of Review committee.
Registration Board in 245th meeting considered following recommendations of review
committee and advised PPMA and Pharma Bureau to forward their comments for consideration
of Registration Board. Now both stake holders forwarded their comments on these
recommendations, as follows:

A.
PPMA:
Trimethyl Phologlucinol 80mg+Phloroglucinol 80mg.
i.
Products Containing Phloroglucinol are available in many countries of the world, including Italy,
France, Switzerland, Luxemburg, Belgium, China and South Korea where more than 42
Companies including Multinationals have market since many years.
ii.
In Italian health system, inclusion of Phloroglucinol as a fully reimbursed product is a further
guarantee of its efficacy and safety. In June , 2011 the transparency Committee of the Prestigious
HAS, France as recommended continued inclusion on the list of medicines refundable by national
health insurance and on the list of medicines approved for hospital uses in the indication of
“Symptomatic Treatment of Pain Related to Functional Disorder of the Gastrointestinal tract
including IBS and dosages given in the marketing authorization”.
iii.
The product containing this molecule in France has been in the market since very long and is one
of the highest used specialties in gynaecology. Today about 15 French and multinational
companies have marketed their brands in France only.
iv.
Also in Pakistan where this is the most used specialty for renal colic, biliary colic, abdominal
colics, IBS andfor the facilitation of labor, since almost 20 years with excellent safety and
efficacy.
v.
All the leading medical specialists of Pakistan in related fields confirm its usefulness and are
completely satisfied.
vi.
The clinical trials conducted within Pakistan have been included in International Literatures.
Volumes of data speak about its safety and efficacy.
Minutes246thMeetingRegistrationBoard
Page24
vii.
Phloroglucinol is well documented in well reputed medical reference books including Extra
pharmacopeia Martindale and Merck Index.
viii.
The molecule Phloroglucinol is not under any review by EMA (European Medicine Agency) and
FDA (Food and Drug Authority of America).
ix.
Only authentic documents about the safety of a product in Europe are PSUR (Periodic Safety
Update Report), which confirms the safety of the product.
B. Omeprazole + Sodium Bicarbonate 20mg, 40mg.
i.
The product is safe for use to cure GERD. Authentic clinical trials/study attached to your
reference to use product for short term only (4 to 8 weeks) depending upon the patient health
severity. Minor side effects like hypokalemia, alkalosis and problem with acids base balance only
related with long term use. Companies already not recommended product for long term use.
ii.
Product is approved in USFDA and on under prescription.
C. Citicoline.
i.
Availability in Multiple Countries:
Citicoline is available in multiple European, North America and Asia Pacific Countries. It
highlights the wide spread usage of Citicoline as Nootropic and Neurotonic agent with
established efficacy and safety.
ii.
Evidence of Citicoline’s Mode of Action as Neuroprotective:
A study of International Society for Neurochemistry in Journal of Neurochemistry has established
Citicoline as an intermediate in the biosynthesis of phosphahatidylcholine which has beneficial
effects in number of CNS injury models and patholological conditions of brain.
iii.
Reference of Citicoline in Authentic & Reputable Journals:
a. British Medical Journal has highlighted Citicoline as more effective if given within 24 hours of
stroke than placebo while referring the study of clinical trial “Stroke Management” by Elizabeth
Warburton; Josef A Alawneh; Philip L Clatworthy; Rhiannon S Morris”.
b. Journal of the American Heart Association has highlighted beneficial therapeutic effect of the
long term treatment of Citicoline in acute cerebral infarction.
c. According to Clinical Interventions in Aging, a world renowned journal, Citicoline is effective
and well tolerated in patients with mild vascular cognitive impairment.
iv.
Citicoline Granted Novel Food Ingredient Status in EU
Minutes246thMeetingRegistrationBoard
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Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition
and Allergies (NDA) delivered a scientific opinion on Citicoline as a novel food ingredient (NFI),
which concluded on October 2013 that Citicoline is safe under the proposed use and use levels.
The Commission Implementing Decision 2014/423/EU on July 1, 2014 authorized Kyowa Hakko,
New York, NY, to market and manufacture Citicoline as a NFI under Regulation (EC) No 258/97 of
the European Parliament and of the Council.
v.
Huge prescription base in Pakistan
According to the latest “Sales” data, around 700,000 injections of 250mg whereas 1,000,000 tablets
have been selling in a year in Pakistan. It reflects strong confidence of leading neurologists and
neuro-surgeons in efficacy and safety of the product which leads to such a massive prescription base.
D. Diacerein.
i.
ii.
iii.
The molecule is registered with the European Medicines Agency.
The product is very effective for the treatment of Osteoarthritis Specially in advanced age
The product is available and authorized to be used in the European Union Including France.
E. Calcium Dobesilate.
i. The molecule is included in the European Pharmacopoeia.
ii. Molecule is registered and available in Switzerland (COPP available)
iii. Molecule is registered in more than sixty countries of the world and marketed in more than fifty
countries.
iv. The molecule has been registered and marketed since 1972 and available in European Union
since 1975.
F. Smectite.
i.
ii.
iii.
iv.
The molecule is available in France, Greek and USA.
The molecule is extremely useful in the treatment of Acute Diarrhea.
It is a time tested and important product for treatment of Dierrhea specially in children.
The molecule is available in the European Union including Switzerland, Germany, Austria, Italy,
Spain and countries of Eastern Europe as well as South America and South Anastasia.
v. It is an important molecule to prevent Hepatotoxicity.
G. Saccharomyces Boulardi.
i. Clinical efficacy has been established for chronic disease like Crohn disease, Ulcerative Colitis,
Irritable Bowel Syndrome, Parasitic infection & Human Immunodeficiency virus related
Diarrhea. An overdose of saccharomyces boulardii and long term use ae not likely to cause lifethreatening symptoms.
Minutes246thMeetingRegistrationBoard
Page26
ii. USFDA are withdrawing a notice of eligibility and recommendation of safety data for
consideration as OTC product and recommended product monograph for antidiarrheal drug..
iii. Product is already approved and recommended by TGA.
iv. In many of countries like in Vietnam, Product registered as drug and in Pakistan this product is
under price control and if product transfers to OTC division then market price might be change
and ultimately effect on patient.
H. Piracetam.
i. Availability in Multiple Countries:
Piracetam is available as “Central Stimulant” and “Nootropic Agent” in large number of countries
including multiple European, South America and Asia Pacific Countries. Among them the most
significant are Germany, France, Belgium, India, Malaysia, Turkey, Singapore etc.
ii. Authentic References:
Assay method given in “British Pharmacopoeia” highlighting the authenticity of the product.
Piracetam has been mentioned in “Martindale - The extra Pharmacopoeia” 36th Edit on with
mode of action and its therapeutic uses.
iii. Mode of Action:
‐
‐
Mode of Action of Piracetam is well-explained which highlights its beneficial influence on
neuronal and vascular functions. Further Piracetam also improves the function of neurotransmitter
acetylcholine.
iv. Wide-spread Usage of Piracetam by leading Neurologists & Neuro-Surgeons in Pakistan:
There are significant number of Piracetam users all around the Pakistan who are very much
satisfy with therapeutic results as Nootropic and Neurotonic Agent.
v. Huge Prescription Base in Pakistan:
According to the latest “Sales” data, around 400,000 syrups have been selling in a year in
Pakistan. It reflects strong confidence of leading neurologists and Neuro-surgeons in efficacy and
safety of the product which leads to such a massive prescription base.
I.
Thiocolchicoside.
i. Committee for Medicinal Products for Human use (CHMP) of the European medicines agency in
its assessment report no. EMA/40340/2014 dated 17th January, 2014 as made the following
conclusion.
a. Having considered all available data from pre-clinical studies, Pharmacoepidemiological studies,
published literature, post-marketing experience on the safety of thiocolchicoside containing
medicinal products for systemic use with regards to its genotoxicity, the Committee considered
Minutes246thMeetingRegistrationBoard
Page27
that thiocolchicoside containing medicinal products for systemic use remain an effective adjuvant
treatment of painful muscle contractures in acute spinal pathology.
b. However, having considered the risks, thiocolchicoside containing medicinal products for
systemic use should only be administered to patients over 16 years of age in acute conditions.
With treatment duration limited to 7 (oral) and 5 (IM) consecutive days. In that respect, the
CHMP was of the view that the indication in “Parkinson’s disease and drug-induced
Parkinsonism with special consideration to neurodyslectic syndrome” should be removed as this
is a chronic condition which requires longer treatment duration. The package size should be
adapted to new recommended treatment-days.
c. The committee considered also that thiocolchicoside containing medicinal products for systemic
use should be contraindicated during the entire pregnancy period. These products should also be
contraindicated in women of childbearing potential not using contraception and during lactation.
The CHMP also recommended further changes to the product information including information
on fertility.
d. The Committee as consequence concluded that the benefit-risk balance of thiocolchicoside
containing medicinal products for systemic use as adjuvant treatment of painful muscle
contractures acute spinal pathology in adults and adolescents from 16 years onwards remains
favorable, subject to the restrictions, warnings, other changes to the products information,
additional pharmacovigilance activities and risk minimization measures agreed.
ii. The molecule is available in France, Greece, Italy, Portugal, Malta, Spain, Hungary, Czech
Republic, India and many countries of the Fareast.
iii. The molecule has been in use in Europe since last more than 30 years.
J. Dry Powder Suspension of Famotidine.
Famotidine has many advantages in the Dry Powder form (reconstitute before use) as compared
to liquid suspension due to the following reasons.
i. International Availability of Dry Powder Suspension by the Innovator: Please see the
attached Annexure, I, which clearly shows that in USA, the research company Merck & Co is
manufacturing Famotidine in Dry Powder Suspension. We have attached Product information
available freely on internet for your perusal and record.
ii. Proof of availability of this formulation i.e. Dry Powder Suspension is attached as Annexure II –
IV, which shows that renowned companies such as Zydus Pharmaceutical USA, Paddock
Laboratories Inc., Minneapolis and Lupin Pharmaceuticals Inc., USA are manufacturing and
marketing their products in USA which is approved by USA FDA. We have attached the product
details downloaded from Internet.
iii. Pharmacopeial Monograph: For your kind record, please note that Dry Powder Suspension is
mentioned in the Monograph of Famotidine in USP (Please see Annexure - V ). It is mentioned in
Minutes246thMeetingRegistrationBoard
Page28
the monograph that total impurities in the Oral suspension should not be more than 2.0%. it is
very unlikely that Famotidine that is not stable in water could meet criteria of impurities of 2% if
provided in the form of liquid suspension.
iv. Comments on Stability: Famotidine stability in aqueous solution is temperature dependent,
therefore storage condition for Famotidine injection is recommended at 2-8oC(See Annexure VI).
Various studies are available in the literature which supports termal degradation of Famotidine in
Aqeouse Solution at room temperature (See Annesure VII), hence liquid suspension degrade at
room temperature.
v. Based on the above authentic references, it may be noted that Dry Powder Suspension is more
stable and is used within 30 days after reconstitution (USA product brief). Therefore this
formulation is the benchmark as marked by its researcher. Therefore liquid suspension at room
temperature is not stable and should be look into for patient safety.
K.
Silymarin
Silymarin is mentioned in more than one standards books like:
1) Martindale: The complete drug Reference, which is a comprehensive & reliable reference
source on drug & medicines used throughout the world.
2) U.S.P 34: Silymarin is prescribed in more than 50 countries of the world, we are enclosing
herewith reference of substantial internationally available brands.
S.No
Brand name
Manufacturing/Availability
1
Lagalon
Austria,Bahrain,Balgaria,China,Colombia,Georgia
Germany, Italy,Hungary,Mexico,Philippine, Poland,
Portugal,Romania,
South
Africa,
Spain,
Switzeland,Slovakia,Thailand, Venezuela.
2
Simepar
Switzerland
3
Cefasilymarin
Germany
4
Samarin 140
Thailand
5
Doindi
Vietnam
6
Silymarin Forte Romania
7
Silymarin Duo
Macedonia
8
Hepasil
Bangladesh
Minutes246thMeetingRegistrationBoard
Page29
9
Esimerin Plus
India
10
Good Liver
India
11
Heptosil 200ml
India
12
Livoriv-B
India
13
Livosil-B
India
14
Silyvit
India
15
Tezaliv
India
It is an important molecule used in various liver disorders. Various studies regarding
usage of Silymarin are available in different medical Journals.
Various manufacturers have also forwarded their comments on various formulations.
Recommendations of review committee considered by Registration Board in 245th meeting
are as follows:
S.
No
Drug Name
Generic (Brands)
Approv
al by
Internat
ional
Regulat
ory
Bodies
1.
Keto Injection
Yes
Minutes246thMeetingRegistrationBoard
Status in
Authentic
Textbooks
(Pharmacol
ogical basis
of
therapeutic
s-Goodman
& Gilman,
Basic &
Clinical
pharmacolo
gy-B G
Katzung,
Current
Medical
Diagnosis &
Treatment
– 2013)
Recommend
Research
published in
Reputed/
Authentic
Journals
Concluding
Remarks
&
Recommendation
Numerous
Ketamine
Page30
is
2.
Each vial contains:Ketamine HCl
 Ketamine 500 mg
(General Anesthetics)
FDA
EMA &
others
ed for use in
general
anesthesia.
chemically related to
phencyclidine
and
therefore
has
a
potential for abuse.
The drug is included in
the controlled list and
is placed in Schedule
III in USA.
In view of its useful
role in anesthesia,
Ketamine
is
recommended to be
retained
as
a
registered
drug.
However, it should be
dealt with narcotics
and
appropriate
restrictions may be
applied to prevent its
abuse.
Recommended
for
registration.
Fluoxetine + Olenzapine
Citrate
Each capsule contains:Fluoxetine HCl 25 mg
Olenzapine Citrate
 Olenzapine 12 mg
(Antidepressant)
FDA
only
The
Available
individual
drugs are
recommende
d but the
combination
has not been
mentioned.
Fluoxetine is an
SSRI
and
can
interact with MOAIs
to cause serotonin–
syndrome. Since it is
converted into a very
long
acting
metabolite,
the
interaction can occur
during 4 weeks after
cessation
of
Fluoxetine. The risk
of QT prolongation
and causing Torsade
de
pointes
also
exists.
The
Fixed-Dose
combination may
be allowed with
relevant
warning
and to be dispensed
on prescription by
qualified
psychiatrist only.
Minutes246thMeetingRegistrationBoard
Page31
3.
Each capsule contains:Omeprazole 20 mg
Sodium Bicarbonate 1100
mg
(Proton Pump Inhibiter)
Tentativ
e
approval
by FDA
only.
Not
approve
d by
EMA,
PMDA,
TGA
The
individual
drugs
are
recommende
d but the
combination
has not been
mentioned.
4.
Each capsule contains:Omeprazole 40 mg
Sodium Bicarbonate 1100
Tentativ
e
approval
The
No independent
individual
scientifically
drugs
are designed studies
Minutes246thMeetingRegistrationBoard
No independent
scientifically
designed studies
available
to
support
the
combination of
these two drugs.
Recommended for
registration.
Omeprazole, a PPI,
is a prodrug which
requires
acidic
environment
for
conversion
into
active form. It blocks
the H/K ATPase
irreversibly
and
reduces the gastric
acid secretion to very
low levels (most
potent among all
antisecretory
drugs).
Sodium bicarbonate
is a rapidly acting
systemic antacid. It
absorbs into blood
and long-term use
may cause systemic
alkalosis,
besides
other toxicity.
It is irrational to
combine the two
drugs as the antacid
may
impair
activation
of
Omeprazole. Further,
in the face of strong
acid-inhibiting effect
of Omeprazole, it is
superfluous
to
administer an antacid
on regular basis.
The
combination
adds to the cost and
increases
adverse
effects.
Not Recommended
for registration.
Omeprazole, a PPI,
is a prodrug which
requires
acidic
Page32
5.
mg
(Proton Pump Inhibiter)
by FDA
only.
Not
approve
d by
EMA,
PMDA,
TGA
U-Fit 10 mg Dry Suspension
Each 5ml contains:Famotidine 10 mg
(Antiulcer)
Famotidi NA
ne in dry
suspensi
on form
is not
approve
d by any
reputed
Minutes246thMeetingRegistrationBoard
recommende
d but the
combination
has not been
mentioned.
available
to
support
the
combination of
these two drugs.
NA
environment
for
conversion
into
active form. It blocks
the H/K ATPase
irreversibly
and
reduces the gastric
acid secretion to very
low levels (most
potent among all
antisecretory
drugs).
Sodium bicarbonate
is a rapidly acting
systemic antacid. It
absorbs into blood
and long-term use
may cause systemic
alkalosis,
besides
other toxicity.
It is irrational to
combine the two
drugs as the antacid
may
impair
activation
of
Omeprazole. Further,
in the face of strong
acid-inhibiting effect
of Omeprazole, it is
superfluous
to
administer an antacid
on regular basis.
The
combination
adds to the cost and
increases
adverse
effects.
Not Recommended
for registration.
Famotidine is widely
available in Tablet,
Capsule, Suspension,
Chewable
&
Dispersible
tablet
forms.
Dry
suspension does not
seem to offer any
Page33
internati
onal
agency
6.
Sacopan Sachets
Each sachet contains:Saccharomyces
Boulardii 250mg
(anti Diarrhoeal)
Not
approve
d by
FDA,
EMA,
PMDA
Approve
d by
TGA
only
7.
Ritocin-B Dry Suspension
200 mg
Each 5ml contains:Erythromycin Ethyl
Succinate.
 Erythromycin 200mg
Bromhexine HCl 4mg
(Macrolide)
Not
approve
d by
FDA,
EMA,
TGA &
PMDA.
Minutes246thMeetingRegistrationBoard
advantage over the
existing formulations
and is not supported
by
international
market scenario.
Not Recommended
for registartion.
Erythromyci
n as single
drug
is
recommende
d by books
for
infections by
susceptible
organisms.
Bromhexine
is not even
mentioned.
Some
studies
about the role of
probiotics
in
IBS and CD
infection have
been published
but their role
requires more
elucidation.
The probiotics are in
evaluation stage and
their benefits in IBS,
Crohn’s disease, C.
difficle infection etc.
have
not
been
established.
In
immune-compromised
patients these may
cause life-threatening
infection. In most of
the countries these are
available as foodsupplements or OTCs.
Some of these are
already available as
additives
in
milk
formulas for infants.
May be de-registered
as drug and allowed
as food supplements.
Studies
have
been published
showing in vitro
effect
of
bromhexine as
mucolytic.
There is no
evidence
for
such action in
vivo after oral
administration.
Mucolytics
are
useful
in
management
of
COPD
after
administration
by
inhalation. Evidence
is lacking for any
benefit after oral
administration.
All
oral
formulations
containing
bromhexine
as
single drug or in
combination with
other drugs, are
recommended to be
Page34
8.
Spardix Tablets 100mg
Each tablet contains:Sparfloxacin 100 mg
(Anti-infective,
Fluoroquinolone)
Not
approve
d by
FDA,
EMA,
TGA &
PMDA.
Mentioned
as member
of
fluoroquinol
one group.
Studies
have
been published
showing activity
of sparfloxacin
against
Gram
positive
bacteria.
Reports
are
published
describing
potassium
channel
blocking
activity causing
QT prolongation
and
lifethreatening
torsade
de
pointes
arrhythmias.
9.
ES ZIN 20mg Tablets Each
tablet contains:Esomeprazole 20mg
Magnesium 700mg
Sodium Bicarbonate 20mg
Not
approve
d
by
FDA,
EMA,
TGA &
PMDA.
The
individual
drugs
are
recommende
d but the
combination
has not been
mentioned.
Not
The
approve individual
d
by drugs
are
FDA,
recommende
EMA,
d but the
TGA & combination
PMDA. has not been
mentioned.
Not
Not
approve mentioned
d
by in any
FDA,
standard
EMA,
textbook.
TGA &
PMDA.
No independent
scientifically
designed studies
available
to
support
the
combination of
these drugs.
10.
ES ZIN 40mg Tablets Each
tablet contains:Esomeprazole 40 mg
Magnesium 700 mg
Sodium Bicarbonate 40mg
11.
Calzob-500 Capsules
Each capsule contains:Calcium dobesilate 500mg
(Vasotherapeutics,
Coagulants, Haemostatics)
Minutes246thMeetingRegistrationBoard
No independent
scientifically
designed studies
available
to
support
the
combination of
these drugs.
The published
clinical
trials
have shown that
calcium
dobesilate does
not reduce the
occurrence
of
de-registered.
Several
of
the
Fluoroquinolones
have been reported
to
cause
QT
prolongation
and
cardiac arrhythmias.
The potential is
highest
for
Sparfloxacin.
In view of the
unfavorable
risk/benefit ratio,
the drug is not
recommended for
registration.
The comments given
above at No.3 also
hold good for this
preparation.
All
dosage
strengths
recommended for
de-registration.
The comments given
above at No.3 also
hold good for this
preparation.
All
dosage
strengths
recommended for
de-registration.
Calcium dobesilate
was developed for
prevention
of
diabetic retinopathy.
Theoretically
its
mechanism of action
(inhibition of aldose
Page35
diabetic
retinopathy
patients.
reductase
and
in reduction of capillary
permeability)
supports its use for
this
purpose.
However,
in
evidence-based
medicine, benefits of
this drug could not
be established.
Recommended for
de-registration.
12.
Ciprozan Tablets 1gm
Each film coated SR-tablet
contains:Ciprofloxacin ……… 1 gm
(Quinolone Antibiotic)
One Gm
SR
dosage
form not
approve
d by
FDA,
EMA,
TGA &
PMDA.
One
Gm
extendedrelease
tablet
mentioned
by B G
Katzung
The strength is
within
the
therapeutic
range of dose
described
in
published
studies.
13.
Diacin 50mg
Capsules Each capsule
contains:Diacerein 50mg
( Anti-Rheumatic )
Not
approved
by FDA,
TGA &
PMDA.
Approved
by EMA
for use in
epidermo
lysis
bullosa
Not
mentioned
in any
standard
textbook
Some in vitro
studies
on
chondrocytes
have
been
published.
Clinical
trials
have
reported
slight
but
statistically
significant
Minutes246thMeetingRegistrationBoard
The slow release
tablet of 1 Gm is not
in vogue but has
been described by
the
standard
textbook and lies
within
the
therapeutic range of
dose. The applicant
may be asked to
provide
full
justification for the
formulation, quoting
examples
of
countries
where
similar forms are
available.
Final decision may
be pended till point
of view of the
applicant
is
evaluated.
Diacerein is an antiinflammatory drug
acting by inhibition
of Interleukin-1beta.
It has been used in
osteoarthritis where
it may produce slight
improvement.
In
limited number of
countries where it is
Page36
only
14.
Swanliag 5 mg Tablet
Each tablet contains:Cyclobenzaprine 5mg
(Skeletal Muscle Relaxant)
Not
Mentioned
approved by BG
by EMA, Katzung
TGA &
PMDA.
5
mg
dosageform
discontin
ued
by
FDA.
superiority over available, it is being
placebo.
reviewed
and
withdrawn due to
hepatotoxicity.
In view of the
limited usefulness
and concerns of
toxicity, diacerein is
not recommended
for registration.
Studies
have Although 5 mg dosage
has
been
been published form
discontinued
by
FDA,
in
which
cyclobenzaprine but other dosage forms
was found to be contain higher doses
which
may
be
superior
to associated with more
placebo
and side effects. By virtue
equivalent
to of its non-addictive
other
nature It may be
spasmolytics.
superior
to
benzodiazepines.
In view of the
scientific evidence for
efficacy of the drug,
Cyclobenzaprine may
be retained as a
registered drug.
15.
Mepridone 20mg Capsules
Each capsule contains:Esomeprazole Magnesium
Trihydrate Pellets eq. to 
Esomeprazole 20 mg
Domperidone 30mg
(Proton Pump Inhibitor /
Anti-Dopaminergic)
16.
Each Sachet contains:Omeprazole 20 mg
Sodium Bicarbonate 1100
mg
Not
approve
d by
FDA,
EMA,
TGA &
PMDA
Besides
the
combination,
Domperidone as an
individual drug is not
approved by FDA. It
has been associated
with
cardiac
arrhythmias.
The
combination
is
irrational and carries
the risk of toxicity.
Recommended to
be de-registered.
Tentativ The
No independent Omeprazole, a PPI,
e
individual
scientifically
is a prodrug which
approval drugs
are designed studies requires
acidic
by FDA recommende available
to environment
for
Minutes246thMeetingRegistrationBoard
The
individual
drugs
are
recommende
d but the
combination
has not been
mentioned.
Studies on
individual drugs
are available but
not on this
combination.
Page37
17.
(Proton Pump Inhibiter)
only.
Not
approve
d by
EMA,
PMDA,
TGA
d but the support
the
combination combination of
has not been these two drugs.
mentioned.
Floronol Tablets
Each tablet contains:Phloroglucinol hydrate 80
mg Trimethyl
Phloroglucinol 80 mg (Anti
Spasmodic)
Not
approve
d by
FDA,
EMA,
TGA &
PMDA
Not
mentioned
by any
standard
textbook
Minutes246thMeetingRegistrationBoard
No scientifically
designed
clinical studies
are available. In
vitro
and
toxicological
studies
have
been published.
conversion
into
active form. It blocks
the H/K ATPase
irreversibly
and
reduces the gastric
acid secretion to very
low levels (most
potent among all
antisecretory
drugs).
Sodium bicarbonate
is a rapidly acting
systemic antacid. It
absorbs into blood
and long-term use
may cause systemic
alkalosis,
besides
other toxicity.
It is irrational to
combine the two
drugs as the antacid
may
impair
activation
of
Omeprazole. Further,
in the face of strong
acid-inhibiting effect
of Omeprazole, it is
superfluous
to
administer an antacid
on regular basis.
The
combination
adds to the cost and
increases
adverse
effects.
Not Recommended
for registration.
Phloroglucinol is a
synthetic
phenol
having
antispasmodic
properties. However
its use in medicine
has
remained
restricted due to
toxicity concerns. It
Page38
is mainly used in
explosive industry.
The adverse effects
reported by FDA
include neutropenia,
hepatotoxicity, renal
failure,
metabolic
acidosis,
hyperkalemia
and
allergic reactions.
In view of severely
unfavorable
benefit/risk ratio all
preparations
containing
phloroglucinol are
recommended to be
de-registered.
18.
EsmoDome 20 Tablets
Each tablet contains:Esomeprazole Magnesium
 Esomeprazole 20 mg
Domperidone Maleate
 Domperidone 30 mg
(Antiemetics &
Antinauseants)
Not
approve
d by
FDA,
EMA,
TGA &
PMDA
The
individual
drugs
are
recommende
d but the
combination
has not been
mentioned.
Studies on
individual drugs
are available but
not on this
combination.
19.
EsmoDome 40 Tablets Each
tablet contains:Esomeprazole as
Magnesium……..40mg
Domperidone Maleate
 Domperidone 30 mg
(Antiemetics &
Antinauseants)
Not
approve
d by
FDA,
EMA,
TGA &
PMDA
The
individual
drugs
are
recommende
d but the
combination
has not been
mentioned.
Studies on
individual drugs
are available but
not on this
combination.
Minutes246thMeetingRegistrationBoard
Besides
the
combination,
Domperidone as an
individual drug is not
approved by FDA. It
has been associated
with
cardiac
arrhythmias.
The
combination
is
irrational and carries
the risk of toxicity.
Recommended to
be de-registered.
Besides
the
combination,
Domperidone as an
individual drug is not
approved by FDA. It
has been associated
with
cardiac
arrhythmias.
The
combination
is
irrational and carries
the risk of toxicity.
Recommended to
be de-registered.
Page39
20.
Piram 1 gm Syrup
Each 5 ml contains:Piracetam 1g
(Psychostimulants,
Nootropic, Neurotonic)
Not
approve
d by
FDA,
EMA,
TGA &
PMDA
Not
mentioned
by any
standard
textbook
Scientifically
conducted
clinical studies
have not shown
any benefit of
piracetam.
Piracetam is used in
treatment
of
cognitive disorders
and myoclonus but
scientific evidence
for
efficacy
is
lacking. Side effects
including
anxiety,
insomnia, irritability,
headache, agitation,
nervousness, tremor,
and
hyperkinesia,
have been reported
with its use.
Not Recommended
for registration.
21.
Wincoline 250 mg Injection
Each 2ml ampoule
contains:- Citicoline
Sodium
 Citicholine 250 mg
(Nootropics & Neurotonic)
Not
approve
d by
FDA,
EMA,
TGA &
PMDA
Not
mentioned
by any
standard
textbook.
Efficacy has not
been established
in scientifically
conducted
clinical trials.
22.
Each film coated tablet
contains:- Citicoline
Sodium
 Citicholine 500 mg
(Nootropics and
Vasotherapeutic)
Not
approve
d by
FDA,
EMA,
TGA &
PMDA
Not
mentioned
by any
standard
textbook.
Efficacy has not
been established
in scientifically
conducted
clinical trials.
Citicoline is cytidine
diphosphate choline
which is said to
increase
dopaminergic
receptor density in
brain. It has been
used in cognitive and
some other disorders
on this basis but
evidence for efficacy
is lacking.
Not recommended
for registration.
Citicoline is cytidine
diphosphate choline
which is said to
increase
dopaminergic
receptor density in
brain. It has been
used in cognitive and
some other disorders
on this basis but
evidence for efficacy
is lacking.
Minutes246thMeetingRegistrationBoard
Page40
23.
Esso Forte Tablets Each
tablet contains:Naproxen USP 500 mg
Esomeprazole Magnesium
Trihydrate
 Esomeprazole 20mg
( NSAID + PPI )
Delayed
release
tablets
are
approve
d by
FDA
and
TGA.
Not
approve
d by
EMA &
PMDA.
24.
Valex Talets
Each film coated tablet
contains:- Phloroglucinol
hydrate 80 mg Trimethyl
Phloroglucinol 80 mg
(Gastrointestinal/Antispasm
odics)
Not
approve
d by
FDA,
EMA,
TGA &
PMDA
Minutes246thMeetingRegistrationBoard
This
particular
combination
is not
mentioned
but
combining
NSAIDs
with PPIs
and H2
blockers is
recommende
d in general
for
prevention
of
gastropathy.
Not
mentioned
by any
standard
textbook
Studies on this
particular
combination are
not found.
No scientifically
designed
clinical studies
are available. In
vitro
and
toxicological
studies
have
been published.
Not recommended
for registration.
It is rational to
combine
NSAIDs
with
PPIs
for
prevention
of
gastropathy. Both the
drugs
individually
are well established
in their respective
categories.
Recommended for
registration.
Phloroglucinol is a
synthetic
phenol
having
antispasmodic
properties. However
its use in medicine
has
remained
restricted due to
toxicity concerns. It
is mainly used in
explosive industry.
The adverse effects
reported by FDA
include neutropenia,
hepatotoxicity, renal
failure,
metabolic
acidosis,
hyperkalemia
and
allergic reactions.
In view of severely
unfavorable
benefit/risk ratio all
preparations
containing
phloroglucinol are
Recommended to
Page41
be de-registered.
Besides
the
combination,
Domperidone as an
individual drug is not
approved by FDA. It
has been associated
with
cardiac
arrhythmias.
The
combination
is
irrational and carries
the risk of toxicity.
Recommended to
be de-registered.
25.
S.OM-D 30mg Capsules
Each capsule contains:Esomeprazole Enteric
Coated Pellets eq.
 Esomeprazole 40 mg
Domperidone 30mg
(Proton Pump Inhibitor /
antiemetic)
Not
approve
d by
FDA,
EMA,
TGA &
PMDA
The
individual
drugs
are
recommende
d but the
combination
has not been
mentioned.
Studies on
individual drugs
are available but
not on this
combination.
26.
Thicol 4mg Capsules
Each capsule contains:Thiocolchicoside……..4 mg
(Muscle Relaxant)
Not
approve
d by
FDA,
EMA &
TGA
Not
mentioned
by any
standard
textbook.
No reference
found in
authentic
journals
Thiocolchicosideis a
muscle relaxant with
anti-inflammatory and
analgesic effects. It
acts as a competitive
GABAA
receptor
antagonist and also
glycine
receptor
antagonist. A variety
of adverse effects have
been reported with this
drug. Particularly of
concern are its ability
to cause seizures and
potential to cause
tratogenecity and male
infertility.
Not recommended for
registration.
27.
Darcin ER 15mg Tablets
Each extended release tablet
contains:Darifenacin 15 mg
(Anti-Cholinergic)
Approve
d by
EMA &
TGA.
Tentativ
e
approval
Recommend
ed for use in
genitourinary
disorders.
Available.
Darifenacin is a M 3
selective
antimuscarinic drug
used for control of
urinary incontinence
in
adults.
A
congener, solifenacin
Minutes246thMeetingRegistrationBoard
Page42
granted
by FDA.
28.
Darcin ER 7.5mg Tablets
Each extended release tablet
contains:Darifenacin ………. 7.5mg
(Anti-Cholinergic)
Approve
d by
EMA &
TGA.
Tentativ
e
approval
granted
by FDA.
Recommend
ed for use in
genitourinary
disorders.
Available.
29.
CarionJect 500mg Injection
Each 10 ml injection
contains:- Iron Ferric
Carboxymaltose
 Iron Element 500mg
(Haematinic)
Approved
by FDA
(750mg/1
5 ml) &
TGA
(500mg/1
0ml)
This
particular
preparation
not
mentioned.
Few but
available.
30.
C-Zyme Tablet
Each tablet contains:Metoclopramide HCl 6mg
Sodium dehydrocholate 20
mg Bromelain 35000 PU
Pancreatin 210 FIPPU
Simethicone 50 mg
Not
approve
d by
FDA,
EMA,
TGA &
PMDA.
Not
mentioned
by any
standard
textbook.
No reference
found in
authentic
journals.
31.
Carolate Injection
Each 1ml ampoule
contains:- Glycopyrrolate
0.5 mg Neostigmine
methylsulphate 2.5mg
Not
approve
d by
FDA,
EMA,
TGA &
PMDA.
This
Available
particular
combination
is not
mentioned
but use of
atropine-like
drugs to
counter the
muscarinic
effects of
anticholinest
erases is
recommende
d.
Minutes246thMeetingRegistrationBoard
is already registered.
Recommended for
registration.
Darifenacin is a M 3
selective
antimuscarinic drug
used for control of
urinary incontinence
in
adults.
A
congener, solifenacin
is already registered.
Recommended for
registration.
It is a new parenteral
form
of
iron.
Comparable to the
existing formulations
in efficacy and safety
profiles.
Recommended for
registration.
A
completely
irrational
combination
containing
drugs
whose efficacy is not
established.
Not recommended
for registration.
Neostigmine
is
generally used to
reverse
muscle
paralysis induced by
curare-like
drugs
during
anesthesia.
This action is exerted
on
nicotinic
receptors but
is
accompanied
with
unwanted muscarinic
stimulation. This is
countered
by
administration
of
antimuscarinic drugs
like glycopyrrolate.
Page43
Recommended for
registration.
32.
Isotretinoin Cap/
Isotretinoin Tablet
Recdommen
ded for
severe acne
and certain
malignant
disorders.
Available
33.
Amoxicillin + Sulbactum
The general
principal for
combining
penicillins
with beta
lacatmase
inhibitors is
described.
34.
Silymarin
It is rational to
combine penicillin
with beta lactamase
inhibitors
but
Amoxicillin
is
generally combined
with
clavulanate.
The manufacturers
may be asked to
provide reasons for
using
sulbactam
along with references
in the favor of this
combination.
May be deferred for
the time being.
No scientifically Silymarin is a dried
designed studies extract obtained from
available in
Milk thistle plant.
authentic
Efficacy in hepatic
journals.
disorders has not
been
proved
in
authentic
clinical
trials.
Adverse
effects have been
reported in patients
Not
approve
d by
FDA,
EMA,
TGA &
PMDA.
Minutes246thMeetingRegistrationBoard
Not
mentioned
by any
standard
textbook.
Isotretinoin is 13-cis
retinoic acid. It is used
in treatment of cystic
acne, squamous cell
carcinoma of skin and
certain
other
malignancies. In view
of
its
established
efficacy, the drug is
recommended to be
retained.
Any issues related to
dosage
form/formulation
may be resolved after
obtaining view point
of manufacturers.
Page44
35.
Aescin
Not
approve
d by
FDA,
EMA,
TGA &
PMDA.
Not
mentioned
by any
standard
textbook.
36.
Solcoseryl
Not
approve
d by
FDA,
EMA,
TGA &
PMDA.
Not
mentioned
by any
standard
textbook.
37.
Serratiopeptidase
Not
approve
d by
FDA,
EMA,
TGA &
PMDA.
Not
mentioned
by any
standard
textbook.
Minutes246thMeetingRegistrationBoard
using milk thistle
capsules.
Not recommended
for registration.
No scientifically Aescin is a mixture
designed studies of saponins present
available in
in horse chestnut
authentic
plant. It is claimed to
journals.
have
anti
inflammatory
and
vasoprotective
effects but this has
not been proved in
scientifically
designed
clinical
studies
Not recommended
for registration.
No scientifically
designed studies
available in
authentic
journals.
Solcoseryl
is
deproteinated blood
of calves. It has been
used in a variety of
formulations
for
various purposes but
scientific evidence
for
efficacy
is
lacking.
Not
recommended for
registration.
No scientifically Serratiopeptidase is a
designed studies proteolytic enzyme
available in
present in silkworm
authentic
gut which helps it to
journals.
dissolve the cocoon.
It has been used as
an anti-inflammatory
agent without any
scientific evidence of
efficacy.Takeda
Pharmaceuticals, the
brand
leader
Japanese company,
had
agreed
for
voluntary withdrawal
Page45
from market in 2011.
Not recommended
for registration.
38.
Smectite
Decision:
Not
mentioned
by any
standard
textbook.
No clinical
studies available
to support
efficacy.
Smectite is mineral
clay
having
adsorbent properties.
It is similar to kaolin
in its medicinal
value.
Not recommended
for registration.
Keeping in view recommendations of Review Committee and comments of
stake holders, Registration Board decided as follows:

Following formulations will be considered for registration by Registration Board
and thus the Board advised P E & R Division to place all deferred cases in agenda of
the meeting.
i.
ii.
iii.
iv.
v.
vi.
vii.

Ampoule (1ml) containing Glycopyrrolate 0.5 mg Neostigmine + methylsulphate
2.5mg
Injection (10 ml) containing Iron Ferric Carboxymaltose  Iron Element 500mg.
Extended release tablet containing Darifenacin 7.5mg, 15mg.
Tablet containing Naproxen USP 500 mg + Esomeprazole Magnesium Trihydrate 
Esomeprazole 20mg.
Tablet containing Cyclobenzaprine 5mg.
Capsule containing Fluoxetine HCl 25 mg + Olenzapine Citrate  Olenzapine 12
mg.
Injection containing Ketamine HCl  Ketamine 500 mg
Registration Board discussed comments of stakeholders for following formulations
and decided that Review Committee will review these comments for framing its final
recommendation. The Board also advised the committee to take assistance of any
expert (if required) and can also call any stakeholder for their views. These
formulations are as follows:
viii.
ix.
x.
xi.
xii.
Trimethyl Phologlucinol 80mg+Phloroglucinol 80mg.
Omeprazole + Sodium Bicarbonate 20mg+1100mg, 40mg+1100mg.
Citicoline.
Diacerein.
Calcium Dobesilate.
Minutes246thMeetingRegistrationBoard
Page46
xiii.
xiv.
xv.
xvi.
xvii.
xviii.

Smectite.
Saccharomyces Boulardi.
Piracetam.
Thiocolchicoside.
Dry Powder Suspension of Famotidine.
Silymarin
Keeping in view recommendations of Review Committee, Registration Board
decided to proceed further for cancellation of registration as per procedure laid
down in Drugs (L R & A) Rules, 1976 of following items.
xix.
xx.
xxi.
xxii.
xxiii.
xxiv.
xxv.
xxvi.
xxvii.

Suspension containing Erythromycin Ethyl Succinate  Erythromycin 200mg +
Bromhexine HCl 4mg
Sparfloxacin 100mg
Tablets containing Esomeprazole 20mg + Magnesium 700mg + Sodium Bicarbonate 20mg
Tablets containing Esomeprazole 40mg + Magnesium 700mg + Sodium Bicarbonate 20mg
Capsule and tablet containing Esomeprazole 20mg, 40mg + Domperidone 30mg
Serratiopeptidase.
Solcoseryl
Aescin
Tablet containing Metoclopramide HCl 6mg + Sodium dehydrocholate 20 mg + Bromelain
35000 PU + Pancreatin 210 FIPPU + Simethicone 50 mg.
Registration Board advised Review Committee to finalize recommendation for
following formulations. The Board also advised the committee to take assistance of
any expert (if required) and can also call any stakeholder for their views. These
formulations are as follows:
xxviii.
xxix.
xxx.
Amoxicillin + Sulbactum
Isotretinoin Capsule/ Tablet
Film coated Sustained release containing 1 gm Ciprofloxacin
f.
Manufacturing requirement for various classes of drugs.
Registration Board in 245th meeting discussed manufacturing requirements for various
classes of drugs, and Chairman advised all members, PPMA and Pharma Bureau to forward their
scientific comments and relevant references on manufacturing requirements for following classes
of drugs:
-
Steroids.
Immunosuppresants.
Clomiphene and letrozole
Prostaglandins and its analogues.
Minutes246thMeetingRegistrationBoard
Page47
-
Storage requirement of Misoprostol
Vancomycin
Two members and PPMA has forwarded their comments on manufacturing requirements for
steroids, as follows:

Dr. Amanullah Khan (Director, DTL, Quetta).
For all steroidal preparations except topical preparations must have separate
manufacturing area, so it may be added that topical preparations may be manufactured in the
same approved area and exempted from separate area.

Lt General (R) Karamat Ahmed Karamat.
Reference to the Board meeting proceedings, all non-inflammatory steroids like
prednisolone, Dexamethasone are manufactured in the same general area on campaign basis.
Topical steroids like eye preparations/drops, otic drops, creams and ointments are manufactured
through wet process and should be allowed to manufacture across the board as everywhere in the
world. However, sensitive steroids which fall under category A like penicillin, cytotoxic
substances, Beta lactam and sex hormones may be considered to be manufactured in the
dedicated area.

PPMA.
Requirement by international regulatory agencies / cGMP
Internationally the dedicated facility is recommended for certain hormones, as evident from the
following:
Medicinal Control Agency U.K Requirements:
The Orange book published by Medicine Control Agency (MCA) of U.K in chapter 3 dealing
with premises and equipment, of guide to Good Manufacturing Practices for Medicinal Products,
under section 3.6 states requirements which are very close to section 5.2 of Pakistan drug rules.
“In order to minimize the risk of serious medical hazard due to cross contamination, dedicated
and self contained facilities must be available for the production of particular medicinal products,
such as highly sensitizing materials {e.g Penicillin} or biological preparations {e.g from live
microorganism}. The production of certain additional products, such as certain antibiotics,
Certain hormones, certain cytotoxics, certain highly active drugs and non medicinal products
Minutes246thMeetingRegistrationBoard
Page48
should not be conducted in the same facilities. For those products, in exceptional cases, the
principle of campaign working in the same facilities can be accepted provided that specific
precautions are taken and the necessary validation made. The manufacture of technical poisons,
such as pesticides and herbicides, should not be allowed in premises used for the manufacture of
medicinal products.
As can be observed that requirement is for certain hormones.
Canadian GMP:
11. Prevention of cross-contamination druring manufacturing is the responsibility of the
fabricator and packager. They must demonstrate that the premises are designed in such a manner
that the risk of cross-contamination between products is minimized.
11.1 In order to minimize the risk of a serious health hazard due to cross-contamination,
additional controls, including the need for self-contaiment, should be considered for particular
drugs such as:
-Certain hormones (e.q. estrogen)
-Certain cytotoxic drugs
-other highly active drugs
Factors to consider are the manufacturing process, use of closed systems, dedication of product
contact equipment parts, HVAC controls, engineering controls such as fail safe systems, coupled
with validation and ongoing monitoring using highly sensitive analytical methods.
11.2 Campaign production can be accepted where, on a product by product by basis,
proper justification is provided, validation conducted and rigorous, validated controls and
monitoring are in place and demonstrate the minimization of any risk of cross
contamination.
As can be observed tht requirment is for certain hormones, Specifically Canadian cGMP
refers to Estrogens, Further Canadian GMP allows campaign production provided validation
conducted.
Indian cGMP
Schedule M describing GMP & requirements of Premises Plant & equipment for pharmaceuitcal
product, under section 8.2 states as under:
The licensee shall ensure processing or sensitive drugs like Beta-Lactum antibiotics, Sex
hormones and cycotoxic substances in segregated areas or isoliated production areas within the
Minutes246thMeetingRegistrationBoard
Page49
building with independent air-handling unit and proper pressure differentials. The effective
segregation of these areas shall be demonstrated with adequate records of maintenance and
services.
As can be observed tht requirment is for certain hormones which are sex hormones.
Technical perspective
In order to exercise better control on Steroids, the PPMA Technial Committee members
observed that there should be clarity between the definition of “Anabolic Steroids” and
“Corticosteroids”.
References reveal that in human body, adrenal glands produce an anti-inflammatory steroid
similar to cortisone {corticosteroids}. Simulating human body secretion, synthetic Cortisone are
developed and prescribed to treat asthma, rashes, and various kinds of swelling or inflammation.
Whereas, another kind of steroids are calles anabolic steroids. The term anabolic means building
up of a bodily substance. Anabolic steroids are related to the major sex hormones, which are
produced in both men and women and their synthetic substitutes are uese as supporitve therapy.
Ref. Hormone Abuse Overview, http://www.hormone.org/Abuse/overview.com
Above references cleary state that all Steroids doesn’t fall under the category of “Highly
sensitizing materials”. Furhter, that the Steroids are classified as Corticosteroids (AntiInflammatory hormones) and Anabolic Steroids (Sex hormones) and later are requirmed to be
manufactured under special controlled conditions.
Based on above submissions, our recommendations are;
1. That all Steroids do not fall in the category of “Highly sensitizing materials”
2. Anabolic/Sex hormones e.q. Progesterone., Testosteron and Contraceptive hormone
needs special conditions for manufacturing.
3. Corticosteroids, Dexamethasone, Prednisolone and others are used as anti-inflammatory
drugs which are not included in the category of “highly sensitizing materials” as such
should be allowed tomanufacture in general purpose are exercising standard controls to
avoid cross contamination.
4. Since several companies have been granted license to manufracture sex hormones in their
existing facility, campaign manufacturing may be allowed if necessary precautions have
been taken and that future plans for seprate facility are in place.
Minutes246thMeetingRegistrationBoard
Page50

M/s Sante Pharmaceuticals, Karachi.
1. Drugs (Licensing, Registration & Advertisement) Rules 1976.
Dedicated Facility for production states that:
Schedule B- 5.2.
Dedicated and self -contained facilities for the production of particular drugs shell be provided in
addition to general facilities such as highly sensitizing materials ( e.g. penicillin) or biological
preparation (e.g. live microorganism) or cytotoxic substances or veterinary immunological preparations
or sterile products or for that matter such other highly active pharmaceutical products, antibiotics,
hormones as may be identified by the Central Licensing Board at any stage in order to minimize the risk
of serious medical hazard due to cross- contamination. In exceptional cases of emergency, the principal of
campaign working in the same facilities may be allowed by the Central Licensing Board provided that
specific precautions are taken and necessary validations are made.
2. In 195th Meeting of Central Licensing & Registration Board held on 24th Nov. 2005 a
presentation was made by PPMA and Pharma Bureau
 Item No.3.
Dedicated /Segregated Facilities for Particular Drugs : Detailed history of dedicated facilities was
discussed.
A team of Pharma Bureau and PPMA members presented their view about the matter of segregated
facilities for “Quinolones / Antibiotics (except Beta lactam antibiotics) and psychotropic / Narcotic drugs.
They explained that the dedicated facilities are required for highly sensitizing drugs e.g. Penicillin,
Cephalosporin, and Biological which fall under category A drugs.
 Decision of Registration Board:
It was decided that the permission to manufacture the Quinolone products will be allowed on the
basis of campaign manufacturing, subject to compliance to the GMP and cGMP regulation.
HVAC system and cleaning validation is mandatory.
3. EU guideline for GMP for Medicinal Products and Veterinary Use Part I Chapter
5:Production
Section 3.6: Production Area states that:
Dedicated facilities are required for manufacturing when a medicinal product present a risk;
a) Which cannot be adequately controlled by operational and/ technical measures.
b) Scientific data does not support threshold values ( e.g. allergic potential from highly sensitizing
materials such as beta lactam) or
c) Threshold values derived from toxicological evaluation are below the level of detection
4. GMP and requirements of Premises, Plant and Equipments of PHARMACEUTICAL
PRODUCTS
PART II-SECTION 3, SUB-SECTION (i)] - Ministry of Health -New Delhi- INDIA
Minutes246thMeetingRegistrationBoard
Page51
SCHEDULE M.

Production area.—
In order to avoid the risk of cross-contamination, separate dedicated and self contained facilities
shall be made available for the production of sensitive pharmaceutical products like penicillin or
biological preparations with live micro-organisms. Separate dedicated facilities shall be provided
for the manufacture of contamination causing and potent products such as Beta lactam, Sex
Hormones and Cytotoxic substances.
5. ICH guideline
“Self-contained facilities shall be made available for the production of highly
sensitive pharmaceutical products like penicillin or biological preparations with live microorganisms. Separate dedicated facilities shall be provided for the manufacture of
contamination causing and potent products such as Beta lactam, Sex Hormones and
Cytotoxic substances.”
6. Based on the current guidelines by EU Orange Guide, ICH, WHO, Indian GMP guidelines, Saudi
FDA and others;
“Dedicated facility is required for highly sensitive products like Beta lactam, Sex
Hormones, Cephalosporin and Cytotoxic products”
DEFINITION OF HORMONES
1. Different types of steroid hormones, a class of hormones chemically similar to each other, have
different functions. For example, the adrenal glands produce an anti-inflammatory steroid similar
to cortisone. Cortisone may be prescribed to treat asthma, rashes, and various kinds of swelling or
inflammation.
2. The term anabolic means building up of a bodily substance. Anabolic steroids are related to the
major male hormone testosterone, which is produced in the testes in men and in the adrenal
glands in both men and women. These chemicals are recognized for their effects on building up
muscle.
3. Anabolic steroids should not be confused with corticosteroids, which are used routinely as antiinflammatory medications to help treat illnesses in which inflammation is part of the disease
process.
4. Steroids include the dietary fat cholesterol, the sex hormones estradiol and testosterone, and the
anti-inflammatory drug Dexamethasone.
5. Steroid: One of a large group of chemical substances classified by a specific carbon structure.
Steroids include drugs used to relieve swelling and inflammation, such as Prednisone and
Cortisone.
IMPACT OF CROSS CONTAMINATION
There are certain categories of hormones
Minutes246thMeetingRegistrationBoard
Page52
1. Sex Hormones
Sex hormones comes under category A. In category A, Sex hormones like progesterone (female
sex hormone), testosterone (male sex hormone) contraceptive hormones (estrogens). They fall
under “Highly sensitizing materials” where cross contamination in very less quantity (microgram)
can cause risk of serious health hazard. The cross contamination of male sex hormone with in a
manufacturing process can produce changes in the secondary behavior in female like extra hair
growth, voice change etc. and vice versa female sex hormone cross contamination during
manufacturing operation can cause serious health hazard like diminishing of sexual desire,
enlargement of mammary glands etc. therefore in order to minimize the risk of serious health
hazard due to cross contamination addition control during manufacturing operation, used of
closed system, dedicated product contact equipment parts, HVAC control are necessary.
2. Anabolic Steroids
They also fall in category A and are those used for muscle building weight gain and weak
anabolic activities. Same principal followed during the manufacturing operation for cross
contamination.
3. Corticosteroids (Dexamethasone, Prednisolone & Hydrocortisone)
Corticosteroids should not be confused with sex hormones as they do not fall in category A of
highly sensitive materials and used in topical preparations as anti inflammatory drugs in Eye
preparation, Otic preparation and Eye / Skin Ointments. The cross contamination of
corticosteroids during the manufacturing operation can not impact the same health hazards as sex
hormones even in micro grams quantities hence no dedicated self contained facility is suggested
by international guideline agencies like Eur. ICH, and orange guide where they recommend use
of same facility with following instructions on campaign bases and cleaning validation.
RISK ASSESSMENT / ANALYSIS
MANUFACTURING OPERATION
OF
CROSS
CONTAMINATION
DURING
What is the risk involved in case a cross contamination of corticosteroids occur during the manufacturing
operation in spite of observing instructions and guidelines provided by the international agencies due to
certain negligence and improper supervision? The quantities of API (Active Pharmaceutical Ingredients
i.e. Dexamethasone, Prednisolone, Mometasone, Betamethasone, and Triamcenolone) is very minute i.e.
in 0.1%, 0.2% up to 0.5%. The entire manufacturing process is wet process, after the dispensing of API it
is transferred to glass jar under Laminar Air Flow hood in a diluent system comprising of HPMC / water
dispersion, then these glass jars with glass beads are placed on Ball Mill to get the desired particle size
finally blend was transferred to main bulk container in liquid form there is no less chances of dust
generation during the process. During the product change over a cleaning validation procedure is
followed by QC who only allows next batch processing after their approval.
There are two strong arguments in favor of using the same facility for steroid and non-steroid
preparations.
Minutes246thMeetingRegistrationBoard
Page53
1. If there is any risk of health hazard involved due to cross contamination of corticosteroids during
the manufacturing operation the international agencies like European Union (Orange Guide),
WHO and ICH will never recommend the same facility on campaign basis following the cleaning
validation method as in case of sex hormones because corticosteroids are not classified under the
highly sensitizing materials even the cross contamination of corticosteroids cannot impact any
bad health hazard.
2. Currently topical steroid containing preparations are produced in same facility (Non Steroids)
under toll manufacturing agreement for international brands like Allergan, Alcon, Bausch &
Lomb etc. and there audit for facility will also conducted by their corporate office under
international GMP guidelines, who allows them to manufacture steroids and non steroids in the
same facility. So far no adverse drug reaction was reported internationally and nationally which is
due to cross contamination.
CONCLUSION
1. All Steroids do not fall in the category of “Highly sensitizing materials”.
2. Sex hormones e.g. Progesterone, Testosterone and Contraceptive hormone may be classified in
category A.
3. Anabolic Steroids are those used for muscles building and used by weightlifters, wrestlers and
sportsmen may be classified in category A
4. Corticosteroids
(Dexamethasone,
Prednisolone,
Mometasone,
Betamethasone,
and
Triamcenolone) are used as anti-inflammatory drug and are not potent and highly sensitizing
materials.
 Corticosteroids do not fall in the category of highly sensitive materials and the companies
like Alcon, Allergan, Bausch & Lomb and many Local Companies are manufacturing eye
drops, ointments, creams etc. containing steroids like Dexamethasone, Prednisolone,
Mometasone, Betamethasone and Triamcenolone in the same facility with following the
instructions on campaign basis.
MANUFACTURING OF EYE DROPS, OINTMENT & CREAMS
 In eye drops the entire manufacturing method is wet process except dispensing of materials.
 The concentration of steroids in Topical and Tropical preparations
Ophthalmic Preparation is 0.1 to 0.2 %
Otic Preparations (Drops and Ointments) is 0.1 to 0.2%
 The steroids are dispensed in dispensing booth with laminar flow having strong extraction
system.
 These steroids are immediately transferred under laminar flow, into glass jars containing a
mixture of water and HPMC
 Tightly close Jars are placed on ball mill to reduce the particle size of steroids.
 Then ready slurry is transferred into bulk under laminar flow.
Minutes246thMeetingRegistrationBoard
Page54
Eye Drops, Eye Ointments, Otic Drops and Creams are being manufactured by local manufacturers
having Dexamethasone, Prednisolone, Hydrocortisone in the same manufacturing facility for the last
many years.
Decision:
Registration Board discuused comments of its members, stakeholders and
international practices and agreed that for all topical preparations viz. eye / ear preparations,
external preparations (cream / ointment / gel / lotion / spary) and aerosols, steroid
manufacturing may be permitted on campaign manufacturing basis in general manufacturing
areas for these dosage forms provided that manufacturer has segregated dispensing booths,
validation and controls studies for processes and adequate system to minimize any potential
risk of cross contamination. Registration Board decided to forward above recommendation to
Licensing Division for ultimate decision by Central Licensing Board.

Storage requirement of Misoprostol.
-
M/s Pfizer Pakistan, Karachi.
There is an obligation to maintain a temperature of -200C and has to kept in an air tight
container.
-
M/s Rasco Pharma, Lahore.
The firm has provided assessment report (EMA) of misoprostol API which is reproduced as
under:
Misoprostol, as described in the Ph.Eur., is an only liquid which is very unstable and
difficult to be process into a drug product in liquid form. The stability of misoprostol is
significantly enhanced when it is dispersed in hypromellose. Hence, misoprostol
dispersed in hypromellose is used as an intermediate in the manufacture of misoprostol
tablet. The dispersion consists of a powder that can be stored at 5+3 °C, whereas the
actual active substance is an oily liquid that needs to be stored at -20 °C.

The certificate of analysis of the misoprostol API of the firm shows that the product is
Misoprostol 1% HMPC dispersion (White to off-white powder) and it is to be stored at 28 °C.
Decision: Registration Board deliberated on the matter indetail and keeping in view
EMA’s assessment report decided that as per EMA,s report, Misoprostol 1% HMPC
(processed material) dispersion will be permitted for use in tablet dosage form with
storage condition of 5+3 °C.
Minutes246thMeetingRegistrationBoard
Page55
Chairman again advised all members, PPMA and Pharma Bureau to forward their
scientific comments and relevant references till 15.01.2015 on manufacturing requirements
for following classes of drugs:
a.
b.
c.
d.
Immunosuppresants.
Clomiphene and letrozole
Prostaglandins and its analogues.
Vancomycin
Minutes246thMeetingRegistrationBoard
Page56
Item No. V
Registration of drugs – Pharmaceutical Evaluation Cell.
Case No.01.
Correction in minutes M-245
S/N
Name
and
address
of
manufacturer
/ Applicant
1. Brand Name
2. Dosage Form
3. Composition
4. Pharmacological
group
1. Type of Form
2.
Type
of
application
3.
Demanded
Price / Pack size
4. Initial date,
diary. 5. Date on
which
fee
becomes
complete
according to type
of application /or
Form
1.
M/s. Ali Gohar
&
Company
(Pvt) Limited,
Karachi.
Manufacturer
M/s.
Boehringer
Ingelheim
Pharma GmbH
& Co. KG,
Located
in
Binger Strasse
173,
55216
Ingelheim am
Rhein,
Germany.
Jentadueto
2.5mg/850mg
Tablets
Each Film Coated
Tablets contains:Linagliptin…..2.5
mg
Metformin
Hydrochloride…….
850mg
(Drugs used in
Diabetes,
combination of oral
blood
glucose
lowering drugs).
Form 5 A
01-07-2013
Rs.50000/Rs. 7130/
Per packs of 60
Tablets.
1.Finished
Product
Specification
2.
Facility
where drug has
to
be
manufactured
with
status
whether
approved
by
CLB or not
3. Last GMP
inspection
report with date
& status.
International:
Jantadueto
2.5/850 (FDA)
Local: Me too
(M 243)
Decision in
245th
meeting of
the
Registration
Board
Correction
required by
the
applicant
Decision
Approved.
The
firm
applied for
packs
of
10’s & 30’s
as
under
just before
meeting of
Registratio
n
Board
that’s why
it
was
missed in
agenda &
minutes.
The Board
acceded to
the request
of the firm
with
approval of
following
price & pack
sizes.
Rs. 0.9 x 10
USD
for
10’s
Rs. 0.9 x 30
USD
for
30’s &
Rs. 7130/
Per packs of
60 Tablets.
1. Rs. 7130/
Per packs of
60 Tablets.
2. CIF price
for 10’s pack
size:
0.9 x 10 USD
for 10’s
3. CIF price
for 30’s pack
size:
0.9 x 30 USD
for 30’s
(Word CIF
as appeared
in
firm’s
request was
inadvertantl
Minutes246thMeetingRegistrationBoard
Page57
y missed for
10’s & 30’s
pack sizes).
2.
M/s. Ali Gohar
&
Company
(Pvt) Limited,
Karachi.
Manufacturer
M/s.
Boehringer
Ingelheim
Pharma GmbH
& Co. KG,
Located
in
Binger Strasse
173,
55216
Ingelheim am
Rhein,
Germany.
Jentadueto
2.5mg/1000mg
Tablets
Each Film Coated
Tablets contains:Linagliptin…..2.5
mg
Metformin
Hydrochloride…….
1000mg
Form 5 A
01-07-2013
Rs.50000/Rs.7130/
Per packs of 60
Tablets
(Drugs used in
Diabetes,
combination of oral
blood
glucose
lowering drugs).
International:
Jantadueto
2.5/1000 (FDA)
Local: Me too
(M 243)
Approved.
The
firm
applied for
packs
of
10’s & 30’s
as
under
just before
meeting of
Registratio
n
Board
that’s why
it
was
missed in
agenda &
minutes.
Rs. 0.9 x 10
USD
for
10’s
Rs. 0.9 x 30
USD
for
30’s &
Rs. 7130/
Per packs of
60 Tablets.
The Board
acceded to
the request
of the firm
with
approval of
following
price & pack
sizes.
1. Rs. 7130/
Per packs of
60 Tablets.
2. CIF price
for 10’s pack
size:
0.9 x 10 USD
for 10’s
3. CIF price
for 30’s pack
size:
0.9 x 30 USD
for 30’s
(Word CIF
as appeared
in
firm’s
request was
inadvertantl
y missed for
10’s & 30’s
pack sizes).
Minutes246thMeetingRegistrationBoard
Page58
S/N
Name
and Brand Name
address
of
manufacturer / (Proprietary
name + Dosage
Applicant
Form
+
Strength)
Composition
Pharmacological
Group
Finished
product
Specification
Type of Form
Initial
diary
Fee including
differential
fee
of Remarks on the Decision
formulation (if any)
including
International status
in stringent drug
regulatory agencies /
authorities.
Demanded
Price / Pack
size
3.
M/s. Medisearch
Pharmacal (Pvt)
ltd,
5-Km,
Raiwind Manga
Road, Lahore.
Molus
Dry Suspension
When
reconstituted
Each
5ml
contains:Montelukast
Sodium…..5mg
(anti-asthmatic)
(Manufacturer’s
Spec.s)
Form-5
4.
M/s Allmed Pvt.
Ltd.
(Formerly,
EverGreen
Pharmaceuticals,
Pvt.
Ltd.
Plot.No.590,
Sundar Industrial
Estate Lahore.
Reevo Tablets
Each
tablet
contains:
Levocarnitin……
………….250mg
(Aminoacid
derivative/suppli
ment)
Form5
Approved.
Letter will be
20-12issued
after
2013(1308)
rectification
Rs.20,000/of
shortcomings.
As
per (M-243)
SRO/60ml
06-08-2010
Rs.8000/11-10-2012
Rs.12,000/Rs.350/10’s
Minutes246thMeetingRegistrationBoard
Decision
Previous
date, Meeting
Deferred
for
confirmation of
pharmacologic
al group as
applied
by
firm.
(M-244)
The
Formulation
was
erroneously
approved by the
Drug Registration
Board.
This
Formulation
is
under review by the
Review Committee.
Deferred till
review
of
formulation
by Review
Committee.
Initially the Firm Deferred for
had applied for the
Levocarnitine……… following:
……250mg
per 1) Fee for
Tablet formulation on application
Form 5. Before the on Form 5D
formation
of
for 330 mg
Pharmaceutical
Tablet
Evaluation Cell some
strength.
Registration
applications
were 2) Evaluation
sent to various DRAP of Form 5D.
officers
for 3)
evaluation including Confirmation
this one. Agenda of of
these
applications pharmacolog
Page59
was prepared for M- ical group as
242 but could not be applied
by
discussed. Later on the firm.
the Firm submitted
Form 5-D for this
formulation
and
changed
the
formulation
to
Levocarnitine…330m
g mg per Tablet. The
left over agenda of
M-244 was discussed
in M-244 but the
change
was
not
incorporated.
The
Registration
Board
considered
the
formulation
as
Levocarnitine…250m
g per Tablet and
deffered it merely for
confirmation
of
pharmacological
group as applied by
firm.
Registration
Board may ask the
firm to submit the
firm
to
submit
differential
fee
required
for
application on Form
5-D and evaluate the
application
accordingly.
Minutes246thMeetingRegistrationBoard
Page60
Evaluator – III
Case No.02. Registration of a Patent Drug – Iodine Complex
M/s MTI Medical (Pvt) Limited Lahore has informed that they have developed Iodine complex
molecule in their Research & Development Laboratories and the said molecule has been awarded patent in
Pakistan. The firm submitted that they have conducted preclinical studies in UVAS (University of Veterinary
& Animal sciences, Lahore) and human studies in different teaching hospitals in Pakistan. Results of these
studies have been published in international and national journals which show that addition of iodine complex
with standard therapy of Hepatitis gives significant results.
S/N
Brand Name
(Proprietary name
Dosage
Form
Strength)
Composition
+
Group
+ Pharmacological
submitted by the firm)
Type of Form
(as Initial date, diary
Fee including differential fee
Finished product Specification
Demanded Price / Pack size
1.
IODIRIN
200mcg
Tablets Each tablet contains:
Iodine complex equivalent
elemental Iodine…….200mcg
Iodine
deficiency
Antithyroid
Form-5E
to
23-10-14 Dy. No: 1271
disorder/ 50,000/Not provided
2.
3.
IDOMARINE
50mg
RENESSANS
200mg
Manufacturer
Capsules Each capsule contains:
Iodine complex equivalent
elemental Iodine…….50mg
Form-5E
to
23-10-14 Dy. No: 1271
Iodine
deficiency
disorder/ 50,000/Antithyroid/ Immunomodulator
Not provided
Manufacturer
Form-5E
Capsule Each capsule contains:
Iodine complex equivalent to
23-10-14 Dy. No: 1271
elemental Iodine…….200mg
Antiviral/
Hepatic
Preps/ 50,000/Antithyroid/ Immunomodulator
Minutes246thMeetingRegistrationBoard
Page61
Not provided
4.
RENESSANS
Suspension 15mg/ 5ml
Manufacturer
Each 5ml contains:
Iodine complex equivalent
elemental Iodine…….15mg
Form-5E
to
23-10-14 Dy. No: 1271
Antiviral/
Hepatic
Preps/ 50,000/Antithyroid/ Immunomodulator
Not provided
Manufacturer
The firm has also claimed that the above mentioned molecule is a major breakthrough avoiding and
treating some deadly diseases and diseases due to iodine deficiency, therefore requested to register the drug on
fast track basis in public interest. In this regard, they have submitted registration applications on Form-5 E in
different dosage forms. Details of which are tabulated below.
2. The request of the firm has been evaluated / assessed by the cell. Prima facie the following
observations have been noticed:
a. The applicant has been granted patent for the said molecule named as “Iodine Complex” for cure
against Hepatitis C. Here, the question arises that whether patent is valid for purpose of getting
the registration for a patent drug or not.
b. The application has been filed on Form 5-E for the purpose of registration of a patent drug and
currently the Pharmaceutical Evaluation Cell has no approved check list for the said form. There
are many clauses of the said form wherein the applicant is unable to answer properly. Evaluation
reports clearly depicts the same.
c. The Safety & Efficacy aspects of the drug are important to be evaluated in the instant case (being
new molecule not else- where approved in the world). At present, the Cell for the said purpose
(especially in cases of new drug molecule), relies on the approvals by the Stringent or Reference
Drug Regulatory Agencies of the world like USFDA, EMA, TGA, Health Canada & PMDA
Japan etc. While the drug under discussion has no such approval from any of the drug regulatory
agency in the world.
5. In the light of the above observations, the case was handed over to Pharmacy Services Division, who has
taken up the case. The said Division has forwarded the submitted clinical trial data / research publication
of the applicant to the Executive Director of PMRC for the validity of the trials / research conducted.
Their reply is awaited. The case is therefore, placed for consideration before Registration Board.
Decision:
Dr. Muhammad Ajmal and his team appeared and presented before the Board
about development of above formulations and results of clinical trials conducted on the above
Minutes246thMeetingRegistrationBoard
Page62
formulations. Registration Board then directed the applicant to provide all the documents
related to development of formulations and their clinical studies for confirmation of safety and
efficacy Prof. Dr. Muzammil H.Najmi, Member Registration Board for further evaluation.
Recommendations / views the expert will be considered by the Board for further processing of
case.
Case No.03. Grant of registrations of newly approved DMLs (Drug Manufacturing Licenses).
Evaluator – II
S/N
Name
and Brand Name
Type of Form
address
of
manufacturer / (Proprietary name + Initial date, diary
Dosage
Form
+
Applicant
Fee
including
Strength)
differential fee
Composition
Demanded Price /
Pharmacological
Pack size
Group
Finished
Specification
1.
2.
M/s
Sigma
Pharma
International Pvt.
Limited
E-50,
N.W.I.Z.,
Port
Qasim Karachi
(Tablet General:
No. F.6-6/2014Lic (M-237 dated
17-10-2014)
-do-
Me-too status
GMP
status
as
depicted in latest
inspection
report
(with date) by the
Evaluator
product
Klar 250mg Tablet
Each film coated Tablet
contains:Clarithromycin(USP)…
250mg
(Macrolide Antibiotic)
(USP Spec,s)
Form 5
17-11-2014 (232)
Rs. 20,000/As Per SRO/
Pack 10’s
Klar 500mg Tablet
Each film coated Tablet
contains:Clarithromycin(USP)…
Form 5
17-11-2014(228)
Rs. 20,000/As Per SRO/
Minutes246thMeetingRegistrationBoard
Remarks on the Decision
formulation (if any)
including
International status
in stringent drug
regulatory agencies /
authorities
BNF: Klaricid
(Abbott Healthcare)
Approved
Claritek 250mg Tablet
Getz Pharma Pvt. Ltd.
Karachi
New Licensee
BNF: Klaricid
(Abbott Healthcare)
Approved
Claritek 250mg Tablet
Page63
500mg
(Macrolide Antibiotic)
(USP Spec,s)
3.
-do-
4.
-do-
Monti 10mg Tablet
Each film coated Tablet
contains:Montelukast Sodium as
Montelukast…10mg
(Bronchodilators
&
Anti-asthma
(Leukotriene
antagonist))
(Manufacturer’s Spec.s)
Cip 250mg Tablet
Each film coated Tablet
contains:-Ciprofloxacin
as
Ciprofloxacin
HCl…250mg
(Quinolones Antibiotic)
(B.P Spec,s)
Pack 10’s
Form 5
17-11-2014(229)
Rs. 20,000/As Per SRO/
Pack 14’s
Getz Pharma Pvt. Ltd.
Karachi
New Licensee
Singulair 10mg
Tablet of Merck & Co.
Inc. USA
Approved
Myteka 10mg Tablet
Hilton Pharma Pvt.
Ltd. Karachi
New Licensee
Form 5
17-11-2014(235)
Rs. 20,000/As Per SRO/
Pack 10’s
CIPROXIN
250mg Approved
Tablet Bayer Australia
Limited
GETCIPRO 250mg
Tablet Getz Pharma
(Pvt.) Ltd. Karachi
New Licensee
5.
-do-
Cip 500mg Tablet
Each film coated Tablet
contains:-Ciprofloxacin
as
Ciprofloxacin
HCl…500mg
(Quinolones Antibiotic)
(B.P Spec,s)
Form 5
17-11-2014
Rs. 20,000/As Per SRO/
Pack 10’s
CIPROXIN
500mg Approved
Tablet Bayer Australia
Limited
GETCIPRO 500mg
Tablet Getz Pharma
(Pvt.) Ltd. Karachi
New Licensee
6.
-do-
Levof 250mg Tablet
Each film coated Tablet
contains:Levofloxacin
(as
hemihydrate)…250mg
(Quinolones Antibiotic)
(USP Spec,s)
Form 5
17-11-2014(234)
Rs. 20,000/As Per SRO/
Pack 10’s
LEVAQUIN 250mg Approved
Tablet Janssen Pharma
USA
LEFLOX 250mg
Tablet Getz Pharma
(Pvt.) Ltd Karachi
New Licensee
7.
-do-
Levof DS 500mg Tablet Form 5
Each film coated Tablet 17-11-2014(233)
contains:Rs. 20,000/-
Minutes246thMeetingRegistrationBoard
LEVAQUIN 500mg Approved
Tablet Janssen Pharma
Page64
Levofloxacin
(as As Per SRO/
hemihydrate)…500mg
Pack 10’s
(Quinolones Antibiotic)
(USP Spec,s)
8.
-do-
9.
-do-
10.
11.
-do-
M/s
Sigma
Pharma
International Pvt.
Limited
E-50,
N.W.I.Z.,
Port
Qasim Karachi
(Capsule General:
No. F.6-6/2014-
Moxif 400mg Tablet
Each film coated Tablet
contains:Moxifloxacin
(as
Moxifloxacin
HCl)…400mg
(Quinolones Antibiotic)
(Manufacturer’s Spec.s)
Form 5
17-11-2014(237)
Rs. 20,000/As Per SRO/
Pack 5’s
Mecob 500mcg Tablet
Each
sugar
coated
Tablet contains:Mecobalamin
(JP)…500mcg
(Co-enzyme
Vitamin
B12)
(Manufacturer’s Spec.s)
Form 5
17-11-2014(230)
Rs. 20,000/As Per SRO/
Pack 20’s
50’s & 100’s
Trump
37.5/325mg
Tablet
Each film coated Tablet
contains:Tramadol HCl…37.5mg
Paracetamol…325mg
(Opiate
analogue/analgesic )
(USP Spec,s)
Form 5
17-11-2014(231)
Rs. 20,000/As Per SRO/
Pack 10’s
Coxib 200mg Capsule
Each Capsule Contains:Celecoxib…200mg
(Cox-2 Inhibitor)
(Manufacturer’s Spec.s)
Form 5
17-11-2014 (196)
Rs. 20,000/As Per SRO/
Pack 20’s
Minutes246thMeetingRegistrationBoard
USA
LEFLOX
500mg
Tablet Getz Pharma
(Pvt.) Ltd Karachi
New Licensee
VIGAMOX
400mg Approved
Tablet Alcon Lab,
USA
MOXIGET 400mg
Tablet Getz Pharma
(Pvt.) Ltd.
New Licensee
METHYCOBAL
500mcg Tablet Eisai
Co Ltd. JAPAN
Approved
METHYCOBAL
500mcg Tablet Hilton
Pharma (Pvt.) Ltd
Karachi
New Licensee
BNF: Tramacet
(Gru¨nenthal)
Approved
TONOFLEX Tablet
Sami Pharmaceuticals
Karachi
New Licensee
CELEBREX 200mg
Capsule of Pfizer
Laboratories USA
Approved
CELBEX 200mg
Capsule Getz Pharma
Pvt. Ltd. Karachi
New Licensee
Page65
Lic (M-237 dated
17-10-2014)
12.
-do-
Coxib 100mg Capsule
Each Capsule Contains:Celecoxib…100mg
(Cox-2 Inhibitor)
(Manufacturer’s Spec.s)
Form 5
18-11-2014(Nil)
Rs. 20,000/As Per SRO/
Pack 20’s
CELEBREX 100mg
Capsule of Pfizer
Laboratories USA
Approved
CELBEX 100mg
Capsule Getz Pharma
Pvt. Ltd. Karachi
New Licensee
13.
-do-
14.
-do-
Profile 20mg Capsule
Each Capsule Contains:Omeprazole
enteric
coated
Pellets 8.5%
equivalent
to
Omeprazole…20mg
(Source of Pellets:
M/s Titan Laboratories
Private Limited Plot No.
E27/1, E27/2, MIDC,
Mahad Village Jite
District, Raigad,
Maharashtra, India)
(Proton pump inhibitor)
(Manufacturer’s Spec.s)
Profile 40mg Capsule
Each Capsule Contains:Omeprazole
enteric
coated
Pellets 8.5%
equivalent
to
Omeprazole…40mg
(Source of Pellets:
M/s Titan Laboratories
Private Limited Plot No.
E27/1, E27/2, MIDC,
Mahad Village Jite
District, Raigad,
Minutes246thMeetingRegistrationBoard
Form 5
17-11-2014 (192)
Rs. 100,000/As Per SRO/
Pack 14’s
Form 5
17-11-2014(193)
Rs. 100,000/As Per SRO/
Pack 14’s
BNF:
(AstraZeneca)
Losec Approved. Firm
will
provide
legalized GMP
the
RISEK 20mg Capsule of
manufacturer
of
Getz Pharma (Pvt.)
pellets and then
Ltd
registration
letter will be
New Licensee
issued
after
approval
of
1. Original Legalized
Chairman, RB.
Copy of Valid
GMP certificate of
manufacturer of
Pellets is required.
BNF:
(AstraZeneca)
Losec Approved. Firm
will
provide
legalized GMP
the
RISEK 40mg Capsule of
manufacturer of
Getz Pharma (Pvt.)
pellets and then
Ltd
registration
letter will be
New Licensee
issued
after
of
1. Original Legalized approval
Chairman, RB.
Copy of Valid
GMP certificate of
Page66
Maharashtra, India)
(Proton pump inhibitor)
(Manufacturer’s Spec.s)
15.
-do-
16.
-do-
Somep 40mg Capsule
Each Capsule Contains:Esomeprazole
enteric
coated Pellets 22.50%
equivalent
to
Esomeprazole…40mg
(Source of Pellets:
M/s Titan Laboratories
Private Limited Plot No.
E27/1, E27/2, MIDC,
Mahad Village Jite
District,
Raigad,
Maharashtra, India)
(Proton pump inhibitor)
(Manufacturer’s Spec.s)
Somep 20mg Capsule
Each Capsule Contains:Esomeprazole
enteric
coated Pellets 22.50%
equivalent
to
Esomeprazole…20mg
(Source of Pellets:
M/s Titan Laboratories
Private Limited Plot No.
E27/1, E27/2, MIDC,
Mahad Village Jite
District,
Raigad,
Maharashtra, India)
(Proton pump inhibitor)
(Manufacturer’s Spec.s)
Minutes246thMeetingRegistrationBoard
manufacturer of
Pellets is required.
Form 5
17-11-2014(191)
Rs. 100,000/As Per SRO/
Pack 14’s
NEXIUM
40mg Approved. Firm
will
provide
Capsule AstraZeneca
legalized GMP
of
the
E-CAP 40mg
manufacturer of
Capsule Brookes
pellets and then
Pharmaceutical
registration
Laboratories
letter will be
issued
after
New Licensee
approval
of
1. Original Legalized Chairman, RB.
Copy of Valid
GMP certificate of
manufacturer of
Pellets is required.
Form 5
17-11-2014(190)
Rs. 100,000/As Per SRO/
Pack 14’s
NEXIUM
40mg Approved. Firm
will
provide
Capsule AstraZeneca
legalized GMP
of
the
E-CAP 40mg
manufacturer of
Capsule Brookes
pellets and then
Pharmaceutical
registration
Laboratories
letter will be
issued
after
New Licensee
approval
of
Chairman,
RB.
1. Original Legalized
Copy of Valid
GMP certificate of
manufacturer of
Pellets is required.
Page67
17.
-do-
18.
-do-
Zith 250mg Capsule
Each Capsule contains:Azithromycin
(as
Dihydrate)…250mg
(Macrolide Antibiotic)
(USP Spec,s)
Form 5
17-11-2014(194)
Rs. 20,000/As Per SRO/
Malrid Capsule
Form 5
17-11-2014(195)
Rs. 20,000/As Per SRO/
Pack 8's
Each Capsule contains:Dihydroartemisinin…
40mg
Piperaquine
Phosphate… 320mg
(Anti-Malarial)
(Manufacturer’s Spec.s)
19.
-do-
Tranex 500mg Capsule
Each Capsule contains:Tranexamic
Acid…500mg
(Haemostatic/
Fibrinolytic)
(Manufacturer’s Spec.s)
Minutes246thMeetingRegistrationBoard
Pack 6's & 10's
ZITHROMAX 250mg Approved
Capsule Pfizer
Laboratories
ZETRO 250mg
Capsule Getz Pharma
(Pvt.) Ltd.
New Licensee
Not confirmed
DIPIP 40/320mg
Capsule Hilton
Pharma (Pvt.) Ltd
Deferred
for
views
of
recommendation
s of WHO.
New Licensee
Form 5
17-11-2014(197)
Rs. 20,000/As Per SRO/
Pack 20's & 100's
1. Availability
in
SRA’s
not
confirmed. Firm
has
provided
international
availability
in
Italy.
Deferred
for
Not confirmed
confirmation of
formulation
/
XED 500mg Capsule
strength whether
Indus Pharma
approved
in
reference
New Licensee
Stringent
1. Availability
in Regulatory
Agencies or not.
SRA’s
not
confirmed. Firm
has
provided
international
availability
in
Bangladesh.
Page68
20.
-do-
Flucap 150mg Capsule
Each Capsule contains:Fluconazole …150mg
(Antifungal)
(Manufacturer’s Spec.s)
Form 5
17-11-2014(198)
Rs. 20,000/As Per SRO/
Pack 1's
CANESTEN 150mg Approved.
Capsule Bayer
Healthcare
FLUDERM 150mg
Capsule Nabiqasim
Industries (Pvt.) Ltd
New Licensee
21.
22.
M/s
Sigma
Pharma
International Pvt.
Limited
E-50,
N.W.I.Z.,
Port
Qasim Karachi
(Sachet General:
No. F.6-6/2014Lic (M-237 dated
17-10-2014)
-do-
23.
-do-
Onitum 2gm Sachet
Each Sachet contains:Strontium Ranelate… 2g
(Anti-osteoporotic)
(Manufacturer’s Spec.s)
Pack 7’s
PROTELOS
Sachet Approved.
Les
Laboratoires
Servier Industrie
ONITA Sachet
PharmEVO
New Licensee
Form 5
17-11-2014(218)
Each Sachet contains:Rs. 20,000/Montelukast
Sodium As Per SRO/
equivalent
to
Montelukast 4mg
Pack 14’s
(Bronchodilators
&
Anti-asthma
(Leukotriene antagonist)
(Manufacturer’s Spec.s)
Malrid 15/120mg Sachet Form 5
17-11-2014(206)
Each Sachet contains:Rs. 20,000/Dihydroartemisinin…
As Per SRO/
15mg
Piperaquine Phosphate Pack 16’s
…120mg
(Anti-Malarial)
(Manufacturer’s Spec.s)
Monti 4mg Sachet
Minutes246thMeetingRegistrationBoard
Form 5
17-11-2014(204)
Rs. 20,000/As Per SRO/
Singulair (MSD
Approved.
MONTIKA 4mg
Sachet Sami
Pharmaceutical (Pvt.)
Ltd
New Licensee
Not confirmed
ARMIQIN Sachet
PharmEVO
Deferred
for
views
of
recommendation
s of WHO.
New Licensee
1. Availability
in
SRA’s
not
confirmed. Firm
has
provided
international
availability
in
Taiwan
Page69
24.
-do-
25.
-do-
Citrosalt 4mg Sachet
Each Sachet contains:Sodium Bicarbonate…
1.716gm Sodium Citrate
Anhydrous… 0.613gm
Citric Acid
Anhydrous…0.702gm
Tartaric Acid…
0.856gm
(Antacids,
Antiflatulents)
(Manufacturer’s Spec.s)
Form 5
17-11-2014(217)
Rs. 20,000/As Per SRO/
Profile 20mg Sachet
Form 5
17-11-2014(206)
Rs. 20,000/As Per SRO/
Pack 20’s & 100’s
Each Sachet contains:Omeprazole… 20mg
Sodium Bicarbonate…
1680mg
(Proton
pump Pack 10’s
inhibitor/antacid)
(Manufacturer’s Spec.s)
26.
-do-
Profile 40mg Sachet
Form 5
17-11-2014(212)
Rs. 20,000/As Per SRO/
Each Sachet contains:Omeprazole… 40mg
Sodium
Bicarbonate
…1680mg
(Proton
pump Pack 10’s
inhibitor/antacid)
(Manufacturer’s Spec.s)
27.
-do-
ORES Sachet
Minutes246thMeetingRegistrationBoard
Form 5
17-11-2014(213)
Not confirmed
CITRO SODA Sachet
Abbott Laboratories,
Pakistan
New Licensee
Deferred
for
confirmation of
approval
in
reference
Stringent
Regulatory
Agencies.
1. Availability
in
SRA’s
not
confirmed. Firm
has
provided
international
availability
in
India.
Deferred
till
FDA: Zegerid
review
of
formulation
by
RISEK INSTA
Review
Powder 20mg Sachet
Committee.
Getz Pharma (Pvt.)
Ltd
New Licensee
1. Formulation
is
under review by
the
Review
Committee
of
DRB.
Deferred
till
FDA: Zegerid
review
of
formulation by
RISEK INSTA
Review
Powder 40mg Sachet
Committee.
Getz Pharma (Pvt.)
Ltd
New Licensee
1. Formulation
is
under review by
the
Review
Committee
of
DRB.
BNF:
Oral Approved.
Rehydration
Salts
Page70
Each Sachet contains:Rs. 20,000/Sodium Chloride… 2.6g As Per SRO/
Sodium Citrate…2.9g
Potassium Chloride…
Pack 20's
1.50g
Glucose Anhydrous…
13.50g
(Non-proprietary)
WHO Formulation
OEM Sachet Indus
Pharma Pvt. Ltd.
New Licensee
(Electrolytes)
(BP Spec,s)
28.
-do-
Cysteine Sachet
Each Sachet contains:Acetylcysteine …200mg
(Mucolytic Agent)
(Manufacturer’s Spec.s)
Form 5
17-11-2014 (210)
Rs. 20,000/As Per SRO/
Pack 30’s
Not confirmed (ACC Deferred
for
Sandoz Switzerland by confirmation of
approval
in
Firm)
reference
Stringent
MUCOLATOR
Regulatory
200mg Sachet Abbott
Agencies.
Laboratories
(Pakistan) Ltd
New Licensee
1. Availability
in
SRA’s
not
confirmed. Firm
has
provided
international
availability
in
Switzerland.
29.
-do-
Form 5
17-11-2014 (211)
Each Sachet contains:Rs. 20,000/Polyethylene
Glycol As Per SRO/
3350… 13.125g
Sodium
Chloride…
0.3507g
Pack 10’s
Sodium Bicarbonate…
0.1785g
Potassium
chloride…
0.0466g
(Laxatives)
(Manufacturer’s Spec’s)
Laxit Sachet
Minutes246thMeetingRegistrationBoard
Not confirmed
MOVCOL Sachet
Genix Pharma Private
Limited
Approved as it
is
BNF
approved
formulation
New Licensee
1. Availability
in
SRA’s
not
confirmed in same
strength.
Page71
30.
31.
-do-
M/s
Sigma
Pharma
International Pvt.
Limited
E-50,
N.W.I.Z.,
Port
Qasim Karachi
(Oral Dry Powder
Suspension
General: No. F.66/2014-Lic
(M237 dated 17-102014)
32.
-do-
33.
-do-
Gastolyte Sachet
Each Sachet contains:Rice Powder …6g
Sodium
Citrate
…0.580g
Sodium
Chloride
…0.350g
Potassium Chloride…
0.3g
(Electrolytes)
(Manufacturer’s Spec.s)
Klar 125mg/5ml Dry
Suspnsion
Each 5ml contains:Clarithromycin…125mg
(Macrolide Antibiotic)
(USP Spec.s)
{Source
of
Clarithromycin
taste
masked Granules:
M/s Surge Lab10th KM
Faisalabad
road
Sheikhupura}
Klar 250mg/5ml Dry
Suspnsion
Each 5ml contains:Clarithromycin…250mg
(Macrolide Antibiotic)
(USP Spec.s)
{Source
of
Clarithromycin
taste
masked Granules:
M/s Surge Lab10th KM
Faisalabad
road
Sheikhupura}
Fantin 15mg/90mg/5ml
Dry Suspnsion
Each 5ml contains:Artemether… 15mg
Lumefantrine… 90mg
(Antimalarial )
Minutes246thMeetingRegistrationBoard
Form 5
17-11-2014(216)
Rs. 20,000/As Per SRO/
BNF: Dioralyte Relief
(Sanofi-Aventis)
Pack
New Licensee
Approved.
GASTROLYTE
Sachet Sanofi-Aventis
Pakistan Limited
1 x 10’s
Form 5
17-11-2014(222)
Rs. 20,000/As Per SRO/
Pack 30ml & 60ml
BNF . Klaricid
(Abbott)
Approved
(Klaricid (Abbott))
New Licensee
Form 5
17-11-2014(223)
Rs. 20,000/As Per SRO/
Pack 60ml
Form 5
17-11-2014(225)
Rs. 20,000/As Per SRO/
Pack 15ml
BNF . Klaricid
(Abbott)
Approved
(Klaricid (Abbott))
New Licensee
Stability studies of
zone
IV-A
of
granules
Valid
GMP
certificate.
ATRENAM
Approved.
15/90mg/5ml
Dry
Suspension Areneco
Pharma Belgium
ARTHEGET
15/90mg/5ml Dry
Page72
(Manufacturer’s Spec.s)
30ml & 60ml
Suspension Getz
Pharma (Pvt.) Ltd.
Karachi
New Licensee
34.
-do-
35.
-do-
Fantin
DS
30mg/180mg/5ml
Dry Suspnsion
Each 5ml contains:Artemether… 30mg
Lumefantrine… 180mg
(Antimalarial )
(Manufacturer’s Spec.s)
Cip 250mg/5ml
Dry Suspnsion
Each 5ml contains:Ciprofloxacin
(as
Ciprofloxacin
HCl
Monohydrate) 250mg
( Quinolones Antibiotic
)
(Manufacturer’s Spec.s)
Form 5
17-11-2014(221)
Rs. 20,000/As Per SRO/
ATRENAM
Approved.
30/180mg/5ml
Dry
Suspension Areneco
Pharma
Pack 30ml & 60ml
Belgium ARTHEGET
30/180mg/5ml Dry
Suspension Getz
Pharma (Pvt.) Ltd.
Karachi
Form 5
17-11-2014(220)
Rs. 20,000/As Per SRO/
Pack 60ml
New Licensee
CIPROXIN
(Formulation
different)
till
Bayer Deferred
of
is review
formulation by
Review
HIFLOX Hilton
Committee
Pharma (Pvt.) Ltd
Karachi
New Licensee
1. Formualtion is
under review by
the
Review
Committee
of
DRB.
36.
-do-
37.
-do-
Zith 200mg/5ml
Dry Suspnsion
Each 5ml contains:Azithromycin
(as
Azithromycin
Dihydrate)…200mg
(Macrolide Antibiotic )
(USP Spec.s)
Form 5
17-11-2014(224)
Rs. 20,000/As Per SRO/
Eryt 200mg/5ml
Dry Suspnsion
Form 5
17-11-2014(225)
Minutes246thMeetingRegistrationBoard
BNF:
(Pfizer)
Zithromax Approved.
ZETRO Getz Pharma
(Pvt.) Ltd Karachi.
Pack 15ml, 22.5ml, New Licensee
25ml, 30ml, &
60ml
Not confirmed
ERYTHROCIN Indus
Deferred
for
confirmation of
Page73
Rs. 20,000/Each 5ml contains:- As Per SRO/
Erythromycin
Ethyl
succinate Monohydrate Pack 60ml
equivalent
to
Erythromycin… 200mg
( Macrolide Antibiotic
)
(USP Spec.s)
38.
-do-
Fosil 250mg/5ml
Dry Suspnsion
Each 5ml contains:Fosfomycin
(as
Fosfomycin
Calcium)…250mg
(Anti Bacterial Agent )
(Manufacturer’s Spec.s)
Form 5
17-11-2014 (219)
Rs. 20,000/As Per SRO/
Pack 60ml
Pharma Karachi.
formulation
approval
New Licensee
reference
Stringent
1. Availability
in Regulatory
same strength in Agencies
SRA’s
not
confirmed. Firm
has
provided
international
availability
in
Jordan.
Deferred
FOSFOCINA
Laboratories
ERN, confirmation
formulation
Spain
approval
MIFOS 250mg/5ml
reference
Dry Suspension
Stringent
Remington Pharma
Regulatory
Lahore
Agencies
New Licensee
1. Availability
39.
-do-
40.
-do-
Flucap 50mg/5ml
Dry Suspnsion
Each 5ml contains:Fluconazole…50mg
(Antifungal)
(USP Spec.s)
Linz 100mg/5ml
Dry Suspnsion
Minutes246thMeetingRegistrationBoard
Form 5
17-11-2014(227)
Rs. 20,000/As Per SRO/
Pack 35ml
Form 5
20-11-2014(Nil)
Rs. 20,000/-
in
same strength in
SRA’s
not
confirmed. Firm
has
provided
international
availability
in
Spain.
BNF: Diflucan
Approved.
(Pfizer)
FLUCANOL
50mg/5ml Dry
Suspension Rock
Pharma Nawshehra
New Licensee
BNF:
Zyvox(Pharmacia)
Approved.
Page74
in
for
of
in
Each 5ml contains:- As Per SRO/
Linezolid 100mg
(Antibacterial )
Pack 60ml
(Manufacturer’s Spec.s)
NEZOCIN
100mg/5ml Dry
Suspension Brookes
Pharma (Private)
Limited
New Licensee
Minutes246thMeetingRegistrationBoard
Page75
Evaluator – III
Type of Form
S/N Name
and Brand Name
name
+
address
of (Proprietary
Initial
date,
manufacturer Dosage Form + Strength)
diary
/ Applicant
Composition
Fee
including
differential fee
Pharmacological Group
Finished
Specification
41.
M/s
MTI
Medical (Pvt)
Limited, 586587
Sunder
Industrial
Estate,
Raiwind Road
Lahore.
(Tablet
General)
42.
-do-
Remarks on the Recommendations
formulation (if any) by the Evaluator
including
International status
in stringent drug
regulatory agencies /
authorities
product Demanded Price Me-too status
/ Pack size
GMP
status
as
depicted in latest
inspection
report
(with date) by the
Evaluator
Levaquin Tablet of Approved.
Janssen
Pharms
Each film coated tablet Dy No: 1258 (USFDA)
dated 20-10-2014
contains:
Leflox
of
Getz
Levofloxacin
as
Karachi.
20,000/hemihydarte…..250mg
LOFAMIN Tablet 250mg
Form-5
As per SRO/ The CLB in its 236th
Pack of 10’s
meeting approved the
Manufacture
grant of DML by the
way of formulation
with sections namely:
a. Oral
Liquid
General
b. Tablet General
c. Capsule General
d. Oral Dry Powder
suspension
General
Levaquin Tablet of Approved.
Form-5
LOFAMIN Tablet 500mg
Janssen
Pharms
Each film coated tablet Dy No: 1262 (USFDA)
dated 20-10-2014
contains:
Leflox
of
Getz
Levofloxacin
as
Karachi.
20,000/hemihydarte…..500mg
Fluoroquinolone
Fluoroquinolone
As per SRO/
Pack of 10’s
Manufacture
Minutes246thMeetingRegistrationBoard
Page76
43.
-do-
TEMURIN Tablet 100mg
Each
chewable
tablet
contains:
Iron
III
Hydroxide
Polymatose
Complex
equivalent to elemental
Iron…..100mg
Anti- Anemic
Approved.
International
availability requires
Dy No: 1018 confirmation.
dated 26-09-2014
Rubifer
Chewable
Tablets of AGP (Pvt)
20,000/Limited, Karachi.
As per SRO/
Pack of 1x10’s,
2x10’s
Form-5
Manufacturer
44.
-do-
(Word film coated has been
replaced with chewable as
firm applied as chewable)
Form-5
TEMURIN-F Tablet 100mg
Each
chewable
tablet
contains:
Iron
III
Hydroxide
Polymaltose
Complex
equivalent to elemental
Iron…..100mg
Folic acid……0.35mg
Deferred
for
International
specific
availability requires product
inspection by panel
Dy No: 1261 confirmation.
comprising
of
dated 20-10-2014
Rubifer-F Chewable Director DTL &
Tablet of AGP (Pvt) Area FID
20,000/Limited Karachi.
As per SRO
Pack of 1x10’s,
2x10’s
Anti- Anemic
Manufacturer
45.
-do-
(Word film coated has been
replaced with chewable as
firm applied as chewable)
Form-5
CYTO Tablet 250mg
Cipro of Bayer Health Approved.
Care
Each film coated tablet Dy No: 1019
dated 26-09-2014 Cipro of Bayer Health
contains:Care Karachi
Ciprofloxacin
as
20,000/hydrochloride….250mg
Fluoroquinolone
As per SRO
1x10’s
BP
Minutes246thMeetingRegistrationBoard
Page77
46.
-do-
CYTO Tablet 500mg
Form-5
Cipro of Bayer Health Approved.
Care
Each film coated tablet Dy No: 1017
dated 26-09-2014 Cipro of Bayer Health
contains:Care Karachi
Ciprofloxacin
as
20,000/hydrochloride….500mg
Fluoroquinolone
47.
-do-
BP
PRIZO Tablets 100mg
As per SRO/
Pack of 1x10’s
Form-5
Each film coated tablet Dy No: 1054
dated 26-09-2014
contains:Flurbiprofen…..100mg
20,000/Cyclo-oxygenase Inhibitor,
Analgesic,
Anti- As per SRO/
Pack of 3x10’s
inflammatory
48.
-do-
49.
-do-
BP
OSTIM Tablets 50mg
Ansaid of Pharmacia Approved.
(USFDA)
Ansaid of
Karachi
Pfizer
till
Serophene of EMD Deferred
decision on the
Serno (USFDA)
manufacturing
Each film coated tablet Dy No: 1020
for
dated 26-09-2014 Cerophene of Hilton requirement
contains:
this product.
Pharma Karachi.
Clomiphene Citrate…..50mg
20,000/Antioestrogen
As per SRO/
Pack of 1x10’s,
USP
2x10’s
and
3x10’s
Avelox Tablet of Approved.
Form-5
MOZEX Tablet 400mg
Bayer Health Care
Each film coated tablet Dy No: 1046
dated 26-09-2014 Avelox of Bayer
contains:
Health Care Karachi
Moxifloxacin
as
20,000/HCL….400mg
Fluoroquinolone
Form-5
As per SRO/
Pack of 5’s
Manufacturer
(Word film coated has been
omitted in the agenda so has
been added in the minutes)
Minutes246thMeetingRegistrationBoard
Page78
50.
-do(Capsule
General)
Form-5
ESTO Capsules 20mg
Dy No: 1047
Each capsules contains:Esomeprazole Magnesium dated 26-09-2014
Trihydrate
enteric coated
pellets (22.5%) equivalent to 20,000/Esomeprazole……20mg
As per SRO/
1x10’s & 1x7’s
PPI
Nexium
of Approved.
AstraZeneca USFDA
Esso Capsules
Shaigan
Pharmaceuticals,
Islamabad.
of
Manufacturer
51.
-do-
Source:
M/s
Vision
Pharmaceuticals, Islamabad.
Form-5
ESTO Capsules 40mg
Dy No: 1048
Each capsules contains:Esomeprazole Magnesium dated 26-09-2014
Trihydrate
enteric coated
pellets (22.5%) equivalent to 20,000/Esomeprazole………40mg
As per SRO/
1x10’s & 1x14’s
PPI
Nexium
of Approved.
AstraZeneca USFDA
Esso Capsules
Shaigan
Pharmaceuticals,
Islamabad.
of
Manufacturer
52.
-do-
Source:
M/s
Vision
Pharmaceuticals, Islamabad.
Form-5
AZOl Capsules 250mg
Each capsule contains:
Azithromycin
dihydrate…..250mg
Zithromax of Pfizer Approved.
(USFDA).
Dy No: 1050
as dated 26-09-2014 Zithromax of Pfizer
Karachi.
20,000/-
Macrolide
53.
54.
-do-
-do-
USP
GRIBOL Capsules 150mg
As per SRO/
1x6’s & 1x10’s
Form-5
Each capsule contains:
Fluconazole…..150mg
Dy No: 1260
dated 20-10-2014
Antifungal
20,000/-
Manufacturer
As per SRO/
1x4’s
Form-5
GOTEC Capsules 40mg
Minutes246thMeetingRegistrationBoard
Diflucan of Pfizer Approved.
(USFDA)
Diflucan Of Pfizer
Karachi.
Prilosec
AstraZeneca
of Approved.
Page79
Dy No: 1055 (USFDA)
Each capsule contains:
Omeprazole enteric coated dated 26-09-2014
Risek of Getz Karachi
pellets (8.5%) equivalent to
20,000/Omeprazole ……40mg
PPI
As per SRO/
1x10’s, 1x14’s
BP
55.
-do-
Source:
M/s
Vision
Pharmaceuticals, Islamabad.
Form-5
GOTEC Capsules 20mg
Prilosec
of Approved.
AstraZeneca
Dy No: 1044 (USFDA)
Each capsule contains:
Omeprazole enteric coated dated 26-09-2014
Risek of Getz Karachi
pellets (8.5%) equivalent to
20,000/Omeprazole ……20mg
PPI
As per SRO/
1x10’s, 1x14’s
BP
56.
Source:
M/s
Vision
Pharmaceuticals, Islamabad.
Form-5
APRIN Syrup
-doOral
liquid
(General)
Each ml contains:
Cetirizine
dihydrochloride ………1mg
Benadryl Allergy Oral Approved.
Syrup of McNeil
Dy No: 1051 Products UK
dated 26-09-2014
Baydal
of
Bayer
Health Care Karachi.
20,000/-
Antihistamine
Manufacturer
57.
-do-
APHOLAC Suspension
Each 5ml contains:
Lactulose…..3.35gm
Laxative
BP
Minutes246thMeetingRegistrationBoard
As per SRO
Pack of 30ml
and 60ml bottle
Duphalac of Solvay
Form-5
(USFDA)
Dy No: 1052
dated 26-09-2014 Duphalac of Abbot
Pharma, Karachi
20,000/Firm has submitted
As per SRO/ invoice of purchase of
Index
Pack of 120ml & Refractive
detector.
240ml bottle
Deferred for:
1. confirmation of
dosage form &
verification
of
HPLC
equipped
with RI detector by
area FID.
2. Fee for import.
3. Legalized GMP
of source.
4. Stability studies.
Page80
58.
59.
Form-5
TEMURIN Syrup
Availability in SRA’s Approved.
need confirmation
Dy No: 1053
Each 5ml contains:
Syrup
of
Iron
III
Hydroxide dated 26-09-2014 Engfer
English Pharma Lahore
Polymatose
Complex
equivalent to elemental 20,000/Iron…….50mg
As per SRO/
Pack of 60ml &
Anti-anemic
120ml bottle
Manufacturer
Zithromax of Pfizer Approved.
Form-5
AZOL Suspension
-do(USFDA)
(Oral
Dry
Dy No: 1257
Each 5ml contains:
Powder
Azithromycin
dihydrate dated 20-10-2014 Zithromax of Pfizer
Suspension
Karachi
equivalent to Azithromycin
General)
20,000/…..200mg
As per SRO/
Pack of 15ml
bottle
USP
Not
available
in
Form-5
CYTO Suspension
SRA’s
Dy No: 1259
Each 5ml contains:
Ciprofloxacin as HCL taste dated 20-10-2014 Novidat of Sami
Pharma Karachi
masked
pellets
25%
equivalent
to 20,000/Ciprofloxacin..…..250mg
As per SRO/
60ml bottle
Fluoroquinolone
Macrolide
60.
-do-
Deferred till review
of formulation by
Review
Committee.
Manufacturer
Evaluator – III (Veterinary New DML)
S/N
Name
and
address
of
manufacturer /
Applicant
Remarks on the Recommendations
formulation (if any) by the Evaluators
including
International status
in stringent drug
Fee
including regulatory agencies /
authorities
differential fee
Type of Form
Brand Name
(Proprietary name +
date,
Dosage
Form
+ Initial
diary
Strength)
Composition
Pharmacological
Group
Finished
Specification
Demanded Price Me-too status
/ Pack size
GMP
status
as
product
depicted in latest
inspection
report
Minutes246thMeetingRegistrationBoard
Page81
(with date) by the
Evaluator
Trisolizin of Star Labs Deferred
for
Lahore.
confirmation of TOC
10-07-14 Dy. No:
analyzer & Liquid
The CLB in its 236th Particle Counter.
64
meeting
of
20,000/Registration
Board
approved the grant of
Decontrolled/
DML with following
50ml vial
sections namely:
a. Veterinary Liquid
Injection (General
Antibiotic)
b. Veterinary Liquid
Injection (General)
61.
M/s
Izfaar TRIOZIN Injection
Pharmaceutical
Each ml contains:
Industries,
Sulphadiazine…..400mg
Lahore
Trimethoprim……80mg
Veterinary Liquid
Antibiotic
Injection
(General
Manufacturer
Antibiotic)
Form-5
62.
-do-
Form-5
TYLOGEN Injection
Tygent Injection
Selmore
03-07-14 Dy. No: Pharmaceuticals
Lahore
15
Each ml contains:
Tylosin Tartrate….10mg
Gentamicin
as
20,000/sulphate…..50mg
Antibiotic
63.
-do-
Manufacturer
OXY FAR LA Injection
-do-
Manufacturer
OXY FAR Injection
-do-
Manufacturer
ENRO-100 Injection
Minutes246thMeetingRegistrationBoard
Form-5
Decontrolled/
100ml vial
Oxy-5 injection
Selmore
10-07-14 Dy. No: Pharmaceuticals,
Each ml contains:
Lahore
Oxytetracycline
as 63
Hydrochloride…….50m
20,000/g
Antibiotic
65.
Decontrolled/
50ml vial
Oxy-LA injection of Deferred
for
Selmore
confirmation of TOC
analyzer & Liquid
10-07-14 Dy. No: Pharmaceuticals,
Each ml contains:
Lahore
Particle Counter.
Oxytetracycline
as 63
Hydrochloride…….200
20,000/mg
Antibiotic
64.
for
of Deferred
confirmation of TOC
analyzer & Liquid
Particle Counter.
Form-5
for
of Deferred
confirmation of TOC
analyzer & Liquid
Particle Counter.
Decontrolled/
50ml Vial
Form-5
Enroxsel of Selmore Deferred
Page82
for
Each ml contains:
Enrofloxacin….100mg
-do-
FLOXIN Injection
Each ml contains:
Oxytetracycline
HCL…..300mg
confirmation of TOC
analyzer & Liquid
Particle Counter.
20,000/-
Fluoroqunolone
Antibacterial
66.
Pharmaceuticals
03-07-14 Dy. No: Lahore
17
Decontrolled/
50ml vial
Form-5
I-Fom of International Deferred
for
Pharma Labs Lahore
confirmation of TOC
analyzer & Liquid
03-07-14 Dy. No:
Particle Counter.
as 19
20,000/-
Flunixin
as
Decontrolled/
Meglumine……20mg
50ml vial
Antibiotic/ Analgesic,
Anti-inflammatory
67.
-do-
Manufacturer
TYLOFAR Injection
Tylosel of Selmore Deferred
for
Pharmaceuticals,
confirmation of TOC
analyzer & Liquid
03-07-14 Dy. No: Lahore
Particle Counter.
15
Form-5
Each ml contains:
Tylosin
Tartrate……200mg
20,000/Antibiotic
68.
-do-
Ketoxay LA
Each ml contains:
Oxytetracycline
HCL…….200mg
Ketoprofen….30mg
Oxyfen-LA
Selmore
03-07-14 Dy. No: Pharmaceuticals,
Lahore
as 19
Antibiotic/ Analgesic
69.
-do-
Manufacturer
TYLOPRIM Injection
for
of Deferred
confirmation of TOC
analyzer & Liquid
Particle Counter.
20,000/Decontrolled/
50ml vial
Tylotrim of Selmore Deferred
for
Pharmaceuticals
confirmation of TOC
analyzer & Liquid
03-07-14 Dy. No: Lahore
Each ml contains:
Particle Counter.
Sulphamethoxypyridazin 15
e……150mg
Trimethoprim……30mg 20,000/Tylosin tartrate…..50mg
Decontrolled/
50ml vial
Antibiotic
Minutes246thMeetingRegistrationBoard
Decontrolled/
50ml vial
Form-5
Form-5
Page83
70.
-do-
Manufacturer
DICOTYL Injection
Each ml contains:
Tylosin tartrate….50mg
Colistin
sulphate…..10mg
Dimetridazole…..100mg
Antibiotic/
Protozoal
Bacticom of Selmore Deferred
for
Pharmaceuticals
confirmation of TOC
analyzer & Liquid
03-07-14 Dy. No: Lahore
Particle Counter.
17
Form-5
20,000/-
Decontrolled/,
Anti- 50ml vial
Manufacturer
71.
72.
73.
-do-
-do-
-do-
Each ml contains:
Ivermectin….10mg
Actimec Injection of Deferred
for
Selmore
confirmation
of
Liquid
Particle
03-07-14 Dy. No: Pharmaceuticals
Lahore
Counter.
14
Anthelmintic
20,000/-
BP
Decontrolled/
50ml vial
Form-5
Form-5
IVERIN Injection
Each ml contains:
Ivermectin….20mg
Elvomec D/S of Elko Deferred
for
Karachi
confirmation
of
Liquid
Particle
03-07-14 Dy. No:
Counter.
14
Anthelmintic
20,000/-
BP
Decontrolled/
50ml vial
Form-5
PARACTIN Injection
MELOXAM Injection
Each ml contains:
Meloxicam…….7.5mg
Analgesic/
inflammatory
74.
-do-
Calimox of Selmore Deferred
for
Pharma
confirmation of TOC
analyzer & Liquid
03-07-14 Dy. No:
Particle Counter.
14
Anti- 20,000/-
BP
B-Vita Injection
Each ml contains:
Cyanocobalamin…..125
mcg
Decontrolled/ 50
ml vial
B-Vita of Kakasian
Form-5
Pharma Lahore
03-07-14 Dy. No:
15
Deferred
for
confirmation of TOC
analyzer & Liquid
Particle Counter.
20,000/Vitamin
Minutes246thMeetingRegistrationBoard
Page84
USP
75.
-do-
ADE-FAR Injection
Each ml contains:
Vitamin
A…….100,000IU
Vitamin
D3……40,000IU
Vitamin E…….40mg
Vitamin and
promoters
76.
-do-
Decontrolled/
Pack of 50 ml
vial
Nawan
Form-5
Karachi
03-07-14 Dy. No:
17
Laboratories Deferred
for
confirmation of TOC
analyzer & Liquid
Particle Counter.
20,000/Decontrolled/
50ml vial
Growth
Manufacturer
VITOBION Injection
Each ml contains:
Thiamine HCL……5mg
Riboflavin……2.5mg
Pyridoxine
HCL……2.5mg
Nicotinamide……37.5m
g
Thiaprin Injection of Deferred
for
Star Labs Karachi
confirmation of TOC
analyzer & Liquid
03-07-14 Dy. No:
Particle Counter.
15
Form-5
20,000/Decontrolled/ 50
ml vial
Vitamin
77.
-do-
Manufacturer
HEPAFAR Injection
Each ml contains:
Phenoxy-2-methyl-2propionic acid…..100mg
78.
-do-
Form-5
Hepaguard of
Labs Lahore
03-07-14 Dy. No:
15
Star Deferred
for
confirmation of TOC
analyzer & Liquid
Particle Counter.
20,000/Hepatoprotectant/ Liver
Decontrolled/
Tonic
50ml vial
Manufacturer
Form-5
IMIDO-FAR Injection
Each ml contains:
Imidocarb
dipropionate……120mg
IMIPRO of Selmore Deferred
for
Pharmaceuticals,
confirmation of TOC
analyzer & Liquid
03-07-14 Dy. No: Lahore
Particle Counter.
15
20,000/-
Antiprotozoal
79.
-do-
AAVIL Injection
Minutes246thMeetingRegistrationBoard
Decontrolled/
50ml vial
Form-5
Anril
Injection
of Deferred
Page85
for
Syman Pharma Lahore
Each ml contains:
Pheniramine
maleate…..11.35mg
03-07-14 Dy. No:
15
confirmation of TOC
analyzer & Liquid
Particle Counter.
20,000/Antihistamine
80.
-do-
Manufacturer
ATRO Injection
Each ml contain:
Atropine
Sulphate…..1mg
Decontrolled/
50ml vial
Form-5
Atrovet Injection of Deferred
for
Selmore
confirmation of TOC
analyzer & Liquid
03-07-14 Dy. No: Pharmaceuticals
Lahore
Particle Counter.
15
20,000/-
Anti-muscarinic
BP
Minutes246thMeetingRegistrationBoard
Decontrolled/
Pack of 50ml vial
Page86
Case No.04.
Grant of registrationsfor additional sectionsof already licensed manufacturers.
Evaluator – II
S/N
Name and address of Brand Name
manufacturer
/
(Proprietary
Applicant
name + Dosage
Form
+
Strength)
Composition
Pharmacological
Group
Type of Form
Remarks on the Decision
formulation
(if
Initial
date, any)
including
diary
International
Fee including status in stringent
differential fee drug regulatory
agencies
/
authorities
Demanded
Price / Pack
Me-too status
size
GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator
Finished
product
Specification
81.
M/s
Pharmatec
Pakistan (Pvt.) Limited,
D-86/A,
S.I.T.E.,
Karachi-75700.
(Cream/Oint General:
No.
F.6-6/2014-Lic
(M-237 dated 14-102014)
Adagel Gel
Contains:Adapalene
(B.P)…0.1%w/w
Benzoyl Peroxide
(B.P)…2.5%w/w
(Anti-acne
Preperation)
(Manufacturer’s
Spec.s)
Minutes246thMeetingRegistrationBoard
Form 5
13-10-2014
(31)
Rs. 20,000/As
Per
SRO/15gm,
30gm
BNF: Epiduo
(Galderma)
Approved.
ADAPLUS
(BIOGEN
PHARMA,Islamab
ad)
Grant of additional
section
Cream/Ointment
(General)
recommended.(2407-2014)
Page87
82.
-do-
83.
M/s Sami
Pharmaceuticlas (Pvt.)
Limited, F-95, S.I.T.E.
Karachi-Pakistan
Tablet (Psychotropic)
Section (No. F.65/2014-Lic (M-236)
dated 8th Sep, 2014.
Pamulin
Ointment
Contains:Retapamulin…1.
0%w/w
(Antibiotic and
chemotherapeutic
for
dermatological
use)
(Manufacturer’s
Spec.s)
Pralzo
0.25mg
Tablets
Each
tablet
contains:Alprazolam
(USP)…0.25mg
(Benzodiazepine)
(USP Spec.s)
Form 5
13-10-2014
(34)
Rs. 50,000/As
Per
SRO/5gm,15g
m
BNF: Altargo
(GSK)
Approved
Altapam
Ointment of M/s
Atco Lab, Regn
No 061764
Grant of additional
section
Cream/Ointment
(General)
recommended.(2407-2014)
Form 5
09-09-2014
(240)
Rs. 20,000/Rs.157.47/30’s
1. Me-too status
has been given as
Altapam Ointment
of M/s Atco Lab
(Reg. No 061764)
that
needs
confirmation.
Pricing
of
formulation
has
been done in 9th
PAC.
Approved.
BNF: Alprazolam
(Non-proprietary)
XANAX (PFIZER
LABORATORIES
LTD.,Karachi)
Very good, Panel
recommends all the
additional sections
as per approved
layout plan. (24-0614)
1. Alprazolam is a
84.
-do-
Pralzo
Tablets
0.5mg Form 5
09-09-2014
Minutes246thMeetingRegistrationBoard
controlled drug
substance.
BNF: Alprazolam
Approved.
(Non-proprietary)
Page88
Each
tablet (239)
contains:Rs. 20,000/Alprazolam
Rs.157.47/30’s
(USP)…0.5mg
(Benzodiazepine)
(USP Spec.s)
85.
-doTablet (General)
Section (No. F.65/2014-Lic (M-236)
dated 8th Sep, 2014.
XANAX (PFIZER
LABORATORIES
LTD.,Karachi)
Very good, Panel
recommends all the
additional sections
as per approved
layout plan. (24-0614)
1. Alprazolam is a
controlled drug
substance.
Gasicol
Deferred
for
Form 5
BNF: Gaviscon
application
on
Form
Advance
Chewable Tablets 03-04-2014
5D
alongwith
Each Chewable (201)
requisite fee & other
Not confirmed
tablet contains:Rs. 20,000/codal formalities.
Sodium
Rs.
5
per Very good, Panel
Alginate(BP)…5 Tablet,
Rs. recommends all the
00mg
80/16’s
additional sections
as per approved
Potassium
layout plan. (24-06Bicarbonate
14)
(BP)…100mg
(Antacid)
1. Verification of
(Manufacturer’s
photocopy of
Spec.s)
fee receipt is
required.
2. Me-too status
needs
confirmation.
86.
-do-
Solfy
5mg
Tablets
Each film coated
tablet contains:Solifenacin
Succinate…5mg
(Muscarinic
antagonist)
(Manufacturer’s
Spec.s)
Minutes246thMeetingRegistrationBoard
Form 5
21-10-2014
(72)
Rs. 20,000/As per PRC
BNF: Vesicare
(Astellas)
Approved.
Fenaso (Highnoon)
Very good, Panel
recommends all the
additional sections
as per approved
layout plan. (24-0614)
Page89
87.
-do-
88.
-do-
89.
-doCapsule (General)
Section (No. F.65/2014-Lic (M-236)
dated 8th Sep, 2014.
Urigo
80mg
Tablets
Each film coated
tablet contains:Febuxostat……
……….…80mg
(Xanthine
Oxidase
Inhibitor)
(Manufacturer’s
Spec.s)
Urigo
40mg
Tablets
Each film coated
tablet contains:Febuxostat…40m
g
(Xanthine
Oxidase
Inhibitor)
(Manufacturer’s
Spec.s)
Beritex
150mg
Capsules
Each
capsule
contains:Polysaccharide
Iron
Complex
equivalent
to
Elemental
Iron…150mg
(Iron compound)
(Manufacturer’s
Spec.s)
Minutes246thMeetingRegistrationBoard
Form 5
21-10-2014
(73)
Rs. 20,000/As per PRC
FDA: Uloric
Form 5
21-10-2014
(71)
Rs. 20,000/As per PRC
FDA: Uloric
Form 5
09-09-2014
(241)
Rs. 20,000/As per PRC
Not confirmed
Approved.
Zurig (Getz)
Very good, Panel
recommends all the
additional sections
as per approved
layout plan. (24-0614)
Approved.
Zurig (Getz)
Very good, Panel
recommends all the
additional sections
as per approved
layout plan. (24-0614)
Approved.
Ferricure (S. J. &
G)
Very good, Panel
recommends all the
additional sections
as per approved
layout plan. (24-0614)
1. Availability in
SRA’s
not
confirmed.
Firm
has
provided
international
availability of
un
approved
products
in
USA, Canada,
Page90
UK.
Evaluator – III
S/N Name
and
address
of
manufacturer /
Applicant
Type
of
Brand Name
(Proprietary name + Form
Dosage
Form
+
Initial
Strength)
date, diary
Composition
Fee
including
Pharmacological
differential
Group
fee
Finished
product
Demanded
Specification
Price
/
Pack size
Remarks on Recommendations Decision
by the Evaluator
the
formulation
(if
any)
including
International
status
in
stringent
drug
regulatory
agencies
/
authorities
Me-too status
GMP status
as depicted in
latest
inspection
report (with
date) by the
Evaluator
90.
M/s
Rasco PARA-RAS Infusion
Pharma,
5.5
100ml
vial
Km
Raiwind Each
contains;
Road, Lahore
Paracetamol
Liquid Injection (BP)…..1000mg
General (Small
Antipyretic/ Analgesic
Volume Vial)
Manufacturer
Minutes246thMeetingRegistrationBoard
Form-5
PERFALGAN
10
mg/ml,
Dy No: 659 solution
for
dated 22- infusion (100
09-2014
ml
vial
contains 1000
20,000/mg
paracetamol)
As
per of BMS UK
SRO
1x 100ml
Provas
of
Firm has submitted
the invoices of
purchase of Liquid
Particle counter and
TOC analyzer.
Approved.
Area FID will
confirm
instalation &
operational
qualifications
of TOC &
Liquid
Particle
Counter and
then
Page91
Sami Karachi
91.
-do-
The
inspection of
firm
was
carried out on
03-06-2014
by the panel
of inspectors
and
recommended
the renewal of
DML
and
additional
section
namely Liquid
Injection
General
(Small
Volume Vial)
Tevanic
of
Form-5
LEVOFLOXA Infusion
Sanofi
Each
100ml
vial Dy No: 660 Aventis
dated 22- (BNF)
contains:
09-2014
Levofloxacin
Levocil
of
hemihydarte equivalent
CCL Pharma
to
Levofloxacin 20,000/Lahore.
USP…..500mg
As
per
SRO
Quinolone
1x 100ml
Manufacturer
Minutes246thMeetingRegistrationBoard
registration
letter will be
issued after
approval of
Chairman,
RB.
Approved.
Area FID will
confirm
instalation &
operational
qualifications
of TOC &
Liquid
Particle
Counter and
then
registration
letter will be
issued after
approval of
Chairman,
RB.
Page92
92.
-do-
LEVOFLOXA Infusion
Form-5
Deferred for
confirmation
of approval
by
the
reference
Stringent
Regulatory
Agencies for
this strength /
volume.
93.
-do-
CIP-RX Infusion
Form-5
Deferred for
confirmation
of approval
of
formaulation
in Stringent
Regulatory
Agencies in
the
same
strength.
94.
-do-
CIP-RX Infusion
Form-5
Approved.
Area FID will
confirm
instalation &
operational
qualifications
of TOC &
Liquid
Particle
Counter and
then
registration
letter will be
issued after
approval of
Chairman,
RB.
250mg
levofloxacin
Each
100ml
vial Dy No: 665 (as
dated 22- hemihydarte)
contains:
09-2014
in
50ml
Levofloxacin
hemihydarte equivalent
solution
to
Levofloxacin 20,000/(Tavanic
of
USP…..250mg
sanofi)
As
per
SRO
Quinolone
Levocil
of
1x 100ml
CCL Pharma
Manufacturer
Lahore
Ciprofloxacin
2
mg/ml
Each
100ml
vial Dy No: 656 Solution for
dated 22- Infusion
contains:
Ciprofloxacin
lactate 09-2014
400mg/200ml
equivalent
to
vial
of
20,000/Ciprofloxacin
Hospira UK
USP….400mg
Limited
As
per
SRO
Quinolone
Novidat
of
1x 100ml
Sami Karachi
USP
Ciprofloxacin
2
mg/ml
Each
100ml
vial Dy No: 660 Solution for
dated 22- Infusion
contains:
Ciprofloxacin
lactate 09-2014
200mg/100ml
equivalent
to
vial
of
20,000/Ciprofloxacin
Hospira UK
USP….200mg
Limited
As
per
SRO
Quinolone
Novidat
of
1x 100ml
Sami Karachi
USP
Minutes246thMeetingRegistrationBoard
Page93
95.
-do-
Zyvox
of
Pfizer USA
LINZO Infusion
Form-5
Each 100ml contains:
Linezolid….200mg
Dy No: 654
dated 22- Nezocin
Brookes
09-2014
Pharma
20,000/-
Oxazolidinone
of
Manufacturer
As
per
SRO
1x 100ml
96.
-do-
RESGYL Infusion
Each 100ml contains:
Metronidazole…500mg
Antiprotozoal
Flagyl
of
Sanofi
Dy No: 657 (USFDA)
dated 22Metrozine of
09-2014
Searle Karachi
20,000/Form-5
Manufacturer
As
per
SRO
1x 100ml
97.
-do-
RE-VED Infusion
Form-5
Teravid
of
Sanofi USA
Dy No: 658
Each 100ml contains:
Ofloxacin
HCL dated 22- Loxat of Siza
Lahore
equivalent
to 09-2014
Ofloxacin……200mg
20,000/Quinolone
As
per
SRO
Manufacturer
1x 100ml
Minutes246thMeetingRegistrationBoard
Approved.
Area FID will
confirm
instalation &
operational
qualifications
of TOC &
Liquid
Particle
Counter and
then
registration
letter will be
issued after
approval of
Chairman,
RB.
Approved.
Area FID will
confirm
instalation &
operational
qualifications
of TOC &
Liquid
Particle
Counter and
then
registration
letter will be
issued after
approval of
Chairman,
RB.
Approved.
Area FID will
confirm
instalation &
operational
qualifications
of TOC &
Liquid
Particle
Counter and
then
registration
letter will be
Page94
issued after
approval of
Chairman,
RB.
98.
-do-
MOXILINE Infusion
Each
250ml
vial
contains:
Moxifloxacin
HCL
equivalent
to
Moxifloxacin……400mg
Manufacturer
As
per
SRO
1x 250ml
RELAXIM Tablet 3mg
Form-5
Quinolone Antibiotic
99.
M/s
Arsons
Pharmaceuticals
Industries (Pvt)
Limited, Lahore
(Tablet
Psychotropic)
Each tablet contains:
Bromazepam…….3mg
Benzodiazepine
Manufacturer
Minutes246thMeetingRegistrationBoard
Avelox
of
Bayer Health
Dy No: 662 Care USA
dated 22Moxiget
of
09-2014
Getz Karachi
20,000/Form-5
Lexotan
Tablets
of
Roche (TGA
23-09-14
Dy.
No: Approved)
793
Tensium
Tablets
of
20,000/Werrick
As
per Pharma
Islamabad.
SRO
3x10’s
The
inspection of
the firm was
conducted on
08-05-2014
by the panel
of inspectors
and
recommended
the renewal of
DML
and
Applied volume is
250ml however the
approval of section
is
for
Liquid
Injection General
(Small
Volume
Vial)
Approved.
Area FID will
confirm
instalation &
operational
qualifications
of TOC &
Liquid
Particle
Counter and
then
registration
letter will be
issued after
approval of
Chairman,
RB.
Approved
with change
in
applied
brand name.
Page95
grant
of
additional
section
of
tablets
psychotropic.
100. -do-
101. -do-
102. -do-
Clonazepam
Tablet of Teva
Dy No: 788 (USFDA)
dated 23Each tablet contains:
Clonzil
of
09-2014
Clonazepam……0.5mg
English
Pharma
20,000/Benzodiazepine
Lahore
As
per
BP
SRO
5x10’s
Clonazepam
ARVOTRIL
Tablets Form-5
Tablet of Teva
2mg
Dy No: 790 (USFDA)
dated 23Each tablet contains:
Clonzil
of
09-2014
Clonazepam……2mg
English
Pharma
20,000/Benzodiazepine
Lahore
As
per
BP
SRO
3x10’s
Ativan
of
ARTIVAN Tablets 1mg Form-5
Pfizer
Dy No: 792 (USFDA)
Each tablet contains:
dated 23Lorazepam……1mg
Ativan
of
09-2014
Pfizer Karachi
Benzodiazepine
20,000/BP
As
per
SRO
10x10’s
ARVOTRIL
0.5mg
Tablets Form-5
Minutes246thMeetingRegistrationBoard
Approved
with change
in
applied
brand name.
Approved
with change
in
applied
brand name.
Approved
with change
in
applied
brand name.
Page96
103. -do-
ARTIVAN Tablets 2mg
Each tablet contains:
Lorazepam……2mg
Benzodiazepine
Ativan
of
Pfizer
Dy No: 791 (USFDA)
dated 23Ativan
of
09-2014
Pfizer Karachi
20,000/Form-5
Approved
with change
in
applied
brand name.
BP
104. -do-
XALLIUM Tablets 5mg
Each tablet contains:
Diazepam………5mg
Benzodiazepine
As
per
SRO
10x10’s
Diazeoam of
Form-5
Wockhardt
Dy No: 794 UK
dated 23Valium
of
09-2014
Martin Dow
Karachi
20,000/-
Approved
with change
in
applied
brand name.
BP
105. -do-
As
per
SRO
3x10’s
Hypnovel
ARMICUM
Tablet Form-5
tablets
of
7.5mg
Dy No: 794 Roche New
dated 23- Zealand
Each tablet contains:
Midazolam
as 09-2014
Dormicum of
meleate……7.5mg
Martin Dow
20,000/Karachi
Benzodiazepine
As
per
SRO
Manufacturer
3x10’s
Approved
with change
in
applied
brand name.
5. Left-over agenda (245)
a)
Remaining application of previously approved new sections
Evaluator - II
Minutes246thMeetingRegistrationBoard
Page97
S/N
Name
and Brand Name
Type of Form
address
of
manufacturer / (Proprietary name + Initial date, diary
Dosage Form +
Applicant
Fee
including
Strength)
differential fee
Composition
Demanded Price
Pharmacological
/ Pack size
Group
Finished
product
Specification
106.
M/s Herbion
Pakistan (Pvt)
Ltd., Kahuta
Road, industrial
Triangle, Humak,
RawalpindiIslamabad.
107.
-do-
EsNovex/AciNovex/
GastriNovex
Capsules 20mg
Each capsule
contains:-Enteric
coated pellets of
Esomeprazole
Magnesium
Trihydrate
eq. to
Esomeprazole…20m
g
( Antipeptic
Ulcerants / Proton
Pump Inhibitor)
(Manufacturer’s
Spec.s)
{Source of Pellets:
M/s Glukem
Pharmaceuticals (P)
Ltd Plot # 205/2A, 1st
Floor , IDA, Phase-II,
Cherlapally,
Hyderabad-Andhra
Pradesh, India}
Form 5
02-05-2014
Dy.No.2076
Rs.20,000/=+Rs.
80,000/- (05-092014)
Rs.200.00/
2x7’s
EsNovex/AciNovex/
GastriNovex
Capsules 40mg
Each capsule
contains:-Enteric
coated pellets of
Form 5
Minutes246thMeetingRegistrationBoard
02-05-2014
Dy.No.2077
Rs.20,000/- +
Rs. 80,000/- (05-
Remarks on the Decision
formulation (if any)
including
International status
in stringent drug
regulatory agencies /
authorities
Me-too status
GMP
status
as
depicted in latest
inspection
report
(with date) by the
Evaluator
Nexium
of Approved. Firm will
provide
legalized
AstraZeneca
GMP
of
the
of
Esso
of
Shaigan manufacturer
pellets
and
then
Pharmaceuticals
registration letter will
Islamabad.
be
issued
after
of
Grant
of
DML approval
recommended (23-24th Chairman, RB.
January 2014)
1. Valid
and
legalized
GMP
Certificate
of
Source, COA and
stability
studies
according to zone
IV-a of pellets are
required.
The stability & COA
have been provided
by the applicant
before the meeting of
the Board.
Nexium
of Approved. Firm will
provide
legalized
AstraZeneca
GMP
of
the
of
Esso
of
Shaigan manufacturer
pellets
and
then
Pharmaceuticals
registration letter will
Islamabad.
be
issued
after
Page98
108.
-do-
Esomeprazole
Magnesium
Trihydrate
eq. to
Esomeprazole …40
mg
( Antipeptic
Ulcerants / Proton
Pump Inhibitor)
(Manufacturer’s
Spec.s)
{Source of Pellets:
M/s Glukem
Pharmaceuticals (P)
Ltd Plot # 205/2A,
1st Floor , IDA,
Phase-II,
Cherlapally,
Hyderabad-Andhra
Pradesh, India}
OmeNovex /
SecNovex /
PeptiNovex
Capsules 20mg
Each capsule
contains:Omeprazole enteric
coated Pellets eq. to
Omeprazole
…20mg
( Antipeptic
Ulcerants / Proton
Pump Inhibitor)
(Manufacturer’s
Spec.s)
{Source of Pellets:
M/s Vision
Pharmaceuticals,
Plot No.224, Street
No.1, I-10/3,
Industrial Area,
Islamabad.}
Minutes246thMeetingRegistrationBoard
09-2014)
Rs.371.00/2x7’s
Grant
of
DML approval
recommended (23-24th Chairman, RB.
January 2014)
1. Valid
and
legalized
GMP
Certificate
of
Source, COA and
stability
studies
according to zone
IV-a of pellets are
required.
The stability & COA
have been provided
by the applicant
before the meeting of
the Board.
Form 5
02-05-2014
Dy.No.2078
Rs.20,000/=
Rs.290.00/
2x7’s
Losec (Astrazeneca)
Approved.
Omega(Ferozsons)
Grant
of
DML
recommended (23-24th
January 2014)
Page99
of
109.
-do-
110.
-do-
OmeNovex /
SecNovex /
PeptiNovex
40mg Capsules
Each capsule
contains:Omeprazole enteric
coated Pellets
eq. to
Omeprazole…
40mg
( Antipeptic
Ulcerants / Proton
Pump Inhibitor)
(Manufacturer’s
Spec.s)
{Source ofPellets:
M/s Vision
Pharmaceuticals, Plot
No.224, Street No.1,
I-10/3, Industrial
Area, Islamabad.}
Form 5
02-05-2014
Dy.No.2079
Rs.20,000/=
Rs.354.00/
2x7’s
FluNovex / CFNovex / TheraNovex
Extra Tablets
Each film coated
tablet contains:Paracetamol BP
….…..650mg
Chlorphenirmine
Maleate
BP………………..…
…..4mg
Phenylephrine HCl
BP…10mg
(Analgesic +
Decongestant
Combination)
(Manufacturer’s
Spec.s)
Form 5-D
24-02-2014
Dy.No.194
Rs.20,000+Rs.
30,000/- (07-0514)
Minutes246thMeetingRegistrationBoard
Rs.230.00/
10x10’s
Losec (Astrazeneca)
Approved.
Omega(Ferozsons)
Grant
of
DML
recommended (23-24th
January 2014)
Not confirmed
Form 5-D
Grant
of
DML
recommended (23-24th
January 2014)
1. The firm had
applied on Form 5
, after evaluation
the Firm applied
on Form 5-D and
submitted
additional fee of
Rs. 30,000/2. International
availability
not
confirmed
in
stringent DRS’s.
Deferred
for
confirmation
of
approval in reference
Stringent Regulatory
Agencies. It will be
followed
by
assessment
of
stability studies and
expert opinions by
Brig
Aslam,
Dr.Rehana
Kauser
and
Dr.Shazli
Manzoor.
Page100
111.
-do-
VitaNovex /
CilaNovex /
BonNovex
Suspension
Each 5ml contains:Ossein Mineral
Complex …250mg
Vitamin D … 400 i.u
(Calcium-Phosphorus
Supplements)
(Manufacturer’s
Spec.s)
Minutes246thMeetingRegistrationBoard
Form 5
26-02-2014
Dy.No.211
Rs.20,000
Rs.144.00/
60ml
Not confirmed
Deferred for approval
in reference Stringent
Not confirmed
Regulatory Agencies
& me-too status
Grant
of
DML alongwith
recommended (23-24th installational
&
January 2014)
operational
1. International
qualification
of
atomic
absorption
availability
not
confirmed
in spectrophotometer by
area FID.
stringent DRA’s.
2. Me-too status not
confirmed.
3. Firm has claimed
that they possess
Atomic Absorption
(PerkinElmerA
Analyst
300)
spectrophometer
and has submitted
that it can be
verified by area
FID.
Page101
Evaluator – I
S/N
Name
and
address
of
Manufacturer /
Applicant
Type of Form
Brand Name
(Proprietary
name + Dosage Initial date,
diary.
form + Strength)
Composition
Fee including
differential fee
Pharmacological
Group
Internationa Remarks /
l status in Observations
stringent
regulatory
agencies
Decision
Me-too
status
Demanded
Price / Pack GMP status
as depicted
Finished product size
in inspection
specification
report
(dated)
112.
113.
M/s
Hiranis
Pharmaceuticals
(Pvt) Ltd., Plot
No. E-145 – E149,
North
Western
Industrial Zone,
Port
Qasim,
Karachi.
M/s
Hiranis
Pharmaceuticals
(Pvt) Ltd., Plot
No. E-145 – E149,
North
Western
Industrial Zone,
Port
Qasim,
Karachi.
Acen Effervescent
Tablet 200mg
Each effervescent
tablet contains:
N-acetylcysteine
…………..200mg
Form-5D
(Manufacturer’s
Specs)
Rs. 800 / per
10’s
Mucolytic agent
Rs. 50,000/-
Glucort S.R. Tablet
5mg Each enteric
coated
tablet
contains:Beclomethasone
Dipropionate
...
5mg
Form-5D
(Manufacturer’s
Specs)
New License
28-05-2014
804 R&I
New License
28-05-2014
808 R&I
Rs. 1,000 / per
10’s
Rs. 50,000/-
Corticosteroid
Minutes246thMeetingRegistrationBoard
ACC™ 200
effervescent
tablets
Nacetylcystein
e 200mg
South Africa
CLIPPER
Gastroresistant
prolonged
release tablet
5mg
MHRA
References
and
data of various
international
clinical
studies
have been provided
along
with
06
months accelerated
and
real
time
stability summary.
Deferred
approval
reference
Stringent
Regulatory
Agencies
establish
safety
efficacy
product.
References
and
data of various
international
clinical studies has
been
provided
along
with
06
months accelerated
and
real
time
stability summary.
Firm
has
also
submitted
undertaking
to
submit comparative
dissolution profile
with
established
brand
before
marketing
the
product.
Deferred for
expert
opinions
by
Brig Aslam,
Dr.Rehana
Kauser
and
Dr.Shazli
Manzoor and
evaluation of
stability
studies
by
Incharge,
PEC.
Page102
for
in
to
&
of
114.
M/s
Hiranis
Pharmaceuticals
(Pvt) Ltd., Plot
No. E-145 – E149,
North
Western
Industrial Zone,
Port
Qasim,
Karachi.
Lafelax
Liquid
Sachet
Each 15ml sachet
contains:Lactulose………6
7% w/v
Form-5D
(USP
Specification)
Rs. 250 / per
10’s
Laxative
Source:
Fresenius
Austria
115.
M/s
Hiranis
Pharmaceuticals
(Pvt) Ltd., Plot
No. E-145 – E149,
North
Western
Industrial Zone,
Port
Qasim,
Karachi.
New License
LAEVOLAC
10g/15ml
Sachet
MHRA
28-05-2014
811 R&I
Rs. 50,000/28/05/2014
M/s Rs. 50,000/Kabi, 24/09/2014
Total fee: Rs.
100,000/-
Diolyte Rice
Sachet
Each sachet
contains:Rice Powder…6g
Sodium
Citrate……. 0.58g
Form 5
New License
05-05-2014
662 R&I
As per PRC
10’s
References
and
data of various
international
clinical studies /
literature have been
provided
along
with 06 months
accelerated and real
time
stability
summary.
GMP certificate of
the
source
of
Lactulose dated 1302/2012 with the
statement that this
certificate reflects
the
status
of
manufacturer at the
time of inspection
(31-01-2012) and
should not be relied
upon to reflect the
compliance status if
more than three
years have elapsed
since the date of
that inspection.
DIAROLYT
E
Deferred for
confirmation
of
same
strength
internationally
, evaluation of
stability
studies,
confirmation
of
HPLC
equipped with
RI detector &
legalized
GMP
of
source.
Approved
with change in
brand name.
GASTROLY
TE
Sanofi
Rs. 20,000/-
Sodium Chloride
………….. 0.35g
Potassium Chloride
…………… 0.3g
(Manufacturer’s
Specs)
Minutes246thMeetingRegistrationBoard
Page103
ORS
116.
M/S
Pharma CPRO 125mg/5ml Form 5
Lord (Pvt) Ltd., Suspension
Rs. 125/- per
12 Km, Lahore
Road, Layyah.
Dry Suspension
60ml
Tablet (General)
Capsule
(General)
Oral Dry Powder
Suspension
(General)
Each reconstituted R&I diary No.
5ml contains:
and date not
available
Ciprofloxacin
………..... 125mg
Rs.20,000
(Duplicate)
(Anti-infective /
Quinolone)
Reference
formulation:
CIPRO Oral
Suspension (M/s
Bayer HealthCare
Pharmaceuticals
Inc.)
Ciprofloxacin Oral
Suspension
is
available in 5% (5
g ciprofloxacin in
100 mL) and 10%
(10 g ciprofloxacin
in
100
mL)
strengths.
Ciprofloxacin Oral
Suspension is a
white to slightly
yellowish
suspension
with
strawberry flavor
which may contain
yellow-orange
droplets.
It
is
composed
of
ciprofloxacin
microcapsules and
diluent which are
Minutes246thMeetingRegistrationBoard
1.
Under Deferred for
review
of
international
availability Cipro formulation.
of M/s Bayer, Italy
has
been
Panel
mentioned.
inspection
Role
of
report
for 2.
grant
of ingredients has not
DML dated been provided.
3.
Ciprofloxacin
14th
25% granules had
December,
been
proposed
2012
earlier. However,
attached.
now
firm
has
proposed
dry
powder suspension
containing
Ciprofloxacin
(base) with water
as diluent which is
different from the
reference
international
brand*.
4. Copy of latest
GMP
report
required.
NOVIDAT
125mg/5ml
Sami
Page104
mixed prior to
dispensing.
The
components of the
suspension
have
the
following
compositions:
Microcapsules–
ciprofloxacin,
povidone,
methacrylic
acid
copolymer,
hypromellose,
magnesium
stearate,
and
Polysorbate 20.
Diluent–mediumchain triglycerides,
sucrose, lecithin,
water, and
strawberry flavor.
Minutes246thMeetingRegistrationBoard
Page105
Evaluator – III
S/N Name
and
address
of
manufacturer /
Applicant
Type of Form
Brand Name
(Proprietary name +
Dosage
Form
+ Initial date, diary
Strength)
Fee
including
differential fee
Composition
Pharmacological
Group
Demanded Price /
Me-too status
Pack size
GMP
status
as
depicted in latest
inspection
report
(with date) by the
Evaluator
Finished
product
Specification
117. M/s
Faas
Pharmaceuticals
(Pvt) Limited, F748/ L S.I.T.E.
Karachi
(Tablet General)
Ciploxin
250mg
Cipro of Byaer Health Approved.
Care
Tablet Form-5
Dy No:977
Each film coated tablet 12-06-2014
contains:
Ciprofloxacin
as 20,000/HCL…..250mg
As per SRO
Anti-Infective
dated
Cipro
of
Bayer
Healthcare Karachi
Inspection of the firm
was conducted on 1803-2014 by the area
FID
and
GMP
compliance was found
satisfactory.
Cipro of Byaer Health Approved.
Care
USP
118. -do-
Ciploxin
500mg
Tablet Form-5
Dy No:975
Each film coated tablet 12-06-2014
contains:
Ciprofloxacin
as 20,000/HCL…..500mg
As per SRO
Anti-Infective
119. -do-
USP
Levoquin
250mg
Dy No:976
Each film coated tablet 12-06-2014
contains:
Levofloxacin
as 20,000/hemihydarte…..250mg
As per SRO
dated
Cipro
of
Bayer
Healthcare Karachi
Levaquin
USFDA
Tablet Form-5
Minutes246thMeetingRegistrationBoard
Remarks on the Decision
formulation (if any)
including
International status
in stringent drug
regulatory agencies /
authorities
Approved Approved.
dated
Leflox of Getz Pharma
Karachi
Page106
Anti-Infective
Manufacturer
120. -do-
Levoquin
500mg
Levaquin
USFDA
Tablet Form-5
Dy No:974
Each film coated tablet 12-06-2014
contains:
Levofloxacin
as 20,000/hemihydarte…..500mg
As per SRO
Anti-Infective
Approved Approved.
dated
Leflox of Getz Pharma
Karachi
Manufacturer
121. -doCapsule (General)
Omezole-D Capsule
Each
contains:-
Form-5
capsule Dy No:974
12-06-2014
Blended pellets of 100,000/Omeprazole
20mg
As per SRO
EC….20mg
Domperidone
IR
….10mg
Anti-Ulcer and AntiEmetic
Manufacturer
Source: M/s Glukem
Pharmaceuticals, Plot
No. 205/2A, IDA,
Phase II, Chedapally,
Hyderabad, India
122. M/s Martin Dow
Limited, Plot No.
37, Sector 19,
Korangi Industrial
Area, Karachi
Not
available
in Deferred till review
of formulation.
stringent SRA,s
dated Me too status is not
submitted by the firm.
a. Evidence
of
approval of same
dosage form and
strength in FDA,
TGA,
EMA,
MHLW,
and
Health Canada is
required.
b. GMP certificate
of the source
(which shall be
legalized)
and
stability studies
as per ZONE-IV
A needs to be
submitted.
Hepa-MerzMerz
Pharmaceuticals
Each sachet conatins:- Dy No. 1067 dated : Germany
L-Ornithine
–L- 30-06-2014
Hepa-Merz of Brookes
Aspartate……3gm
As per brand leader Pharma, Karachi.
Cholagogues
and price/ Pack of 5,10
& 30’s
Hepatic Protectors\
Sparta Sachet
Form-5
Deferred
for
confirmation
of
approval
in
reference Stringent
Regulatory
Agencies & me too
status.
Manufacturer
Minutes246thMeetingRegistrationBoard
Page107
123. -do-
124. -do-
Olyte Sachet
Each sachet contains:Precooked
Rice
Powder ……6gm
Sodium
citrate…..0.58gm
Sodium
chloride…..0.35gm
Potassium
chloride……0.30gm
Evrease Sachet
Doalyte Relief Black Approved.
current
sachet
of
Dy No. 1069 dated : Aventis Pharma UK
30-06-2014
Diarolyte of Sanofi
As per brand leader Avnetis Karachi
price/ Pack of 6,10
& 20’s
Form-5
Fybogel Mebeverine Approved.
of Reckitt Benkiser
Dy No. 1070 dated : UK
Each sachet contains:
Mebeverine
as 30-06-2014
Ispamer Sachet of
Hydrochloride:
Rs.155.52 per pack Getz, Karachi
135mg
of 10’s
Physillium
Rs. 310.50 per pack
Husk…..3.5gm
of 20’s
Antispasmodic
and Rs.465.75 per pack
of 30’s
Laxative
Form-5
Manufacturer
125. M/s Elite Pharma Flucolite
Infusion Form-5
(Pvt) Limited, 9.5 50ml
Dy No. 885 dated :
Km Sheikhupura
25-11-2013
Road Lahore
Each ml contains:Fluconazole……2mg
20,000/Antifungal
Price not submitted
/Pack of 100ml of
Manufacturer
1’s
Diflucan of Pfizer.
Diflucan of
Labs Karachi
Pfizer
Evidence
of
availability of TOC is
required
as
BP
specifications
are
claimed.
Deferred
for
confirmation
of
installation
and
performance
qualification
of
TOC analyser &
Liquid
Particle
Counter by Area
FID.
Panel inspection of the
firm was conducted on
28-01-13 and the
panel recommended
the liquid injectable
infusion (100ml)
Minutes246thMeetingRegistrationBoard
Page108
126. -do-
127. -do-
128. -do-
Percemol
1gm/100ml
Infusion Form-5
Perfalgan of BMS, UK
of
SAMI
Dy No. 883 dated : Provas
Pharmaceuticals
Each 100ml conatins:- 25-11-2013
Karachi
Paracetamol……1gm
20,000/Evidence
of
Analgesic
Price not submitted availability of TOC is
as
BP
/Pack of 100ml of required
Manufacturer
specifications
are
1’s
claimed.
Not
available
in
Capronic
Infusion Form-5
SRA,s.
50mg/ml
Dy No. 883 dated :
Me too is not provided
25-11-2013
Each ml contains:by the company.
Aminocaproic
20,000/acid…..50mg
Evidence
of
Price not submitted availability of TOC is
Hemostatis
as
BP
/Pack of 100ml of required
specifications
are
1’s
claimed.
Elite Reserbelakta
Each ml contains:Sorbitol…..200mg
Sodium
Lactate…..1.9mg
So+dium
chloride…..6mg
Calcium
chloride…..0.1mg
Potassium
Chloride……0.3mg
Magnesium
Chloride…..0.2mg
Hyperosmoler
complex and infusion
solution
Not
available
in
stringent SRA’s. Firm
Dy No. 884 dated : has submitted the
applied product is
25-11-2013
available in Ukraine
(Saorbilactum infusion
20,000/of Yuria Pharma)
Price not submitted which also needs
/Pack of 400ml of verification.
1’s
Firm submitted that
product
is
not
available locally.
Form-5
Evidence
of
availability of TOC is
required
as
BP
specifications
are
claimed.
Deferred
for
confirmation
of
installation
and
performance
qualification
of
TOC analyser &
Liquid
Particle
Counter by Area
FID.
Deferred
for
confirmation
of
following:
1. Installation and
performance
qualification
of
TOC analyser &
Liquid
Particle
Counter by Area
FID.
2. Me too status &
approval
by
referenece
Stringent
Regulatory
Agencies.
Deferred
for
confirmation
of
folowing:
1. Installation and
performance
qualification
of
TOC analyser &
Liquid
Particle
Counter by Area
FID.
2. Me too status &
approval
by
referenece
Stringent
Regulatory
Agencies.
Manufacturer
Minutes246thMeetingRegistrationBoard
Page109
129. -do-
Elite Reserbelakta
Each ml contains:Sorbitol…..200mg
Sodium
Lactate…..1.9mg
Sodium
chloride…..6mg
Calcium
chloride…..0.1mg
Potassium
Chloride……0.3mg
Magnesium
Chloride…..0.2mg
Deferred
for
confirmation
of
folowing:
1. Installation and
performance
qualification
of
TOC analyser &
Liquid
Particle
Counter by Area
FID.
2. Me too status &
approval
by
referenece
Stringent
Evidence
of Regulatory
availability of TOC is Agencies.
required
as
BP
specifications
are
claimed.
Not
available
in
stringent SRA’s. Firm
Dy No. 888 dated : has submitted the
applied product is
25-11-2013
available in Ukraine
(Saorbilactum infusion
20,000/of Yuria Pharma)
Price not submitted which also needs
/Pack of 200ml of verification.
1’s
Firm submitted that
product
is
not
available locally.
Form-5
Hyperosmoler
complex and infusion
solution
Manufacturer
b) Routine applications
Evaluator – II
S/N
Name and address of Brand Name
Type of Form
Remarks on the Decision
manufacturer
/
formulation (if any)
(Proprietary name + Initial date, diary
Applicant
including
Dosage Form +
Fee
including International status
Strength)
in stringent drug
differential fee
regulatory agencies /
Composition
Demanded Price / authorities
Pharmacological
Pack size
Me-too status
Group
GMP
status
as
depicted in latest
inspection
report
(with date) by the
Evaluator
Finished
product
Specification
130.
M/s Maple
Pharmaceuticals (Pvt.)
Ltd., 147/23, Korangi
Faxim-E 200mg
Tablet
Each film coated
Minutes246thMeetingRegistrationBoard
Form-5
15-07-2010
(N/A)
BNF: Xifaxanta
(Norgine)
Approved.
Reference
will be sent
Page110
Industrial Area,
Karachi.
131.
-do-
Tablet contains:Rifaximin
(B.P)…200mg
(Antibacterial)
(Manufacturer’s
Spec.s)
Rs.8,000/-+Rs. 12,000
(14-05-2013)
As per PAC
Nimixa (Getz Pharma)
Faxim 550mg Tablet
Each Tablet
contains:-Rifaximin
(B.P)…550mg
(Antibacterial)
(Manufacturer’s
Spec.s)
Form-5
15-07-2010
(N/A)
Rs.8,000/-+Rs. 12,000
(25-07-2013)
As per PAC
BNF: Xifaxanta
(Norgine)
to B & A
Division,
Overall cGMP
DRAP
for
measures are followed
verification
in the Firm (31-03of photocopy
2014)
of
fee
If
1. Verification
of challan.
photocopies of fee confirmed,
challan
is then
Chairman,
required.
RB
will
permit
issuance of
registration
letter.
Nimixa (Getz Pharma)
Overall cGMP
measures are followed
in the Firm (31-032014)
1. Verification of
photocopies of fee
challan is
required.
132.
M/s Sami
Pharmaceuticlas (Pvt.)
Limited, F-95, S.I.T.E.
Karachi-Pakistan
Neege 20mg Tablets
Each delayed release
Tablet contains:Pantoprazole Sodium
Sesuiquihydrate
equivalent to
Pantoprazole
(USP)…20mg
Minutes246thMeetingRegistrationBoard
Form 5
06-07-2010
Rs.8,000/ (69)
+Rs. 12000 (10-052013)
As Per PRC
BNF. Pantoprazole
(Non-proprietary)
Zentro (Bosch)
Good (28-11-2013)
Very good (24-062014) Grant of
Additional sections
Approved.
Reference
will be sent
to B & A
Division,
DRAP
for
verification
of photocopy
of
fee
challan.
If
confirmed,
then
Chairman,
RB
will
permit
issuance of
registration
letter.
Approved.
Reference
will be sent
to B & A
Division,
DRAP
for
verification
of photocopy
Page111
(Proton Pump
Inhibitor) USP
Spec.s)
Satisfactory (07-112013) Routine
of
fee
challan.
If
confirmed,
1. Verification
of
then
photocopy of fee
Chairman,
of Rs. 12000/- is
RB
will
required.
permit
issuance of
registration
letter.
1. The Routine applications checked by the Field Officers before establishment of Cell
Evaluator - II
S/N
Name
and
address
of
manufacturer/
Applicant
1.
Brand
Name
2.
Dosage
Form
3.
Composition
4.
Pharmacologi
cal
group
1.Type
of
Form
2. Type of
application
3.
Demanded
Price / Pack
size
4.
Initial
date, diary.
5. Date on
which
fee
becomes
complete
according to
type
of
application
/or
Form
(total Fee)
1. Finished
Product
Specification
2. Me-too status
Comments
/ Decision
observation on
the product (if
any)
Registration-II
133. M/s Barrett
Hodgson
Pakistan Pvt.
Ltd. F/423,
SITE, Karachi
1.DutaBar
2.Capsule
3.Each
Capsule
contain:
Dutasteride…
……….0.5mg
4.AlphaReductase
1.Form5
2.Routine
3. Rs.
1200/20’s
4.28/09/2010
Dy. No. 1738
Form 5
Rs. 8000/(Original)
Minutes246thMeetingRegistrationBoard
Me too confirmed
Advodart of GSK
FDA : Avodart Deferred
for
(GSK)
confirmation
of
formualtion in soft
gelatin capsule form.
Reference will
sent to B &
Division, DRAP
verification
Page112
be
A
for
of
134. -do-
Inhibitors
21-5-2013
Rs.12,000/(Photo copy)
1.MindSet
2.Capsules
3.Each
Capsule
contains:
Ziprasidone
……….20mg
4.Atypical
AntiPsychotropic
Agent
1.Form5
2.Routine
3. Rs.
900/14’s
4.28/09/2010
Dy. No. 1742
Form 5
Rs. 8000/(Original)
21-5-2013
Rs.12,000/(Photo copy)
135. -do1.MindSet
2.Capsules
3.Each
Capsule
contains:
Ziprasidone…
…….40mg
4.Atypical
AntiPsychotropic
Agent
136. -do1.MindSet
2.Capsules
3.Each
Capsule
contains:
Ziprasidone
……….60mg
4.Atypical
AntiPsychotropic
Agent
137. -do-
1.MindSet
2.Capsules
3.Each
1.Form5
2.Routine
3. Rs.
1500/14’s
4.28/09/2010
Dy. No. 1741
Rs. 8000/(Original)
21-5-2013
Rs.12,000/(Photo copy)
1.Form5
2.Routine
3. Rs.
2100/14’s
4.28/09/2010
Dy. No. 1740
Rs. 8000/(Original)
21-5-2013
Rs.12,000/(Photo copy)
1.Form5
2.Routine
3. Rs.
Minutes246thMeetingRegistrationBoard
photocopy of fee
challan.
If
confirmed,
then
Chairman, RB will
permit issuance of
registration letter.
Me
too
confirmed.
status FDA : Geodon Approved
with
(Pfizer)
change in applied
brand name.
Reference will be
sent to B & A
Division, DRAP for
verification
of
photocopy of fee
challan.
If
confirmed,
then
Chairman, RB will
permit issuance of
registration letter.
Me
too
status FDA : Geodon Approved
with
confirmed.
(Pfizer)
change in applied
brand name.
Reference will be
sent to B & A
Division, DRAP for
verification
of
photocopy of fee
challan.
If
confirmed,
then
Chairman, RB will
permit issuance of
registration letter.
Ziprox of Nabi FDA : Geodon Approved
with
qasim
(Pfizer)
change in applied
brand name.
Reference will be
sent to B & A
Division, DRAP for
verification
of
photocopy of fee
challan.
If
confirmed,
then
Chairman, RB will
permit issuance of
registration letter.
Me
too
status FDA : Geodon Approved
with
confirmed
(Pfizer)
change in applied
brand name.
Page113
138. M/s Macter
International Ltd.
F-216, SITE,
Karachi
139. -do-
140. -do-
141. -do-
Capsule
contains:
Ziprasidone…
…….80mg
4.Atypical
AntiPsychotropic
Agent
2800/14’s
4.28/09/2010
Dy. No. 1739
Rs. 8000/(Original)
21-5-2013
Rs.12,000/(Photo copy)
1.Amlotel
2.Tablet
3.Each tablet
contains:
Telmisartan…
…………….4
0mg
Amlodipine…
…………..….
5mg
4.antihyperten
sive
1.Amlotel
2.Tablet
3.Each tablet
contains:
Telmisartan…
…………….8
0mg
Amlodipine…
…………..….
5mg
4.antihyperten
sive
1.Amlotel
2.Tablet
3.Each tablet
contains:
Telmisartan…
…….40mg
Amlodipine…
………10mg
4.antihyperten
sive
1.Form5
2.Routine
3.14’s / As
per PRC
4.22/09/2010
Dy. No. 1709
Rs. 8000/(Original)
22-5-2013
Rs.12,000/(Not
attached)
1.Form5
2.Routine
3.14’s / As
per PRC
4.22/09/2010
Dy. No. 1708
Rs. 8000/(Original)
22-5-2013
Rs.12,000/(Not
attached)
1.Form5
2.Routine
3.14’s / As
per PRC
4.22/09/2010
Dy. No. 1710
Rs. 8000/(Original)
22-5-2013
Rs.12,000/(Not
attached)
1.Form5
2.Routine
3.14’s / As
1.Amlotel
2.Tablet
3.Each tablet
Minutes246thMeetingRegistrationBoard
Me too confirmed
Reference will be
sent to B & A
Division, DRAP for
verification
of
photocopy of fee
challan.
If
confirmed,
then
Chairman, RB will
permit issuance of
registration letter.
FDA: Generic Approved.
(TORRENT
Reference will be
PHARMS LTD) sent to B & A
Division, DRAP for
verification
of
photocopy of fee
challan.
If
confirmed,
then
Chairman, RB will
permit issuance of
registration letter.
Me too confirmed
FDA: Generic Approved.
(TORRENT
Reference will be
PHARMS LTD) sent to B & A
Division, DRAP for
verification
of
photocopy of fee
challan.
If
confirmed,
then
Chairman, RB will
permit issuance of
registration letter.
Me too confirmed
FDA: Generic Approved.
(TORRENT
Reference will be
PHARMS LTD) sent to B & A
Division, DRAP for
verification
of
photocopy of fee
challan.
If
confirmed,
then
Chairman, RB will
permit issuance of
registration letter.
Me
too
confirmed
status FDA: Generic Approved.
(TORRENT
Reference will be
PHARMS LTD) sent to B & A
Page114
142. -do-
143. M/s Nabiqasim
Industries Pvt
Ltd. 17/24,
Korangi
industrial Area,
Karachi.
144. -do-
per PRC
4.22/09/2010
Dy. No. 1707
Rs. 8000/(Original)
22-5-2013
Rs.12,000/(Not
attached)
1.Form5
2.Routine
3. 60ml/As
per PRC
4.22/09/2010
Dy. No. 1711
Rs. 8000/(Original)
22-5-2013
Rs.12,000/(Not
attached)
1.Qutex
2.Tablet
3.Each film
coated tablet
contains:
Quetiapine
fumarate eq to
quetiapine.100
mg
4.anti
psychotic,
dibenzothiaze
pine)
Specs:
NabiQasim
1.Bepcor
2.Tablet
3.Each film
coated tablet
contains:
Bosentan (as
monohydrate)
…………...12
5mg
1.Form5
2.Routine
3. 10’s, 30’s/
As per PRC
4.16/09/2010
Dy. No. 1699
Rs. 8000/(Original)
14-5-2013
Rs.12,000/(Photo copy)
for
Rovinac of Rock Int. avail not Deferred
of
pharmaceutical
confirmed in Str confirmation
approval in reference
DRAs.
Stringent Regulatory
Agencies.
Psychotropic
Reference will be
precursor
sent to B & A
Division, DRAP for
(For
verification
of
Psychotropic
photocopy of fee
Precursors,
there is no challan.
requirement
for dedicated /
separate
manufacturing
facility)
Me
too
status FDA: Generic Approved.
confirmed
(DR. REDDYS Reference will be
LABS LTD)
sent to B & A
Division, DRAP for
verification
of
photocopy of fee
challan.
If
confirmed,
then
Chairman, RB will
permit issuance of
registration letter.
1.Form5D
2.Routine
3. Rs.
30,000/10’s
4.16/09/2010
Dy. No. 1690
Rs. 15000/(Original)
14-5-2013
FDA: Tracleer
1. It is a me too
2. At the time of
filing application,
the drug was new.
The firm submitted
Form 5-D with fee
Rs. 15,000/-. Now
the
drug
has
become registered.
Minutes246thMeetingRegistrationBoard
Division, DRAP for
verification
of
photocopy of fee
challan.
If
confirmed,
then
Chairman, RB will
permit issuance of
registration letter.
contains:
Telmisartan…
…………….8
0mg
Amlodipine…
…………..….
10mg
4.antihyperten
sive
1.Prophed
2.Suspension
3.Each 5ml
contains:
Ibuprofen.100
mg
Pseudoephedri
ne
HCI……15mg
4.Pain reliever
/fever reducer
nasal
decongestant)
Approved.
Reference will be
sent to B & A
Division, DRAP for
verification
of
photocopy of fee
challan.
If
confirmed,
then
Chairman, RB will
Page115
4.Pulmonary
arterial
hypertension)
(PAH),
systemic
sclerosis with
ongoing
digital ulcer
disease
Specs:
NabiQasim
1.Qrist
2.Tablets
3.Each
extended
release tablet
contains:
Desvenlafaxin
e succinate eq
to
desvenlafaxine
……….50mg
4.Antidepressa
nt
Specs:
NabiQasim
Rs.5000/(Photo copy)
The
firm
has
submitted the from
5.
permit issuance of
registration letter.
1. Form 5
2.Routine
3. 10’s, 14’s,
/
As per PRC
4.16/09/2010
Dy. No. 1689
Rs. 8000/(Original)
14-5-2013
Rs.12,000/(Photo copy)
Approved.
Reference will be
sent to B & A
Division, DRAP for
verification
of
photocopy of fee
challan.
If
confirmed,
then
Chairman, RB will
permit issuance of
registration letter.
146. -do-
1.Qrist
2.Tablets
3.Each
extended
release tablet
contains:
Desvenlafaxin
e succinate eq
to
desvenlafaxine
………..….10
0mg
4.antidepressa
nt
Specs:
NabiQasim
1. Form 5
2.Routine
3.
10’s,14’s/As
per PRC
4.16/09/2010
Dy. No. 1693
Rs. 8000/(Original)
14-5-2013
Rs.12,000/(Photo copy)
147. -do-
1.Qutex
2.Tablet
3.Each film
coated tablet
1. Form 5
2.Routine
3.
10’s,30’s/As
1.Me too status FDA : Khedezla
confirmed
Denla
XR
50mg&100mg of
M/s
Semos
Pharma,
(Reg.No.070433&0
70434)
2.The firm has
submitted
the
undertaking
regarding
submission
of
comparative
dissolution profile
before marketing of
the product
1.Me too status FDA: Kheedezla
confirmed
Denla
XR
50mg&100mg of
M/s
Semos
Pharma,
(Reg.No.070433&0
70434)
2.The firm has
submitted
the
undertaking
regarding
submission
of
comparative
dissolution profile
before marketing of
the product
Me
too
status FDA: Seroquel
confirmed
145. -do-
Minutes246thMeetingRegistrationBoard
Approved.
Reference will be
sent to B & A
Division, DRAP for
verification
of
photocopy of fee
challan.
If
confirmed,
then
Chairman, RB will
permit issuance of
registration letter.
Approved.
Reference will be
sent to B & A
Division, DRAP for
Page116
contains:
Quetiapine
fumarate eq to
quetiapine..25
mg
4.anti
psychotic,
dibenzothiaze
pine
Specs:
NabiQasim
148. -do-
1.Qutex
2.Tablet
3.Each film
coated tablet
contains:
Quetiapine
fumarate eq to
quetiapine.200
mg
4.anti
psychotic,
dibenzothiaze
pine
Specs:
NabiQasim
149. -do-
1.Bepcor
2.Tablet
3.Each film
coated tablet
contains:
Bosentan (as
monohydrate)
……..62.5mg
4.Pulmonary
arterial
hypertension
(PAH)
Specs:
NabiQasim
1. Form 5
2.Routine
3. 10’s, 30’s /
As per PRC
4.16/09/2010
Dy. No. 1695
Rs. 8000/(Original)
14-5-2013
Rs.12,000/(Photo copy)
Me
too
confirmed
1. Form 5
2.Routine
3. Rs.
19000/10’s
4.16/09/2010
Dy. No. 1696
Rs. 15000/(Original)
14-5-2013
Rs.5000/(Photo copy)
1. It is a me too.
Minutes246thMeetingRegistrationBoard
verification
of
photocopy of fee
challan.
If
confirmed,
then
Chairman, RB will
permit issuance of
registration letter.
per PRC
4.16/09/2010
Dy. No. 1698
Rs. 8000/(Original)
14-5-2013
Rs.12,000/(Photo copy)
status FDA: Seroquel
Approved.
Reference will be
sent to B & A
Division, DRAP for
verification
of
photocopy of fee
challan.
If
confirmed,
then
Chairman, RB will
permit issuance of
registration letter.
FDA: Tracleer
Approved.
Reference will be
sent to B & A
Division, DRAP for
verification
of
photocopy of fee
challan.
If
confirmed,
then
Chairman, RB will
permit issuance of
registration letter.
2. The firm has
now
submitted
form 5.
Page117
Registration-V
150.
M/s Care
Pharmaceuticals,
8Km, Thokor
Raiwind Road,
Lahore
1.Sinocare
2.Cream
3.Each gm
contains:
Fluocinolone
acetonide..2.5
mg
4.Corticosteroi
d
151.
-do-
1.Fusidcare
2.Cream
3.Each gm
contains:
Fusidic Acid
(2%)…….20
mg
4.Antibacterial
152.
-do-
1.Clomezole
2.Cream
3.Each gm
contains:
Clotrimazole
………….10
mg
4.Antifungal
153. M/s CCL
Pharmaceuticals,
Pvt. Ltd.
62-Industrial
Estate, Kot
Lakhpat, Lahore
1.Cip
2.Suspension
3.Each 5ml
contains:
Ciprofloxacin
hydrochloride
eq. to
ciprofloxacin
…..................1
25mg
4.Antibiotic.
1.Form5
2.Routine
3.Rs.50/15g
m,
Rs.90/30gm
4.30-09-2010
Dy.No.4032
Rs.8000/Rs.12,000/13-5-2013
1.Form5
2.Routine
3.Rs.65/5gn,
Rs.165/15gm
4.30-09-2010
Dy.No.4033
Rs.8000/15-05-2013
Rs.12,000/1.Form5
2.Routine
3.
Rs.41/10gn,
Rs.70/20gm
4.30-09-2010
Dy.No.4029
Rs.8000/15-05-2013
Rs.12,000/1.Form5
2.Routine
3.60ml/ Price
not
mentioned
4.06-09-2010
Rs.8000/(Photo copy)
20-05-2013
20-05-2013
Rs.12,000/(Original)
Minutes246thMeetingRegistrationBoard
Reply has
received.
been FDA:
(Taro)
Reply
is
still
awaited.
The
firm
was
communicated
twice. They have
stated that they are
no more interested
in the product
registration.
Reply
is
still
awaited.
The
firm
was
communicated
twice. They have
stated that they are
no more interested
in the product
registration.
Generic Deferred
for
confirmation
of
steroidal section.
BNF:
(Leo)
Fucidin Last reminder will be
issued to the firm for
rectification
opf
shortcomings.
FDA:
(Taro)
Generic Last reminder will be
issued to the firm for
rectification
opf
shortcomings.
FDA:
Cipro Deferred for review
of formulation by
(Different
Review Committee.
formulation)
The originator’s
(M/s
Bayer)
formulation
contains
ciprofloxacin in
base
form,
however
the
firm
has
submitted that a
number
of
products
in
Page118
154. M/s Schazoo
Pharmaceuticals
Laboraories Pvt.
Ltd. Kaolawala
Stop, 20, KM
Jaranwala Road,
District
Shehikhupura.
1.Cavrex
2.Tablet
3.Each film
coated tablet
contains:
Entecavir as
monohydrate
(M.S)……1
mg
4.Anti viral.
1.Form5
2.Routine
3.Rs.15,000/
30’s
4.24-09-2010
Rs.8000/(Original)
28-05-2013
Rs.12,000/(Original)
155. -do-
1.Ceretek
2.Injection
3.Each 1ml
contains:
Haloperidol as
lactate…5mg
4.Anti
Psychotic
156. -do-
1.Ceretek
2.Tablet
3.Each tablet
contains:
Haloperidol
Usp……….20
mg
4. Anti
Psychotic
1.Form5
2.Routine
3.Rs.300/(2x
5) 1ml
Ampoule
4.24-09-2010
Rs.8000/(Original)
28-05-2013
Rs.12,000/(Original)
1.Form5D
2.Routine
3.Rs.300/3x1
0’s
4.24-09-2010
Rs.8000/(Original)
28-05-2013
Rs.12,000/(Original)
Minutes246thMeetingRegistrationBoard
Tacavair of
Consolidated
chemical Lab.
Pakistan
are
registered
in
which
ciprofloxacin is
present in HCl
form. The firm
has
also
provided
labeling
and
outer packaging
of
Novidate
(product of Sami
pharmaceuticals,
Karachi) which
confirms
the
stance of the
firm.
M/s FDA: Baraclude Approved.
Me too status
confirmed
for
FDA: Generic Deferred
(Sagent Pharms) confirmation
of
Me too status installation
and
confirmed
operational
qualification of TOC
analyser & Liquid
Particle Counter by
area FID.
1. It is new drug.
2. Differential fee
of Rs. 30,000/- is
required to be
deposited by the
applicant.
FDA: Generic Deferred
for
(Sandoz)
submission
of
differential
fee,
The firm has assessment
of
been asked for stability studies &
submission of opinion
by
the
fee.
Her experts.
responses still
awaited.
Page119
Registration – II
157. M/s Genix
Pharma (Pvt.)
Ltd;
44, 45-B,
Korangi Creek
Road,
Karachi
Diphos Dry
Suspension
Each 5ml
contains:
Dihydroartemi
sinin………15
mg
Piperaquine
Phosphate…
…...…120mg
158.
-do-
159.
-do-
Diphos DS
Sachet
30/240mg
Each Sachet
contains:
Dihydroartemi
sinin
(Ph.I)….30mg
Piperaquine
Phosphate
Anhydrous…
….….. 240mg
1.Diphos
2. Syrup
3.Each 5ml
contains:
Dihydroartemi
sinin……..15
mg
Piperaquin
Phosphate
………120mg
4.Anti
Malarial
1.Form5
2.Routine
3. 30 ml Rs.
250/60 ml Rs.
500/80 ml Rs.
667/4.14-09-2010
5.Dy. No.72
Rs.8,000/Rs.12,000/21-05-2013
1.Form5
2. Routine
3. per sachet
Rs. 45/10’s Rs.450/16’s Rs.
720/4.14-09-2010
5.Dy. No.64
Rs.8,000/Rs.12,000/(21-5-2013)
Me too confirmed
1.Form5-D
2. Routine
3. 30 ml Rs.
250/60 ml Rs.
500/80 ml Rs.
667/4.14-09-2010
Dy. No.73
Rs.8,000/Rs.12,000/(21-5-2013)
1. Me too status Int. avail not Deferred for views
needs confirmation confirmed in Str of recommendations
of WHO.
DRAs.
Minutes246thMeetingRegistrationBoard
Int. avail not Deferred for views
confirmed
in of recommendations
Stringent DRAs. of WHO.
The firm has
submitted
reference of Me
too as Poart
susp. of Neutro
pharma (62770)
1. Me too status Int. avail not Deferred for views
needs confirmation confirmed in Str of recommendations
DRAs.
of WHO.
Page120
160.
-do-
1.Diapil
2.Tabs
3.Each film
coated tablet
contains:
Saxagliptin
HCl e.q to
Saxagliptin…
…….…5mg
4.Anti Diabetc
161.
-do-
162.
-do-
1.Diapil
2.Tablet
3.Each film
coated tablet
contains:
Saxagliptin
HCl e.q to
Saxagliptin…
……..……2.5
mg
4. Anti
Diabetc
1.Diphos DS
2.Tablet
3.Each Tablet
contains:
Dihydroartemi
sinin
(Ph.I)…….80
mg
Piperaquine
Phosphate
(M.S) 640mg
4.Anti
Malarial
1.Form5D
2.Routine
3. Rs.
4500/10’s
Rs. 9000/20’s
Rs.
13500/30’s
4.14/09/2010
Dy. No. 1684
Rs. 15000/Rs.12,000/21-5-2013
1.Form5D
2.Routine
3. Rs.
2500/10’s
Rs. 5000/20’s
Rs. 7500/30’s
4.14/09/2010
Dy. No. 1681
Rs. 15000/Rs.12,000/21-5-2013
Gliplyza
5mg FDA: Onglyza
Tablet,
Regn
no.076316,
M/s
Macter int, Karachi
Approved
Gliplyza
2.5mg FDA: Onglyza
Tablet,
Regn
no.076316,
M/s
Macter
int,
Karachi.
Approved
1.Form-5 D
2.Routine
3. Rs.800/8’s
4.14/09/2010
Dy. No. 67
(Moh)
Rs. 8000/Rs.12,000/21-5-2013
Me too status needs Int. avail not Deferred for views
confirmation.
confirmed in Str of recommendations
DRAs.
of WHO.
Minutes246thMeetingRegistrationBoard
Page121
163.
-do-
164.
1.Diphos DS
2.Suspension
3.Each 5ml
contains:
Dihydroartemi
sinin
(PhI)….30mg
Piperaquine
Phosphate
Anhydrous…
……..…240m
g
4.Anti
Malarial
M/s Noa Hemis
Pharmaceuticals,
Plot No. 154,
Sector-23, Korangi
Industrial Area,
Karachi-74900
1.Form-5
2.Routine
3. Rs.
450/10’s
Rs. 720/16’s
4.16/09/2010
Dy. No. 69
(Moh)
Rs. 8000/Rs.12,000/21-5-2013
Loxicam 4mg
Tablet
Each film coated
tablet contains:
Lornoxicam
…………4 mg
(NSAID)
Me too status needs Int. avail not Deferred for views
confirmation.
confirmed in Str of recommendations
DRAs.
of WHO.
Form-5
30-7-2010
Dy.No.1507
Rs.8000/-+Rs.
12000/- (10-0513)
Rs.1200/-/10’s
(Manufacturer’s
Spec.s)
165.
-do-
Loxicam-DS 8mg
Tablet
Each film coated
tablet contains:
Lornoxicam
…………8 mg
Minutes246thMeetingRegistrationBoard
Form-5
30-7-2010
Dy.No.1505
Rs.8000/+Rs. 12000/-
The
formulation
found to be EMA
approved
but
appeared as not
confirmed in the
agenda erroneously.
Xefast (Pharmevo)
Good (09-06-2014)
2. Verification
of
photocopy of fee
of Rs. 8000/- is
required.
3. International
availability
in
stringent DRA,s
not confirmed.
The
formulation
found to be EMA
approved
but
appeared as not
confirmed in the
agenda erroneously.
Xefast (Pharmevo)
Approved (as found
approved by EMA).
Reference will be sent
to B & A Division,
DRAP for verification
of photocopy of fee
challan. If confirmed,
then Chairman, RB
will permit issuance of
registration letter.
Approved (as found
approved by EMA).
Reference will be sent
to B & A Division,
DRAP for verification
of photocopy of fee
challan. If confirmed,
then Chairman, RB
will permit issuance of
Page122
(NSAID)
(Manufacturer’s
Spec.s)
166.
-do-
Resipa 1mg Tablet
Each film coated
tablet contains:
Risperidone …1
mg
(Antipsychotic)
(Manufacturer’s
Spec.s)
167.
-do-
Resipa 2mg Tablet
Each film coated
tablet contains:
Risperidone…2 mg
(Antipsychotic)
(Manufacturer’s
Spec.s)
168.
-do-
Resipa 3mg Tablet
Each film coated
tablet contains:
Risperidone ...3 mg
Minutes246thMeetingRegistrationBoard
(10-05-13)
Good (09-06-2014)
registration letter.
Rs.2300/-/10’s
1. Verification
of
photocopy of fee
of Rs. 8000/- is
required.
2. International
availability
in
stringent DRA,s
not confirmed.
Form-5
BNF : Risperdal
Approved. Reference
will be sent to B & A
30-7-2010
(Janssen)
Division, DRAP for
verification
of
Dy.No.1500
Risperdal
photocopy of fee
challan. If confirmed,
Rs.8000/-+Rs. (Janssen)
then Chairman, RB
12000/- (14-05Good
(09-06-2014)
will permit issuance of
13)
registration letter.
1. Verification
of
As per PRC
photocopy of fee
of Rs. 8000/- is
required.
Form-5
BNF : Risperdal
30-7-2010
(Janssen)
Dy.No.1509
Risperdal
Rs.8000/-+Rs. (Janssen)
12000/- (14-0513)
Good (09-06-2014)
As per PRC
1. Verification
of
photocopy of fee
of Rs. 8000/- is
required.
Form-5
BNF : Risperdal
30-7-2010
(Janssen)
Dy.No.1503
Risperdal
Rs.8000/-+Rs.
Approved Reference
will be sent to B & A
Division, DRAP for
verification
of
photocopy of fee
challan. If confirmed,
then Chairman, RB
will permit issuance of
registration letter.
Approved Reference
will be sent to B & A
Division, DRAP for
verification
of
photocopy of fee
challan. If confirmed,
Page123
(Antipsychotic)
(Manufacturer’s
Spec.s)
169.
-do-
Gasiton 50mg
Tablet
Each tablet
contains:
Itopride
Hydrochloride……
…….50 mg
(Gastroprokinetic)
(Manufacturer’s
Spec.s)
170.
-do-
Etecav 0.5 mg
Tablet
Each film coated
tablet contains:
Entecavir (as
monohydrate)……
……...0.5 mg
(Anti Viral)
(Manufacturer’s
Spec.s)
Minutes246thMeetingRegistrationBoard
12000/- (14-05- (Janssen)
then Chairman, RB
13)
will permit issuance of
Good (09-06-2014)
registration letter.
As per PRC
1. Verification
of
photocopy of fee
of Rs. 8000/- is
required.
Form-5
Not confirmed
Deferred for review
of formulation by
30-7-2010
GANATON
Review Committee.
(ABBOTT)
Dy.No.1508
Good (09-06-2014)
Rs.8000/-+Rs.
of
12000/- (10-05- 1. Verification
photocopy of fee
13)
of Rs. 8000/- is
As per PRC
required.
2. International
availability
in
stringent DRA,s
not confirmed.
3. Formulation
is
under review by
the
review
committee.
Form-5
BNF : Baraclude
Deferred for product
(Bristol-Myers
specific inspection by
30-7-2010
Squibb)
panel comprising of
Director DTL Karachi,
Dy.No.1506
Centauru S
DDG (E & M) & area
(Ferozsons)
FID.
Rs.8000/-+Rs.
12000/- (10-05Good (09-06-2014)
13)
As per PRC
1. Verification
of
photocopy of fee
of Rs. 8000/- is
required.
2. Amount of active
drug is very less
(500mcg), may be
considered
for
Product specific
Page124
171.
-do-
Proxat 20mg Tablet
Each film coated
tablet contains:
Paroxetine (as
HCl)…..…20 mg
(Antidepressant,
selective serotonin
reuptake inhibitor)
Form-5
inspection.
BNF : Seroxat (GSK)
Form-5
Not confirmed
Approved. Reference
will be sent to B & A
30-7-2010
Seroxat (GSK)
Division, DRAP for
verification
of
Dy.No.1504
photocopy
of
fee
Good (09-06-2014)
challan. If confirmed,
Rs.8000/-+Rs.
1.
Verification
of
then Chairman, RB
12000/- (10-05photocopy
of
fee
will permit issuance of
13)
of Rs. 8000/- is registration letter.
As per PRC
required.
(B.P Spec.s)
172.
-do-
Muscolex 4mg
Capsule
Each capsule
contains:
Thiocolchicoside…
…..4 mg
(Muscle relaxant)
(Manufacturer’s
Spec.s)
173.
-do-
Gabagyl 200mg
Capsule
Each capsule
contains:
Gabapentin………
……...200 mg
(Anticonvulsant)
(Manufacturer’s
Minutes246thMeetingRegistrationBoard
30-7-2010
Muscoril (Searle)
Deferred for review of
formulation by
Review Committee.
Dy.No.1502
Good (09-06-2014)
Rs.8000/-+Rs.
of
12000/- (10-05- 1. Verification
photocopy
of
fee
13)
of Rs. 8000/- is
As per PRC
required.
2. International
availability
in
stringent DRA,s
not confirmed.
3. Formulation
is
under review by
the
review
committee.
Form-5
Gebapentin in 200mg
Deferred
for
strength Not found in
confirmation
of
30-7-2010
FDA & UK
approval in reference
Stringeny Regulatory
Dy.No.1510
Gabin of PharmEvo
Agencies.
Rs.8000/-+Rs.
12000/- (10-05- Good (09-06-2014)
13)
1. Verification
of
As per PRC
photocopy of fee
of Rs. 8000/- is
Page125
Spec.s)
174.
-do-
Zofen 0.25mg/5ml
Syrup
Each 5ml contains:
Pizotifen( as
Hydrogen
Maleate)…………
………………..0.2
5 mg
(Appetite
stimulant)
(Manufacturer’s
Spec.s)
Minutes246thMeetingRegistrationBoard
required.
2. International
availability
in
stringent DRA,s
not confirmed.
Form-5
BNF : Sanomigran
Rejected
on
the
(Novartis)
grounds
that
the
30-7-2010
applicant applied the
Not confirmed
formulation for wrong
Dy.No.1501
pharmacological
Good (09-06-2014)
indication.
Rs.8000/-+Rs.
12000/- (10-05- 1. Verification
of
13)
photocopy of fee
of Rs. 8000/- is
As per PRC
required.
2. The
firm
has
applied
the
formulation
as
appetite stimulant
which
is
not
rational.
Page126
2. Veterinary applications
S/N
Name of
Applicant
175.
M/s. Nawan
Laboratories
(Pvt) Ltd.,
Karachi.
Name of Drug(s) /
Composition
Price/Pack
Size
Shelf Life
Date of
application
receiving.
Decision
Pameron Injection
Decontrolled
10ml
50ml
100ml
2 years
24-12-2010
Deferred for confirmation
of
installation
and
operational qualification of
TOC analyser and Liquid
Particla Counter, Me-too
status & GMP status of the
firm.
Each ml contains:Methampyrone…
…………100mg
Rs.8000 + Rs.
12000 =
Rs.20,000/-
Chlorpheniramine
Maleate…..1mg
Caffeine……10mg
(Antipyretic and
Analgesic).
176.
M/s. Mallard
Pharmaceutic
als (Pvt) Ltd.,
Multan.
Shina Gold Drench
Decontrolled
Each ml contains:-
100ml
Oxyclozanide……
….…..62.50mg
250ml
Oxfendazole……
…….…25mg
Cobalt
Sulphate…..2mg
2 years
15-12-2010
Rs.8000 + Rs.
12000 =
Deferred for name change,
Me-too & GMP status of
the firm.
Rs.20,000/-
500ml
1000ml
2.5 Liter
Sodium
Selenite……0.5mg
(Anthelmentic).
177.
M/s. Mallard
Pharmaceutic
als (Pvt) Ltd.,
Multan.
Shinazan Plus
Drench
Each ml contains:-
Decontrolled
100ml
150ml
Oxyclozanide……
……...30mg
250ml
Levamisole
500ml
Minutes246thMeetingRegistrationBoard
2 years
15-12-2010
Rs.8000 + Rs.
12000 =
Deferred for name change,
Me-too & GMP status of
the firm.
Rs.20,000/-
Page127
HCI………...15mg
1000ml
Cobalt
Sulphate………....
0.75mg
2.5 Liter
Sodium
Selenite……..…..0
.35mg
Vitamin
K……………....3
mg
(Anthelmentic).
178.
M/s. Mallard
Pharmaceutic
als (Pvt) Ltd.,
Multan.
Shina Fax Liquid
Decontrolled
Each ml contains:-
100ml
Oxfendazole……
…..22.65mg
250ml
Zinc
Sulphate………2.6
mg
(Anthelmentic).
179.
M/s. Mallard
Pharmaceutic
als (Pvt) Ltd.,
Multan.
Shina Zole 12.5%
SC Liquid
Each ml contains:Albendazole……
………..125mg
Sodium Selenite
………..1.67mg
Cobalt
Sulphate…………
0.50mg
2 years
15-12-2010
Rs.8000 + Rs.
12000 =
Deferred for name change,
Me-too & GMP status of
the firm.
Rs.20,000/-
450ml
500ml
1000ml
2.5 Liter
Decontrolled
30ml
100ml
250ml
2 years
15-12-2010
Rs.8000 + Rs.
12000 =
Deferred for name change,
Me-too & GMP status of
the firm.
Rs.20,000/-
500ml
1000ml
2.5 Liter
(Anthelmentic).
Minutes246thMeetingRegistrationBoard
Page128
180.
M/s. Sanna
Laboratories,
Faisalabad.
Sanoxicam
Injection
Decontrolled
10ml
30ml
50ml
100ml
2 years
SCS-Forte
Injection
Each ml contains:Colistin
Sulphate……...1
MIU
(Polymyxin
Antibiotic).
Sanacol-50 Water
Soluble Powder
Each gram
contains:Colistin
Sulphate…….50,0
0,000 IU
(Polymyxin
Antibiotic).
Decontrolled
50ml
100ml
2 years
Decontrolled
100gm
300gm
500gm
1 Kg
2 years
ECS-150 Oral
Liquid
Each 100ml
contains:Enrofloxacin
…………10gm
Colistin
Sulphate…50,000,
000 IU
(Antibiotic).
Decontrolled
100ml
500ml
1 Liter
2 years
Each ml contains:Meloxicam...7.5mg
30-12-2010
Rs.8000 + Rs.
12000 =
Deferred for Me-too &
GMP status of the firm.
Rs.20,000/-
(Analgesic).
181.
182.
183.
M/s. Sanna
Laboratories,
Faisalabad.
M/s. Sanna
Laboratories,
Faisalabad.
M/s. Sanna
Laboratories,
Faisalabad.
Rs.8000 + Rs.
12000 =
Deferred for Me-too &
GMP status of the firm.
Rs.20,000/-
Minutes246thMeetingRegistrationBoard
30-12-2010
30-12-2010
Rs.8000 + Rs.
12000 =
Deferred for Me-too &
GMP status of the firm.
Rs.20,000/-
30-12-2010
Rs.8000 + Rs.
12000 =
Deferred for Me-too &
GMP status of the firm.
Rs.20,000/-
Page129
Evaluator – I
S. N
Name
and
address
of
Manufacturer /
Applicant
Type of Form
Brand Name
(Proprietary
date,
name + Dosage Initial
form + Strength) diary.
Composition
Remarks /
International
status
in Observations
stringent
regulatory
agencies
Decision
Fee including
Me-too status
differential fee
Pharmacological
Group
GMP status as
Demanded
in
Price / Pack depicted
inspection
Finished product size
report (dated)
specification
184.
M/s Ray Pharma
(Pvt.) Ltd, S-58,
S.I.T.E.
Extension
Hawksbay
Road, Karachi
Raylox Tablet
Form 5
Film Coated
Tablet
10’s /Rs.299/-
Each Film Coated
Tablet Contains.
Levofloxacin as
Hemihydrate
..........750mg
(Quinolone group
Antibacterial)
Manufacturers
Specifications
Dy. No. Not
mentioned
(Duplicate
Dossier)
Dossier dated
29-06-2010
Rs.8000/- (1705-2010)
LEVAQUIN
750mg
Film
coated tablet
US FDA
Approved.
LEFLOX
750mg
Getz
Inspection report
dated 06/05/2014
good level of
GMP compliance
reported.
Dy. No. Not
mentioned
Rs.12,000/dated 26-092013 (Fee
challans are
duplicate)
Total
Rs.20,000/-
185.
M/s Ray Pharma
(Pvt.) Ltd, S-58,
S.I.T.E.
Extension
Hawksbay
Road, Karachi
Rayart DS Tablet
Form 5
Tablet
8’s /Rs.264/-
Each Tablet
Contains.
Dy. No. Not
mentioned
(Duplicate
Minutes246thMeetingRegistrationBoard
ARTHEGET
40/240mg tablet
Getz
Approved
Inspection report
dated 06/05/2014
good level of
Page130
Artemether
……….40mg
Lumefantrine……
.240mg
Dossier)
Dossier dated
29-06-2010
Rs.8000/- (1705-2010)
(Anti Malarial)
Dy. No. Not
mentioned
Rs.12,000/dated 26-092013 (Fee
challans are
duplicate)
Manufacturers
Specifications
GMP compliance
reported.
Total
Rs.20,000/186.
M/s Ray Pharma
(Pvt.) Ltd, S-58,
S.I.T.E.
Extension
Hawksbay
Road, Karachi
Rayart Tablet
Form 5
Tablet
4’s /Rs.220/-
Each Tablet
Contains.
Dy. No. Not
mentioned
(Duplicate
Dossier)
Dossier dated
19-07-2010
Rs.8000/- (1705-2010)
Artemether
……….80mg
Lumefantrine……
.480mg
(Anti Malarial)
Manufacturers
Specifications
ARTHEGET
80/480mg tablet
Getz
Approved.
Inspection report
dated 06/05/2014
good level of
GMP compliance
reported.
Dy. No. Not
mentioned
Rs.12,000/dated 26-092013 (Fee
challans are
duplicate)
Total
Rs.20,000/-
187.
M/s Ray Pharma Rayaz Tablet
(Pvt.) Ltd, S-58,
S.I.T.E.
Form 5
3’s /Rs.160/Dy. No. Not
Minutes246thMeetingRegistrationBoard
ZITHROMAX
500mg tablets
US FDA
Approved.
Page131
Extension
Hawksbay
Road, Karachi
Tablet
Each Film Coated
Tablet Contains.
Azithromycin as
dihydrate
………………….
500mg
(Macrolide
Antibiotic)
Manufacturers
Specifications
188.
M/s
Macter Micam
International
(Pvt.) Ltd. F- Tablet
216,
S.I.T.E.,
Each film coated
Karachi
tablet Contains:Lornoxicam
…..4mg
(Analgesic and
antiinflammatory)
189.
M/s
Bosch
Pharmaceutical,
221,
Bosch
House, Sector
23,
Korangi
Industrial Area,
Karachi.
Falgan
500mg/50ml
Infusion
Each Vial
Contains.
Paracetamol
….(B.P)
500mg/50ml
mentioned
(Duplicate
Dossier)
Dossier dated
29-06-2010
Rs.8000/- (1705-2010)
Dy. No. Not
mentioned
Rs.12,000/dated 26-092013 (Fee
challans are
duplicate)
Total
Rs.20,000/Form 5
5’s and 10’s/As
Per PRC
Dy No 255 R&I
dated 23-072010 Rs.8000/Rs.12,000/22-05-2013
Form 5-D
1,s /Rs.60/Dy
No.1386/R&I
dated 22-072010/
Rs.15,000/-
Minutes246thMeetingRegistrationBoard
AZOMAX
500mg tablet
Novartis
Inspection report
dated 06/05/2014
good level of
GMP compliance
reported.
Approved.
VICTRA
4mg tablet
Scitech
Lornoxicam
4mg f/c tablet
EMA
Inspection report
dated 10-04-2014
considered to be
operating
at
satisfactory level
of GMP.
Capsule section
mentioned
in
inspection report.
PERFALGAN
10mg/ml (50ml
Vial)
MHRA
Injectable Liquid
section granted
vide letter No. F.
2-4/91-Lic (VolII) (M-196).
Routine
GMP
1.
Copy
of
cashiers’
cheque
amounting
to
168,000/(Rs.
12,000/- each for
14
products,
including
Falgan
500mg/50ml).
However,
the
cheque
or
the
covering is not
endorsed by STO
Deferred for
rectification of
following
shortcomings
in the dossier:
1. Copy of
cashiers’
cheque
amounting to
168,000/(Rs. 12,000/each for 14
Page132
(Analgesics and
Antipyretics)
(Manufacturer’s
Specs)
Copy of cashiers
cheque
amounting
to
168,000/- (Rs.
12,000/each
for 14 products,
including Falgan
500mg/50ml).
However,
the
cheque or the
covering is not
endorsed
by
STO and is also
not
the
prescribed fee
for
Form-5D
applications.
Minutes246thMeetingRegistrationBoard
inspection report
dated 12-08-2014
cGMP level rated
as good.
and is also not the
prescribed fee for
Form-5D
applications.
2. Pyrogen free
distilled water has
been mentioned in
the
master
formulation
whereas,
the
reference
brand
contains WFI for
which evidence of
TOC analyzer and
liquid
particle
counter is required.
However, firm has
provided copies of
operator’s manual
of particle counter
only, as evidence.
3.
Stability
summary at 30 C
and 65% RH for
only one batch of
3,000/vials
submitted.
products,
including
Falgan
500mg/50ml)
. The cheque
or
the
covering is
not endorsed
by STO and
is also not the
prescribed
fee for Form5D
applications.
2. Pyrogen
free distilled
water
has
been
mentioned in
the
master
formulation
whereas, the
reference
brand
contains WFI
for
which
evidence of
TOC
analyzer and
liquid
particle
counter
is
required.
However,
firm
has
provided
copies
of
operator’s
manual
of
particle
counter only,
as evidence.
Confirmation
from FID is
required for
the
Installational
& Operation
Qualification
Page133
190.
M/s
Pakistan
Pharmaceutical
Products (Pvt)
Ltd.
D-122,
Sindh Industrial
Trading Estate,
Karachi
Pioglit 15mg +
2mg Tablet
Tablet
Each Tablet
Contains.
Pioglitazone..
…..…. 15mg
Glimepiride..
…….. 2mg
(AntiHyperglycemic)
Form 5
Dy. No. Not
mentioned / R&I
date not
mentioned
(Covering letter
dated
07/07/2010)
Rs.8000/(19/07/2010)
Rs.12,000/(15/05/2013) fee
challans are
duplicate
Glibetic
15/2mg
ICI
Inspection report
dated 13-02-2013
and 03-06-2014
considered to be
operating
at
satisfactory level
of GMP.
Evidence
of
approval of same
formulation
by
stringent regulatory
authority
e.g.,
FDA,
TGA,
MHLW, EMA and
Health
Canada
required.
of
liquid
particle
counter
&
TOC
analyzer.
3. Stability
summary at
30 C and
65% RH for
only
one
batch
of
3,000/- vials
submitted.
Which
is
required to be
as per WHO
guidelines.
Deferred for
confirmation
of approval
in reference
Stringent
Regulatory
Agencies.
Total
Rs.20,000/14’s / Rs. 10 per
tablet
191.
M/s
Pakistan
Pharmaceutical
Products (Pvt)
Ltd.
D-122,
Sindh Industrial
Trading Estate,
Karachi
Glitter 4mg Tablet
Form 5
Tablet
Dy. No Not
mentioned / R&I
dated not
mentioned
(Covering letter
Each Tablet
Contains.
Glimepiride ……..
Minutes246thMeetingRegistrationBoard
Amaryl
MHRA
Approved.
Amaryl
Sanofi-Aventis
Inspection report
Page134
4mg
(AntiHyperglycemic)
192.
M/s
Pakistan
Pharmaceutical
Products (Pvt)
Ltd.
D-122,
Sindh Industrial
Trading Estate,
Karachi
Glitter 3mg Tablet
Tablet
Each Tablet
Contains.
Glimepiride ……..
3mg
(AntiHyperglycemic)
dated
20/07/2010)
Rs.8000/(22/07/2010)
Rs.12,000/(15/05/2013)
fee challans are
duplicate
Total
Rs.20,000/20’s As per PRC
Form 5
Dy. No. Not
mentioned / R&I
dated not
mentioned
(Dossier dated
20/07/2010)
Rs.8000/(22/07/2010)
Rs.12,000/(15/05/2013)
fee challans are
duplicate
Total
Rs.20,000/-
dated 13-02-2013
and 03-06-2014
considered to be
operating
at
satisfactory level
of GMP.
Amaryl
MHRA
Approved.
Amaryl
Sanofi-Aventis
Inspection report
dated 13-02-2013
and 03-06-2014
considered to be
operating
at
satisfactory level
of GMP.
20’s / As per
PRC
193.
M/s
Pakistan
Pharmaceutical
Products (Pvt)
Ltd.
D-122,
Sindh Industrial
Trading Estate,
Karachi
Glitter 2mg Tablet
Form 5
Tablet
Dy. No. Not
mentioned / R&I
dated not
mentioned
(Dossier dated
20/07/2010)
Each Tablet
Contains.
Glimepiride ……..
2mg
Minutes246thMeetingRegistrationBoard
Amaryl
MHRA
Approved.
Amaryl
Sanofi-Aventis
Inspection report
dated 13-02-2013
and 03-06-2014
Page135
(AntiHyperglycemic)
Rs.8000/(22/07/2010)
Rs.12,000/(15/05/2013)
fee challans are
duplicate
Total
Rs.20,000/-
considered to be
operating
at
satisfactory level
of GMP.
20’s / As per
PRC
194.
M/s
Pakistan
Pharmaceutical
Products (Pvt)
Ltd.
D-122,
Sindh Industrial
Trading Estate,
Karachi
Glitter 1mg Tablet
Form 5
Tablet
Dy. No. Not
mentioned / R&I
dated not
mentioned
(Dossier dated
20/07/2010)
Each Tablet
Contains.
Glimepiride ……..
1mg
(AntiHyperglycemic)
Rs.8000/(22/07/2010)
Rs.12,000/(15/05/2013)
fee challans are
duplicate
Total
Rs.20,000/-
Amaryl
MHRA
Approved.
Amaryl
Sanofi-Aventis
Inspection report
dated 13-02-2013
and 03-06-2014
considered to be
operating
at
satisfactory level
of GMP.
20’s / As per
PRC
Minutes246thMeetingRegistrationBoard
Page136
6. Routine drug registration applications
Evaluator – II
S.No Name
Type of Form
and Brand Name
address
of (Proprietary name +
manufacturer / Dosage Form + Strength) Initial date, diary
Applicant
Fee
including
Composition
differential fee
Pharmacological Group
Demanded Price /
Finished
product Pack size
Specification
Remarks
on
the Decision
formulation (if any)
including
International status in
stringent
drug
regulatory agencies /
authorities
Me-too status
GMP
status
as
depicted
in
latest
inspection
report
(with date) by the
Evaluator
195.
M/s
Macter
International
(Pvt) Ltd. F-216,
S.I.T.E, Karachi.
Affient 5mg Tablet
Each film coated tablet
contains:
Prasugrel HCl eq. to
Prasugrel…………….5
mg
(Inhibitor of platelet
activation and
aggregation)
(Manufacturer’s Spec.s)
Minutes246thMeetingRegistrationBoard
Form 5
05‐7‐2010(54)
Rs.15000/‐
22‐5‐2013
Rs.5,000/‐
Rs. 8.42/Tab
Rs. 118/14’s
Rs.236/28’s
BNF: Efient(Lilly)
Prasu (Amson)
Satisfactory level of
GMP compliance. (1004-14)
1. Verification
of
photocopy
of
differential fee (Rs.
5000/-) paid is
required.
2. The
Firm
had
applied on Form 5D initially but has
now
submitted
Form 5.
3. Approval of section
/
manufacturing
facility of applied
drug from licensing
section is required.
The
Firm
has
submitted
GMP
insp. Report dated
10-04-14
which
Approved.
Reference will
be sent to B &
A
Division,
DRAP
for
verification of
photocopy of
fee challan. If
confirmed,
then Chairman,
RB will permit
issuance
of
registration
letter.
Page137
196.
-do-
197.
-do-
Affient 10mg Tablet
Each film coated tablet
contains:
Prasugrel HCl eq. to
Prasugrel…………….10
mg
(Inhibitor of platelet
activation and
aggregation)
(Manufacturer’s Spec.s)
Tamsyl Tablets
Each Tablet contains:
Etamsylate
(B.P)….250mg
(Antifibrinolytic, synthetic
antihaemorrhagic and
angioprotective)
(Manufacturer’s Spec.s)
Minutes246thMeetingRegistrationBoard
Form 5
05‐7‐2010(46)
Rs.15000/‐
22‐5‐2013
Rs.5,000/‐
Rs. 14/Tab
Rs. 96/14’s
Rs.392/28’s
Form 5
05‐7‐2010(N/A)
Rs.15000/‐
22‐5‐2013
Rs.5,000/‐
Rs. 7.5/Tab
Rs. 75/10’s
Rs.150/20’s
mentions
Tablet
(General) Section.
Approved.
BNF: Efient(Lilly)
Reference will
be sent to B &
Prasu (Amson)
A
Division,
DRAP
for
Satisfactory level of
verification of
GMP compliance. (10photocopy of
04-14)
fee challan. If
1. Verification
of confirmed,
photocopy
of then Chairman,
differential fee (Rs. RB will permit
of
5000/-) paid is issuance
registration
required.
2. The
Firm
had letter.
applied on Form 5D initially but has
now
submitted
Form 5.
Not confirmed
Deferred for
confirmation
Not confirmed
of me too
status
&
Satisfactory level of
approval
in
GMP compliance. (10reference
04-14)
Stringent
Regulatory
1. Verification
of Agencies.
photocopies of fee Reference will
(Rs. 15000/- + Rs. be sent to B &
A
Division,
5000/-) paid is
DRAP
for
required.
verification of
2. The
Firm
had photocopy of
applied on Form 5- fee challan.
D initially but has
now
submitted
Form 5.
3. International
availability
not
confirmed in same
strength.
4. Me-too status given
as Dicynone of
French
Pharmaceuticals
Page138
198.
-do-
199.
-do-
200.
-do-
Tamsyl Tablets
Each Tablet contains:
Etamsylate
(B.P)….500mg
(Antifibrinolytic, synthetic
antihaemorrhagic and
angioprotective)
(Manufacturer’s Spec.s)
Valsitan Tablets
Each film coated tablet
contains:
Amlodipine (as
besilate)…5mg
Valsartan….160mg
(Calcium Antagonist)
(Manufacturer’s Spec.s)
Valsitan Plus Tablets
Each tablet contains:
Amlodipine (as
besilate)…10mg
Valsartan….160mg
(Calcium Antagonist)
Minutes246thMeetingRegistrationBoard
Form 5
05‐7‐2010(N/A)
Rs.15000/‐
22‐5‐2013
Rs.5,000/‐
Rs. 15/Tab
Rs. 150/10’s
Rs.300/20’s
Form 5
06‐7‐2010(N/A)
Rs.8000/‐
22‐5‐2013
Rs.12,000/‐
AS per PRC
Form 5
06‐7‐2010(N/A)
Rs.8000/‐
22‐5‐2013
Rs.12,000/‐
Group (Reg. No.
004229)
needs
confirmation.
BNF: Dicynene
Deferred for
(Sanofi-Aventis)
confirmation
of me too
Cytoplex of M/s AGP
status.
Reg. No. 061420
Reference will
(Me too status appeared be sent to B &
in agenda as not A
Division,
confirmed erroneously) DRAP
for
verification of
Satisfactory level of
photocopy of
GMP compliance. (10fee challan.
04-14)
1. Verification
of
photocopies of fee
(Rs. 15000/- + Rs.
5000/-) paid is
required.
2. The
Firm
had
applied on Form 5D initially but has
now
submitted
Form 5.
Approved.
BNF: Exforge
Reference will
(Novartis)
be sent to B &
A
Division,
Exforge
DRAP
for
(Novartis)
verification of
photocopy of
Satisfactory level of
fee challan. If
GMP compliance. (10confirmed,
04-14)
then Chairman,
1. Verification
of RB will permit
of
photocopies of fee issuance
registration
(Rs. 8000/- + Rs.
letter.
12000/-) paid is
required.
Approved with
BNF: Exforge
change
in
(Novartis)
brand
name.
Reference wil
Exforge
be sent to B &
(Novartis)
Page139
(Manufacturer’s Spec.s)
AS per PRC
Satisfactory level of
GMP compliance. (1004-14)
1. Verification
of
photocopies of fee
(Rs. 8000/- + Rs.
12000/-) paid is
required.
201.
-do-
Alozin Tablets
Each film coated extended
release tablet
contains:
Ranolazine…1000mg
(anti‐ischemic And
antianginal)
(Manufacturer’s Spec.s)
Form 5
06‐7‐2010(N/A)
Rs.8000/‐
22‐5‐2013
Rs.12,000/‐
AS per PRC
FDA: Ranexa (Gilead)
Ranola (Highnoon)
Satisfactory level of
GMP compliance. (1004-14)
1. Verification
of
photocopies of fee
(Rs. 8000/- + Rs.
12000/-) paid is
required.
202.
-do-
Tamsyl 2ml Injection
Each 2ml ampoule
contains:
Etamsylate……….250 mg
(Antifibrinolytic synthetic
antihaemorrhagic and
angioprotective)
(Manufacturer’s Spec.s)
Form 5-D
06‐7‐2010(N/A)
Rs.15,000/‐
22‐5‐2013
Rs.5,000/‐
AS per PRC/4’s,
100’s
Not confirmed
Cytoplex of M/s AGP
Reg. No. 061419
(Me too status appeared
in agenda as not
confirmed at that time)
Satisfactory level of
GMP compliance. (1004-14)
1. Verification
of
photocopies of fee
(Rs. 15000/- + Rs.
5000/-) paid is
required.
2. The
Firm
had
applied on Form 5D initially but has
now
submitted
Form 5.
Minutes246thMeetingRegistrationBoard
A
Division,
DRAP
for
verification of
photocopy of
fee challan. If
confirmed,
then Chairman,
RB will permit
issuance
of
registration
letter.
Approved.
Reference will
be sent to B &
A
Division,
DRAP
for
verification of
photocopy of
fee challan. If
confirmed,
then Chairman,
RB will permit
issuance
of
registration
letter.
Deferred for
confirmation
of followings:
1. Installation
and
performance
qualifications
of
TOC
analyser
&
Liquid Particle
Counter
by
area FID.
2. Approval in
reference
Stringent
Regulatory
Agencies.
Reference will
be sent to B &
A
Division,
DRAP
for
verification of
photocopy of
fee challan.
Page140
3. Approval of section
/
manufacturing
facility of applied
drug from licensing
section is required.
The
Firm
has
submitted
GMP
insp. Report dated
10-04-14
which
mentions
Sterile
Products
(Liquid
injections,
Opthalmic/Otic
drops).
4. International
availability
not
confirmed.
5. Verification
of
Total
Organic
Testing Facility is
required.
203.
M/s. WelMark
Pharmaceuticals
Plot # 122,
Block-B, PhaseV Industrial
Estate Hattar.
Rismek 3mg Tablets
Each film coated tablet
contains:Risperidone(USP)….3mg
(Antipsychotic)
(USP Spec.s)
Form 5
12-07-2010 (17)
Rs.8,000/
+Rs. 12000 (0905-2013)
As Per PRC
204.
-do-
Welfam 40mg Tablets
Each tablet contains:Famotidine (USP)…40mg
(H2 receptor Blocker,
Antipeptic ulcerate)
(USP Spec.s)
Minutes246thMeetingRegistrationBoard
Form 5
12-07-2010 (16)
Rs.8,000/
+Rs. 12000 (0905-2013)
BNF. Risperdal
(Janssen)
Approved.
Benzisox (Highnoon)
No
conclusion
of
inspection
report,
recommendations
of
some corrections (2405-14 routine GMP
inspection)
The Board considered
the above inspection
report & satisfied with
the same.
BNF: Famotidine (Nonproprietary)
Acicon
Hodgson)
Approved
uncoated
Tablets.
(Barrett
Page141
in
As Per PRC/10’s
205.
M/s Atco
Laboratories
Limited B-18,
S.I.T.E, Karachi.
Combinol-D Sugar Free
Syrup
Each 5ml contains:Dextromethorphan
Hydrobromide
(B.P)…10mg
Ephedrine Hydrochloride
(B.P)…7.5mg
Chlorphenamine Maleate
(B.P)…4mg
Terpin Hydrate (USP)…
3.5 mg
Ammonium Chloride
(B.P)…90mg
(Bronchodilator)
(Manufacturer’s Spec.s)
Minutes246thMeetingRegistrationBoard
Form 5
06-07-2010
Rs.8,000/ (N/A)
+Rs. 12000 (2205-2013)
Rs. 38/- Per 120ml
bottle
No
conclusion
of
inspection
report,
recommendations
of
some corrections (2405-14 routine GMP
inspection)
The Board considered
the above inspection
report & satisfied with
the same.
1. BNF describes the
product as uncoated
while the Firm has
applied for the film
coated formulation.
Not confirmed
Deferred for
review
of
Combinol-D
Syrup formulation by
(Atco Laboratories)
Review
Committee.
Good level of GMP
(18-06-2014)
1. Verification
of
photocopies of fee
(Rs. 8000/- + Rs.
12000/-) paid is
required.
2. Approval of section
/
manufacturing
facility of applied
drug from licensing
section was asked.
The
Firm
has
submitted
GMP
insp. Report dated
18-06-14
which
mentions
Oral
Liquid
(Syrup/Suspension)
section
Non
Antibiotic.
3. International
Page142
availability
of
formulation
in
SRA’s
not
confirmed.
4. Formulation
contains Ephedrine
Hydrochloride,
a
controlled
drug
substance.
206.
M/s Nenza
Pharmaceuticals,
33 A Industrial
Estate
Hayatabad
Peshawar
207.
-do-
NenKast 5mg Tablets
Each Chewable Tablet
contains:Montulekast Sodium
Equivalent to
Montelukast(B.P)…5mg
(Antiasthmatic)
(Manufacturer’s Spec.s)
Nenmether DS Tablets
Each Tablet contains:Artemether…40mg
Lumefantrine…240mg
(Antimalarial)
(USP Salmous Spec.s)
Form 5
16-07-2010
Rs.8,000/ (80)
+Rs. 12000 (2305-2013)
As Per SRO/- 14’s
Form 5
16-07-2010
Rs.8,000/ (79)
+Rs. 12000 (2305-2013)
As Per SRO/- 8’s
Minutes246thMeetingRegistrationBoard
BNF: Singulair (MSD)
Approved.
Montiget (Getz)
No conclusion
regarding GMP of the
Firm, some minor
observations at which
the management was
agreed to rectify.
(routine GMP 10-042014)
The Board considered
the above inspection
report & satisfied with
the same.
Approved.
WHO approved
formulation
A-Fantrine 40/240 by
M/s Atco
No conclusion
regarding GMP of the
Firm, some minor
observations at which
the management was
agreed to rectify.
(routine GMP 10-042014)
The Board considered
the above inspection
report & satisfied with
the same.
Page143
208.
209.
M/s PharmEvo
(Private Limited
Plot #A-29,
North West
Industrial Zone,
Port Qasim,
Karachi-75020
M/s Maple
Pharmaceuticals
(Pvt.) Ltd.,
147/23, Korangi
Evorox 1.5g Injection
(Powder for reconstitution)
Each Vial contains:Cefuroxime Sodium
equivalent to Cefuroxime
(USP) …1.5g
(Antibiotic)
(USP Spec.s)
Defrinac Plus Tablets
Each film coated tablet
contains:Dexibuprofen
Minutes246thMeetingRegistrationBoard
Form 5
06-07-2010, Rs.
8000/- + Rs.
12,000 (22-052013)
As per PRC
BNF: Zinacef (GSK)
Zecef (Bosch)
Good, GMP compliance
(01-04-14) Provincial
Drug Inspector.
The firm later on
submitted inspection
report dated 20.03.2013
conducted by DRAP.
The Board considered
the above inspection
report & satisfied with
the same.
Approved.
Reference will
be sent to B &
A
Division,
DRAP
for
verification of
photocopy of
fee challan. If
confirmed,
then Chairman,
RB will permit
issuance
of
registration
letter.
1. Verification
of
copies
of
fee
challans is required.
2. Evidence
of
approval
of
technical staff from
licensing section is
required.
(The
firm
provided
the
technical
staff
approval
but
missed
erroneously
in
agenda).
3. Firm has submitted
inspection report of
provincial
drug
inspector and has
informed that they
will submitt latest
inspection report of
FID
when
inspection
report
would be received.
Form 5-D
Form 5-D
Deferred for
01-07last reminder
2010(11)Rs.8,000/for correction
Overall cGMP
+Rs. 12,000 (25in form 5-D
Page144
Industrial Area,
Karachi.
210.
-do-
211.
M/s Nabiqasim
Industries (Pvt)
Ltd.
17/24,
Korangi
Industrial Area,
Karachi.
(M.S)…300mg
Pseudoephidrine
Hydrochloride(B.P)…60mg
(NSAID+Decongestant)
(Manufacturer’s Spec.s)
measures are followed
in the Firm (31-032014)
alongwith
stability
studies.
Reference will
be sent to B &
A
Division,
DRAP
for
verification of
photocopy of
fee challan.
1. The
Firm
had
applied on Form 5,
but after evaluation
the
Firm
has
deposited
differential fee for
application on Form
5-D. Form 5-D is
incorrect.
2. Verification of fee
of Rs. 12000/- is
required.
3. Formulation
contains controlled
drug substance.
Form-5
Fastofen Tablets
Form 5-D
Deferred for
Each film coated tablet
05-07last reminder
Overall
cGMP
contains:2010(44)Rs.8,000/for correction
measures are followed
Ibuprofen lysinate…342mg
+Rs. 12,000 (14in form 5-D
in the Firm (31-03(NSAID)
05-2013) Rs.
alongwith
2014)
(Manufacturer’s Spec.s)
30,000/- (01-12stability
2014)
1. The
Firm
had studies.
Rs. As per PAC
applied on Form 5, Reference will
/30’s
but after evaluation be sent to B &
Division,
the
Firm
has A
DRAP
for
deposited
verification
of
differential fee for
application on Form photocopy of
5-D. Form 5-D is fee challan.
incorrect.
2. Verification of fee
of Rs. 12000/- is
required.
Deferred
for
BNF: Arthrotec
Form 5
Misocot 50 mg Tablets
Product specific
(Pharmacia)
Each tablet contains:inspection by
Diclofenac
Sodium 01/07/10(Nil)
panel
Arthrotec (Pfizer)
Rs.8000/(B.P)…50mg
comprising of
+Rs.12000/Misoprostol…200mcg
Good GMP compliance Director DTL,
(14/05/13)
(NSAIDs)
Karachi, DDG
(18-12-13)
(Manufacturer’s Spec.s)
Minutes246thMeetingRegistrationBoard
07-2013)+Rs.
30,000/- (01-122014)
Rs. As per PRC
/3×10’s
Page145
As
per
/10’s,20’s
PRC
1. Verification
of
photocopies of fee
submitted
is
required.
2. Other strength of
the product Misocot
75 mg Tablets has
already
been
deferred for Product
specific inspection
by
panel
comprising
of
Director
DTL,
DDG (E&M) and
area FID
(E&M)
area FID.
Reference
will be sent to
B
&
A
Division,
DRAP
for
verification
of photocopy
of
fee
challan.
Evaluator – II
Applications checked by Evaluator IV (human)
Type of Form
S.No Name
and Brand Name
address
of (Proprietary
name
+
manufacturer / Dosage Form + Strength) Initial date,
diary
Applicant
Composition
Fee including
differential
Pharmacological Group
fee
Finished
product
Demanded
Specification
Price / Pack
size
212.
M/s Pfizer
Pakistan Limited.
B-2, S.I.T.E.,
Karachi
Zetamax Tablet
Each film coated tablet
contains
Azithromycin Dihydrate eq
to Azithromycin USP
……….500mg
Antibiotic
Minutes246thMeetingRegistrationBoard
Form 5
23-07-2010
Dy. No. 264
Rs. 8000 +
12000
Rs 340/ 6’s
Remarks on the Decision
formulation (if any)
including
International status
in stringent drug
regulatory agencies /
authorities
Me-too status
GMP
status
as
depicted in latest
inspection
report
(with date) by the
Evaluator
International: BNF: Approved.
Azithromycin (Nonproprietary)
Local:
Azitor of Macter Int
Pvt Limited Karachi
According
and
to
Page146
Finished product
specifications are USP
213.
-do-
Zetamax Tablet
Each film coated tablet
contains
Azithromycin Dihydrate eq
to Azithromycin USP
……….250mg
Antibiotic
Finished product
specifications are USP
Minutes246thMeetingRegistrationBoard
inspection
report
dated
16-05-2012,
factory premises and
manufacturing
operations were found
in line and good with
GMP
compliance
standards at time of
inspection.
Latest
inspection
report is required. The
firm
later
on
submitted inspection
report
dated
09.09.2014 conducted
by DRAP.
The Board considered
the above inspection
report & satisfied
with the same.
Form 5
05-07-2010
Dy. No. 37
Rs. 8000 +
12000
Rs 240/ 6’s
According to BNF
Azithromycin
has
been approved in UK
as
Azithromycin
monohydrate hemiethanolate in Tablet
dosage form.
International: BNF: Approved.
Azithromycin (Nonproprietary)
Local:
Azitor of Macter Int
Pvt Limited Karachi
According
to
inspection
report
dated
16-05-2012,
factory premises and
manufacturing
operations were found
in line and good with
GMP
compliance
standards at time of
inspection.
Latest
inspection
report is required. The
firm
later
on
submitted inspection
Page147
report
dated
09.09.2014 conducted
by DRAP. The Board
considered the above
inspection report &
satisfied with the
same.
214.
215.
M/s Genome
Pharmaceuticals
(Pvt) Limited.,
Plot No. 16/IPhase IV,
Industrial Estate,
Hattar
Ovulin Tablet
Each tablet contains
Clomiphene Citrate USP
…… 50mg
Anti estrogen
M/s Rotexmedica
Pakistan (Pvt)
Ltd.,
Plot no 206 &
207, Industrial
triangle,
Kahuta Road,
Islamabad
Texpami Capsule
Each capsule contains
Pamidronate as disodium
USP ………..100 mg
(bone Resorption Inhibitor)
Form 5
17-08-2010
Rs 20,000/As per PRC
Finished product
specifications are USP
Finished product
specifications are
Manufacturer
Form 5
19-05-2010
Rs 8000 +
12000
10’s as per
SRO
According to BNF
Azithromycin
has
been approved in UK
as
Azithromycin
monohydrate hemiethanolate in Tablet
dosage form.
till
BNF:
Clomid Deferred
decision on the
(Sanofi-Aventis)
manufacturing
requirement for this
Ovi-F (Merck)
product.
Grant of GMP for
Export recommended
(27-12-13)
Deferred
for
confirmation
of
in
Aminomux
Cap approval
100mg
by
M/s reference Stringent
Regulatory Agencies
Seignior
& latest GMP report.
A compliance report
was asked to be
submitted for follow
up inspection. (13-0214)
Not confirmed
Firm has not given
international
availability. It is
required as it is part
of Form 5. Firm has
replied reference of
argentina.
Latest
satisfactory
GMP
inspection
report is required. A
Minutes246thMeetingRegistrationBoard
Page148
compliance
report
was asked to be
submitted for follow
up inspection. (13-0214)
216.
M/s Macter
International
(Pvt.) Limited. F216, S.I.T.E.,
Karachi.
Zincasa Syrup 10 mg/ 5 ml
Each 5 ml contains
Zinc Sulphate Monohydrate
USP eq to elemental
Zinc……10 mg
Antidiarrheal
Form 5
20-08-2010
Dy. No. 151
Rs. 8000 +
12000
As per PRC
Finished Product
Specifications are
Manufacturer
Me too Zegen Syrup
10 mg/5ml by Genera
International
available in India,
China, Bangladesh
According
to
inspection
report
dated
10-04-2014,
firm was considered
to be operating at
satisfactory level of
compliance
with
GMP guidelines.
Approved with USP
specification
(as
formulation is WHO
recommended).
International
availability in SRA’s
not confirmed. USP
mentions
the
formulation as Oral
Solution with pH of
2.5to
4.5
while
Manuf. Spec.s for this
formulation has pH of
5 to 6.
217.
M/s Macter
International
(Pvt.) Limited. F216, S.I.T.E.,
Karachi.
Mclevo Infusion 250mg
Form 5
Each 100 ml contains
21-07-2010
Levofloxacin USP 250 mg
Dy. No. 1371
Broad Spectrum
Antibacterial Agent
Rs. 8000 +
12000
Finished Product
Specifications are
Manufacturer
Rs 500
FDA
has
not
approved strength of
2.5mg/ml.
FDA
approved 5ml/ml with
Dextrose5%.
Firm
has
not
submitted undertaking
(The
firm
had
submitted the above
undertaking but was
erroneously missed
in the agenda)
According
Minutes246thMeetingRegistrationBoard
Deferred
for
approval
in
reference Stringent
Regulatory Agencies
in same strength &
volume along with
confirmation
of
installation
and
operational
qualifications
of
TOC analyser &
Liquid
Particle
Counter by area
FID.
to
Page149
inspection
report
dated
10-04-2014,
firm was considered
to be operating at
satisfactory level of
compliance
with
GMP guidelines.
International: FDA
has not approved 2.5
mg/ml
Local: Bexus Inf
250mg/100ml by M/s
Shaigan
218.
M/s Macter
International
(Pvt.) Limited. F216, S.I.T.E.,
Karachi.
Mclevo Infusion 250mg
Form 5
Each 50 ml contains
21-07-2010
Levofloxacin 250 mg
Dy. No. 1371
Broad Spectrum
Antibacterial Agent
Rs. 8000 +
12000
Finished Product
Specifications are
Manufacturer
Rs 400/ 50 ml
Firm
has
not Deferred
for
submitted undertaking confirmation
of
installation
and
(The
firm
had operational
submitted the above qualifications
of
undertaking but was TOC analyser &
erroneously missed Liquid
Particle
in the agenda)
Counter by area
According
to FID.
inspection
report
dated
10-04-2014,
firm was considered
to be operating at
satisfactory level of
compliance
with
GMP guidelines.
International:
Levaquine 250mg/50
ml (FDA)
Local: Xeflox Inf
250mg/50ml by M/s
Helix
219.
M/s Macter
International
(Pvt.) Limited. F-
Mclevo Infusion 750mg
Form 5
Each 100 ml contains
21-07-2010
Minutes246thMeetingRegistrationBoard
Firm
has
not Deferred
submitted undertaking approval
reference
for
in
Stringent
Page150
216, S.I.T.E.,
Karachi.
Levofloxacin 750 mg
Dy. No. 1371
Broad Spectrum
Antibacterial Agent
Rs. 8000 +
12000
Finished Product
Specifications are
Manufacturer
Rs 800/ 100 ml
(The
firm
had
submitted the above
undertaking but was
erroneously missed
in the agenda)
According
to
inspection
report
dated
10-04-2014,
firm was considered
to be operating at
satisfactory level of
compliance
with
GMP guidelines.
Regulatory Agencies
in same strength &
volume along with
confirmation
of
installation
and
operational
qualification of TOC
analyser & Liquid
Particle Counter by
area FID.
International: FDA
has not approved 7.5
mg/ml
Local: Bexus Inf
750mg/100ml by M/s
Shaigan
220.
M/s Macter
International
(Pvt.) Limited. F216, S.I.T.E.,
Karachi.
Mclevo Infusion 500mg
Form 5
Each 20 ml contains
21-07-2010
Levofloxacin 500 mg
Dy. No. 1373
Broad Spectrum
Antibacterial Agent
Rs. 8000 +
12000
Finished Product
Specifications are
Manufacturer
Rs 500/ 20 ml
Firm
has
not Deferred
for
submitted undertaking verification of me
too status along with
(The
firm
had confirmation
of
submitted the above installation
and
undertaking but was operational
erroneously missed qualification of TOC
in the agenda)
analyser & Liquid
According
to Particle Counter by
inspection
report area FID.
dated
10-04-2014,
firm was considered
to be operating at
satisfactory level of
compliance
with
GMP guidelines.
International:
Levaquine 500mg/20
ml (FDA)
Minutes246thMeetingRegistrationBoard
Page151
Local: Me too status
needs confirmation
221.
M/s Macter
International
(Pvt.) Limited.
F-216, S.I.T.E.,
Karachi.
Kirin Tablet
Form 5
Each film coated tablet
contains
30-08-2010
Aliskirin hemifumarate
MS……150 mg
Hydrochlorothiazide USP
…..12.5 mg
Dy. No. 191
Rs. 8000
As per PRC
1 × 14’s
Non peptide, direct rennin
inhibitor
Finished Product
Specifications are
Manufacturer
Me too Co-Kiren Approved.
Tablet by
Tabros
Pharma
International
Tekturna HCT tablet
(USA)
According
to
inspection
report
dated
10-04-2014,
firm was considered
to be operating at
satisfactory level of
compliance
with
GMP guidelines.
Firm
has
submitted
undertaking.
not
(The
firm
had
submitted the above
undertaking but was
erroneously missed in
the agenda)
222.
M/s Macter
International
(Pvt.) Limited.
F-216, S.I.T.E.,
Karachi.
Mimin Tablet 200 mg
Form 5
Each film coated tablet
contains
30-08-2010
Rifaximin……..200 mg
Non systemic Antibiotic
Finished Product
Specifications are
Manufacturer
Minutes246thMeetingRegistrationBoard
Dy. No. 196
Rs. 8000
As per PRC
1 × 10’s
Me
too
Xerifax Approved.
Tablet 200 mg
International
Xifaxan Tablet 200
mg (FDA)
According
to
inspection
report
dated
10-04-2014,
firm was considered
to be operating at
satisfactory level of
compliance
with
Page152
GMP guidelines.
Firm
has
submitted
undertaking.
not
(The
firm
had
submitted the above
undertaking but was
erroneously missed
in the agenda)
223.
M/s Macter
International
(Pvt.) Limited.
Mirin Capsule 50 mg
Form 5
Each capsule contains
30-08-2010
F-216, S.I.T.E.,
Karachi.
Diacerein MS …..50 mg
Dy. No. 198
Antirheumatics/ Pain
Management
Rs. 8000 +
12000
Finished Product
Specifications are
Manufacturer
As per PRC
Me too Diora Capsule Deferred for review
50 mg by Getz
of formulation by
Review Committee.
International
Diacerein Capsule 50
mg available in India.
EMA
approved
Diacerein for rare
disease
(epidermolysis
bullosa).
According
to
inspection
report
dated
10-04-2014,
firm was considered
to be operating at
satisfactory level of
compliance
with
GMP guidelines.
Firm
has
submitted
undertaking.
not
(The
firm
had
submitted the above
undertaking but was
erroneously missed in
the agenda)
Firm has given assay
limit for finished
Minutes246thMeetingRegistrationBoard
Page153
product as 288-368
mg/capsule.
Firm has given assay
for tablets while
applied product is
capsule.
The
firm
has
submitted the correct
assay method with
correct limits.
224.
M/s Macter
International
(Pvt.) Limited.
Micam Injection 8 mg
Form 5
Each vial contains
30-08-2010
F-216, S.I.T.E.,
Karachi.
Lornoxicam…….8 mg
Dy. No. 200
Analgesic & Anti
inflammatory
Rs. 8000 +
12000
Finished Product
Specifications are
As per PRC
Firm has not provided
reference
of
specifications
of
finished product.
Deferred
for
confirmation
of
installation
and
operational
qualification of TOC
The firm submitted analyser & Liquid
Finished
Product Particle Counter by
Specification
as area FID.
Manufacturer’s
specifications
Firm has written
Glenmark
as
reference
to
specifications
of
active raw material
for
description,
identification,
solubility and Aydin/
Turkey for assay of
active raw material.
QC tests for injections
have
not
been
provided.
Me too Xefast tablet
8 mg by PharmEvo
International Xefo
powder for injection 8
Minutes246thMeetingRegistrationBoard
Page154
mg (EMA)
225.
-do-
Zincasa DS Syrup 20 mg/ 5
ml
Each 5 ml contains
Zinc Sulphate Monohydrate
USP eq to elemental
Zinc……20 mg
Antidiarrheal
Form 5
20-08-2010
Dy. No. 151
Rs. 8000 +
12000
As per PRC
Finished Product
Specifications are
Manufacturer
226.
M/s Pharmatec
Pakistan (Pvt.)
Ltd.
Alptec 0.25mg Tablet
Form 5
Each tablet contains
31-05-2013
D- 86/A., S.I.T.E.,
Karachi.
Alprazolam USP
….0.25mg
Rs 60,000/3 × 10
Anxiolytic
Finished product
specifications are USP
227.
M/s Benson
Pharmaceuticals.
Plot No 119, street
No 8, I-10/3,
Industrial area
Islamabad.
Moxi Tablet
Each film coated tablet
contains
Moxifloxacin (as
hydrochloride)
(USP...400mg
Minutes246thMeetingRegistrationBoard
Me too Zegen Syrup
10 mg/5ml by Genera
International
available in India,
China, Bangladesh
According
to
inspection
report
dated
10-04-2014,
firm was considered
to be operating at
satisfactory level of
compliance
with
GMP guidelines.
Approved with USP
specification
as
formulation is WHO
recommended.
International
availability in SRA’s
not confirmed. USP
mentions
the
formulation as Oral
Solution with pH of
2.5to
4.5
while
Manuf. Spec.s for this
formulation has pH of
5 to 6.
Deferred
for
International:
Alprazolam 0.25mg confirmation
of
(FDA)
segregated
manufacturing
Me too: Alloram 0.25 facility for Narcotic
mg by M/s Global
Drugs
and
Psychotropic
According
to
inspection
report substances.
dated 23-10- 2013,
firm was considered
to be operating at
good
level
of
compliance
with
GMP guidelines.
Form 5
09-06-2010
Rs 8000 +
12000
5’s as per SRO
Deferred
for
provision of assay
Local: Morax tab method of Finished
400mg by M/s Global Product.
BNF: Avelox (Bayer)
Firm is operating at
Page155
(Fluroquinolone)
(Manufacturer’s Spec.s)
satisfactory level of
GMP compliance (1504-14)
Assay method had not
been
given
in
Finished
Product
specifications.
-do-
228.
Piclo Tablet
Each film coated tablet
contains
Piroxicam (as beta
cyclodextrin)……………20
mg
(NSAID)
(Manufacturer’s Spec.s)
Form 5
09-06-2010
Rs 8000 +
12000
5’s as per SRO
Deferred
for
correction in coating
& speficication of
Local: Brexidol cap active material &
20mg by M/s Genome finished product.
BNF:
Brexidol(Chiesi)
Firm is operating at
satisfactory level of
GMP compliance (1504-14)
Originator’s
formulation
is
uncoated while the
Firm has applied Film
coated formulation.
229.
M/s WnsFeild
Pharmaceuticals
Plot no. 122,
Block B, Phase V,
Industrial Estate,
Hattar
230.
-do-
Venlax tablet 37.5 mg
Each extended release film
coated tablet contains
Venlafaxine (as HCl)
……..37.5 mg
(Anti depressant)
(B.P Spec.s)
Form 5
04-08-2010
Rs 20,000/Pack of 20’s
As fixed by
Govt
Venlax tablet 75mg
Form 5
Minutes246thMeetingRegistrationBoard
Firm has not given
active raw material
specifications.
Finished
product
specifications
are
incomplete
and
without
reference.
Assay, identification,
dissolution methods
have
not
been
provided.
BNF:
Venlafaxine Approved
change in
(Non-proprietary)
name.
Local: Zaxine (Araf
Pharma)
Grant
of
GMP
Certificate for Export
recommended (04-0914)
BNF:
Venlafaxine Approved
Page156
with
brand
with
231.
-do-
232.
-do-
Each extended release film
coated tablet contains
Venlafaxine (as HCl)
……..75 mg
(Anti depressant)
(B.P Spec.s)
04-08-2010
Rs 20,000/Pack of 2 × 7’s
As fixed by
Govt
Venlax tablet
Each film coated tablet
contains
Venlafaxine (as HCl)
(USP)……..50 mg
(Anti depressant)
(BP Spec.s)
Form 5
04-08-2010
Rs 20,000/Pack of 20’s
As fixed by
Govt
Artidoxin DS co-blister
Tablet
(i) 3Tablets of which Each
coblister tablet contains
Sulphadoxin USP ……..
500mg
Pyrimethamine USP
……..25mg
(USP Spec.s)
(ii) 6Tablets of which Each
tablet contains
Artisunate……100mg
(Antimalarial)
Finished product
specifications are
(Manufacturer’s Spec.s)
Form 5
04-08-2010
Rs 20,000/2 × 10’s tab
As fixed by
Govt
change
name.
(Non-proprietary)
in
Local: Zaxine (Araf
Pharma)
Grant
of
GMP
Certificate for Export
recommended (04-0914)
FDA: Venlafaxine (as Approved
change in
HCl) by Teva
name.
Amfax (Amson)
Grant
of
GMP
Certificate for Export
recommended (04-0914)
International: Not
confirmed.
(Formulation
is
found
WHO
approved)
Local:Fansi
(Wilshire)
with
brand
Deferred
for
confirmation of coblister facility by
area FID.
Plus
Grant
of
GMP
Certificate for Export
recommended (04-0914)
International
availability in SRA’s
not confirmed. Firm
has
provided
reference from China.
For verification of
Facility
(Co-blister
Machine etc) Firm
has submitted that
they possesses the
Chinese made blister
machine which has
the capability
of
blistering
different
size
of
tablets
together I to one
Minutes246thMeetingRegistrationBoard
brand
Page157
233.
-do-
Artidoxin co-blister Tablet
(i) 3Tablets of which Each
coblister tablet contains
Sulphadoxin USP ……..
500mg
Pyrimethamine USP
……..25mg
(USP Spec.s)
(ii) 6Tablets of which Each
tablet contains
Artisunate……50mg
(Antimalarial)
Finished product
specifications
are(Manufacturer’s Spec.s)
Minutes246thMeetingRegistrationBoard
Form 5
04-08-2010
Rs 20,000/2 × 10’s tab
As fixed by
Govt
blister. The machie is
convertible from Alu
Alu to Alu PVC and
vice versa. The have
given
undertaking
that they will procure
the specific dye for
the purpose if the
product is registered.
International: Not Deferred
for
confirmed.
confirmation WHO
recommended
Local: Arteka of formulation / Pack
& verification of coHemis
Grant
of
GMP blister facility by
Certificate for Export area FID.
recommended (04-0914)
International
availability in SRA’s
not confirmed. Firm
has
provided
reference from China.
Me-too status needs
confirmation. (Arteka
of Hemis), Pricing of
formulation has been
fixed in 19th PRC.
For verification of
Facility
(Co-blister
Machine etc) Firm
has submitted that
they possesses the
Chinese made blister
machine which has
the capability
of
blistering
different
size
of
tablets
together I to one
blister. The machie is
convertible from Alu
Alu to Alu PVC and
vice versa. The have
given
undertaking
that they will procure
the specific dye for
the purpose if the
product is registered.
Page158
234.
-do-
235.
M/s Qintar
Pharmaceuticals,
14-A P.S.I.E.,
Lahore road,
Sargodha
236.
-do-
Winprid Tablet
Each film coated tablet
contains:Itopride HCl…..50mg
Gastroprokinetic
(Manufacturer’s Spec.s)
Form 5
04-08-2010
Rs 20,000/1 × 10’s tab
As fixed by
Govt
HEMA Chewable (Sugar
Free) Tablets
Each chewable tablet
contains
Mecobalamin (J.P)…500
mcg
(Co enzyme type vitamin
B12)
(Manufacturer’s Spec.s)
Form 5
27-03-2010
Rs 8000 +
12000
Rs 178 for
20’s
Rs 267 for
30’s
Rs 890 for
100’s
Gexin Tablets
Each film coated tablet
contains:Gemifloxacin as
mesylate………… 320 mg
(Fluroquinolone)
Form 5
27-03-2010
Rs 8000 +
12000
Rs 625 for 7’s
Deferred for review
International:
of formulation by
Ganaton
Review Committee.
Local:Ganaton
(Abbot)
Grant
of
GMP
Certificate for Export
recommended (04-0914)
Formulation is under
review by the review
committee.
International:
Not
confirmed
Local:
Hicobal
500mcg
by
M/s
Himont
Renewal of DML
recommended (08-1012)
International
availability
not
confirmed in SRAs.
Firm
has
given
reference
of
international
availability
from
India.
Formulation given is
not
of
chewable
Tablets
Latest
inspection
report is required.
International:
FDA
Factive
Local: Actigem tab
320mg
by
M/s
Ferozsons
Deferred
for
confirmation
of
approval of same
dosage form in
reference Stringent
Regulatory Agencies
and clarification of
formulation as not
given for applied
chewable
dosage
form and submission
of
latest
GMP
inspection report.
Deferred
for
submission of latest
GMP
inspection
report.
Renewal of DML
recommended (08-1012)
(Manufacturer’s Spec.s)
Latest
inspection
report is required.
-do-
237.
Smart XR Tablets
Minutes246thMeetingRegistrationBoard
Form 5
International:ALLEGRA- Deferred
Page159
for
Each film coated XR tablet
contains
Fexofenadine HCL (USP)
as immediate Layer…..60
mg
Pseudoephedrine HCL
(USP) as extended
release….. 120 mg
(Histamine H1 receptor
antagonist & adrenergic
vasoconstrictor)
Finished product
specifications are USP
-do-
238.
Rovax Tablet
Each film coated tablet
contains
Rosuvastatin Calcium eq to
Rosuvastatin….. ……..5mg
(Hypolipidaemics)
(Manufacturer’s Spec.s)
27-03-2010
Rs 8000 +
12000
Rs 120 for
10’s
D 12 HOUR ALLERGY AND
CONGESTION (Sanofi)
Local: Fexet D by
M/s Getz
Renewal of DML
recommended (08-1012)
Formulations
is
specialized
dosage
form, Product specific
inspection may be
carried out for the
product
for
verification of facility
etc.
Form 5
27-03-2010
Rs 8000 +
12000
Rs 100 for
10’s
submission of latest
GMP
inspection
report & product
specific inspection
by panel comprising
of DDG, Lahore and
area
FID
for
verification
of
manufacturing
&
testing facilities of
the
applied
formulation.
Confirmation
of
section is required.
Latest
inspection
report is required.
for
BNF:
Crestor Deferred
submission of latest
(AstraZeneca)
GMP
inspection
Local: Rast 5mg by report.
M/s Tabros
Renewal of DML
recommended (08-1012)
Latest
inspection
report is required.
-do-
239.
240.
M/s Nenza
Pharmaceuticals,
Rovax Tablet
Each film coated tablet
contains
Rosuvastatin Calcium eq to
Rosuvastatin…..
……..10mg
(Hypolipidaemics)
(Manufacturer’s Spec.s)
Flotin Tablet 20 mg
Each tablet contains
Minutes246thMeetingRegistrationBoard
Form 5
27-03-2010
Rs 8000 +
12000
Rs 180 for
10’s
for
BNF:
Crestor Deferred
submission of latest
(AstraZeneca)
GMP
inspection
Local: Rast 5mg by report.
M/s Tabros
Renewal of DML
recommended (08-1012)
Form 5
15-07-2010
Latest
inspection
report is required.
Me too Floxac tablet Approved.
20 mg by Schazo
Page160
Plot No. 33 A,
Phase- V,
Industrial Estate,
Hayatabad,
Peshawar.
Fluoxetin HCl USP eq to
Fluoxetin….
20 mg
(Antidepressant)
8000 + 12000
As fixed by
govt
1 × 10 pack
Finished product
specifications are USP
241.
M/s Genix
Pharma (Pvt.) Ltd.
44, 45- B, Korangi
Creek Road,
Karachi.
Triptan Tablet
Each film coated tablet
contains
Frovatriptan (as Succinate
monohydrate)….. …2.5 mg
Anti migraine
Finished product
specifications are
Manufacturer.
Form 5 D
10-082010(52)
Rs 15000/-+
Rs. 12000/(21-0513)+Rs.
23000/- 21-112014
Rs. 200 per
tablet
Pack of 10’s
for Rs 2000/-
International
Selfemra tablet 20 mg
(FDA)
No
conclusion
regarding GMP of the
Firm, some minor
observations at which
the management was
agreed to rectify.
(Routine GMP 10-042014).
The
Board
considered the above
inspection report &
satisfied with the
same.
Deferred
for
International:Frova
of
Tablet 2.5 mg (FDA) rectification
following
observations in the
Local: Form 5-D
dossier:
Good GMP (30-04- 1. Reference will be
sent to B & A
2014)
Division, DRAP for
of
Verification of copy verification
of Rs.12000/- fee photocopy of fee
challan.
challan is required.
No
authentic
reference to clinical
use & doses given in
clinical part of dossier
2. No authentic
reference to clinical
use & doses given in
clinical
part
of
dossier
Stability
studies
conducted under Zone
IV A conditions as
per
ICH/
WHO
guidelines, Clinical
data/ clinical trials are
required.
3. Stability studies
conducted
under
Zone
IV
A
conditions as per
ICH/
WHO
guidelines, Clinical
data/ clinical trials
Reference
of are required.
specifications/testing
methods of finished 4. Reference of
specifications/testing
product is required.
methods of finished
Minutes246thMeetingRegistrationBoard
Page161
product is required.
242.
M/s Genix
Pharma (Pvt.) Ltd.
44, 45- B, Korangi
Creek Road,
Karachi.
Eltram Tablet
Each film coated tablet
contains
Eltrambopag (as
olamine)….. …50 mg
Haematopoietic
Finished product
specifications are
Manufacturer.
Form 5-D
10-08-2010
Rs 15000/-+
Rs. 12000/(21-05-13)
Rs. 200 per
tablet
Pack of 10’s
for Rs 2000/Pack of 20’s
for Rs 4000/-
Deferred
for
rectification
of
following
observation in the
dossier:
1. Reference will be
sent to B & A
Division, DRAP for
verification
of
Verification of copy photocopy of fee
of Rs.12000/- fee challan.
challan is required.
2. Form 5 is
Firm has requested to required.
change Form 5-D to
Form 5 as at the time 3. Evidence of Mestatus
is
of initial application, too
the product was new required.
but now it has
become me-too.
International:
Promacta Tablet 50
mg (FDA)
Local:
Not
confirmed.
Good GMP (30-042014)
Form 5 is required.
243.
M/s Genix
Pharma (Pvt.) Ltd.
44, 45- B, Korangi
Creek Road,
Karachi.
Eltram Tablet
Each film coated tablet
contains
Eltrambopag (as
olamine)….. …25 mg
Haematopoietic
Finished product
specifications are
Manufacturer.
Form 5 D
10-08-2010
Rs 15000/-/-+
Rs. 12000/(21-05-13)
Rs. 150 per
tablet
Pack of 10’s
for Rs 1500/Pack of 20’s
for Rs 3000/-
Evidence of Me-too
status is required.
International:
Promacta Tablet 50
mg (FDA)
Local:
Good GMP (30-042014)
Deferred
for
rectification
of
following
observation in the
dossier:
1. Reference will be
sent to B & A
Verification of copy Division, DRAP for
of
of Rs.12000/- fee verification
photocopy of fee
challan is required.
challan
Firm has requested to
change Form 5-D to 2. Form 5 is
Form 5 as at the time required.
of initial application,
the product was new 3. Evidence of Mestatus
is
but now it has too
required.
become me-too.
Form 5 is required.
Evidence of Me-too
status is required.
Minutes246thMeetingRegistrationBoard
Page162
244.
M/s Genix
Pharma (Pvt.) Ltd.
44, 45- B, Korangi
Creek Road,
Karachi.
Art-M Tablet
Each tablet contains
Artesunate …….60 mg
Pyronaridine Phosphate eq
to Pyronaridine…180 mg
Anti malarial
Finished product
specifications are
Manufacturer.
Form 5 D
10-082010(52)
Rs 15000/-+
Rs. 12000/(21-0513)+Rs.
23000/- 21-112014
Rs. 300 per
tablet
Pack of 10’s
for Rs 3000/Pack of 20’s
for Rs 6000/Pack of 30’s
for Rs 9000/-
Deferred
for
rectification
of
following
Local: Form 5-D
observation in the
Good GMP (30-04- dossier:
2014)
Verification of copy 1. Reference will be
of Rs.12000/- fee sent to B & A
Division, DRAP for
challan is required.
verification
of
No
authentic photocopy of fee
reference to clinical challan.
use & doses given in
clinical part of dossier 2. No authentic
reference to clinical
Stability
studies use & doses given in
part
of
conducted under Zone clinical
IV A conditions as dossier
per
ICH/
WHO
guidelines, Clinical 3. Stability studies
under
data/ clinical trials are conducted
Zone
IV
A
required.
conditions as per
WHO
Reference
of ICH/
guidelines, Clinical
specifications/testing
methods of finished data/ clinical trials
are required.
product is required.
International:
Evidence
of 4. Reference of
Availability
in specifications/testing
Stringent SRA’s is methods of finished
product is required.
required.
245.
M/s Helix Pharma
(Pvt) Ltd.,
Hakimsons
House, A/ 56,
S.I.T.E., Karachi
Primavera/ Omni Plus/
Ristor/ Omnita Omitag/
OSB Capsule
Each capsule contains
Omeprazole…..20mg
Sodium Bicarbonate
…….1100mg
(Strength
has
been
corrected as 1100 mg which
was typed as 110mg in the
agenda copy)
Proton Pump Inhibitor &
Minutes246thMeetingRegistrationBoard
Form 5
30-08-2010
Dy No 203
Rs 8000+Rs.
12000/- (2207-13)
MRP of 10
capsules as per
PRC
International:
Zegerid (FDA)
Local: Rapid (global)
Satisfactory
GMP
compliance (11-0814)
Verification of copy
of Rs.12000/- fee
challan is required.
5.
Evidence
of
Availability
in
Stringent SRA’s is
required.
Deferred for review
of formulation by
Review Committee.
Page163
246.
M/s AGP
(Private) Limited.
B-23, S.I.T.E.,
Karachi
Antacid
(Manufacturer’s Spec.s)
Maxna Injection
Each ml contains
Tranexamic acid BP
……….100mg
Anti Fibrinolytic Agent
Finished product
specifications are BP
Form 5
30-08-2010
Rs. 8000 +
12000
As fixed by
DPC
5 × 10 ml
ampoules
International:
Local:
Satisfactory
GMP
compliance (26-1113)
Verification of copy
of fee challans is
required.
Verification of TOC
analyzer & liquid
particle counter is
required.
Confirmation of Me
too status in 1g/10ml
is required.
247.
M/s Bloom
pharmaceuticals
(Pvt) Ltd. Phase I
& II Industrial
Estate, Hattar
Surfen Plus Tablet
Each film coated tablet
Contains:
Hyoscine N
Butylbromide BP…………
10 mg
Paracetamol BP……
500mg
Anticholinergic &
Analgesic
(B.P Spec.s)
Minutes246thMeetingRegistrationBoard
Form 5
05-08-2010
Rs 20,000/10 × 10’s tab
As per SRO
Deferred
for
rectification
of
following
observations in the
dossier:
1. Reference will be
sent to B & A
Division, DRAP for
verification
of
photocopy of fee
challan.
2. confirmation of
installation
and
operational
qualification
for
TOC analyzer &
liquid
particle
counter by area FID.
3. Confirmation of
Me too status in
1g/10ml is required.
4. Letter of approval
of injection section
is required.
Letter of approval of
injection section is
required. Inspection
report dated 26-092012
mentions
Injectable (Antibiotic,
Analgesic,
Spasmolytics
etc)
Section.
Deferred
for
International:
rectification
of
Local:
Buscopan following
observations in the
Plus Tablets
dossier:
International
NO conclusion , 1.
(in
routine
GMP availability
inspection
, Stringent Regulatory
Shortcomings
have Agencies) required
been improved (25- as part of Form 5.
2. Reference to
07-14)
finished
product
specifications
has
International
availability has not been given as B.P
the
been written. It is while
required as it is part formulation is not
included in B.P.
of Form 5.
Reference to finished
product specifications 3. Undertaking on
has been given as B.P desired format has
Page164
while the formulation not been submitted.
is not included in B.P.
248.
M/s Bloom
Pharmaceuticals
(Pvt) Ltd. Phase
I & II Industrial
Estate, Hattar
Amalar Suspension
Each 5 ml contains
Artemether…..15mg
Lumefantrine…..90mg
Antimalarial
Form 5
05-08-2010
Rs 20,000/As per SRO
30 ml & 60 ml
Finished product
specifications are
Manufacturer.
249.
Rogen
Pharmaceuticals.
Plot No. 30, St
No. S-4
Olirag 10 mg Tablet
Form 5
Each film coated tablet
contains:
19-07-2010
Olanzapine 10 mg
National Industrial
Minutes246thMeetingRegistrationBoard
20,000
As per SRO
Undertaking
on
desired format has not
been submitted.
Deferred
for
International:
rectification
of
Local:
Buscopan following
observations in the
Plus Tablets
dossier:
International
NO conclusion , 1.
routine
GMP availability has not
inspection
, been submitted.
Active
raw
Shortcomings
have 2.
been improved (25- material
specifications have
07-14)
been given as B.P
Firm has written that while these are not
“we will surrender included in B.P.
our already registered 3. Undertaking on
product
Benol desired format has
Capsule Reg No. not been submitted.
022525 in case of fast
track registration of
our
this
product
Amalar Suspension.”
No clarification has
been given in reply.
International
availability has not
been written. It is
required as it is part
of Form 5.
Active raw material
specifications
have
been given as B.P
while these are not
included in B.P.
Undertaking
on
desired format has not
been submitted.
Approved.
International:
Olanzapine 52 mg
(FDA)
Me too:
tablet 5
Amprex
mg by
Page165
Zone (RCCI),
Rawat, Islamabad.
(Tranquilizers, Sedative,
Hypnotics)
for 10’s
The firm has rectified
the
short-comings
conveyed to him.
USP Specifications
250.
Rogen
Pharmaceuticals.
19-07-2010
Olanzapine 5 mg
20,000
National Industrial
Zone (RCCI),
Rawat, Islamabad.
(Tranquilizers, Sedative,
Hypnotics)
As per SRO
for 10’s
Rogen
Pharmaceuticals.
Rocep 250 mg Capsule
Form 5
Each capsule contains:
19-07-2010
Ciprofloxacin HCL USP
250 mg
20,000
Plot No. 30, St
No. S-4
National Industrial
Zone (RCCI),
Rawat, Islamabad.
252.
Rogen
Pharmaceuticals.
Plot No. 30, St
No. S-4
National Industrial
Zone (RCCI),
Rawat, Islamabad.
253.
Form 5
Each tablet contains:
Plot No. 30, St
No. S-4
251.
Olirag 5 mg Tablet
Rogen
Pharmaceuticals.
Plot No. 30, St
International:
Olanzapine 5
(FDA)
Me too:
tablet 5
Amarant
Approved.
mg
Amprex
mg by
USP Specifications
(Quinolone)
As per SRO
for 10’s
International: Not Deferred for review
approved by reference of formualation by
DRAs
Review Committee.
Local: Ciprocin cap
250mg
by
M/s
Miracle
Finished product
specifications are
Manufacturer
Rocep 500 mg Capsule
Form 5
Each capsule contains:
19-07-2010
Ciprofloxacin HCL 500
mg
20,000
(Quinolone)
As per SRO
for 10’s
International: Not Deferred for review
approved by reference of formualation by
DRAs
Review Committee.
Local: Ciprocin cap
250mg
by
M/s
Miracle
Finished product
specifications are
Manufacturer
Sulrog Tablet 25 mg
Form 5
Each tablet contains:
19-07-2010
International: Not Deferred for review
approved by reference of formualation by
DRAs
Review Committee.
Levosulpride 25 mg
20,000
Local:
Minutes246thMeetingRegistrationBoard
Amarant
levopraid
Page166
No. S-4
As per SRO
for 20’s
tablet 25mg by M/s
Pacific
Sulrog Tablet 50 mg
Form 5
Each tablet contains:
19-07-2010
International: Not Deferred for review
approved by reference of formualation by
DRAs
Review Committee.
Levosulpride 50 mg
20,000
National Industrial
Zone (RCCI),
Rawat, Islamabad.
(Antidepressant/
Gastroprokinetic)
As per SRO
for 20’s
Rogen
Pharmaceuticals.
Sulrog Tablet 100 mg
Form 5
Each tablet contains:
19-07-2010
Levosulpride 100 mg
20,000
National Industrial
Zone (RCCI),
Rawat, Islamabad.
(Antidepressant/
Gastroprokinetic)
As per SRO
for 20’s
Rogen
Pharmaceuticals.
Mecrogen 500 mcg Tablet
Form 5
Each film coated tablet
contains
19-07-2010
National Industrial
Zone (RCCI),
Rawat, Islamabad.
254.
Rogen
Pharmaceuticals.
Plot No. 30, St
No. S-4
255.
Plot No. 30, St
No. S-4
256.
(Antidepressant/
Gastroprokinetic)
Plot No. 30, St
No. S-4
National Industrial
Zone (RCCI),
Rawat, Islamabad.
Finished product
specifications are
Manufacturer
Local:
levopraid
tablet 50mg by M/s
Pacific
Finished product
specifications are
Manufacturer.
International: Not Deferred for review
approved by reference of formualation by
DRAs
Review Committee.
Local:
levopraid
tablet 100mg by M/s
Pacific
Finished product
specifications are
Manufacturer
Macobalamin……..500
mcg
20,000
As per SRO
for 30’s
Approved with sugar
International:
Methycobal
tablet coating.
(Japan)
Local:
levopraid
tablet 100mg by M/s
Pacific
Vitamin B12
Finished product
specifications are
Manufacturer
Minutes246thMeetingRegistrationBoard
Page167
Evaluator – II
Applications of impot checked by Evaluator – IV
Type of Form
S.No Name and address of Brand Name
manufacturer
/ (Proprietary name +
Applicant
Dosage Form + Strength) Initial date,
diary
Composition
Fee including
differential
Pharmacological Group
fee
Finished
product
Demanded
Specification
Price / Pack
size
257.
M/s. Novartis Pharma
(Pvt) Ltd, Karachi. /
Product License
Holder:M/s. Novartis Pharma
Schweiz Ltd
Monbijoustrasse Bern,
Switzerland.
Manufacturing Site:M/s. Novartis Pharma
SAS, rue la Chapelle,
Huningue, France.
Sebivo Oral Solution
20mg/ml
Each ml of oral solution
contains: Telbivudine…………20mg
(Hepatitis B)
Remarks
on
the Decision
formulation (if any)
including
International status in
stringent
drug
regulatory agencies /
authorities
Me-too status
GMP
status
as
depicted
in
latest
inspection report (with
date) by the Evaluator
Form 5-A
FDA: Tyzeka (Novartis)
11-11-2009
Diary No. 659
Rs.15000/12-02-2014
Rs.35000/Total
Rs.50,000/-
New Application
N/A
Following
objections
were raised on
the
applications:
1.
Firm
has
not
provided Studies like
Demanded
process
validation,
Price/Pack
pharmaceutical
Size
studies,
Rs.3915/300ml development
validation of analytical
methods.
2.Firm has not provided
chromatographs
for
sample and reference of
active
ingredient,
benzoic
acid,
degradation products in
analytical
procedures
and stability studies.
3.Clinical trial data/
clinical data
Approved
`(The firm submitted
the relevant portion
of CTD showing the
Process validation,
validation
of
analytical method &
chromatograms of
sample and standard
of :
(i)
API
(ii)
Benzoic acid
(iii) Degradation
products.
The referred CTD
mentions same the
manufacturing site
as applied).
Firm had objected on
these observations and
regarding limited time
Minutes246thMeetingRegistrationBoard
Page168
258.
Applicant:
M/s. Mehran Dental,
Karachi.
M No. Al Noor
Centre Randle Road,
ADJANKLESeriaHospital,
Karachi
Manufacturer:
M/s.
Laboratorios
Zeyco S.A. DE C.V.
CAMINO A SANTA
ANA TEPETITLAN
NO. 2230 COLONIA
SANTA
ANA
TEPETITLAN 45230
ZAPOPAN
JALISCO, Mexico.
FD Injection IV
Each 1.8ml ampoule
contains: Lidocaine HCl…36.0mg
Epinephrine…0.018mg
Local Anesthetic
/Adrenergic agonist
Finished product
specifications are USP
Minutes246thMeetingRegistrationBoard
Form 5-A
17-02-2009
Diary No.153
Rs.15000/18-06-2013
Rs.85000/Rs.1200 /
1
x
10
cartridge
in
each blister
Total 5 blister
in packet
Total
50
Pieces
of
cartridges in
Packet
period provided for
reply of these objections
but now has submitted
the reply of these
observations.
Assessment of reply
reveals that the Firm has
not
submitted
the
validation
reports
regarding process and
analytical methods in a
prescribed manner viz.
without contents like
specificity,
linearity,
precision,
accuracy,
limit
of
detection,
Range , Robustness etc.
Further, the Firm has
also not submitted the
chromatograms
of
sample and standard of :
(i) API
(ii) Benzoic Acid
(iii) Degradation
products.
International:
Local:
Sole agency agreement
has been expired.
GMP certificate of
manufacturer has been
expired.
Firm has not provided
original & legalized
Certificate
of
Pharmaceutical Product
with english translation.
Firm has not provided
long
term
stability
studies under zone IV A
conditions are ICH/
WHO
guidelines.
Chromatograms
in
analytical methods &
stability studies have
not been provided along
with data.
Firm gave reference of
USP
for
finished
Deferred
for
rectification
of
following
observations in the
dossier:
1.
Sole
agency
agreement has been
expired.
2. GMP certificate
of manufacturer has
been expired.
3. Firm has not
provided original &
legalized Certificate
of
Pharmaceutical
Product with english
translation.
4. Firm has not
provided long term
stability
studies
under zone IV A
conditions are ICH/
WHO guidelines.
5. Chromatograms in
Page169
analytical methods
& stability studies
have
not
been
provided along with
data.
6.
Firm
gave
reference of USP for
finished
product
specifications while
given assay method
is not as same as
given in USP 35.
7. Firm has not
provided active raw
material
specifications.
8. Firm has not
provided
specifications
of
primary packaging
material (glass vial).
9. Undertaking on
desired format has
not been submitted.
Reply of the Firm needs Deferred
for
further evaluation.
evaluation of replies
submitted by the
firm.
product specifications
while
given
assay
method is not as same
as given in USP 35.
Firm has not provided
active raw material
specifications.
Firm has not provided
specifications
of
primary
packaging
material (glass vial).
Undertaking on desired
format has not been
submitted.
259.
Applicant:
M/s. Haroon Brothers,
1/
A,
KarimjeeBuilding,
Opposite HBL Napier
Rd Branch, Near
Denso Hall,
Karachi.
Mydriaticum Stulln UD
Eye Drops
Each ml contains: Tropicamide Ph. Eur.
….…5mg
Ophthalmic Preparation /
Mydriatic & Cycloplegic
Finished product
Manufacturer:
M/s. Pharma Stulln specifications are
GmbH Werksstrasse
3, D-92551 Stulln,
Germany.
260.
Applicant:
M/s. Haroon Brothers,
1/
A,
KarimjeeBuilding,
Opposite HBL Napier
Rd Branch, Near
Denso Hall,
Karachi.
Manufacturer:
M/s.
Penta
Blupan UD Eye Drops
Each ml contains: Sodium
Hyaluronate Ph. Eur.
…1.5057mg
Dexpanthenol (Vitamin
B5) USP….20.0000 mg
Ophthalmic Preparation
Minutes246thMeetingRegistrationBoard
Form 5-A
30-04-2009
Rs.15000 +
Rs.85000 =
Rs.100000/
Rs.30/ Per Vial
(0.4ml),
depending on
pack size
Reply of the Firm needs
Form 5-A
further evaluation.
30-04-2009
Rs.15000
+
Rs.85000 =
Rs.100000/
Rs.36/ per vial
(0.5ml)
Deferred
for
evaluation of replies
submitted by the
firm.
Page170
Arzneimittel
Werksstrasse
Germany.
GmbH Finished product
3, specifications are
Evaluator – III
S/N Name
and
address
of
manufacturer /
Applicant
on Recommendations Decision
of Remarks
by the Evaluator
the
formulation (if
+
any) including
Initial
date, diary International
status
in
Composition
stringent drug
Fee
regulatory
including
Pharmacological Group
/
differential agencies
authorities
Finished
product fee
Specification
Demanded Me-too status
Price
/
GMP status as
Pack size
depicted
in
latest
inspection
report
(with
date) by the
Evaluator
Type
Form
Brand Name
(Proprietary name
+
Dosage
Form
Strength)
261. M/s
Atco ADVOCORT
Ointment 0.1%
Laboratories
(Pvt)
Limited
Each gram contains:
Karachi.
Methylprednisolone
aceponate…….1mg
Fatty Form-5
Synthetic corticosteroid
Advantan Fatty
Ointment
of
Dy.
No: CSL
Limited
126 dated (TGA
14th
Approved)
October
Advantan
of
2010
Bayer Pakistan
Karachi.
8,000/-
Manufacturer
Rs. 95/- per
5gm tube
Rs. 176/per 10gm
tube
Rs. 250/per 15gm
tube
Minutes246thMeetingRegistrationBoard
Inspection
of
the firm was
conducted on
18-06-14 by the
area FID and
GMP
Compliance
was
found
good.
Firm has submitted
that they are in
process
of
establishing
the
steroidal
section
facility. The firm
has also submitted
letter
regarding
approval
of
proposed
layout
plan for Ointment
(Steroid) and Oral
Liquid
Section
(General).
Deferred for
confirmation
of
manufacturing
facility
for
steroids.
Page171
262. -do-
ADVOCORT
0.1%
Deferred for
confirmation
of
manufacturing
facility
for
steroids.
Advantan
Ointment
of
Limited
Dy.
No: CSL
125 dated (TGA
Approved)
14th
October
Advantan
of
2010
Bayer Pakistan
Karachi
8,000/-
Ointment Form-5
Each gram contains:
Methylprednisolone
aceponate…….1mg
Synthetic corticosteroid
Manufacturer
263. -do-
ADVOCORT Lotion 0.1%
Each ml contains:
Methylprednisolone
aceponate…….1mg
Synthetic corticosteroid
Manufacturer
Rs. 95/- per
5gm tube
Rs. 176/per 10gm
tube
Rs. 250/per 15gm
tube
a. Stability studies
Advantan
Form-5D
needs to be
Lotion of CSL
submitted as per
Dy.
No: Limited (TGA
ICH/
WHO
127 dated Approved)
guidelines.
14th
trial
Inspection
of b. Clinical
October
data is required
the firm was
2010
along
with
conducted on
clinical
18-06-14 by the
15,000/justification.
dated 14- area FID and
GMP
10-10
Compliance
35000/found
dated 05- was
good.
12-13
Rs. 225/30ml
Rs. 330/per 60ml
Minutes246thMeetingRegistrationBoard
Deferred for
followings:
1.
Confirmation
of
manufacturing
facility
for
steroids.
2.
Stability
studies as per
ICH/ WHO
guidelines.
3.
Clinical
trial
data
along
with
clinical
justification.
Page172
264. M/s
Linear PYRETIC
Effervescent
Pharma, Rawat Tablets 500mg
Islamabad.
Each tablet contains:
Paracetamol….500mg
Form-5
06-10-2010
Dy.
No.9220
8,000/-
Analgesic/ Antipyretic
Manufacturer
28-02-2014
Dy. No.595
12000/-
Paracetamol
effervescent
tablet of Accord
Health
Care
UK.
Approved.
Acetosol
of
Shigan Pharma
Islamabad.
Inspection
of
per the firm was
conducted by
of the area FID on
13-11-14 and
the
was
complying the
GMP
Lariam Tablet
Form-5
of Roche UK
06-10-2010
Meflogen
of
Dy.
Genome
No.9226
Pharmaceuticals
8,000/-
As
SRO/
Pack
100’s
265. -do-
MEFQUINE Tablets 250mg
Each tablet contains:
Mefloquine
Hydrochloride…..250mg
Approved.
Antimalarial
Manufacturer
28-02-2014
Dy. No.594
12000/As
SRO/
Pack
25’s
266. -do-
of
Not available in
SRA’s
PENTO Capsule 40mg
Form-5
Each capsule contains:
Pantoprazole sodium 22.5
% pellets equivalent to
Pantoprazole…..40mg
06-10-2010
Dy.
No.9226
8,000/-
PPI
28-02-2014
Dy. No.596
12000/-
Manufacturer
Source:
Vision As
Pharmaceuticals Islamabad. SRO/
Pack
14’s
Minutes246thMeetingRegistrationBoard
per
Deferred for
review
of
formulation.
Pentoloc
of
Aeries Pharma
per
of
Page173
Form-5
267. M/s
Innvotek LETRO Tablets
Pharmaceuticals
No:
Islamabad.
Each film coated tablet Dy.
1037/ 20contains:
10-10
Letrozole……2.5mg
Non steroidal
Inhibitor
of
Femara
Novartis
Karachi
of
Deferred till
decision
on
the
manufacturing
requirement
for
this
product.
aromatase 20,000/-
USP
268. -do-
Femara
Novartis
MILTEFO Capsules
Each capsule contains:
Miltefosine…..50mg
Antiprotozoal
Inspection
of
As
per the firm was
PRC/ Pack conducted on
04-07-14 by the
of 10’s
area FID and
GMP
compliance was
found
satisfactory.
Impavido
of
Form-5
Knight Theraps
Dy.
No: (USFDA)
1036/ 20Fosin Capsules
10-10
of Nimral Labs
20,000/-
Approved.
Manufacturer
As
per
PRC/ Pack
of 8x7’s
269. M/s
Fedro RANIDOL Tablets 150mg
Pharmaceutical
Labs. Peshawar
Each film coated tablet
contains:
Ranitidine
as
hydrochloride……150mg
H2 Blocker
BP
Minutes246thMeetingRegistrationBoard
a. Evidence
of
Ranitidine
approval
of
tablets
of
section
from
20-09-2010 Aurobindo
Drug Licensing
Dy.
No. Pharma.
division is not
1148
submitted.
Zantac of GSK
20,000/b. Inspection of the
Firm
was
As
per
conducted
by
SRO
the area FID on
1x10’s
23-07-14
and
certain
shortcomings
were
found,
which
are
discussed with
the management
of which they
agreed
to
rectify.
Form-5
Deferred till
rectifications
of
shortcomings
as mentioned
in
GMP
inspection
report dated
23.07.2014.
Page174
(“drainage line
found
not
cleaned properly
in tablet section,
three blistering
and
one
stripping
machines found
kept in one
room
without
segregation and
advised
to
provided
partition and AC
facilities
to
control
temperature and
humidity.”)
270. -do-
271. -do-
272. -do-
Ranitidine
tablets
of
Each film coated tablet 20-09-2010 Aurobindo
Dy.
No. Pharma.
contains:
Ranitidine
as 1137
Zantac of GSK
hydrochloride……300mg
20,000/H2 Blocker
As
per
SRO
BP
1x10’s
Not found in
Form-5
FEKAST Tablets 4mg
SRA’s, (applied
is
Each film coated tablet 20-09-2010 strength
as
Dy.
No. approved
contains:
chewable
Montelukast
as 1138
tablet.)
sodium……4mg
20,000/Me too status
Leukotriene
Receptor
As
per needs
Antagonist
confirmation
SRO
2x7’s
Manufacturer
Not found in
Form-5
FEKAST Tablets 5mg
SRA’s, applied
is
Each film coated tablet 20-09-2010 strength
as
Dy.
No. approved
contains:
chewable tablet.
Montelukast
as 1146
sodium……5mg
Me too status
20,000/needs
Leukotriene
Receptor
As
per confirmation
Antagonist
RANIDOL Tablets 300mg
Minutes246thMeetingRegistrationBoard
Form-5
Deferred till
rectifications
of
shortcomings
as mentioned
in
GMP
inspection
report dated
23.07.2014.
Deferred till
rectifications
of
shortcomings
as mentioned
in
GMP
inspection
report dated
23.07.2014.
Deferred till
rectifications
of
shortcomings
as mentioned
in
GMP
inspection
report dated
23.07.2014.
Page175
SRO
2x7’s
Form-5
273. -do-
Manufacturer
FEKAST Tablets 10mg
274. -do-
Each film coated tablet 20-09-2010
Dy.
No.
contains:
Montelukast
as 1143
sodium……10mg
20,000/Leukotriene
Receptor
As
per
Antagonist
SRO
2x7’s
Manufacturer
Form-5
FINFLEX-S Tablets 50mg
275. -do-
FINFLEX-S Tablets 75mg
Deferred till
rectifications
of
shortcomings
as mentioned
in
GMP
inspection
report dated
23.07.2014.
of
Aerokast
of
Barrett
&
Hodgson (Pvt)
Limited
Karachi
of Master formulation
submitted is of film
coated
tablets
Each enteric coated tablet 20-09-2010
applied
of however
Dy.
No. Fastaid
contains:
product is enteric
Platinum
Diclofenac
Sodium 1147
Pharma Karachi coated.
BP…….50mg
20,000/Antirehumatic
As
per
SRO
BP
2x10’s
Voltral
Novartis
Diclofenac
sodium
of
Each enteric coated tablet 20-09-2010 Sandoz
Dy.
No. (USFDA)
contains:
Diclofenac
Sodium 1142
Fastaid
of
BP…….75mg
Platinum
20,000/Pharma Karachi
Antirehumatic
As
per
SRO
BP
2x10’s
Minutes246thMeetingRegistrationBoard
Motelukast
Accord
Healthcare
Form-5
Master formulation
submitted is of film
coated
tablets
however
applied
product is enteric
coated.
Deferred till
rectifications
of
shortcomings
as mentioned
in
GMP
inspection
report dated
23.07.2014 &
rectification
of following
observation:
Master
formulation is
of film coated
tablets while
applied
product
should
be
enteric coated.
Deferred till
rectifications
of
shortcomings
as mentioned
in
GMP
inspection
report dated
23.07.2014 &
rectification
of following
observation:
Master
formulation is
of film coated
tablets while
Page176
applied
product
should
be
enteric coated.
276. -do-
FEDRACAM-BCD Tablets Form-5
20mg
20-09-2010
Dy.
No.
Each tablet contains:
Piroxicam
as
Beta 1140
Cyclodextrin……20mg
20,000/NSAID
As
per
SRO
Manufacturer
2x10’s
277. -do-
CERIGEX-L Tablet 5mg
278. -do-
Each film coated tablet 20-09-2010
Dy.
No.
contains:
Levocetirizine
as 1139
dihydrochloride…..5mg
20,000/Antihistamine
As
per
Manufacturer
SRO
Pack
of
10’s
Form-5
DI- METHER Tablets
Each tablet contains:
Artemether ……40mg
Lumefantrine….240mg
Antimalarial
Minutes246thMeetingRegistrationBoard
Form-5
Brexidol
of Master formulation
Chesi (BNF)
needs rectification
regarding quantity
Brexin
of of API.
Chiesi Karachi.
Levocetirizine
of Actavis UK
Alergocit
of
Global Pharma
Islamabad.
WHO
recommended
Formulation
20-09-2010
Dy.
No.
Artem DS of
1145
Hilton
20,000/-
Deferred till
rectifications
of
shortcomings
as mentioned
in
GMP
inspection
report dated
23.07.2014 &
rectification
of following
observation:
Master
formulation
needs
rectification
regarding
quantity
of
API.
Deferred till
rectifications
of
shortcomings
as mentioned
in GMP
inspection
report dated
23.07.2014
Deferred till
rectifications
of
shortcomings
as mentioned
in GMP
inspection
Page177
USP (Salmus)
279. M/s
Asian FEVEREN
6
Plus
Continental
Suspension
(Pvt) Limited,
Karachi
Each 5ml contains:
Paracetamol……..250mg
As
SRO
Pack
10’s
report dated
23.07.2014
per
of
Calpol 6 Plus
(BNF)
Form-5
Approved.
Dated: 08Calpol 6 Plus
10-2010
GSK Karachi
8,000/-
of
Dated: 31- Inspection
the firm was
07-2013
conducted on
12000/USP
09-09-14 by the
As
per area FID and
concluded that
SRO/
Pack of 1’s the firm is
at
90ml bottle working
acceptable level
of
GMP
compliance.
Xyzal
Oral
Form-5
ATIZA Syrup 2.5mg/ 5ml
Solution
Dated: 12- (USFDA)
Each 5ml contains
10-2010
Levocetirizine
T-Day
of
dihydrochloride……..2.5mg 8,000/Novartis
Dated: 31- Karachi
Antihistamine
07-2013
12000/Manufacturer
Analgesic and Antipyretic
280. -do-
281. -do-
FEVEREN Tablet 500mg
Each tablet contains:
Pracetamol……500mg
As
per
SRO/
Pack of 1’s
90ml bottle
Panadol
Form-5
USA
Dy.
No:
1916/ 29- Panadol
Karachi
10-10
GSK
Approved.
Approved.
GSK
Analgesic
8,000/Manufacturer
As
Minutes246thMeetingRegistrationBoard
per
Page178
PRC
282. -do-
FEVEREN
500mg
Extra
Tablet Form-5
8,000/dated 2710-10
Analgesic
As
per
PRC
Not available in
Form-5
SRA’s
Dy.
No:
9229 dated Me too status
needs
06-10-10
confirmation.
20,000/Inspection
of
As
per the firm was
SRO/ Pack conducted by
the area FID on
of 10’s
13-11-14 and
the
was
complying the
GMP
283. M/s
Linear FACAL Tablet
Pharma, Rawat
Islamabad
Each tablet contains:
Alfacalcidol….0.25mg
Elemental
Calcium…..50mg
Vitamin D supplement
Manufacturer
ALEND Tablets
Each tablet contains:
Alendronate
sodium…..10mg
Biphosphonates
Alendronic acid
of
Accord
Dy.
No: HealthCare UK
as 1139 dated
Alendrate
of
03-11-10
Global Pharma
20,000/-
Manufacturer
Minutes246thMeetingRegistrationBoard
Approved.
Dy.
No:
Panadol Extra
Not
GSK Karachi.
provided
Each tablet contains:
Pracetamol……500mg
Caffiene…….65mg
284. -do-
Panadol Extra
GSK USA
Form-5
Deferred for
confirmation
of approval in
reference
Stringent
Regulatory
Agencies &
me too status.
Approved.
As
per
SRO/ Pack
of 10’s
Page179
285. -do-
Form-5
DOMELATE-C Tablet
Each tablet contains:
Domperidone
meleate….15mg
Cinnarizine……25mg
Not available in
SRA’s
Dy.
No:
as 1148 dated Me too status
needs
03-11-10
confirmation
20,000/-
Deferred for
review
of
formulation
by
Review
Committee.
Antidopaminergic/
Antihistamine
286. -do-
287. -do-
288. -do-
As
per
SRO/ Pack
of 2x10’s
Manufacturer
Depakote
of
Form-5
DIVAL Tablets
Abbive
No:
Each delayed release tablet Dy.
of
1147 dated Divarex
contains:
Medera Pharma
03-11-10
Divalproex
sodium…….500mg
20,000/Antiepileptic
As
per
SRO/ Pack
USP
of 10x10’s
Depakote
of
Form-5
DIVAL Tablets
Abbive
No:
Each delayed release tablet Dy.
of
1146 dated Divarex
contains:
Medera Pharma
03-11-10
Divalproex
sodium…….250mg
20,000/Antiepileptic
As
per
SRO/ Pack
USP
of 10x10’s
Seroquel
of
Form-5
LINQUE Tablets
AstraZeneca
No: (USFDA)
Each film coated tablet Dy.
1151 dated
contains:
Dequit
of
Quetiapine
Fumarate 03-11-10
Shaheen
equivalent
to
Pharma
20,000/Quetiapine….200mg
As
per
SRO/ Pack
of 3x10’s
Seroquel
of
Form-5
LINQUE Tablets
AstraZeneca
No: (USFDA)
Each film coated tablet Dy.
1150 dated
contains:
Dequit
of
Quetiapine
Fumarate 03-11-10
Approved.
Approved.
Approved.
Hypnotic
289. -do-
Minutes246thMeetingRegistrationBoard
Approved.
Page180
equivalent
Quetiapine….400mg
to
20,000/-
Shaheen
Pharma
As
per
SRO/ Pack
of 10’s
Manufacturer
Exforge
Form-5
ALMOVAL Tablets
Novartis
No: (USFDA)
Each film coated tablet Dy.
1142 dated
contains:
Exforge
Amlodipine
as 03-11-10
Novartis
besylate……5mg
Karachi
20,000/Valsartan….80mg
Hypnotic
290. -do-
of
Approved.
of
As
per
SRO/ Pack
of 14’s
Manufacturer
Froben Tablet
Form-5
AMEASAID Tablets
of
Abbot
No: HealthCare UK
Each sugar coated tablet Dy.
1152 dated
contains:
Ansaid of Pfizer
03-11-10
Flurbiprofen….100mg
Karachi
20,000/Antirheumatic
Antihypertensive
291. -do-
As
per
SRO/ Pack
of 30’s
Aldomet
Form-5
ALDONATE Tablet
Aspen UK
No:
Each film coated tablet Dy.
1155 dated Aldomet
contains:
MSD
03-11-10
Methyldopa….250mg
Approved (As
sugar coated
approved in
UK).
Manufacturer
292. -do-
Antihypertensive
of
Approved.
of
20,000/-
As
per
SRO/ Pack
of 100’s
Aerius
Form-5
LINESTIN Tablet
Dermagen
No: Pharma
Each film coated tablet Dy.
1149 dated Islamabad
contains:
03-11-10
Ebastine……10mg
Manufacturer
293. -do-
Antihistamine
of
Approved.
20,000/As
per
SRO/ Pack
Minutes246thMeetingRegistrationBoard
Page181
of 10’s
294. -do-
L-FENAC Capsule
Each capsule contains:
Acitretin…..10mg
Acitretin
Capsules
of
Dy.
No: Genus
1136 dated Pharmaceuticals
UK
03-11-10
Form-5
Approved.
Vitamin A Derivative
20,000/-
295. -do-
Neotigason of
Roche Karachi
As
per
SRO/ Pack
of 3x10’s
Detrusitol
Form-5
TOLFERID Tablet
Tablet of Pfizer
No: UK
Each film coated tablet Dy.
1153 dated
contains:
Detrusitol
Tolterodine tartrate…..2mg 03-11-10
Tablet of Pfizer
Karachi
20,000/Urinary antispasmodic
As
per
SRO/ Pack
of 28’s
Terivid
of
Form-5
OFLOX Tablet
Sanofi UK
No:
Each film coated tablet Dy.
of
9221 dated Treivid
contains:
Sanofi Karachi
06-10-10
Ofloxacin……200mg
Approved.
Manufacturer
296. -do-
Fluoroquinolone
20,000/-
Manufacturer
As
per
SRO/ Pack
of 10’s
Minutes246thMeetingRegistrationBoard
Approved.
Page182
297. -do-
Form-5
CITAL Tablet
Each
chewable
contains:
Escitalopram
oxalate……10mg
Not available in
SRA’s
No:
tablet Dy.
9228 dated Me too status
needs
as 06-10-10
confirmation
20,000/-
Deferred for
approval
in
reference
Stringent
Regulatory
Agencies &
me too status.
Antidepressant
298. -do-
299. -do-
As
per
SRO/ Pack
Manufacturer
of 10’s
Not available in
Form-5
LEVRINE Tablets
SRA’s
No:
Each film coated tablet Dy.
1140 dated Me too status
contains:
needs
03-11-10
Alverine Citrate…..60mg
confirmation.
Simethicone….300mg
20,000/Antispasmodic
As
per
SRO/ Pack
Manufacturer
of 2x10’s
Flomax
MR
Form-5
TAMSIN Capsule
Capsules
of
Dy.
No: Boehringer
Each capsule contains:
Tamsulosin
HCL
as 1154 dated Inghelheim UK
modified release pellets 03-11-10
Tamsolin
of
(0.2%)
equivalent
to
Getz Karachi
20,000/Tamsulosin……0.4mg
Alpha-1 Blocker
Manufacturer
300. -do-
Deferred for
approval
in
reference
Stringent
Regulatory
Agencies &
me too status.
Approved.
As
per
SRO/ Pack
of 10’s
Source:
Vision
Pharmaceuticals Islamabad
Form-5
LINAKSAT Tablets
Singulair
MSD
of
Approved.
No:
Each film coated tablet Dy.
of
9222 dated Montiget
contains:
Getz Karachi
Montelukast
as 06-10-10
sodium……10mg
20,000/Antihistamine
As
per
SRO/ Pack
Manufacturer
of 30’s
Minutes246thMeetingRegistrationBoard
Page183
301. -do-
302. -do-
Approved.
Factive of LG
Life Sciences
No: (USFDA)
Each film coated tablet Dy.
1157 dated
contains:
Factiflox
of
Gemifloxacin
as 03-11-10
Envoy Pharma
mesylate…..320mg
20,000/Quinolone
As
per
SRO/ Pack
Manufacturer
of 7’s
Solian Tablet
Form-5
LINPRIDE Tablets
GEMNILOX Tablets
Each tablet contains:
Amisulpride…..50mg
Form-5
Approved.
Dy.
No: Solian Tablet of
1141 dated Sanofi Karachi
03-11-10
Antipsycotic
20,000/Manufacturer
303. -do-
Each capsule contains:
Calcium
dobisilate….500mg
As
per
SRO/ Pack
of 2x10’s
Not available
Form-5
in SRA’s
Dy.
No:
of
1138 dated Doxium
AGP Karachi
03-11-10
Vasotherapeutic
20,000/-
DOB-C Capsules
304. M/s
Caraway ONDENLES Injection 8mg
Pharmaceuticals,
Islamabad.
Each ml contains:
Ondansetron hydrochloride
dihydrate equivalent to
Ondansetron……2mg
5HT-3 Antagonist
USP
Minutes246thMeetingRegistrationBoard
As
per
SRO/ Pack
of 2x10’s
Form-5
Zofran of GSK
Dy.
No:
9773 dated
18th
October
2010
Zofran of GSK,
Karachi
The inspection
of the firm was
conducted on
24-09-12 by the
20,000/panel
of
As
per inspectors and
they concluded
SRO
that the firm is
operating
at
good level of
GMP
Deferred for
review
of
formulation
by the Review
Committee.
a. Evidence
of
availability of
TOC and liquid
particle counter
is not provided
by the firm.
b. Latest
inspection
report
is
required.
Deferred for
the
followings:
1.
Confirmation
of installation
and
operational
qualifications
of
TOC
analyser and
liquid particle
counter
by
FID.
2.
Latest
inspection
Page184
compliance.
305. -do-
ONDENLES Tablet 8mg
Form-5
5HT-3 Antagonist
20,000/-
report
required.
Zofran of GSK
Latest inspection Deferred for
report is required.
latest
GMP
No: Zofran of GSK,
status of the
Each film coated tablet Dy.
9774 dated Karachi
firm.
contains:
Ondansetron hydrochloride 18th
dihydrate equivalent to October
Ondansetron……8mg
2010
USP
As
per
SRO
Kytril Tablet of
Form-5
306. M/s
Genix GRANI Tablet
Roche
Pharma
(Pvt)
No:
Limited,
Each film coated tablet Dy.
1899 dated Kytril Tablets
Karachi.
contains:
of
Roche
Granisetron HCL equivalent 29-10-10
Karachi
to Granisetron…….1mg
8,000/Inspection
of
Antiemetic
Rs. 3250/- the firm was
Pack
of conducted on
Manufacturer
30-04-14 by the
10’s
Rs. 6500/- area FID and
Pack
of GMP
compliance is
20’s
rated as GOOD
Kytril Syrup of
Form-5
307. -doGRANI Syrup
Roche
Dy.
No:
Each 5ml contains:
Granisetron HCL equivalent 1907 dated Graniset Syrup
of SJ & G Fazul
29-10-10
to Granisetron…….1mg
Elahi Karachi
8,000/Antiemetic
Manufacturer
Minutes246thMeetingRegistrationBoard
is
Approved.
Approved.
Rs. 210/Pack
of
30ml
Rs. 420/Pack
of
60ml
Page185
Evaluator – III (Veterinary Cases)
Remarks on the Recommendat Decision
formulation
(if ions by the
any)
including Evaluators
International
status
in
drug
Fee including stringent
Composition
regulatory
differential fee
agencies
/
Pharmacological
authorities
Demanded
Group
Price / Pack
Me-too status
Finished product size
Specification
GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator
Type of Form
Brand Name
(Proprietary name
date,
+ Dosage Form + Initial
diary
Strength)
S/N
Name
and
address
of
manufacturer /
Applicant
308.
M/s
Noble NOBI-LINCOL
Pharma, Mirpur Powder
Azad Kashmir
Each 1gm contains:
Lincomycin
Sulphate…..100mg
Colistin
Sulphate……8,00,0
00IU
Vety
Lincon
Powder of Leads
Dy. No: 05 Pharma Karachi.
dated 02-10-10
Form-5
Approved.
20,000/Decontrolled/
100gm, 500gm
and 1kg
Antibacterial
309.
-do-
Manufacturer
TRIDOX-TD Oral Form-5
Powder
Dy. No: 85
08th
Each
1000gm dated
contains:
November 2010
Doxycycline
HCL……200gm
20,000/Tylosin
Tartrate…..100gm
Decontrolled/
Bromohexine
100gm, 500gm,
HCL…..5ogm
and 1Kg
Colistin
sulphate…..48MIU
Minutes246thMeetingRegistrationBoard
Pulmotin
Water
Soluble Powder of
Attabak Pharma
Islmabad.
Approved.
Page186
Evaluator – III (Import applications)
S/N
Name
and
address
of
manufacturer
/ Applicant
Remarks on Recommendatio Decision
ns
by
the
the
Evaluators
formulation
(if
any)
including
Fee including International
Composition
status
in
differential fee
stringent
Pharmacological
drug
Demanded
Group
Price / Pack regulatory
agencies
/
Finished product size
authorities
Specification
Type of Form
Brand Name
(Proprietary name
date,
+ Dosage Form + Initial
diary
Strength)
Me-too status
GMP status
as depicted in
latest
inspection
report (with
date) by the
Evaluator
310.
Famous
Brand
Applicant
M/s
Bajwa Single Blood Bags
Sons,
129
Circular Road,
Each 100ml of
Lohari Lahore
CPDA
(Citrate
Manufacturer Phosphate Dextrose
Adenine Solution,
Shanghai
Anticoagulant)
Transfusion
contains:
Technology
Citric
acid
Co. Ltd.
Add: No.500 monohydrate……0
You
Dong .299g
Sodium
citrate
Road,
dihydrate…………
Minhang,
2.63g
Shanghai,
201100, P.R of Sodium
biphosphate
China
monohydrate……0
.222g
Dextrose
monohydrate……..
3.19g
Adenine……….0.0
275g
Form-5A
Dy No:
provided
15000/dated
08-10-10
Rs 150/ Blood
Bag of 250ml
Rs 150/ Blood
Bag of 450ml
Rs 160/ Blood
Bag of 500ml
Minutes246thMeetingRegistrationBoard
Not
a. Evidence
of
Balance fee is
not submitted.
b. Stability studies
as per Zone-IVA conditions as
per ICH/ WHO
guidelines need
to be submitted.
c. Original
Legalized and
valid COPP as
per
WHO
format
or
original
and
legalized GMP
certificate
along with Free
sale certificate
from regulatory
body of country
of origin, needs
to be submitted.
d. Clinical
trial
data is not
Deferred for the
followings:
1. Evidence of
Balance fee is
not submitted.
2.
Stability
studies as per
Zone-IV-A
conditions as
per ICH/ WHO
guidelines need
to be submitted.
3.
Original
Legalized and
valid COPP as
per
WHO
format
or
original
and
legalized GMP
certificate
along with Free
sale certificate
from regulatory
body of country
of origin, needs
Page187
Water
for
Injection….Qs
Disposable
311.
Famous
Brand Form-5A
Double Blood Bags
Dy No: 29 dated
Each 100ml of 08-10-10
CPDA
(Citrate
dated
Phosphate Dextrose 15000/Manufacturer Adenine Solution, 08-10-10
Anticoagulant)
Shanghai
Rs 300/ Blood
contains:
Transfusion
Citric
acid Bag of 450ml
Technology
monohydrate……0 Rs 315/ Blood
Co. Ltd.
Bag of 500ml
Add: No.500 .299g
citrate
You
Dong Sodium
dihydrate…………
Road,
2.63g
Minhang,
Sodium
Shanghai,
201100, P.R of biphosphate
monohydrate……0
China
.222g
Dextrose
monohydrate……..
3.19g
Adenine……….0.0
275g
Water
for
Injection….Qs
Applicant
M/s
Bajwa
Sons,
129
Circular Road,
Lohari Lahore
Disposable
312.
Applicant
M/s
Bajwa
Sons,
129
Circular Road,
Lohari Lahore
Manufacturer
Famous
Brand Form-5A
triple Blood Bags
Dy No: Not
Each 100ml of provided
CPD
(Citrate
dated
Phosphate Dextrose 15000/08-10-10
Solution,
Minutes246thMeetingRegistrationBoard
to be submitted.
submitted.
4. Clinical trial
e. Packaging
data is not
material
submitted.
specification
Packaging
are
not 5.
material
provided
specification
has not been
provided
a. Evidence
of Deferred for the
Balance fee is followings:
not submitted.
1. Evidence of
b. Stability studies Balance fee is
as per Zone-IV- not submitted.
Stability
A conditions as 2.
per ICH/ WHO studies as per
guidelines need Zone-IV-A
to be submitted. conditions as
per ICH/ WHO
c. Original
Legalized and guidelines need
valid COPP as to be submitted.
Original
per
WHO 3.
format
or Legalized and
original
and valid COPP as
WHO
legalized GMP per
format
or
certificate
and
along with Free original
sale certificate legalized GMP
from regulatory certificate
body of country along with Free
of origin, needs sale certificate
to be submitted. from regulatory
d. Clinical
trial body of country
data is not of origin, needs
to be submitted.
submitted.
4. Clinical trial
e. Packaging
data is not
material
submitted.
specification
Packaging
are
not 5.
provided
material
specification has
not been provided
a. Evidence
of Deferred for the
Balance fee is followings:
not submitted. 1. Evidence of
Balance fee is
b. Stability
studies as per not submitted.
2.
Stability
Zone-IV-A
conditions as studies as per
Page188
Shanghai
Transfusion
Technology
Co. Ltd.
Add: No.500
You
Dong
Road,
Minhang,
Shanghai,
201100, P.R of
China
Anticoagulant)
contains:
Citric
acid
monohydrate……0
.299g
Sodium
citrate
dihydrate…………
2.63g
Sodium
biphosphate
monohydrate……0
.222g
Dextrose
monohydrate……..
3.19g
Water
for
Injection….Qs to
100ml
Rs 510/ Blood
Bag of 450ml
Rs 525/ Blood
Bag of 500ml
Each 100ml of
SAGM
(Saline
Adenine Glucose
Mannitol,
Red
Blood
Cell
Preservative)
contains:
Dextrose
monohydrate…..0.
900g
Sodium
chloride…..0.877g
Adenine…….0.016
9g
DMannitol…….0.52
5g
Water
for
Injection….qs
to
100ml
313.
Applicant
M/s
Bajwa
Sons,
129
Circular Road,
Lohari Lahore
Manufacturer
Shanghai
Disposable
Famous
Brand Form-5A
Quadruple Double
Dy No: Not
Blood Bags
provided
Each 100ml of
dated
CPD
(Citrate 15000/Phosphate Dextrose 08-10-10
Solution,
Minutes246thMeetingRegistrationBoard
per
ICH/
WHO
guidelines
need to be
submitted.
c. Original
Legalized and
valid COPP as
per
WHO
format
or
original
and
legalized GMP
certificate
along
with
Free
sale
certificate
from
regulatory
body
of
country
of
origin, needs
to
be
submitted.
d. Clinical trial
data is not
submitted.
e. Packaging
material
specification
are
not
provided
Zone-IV-A
conditions as
per ICH/ WHO
guidelines need
to be submitted.
3.
Original
Legalized and
valid COPP as
per
WHO
format
or
original
and
legalized GMP
certificate
along with Free
sale certificate
from regulatory
body of country
of origin, needs
to be submitted.
4. Clinical trial
data is not
submitted.
5.
Packaging
material
specification has
not
been
provided
a. Evidence
of
Balance fee is
not submitted.
b. Stability
studies as per
Zone-IV-A
conditions as
per
ICH/
Deferred for the
followings:
1. Evidence of
Balance fee is
not submitted.
2.
Stability
studies as per
Zone-IV-A
Page189
Transfusion
Technology
Co. Ltd.
Add: No.500
You
Dong
Road,
Minhang,
Shanghai,
201100, P.R of
China
Anticoagulant)
contains:
Citric
acid
monohydrate……0
.299g
Sodium
citrate
dihydrate…………
2.63g
Sodium
biphosphate
monohydrate……0
.222g
Dextrose
monohydrate……..
3.19g
Water
for
Injection….Qs to
100ml
Rs 440/ Blood
Bag of 450ml
Rs 445/ Blood
Bag of 500ml
Each 100ml of
SAGM
(Saline
Adenine Glucose
Mannitol,
Red
Blood
Cell
Preservative)
contains:
Dextrose
monohydrate…..0.
900g
Sodium
chloride…..0.877g
Adenine…….0.016
9g
DMannitol…….0.52
5g
Water
for
Injection….qs
to
100ml
WHO
guidelines
need to be
submitted.
c. Original
Legalized and
valid COPP as
per
WHO
format
or
original
and
legalized GMP
certificate
along
with
Free
sale
certificate
from
regulatory
body
of
country
of
origin, needs
to
be
submitted.
d. Clinical trial
data is not
submitted.
e. Packaging
material
specification
are
not
provided
conditions as
per ICH/ WHO
guidelines need
to be submitted.
3.
Original
Legalized and
valid COPP as
per
WHO
format
or
original
and
legalized GMP
certificate
along with Free
sale certificate
from regulatory
body of country
of origin, needs
to be submitted.
4. Clinical trial
data is not
submitted.
5.
Packaging
material
specification has
not been provided
Disposable
Minutes246thMeetingRegistrationBoard
Page190
Case No.07.
Remaining drug registration applications of previously approved new sections
Evaluator – I
M/s Stallion Pharmaceuticals (Pvt) Ltd, Lahore have informed that their 04 products were deferred in
244th meeting of Registration Board held on 8th and 9th May, 2014 due to confirmation of manufacturing
facility and that they are now under process of developing a dedicated Carbapenem facility and that the
04 deferred products may be considered of their approved manufacturing facility. The firm has requested
consideration of the following 04 products on priority basis (according to 10 products per section policy).
S.
N
Type of Form
Name and address Brand Name
of Manufacturer / (Proprietary
date,
Applicant
name + Dosage Initial
form + Strength) diary.
Composition
Fee
including
differential fee
Remarks /
International
status
in Observations
stringent
regulatory
agencies
Decision
Me-too status
Pharmacological
Group
Demanded Price GMP status as
depicted
in
/ Pack size
inspection
Finished product
report (dated)
specification
314. M/s.
Stallion
Pharmaceuticals
(Pvt) Ltd, 581Sunder
Industrial
Estate, Lahore
New License
1.Capsule.(Penicillin
)
2.Dry
Powder
Suspension
(Penicillin)
3.Dry
Powder
Injection (Penicillin)
FLOXAPEN
Fluclox Injection Form-5
Injection 500mg
500mg
MHRA UK
27-10-2014
Dry
Powder 1336 R&I
Injection
Rs. 20,000/A-FLOX
Each
vial
500mg Injection
contains:Pack of one Rs. Laderly
Flucloxacillin
Sodium (B.P) eq. 90/to Flucloxacillin Pack of 5 Rs.
N/A
(New
450/………………..
Pack of 10 Rs. License)
500mg
900/-
(Penicillin)
Vide letter No. F. 133/2009 – Lic dated BP Specifications
6th February, 2014
315. -doStaclox Injection
Dry
Injection
Form-5
Powder 27-10-2014
1337 R&I
Minutes246thMeetingRegistrationBoard
AMPICLOX
250/250mg
Injection
MHRA
Approved.
Approved.
Page191
Each
vial
contains:Ampicillin
Sodium (B.P) eq.
to
Ampicillin
………………..
250mg
Cloxacillin
Sodium (B.P) eq.
to
Cloxacillin
250mg
Rs. 20,000/AMPICLOX
500mg Injection
Pack of one Rs. Gsk
70/Pack of 5 Rs.
N/A
(New
350/Pack of 10 Rs. License)
700/-
(Penicillin)
316. -do-
Manufacturers
Specifications
Flustal Injection
Dry
Injection
Powder
Each
vial
contains:Amoxicillin
Sodium (B.P) eq.
to
Amoxicillin……..
….. 250mg
Flucloxacillin
Sodium (B.P) eq.
to Flucloxacillin
…………………
250mg
Form-5
FLUMOX
250/250mg Inj
EIPICO, Egypt
1) Evidence of
approval
of
same
27-10-2014
formulation in
1338 R&I
Egypt has been
Biflocin
provided
Rs. 20,000/500mg Inj
instead
of
Zam Zam Corp
stringent
regulatory
Pack of one Rs.
144/N/A
(New authority e.g.,
FDA,
TGA,
Pack of 5 Rs. License)
MHLW, EMA
720/and
Health
Pack of 10 Rs.
Canada.
1440/-
Deferred
for
confirmatio
n
of
approval in
reference
Stringent
Reulatory
Agencies.
Form-5
Amoxil 500 mg
Vial
MHRA
Approved.
(Penicillin)
317. -do-
Manufacturers
Specifications
Amoxi Injection
500mg (BP)
Dry
Powder
Injection
Each Vial
Contains:
Amoxicillin
Sodium ( BP) eq.
25-10-2013
643 R&I
Rs. 20,000/-
Amoxil 500 mg
GSK, Pakistan
Rs. 90.0 / 1’s,
N/A
Minutes246thMeetingRegistrationBoard
(New
Page192
to
Amoxicillin ……
500mg
Rs. 900.0 / 10’s
License)
(Penicillin)
BP Specifications
Evaluator – II
The Registration Board has been granting 10 products per section to newly approved sections. Following
are the remaining products of the applicants as per above policy.
S/
N
Name
and Brand Name
Type of Form
address
of
manufacturer / (Proprietary name + Initial date, diary
Dosage Form +
Applicant
Fee
including
Strength)
differential fee
Composition
Demanded Price /
Pharmacological
Pack size
Group
Finished
product
Specification
318.
M/s Rogen
Pharmaceuticals
Plot No. 30 Street
No. # S-4 National
Industrial Zone
Rawat Islamabad.
Semi Solid
(Cream/Ointment)
General Section
(No. F. 1-27/2009Lic Dated 19-07-10
)
Efrog 13.9%Cream
Each gram contains:Eflornithine (as
eflornithine
Hydrochloride
…139mg
(Enzyme Inhibitor)
(Manufacturer’s
Spec.s)
Form 5
26/11/2014 Dy. No.
1907 Rs. 20000/As per SRO
Remarks
on
the Decision
formulation (if any)
including International
status in stringent drug
regulatory agencies /
authorities
Me-too status
GMP status as depicted
in
latest
inspection
report (with date) by
the Evaluator
BNF: Vaniqa (Almirall),
but in 11.5% strength
Approved
in
11.5 % strength.
Vanika (Crystollite) 13.9
% , Depilus Cream (Atco)
in 11.5% strength but no
pricing
The company may be
issued cGMP Certificate
for export purpose. (0906-2014)
1. The
product
is
available in 11.5 %
Minutes246thMeetingRegistrationBoard
Page193
319.
M/s Faas
Pharmaceuticals
(Pvt.) Limited F784/L S.I.T.E.
Karachi
Sachet Section:
F. 2-2/2009-Lic
dated 15-02-2013
320.
-do-
Antisec Sachet
Each Sachet
contains:Racecadotril
(B.P)…10mg
(Anti-Diarrheal)
(Manufacturer’s
Spec.s)
Antisec Sachet
Each Sachet
contains:Racecadotril
(B.P)…15mg
(Anti-Diarrheal)
(Manufacturer’s
Spec.s)
Form 5
29/10/2014 Dy. No.
117 Rs. 20000/As per SRO/1×10’s
Form 5
29/10/2014 Dy. No.
116 Rs. 20000/-
Minutes246thMeetingRegistrationBoard
As per SRO/1×10’s
strength as per BNF.
In Pakistan product is
available in both
13.9% and 11.5 %
strengths but pricing
of 11.5 % strength
could not be traced.
The
Firm
has
submitted
master
formulation of both
strength
after
evaluation of initial
dossier
and
has
requested to grant
them registration of
any one strength.
Deferred
for
BNF: Hidrasec (Abbott
confirmation of
Healthcare)
me too status
otherwise
the
Not confirmed
firm shall apply
Satisfactory level of GMP on form 5-D
with fee & other
compliance(18-03-14)
codal
1. Me-too status needs formalities.
confirmation.
Not confirmed
Deferred
for
confirmation of
Not confirmed
approval
in
reference
Satisfactory level of GMP Stringent
compliance(18-03-14)
Regulatory
Agencies & me
1. International
too status.
availability
of
formulation in SRA’s
not confirmed.
2. Me-too status needs
confirmation.
Page194
321.
-do-
322.
-do-
323.
-do-
324.
-do-
Antisec Sachet
Each Sachet
contains:Racecadotril
(B.P)…30mg
(Anti-Diarrheal)
(Manufacturer’s
Spec.s)
Uronol Sachet 3G
Each Sachet
contains:Fosfomycin (as
Tromethamine
…3gm
(Anti-bacterial)
(Manufacturer’s
Spec.s)
Ostrolife Sachet
Each Sachet
contains:Cholecalciferol
(USP)…60,000IU
(Vitamin)
(Manufacturer’s
Spec.s)
Oraltral Sachet
(Orange Flavor)
Each Sachet
contains:Sodium
Chloride…3.5g
Sodium Citrate
Dihydrate…2.9g
Potassium
Chloride…1.5
Glucose
Anhydrous…20g
(Electrolytes)
(Manufacturer’s
Form 5
29/10/2014 Dy. No.
115 Rs. 20000/As per SRO/1×10’s
Form 5
29/10/2014 Dy. No.
114 Rs. 20000/As per SRO/1×10’s
Form 5
29/10/2014 Dy. No.
276 Rs. 20000/As per SRO/1×10’s
Form 5
29/10/2014 Dy. No.
271 Rs. 20000/-
Minutes246thMeetingRegistrationBoard
As per SRO/1×20’s
Deferred
for
confirmation of
me too status
otherwise
the
Not confirmed
firm shall apply
Satisfactory level of GMP on form 5-D
with fee & other
compliance(18-03-14)
codal
1. Me-too status needs formalities.
confirmation.
Deferred
for
Health Canada: Monurol
confirmation of
(Triton Pharma Inc.)
me too status
otherwise
the
Not confirmed
firm shall apply
Satisfactory level of GMP on form 5-D
with fee & other
compliance (18-03-14)
codal
1. Me-too status needs formalities.
confirmation.
Not confirmed
Deferred
for
confirmation of
Not confirmed
approval
in
reference
Satisfactory level of GMP Stringent
compliance(18-03-14)
Regulatory
Agencies & me
1. International
too status.
availability
of
formulation in SRA’s
not confirmed.
2. Me-too status needs
confirmation.
Not confirmed
Approved as the
formulation is
Peditral (Searle)
WHO approved.
BNF: Hidrasec (Abbott
Healthcare)
Satisfactory level of GMP
compliance(18-03-14)
1. International
availability
of
formulation in SRA’s
not confirmed. WHO
formulation is sodium
chloride
2.6
g,
Page195
Spec.s)
325.
-do-
326.
327.
-do-
-doCapsule Section:
F. 2-2/2009-Lic
dated 15-02-2013
Oraltral Sachet
(Lemon and Lime
Flavor)
Each Sachet
contains:Sodium
Chloride…3.5g
Sodium Citrate
Dihydrate…2.9g
Potassium
Chloride…1.5
Glucose
Anhydrous…20g
(Anti-Malarial)
(B.P Spec.s)
Neomecta Sachet
Each Sachet
contains:Dioctahedral
Smectite…3000mg
(Anti-diarrhioeals)
(Manufacturer’s
Spec.s)
Itometic Capsule
Each capsule
contains:
Itopride
hydrochloride…150
mg
(as sustained release
pellets)
(Gastoprokinetic /
antiemetic)
(Manufacturer’s
Spec.s)
Form 5
17/09/2014 Dy. No.
274 Rs. 20000/As per SRO/1×20’s
Form 5
17/09/2014 Dy. No.
275 Rs. 20000/As per SRO/1×30’s
Form 5
17/09/2014 Dy. No.
270 Rs. 20000/-
Minutes246thMeetingRegistrationBoard
As per SRO/1×10’s
potassium
chloride
1.5 g, sodium citrate
2.9 g, anhydrous
glucose 13.5 g
Not confirmed
Approved as the
formulation is
Peditral (Searle)
WHO approved.
Satisfactory level of GMP
compliance(18-03-14)
1. International
availability
of
formulation in SRA’s
not confirmed. WHO
formulation is sodium
chloride
2.6
g,
potassium
chloride
1.5 g, sodium citrate
2.9 g, anhydrous
glucose 13.5 g.
Not confirmed
Deferred
for
review
of
Smecta (Atco)
formulation by
Review
Satisfactory level of GMP Committee.
compliance(18-03-14)
1. International
availability
of
formulation in SRA’s
not confirmed.
Not confirmed
Deferred
for
review
of
Ganaton OD (Abbott)
formulation
alongwith
the
Satisfactory level of GMP rectification of
compliance(18-03-14)
following
observations:
1. Formulation is under 1.
Fee for
of
review by the Review import
pellets,
Committee.
Legalized Copy
2. Fee for import of
of Valid GMP
pellets,
Legalized certificate
of
Copy of Valid GMP manufacturer of
Page196
328.
-do-
329.
-do-
330.
-do-
(Source of Pellets:
M/s Titan
Laboratories Private
Limited Plot No.
E27/1, E27/2, MIDC,
Mahad Village Jite
District, Raigad,
Maharashtra, India)
Azobact Capsule
250mg
Each capsule
contains:
Azithromycine (As
dihydrate)
(USP)..250mg
(Anti-Infective)
(USP Spec.s)
Pirotrin 20mg
Capsule
Each capsule
contains:
Piroxicam beta
cyclodextrin eq. to
Piroxicam……..20
mg
(Analgesic / antirheumatic/ anti
pyretic)
(Manufacturer’s
Spec.s)
Tamsol 0.4mg
Capsule
Each capsule
contains:Tamsulosin
hydrochloride(as
modified release
pellets)…….0.4 mg
(Anti BPH)
(USP Spec.s)
{Source: M/s Vision
Pharmaceuticals, Plot
No 224, Street No.
certificate
of
manufacturer
of
Pellets;
stability
studies according to
zone of Pakistan of
Pellets are required.
Form 5
17/09/2014 Dy. No.
266 Rs. 20000/As per SRO/1×10’s
Form 5
17/09/2014 Dy. No.
267 Rs. 20000/As per SRO/1×10’s
Form 5
17/09/2014 Dy. No.
268 Rs. 20000/-
Minutes246thMeetingRegistrationBoard
BNF : Zithromax
(Pfizer)
Pellets;
2.
stability
studies
according
to
zone of Pakistan
of Pellets are
required.
.
Approved.
Azomax (Novartis)
Satisfactory level of GMP
compliance(18-03-14)
BNF : Feldene (Pfizer)
Approved.
Pirobet (Highnoon)
Satisfactory level of GMP
compliance(18-03-14)
BNF: Tamsulosin
hydrochloride (Nonproprietary)
Tamsolin (Getz)
As per SRO/1×10’s
Satisfactory level of GMP
compliance (18-03-14)
1. Certificate
of
Analysis,
stability
studies according to
zone of Pakistan of
Pellets are required.
Approved. Firm
will
provide
Certificate
of
Analysis
and
stability studies
of
pellets
according
to
zone IV A and
Chairman, RB
will
permit
issuance
of
registration
letter.
Page197
01, I-10/3 , Industrial
area, Islamabad}
Evaluator – III
S/N
Name
and
address
of
manufacturer /
Applicant
Type
of
Brand Name
(Proprietary name + Form
Dosage
Form
+
Initial date,
Strength)
diary
Composition
Fee
including
Pharmacological
differential
Group
fee
Finished
product
Demanded
Specification
Price / Pack
size
Remarks on Recommendations Decision
by the Evaluator
the
formulation
(if
any)
including
International
status
in
stringent drug
regulatory
agencies
/
authorities
Me-too status
GMP status as
depicted
in
latest
inspection
report (with
date) by the
Evaluator
Klaricid
of
Abbott UK
Dy No: 864 (Lyophilized
dated 24-09- Powder)
2014
Clariset
of
Mediate
20,000/Pharma
Macrolide
As fixed by
Govt.
BP
Pack of 1’s
Prevacid
of
LANSOP
Injection Form-5
Takeds Pharm
30mg
Dy No: 863 (USFDA)
dated 24-09- Lyophilized
Each vial contains:
Powder
Lansoprazole……30mg 2014
331.
M/s
Wenovo CLARITHREM
Injection
Pharmaceuticals,
Taxila
Each vial contains:
(Dry Powder Vial Clarithromycin
….….500mg
Injectable)
332.
-do-
PPI
Manufacturer
Minutes246thMeetingRegistrationBoard
Form-5
Approved.
Approved.
Lansit of SJ &
G Fazul Elhahi
As fixed by Karachi
Govt.
20,000/-
Page198
Pack of 1’s
333.
-do-
Protonix
of
Wyeth
Dy No: 862 (USFDA)
as dated 24-09- Lyophilized
powder
2014
PANTOWEN Injection
Each vial contains:
Pantoprazole
sodium…..40mg
PPI
Manufacturer
334.
-do-
AZINOV Injection
Each vial contains:
Azithromycin….500mg
Form-5
Lesprot
of
Nabiqasim
As fixed by Karachi
Govt.
Pack of 1’s
Zithromax of
Form-5
Pfizer
Dy No: 862 (USFDA)
dated 24-09- Lyophilized
Powder
2014
Approved.
20,000/-
Approved.
Macrolide
Azimycin of
Medicina
As fixed by Pharma Lahore
Govt.
Pack of 1’s
Cymbalta
of
Form-5
WENOLOX Capsule
EliLilly
Dy No: 1277 Netherlands
Each capsule contains:
Duloxetine as HCL dated 24-10Duxafit
of
enteric coated pellets 2014
Wnsfield
(17%)
eq.
to
Hattar
20,000/Duloxetine…..30mg
20,000/-
Manufacturer
335.
-do(Capsule General)
Antidepressant
Manufacturer
Approved.
As per policy
of MOH
1x10’s
Source: Vision Pharma
Islamabad
Minutes246thMeetingRegistrationBoard
Page199
336.
337.
-do-
-do-
Approved.
Cymbalta
of
Eli
Lilly
Dy No: 1276 Netherlands
Each capsule contains:
Duloxetine as HCL dated 24-10Duxafit
of
enteric coated pellets 2014
Wnsfield
(17%)
eq.
to
Hattar
20,000/Duloxetine…..60mg
WENOLOX Capsule
Form-5
Antidepressant
As per policy
of MOH
1x10’s
Gabapentin
Form-5
Capsules
of
Dy No: 1274 Sandoz UK
dated 24-10Nerogabin of
2014
Merck
20,000/-
Manufacturer
GABANOV Capsules
Each capsule contains:
Gabapentin…..300mg
Anticonvulsant
Approved.
USP
338.
-do-
GABANOV Capsules
Each capsule contains:
Gabapentin…..400mg
Anticonvulsant
As per policy
of MOH
1x10’s
Form-5
Gabapentin
Arrow 400mg
Dy No: 1275 Hard Capsules
dated 24-10- of Actavis UK
2014
Nerogabin of
20,000/Merck
Approved
USP
339.
As per policy
of MOH
1x10’s
Evidence
of
Tramdol
-doTRAMANOV Injection Form-5
Injection
of availability of TOC
(Liquid Ampoule
analyzer and liquid
SVP)
Each 2ml ampoule Dy No: 1273 Beacon
particle counter is
dated 23-10- Pharma UK
contains:
required.
2014
Tramadol
Lamadol
of
HCL……100mg
Brooks
20,000/Karachi
Synthetic
opiate
As per policy
analogue
of MOH
Pack of 5’s
Manufacturer
& 10’s
Minutes246thMeetingRegistrationBoard
Deferred for
confirmation
of
installation
and
operational
qualifications
of
TOC
analyser &
liquid
Particle
Counter by
Area FID.
Page200
340.
-do-
of
Availability in Evidence
SRA’s needs availability of TOC
analyzer and liquid
Each 2ml of amber Dy No: 1272 confirmation
particle counter is
glass ampoule contains: dated 23-10Dinopen
of required.
2014
Diclofenac
Global
Sodium…..75mg
Pharma,
20,000/Lidocaine
Islamabad.
HCl…..20mg
As per policy
Analgesic,
Local of MOH
Pack of 5’s
anesthetic
& 10’s
Manufacturer
Form-5
WENOFEN Injection
Deferred for
confirmation
of
installation
and
operational
qualifications
of
TOC
analyser &
liquid
Particle
Counter by
Area FID.
Evaluator – III (Veterinary applications)
S/N
Name
and
address
of
manufacturer /
Applicant
Remarks
on Remarks by the Decision
the formulation Evaluator
(if
any)
including
International
in
Fee including status
Composition
stringent drug
differential
regulatory
fee
Pharmacological
agencies
/
Group
authorities
Demanded
Finished
product Price / Pack
Me-too status
size
Specification
Type of Form
Brand Name
(Proprietary name +
Dosage
Form
+ Initial date,
diary
Strength)
GMP status as
depicted
in
latest
inspection
report
(with
date) by the
Evaluator
341.
M/s
Noble Nobivec Injection 2%
Pharma, Mirpur
Each ml contains:
Azad Kashmir
Ivermectin……..20mg
Liquid Injection
Antiparasitic
Section
(Veterinary)
Approved vide BP
letter No. F.52/207
Lic
dated: 18-02-13
Form-5
Dy. No: 65
dated 20-07-14 Inspection of the
firm
was
conducted
by
20,000/the area FID and
firm was found
Decontrolled/
GMP compliant.
Pack of 50ml
Minutes246thMeetingRegistrationBoard
Elvomec D/S of
Elko Karachi
Deferred for
confirmation
of
installation
and
operational
qualifications
of
liquid
Particle
Counter by
Area FID.
Page201
342.
-do-
Actimec
Injection
of
Dy. No: 66 Selmore
Each ml contains:
Ivermectin……..10mg dated 20-07-14 Pharmaceuticals
Lahore.
20,000/Antiparasitic
Nobivec Injection 1%
Form-5
BP
Decontrolled/
Pack of 50ml
Deferred for
confirmation
of
installation
and
operational
qualifications
of
liquid
Particle
Counter by
Area FID.
Case No.08.
Registration applications of Pregabalin deferred in previous meetings of
Registration Board
Evaluator - I
Type of Form
Sr. Name and address Brand Name
No. of Manufacturer / (Proprietary name
date,
Applicant
+ Dosage form + Initial
diary.
Strength)
Composition
Fee including
differential fee
Remarks /
International
status
in Observations
stringent
regulatory
agencies
Decision
Me-too status
Pharmacological
Group
GMP status as
Demanded
in
Price / Pack depicted
inspection
Finished product size
report (dated)
specification
343. M/S
CCL
Pharmaceutical
(Pvt.) Ltd. 62Industrial Estate ,
Kot
Lakhpat,
Lahore.
Achlin Capsule
25mg
Capsule
Each Capsule
Contains:
Pregabalin……25
mg
(Antiepileptics,
other antiepileptics)
Manufacturers
specifications
Form 5
14-11-2005
Rs.8000/Dy. No. Not
mentioned
14-02-2014
Dy. No.596
Rs.12000/14’s/ As Per
Brand Leader
Minutes246thMeetingRegistrationBoard
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
ZEEGAP
Capsules (25, 50,
75,
100
and
150mg)
Hilton
Panel inspection
for the grant of
GMP certificate
Page202
conducted
06/11/2013,
12/12/2013
18/12/2013.
344. M/S
CCL
Pharmaceutical
(Pvt.) Ltd. 62Industrial Estate ,
Kot
Lakhpat,
Lahore.
Achlin Capsule
50mg
Capsule
Each Capsule
Contains:
Pregabalin……50
mg
(Antiepileptics,
other antiepileptics)
Manufacturers
specifications
345. M/S
CCL
Pharmaceutical
(Pvt.) Ltd. 62Industrial Estate ,
Kot
Lakhpat,
Lahore.
Achlin Capsule
100mg
Capsule
Each Capsule
Contains:
Pregabalin……100
Form 5
14-11-2005
Rs.8000/Dy. No. Not
mentioned
14-02-2014
Dy. No.596
Rs.12000/14’s/ As Per
Brand Leader
&
Capsule
(General) section
mentioned
in
Issuance of /
Revalidation of
DML vide letter
No. F. 1-8/84-Lic
(Vol. II)
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
ZEEGAP
Capsules (25, 50,
75,
100
and
150mg)
Hilton
Panel inspection
for the grant of
GMP certificate
conducted
on
06/11/2013,
12/12/2013
&
18/12/2013.
Form 5
14-11-2005
Rs.8000/Dy. No. Not
mentioned
Minutes246thMeetingRegistrationBoard
on
Capsule
(General) section
mentioned
in
Issuance of /
Revalidation of
DML vide letter
No. F. 1-8/84-Lic
(Vol. II)
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
Page203
mg
(Antiepileptics,
other antiepileptics)
Manufacturers
specifications
346. M/S
NabiQasim
(Pvt) Ltd. 17/24,
Korangi Industrial
Area,
KarachiPakistan.
Preka Capsule
150mg
Capsule
Each Capsule
Contains:
Pregabalin……150
mg
(Anticonvulsant)
Manufacturers
Specifications
14-02-2014
Dy. No.596
Rs.12000/14’s/ As Per
Brand Leader
Panel inspection
for the grant of
GMP certificate
conducted
on
06/11/2013,
12/12/2013
&
18/12/2013.
Form 5
24-04-2008
Rs.8000/Dy. No. Not
mentioned
09-09-2013
Rs.12000/Dy. No. not
mentioned
duplicate dossier
/
10’s, / Rs. 288/20’s / Rs. 547/30’s / 799/-
347. M/S
NabiQasim Preka Capsule
(Pvt) Ltd. 17/24, 75mg
Korangi Industrial Capsule
Area,
Karachi-
Form 5
24-04-2008
Rs.8000/-
Minutes246thMeetingRegistrationBoard
ZEEGAP
Capsules (25, 50,
75,
100
and
150mg)
Hilton
Capsule
(General) section
mentioned
in
Issuance of /
Revalidation of
DML vide letter
No. F. 1-8/84-Lic
(Vol. II)
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
ZEEGAP
Capsules (25, 50,
75,
100
and
150mg)
Hilton
Inspection report
dated
18-122013.
Capsule
section
mentioned
in
report and cGMP
certificate.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
Approved.
Page204
Pakistan.
Each Capsule
Contains:
Pregabalin……75
mg
(Anticonvulsant)
Manufacturers
Specifications
Dy. No. Not
mentioned
300mg)
US FDA
09-09-2013
Rs.12000/Dy. No. not
mentioned
duplicate dossier
/
ZEEGAP
Capsules (25, 50,
75,
100
and
150mg)
Hilton
10’s / Rs.160/20’s / Rs. 304/30’s / Rs. 444/-
348. M/S
NabiQasim
(Pvt) Ltd. 17/24,
Korangi Industrial
Area,
KarachiPakistan.
Preka Capsule
50mg
Capsule
Each Capsule
Contains:
Pregabalin……50
mg
(Anticonvulsant)
Manufacturers
Specifications
Form 5
24-04-2008
Rs.8000/Dy. No. Not
mentioned
09-09-2013
Rs.12000/Dy. No. not
mentioned
duplicate dossier
/
10’s / Rs.144/20’s / Rs. 273/30’s / Rs. 400/-
349. M/S
NabiQasim
(Pvt) Ltd. 17/24,
Korangi Industrial
Area,
KarachiPakistan.
Preka Capsule
100mg
Capsule
Each Capsule
Contains:
Pregabalin……100
mg
(Anticonvulsant)
Manufacturers
Specifications
Form 5
24-04-2008
Rs.8000/Dy. No. Not
mentioned
09-09-2013
Rs.12000/Dy. No. not
mentioned
duplicate dossier
/
Minutes246thMeetingRegistrationBoard
Inspection report
dated
18-122013.
Capsule
section
mentioned
in
report and cGMP
certificate.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
ZEEGAP
Capsules (25, 50,
75,
100
and
150mg)
Hilton
Inspection report
dated
18-122013.
Capsule
section
mentioned
in
report and cGMP
certificate.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
ZEEGAP
Capsules (25, 50,
75,
100
and
150mg)
Hilton
Page205
10’s / Rs.201/20’s / Rs. 382/30’s / Rs. 558/-
350. M/S
Linz
Pharmaceuticals
(Pvt) Ltd., 31-G/H,
Sector 15 Korangi
Industrial
Area,
Karachi-Pakistan.
Pegab 300mg
Capsule
Capsule
Each Capsule
Contains:
Pregabalin……300
mg
(Anticonvulsant
Agent)
Manufacturers
specifications
Form 5
Covering letter
not attached.
Rs.8000/- Jul,
2008
Dy. No. Not
mentioned
28-05-2014
Rs.12000/Dy. No. 802
duplicate dossier
/
14’s/ Rs.390/-
351. M/S
Linz
Pharmaceuticals
(Pvt) Ltd., 31-G/H,
Sector 15 Korangi
Industrial
Area,
Karachi-Pakistan.
Pegab 100mg
Capsule
Capsule
Each Capsule
Contains:
Pregabalin……100
mg
(Anticonvulsant
Agent)
Manufacturers
specifications
Form 5
Covering letter
not attached.
Rs.8000/- Jul,
2008
Dy. No. Not
mentioned
28-05-2014
Rs.12000/Dy. No. Not
mentioned
14’s/ Rs.291/-
352. M/S
Linz Pegab 75mg
Form 5
Minutes246thMeetingRegistrationBoard
Inspection report
dated
18-122013.
Capsule
section
mentioned
in
report and cGMP
certificate.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Panel inspection
dated
27-052014.
Capsule
section
mentioned. Panel
recommended
grant of renewal.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Panel inspection
dated
27-052014.
Capsule
section
mentioned. Panel
recommended
grant of renewal.
LYRICA
Approved.
Page206
Pharmaceuticals
(Pvt) Ltd., 31-G/H,
Sector 15 Korangi
Industrial
Area,
Karachi-Pakistan.
Capsule
Capsule
Each Capsule
Contains:
Pregabalin……75
mg
(Anticonvulsant
Agent)
Manufacturers
specifications
Covering letter
not attached.
Rs.8000/- Jul,
2008
Dy. No. Not
mentioned
28-05-2014
Rs.12000/Dy. No. Not
mentioned
14’s/ Rs.237/-
353. M/S Bosch 221,
Bosch House ,
Sector 23, Korangi
Industrial
Area,Karachi.
Gablin 100mg
Capsule
Capsule
Each Capsule
Contains:
Pregabalin……100
mg
(Anticonvulsant
Agent)
Manufacturers
specifications
354. M/S Bosch 221,
Bosch House ,
Sector 23, Korangi
Industrial
Area,Karachi.
Gablin 75mg
Capsule
Capsule
Form 5
Covering letter
not attached.
June, 2008
Rs.8000/Dy. No. Not
mentioned
28-05-2014
Rs.12000/803 R&I
14’s / Rs.291/-
Form 5
Each Capsule
Contains:
Pregabalin……75
mg
Covering letter
not attached.
June, 2008
Rs.8000/Dy. No. Not
mentioned
(Anticonvulsant
Agent)
28-05-2014
Rs.12000/-
Minutes246thMeetingRegistrationBoard
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Panel inspection
dated
27-052014.
Capsule
section
mentioned. Panel
recommended
grant of renewal.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
ZEEGAP
Capsules (25, 50,
75,
100
and
150mg)
Hilton
Inspection report
dated
12-082014.
Capsule
section approved
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
ZEEGAP
Capsules (25, 50,
75,
100
and
150mg)
Page207
Manufacturers
specifications
355. M/S Bosch 221,
Bosch House ,
Sector 23, Korangi
Industrial
Area,Karachi.
Gablin 300mg
Capsule
Capsule
Each Capsule
Contains:
Pregabalin……300
mg
(Anticonvulsant
Agent)
Manufacturers
specifications
356. M/S
Sami Pregy 50mg
Capsule
Pharmaceutical
Pvt., Limited F-95, Capsule
S.I.T.E. Karachi.
Each Capsule
Contains:
Pregabalin……50
mg
(Anticonvulsant)
Manufacturer
Specifications
803 R&I
Hilton
14’s/ Rs.237/-
Inspection report
dated
12-082014.
Capsule
section approved
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Form 5
Covering letter
not attached.
June, 2008
Rs.8000/Dy. No. 803
28-05-2014
Rs.12000/803 R&I
Form 5
Rs.8000/22-12-2009
Dy. No. not
mentioned
Rs.12000/- fee
challan is
missing
Inspection report
dated
12-082014.
Capsule
section approved
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
As per PRC
Form 5
Rs.8000/22-12-2009
Minutes246thMeetingRegistrationBoard
ZEEGAP
Capsules (25, 50,
75,
100
and
150mg)
Hilton
14’s/ Rs.390/-
duplicate dossier
357. M/S
Sami Pregy 75mg
Pharmaceutical
Capsule
Pvt., Limited F-95, Capsule
Approved.
Panel inspection
report dated 2406-2014. Panel
recommended
grant
of
additional
sections. Capsule
section
mentioned.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
Approved.
Page208
S.I.T.E. Karachi.
Each Capsule
Contains:
Pregabalin……75
mg
(Anticonvulsant)
Manufacturer
Specifications
358. M/S
Sami Pregy 100mg
Pharmaceutical
Capsule
Pvt., Limited F-95, Capsule
S.I.T.E. Karachi.
Each Capsule
Contains:
Pregabalin……100
mg
(Anticonvulsant)
Manufacturers
specifications
359. M/S
Sami Pregy 150mg
Capsule
Pharmaceutical
Pvt., Limited F-95, Capsule
S.I.T.E. Karachi.
Each Capsule
Contains:
Pregabalin……150
mg
Dy. No. not
mentioned
300mg)
US FDA
Rs.12000/29-07-2013
Dy. No. Not
mentioned
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
As per PRC
duplicate dossier
Form 5
Rs.8000/22-12-2009
Dy. No. not
mentioned
Rs.12000/29-07-2013
Dy. No. Not
mentioned
As per PRC
Duplicate
dossier
Form 5
Rs.8000/22-12-2009
Dy. No. not
mentioned
Rs.12000/29-07-2013
Dy. No. Not
mentioned
Minutes246thMeetingRegistrationBoard
Panel inspection
report dated 2406-2014. Panel
recommended
grant
of
additional
sections. Capsule
section
mentioned.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Panel inspection
report dated 2406-2014. Panel
recommended
grant
of
additional
sections. Capsule
section
mentioned.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
GABICA
Capsules (50, 75,
Page209
(Anticonvulsant)
Manufacturers
specifications
360. M/S AGP (Private) Hi-Gab Capsules
Limited,
B-23, 75mg
S.I.T.E., Karachi
Capsule
Each Capsule
Contains:
Pregabalin……75
mg
(Anti-Epileptic)
Manufacturers
specifications
361. M/S AGP (Private) Hi-Gab Capsules
Limited,
B-23, 50mg
S.I.T.E., Karachi
Capsule
Each Capsule
Contains:
Pregabalin……50
mg
(Anti-Epileptic)
Manufacturers
specifications
As per PRC
Duplicate
dossier
Form 5
Rs.8000/17-07-2009
Dy. No. not
mentioned
Rs.12000/19-03-2014
Dy. No. Not
mentioned
14’s / Rs.565/Duplicate
dossier
100, 150
300mg)
Getz
and
Panel inspection
report dated 2406-2014. Panel
recommended
grant
of
additional
sections. Capsule
section
mentioned.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated
26/11/2013.
Capsule section
mentioned in FID
report.
Approved.
Form 5
Rs.8000/17-07-2009
Dy. No. not
mentioned
Rs.12000/19-03-2014
Dy. No. Not
mentioned
14’s / Rs.450/duplicate dossier
Approved.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated
26/11/2013.
Minutes246thMeetingRegistrationBoard
Page210
362. M/S AGP (Private) Hi-Gab Capsules
Limited,
B-23, 200mg
S.I.T.E., Karachi
Capsule
Each Capsule
Contains:
Pregabalin……200
mg
(Anti-Epileptic)
Manufacturers
specifications
363. M/S AGP (Private) Hi-Gab Capsules
Limited,
B-23, 225mg
S.I.T.E., Karachi
Capsule
Each Capsule
Contains:
Pregabalin……225
mg
(Anti-Epileptic)
Manufacturers
specifications
364. M/S AGP (Private) Hi-Gab Capsules
Limited,
B-23, 300mg
S.I.T.E., Karachi
Capsule
Each Capsule
Contains:
Pregabalin ……
300mg
(Anti-Epileptic)
Form 5
Rs.8000/17-07-2009
Dy. No. not
mentioned
Rs.12000/19-03-2014
Dy. No. Not
mentioned
14’s / Rs.1225/duplicate dossier
Form 5
Rs.8000/17-07-2009
Dy. No. not
mentioned
Rs.12000/19-03-2014
Dy. No. Not
mentioned
14’s / Rs.1370/duplicate dossier
Form 5
Rs.8000/17-07-2009
Dy. No. not
mentioned
Rs.12000/19-03-2014
Dy. No. Not
mentioned
Manufacturers
Minutes246thMeetingRegistrationBoard
Capsule section
mentioned in FID
report.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
SYNGAB
Capsules 200mg
Atco
Inspection report
dated
26/11/2013.
Capsule section
mentioned in FID
report.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
1) Evidence Deferred
for
of me too confirmation of
status
me too status.
required.
Evidence of Me
too
status
required
Inspection report
dated
26/11/2013.
Capsule section
mentioned in FID
report.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Page211
specifications
365. M/S AGP (Private) Hi-Gab Capsules
Limited,
B-23, 100mg
S.I.T.E., Karachi
Capsule
Each Capsule
Contains:
Pregabalin……100
mg
(Anti-Epileptic)
Manufacturers
specifications
366. M/S AGP (Private) Hi-Gab Capsules
Limited,
B-23, 25mg
S.I.T.E., Karachi
Capsule
Each Capsule
Contains:
Pregabalin……25
mg
(Anti-Epileptic)
Manufacturers
specifications
367. M/S AGP (Private) Hi-Gab Capsules
Limited,
B-23, 150mg
S.I.T.E., Karachi
Capsule
14’s/Rs.1560/duplicate dossier
Form 5
Rs.8000/17-07-2009
Dy. No. not
mentioned
Rs.12000/19-03-2014
Dy. No. Not
mentioned
14’s/Rs.735/duplicate dossier
Form 5
Rs.8000/17-07-2009
Dy. No. not
mentioned
Rs.12000/19-03-2014
Dy. No. Not
mentioned
14’s / Rs.270/duplicate dossier
Form 5
Rs.8000/17-07-2009
Minutes246thMeetingRegistrationBoard
Inspection report
dated
26/11/2013.
Capsule section
mentioned in FID
report.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated
26/11/2013.
Capsule section
mentioned in FID
report.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
ZEEGAP
Capsules (25, 50,
75,
100
and
150mg)
Hilton
Inspection report
dated
26/11/2013.
Capsule section
mentioned in FID
report.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
Approved.
Page212
Each Capsule
Contains:
Pregabalin……150
mg
(Anti-Epileptic)
Manufacturers
specifications
368. M/s Neutro Pharma Gabin Capsules
(Pvt) Ltd., 9.5 Km, 300mg
Sheikhupura Road, Capsule
Lahore
Each Capsule
Contains:
Pregabalin……300
mg
(GABA Analogue)
Manufacturers
Specifications
369. M/s
Atco Syngab
Capsules75mg
Laboratories
Limited,
B-18, Capsule
S.I.T.E., Karachi
Each Capsule
Contains:
Pregabalin……75
mg
(Anti Epileptic)
Manufacturers
Specifications
Dy. No. not
mentioned
300mg)
US FDA
Rs.12000/19-03-2014
Dy. No. Not
mentioned
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
14’s/Rs.940/duplicate dossier
Form 5
Rs.8000/17-08-2009
Dy. No. not
mentioned
Rs.12000/07-07-2014
Dy. No. 66
As per PRC
Form 5
Rs.8000/29-04-2008
Dy. No. not
mentioned
Rs.12000/08-04-2014
Dy. No. not
mentioned
As per leader
price per 14’s
Minutes246thMeetingRegistrationBoard
Inspection report
dated
26/11/2013.
Capsule section
mentioned in FID
report.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Panel inspection
to check GMP
compliance
conducted
on
6th& 7th January,
2014.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated 18-06-2014
Page213
370. M/s
Atco Syngab Capsules
Laboratories
150mg
Limited,
B-18, Capsule
S.I.T.E., Karachi
Each Capsule
Contains:
Pregabalin……150
mg
(Anti Epileptic)
Manufacturers
Specifications
371. M/s
Atco Syngab Capsules
300mg
Laboratories
Limited,
B-18, Capsule
S.I.T.E., Karachi
Each Capsule
Contains:
Pregabalin……300
mg
(Anti Epileptic)
Manufacturers
Specifications
372. M/S
Pharma
L-20/B,
Industrial
Karachi.
Tabros Grelin Capsule
75mg
Capsule
F.B.
Area, Each Capsule
Contains:
Pregabalin……75
mg
(Anti-Epileptic.)
Manufacturers
specifications
Form 5
Rs.8000/29-04-2008
Dy. No. not
mentioned
Rs.12000/08-04-2014
Dy. No. not
mentioned
As per leader
price per 14’s
Form 5
Rs.8000/22-04-2008
Dy. No. not
mentioned
Rs.12000/08-04-2014
Dy. No. not
mentioned
As per leader
price per 14’s
Inspection report
dated 18-06-2014
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Rs.8000/30-06-2008
Dy. No. Not
mentioned
Rs.12000/Dated 20-032014
Dy. No. not
mentioned
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
14’s / Rs.1100/(Rs. 78.57 per
capsule)
(duplicate
dossier)
Inspection report
dated
11/03/2014.
Overall
conditions noted
improved
as
Form 5
Approved.
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated 18-06-2014
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Minutes246thMeetingRegistrationBoard
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
Page214
373. M/S
Pharma
L-20/B,
Industrial
Karachi.
Tabros Grelin Capsule
100mg
Capsule
F.B.
Area, Each Capsule
Contains:
Pregabalin……100
mg
(Anti-Epileptic.)
Manufacturers
specifications
374. M/S
Pharma
L-20/B,
Industrial
Karachi.
Tabros Grelin Capsule
150mg
Capsule
F.B.
Area, Each Capsule
Contains:
Pregabalin……150
mg
(Anti-Epileptic.)
Manufacturers
specifications
375. M/S
Pharma
L-20/B,
Industrial
Tabros Grelin Capsule
300mg
Capsule
F.B.
Area, Each Capsule
Rs.8000/30-06-2008
Dy. No. Not
mentioned
compared to last
visit.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Rs.12000/Dated.20-032014
Dy. No. not
mentioned
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
14’s/Rs.1300/(duplicate
dossier)
Rs.8000/30-06-2008
Dy. No. Not
mentioned
Inspection report
dated
11/03/2014.
Overall
conditions noted
improved
as
compared to last
visit.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Rs.12000/Dated.20-032014
Dy. No. not
mentioned
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
14’s/Rs.1600/(duplicate
dossier)
Inspection report
dated
11/03/2014.
Overall
conditions noted
improved
as
compared to last
visit.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
Form 5
Form 5
Form 5
Rs.8000/30-06-2008
Dy. No. Not
Minutes246thMeetingRegistrationBoard
Approved.
Approved.
Approved.
Page215
Karachi.
Contains:
Pregabalin……300
mg
(Anti-Epileptic.)
Manufacturers
specifications
376. M/S
Scotmann Foxril Capsule
Pharmaceuticals, 5- 75mg
D, I-10/3, Industrial Capsule
Area Islamabad.
Each Capsule
Contains:
Pregabalin……75
mg
mentioned
US FDA
Rs.12000/Dated.20-032014
Dy. No. not
mentioned
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
14’s/Rs.2600/(duplicate
dossier)
Inspection report
dated
11/03/2014.
Overall
conditions noted
improved
as
compared to last
visit.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Form 5
Rs.8000/15-07-2008
Dy. No. 186
(Anticonvulsant.)
Rs.12000/Dated.08-072014
Dy. No. 1244
Manufacturers
specifications
14’s / Rs. 16.95
/ Capsule
377. M/S
Scotmann Foxril Capsule
Pharmaceuticals, 5- 100mg
D, I-10/3, Industrial Capsule
Area Islamabad.
Each Capsule
Contains:
Pregabalin……100
mg
(Anticonvulsant.)
Form 5
Rs.8000/15-07-2008
Dy. No.176
Rs.12000/Dated.08-072014
Dy. No. 1244
Minutes246thMeetingRegistrationBoard
Approved.
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated
12-042013.
Good
compliance.
Capsule section
mentioned
in
panel inspection
report dated 0212-2008.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Page216
Manufacturers
specifications
14’s/Rs.20.85/C
apsule
Getz
Inspection report
dated
12-042013.
Good
compliance.
Capsule section
mentioned
in
panel inspection
report dated 0212-2008.
378. M/S
Scotmann Foxril Capsule
Pharmaceuticals, 5- 150mg
D, I-10/3, Industrial Capsule
Area Islamabad.
Each Capsule
Contains:
Pregabalin……150
mg
(Anticonvulsant.)
Manufacturers
specifications
379. M/S OBS Pakistan
(Pvt.) Ltd. C-14,
S.I.T.E.,
Manghopir Road
Karachi-75700
Pregalin Capsule
Capsule
Each Capsule
Contains:
Pregabalin……150
mg
(Antiepileptics)
Manufacturers
specifications
Form 5
Rs.8000/15-07-2008
Dy No.181
Rs.12000/Dated.08-072014
Dy. No. 1244
Rs.33.90/Capsul
e
14’s
Form 5
Rs.8000/18-10-2008
Not mentioned
Rs.12000/Dated.29-072013 duplicate
dossier
Dy. No. not
mentioned
14’s/Rs.1300/-
Minutes246thMeetingRegistrationBoard
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated
12-042013.
Good
compliance.
Capsule section
mentioned
in
panel inspection
report dated 0212-2008.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated
06-03Page217
380. M/S OBS Pakistan
(Pvt.) Ltd. C-14,
S.I.T.E.,
Manghopir Road
Karachi-75700
Pregalin Capsule
Capsule
Each Capsule
Contains:
Pregabalin……300
mg
(Antiepileptics)
Manufacturers
specifications
381. M/S OBS Pakistan
(Pvt.) Ltd. C-14,
S.I.T.E.,
Manghopir Road
Karachi-75700
Pregalin Capsule
Capsule
Each Capsule
Contains:
Pregabalin……75
mg
(Antiepileptics)
Manufacturers
specifications
382. M/S Glitz Pharma P-Gab 75
(Pvt.) Ltd; 265- Tablet
Industrial Triangle,
Kahuta
Road Each film coated
Form 5
Rs.8000/18-10-2008
Not mentioned
Rs.12000/Dated.29-072013 duplicate
dossier
Dy. No. not
mentioned
14’s/Rs.2200/-
Form 5
Rs.8000/18-10-2008
Not mentioned
Rs.12000/Dated.29-072013 duplicate
dossier
Dy. No. not
mentioned
14’s/Rs.900/-
Form 5
Rs.8000/31-12-2008
Minutes246thMeetingRegistrationBoard
2014.
GMP
satisfactory and
capsule section
mentioned
in
report.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated
06-032014.
GMP
satisfactory and
capsule section
mentioned
in
report.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated
06-032014.
GMP
satisfactory and
capsule section
mentioned
in
report.
Inspection report
dated
18-032013.
Satisfactory GMP
1) Firm had The request of
the firm has
initially
been
applied
on not
Form 5 for acceded to by
Page218
Islamabad.
tablet Contains:
Pregabalin……75
mg
(Antiepileptics)
Manufacturers
specifications
383. M/S Glitz Pharma
(Pvt.) Ltd; 265Industrial Triangle,
Kahuta
Road
Islamabad.
P-Gab 100
Tablet
Each tablet
Contains:
Pregabalin……100
mg
(Antiepileptics)
Manufacturers
specifications
Dy. No.561
Rs.12000/Dated.08-072014
Dy. No. 1239
10x2=20’s /As
Per SRO
Form 5
Rs.8000/31-12-2008
Dy. No.562
Rs.12000/Dated.08-072014
Dy. No. 1235
10x2=20’s &
14’s /As Per
SRO
Minutes246thMeetingRegistrationBoard
and tablet section registration of
mentioned.
Pregabalin
75mg tablet.
Since
the
product is not
me too, firm
was asked to
provide me
too reference
or application
on Form 5D.
Now,
firm
has requested
to change the
particulars of
the file to
Pregabalin
Oral Solution
20mg/ml.
Firm has also
submitted that
additional fee
if any, will be
deposited.
Inspection report
dated
18-032013.
Satisfactory GMP
and tablet and
capsule section
mentioned.
1) Firm had
initially
applied
on
Form 5 for
registration of
Pregabalin
100mg tablet.
Since
the
product is not
me too, firm
was asked to
provide me
too reference
or application
on Form 5D.
Now,
firm
has requested
to change the
particulars of
the file to
Pregabalin
300mg
capsules.
Firm has also
the Board &
the
Board
rejected
the
application of
P-Gab
75
Tablet
The request of
the firm has
not been
acceded to by
the Board &
the Board
rejected the
application PGab 100,
Tablet
Page219
submitted that
additional fee
if any, will be
deposited.
384. M/S Glitz Pharma
(Pvt.) Ltd; 265Industrial Triangle,
Kahuta
Road
Islamabad.
P-Gab 50
Tablet
Each tablet
Contains:
Pregabalin……50
mg
(Antiepileptics)
Manufacturers
specifications
385. M/S Glitz Pharma P-Gab 150mg
(Pvt.) Ltd; 265- Tablet
Industrial Triangle,
Kahuta
Road
Each film coated
Islamabad.
tablet Contains:
Pregabalin……150
mg
Form 5
Rs.8000/31-12-2008
Dy. No. 560
Rs.12000/Dated.08-072014
Dy. No. 1233
10x2=20’s /As
Per SRO
Form 5
Rs.8000/31-12-2008
Dy. No.563
Rs.12000/Dated.08-072014
Dy. No. 1234
(Antiepileptics)
Manufacturers
specifications
10x2=20’s/As
Per SRO
Minutes246thMeetingRegistrationBoard
Inspection report
dated
18-032013.
Satisfactory GMP
and tablet section
mentioned.
Inspection report
dated
18-032013.
Satisfactory GMP
and tablet section
mentioned.
1) Firm had
initially
applied
on
Form 5 for
registration of
Pregabalin
100mg tablet.
Since
the
product is not
me too, firm
was asked to
provide me
too reference
or application
on Form 5D.
Now,
firm
has requested
to change the
particulars of
the file to
Pregabalin
200mg
capsules.
Firm has also
submitted that
additional fee
if any, will be
deposited.
The request of
the firm has
not been
acceded to by
the Board &
the Board
rejected the
application of
P-Gab 50,
Tablet
1) Firm had
initially
applied
on
Form 5 for
registration of
Pregabalin
100mg tablet.
Since
the
product is not
me too, firm
was asked to
provide me
too reference
or application
on Form 5D.
The request of
the firm has
not
been
acceded to by
the Board &
the
Board
rejected
the
application of
P-Gab 150mg
Tablet
Page220
Now,
firm
has requested
to change the
particulars of
the file to
Pregabalin
150mg
capsules.
Firm has also
submitted that
additional fee
if any, will be
deposited.
386. M/S Glitz Pharma
(Pvt.) Ltd; 265Industrial Triangle,
Kahuta
Road
Islamabad.
P-Gab 100
Capsule
Each capsule
Contains:
Pregabalin……100
mg
(Antiepileptics)
Manufacturers
specifications
387. M/S Glitz Pharma
(Pvt.) Ltd; 265Industrial Triangle,
Kahuta
Road
Islamabad.
P-Gab 75
Capsule
Each capsule
Contains:
Pregabalin……75
mg
(Antiepileptics)
Manufacturers
specifications
Form 5
Rs.8000/31-12-2008
Dy. No.559
Rs.12000/Dated.08-072014
Dy. No. 1236
10x2=20’s &
14’s /As Per
SRO and Rs.
625/- per 20’s
Form 5
Rs.8000/31-12-2008
Dy. No.557
Rs.12000/Dated.08-072014
Dy. No. 1238
10x2=20’s &
14’s/As Per
SRO and Rs.
345/- per 20’s
Minutes246thMeetingRegistrationBoard
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated
18-032013.
Satisfactory GMP
and tablet section
mentioned.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated
18-032013.
Page221
Satisfactory GMP
and tablet section
mentioned.
388. M/S Glitz Pharma
(Pvt.) Ltd; 265Industrial Triangle,
Kahuta
Road
Islamabad.
P-Gab 50
Capsule
Each capsule
Contains:
Pregabalin……50
mg
(Antiepileptics)
Manufacturers
specifications
389. M/S
Global
Pharmaceuticals
(Pvt.) Ltd., Plot No.
204-205, Industrial
Triangle, Kahuta
Road, Islamabad.
Pert 50 mg
Capsules
Capsule
Each capsule
Contains:
Pregabalin……50
mg
(Anticonvulsant)
Manufacturers
Specifications
390. M/S
Global Pert 75 mg
Pharmaceuticals
Capsules
(Pvt.) Ltd., Plot No. Capsule
Form 5
Rs.8000/31-12-2008
Dy. No.556
Rs.12000/Dated.08-072014
Dy. No. 1237
10x2=20’s &
14’s/As Per
SRO
Form 5
Rs.8000/- fee
challan not
attached
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated
18-032013.
Satisfactory GMP
and tablet section
mentioned.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
1) Rs. 8,000/fee
challan
(duly
endorsed by
Statistical
Officer) has
not
been
provided.
However,
copy
of
extracts from
214th meeting
of
Registration
Board
as
evidence of
fee
submission.
Approved.
Reference will
be sent to B &
A Division for
verification of
fee challan. In
acse of nonconfirmation,
firm
will
deposit the fee
(Rs.8000/-)
and Chairman,
RB will permit
for issuance of
registration
letter.
Rs.12000/Dated.05-062014
Dy. No. 566
R&I
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
14’s As Per
SRO
cGMP certificate
dated
21-112014.
Capsule section
mentioned
in
inspection report
and
GMP
certificate dated
31-05-2012 and
21-11-2014.
LYRICA
1) Rs. 8,000/- Approved.
Capsules (25, 50, fee
challan Reference will
75,
100, (duly
be sent to B &
Form 5
Rs.8000/- fee
Minutes246thMeetingRegistrationBoard
Approved.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Page222
204-205, Industrial
Triangle, Kahuta Each capsule
Road, Islamabad.
Contains:
Pregabalin……75
mg
(Anticonvulsant)
Manufacturers
Specifications
challan not
attached
Rs.12000/Dated.05-062014
Dy. No. 565
R&I
14’s As Per
SRO
391. M/S
Genome
Pharmaceutical
Private
Limted,
Factory 16/1-Phase
IV,
Industrial
Estate, Hattar.
Pregabanome-150
Capsule
Capsule
Each Capsule
Contains:
Pregabalin……150
mg
Form 5
Rs.8000/09-08-2008
Dy. No.287
Rs.12000/16-06-2014
Dy. No. 258
(Gaba Analogue)
Manufacturers
specifications
As Per SRO
2x7’s (14)
150,200, 225 and endorsed by
Statistical
300mg)
Officer) has
US FDA
not
been
provided.
GABICA
Capsules (50, 75, However,
of
100, 150 and copy
extracts from
300mg)
214th meeting
Getz
of
cGMP certificate Registration
dated
21-11- Board
as
2014.
evidence of
Capsule section fee
mentioned
in submission.
inspection report
and
GMP
certificate dated
31-05-2012 and
21-11-2014.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
A Division for
verification of
fee challan. In
acse of nonconfirmation,
firm
will
deposit the fee
(Rs.8000/-)
and Chairman,
RB will permit
for issuance of
registration
letter.
Approved.
ZEEGAP
Capsules (25, 50,
75,
100
and
150mg)
Hilton
Panel inspection
for grant of GMP
dated
27-122013.
Capsule General /
Antibiotic
mentioned.
392. M/S
Genome
Pharmaceutical
Private
Limted,
Factory 16/1-Phase
IV,
Industrial
Estate, Hattar.
Pregabanome-75
Capsule
Capsule
Each Capsule
Contains:
Pregabalin……75
mg
Form 5
Rs.8000/09-08-2008
Dy. No.288
Rs.12000/16-06-2014
Minutes246thMeetingRegistrationBoard
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
ZEEGAP
Page223
Dy. No. 258
(Gaba Analogue)
Manufacturers
specifications
393. M/S
Genome
Pharmaceutical
Private
Limted,
Factory 16/1-Phase
IV,
Industrial
Estate, Hattar.
Pregabanome-50
Capsule
Capsule
Each Capsule
Contains:
Pregabalin……50
mg
As Per SRO
2x7’s (14)
Form 5
Rs.8000/09-08-2008
Dy. No. 289
Rs. 12000/16-06-2014
Dy. No. 258
(Gaba Analogue)
Manufacturers
specifications
394. M/S
Genome
Pharmaceutical
Private
Limted,
Factory 16/1-Phase
IV,
Industrial
Estate, Hattar.
Pregabanome100Capsule
Capsule
Each Capsule
Contains:
Pregabalin……100
mg
As Per SRO
2x7’s (14)
Form 5
Rs.8000/09-08-2008
Dy. No.286
Rs.12000/16-06-2014
Dy. No. 258
(Gaba Analogue)
Manufacturers
specifications
As Per SRO
2x7’s (14)
Capsules (25, 50,
75,
100
and
150mg)
Hilton
Panel inspection
for grant of GMP
dated
27-122013.
Capsule General /
Antibiotic
mentioned.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
ZEEGAP
Capsules (25, 50,
75,
100
and
150mg)
Hilton
Panel inspection
for grant of GMP
dated
27-122013.
Capsule General /
Antibiotic
mentioned.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
ZEEGAP
Capsules (25, 50,
75,
100
and
150mg)
Hilton
Panel inspection
for grant of GMP
dated
27-122013.
Minutes246thMeetingRegistrationBoard
Page224
395. M/s Noa Hemis
Pharmaceuticals
Plot No.154,
Sector-23, Korangi
Industrial
Area,Karachi
Gabatil-75mg
Capsule
Each Capsule
Contains:
Pregabalin
……75mg
(Anti epileptic)
Manufacturers
specifications
396. M/s Noa Hemis
Pharmaceuticals
Plot No.154,
Sector-23, Korangi
Industrial
Area,Karachi
Gabatil-150mg
Capsule
Each Capsule
Contains:
Pregabalin
……150mg
(Anti epileptic)
Manufacturers
specifications
397. M/s Noa Hemis
Gabatil-300mg
Form 5
Rs.8000/22-07-2008
Dy. No. not
mentioned
Rs.12000/19-06-2014
1609 R&I
10’s, 14’s/15%
less then brand
leader
Form 5
Rs.8000/22-07-2008
Dy. No. not
mentioned
Rs.12000/19-06-2014
1609 R&I
10’s, 14’s / 15%
less then brand
leader
Form 5
Minutes246thMeetingRegistrationBoard
Capsule General /
Antibiotic
mentioned.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
DDG and FID
inspection report
dated 09-06-2014
GMP compliance
considered good.
Capsule section
mentioned
in
GMP inspection
reports.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
DDG and FID
inspection report
dated 09-06-2014
GMP compliance
considered good.
Capsule section
mentioned
in
GMP inspection
reports.
LYRICA
Approved.
Page225
Pharmaceuticals
Plot No.154,
Sector-23, Korangi
Industrial
Area,Karachi
Capsule
Each Capsule
Contains:
Pregabalin
……300mg
(Anti epileptic)
Manufacturers
specifications
398. M/S
Sharooq
Pharmaceuticals
(Pvt) Ltd. 21-KM
Ferozepur
Road,
Lahore.
Gabmor Capsule
Capsule
Each Capsule
Contains:
Pregabalin……300
mg
(Antiepileptic)
Manufacturers
specifications
399. M/S
Sharooq Gabmor Capsule
Capsule
Pharmaceuticals
(Pvt) Ltd. 21-KM
Ferozepur
Road, Each Capsule
Contains:
Rs.8000/22-07-2008
Dy. No. not
mentioned
Rs.12000/19-06-2014
1609 R&I
10’s, 14’s / 15%
less then brand
leader
Form 5
Rs.8000/19-01-2009
Not mentioned
Rs.12000/Dated.19-062014 duplicate
dossier
Dy. No. 1286
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
DDG and FID
inspection report
dated 09-06-2014
GMP compliance
considered good.
Capsule section
mentioned
in
GMP inspection
reports.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
14’s/As per PRC
Form 5
Rs.8000/19-01-2009
Not mentioned
Minutes246thMeetingRegistrationBoard
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Panel inspection
after
noncompliance
report and grant
of
GMP
certificate dated
28-03-2014.
GMP issued and
capsule section
mentioned.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
Approved.
Page226
Lahore.
Pregabalin……75
mg
(Antiepileptic)
Manufacturers
specifications
US FDA
Rs.12000/Dated.19-062014 duplicate
dossier
Dy. No. 1281
14’s,10’s/As per
PRC
400. M/S
Sharooq
Pharmaceuticals
(Pvt) Ltd. 21-KM
Ferozepur
Road,
Lahore.
Gabmor Capsule
Capsule
Each Capsule
Contains:
Pregabalin………
………..…150mg
(Antiepileptic)
Manufacturers
specifications
Form 5
Rs.8000/19-01-2009
Not mentioned
Rs.12000/Dated.19-062014 duplicate
dossier
Dy. No. 1282
14’s, 10’s/As
per PRC
401. M/s Rasco Pharma, Pregab Capsule
5.5Km
Raiwind 300mg
Road Lahore.
Capsule
Each Capsule
Contains:
Pregabalin
….……300mg
Panel inspection
after
noncompliance
report and grant
of
GMP
certificate dated
28-03-2014.
GMP issued and
capsule section
mentioned.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Rs.8000/25-07-2009
Dy. No. Not
mentioned
Rs.12000/-
GABICA
Form 5
Approved.
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Panel inspection
after
noncompliance
report and grant
of
GMP
certificate dated
28-03-2014.
GMP issued and
capsule section
mentioned.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Minutes246thMeetingRegistrationBoard
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Approved.
Page227
(Anticonvulsant)
Manufacturers
specifications
20-06-2014
Dy. No. 1296
Rs.630/-, 1x14
Capsules (50, 75,
100, 150 and
300mg)
Getz
Panel inspection
dated 03-06-2014
where
panel
recommended
grant of renewal
of DML. Capsule
section
mentioned in said
report.
402. M/s Rasco Pharma, Pregab Capsule
5.5Km
Raiwind 150mg
Road Lahore.
Capsule
Each Capsule
Contains:
Pregabalin
……150mg
(Anticonvulsant)
Manufacturers
specifications
403. M/s Rasco Pharma, Pregab Capsule
5.5Km
Raiwind 50mg
Road Lahore.
Capsule
Each Capsule
Contains:
Pregabalin
……50mg
(Anticonvulsant)
Form 5
Rs.8000/25-07-2009
Dy. No. Not
mentioned
Rs.12000/20-06-2014
Dy. No. 1295
Rs.350/-, 1x14
Form 5
Rs.8000/25-07-2009
Dy. No. Not
mentioned
Rs.12000/20-06-2014
Dy. No. 1294
Minutes246thMeetingRegistrationBoard
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Panel inspection
dated 03-06-2014
where
panel
recommended
grant of renewal
of DML. Capsule
section
mentioned in said
report.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Page228
Manufacturers
specifications
404. M/s
WnsFeild
Pharmaceuticals,
Plot#122, Block-A,
Phase-V, Industrial
Estate, Hattar
Lyricowin 75
Capsule
Each capsule
Contains:
Pregabalin
……75mg
(Anticonvulsants)
Manufacturer’s
specifications
Rs.175/-, 1x14
Form 5
Rs.8000/19-04-2009
Dy. No. Not
mentioned
Rs.12000/19-06-2014
Dy. No. 259
As per SRO
In
agenda,
erroneously
dosage form with
brand
name
written as Tablet
instead
of
Capsule. The firm
actually
mentioned dosage
form as capsule in
form 5.
Form 5
405. M/s
Pakistan Gablin 150mg
Capsule
Pharmaceuticals
Rs.8000/Products (Pvt) Ltd. Capsule
17-06-2009
D-122,
Sindh
(Challan
Industrial Trading Each capsule
submission date)
Contains:
Estate, Karachi.
Dy. No. Not
Pregabalin
mentioned
……150mg
(Anticonvulsants)
Rs.12000/26-07-2013
Dy. No. not
mentioned
Covering letter
Minutes246thMeetingRegistrationBoard
Getz
Panel inspection
dated 03-06-2014
where
panel
recommended
grant of renewal
of DML. Capsule
section
mentioned in said
report.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Panel
report
dated
04-092014.
Panel
recommends
grant of GMP
and
capsule
section
mentioned.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
Reference will
be sent to B &
A Division for
verification of
fee challan for
capsule dosage
form.
If
confirmed,
then Chairman,
RB will permit
for issuance of
registration
letter.
Otherwise case
will be placed
before
the
Board
for
decision.
Approved.
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
Page229
is not attached
Rs.25/Capsule
/not mentioned
406. M/s
Pakistan
Pharmaceuticals
Products (Pvt) Ltd.
D-122,
Sindh
Industrial Trading
Estate, Karachi.
Gablin 75mg
Capsule
Capsule
Each capsule
Contains:
Pregabalin
……75mg
(Anticonvulsants)
Form 5
Rs.8000/17-06-2009
Dy. No. Not
mentioned
Rs.12000/26-07-2013
Dy. No. not
mentioned
Covering letter
is not
attached
Rs.25/Capsule
/not mentioned
407. M/s
Pakistan
Pharmaceuticals
Products (Pvt) Ltd.
D-122,
Sindh
Industrial Trading
Estate, Karachi.
Gablin 300mg
Capsule
Capsule
Each capsule
Contains:
Pregabalin
……300mg
(Anticonvulsants)
Form 5
Rs.8000/17-06-2009
Dy. No. Not
mentioned
Rs.12000/26-07-2013
Dy. No. not
mentioned
Covering letter
is not attached
Rs.25/Capsule
/not mentioned
408. M/s Danas
Pharmaceuticals
(Private) Limited,
Gabfast
Capsule300mg
Capsule
Form 5
Rs.8000/-
Minutes246thMeetingRegistrationBoard
dated 13-02-2013
and 03-06-2014
considered to be
operating
at
satisfactory level
of GMP.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated 13-02-2013
and 03-06-2014
considered to be
operating
at
satisfactory level
of GMP.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated 13-02-2013
and 03-06-2014
considered to be
operating
at
satisfactory level
of GMP.
LYRICA
Capsules (25, 50,
75,
100,
Approved.
Page230
Islamabad.
Each capsule
Contains:
Pregabalin
……300mg
08-12-2009
Dy. No. 57
Rs.12000/05-06-2014
Dy. No. 555
(Gaba analogue)
10’s/As Per
SRO
409. M/s Danas
Pharmaceuticals
(Private) Limited,
Islamabad.
Gabfast
Capsule75mg
Capsule
Each capsule
Contains:
Pregabalin
……75mg
Form 5
Rs.8000/08-12-2009
Dy. No. 55
Rs.12000/05-06-2014
Dy. No. 555
(Gaba analogue)
10’s/As Per
SRO
410. M/s Danas
Pharmaceuticals
(Private) Limited,
Islamabad.
Gabfast
Capsule150mg
Capsule
Each capsule
Contains:
Pregabalin
……150mg
Form 5
Rs.8000/08-12-2009
Dy. No. 56
Rs.12000/05-06-2014
Dy. No. 555
(Gaba analogue)
10’s/As Per
SRO
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
cGMP certificate
dated
28-012014.
Capsule
section
mentioned.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
cGMP certificate
dated
28-012014.
Capsule
section
mentioned.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
cGMP certificate
dated
28-012014.
Capsule
Minutes246thMeetingRegistrationBoard
Page231
411. M/S
Sami Pregy 25mg
Pharmaceutical
Capsule
Pvt., Limited F-95, Capsule
S.I.T.E. Karachi.
Each Capsule
Contains:
Pregabalin……25
mg
(Anticonvulsant)
Manufacturer
Specifications
412. M/S Weather Folds
Pharmaceuticals,
Plot
No.69/2,
Phase-II, Industrial
Area, Hattar, KPK
Gabalin 50mg Cap
Capsule
Each Capsule
Contains:
Pregabalin……50
mg
(Analgesic /
Anticonvulsant
Activity)
Manufacturers
specifications
413. M/S Weather Folds Gabalin 100mg
Pharmaceuticals,
Cap
Plot
No.69/2, Capsule
Rs.8000/07-09-2010
Dy. No. not
mentioned
section
mentioned.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Rs.12000/10-05-2013
duplicate dossier
Dy. No. Not
mentioned
ZEEGAP
Capsules (25, 50,
75,
100
and
150mg)
Hilton
As per PRC
Panel inspection
report dated 2406-2014. Panel
recommended
grant
of
additional
sections. Capsule
section
mentioned.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Form 5
Form 5
Rs.8000/29-12-2010
Dy. No. Not
mentioned
Rs.12000/Dated.11-072014
Dy. No. 323
Approved.
ZEEGAP
Capsules (25, 50,
75,
100
and
150mg)
Hilton
As per SRO
Panel inspection
report dated 0409-2014. Panel
recommended
grant of GMP
certificate.
Capsule section
approved.
Form 5
Rs.8000/-
Minutes246thMeetingRegistrationBoard
Approved.
LYRICA
Capsules (25, 50,
75,
100,
Approved.
Page232
29-12-2010
Dy. No. Not
mentioned
150,200, 225 and
300mg)
US FDA
Rs.12000/Dated.11-072014
Dy. No. not
mentioned
ZEEGAP
Capsules (25, 50,
75,
100
and
150mg)
Hilton
Manufacturers
specifications
As per SRO
Panel inspection
report dated 0409-2014. Panel
recommended
grant of GMP
certificate.
Capsule section
approved.
P-Gablin
150Capsule
Oral Capsule
Form 5
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Phase-II, Industrial
Area, Hattar, KPK
Each Capsule
Contains:
Pregabalin……100
mg
(Analgesic /
Anticonvulsant
Activity)
414. M/S Lowitt Pharma
(pvt.) Ltd. 24Hayatabad
Industrial
Estate
Peshawar.
Each Capsule
Contains:
Pregabalin……150
mg
(Gaba Analogue,
Anticonvulsant.An
algasic)
Manufacturers
specifications
415. M/S Lowitt Pharma P-Gablin
(pvt.) Ltd. 24- 50Capsule
Oral Capsule
Hayatabad
Industrial
Estate
Rs.8000/22-03-2010
(Endorsement
date)
Dy. No. Not
mentioned
Rs.12000/- (for
tablet)
Dated 22-052014
Dy. No. Not
mentioned
Inspection report
dated
21-082014.
Overall
Both pack size firm in good
and price as Per working
condition.
SRO
Capsule section
Duplicate
mentioned
in
Dossier
inspection report
and
revised
layout
plan
approval
dated
13-12-2013.
LYRICA
Form 5
Capsules (25, 50,
75,
100,
Rs.8000/150,200, 225 and
22-03-2010
Minutes246thMeetingRegistrationBoard
ZEEGAP
Capsules (25, 50,
75,
100
and
150mg)
Hilton
1)
Balance
fee
Rs.
12,000/- has
been
submitted for
tablet dosage
form.
Approved.
Reference will
be sent to B &
A Division for
verification of
fee challan for
capsule dosage
form. In acse
of
nonconfirmation,
firm
will
deposit the fee
(Rs.12000/-)
and Chairman,
RB will permit
for issuance of
registration
letter.
Approved.
Page233
Peshawar.
Each Capsule
Contains:
Pregabalin……50
mg
(Endorsement
date)
Dy. No. Not
mentioned
(Gaba Analogue,
Anticonvulsant.An
algasic)
Rs.12000/Dated. 22-052014
Dy. No. Not
mentioned
Manufacturers
specifications
Both pack size
and price as Per
SRO
Duplicate
Dossier
416. M/S Lowitt Pharma
(pvt.) Ltd. 24Hayatabad
Industrial
Estate
Peshawar.
P-Gablin
100Capsule
Oral Capsule
Each Capsule
Contains:
Pregabalin……100
mg
(Gaba Analogue,
Anticonvulsant.An
algasic)
Manufacturers
specifications
Form 5
Rs.8000/22-03-2010
(Endorsement
date)
Dy. No. Not
mentioned
Rs.12000/Dated.21-052014
Dy. No. Not
mentioned
Both pack size
and price as Per
SRO
Duplicate
Dossier
417. M/s
Rogen P-Roglin 75mg
Form 5
Minutes246thMeetingRegistrationBoard
300mg)
US FDA
ZEEGAP
Capsules (25, 50,
75,
100
and
150mg)
Hilton
Inspection report
dated
21-082014.
Overall
firm in good
working
condition.
Capsule section
mentioned
in
inspection report
and
revised
layout
plan
approval
dated
13-12-2013.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Approved.
ZEEGAP
Capsules (25, 50,
75,
100
and
150mg)
Hilton
Inspection report
dated
21-082014.
Overall
firm in good
working
condition.
Capsule section
mentioned
in
inspection report
and
revised
layout
plan
approval
dated
13-12-2013.
LYRICA
Approved.
Page234
Pharmaceuticals
Plot#30,
S-4,
National Industrial
Zone,
Rawat,
Islamabad.
Capsule
Capsule
Each capsule
Contains:
Pregabalin
……75mg
Rs.8000/02-06-2010
Dy. No. 4754
Rs. 12000/16-06-2014
Dy. No.735
(Anti-epileptic)
Manufacturers
specifications
10’s/As Per
SRO
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Panel inspection
report dated 0906-2014. Tablet /
capsule section
mentioned.
418. M/s Focus & Rulz
Pharmaceuticals
(Pvt) Ltd. Plot
No.4, Industrial
Triangle, Kahuta
Road, Islamabad.
Pregab 75mg
Capsule
Capsule
Each capsule
Contains:
Pregabalin
……75mg
(Analgesic and
Anticonvulsant)
Form 5
Rs.8000/61 R&I
28-06-2010
Fee Rs.12000/challans form is
missing
14’s/As Per
SRO
Manufacturers
specifications
419. M/s Focus & Rulz
Pharmaceuticals
(Pvt) Ltd. Plot
No.4, Industrial
Triangle, Kahuta
Road, Islamabad.
Pregab 50mg
Capsule
Capsule
Each capsule
Contains:
Pregabalin
……50mg
Form 5
Rs.8000/62 R&I
28-06-2010
Fee Rs.12000/challans form is
missing
(Analgesic and
Minutes246thMeetingRegistrationBoard
General Capsule
section
mentioned on the
report.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Panel inspection
report dated 2703-2014. Capsule
section approved.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
Approved.
Firm
will
provide
verified challan
of Rs.12000/and Chairman
will authorize
issuance
of
registration
letter.
Approved.
Firm
will
provide
verified challan
of Rs.12000/and Chairman
will authorize
issuance
of
registration
letter.
Page235
Anticonvulsant)
14’s/As Per
SRO
Manufacturers
specifications
420. M/s Amarant
Pharmaceuticals
(Pvt) LTD 158-D,
Toro Gadap Road,
Super highway,
Karachi.
Gabalin Capsule
50mg
Capsule
Each filled Capsule
Contains:
Pregabalin……50
mg
(Anticonvulsant)
Manufacturers
specifications
421. M/s Amarant
Pharmaceuticals
(Pvt) LTD 158-D,
Toro Gadap Road,
Super highway,
Karachi.
Gabalin Capsule
75mg
Capsule
Each filled Capsule
Contains:
Pregabalin……75
mg
(Anticonvulsant)
Manufacturers
specifications
Rs.8000/22-11-2010
Dy. No. not
mentioned
Panel inspection
report dated 2703-2014. Capsule
section approved.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Rs.52,000/(fast track)
19-11-2012
Dy. No. Not
mentioned
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Rs.36/- capsule
duplicate dossier
Rs.8000/22-11-2010
Dy. No. not
mentioned
Inspection report
dated 08-08-2014
observed
that
management is
taking
serious
measures
to
rearrange
and
upgrade
their
whole
manufacturing,
quality
control
and
storage
facilities as per
approved layout
plan.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Rs.52,000/(fast track)
19-11-2012
Dy. No. Not
mentioned
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Rs.71/- capsule
Inspection report
Form 5
Form 5
Minutes246thMeetingRegistrationBoard
300mg)
Getz
Approved.
Approved.
Page236
duplicate dossier
422. M/s Amarant
Pharmaceuticals
(Pvt) LTD 158-D,
Toro Gadap Road,
Super highway,
Karachi.
Gabalin Capsule
100mg
Capsule
Each filled Capsule
Contains:
Pregabalin……100
mg
(Anticonvulsant)
Manufacturers
specifications
423. M/s Amarant
Pharmaceuticals
(Pvt) LTD 158-D,
Toro Gadap Road,
Super highway,
Karachi.
Gabalin Capsule
150mg
Capsule
Each filled Capsule
Contains:
Pregabalin……150
Rs.8000/22-11-2010
Dy. No. not
mentioned
dated 08-08-2014
observed
that
management is
taking
serious
measures
to
rearrange
and
upgrade
their
whole
manufacturing,
quality
control
and
storage
facilities as per
approved layout
plan.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Rs.52,000/(fast track)
18-11-2012
Dy. No. Not
mentioned
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Rs.89/- capsule
duplicate dossier
Inspection report
dated 08-08-2014
observed
that
management is
taking
serious
measures
to
rearrange
and
upgrade
their
whole
manufacturing,
quality
control
and
storage
facilities as per
approved layout
plan.
LYRICA
Capsules (25, 50,
75,
100,
150,200, 225 and
300mg)
US FDA
Form 5
Form 5
Rs.8000/22-11-2010
Dy. No. not
mentioned
Minutes246thMeetingRegistrationBoard
Approved.
Approved.
Page237
mg
(Anticonvulsant)
Manufacturers
specifications
Rs.52,000/(fast track)
19-11-2012
Dy. No. Not
mentioned
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Rs.107/- capsule
duplicate dossier
Inspection report
dated 08-08-2014
observed
that
management is
taking
serious
measures
to
rearrange
and
upgrade
their
whole
manufacturing,
quality
control
and
storage
facilities as per
approved layout
plan.
9. Contract manufacturing applications
Evaluator – II (Application checked by Evaluator - IV)
S.No Name
and
address
of
manufacturer /
Applicant
Remarks on the Decision
formulation
(if
any)
including
International
status in stringent
regulatory
Fee including drug
agencies
/
differential
authorities
fee
Type of Form
Brand Name
(Proprietary
name + Dosage Initial date,
Form + Strength) diary
Composition
Pharmacological
Group
Me-too status
Demanded
Finished product Price / Pack
GMP status as
size
Specification
depicted in latest
inspection report
(with date) by the
Evaluator
424.
M/s Safe
Pharmaceuticals
(Pvt.) Ltd.
Plot No. C-1-20,
Impulse Injection
500 mcg/ml
Each 1 ml
ampoule contains
Form 5
Not mentioned
Rs 150,000
1 ml × 10’s
Minutes246thMeetingRegistrationBoard
Deferred for rectification of
International:
Methycobal Inj by following observation in the
M/s Eisai Co., Ltd. dossier:
Tokyo
Page238
Sector 6-B,
North Karachi
Industrial Area,
Karachi
For
M/s Amarant
Pharmaceuticals
(Pvt.) Ltd.
158, D. Tore,
Gadap Road,
Super Highway,
Karachi.
Me too:Elgin Inj by
M/s Novartis
According
to
inspection
report
dated 20-08-2014 of
M/s
Safe
Pharmaceuticals;
GMP
compliance
level of firm is rated
as good.
Mecobalamin
(J.P)…..500 mcg
(Co-enzyme type
Vitamin B12)
(Manufacturer’s
Spec.s)
1. Reference will be sent to B &
A Division for verification of
challan.
2. Confirmation of installation
and operational qualifications
for TOC analyzer and liquid
particle counter by the area FID.
Only Form 5 of the
application has been
evaluated. Rest of
the conditions of
policy matters have
not been evaluated .
Verification
fee
challan is required.
425.
-do-
Moxina Infusion
400 mg/ 250 ml
Each vial (250 ml)
contains
Moxifloxacin (as
HCl) (USP)….
400 mg
Quinolone
(Manufacturer’s
Spec.s)
Form 5
Not mentioned
Rs 150,000
As per PAC
Evidence of TOC
analyzer and liquid
particle counter is
required. Firm has
replied that these are
under the process of
procurement.
International:
Avelox Inf (FDA)
Me too: Moxiget
Inf 400mg/250ml
According
to
inspection
report
dated 20-08-2014 of
M/s
Safe
Pharmaceuticals;
GMP
compliance
level of firm is rated
as good.
Deferred for rectification of
following observation in the
dossier:
1. Reference will be sent to B &
A Division for verification of
challan.
2. Confirmation of installation
and operational qualifications
for TOC analyzer and liquid
particle counter by the area FID.
Only Form 5 of the
application has been
evaluated. Rest of
the conditions of
policy matters have
not been evaluated .
Verification
fee
challan is required.
Minutes246thMeetingRegistrationBoard
Page239
426.
-do-
427.
-do-
Quvoxin Injection
500 mg/ 100 ml
Each vial (100ml)
contains
Levofloxacin
(USP)…. 500 mg
Quinolone
(Manufacturer’s
Spec.s)
Amadrol Injection
100 mg/ 2 ml
Each 2 ml
contains
Tramadol HCl
(B.P) …..100 mg
Non Narcotic
analgesic
(Manufacturer’s
Spec.s)
Form 5
Not mentioned
Rs 150,000
As per PAC
Form 5
Not mentioned
Rs 150,000
2 ml × 5’s
As per PAC
Minutes246thMeetingRegistrationBoard
Evidence of TOC
analyzer and liquid
particle counter is
required. Firm has
replied that these are
under the process of
procurement.
International:
Levaquine
500mg/100ml
(FDA)
Me too: Raylox Inf
500mg/100ml
by
M/s Ray
According
to
inspection
report
dated 20-08-2014 of
M/s
Safe
Pharmaceuticals;
GMP
compliance
level of firm is rated
as good.
Only Form 5 of the
application has been
evaluated. Rest of
the conditions of
policy matters have
not been evaluated .
Verification
fee
challan is required.
Evidence of TOC
analyzer and liquid
particle counter is
required. Firm has
replied that these are
under the process of
procurement.
International:
Zamadol
Inj
50mg/ml
(100mg
ampoule) in UK
Me too: Tramadol
Inj 50mg/ml by M/s
Highnoon
Latest
GMP
inspection report of
contract giver is
required.
Deferred for rectification of
following observation in the
dossier:
1. Reference will be sent to B &
A Division for verification of
challan.
2. Confirmation of installation
and operational qualifications
for TOC analyzer and liquid
particle counter by the area FID.
Deferred for rectification of
following observation in the
dossier:
1. Reference will be sent to B &
A Division for verification of
challan.
2. Confirmation of installation
and operational qualifications
for TOC analyzer and liquid
Page240
According
to particle counter by the area FID.
inspection
report
dated 20-08-2014 of
M/s
Safe
Pharmaceuticals;
GMP
compliance
level of firm is rated
as good.
428.
-do-
Amblum Injection
Each ml ampoule
contains
Artemether……80
mg
(Anti malarial)
(Manufacturer’s
Spec.s)
Form 5
Not mentioned
Rs 150,000
1 × 5 ampoule
As per PAC
Minutes246thMeetingRegistrationBoard
Only Form 5 of the
application has been
evaluated. Rest of
the conditions of
policy matters have
not been evaluated .
Verification
fee
challan is required.
Evidence of TOC
analyzer and liquid
particle counter is
required. Firm has
replied that these are
under the process of
procurement.
International:
Artem Inj in China
Me too: Artem Inj
by M/s Hilton
According
to
inspection
report
dated 20-08-2014 of
M/s
Safe
Pharmaceuticals;
GMP
compliance
level of firm is rated
as good.
Only Form 5 of the
application has been
evaluated. Rest of
the conditions of
policy matters have
not been evaluated .
Verification
fee
challan is required.
Formulation
was
Deferred in the light
of recommendations
by Malaria Control
Programme in M-
Deferred in the light of
recommendation of National
Malaaria Control programme &
for rectification of following
observation in the dossier:
1. Reference will be sent to B &
A Division for verification of
challan.
2. Confirmation of installation
and operational qualifications
for TOC analyzer and liquid
particle counter by the area FID.
Page241
245 of DRB.
429.
M/s Caraway
Pharmaceuticals
Plot No. 12,
street # N-3,
National
Industrial Zone,
Rawat,
Islamabad.
For
M/s Amarant
Pharmaceuticals
(Pvt.) Ltd.
158, D. Tore,
Gadap Road,
Super Highway,
Karachi.
430.
-do-
Amant- D
Injection
Each ml contains
Cholecalciferol
BP …..5 mg
Vitamin
Form 5
Not mentioned
Rs 150,000
As per PAC
Finished product
specifications are
B.P
Amta- Rose
Injection
Each ampoule
(5ml) contains
Iron Sucrose 420
mg eq to
elemental Iron …..
100mg
Haematinic
Form 5
Not mentioned
Rs 150,000
As per PAC
Finished product
specifications are
USP
Minutes246thMeetingRegistrationBoard
International:
Required
Me too: Calciferol
Inj by M/s Global
Good level of GMP
compliance (24-092012)
Only Form 5 of the
application has been
evaluated. Rest of
the conditions of
policy matters have
not been evaluated .
Verification
fee
challan is required.
International
availability
not
confirmed in SRA’s.
Letter of approval of
injection section is
required. Inspection
report dated 24-0912
mentions
Ampoule and Vial
sections.
Labeling
information
has
been
given
for
malaria.
International:
Venofer Inj (FDA)
Me too: Merofer
JInj by M/s Bosch
Good level of GMP
compliance (24-092012)
Deferred for rectification of
following observation in the
dossier:
Only Form 5 of the
application has been
evaluated. Rest of
the conditions of
policy matters have
not been evaluated .
Verification
fee
challan is required.
Initially on Form 5,
firm
mentioned
quantity of active as
2. Confirmation of installation
and operational qualifications
for TOC analyzer and liquid
particle counter by the area FID.
1. Reference will be sent to B &
A Division for verification of
challan.
2. Confirmation of installation
and operational qualifications
for TOC analyzer and liquid
particle counter by the area FID.
3. Evidence of approval in
reference Stringent Regulatory
Agencies.
4. Approval of manufacturing
facility by Licensing section.
5. Correction in labeling as
submitted label mentions the
use of formulation in malaria.
Deferred for rectification of
following observation in the
dossier:
1. Reference will be sent to B &
A Division for verification of
challan.
3. Initially on Form 5, firm
mentioned quantity of active as
420 mg/ ampoule, in reply firm
mentioned it as 1873 mg/
ampoule.
Clarification
is
Page242
420 mg/ ampoule, in
reply
firm
mentioned it as
1873 mg/ ampoule.
Clarification
is
required.
No
clarification
is
provided in second
reply.
Letter of approval of
injection section is
required.
Not
provided in second
reply.
Inspection
report dated 24-0912
mentions
Ampoule and Vial
sections.
Evidence of TOC
analyzer and liquid
particle counter is
required.
Not
provided in replies.
required. No clarification is
provided in second reply.
4. Letter of approval of
injection section is required.
Not provided in second reply.
Inspection report dated 24-0912 mentions Ampoule and Vial
sections.
Evaluator – III
S/N Name
and
address
of
manufacturer /
Applicant
Remarks
on Recommendations Decision
by the Evaluator
the
formulation (if
any) including
International
status
in
Composition
stringent drug
Fee
regulatory
Pharmacological Group including
/
differential agencies
authorities
Finished
product fee
Specification
Demanded Me-too status
Price
/
GMP status as
Pack size
depicted
in
latest
inspection
report
(with
date) by the
Evaluator
Brand Name
(Proprietary name
Dosage
Form
Strength)
Type
of
+ Form
+
Initial
date, diary
Minutes246thMeetingRegistrationBoard
Page243
431. Contract Giver OD-CEF Injection 500mg
M/s
Dyson
Research Labs, Each vial contains:
Ceftriaxone
sodium
Lahore.
equivalent
to
Ceftriaxone…..500mg
Contract
Acceptor
M/s McOlson Cephalosporin
Research
USP
Laboratories,
Sheikhupura.
Form-5
Dy
No:
2437 dated:
15-04-2013
1,42,000/dated 1504-13
8,000/dated 1805-09
Inspection
of
M/s McColson
Research Labs
conducted on
26-08-14 and
11-09-14 by the
panel
of
inspectors and
recommends
the grant of
renewal
of
DML to the
firm
As
per
SRO
Pack of 1’s
432. Contract Giver
M/s McOlson
Research
Laboratories,
Sheikhupura.
AZIBAC
200mg
Suspension Form-5
Each
5ml
after
reconstitution contains:
Azithromycin dihydrate
equivalent
to
Contract
Azithromycin
Acceptor
M/s
Dyson USP…..200mg
Research Labs,
Macrolide Antibiotic
Lahore.
Dy
No:
2430 dated:
15-04-2013
50,000/dated 1504-13
1,00,000/dated 1405-13
Inspection
of
the M/s Dyson
Research Labs
Sheikhupura
was conducted
on 26-09-14 by
the area FID
and
overall
hygiene
and
condition
is
found good.
USP
As
SRO
Suspension
433. Contract Giver M-XIME
M/s
Masfa 100mg/5ml
Industries (Pvt)
Limited, Lahore Each 5ml contains:
Cefixime
trihydraye
equivalent
to
Contract
Cefixime…..100mg
Acceptor
M/s McOlson
Cephalosporin
Research
Laboratories,
USP
Sheikhupura.
Minutes246thMeetingRegistrationBoard
per
Inspection
of
M/s McColson
Dy
No: Research Labs
2430 dated: conducted on
15-04-2013 26-08-14 and
11-09-14 by the
panel
of
1,50,000/inspectors and
As
per recommends
the grant of
SRO
renewal
of
DML to the
Form-5
The
applications
have
been
evaluated as per
Form-5. However
the formalities as
per
contract
manufacturing
policy may be
fulfilled by the
concerned section
before issuance of
registration letter.
Approved.
Firm
will
provide
undertakings
& agreement
as
per
approved
contract
policy
and
Chairman will
permit
issuance
of
registration
letter.
Permission
will be valid
till
30.06.2015).
Approved.
Firm
will
provide
undertakings
& agreement
as
per
approved
contract
policy
and
Chairman will
permit
issuance
of
registration
letter.
Permission
will be valid
till
30.06.2015).
Approved.
Firm
will
provide
undertakings
& agreement
as
per
approved
contract
policy
and
Chairman will
permit
issuance
of
Page244
firm
434. Contract Giver M-XIME Capsule 400mg
M/s
Masfa
Industries (Pvt) Each capsule contains:
as
Limited, Lahore Cefixime
Trihydrate…..400mg
Contract
Cephalosporin
Acceptor
M/s McOlson
USP
Research
Laboratories,
Sheikhupura.
MECOFOL Injection
Minutes246thMeetingRegistrationBoard
Approved.
Firm
will
provide
undertakings
& agreement
as
per
approved
contract
policy
and
Chairman will
permit
issuance
of
registration
letter.
Permission
will be valid
till
30.06.2015).
Inspection
of
M/s McColson
Dy
No: Research Labs
2405 dated: conducted on
15-04-2013 26-08-14 and
11-09-14 by the
panel
of
1,50,000/inspectors and
As
per recommends
the grant of
SRO
of
Pack of 5’s renewal
DML to the
firm
Form-5
Inspection
of
M/s
Friends
No: Pharma Lahore
Each1ml
ampoule Dy
2383 dated was conducted
contains:
by the panel of
Mecobalamin……500mcg 12-04-13
inspectors
on
21-05-14
Co-Enzyme Vitamin B-12 1,50,000/Contract
concluded the
Acceptor
GMP
As
per firm
M/s
Friends IP
compliant.
SRO
Pharma
(Pvt)
Pack of 1’s
Limited, Lahore
Liquid Injection
for
(general)
section
approval vided
letter No. F.118/
93-Lic
(Vol-II)
(M227) dated 1706-11.
435. Contract Giver
M/s
Arsons
Pharmaceutical
Industries,
Lahore.
registration
letter.
Permission
will be valid
till
30.06.2015).
Form-5
Evidence
of
availability
of
TOC and liquid
particle counter
is not provided.
Deferred for
confirmation
of
installation
and
operational
qualifications
for
TOC
analyser &
Liquid
Particle
Counter by
Area FID.
Page245
Nexium
of a. Quantity of API
in
master
AstraZeneca
formulation
Dy
No:
needs
of
3160 dated Nexium
rectification.
BMS
17-05-13
b. Latest
GMP
Inspection
The inspection
1,50,000/report of M/s
M/s
English
English Pharma
As
per Pharmaceuticals
is required.
Lahore
was
SRO
conducted on
14-11-2012 and
15-11-2012 by
the area FID
and found GMP
complaint
436. Contract Giver ESUN Injection 40mg
M/s M/s Unison
Each vial contains:
Chemical
Sterilized Esomeprazole
Works Lahore.
Sodium
lyophilized
equivalent
to
Contract
Esomeprazole…..40mg
Acceptor
M/s
English
Pharmaceuticals PPI
Lahore
Manufacturer
Form-5
437. Contract Giver U-MIP Injection 40mg
M/s M/s Unison
Each vial contains:
Chemical
Sterilized
Omeprazole
Works Lahore.
Sodium
lyophilized
equivalent
to
Contract
Omeprazole…..40mg
Acceptor
M/s
English
Pharmaceuticals PPI
Lahore
Manufacturer
Form-5
438. Contract Giver BEMOX Infusion
M/s
Dyson
Research Labs, Each 250ml contains:
Lahore.
Moxifloxacin
as
hydrochloride…….400mg
Contract
Fluoroquinolone
Acceptor
M/s
English
Pharmaceuticals Manufacturer
Lahore
Form-5
Minutes246thMeetingRegistrationBoard
of
Losec Infusion a. Quantity
API in master
of AstraZeneca
formulation
Dy
No:
needs
3161 dated Risek of Getz
rectification
Pharma
17-05-13
b. Latest
GMP
Inspection
The inspection
1,50,000/report of M/s
M/s
English
English
As
per Pharmaceuticals
Pharma
is
Lahore
was
SRO
required.
conducted on
14-11-2012 and
15-11-2012 by
the area FID
and found GMP
complaint
Avelox
of a. Specifications
Bayer
of API needs to
Dy
No: HealthCare Inc
be submitted.
2417 dated:
b. Under finished
15-04-2013 Molox Infusion
product
of CCL Pharma
specifications
1,50,000/assay method
needs to be
As
per
submitted.
SRO
c. Evidence
of
facility of TOC
analyzer
and
particle counter
needs to be
submitted.
Deferred for
rectification
of following
observations:
1. Quantity
of API in
master
formulation
needs
rectification.
2.
Latest
GMP
Inspection
report of M/s
English
Pharma
is
required.
Deferred for
rectification
of following
observations:
1. Quantity
of API in
master
formulation
needs
rectification.
2.
Latest
GMP
Inspection
report of M/s
English
Pharma
is
required.
Deferred for
rectification
of following
observations:
1.
Specifications
of API needs
to
be
submitted.
2.
Under
finished
product
specifications
assay method
needs to be
Page246
GMP submitted.
3.
Inspection
report of M/s Confirmation
English Pharma of installation
and
is required.
operational
qualifications
for
TOC
analyzer and
particle
counter.
4.
Latest
GMP
Inspection
report of M/s
English
Pharma
is
required.
Meronem
of a. Evidence
of Deferred for
AstraZeneca
approval
of rectification
of following
manufacturing
Demonem
of
facility
for observations:
Rotex Medica
applied product 1. Evidence of
of
needs to be approval
manufacturing
submitted
for
b. Latest
GMP facility
applied
Inspection
report of M/s product needs
be
English Pharma to
submitted
is required.
2.
Latest
GMP
Inspection
report of M/s
English
Pharma
is
required.
d. Latest
Injection
439. Contract Giver DYPENEM
M/s
Dyson 500mg
Research Labs,
Each vial contains:
Lahore.
Meropenem
trihydrate
equivalent
to
Contract
Meropenem……500mg
Acceptor
M/s
English
Pharmaceuticals Penicillin Antibiotic
Lahore
Manufacturer
Form-5
Dy
No:
2411 dated:
15-04-2013
50,000/dated 1504-13
100,000
dated 1405-13
As
SRO
440. Contract Giver DYPENEM Injection 1g
M/s
Dyson
Research Labs, Each vial contains:
Meropenem
trihydrate
Lahore.
equivalent
to
Meropenem……1g
Contract
Acceptor
M/s
English Penicillin Antibiotic
Pharmaceuticals
Manufacturer
Lahore
Minutes246thMeetingRegistrationBoard
per
Form-5
Dy
No:
2412 dated:
15-04-2013
50,000/dated 15-04
-13
100,000
dated 14-
Meronem
of a. Evidence
of
AstraZeneca
approval
of
manufacturing
Demonem
of
facility
for
Rotex Medica
applied product
needs to be
submitted
b. Latest
GMP
Inspection
report of M/s
English Pharma
Deferred for
rectification
of following
observations:
1. Evidence of
approval
of
manufacturing
facility
for
applied
product needs
to
be
Page247
05-13
As
SRO
Case No.10.
is required.
per
submitted
2.
Latest
GMP
Inspection
report of M/s
English
Pharma
is
required.
Replies of deferred applications
Evaluator – I
Case No. a: The following two products, namely Effiflox 125mg/5ml and Effiflox 250mg/5ml, of M/s
Sami Pharmaceuticals (Pvt) Ltd., Karachi were deferred in the 242nd meeting of the Registration
Board held on 24th – 25th February, 2014 for confirmation of approved dosage form (dry powder
suspension or solution) by stringent regulatory bodies.
2.
The firm has now submitted that they have prepared the drugs against LEVAQUIN of
M/s Janssen Pharma – USA as oral solution and in parallel conducted accelerated stability
studies. The firm has also submitted revised Form – 5 and requested the Board to grant
registration as oral solution.
3.
It is pertinent to mention that evidence of approval of 250mg / 5ml strength by stringent
regulatory agencies was not submitted by the firm instead comments of some local prescribers in
favor of the same have been submitted.
S/N
Name
and
address
of
manufacturer /
Applicant
1. Brand Name
2. Dosage Form
3. Composition
4.
Pharmacologic
al group
1.Type
of
Form
2. Type of
application
3. Demanded
Price / Pack
size
4. Initial date,
diary.
5. Date on
which
fee
becomes
complete
according to
type
of
application
/or Form
Minutes246thMeetingRegistrationBoard
1.Finished
Product
Specification
2. Facility where
drug has to be
manufactured
with
status
whether
approved
by
CLB or not
3. Last GMP
inspection
report with date
& status.
Decision in 242nd Decision
Meeting
of
Registration
Board
Page248
441.
M/s
Sami
Pharmaceuticals
(Pvt) Ltd., F-95,
Off. Hub River
Road, S.I.T.E.,
Karachi.
442.
M/s
Sami
Pharmaceuticals
(Pvt) Ltd., F-95,
Off. Hub River
Road, S.I.T.E.,
Karachi.
1. EFFIFLOX
125 mg/5ml
2. Dry powder
suspension
3.
Each 5ml of
reconstituted
suspension
contains:
Levofloxacin
Hemihydrate
MS
eq.
to
Levofloxacin
……………..
125mg
4.
Fluroquinolone.
1. EFFIFLOX
250 mg/5ml
2. Dry powder
suspension
3. Each 5ml of
reconstituted
suspension
contains:
Levofloxacin
Hemihydrate
MS
eq.
to
Levofloxacin
……………..
250mg
4.
Fluroquinolone.
1. Manufacturers
specification.
2. Dry powder
suspension
General
Antibiotic
available as per
inspection report
dated 02/05.2013.
3. cGMP report
dated 02/05/2013
is
provided
wherein
good
level of GMP
compliance
is
reported.
1. Manufacturers
1. Form-5
specification.
2. Fast track
3. As per 2. Dry powder
PAC, 60ml. 4. suspension
General
20/04/2011,
Antibiotic
263 (R&I)
5. 24/04/2013 available as per
inspection report
Rs.60,000/dated 02/05.2013.
3. cGMP report
dated 02/05/2013
is
provided
wherein
good
level of GMP
compliance
is
reported.
1. Form-5
2. Fast track
3. As per
PAC, 60ml.
4. 20/04/2011,
264 (R&I)
5. 24/04/2013
Rs.60,000/-
Minutes246thMeetingRegistrationBoard
Deferred
for
confirmation
of
approved dosage
form (dry powder
suspension
or
solution)
by
stringent
regulatory bodies.
The Board did not
accede the request
of firm for change
in dosage form &
deferred
the
instant application
for review of
formulation
by
Incharge, PEC..
Deferred
for
confirmation
of
approved dosage
form (dry powder
suspension
or
solution)
by
stringent
regulatory bodies.
The Board did not
acceed the request
of firm for change
in dosage form &
deferred
the
instant application
for review of
formulation
by
Incharge, PEC.
Page249
Case No. b:
Following registration application of M/s Arson Pharmaceutical Industries (Pvt) Ltd., Lahore was
deferred in the 243rd meeting of the Registration Board for status of license in light of inspection report
dated 15-04-2013.
2.
The firm has now submitted copy of panel inspection report dated 08/05/2014 for renewal of
Drug Manufacturing License and Grant of additional section (Tablet Psychotropic). The panel in its
aforesaid report reached on the following recommendations:
a. Recommend the renewal of Drug Manufacturing License of the firm M/s Arson
Pharmaceutical Industries (Pvt) Ltd., Multan Road Lahore.
b. Recommend the grant of license to the additional tablet Psychotropic Section.
3.
The firm has also submitted a copy of certificate of current Good Manufacturing Practices dated
19-08-2014 wherein it is reported that firm is found complying with cGMP in terms of process control,
maintenance of equipment and area, documentation etc. as per provisions of Drugs Act, 1976 and rules
framed there under.
443.
M/s
Arsons
Pharmaceutical
Industries (Pvt) Ltd.
22 Km Multan
Road off 4 Km
Defence
Road,
Lahore
DOXICYCLINE
100mg Capsules
Capsule
As
Per Form-5
SRO 10 x
10’s
28-09-2012
2280 R&I
Each
Capsule
contains:Doxycycline
as
Hyclate…..100 mg
Rs.20,000/-
Anomaly Case:
Capsule (General
Tetracycline
Antibiotic)
Vibramycin
100mg
Capsules
US FDA
Deferred
for
status of lisence
in
light
of
inspection report
dated 15-04-2013
DOTUR
100mg
Capsule
Novartis
Vide letter No. F. 114/95 – Lic (Vol I)
(M – 227) dated
13th June, 2011
Decision: The Board approved the registration of application.
Minutes246thMeetingRegistrationBoard
Page250
Case No. c: Following registration application of M/s A’raf (Pvt) Ltd., Lahore was deferred in the 242nd
meeting of the Registration Board for expert opinion of Dr.Rizwan Taj, PIMS and Brig Jehangeer
Saleem. Now, the firm has informed that same product is already registered in the 214th meeting of the
Registration Board having registration No. 062765 to the firm M/s Schazoo Zaka.
2.
In light of above, firm has requested for registration of their product and to change it to XR.
444. M/s A’RAF (Pvt) 1. Zaxine SR 1. Form-5 D
Ltd. (Former M/s
Remedy
Pharmaceutical Pvt
Limited), 23 Km
Raiwind
Road
Lahore.
150mg tablets 2.
Sustained release
film coated tablet
3. Each tablet
contains:
Venlafaxine as
Hydrochloride
……. 150mg
4. Serotonin and
Noradrenaline
Reuptake
Inhibitors.
2. Fast track
3. Rs. 1100/per 14’s 4.
30/07/2013,
9209 (R&I)
5. Rs.60,000/Rs. 90,000/-
1. B.P. specifications.
2. General Tablet
section available as
per inspection report
dated 19/01/2012.
3. GMP report dated
19/01/2012 attached.
Deferred for expert
opinion
of
Dr.Rizwan
Taj,
PIMS;
Brig
Jehangeer Saleem
The formulation is
found available in
UK
Decision: The Board approved the registration of the product & acceded to the request of
the firm for change in nomenclature from SR to XR.
Minutes246thMeetingRegistrationBoard
Page251
Evaluator - I
S/
N
Name and address
of manufacturer /
Applicant
Brand Name
Type of Form
Decision
Previous
date, Meeting
(Proprietary
Initial
name + Dosage diary
Form + Strength)
Fee including
Composition
differential fee
Pharmacological
Group
Finished product
Specification
445. M/s.
P.D.H. Pyrox-B Tablets
Pharmaceuticals,
Lahore
Each
tablet
contains:Piroxicam
Beta
Cyclodextrin
equivalent
to
Piroxicam
….
20mg
Demanded
Price / Pack
size
Me-too status
GMP status as
depicted
in
latest inspection
report
(with
date) by the
Evaluator
Form-5
Fast Track
28/8/2013 9991
R&I
28/8/2013
(Rs. 60,000/-)
Rs.265.22 per
2x10’s
(NSAID)
Manufacturers
specifications
Minutes246thMeetingRegistrationBoard
of Remarks on the Decision
formulation (if
any) including
International
status
in
stringent drug
regulatory
agencies
/
authorities
Deferred
for
final reminder
for completion
of Form 5
1.
An
undertaking /
commitment
regarding the
submission of
following, as
per decision of
the
Registration
Board, may be
submitted:
a) Label claim
and prescribing
information
being same as
approved
by
reference drug
agencies e.g.,
FDA,
TGA,
MHLW, EMA
and
Health
Canada.
Brexidol, Cheisi, Approved.
BNF
Brexin
Cheisi
20mg,
Inspection report
dated 30/09/2014
provided. Firm
showed
improvement
regarding
previous
shortcomings
/
observations.
Page252
446. M/s.
P.D.H
Pharmaceuticals
(Pvt) Ltd., 19 Km,
Ferozpur
Road,
Lahore.
10mg Form 5
Fast Track
12/4/2013 798
Each film coated R&I
13/11/2013
tablet contains:(Rs. 60,000/-)
Rosuvastatin
Rs.250/10’s
Calcium
equivalent
to
Rosuvastatin
……………..
10mg
Giostatin
Tablets
Statins
Manufacturers
specifications
Minutes246thMeetingRegistrationBoard
2.
Several
observations
have
been
made by the
area FID in the
inspection
report
dated
05/03/2014
regarding
validation of
HVAC,
frequency of In
Process testing,
differential
pressure
maintenance,
old machinery
like fluid bed
dryer, mixer,
granulator to
be
replaced
with
latest
version etc.
Deferred
for
final reminder
for completion
of Form 5
1.
An
undertaking /
commitment
regarding the
submission of
following, as
per decision of
the
Registration
Board, may be
submitted:
a) Label claim
and prescribing
information
being same as
approved
by
reference drug
agencies e.g.,
FDA,
TGA,
MHLW, EMA
and
Health
Canada.
2.
Several
observations
Crestor
FDA
10mg, Approved.
Rosutrol
Pfizer
10mg,
Inspection report
dated 30/09/2014
provided. Firm
showed
improvement
regarding
previous
shortcomings
/
observations.
Page253
447. M/s.
P.D.H
Pharmaceuticals
(Pvt) Ltd., 19 Km,
Ferozpur
Road,
Lahore.
20mg Form 5
Fast Track
12/11/2013 788
Enteric
coated R&I
12/11/2013
pellets
Each
capsule (Rs. 60,000/-)
Rs.231/ 2x7’s
contains:Esomeprazole
Magnesium
trihydrate enteric
coated
pellets
equivalent
to
Esomeprazole
…………..…
20mg
Esogerd
Capsule
Anti-ulcer
Manufacturers
specifications
Source:
M/s
Vision
Pharmaceuticals,
Islamabad
Minutes246thMeetingRegistrationBoard
have
been
made by the
area FID in the
inspection
report
dated
05/03/2014
regarding
validation of
HVAC,
frequency of In
Process testing,
differential
pressure
maintenance,
old machinery
like fluid bed
dryer, mixer,
granulator to
be
replaced
with
latest
version etc.
Deferred
for
final reminder
for completion
of Form 5
1.
An
undertaking /
commitment
regarding the
submission of
following, as
per decision of
the
Registration
Board, may be
submitted:
a) Label claim
and
prescribing
information
being same as
approved by
reference drug
agencies e.g.,
FDA, TGA,
MHLW, EMA
and
Health
Canada.
2.
Several
observations
Nexium
20mg Approved.
Capsules, FDA
Nexum
Capsules
20mg,
Inspection report
dated 30/09/2014
provided. Firm
showed
improvement
regarding
previous
shortcomings
/
observations.
FID mentioned
that
automatic
capsule
filling
machine should
be provided in
capsule
filling
area.
Page254
448. M/s.
P.D.H
Pharmaceuticals
(Pvt) Ltd., 19 Km,
Ferozpur
Road,
Lahore.
Esogerd
Capsule
40mg
Enteric
coated
pellets
Each
capsule
contains:Esomeprazole
Magnesium
trihydrate enteric
coated
pellets
equivalent
to
Esomeprazole
………………
40mg
Anti-ulcer
have
been
made by the
area FID in
the inspection
report dated
05/03/2014
regarding
validation of
HVAC,
frequency of
In
Process
testing,
differential
pressuremaint
enance,
old
machinery like
fluid
bed
dryer, mixer,
granulator to
be
replaced
with
latest
version etc.
Deferred
for Nexium
Form 5
40mg Approved.
final reminder Capsules, FDA
Fast Track
12/11/2013 788 for completion
of Form 5
R&I
12/11/2013
Nexum
40mg,
(Rs. 60,000/-)
Capsules
1.
An
Rs.360/ 2x7’s
undertaking / Inspection report
commitment
dated 30/09/2014
regarding the provided.
Firm
submission of showed
following, as improvement
per decision of regarding
the
previous
Registration
shortcomings
/
Board, may be
observations.
submitted:
Manufacturers
specifications
Source:
M/s
Vision
Pharmaceuticals,
Islamabad
Minutes246thMeetingRegistrationBoard
a) Label claim
and prescribing
information
being same as
approved
by
reference drug
agencies e.g.,
FDA,
TGA,
MHLW, EMA
and
Health
Canada.
FID mentioned
that
automatic
capsule
filling
machine should
be provided in
capsule
filling
area.
Page255
449. M/s
Zanctok Genelor
Pharmaceutical
Syrup
Laboratories, F/5
S.I.T.E
Area,
Each 5ml
Hyderabad
Contains:
Desloratadine……
………….2.5mg
Form5
Routine
23/07/2010
Dy. No. 1411
Rs. 8000/-
Antihistamine
13-05-2013
Rs. 12000/-
Manufacturers
specifications
60ml,120ml/As
per PRC
2.
Several
observations
have
been
made by the
area FID in the
inspection
report
dated
05/03/2014
regarding
validation of
HVAC,
frequency of In
Process testing,
differential
pressure
maintenance,
old machinery
like fluid bed
dryer, mixer,
granulator to
be
replaced
with
latest
version etc.
Deferred for
confirmation
of me too
status
Firm
has Approved.
informed that due
to
typographic
error the strength
was typed as
5mg/10ml
and
that they have
corrected
the
strength
to
2.5mg/5ml.
A
revised Form-5
has
been
submitted by the
firm.
Clarinex
0.5mg/ml, Syrup,
FDA
Desora 0.5mg/ml
Syrup,
Continental
Pharma
Minutes246thMeetingRegistrationBoard
Page256
450. M/s
Hiranis
Pharmaceuticals
(Pvt) Ltd., Plot No.
E-145 – E-149,
North
Western
Industrial
Zone,
Port
Qasim,
Karachi.
Relevo
20mg
Sachet Form-5D
Each
contains:
sachet
New License
Piroxicam betacyclodextrin 191.2
mg eq. to
Piroxicam
………… 20mg
28-05-2014
810 R&I
Rs. 150 / per
10’s
Rs. 50,000/-
Deferred for
evidence
of
approval
of
same
formulation by
reference drug
agencies e.g.,
FDA, TGA,
MHLW, EMA
and
Health
Canada.
BREXIN
PULVER
20mg powder
Torrex-Chiesi
Pharma,Austria
Deferred for:
1) Evidence of
approval
of
same
formulation by
reference drug
agencies e.g.,
FDA, TGA,
MHLW, EMA
and
Health
Canada.
2)
Stability
data.
Now following
reference
in
terms of evidence
of international
availability has
been submitted:
GAVISCON
Liquid Sachet
MHRA
Deferred for
evaluation of
stability data
&
expert
opinion by the
following:
1.Brig.Amjad
Salamat
2.Dr.Najam,
Shifa
3.Prof.Umer,
RMC
Registration
Board referred
Panadol sinus
Caplets
to
Pharmaceutica
l Evaluation
Cell
for
scrutinization
in light of
check
list
approved by
BENYLIN
COLD & SINUS
500/5mg
Health Canada
Deferred for
evaluation of
stability data
which should
be performed
at
the
applicant’s
site & expert
opinion by the
following:
1.Brig.Aslam
Deferred for
evaluation of
stability data
&
expert
opinion by the
following:
1.
Dr.Abid
Farooki, PIMS
2.Brig.Mushta
q, MH
3.Dr.fareedull
ah
Zimri,
NIRM
BREXIN
20mg granules
for oral solution
(Sachet)
Promedica, Italy
(Manufacturer’s
Specs)
NSAIDs
451. M/s
Hiranis
Pharmaceuticals
(Pvt) Ltd., Plot No.
E-145 – E-149,
North
Western
Industrial
Zone,
Port
Qasim,
Karachi.
Gastocon Liquid
Sachet
Each 10ml sachet
contains:
Sodium alginate
(BP) 500 mg
Sodium bicarbonate
(BP) 267mg
Form-5D
New License
28-05-2014
809 R&I
Rs. 100 / per
10’s
Rs. 50,000/-
Calcium carbonate
(BP)…. 160 mg
(BP Specifications)
Reflux suppressant
/ Antacid
Panadol Sinus
452. M/s
Caplets
GlaxoSmithKline
Pakistan limted, F268
S.I.T.E., Caplets
Karachi
Each Caplet
Contains:
Paracetamol…500
mg
Phenylephrine
Hcl. 5.00mg
Form 5-D (Fast
Track)
Rs.8,000/09-12-2010
Dy. No. not
mentioned
Rs.60,000/20-03-2013
Dy. No. not
Minutes246thMeetingRegistrationBoard
Inspection dated
07-01-2014, 2101-2014 & 1902-2014.
Well
maintained
/
retained
unit
Page257
mentioned
Rs.82,000/19-11-2013
Dy. No. not
mentioned
Rs.300/-100’s
Minutes246thMeetingRegistrationBoard
Registration
Board.
reported. Tablet 2.Dr.Shazli
Manzor
section
mentioned
in 3.Dr.Rehana
Kauser, PIMS
report.
1. In terms of
Prescribing
information (PI),
Patient
Information
Leaflet (PIL) and
Summary
of
product
characteristics
(SmPC)
as
approved
by
Drug regulatory
agencies
or
authorities
of
country of origin
or FDA, EMA,
TGA, etc., firm
has
submitted
international data
sheet for the
product.
2.
Data
of
stability studies
conducted
on
three
pilot
batches
at
25C/60%RH,
30C/60%RH,
30C/75%RH and
40C/75%RH.
However, it is
pertinent
to
mention that the
batches
were
manufactured in
Sydney, Australia
as
the
raw
material
and
pharmaceutical
development was
carried out in
firms
R&D
center
in
Australia.
Page258
Evaluator – II
S/
N
Name and address Brand Name
of manufacturer /
(Proprietary
Applicant
name + Dosage
Form
+
Strength)
Composition
Pharmacologic
al Group
Type of Form
Initial
diary
Decision
Previous
date, Meeting
Fee including
differential fee
Demanded
Price / Pack
size
of Remarks on the Decision
formulation (if
any) including
International
status
in
stringent drug
regulatory
agencies
/
authorities
Me-too status
Finished
product
Specification
453. M/s Herbion Pakistan
(Pvt) Ltd., Kahuta
Road,
industrial
Triangle,
Humak,
RawalpindiIslamabad.
LacNovex /
LaxNovex /
ConstiNovex
3.35g Syrup
Each 5ml
contains:Lactulose
(BP)………3.35
g
(Laxative)
(B.P Spec.s)
{Source
of
Lactulose: M/s
Fresenius Kabi
Austria GmbH
EstermannstraB
e 17 4020 Linz}
GMP status as
depicted
in
latest
inspection
report
(with
date) by the
Evaluator
Form 5
26-02-2014
Dy.No.208
Rs.20,000+
Rs.80,000/-(0509-2014)
Minutes246thMeetingRegistrationBoard
Rs.170.00/
120ml
Deferred for
confirmation of
1. Source &
Fee.
2. Testing
facility by DDG
DRAP and FID
(M-243)
BNF
(Lactulose
(Nonproprietary)
61 Approved.
Firm
will
provide
legalized
GMP
of
DUPHALAC(H source
of
IGHNOON
lactulose and
LABORATORI Chairman,
ES LTD.)
RB
will
permit
Grant of DML issuance of
recommended
registration
th
(23-24 January letter.
2014)
Page259
1. The firm has
deposited fee
of
Rs.
80,000/- and
requested for
fixation
of
source
i.e.
M/s Fresenius
Kabi Austria
GmbH
Estermannstr
aBe 17 4020
Linz.
2. Valid
and
legalized
GMP
Certificate of
Source, COA
and stability
studies
according to
zone IV-a of
lactulose are
required.
(The firm has
submitted
COA
&
Stability
studies)
3. Confirmation
of
testing
facility
by
DDG DRAP
and FID.
(The
inspection
report
by
area FID &
DDG dated
02.12.2014
confirms the
testing
facility).
Minutes246thMeetingRegistrationBoard
Page260
454.
-do-
455.
-do-
MonteNovex /
AzmaNovex /
LeukoNovex
5mg Chewable
Tablets
Each chewable
tablet contains:Montelukast
Sodium BP eq.
to
Montelukast…5
mg
(Antiasthmatic
Agent
(Leukotriene
Receptor
antagonist)
(Manufacturer’s
Spec.s)
MonteNovex /
AzmaNovex /
LeukoNovex
10mg Chewable
Tablets
Each chewable
tablet contains:Montelukast
Sodium BP eq.
to
Montelukast…
…….10mg
(Antiasthmatic
Agent
(Leukotriene
Receptor
antagonist)
(Manufacturer’s
Spec.s)
Form 5
24-02-2014
Dy.No.201
BNF
(Singulair
(MSD)
61: Approved.
Aerokast
(Barrett
Hodgson)
Rs.20,000
Rs.400.00/
14’s
Grant of DML
recommended
(23-24th January
2014)
1. The firm has
corrected
master
formulation.
Form 5
24-02-2014
Dy.No.197
Rs.20,000
Minutes246thMeetingRegistrationBoard
Deferred for
correction in
master
formulation.
Rs.460.00/
14’s
Deferred for
correction in
master
formulation and
confirmation of
international
availability
Not confirmed
Rejected on
the grounds
Aerokast
that
the
(Barrett
efficacy
&
hodgson) not in safety of the
chewable
said
dosage form
formulation
Grant of DML has not been
established in
recommended
(23-24th January chewable
dosage form.
2014)
1. The firm has
corrected
master
formulation.
2. Reference of
International
availability
has
been
given from
India
and
Bangladesh.
3. Reference of
Page261
456.
-do-
Neemplast
Plaster
Contains:Acrinol………
…10.4%
(Disinfectant
and Antiseptic)
(Manufacturer’s
)
Form 5
17-03-2014
Dy.No.251
Rs.20,000
Rs. 25/
19×72mm (10
strips)
Rs.
35/19×72mm
(20 strips)
Rs.
160/19×72mm
(100 strips)
Rs.
720/19×72mm
(500 strips)
Minutes246thMeetingRegistrationBoard
Deferred for
confirmation of
me too status
and international
availability.
5mg
chewable
tablets has
been given
from Health
Canada.
Formulation
is in film
coated
dosage form
in
Health
Canada.
Not confirmed
Deferred for
verification
Saniplast
that the said
(Uniferoz
formulation
Karachi)
is registered
in
which
Grant of DML category in
recommended
the reference
th
(23-24 January Stringent
2014)
Regulatory
Agencies
1. The firm has whether as an
provided
OTC
or
reference of Pharmaceutic
Saniplast of al.
Uniferoz for
both
international
availability
and me-too
status.
2. International
availability
not
confirmed in
stringent
DRS’s.
3. Discussion
is requested
from
honorable
Page262
Drug
Registration
Board about
the status of
formulation
that whether
it is a drug
or
HOTC
product.
S/
N
Name and address Brand Name
of manufacturer /
(Proprietary
Applicant
name + Dosage
Form
+
Strength)
Composition
Pharmacologic
al Group
Type of Form
Initial
diary
Decision
Previous
date, Meeting
Fee including
differential fee
Demanded
Price / Pack
size
of Remarks on the Decision
formulation (if
any) including
International
status
in
stringent drug
regulatory
agencies
/
authorities
Me-too status
Finished
product
Specification
457. M/s. Simz
Pharmaceuticals (Pvt)
Ltd, 574-575 Sundar
Industrial Estate,
Raiwind Road
Lahore.
Ibusim DS
200mg
Liquid
Suspension
Each 5ml
contains:Ibuprofen
(B.P)…..200mg
(Antirheumatic,
antiinflammatory)
(B.P Spec.s)
GMP status as
depicted
in
latest inspection
report
(with
date) by the
Evaluator
Form-5
Rs.20,000/-102-2014
Rs.60.00/90ml
Minutes246thMeetingRegistrationBoard
Deferred for
confirmation
of
international
availability.
(M-244)
Health Canada:
Advil Pediatric
Drops
Approved.
Brufen DS
(Abbot)
GMP compliant
(22-11-2013)
1. The product
was deferred
because the Firm
had not provided
Page263
458. M/s. Cibex (Private)
Ltd. F-405, SITE,
Karachi
Batema-F Syrup
Each 15ml
contains:
Iron Protein
Succinylate
800mg
equivalent to
elemental
iron…40mg
Folic
Acid…5mg
(Anti-Anaemic)
(Manufacturer’s
Spec.s)
Form-5
30-04-2014
(611)
Rs.20,000/As per
SRO/60ml,
120ml
Minutes246thMeetingRegistrationBoard
the International
availability
especially in
FDA, EMA,
Health Canada,
TGA & MHLW
for same generic,
dosage form &
strength with
reference is
required. Firm
had provided
Dolan Fp Forte
from Phillipine.
Later on same
formulation was
approved in M245 for M/s
Titles Pharma
Karachi because
international
availability was
confirmed. The
Firm has
requested to
consider their
application for
registration.
Deferred for Not confirmed
confirmation
of Me-Too & Sucrofer-F
International
Syrup
(especially in
(Nexpharm)
Stringent
Regulatory
Agencies)
registration
Status.
(M-245)
Approved
Grant of DML
recommended
(22-10-2013)
1. The Firm has
submitted
that
the
product
is
already
available
locally
manufactured
Page264
459.
-do-
Cimora 20mg
Capsule
Each Capsule
contains:
Esomeprazole
Magnesium
Trihydrate
enteric coated
pellets equivalent
to
Esomeprazole…
20mg
(Anti-Ulcerant)
(Manufacturer’s
Spec.s)
Form-5
30-04-2014
(625)
Rs.20,000/As per
SRO/14
Capsules
Minutes246thMeetingRegistrationBoard
Deferred for
rectification
of following
observation:
by
CCL
under
the
license
of
Nexpharm
and
the
product
is
although not
available in
SRA,s
but
DRAP
has
granted
registration
to
several
companies.
The Firm has
requested for
product
registration.
BNF: Nexium
(AstraZeneca)
C-ESO (Crown
Pharmaceuticals
)
Approved
1. Fee for
import.
Grant of DML
2. Legalized recommended
and
Valid (22-10-2013)
GMP
1. The Firm has
3. Certificate
submitted
of Analysis
documents
4.
Stability
for source of
Studies
pellets, M/s
according to
Surge
Lab
zone assigned
(Pvt. ) Ltd.
to Pakistan.
K.M
10th
Faisalabad
(M-245)
Road
,
Sheikhupura.
2. cGMP
certificate
has
been
issued to M/s
Surge
for
Page265
Enteric
coated
Pellets/Granu
les and Taste
Masked
Granules/
Pellets.
3. Approval by
CLB
for
manufacturin
g
of
Esomeprazol
e
enteric
coated pellets
by M/s Surge
submitted.
Evaluator – III
Cases deferred in M-245 meeting
S/N
Name
and
address
of
manufacturer
/
Applicant
Type of Form
Brand Name
(Proprietary name
+ Dosage Form + Initial date, diary
Strength)
Fee
including
differential fee
Composition
Pharmacological
Group
Demanded Price
/ Pack size
Finished
product
Specification
Decision
in
245th
of
Registration
Board.
Remarks on Decision
the
formulation (if
any) including
International
status
in
stringent drug
regulatory
agencies
/
authorities
Me-too status
GMP status as
depicted
in
latest
inspection
report (with
date) by the
Evaluator
Minutes246thMeetingRegistrationBoard
Page266
Deferred for
submission of
Dated
30/04/14 finished
product
Each gram contains:- Dy No: 602
specifications
Diclofenac
diethylamine….10mg 20,000/-
460. M/s Cibex (Pvt) KATAFEN
Limited Karachi.
Gel 1%
Rapid Form-5
Pack of 1’s, 20gm
& 50gm/ As per
PRC
Anti-Rheumatic
Manufacturer
461. -do-
462. M/s.Shawan
Pharmaceuticals,
Plot #37, Road:
NS-1,
National
Industrial
Zone,
Rawat Islamabad.
The firm has Approved.
submitted the
finished
product
specifications
of
applied
product.
The firm has Approved.
submitted the
assay method
under finished
Each gram contains:product
Polymyxin
B
Under finished specifications
20,000/sulphate….5000IU
of
applied
product
Bacitracin…500IU
Pack of 1’s, 20gm specifications product.
Neomycin…3.5mg
tube/ As per PRC assay method
Lidocaine….40mg
is
not
submitted.
Antibacterial
MYBINA
Ointment
Deferred for
rectification of
Dated
30/04/14 following
observations:
Dy No: 605
Plus Form-5
Manufacturer
DEXPRO Tablet
300mg
Each film coated
Tablet contains:
Dexibuprofen …..
300mg
Deferred for
review
committee for
Fast Track
review
of
Dy.
No.5246 formulation
dated 16-08-2013
Form 5
Rs.60,000/NSAID
Manufacturer
As per SRO
Pack of 10’s
Seractil
of Approved.
Genus (BNF-61)
Dexib of Tabros
Pharma Karachi
Inspection of the
firm
was
conducted on 23
July 2013 and
GMP
compliance is
found GOOD
Cases deferred in M-242 meeting
Minutes246thMeetingRegistrationBoard
Page267
S/N
Name
and
address
of
manufacturer /
Applicant
Decision in 242nd
Type of Form
Brand Name
(Proprietary name
of
Registration
+ Dosage Form + Initial date, diary Board.
Strength)
Fee
including
differential fee
Composition
Pharmacological
Group
Demanded Price
/ Pack size
Finished product
Specification
Remarks on the Decision
formulation (if
any) including
International
status
in
stringent drug
regulatory
agencies
/
authorities
Me-too status
GMP status as
depicted
in
latest inspection
report
(with
date) by the
Evaluator
463.
M/s
Medwell BETADINE Scrub
Pharmaceuticals,
Lawrencepur
Each 5ml contains:
PovidoneIodine…….7.5%
Deferred as
firm
has
Dy.No:
6382 completed
dated: 07-10-2013 requisite
documentation
Form-5
60,000/Form-5
Disinfectant
BP
As
per
SRO/
50ml, 60ml and
450ml bottle
Minutes246thMeetingRegistrationBoard
of Approved.
the Pyodine
not Brookes Pharma
the Karachi
per The inspection of
firm was carried
out on 01-042014 by the area
FID and GMP
compliance was
found good.
Page268
Veterinary cases
S/N
Name
and
address
of
manufacturer /
Applicant
Type of Form Decision in 242nd
Brand Name
of Registration
(Proprietary name
+ Dosage Form + Initial date, Board.
diary
Strength)
Composition
Pharmacological
Group
Fee including
differential
fee
Demanded
Finished product Price / Pack
size
Specification
Remarks
on Decision
the
formulation (if
any) including
International
status
in
stringent drug
regulatory
agencies
/
authorities
Me-too status
GMP status as
depicted
in
latest
inspection
report
(with
date) by the
Evaluator
464.
M/s
Jfrin JF
COLAMINE
Pharmaceuticals,
Oral Powder
Lasbella
Balochistan
Each
100gm
contains:
of
Deferred as the Broncofas
firm has not Zakfas
the Pharmaceuticals
Dy.No:
866 completed
dated: 24-07- requisite
documentation
2013
per Form-5
60,000/Form-5
Tylosin
Tartrate…..100mg
Decontrolled/
Doxycycline
Jar of 100,
HCL…..200mg
500, 1000gm
Phenyl
Butazone….12gm
Bromohexine
HCL….05gm
Colistin
Sulphate…..500MIU
Rejected
as
the
formulation
contains
banned drug
that is Phenyl
Butazone.
Antibiotic
Manufacturer
Minutes246thMeetingRegistrationBoard
Page269
Case No. 11.
NEW APPLICATIONS IN LEIU OF REJECTED ONES
Evaluator - III
Two products of M/s Hiranis Pharmaceuticals are rejected in the 243rd meeting of Registration Board as
the safety and efficacy has not been established in the stringent SRA’s. The firm has submitted new
applications in lieu of the rejected products. The detail is tabulated below:
Sr.
No.
1.
2.
Products Discussed in M- Decision in M-243
243
Acebro
Capsule Rejected as safety and
(Acebrophylline 100mg)
efficacy of formulation has
not been established in
stringent
regulatory
authorities.
Acebro syrup
Rejected as safety and
(Acebrophylline
50mg/ efficacy of formulation has
5ml)
not been established in
stringent
regulatory
authorities.
Minutes246thMeetingRegistrationBoard
New Products applied
Fungisaf Capsule
(Fluconazole 150mg)
Levopearl oral suspension
125mg/5ml (Levofloxacin)
Page270
The detail of new products is follows:
Remarks on the Recommendations Decision
formulation (if by the Evaluator
any) including
International
status
in
Fee
including stringent drug
Composition
regulatory
differential fee
agencies
/
Pharmacological
Demanded Price authorities
Group
/ Pack size
Me-too status
Finished
product
Specification
GMP status as
depicted
in
latest inspection
report
(with
date) by the
Evaluator
Type of Form
Brand Name
(Proprietary name +
date,
Dosage
Form
+ Initial
diary
Strength)
S/N
Name
and
address
of
manufacturer /
Applicant
465.
M/s
Hiranis FUNGISAF Capsule Form-5
Pharmaceuticals 150mg
Dy No: 807 dated
Karachi
Each capsule contains 28-07-14
Fluconazole…..150mg
20,000/Triazole Antifungal
As per PRC
Manufacturer
466.
-do-
LEVOPEARL
Solution
Quinolone
20,000/As per PRC
Manufacturer
Minutes246thMeetingRegistrationBoard
Pfizer
Approved.
Diflucan
of
Pfizer Karachi
Levaquin
Solution
Dy. No: 2067 Janssen
dated:16-12-2013 (USFDA)
Oral Form-5
Each 5ml contains:
Levofloxacin
(USP)….125mg/ 5ml
Diflucan
Inc
Oral The product was
of initially considered
as
dry
oral
suspension in 243rd
meeting
of
Registration Board
and deferred with
following decision:
“Deferred
for
confirmation
of
formulation”
The firm then
revised
the
formulation as Oral
Solution which was
product
again
The Board
did
not
accede to
the request
of firm for
change in
dosage
form
&
deferred
the instant
application
for review
of
formulation
by
Incharge,
Page271
considered in 244th PEC.
meeting
of
Registration Board
and deferred with
decision:
“Deferred as the
Registration Board
has already granted
ten products in
liquid syrup section
(general)”
The firm has now
requested
to
consider
applied
formulation in lieu
of the rejected
product
(Acebro
syrup
(Acebrophylline
50mg/ 5ml) in
243rd meeting of
RB
Minutes246thMeetingRegistrationBoard
Page272
Item No. VI Miscellaneous Cases - Pharmaceutical Evaluation & Registration Division.
Registration-I
Case No.01.
Drugs deferred by Registration Board for expert opinion.
a. Strefen Lozenges - M/s. Reckitt Benckiser Healthcare International, Karachi.
Following drugs deferred for expert opinion. Accordingly product was referred to expert
for views. Comments are as under:S. No.
Name of Indenter/
Manufacturer
Name of drug (s)/
Composition
& Therapeutic Group
1.
M/s. Reckitt Benckiser
Healthcare
International,
Karachi. /
M/s. Notting Site,
Nottingham,
Nottinghamshire,
United Kingdom.
Strefen Lozenge
Each one lozenge
contains:Flurbiprofen
BP……………..8.75mg
Demanded
Price/Pack
Shelf Life
Price not
mentioned.
Dr. M.Ehsan-ul-Haq,
MBBS, DTCD, FCPS,
(Physician (Medicine),
Federal
Govt.
Services
Hospital, Islamabad.
Prof. Dr. Ejaz Hussain
Malik,
Nishtar Medical Institution,
Multan.
The drug Strefen Lozenge
containing flurbiprofen BP 8.75
can be useful addition to the list
of pharmaceutical available in
the country. Since the amount of
the active principle is quite small.
It is les likely to cause untoward
dose-related side effects. The
lozenge formulation of this
compound is already in use in the
world market. However the
therapeutic efficacy and the
I have gone through the literature Awaited.
of Flurbiprofen. The only is good
and sample and recommended
for registration.
Minutes246thMeetingRegistrationBoard
03 years
Date of
application
receiving
& fee.
04-06-2012
Rs.15000 +
Rs.35000 =
Rs.50,000/-
Brig.
(R)
Prof.
Dr.
Muzammil Hasan Najmi,
Chairman, Department of
Pharmacology/Associate
Dean,
Basic
Sciences
Division,
Foundation
University, Medical College,
Rawalpindi.
Page273
social
acceptance
in
our
population can only be accessed
when it is used in our country.
The drug is intended for local use
and has small amount of the
active principle and thus is
expected to be cost effective.
Decision:
Registration Board approved registration of Strefen Lozenge as per detail
mentioned in the case. The approval is subject to inspection of manufacturer abroad as per
import policy, verification of storage facilities and price fixation / calculation by the pricing
Division etc.
b.
AminoFluid ® Infusion Solution 1000ml - M/s Otsuka Pakistan Ltd., Distt. Lasbella
Registration Board in its 238th meeting deferred following products for expert opinion.
Accordingly products were referred for views. Comments are as under:S.
No.
Name of
Indenter/
Manufacturer
Name of drug (s)/
Composition
& Therapeutic Group
Demanded
Price/Pack
Shelf
Life
1.
M/s Otsuka
Pakistan Ltd.,
Distt. Lasbella. /
M/s. PT. Otsuka
Indonesia,
Lawang, Malang.
Indonesia.
AminoFluid ® Infusion Solution
1000ml
Each 150ml contains:L-Leucine…...………………2.100g
L-Isoleucine……………...…1.200g
L-Valine..………………...…1.200g
L-Lysine hydrochloride…….1.965g
(L-Lysine Equivalent)….....(1.573g)
L-Threonine...........................0.855g
L-Tryptophen……………….0.300g
L-Methionine.………………0.585g
L-Cystoine………………….0.150g
L-Phenylalanine…………….1.050g
L-Tyrosine..………………...0.075g
L-Arginine………………….1.575g
L-Histidine………………….0.750g
L-Alanine…………………...1.200g
L-Proline….………………...0.750g
LSerine ……………………..0.450g
Gylcine……...........................0.885g
Rs.4201/Per
1000ml Soft
bags.
02
years
Minutes246thMeetingRegistrationBoard
Date of
application
receiving
& fee.
27-09-2012
Rs.50,000/-
Page274
L-Aspartic acid……………..0.150g
L-Glutamic acid….................0.150g
Dipostassium phosphate…....0.458g
Water for injection ad….........150ml
(Clinical Parrenteral Nutrition).
2.
M/s Otsuka
Pakistan Ltd.,
Distt. Lasbella. /
M/s. PT. Otsuka
Indonesia,
Lawang, Malang.
Indonesia.
3.
M/s Otsuka
Pakistan Ltd.,
Distt. Lasbella. /
M/s. PT. Otsuka
Indonesia,
Lawang, Malang.
Indonesia.
Kidmin ® Injection
Each 1000ml contains:L-Leucine………………….…14.0g
L-Isoleucine………………...…9.0g
L-Valine……………………...10.0g
L-Lysine acetate………………7.1g
(free base)…………………..(5.05g)
L-Threonine…...........................3.5g
L-Tryptophan……………….....2.5g
L-MEthionine…………………3.0g
L-Phenylalanine…………….....5.0g
L-Cysteine….…………………1.0g
L-Tyrosin……………………...0.5g
L-Arginine…..………………...4.5g
L-Histidine………………...…..3.5g
L-Alanine………………...……2.5g
L-Proline…………………...….3.0g
L-Serine……………………….3.0g
L-Aspartic acid..........................1.0g
L-Glutamic acid……………….1.0g
(Clinical Parentertal Nutrition).
Amiparen ® Injection
Each 500ml contains:L-Leucine…...………………..7.00g
L-Isoleucine……………….....4.00g
L-Valine……………………...4.00g
Lysine Acetate……………….7.40g
(L-Lysine equivalent)…....…(5.25g)
L-Threonine………………….2.85g
L-Tryptophan...........................1.00g
L-Methionine...........................1.95g
L-Phenylalanine……………...3.50g
L-Cysteine…………………...0.50g
Total free amino acids……50.00g
Essential amino acids (E)…..29.55g
Nonessential amino acids (N)20.45g
Total nitrogen………………..7.84g
L-Tyrosine…...........................0.25g
L-Arginine...…………………5.25g
L-Histidine…………………...2.50g
L-Alanine…………………….4.00g
L-Proline…..…………………2.50g
Minutes246thMeetingRegistrationBoard
Rs.1708/
Per 200ml
bag
02
years
18-10-2012
Rs.15000 +
Rs.35000 =
Rs.50,000/-
Rs.2512/
Per 500ml
Bag
02
years
24-09-2012
Rs.15000 +
Rs.35000 =
Rs.50,000/-
Page275
L-Serine…...…………………1.50g
Aminoacetic acid………….…2.95g
L-Aspartic Acid.......................0.50g
L-Glutamic acid.......................0.50g
Water for injection……ad 500mL
(Clinical Parenteral Nutrition).
In charge Intensive Care Unit
(ICU),
Pakistan Institute of Medical Sciences,
Islamabad.
In charge Intensive Care Unit
(ICU),
Military Hospital,
Rawalpindi.
I have evaluated the data provided by Otsuka Pakistan
Limited concerning AminoFluid ® 1000ml dual
chamber soft bags, Kidmin ® Injection 200ml soft bag
and Amiparen ® Injection 500ml soft bag. I have
found that the scientific data supports the therapeutic
efficacy and favorable safety profile. I recommended
that this drug be registered according to the drug
authority regulations.
Awaited
Decision:
Brig. Aslam Khan, Member Registration Board / Incharge Intensive Care
Unit (ICU), Military Hospital, Rawalpindi also recommended the appled formulations.
Thus Registration Board approved registration of AminoFluid ® Infusion Solution 1000ml,
Kidmin ® Injection and Amiparen ® Injection as per detail mentioned in the case. The
approval is subject to inspection of manufacturer abroad as per import policy, verification
of storage facilities and price fixation / calculation by the pricing Division etc.
c.
Propilen Surgical Suture with Needle - M/s. Nishat Surgical Hyderabad
Registration Board in its 243rd meeting deferred following products for expert opinion.
Accordingly products were referred for views. Comments are as under:S.
No.
Name of
Indenter/
Manufacturer
Name of drug (s)/
Composition
& Therapeutic Group
Demanded
Price/Pack
Shelf
Life
1.
M/s. Nishat
Surgical
Hyderabad Sindh
Pakistan
manufactured by
M/s. Dogsan
Propilen Surgical Suture with
Needle
As per PRC
05
years
Minutes246thMeetingRegistrationBoard
Date of
application
receiving &
fee.
26-03-2012
Rs.100,000/-
Page276
2.
Tibbi Malzeme
Sanayi A.S.
Trabzon Turkey.
-do-
3.
-do-
4.
-do-
5.
-do-
6.
-do-
Silk Non Absorbable Surgical
Sutures
As per PRC
05
years
26-03-2012
Rs.100,000/-
Pegelak and Pegelak Rapid
Synthetic Absorbable
Surgical Sutures with Needle
Tektel Non Absorbable
Surgical Sutures with Needle
As per PRC
05
years
26-03-2012
Rs.100,000/-
As per PRC
05
years
26-03-2012
Rs.100,000/-
Pedesente Synthetic
Absorbable Surgical Sutures
with Needle
Pegesorb and Pegesorb Rapid
Synthetic Absorbable
Surgical Sutures with Needle
As per PRC
05
years
26-03-2012
Rs.100,000/-
As per PRC
05
years
26-03-2012
Rs.100,000/-
Professor Tanwir Khaliq,
Professor
of
Surgery,
Department of General
Surgery, Pakistan Institute
of
Medical
Sciences,
Islamabad.
We have used the surgical
sutures in our procedures. The
tissue penetration, needle,
suture strength, pliability and
knotting quality have been
found satisfactory.
Dr. I.U Baig, FCPS FRCS,
Consultant Surgeon & HOD,
Federal Government
Polyclinic, Islamabad.
Lt. Col. Dr. Farhan Ahmad
Majeed, Surgeon, Combined
Military Hospital,
Rawalpindi
Samples of sutures supplied
by M/s. Nishat Surgical
Hyderabad Sindh Pakistan
manufactured by M/s. Dogsan
Tibbi Malzeme Sanayi A.S.
Trabzon
Turkey
were
used/tested by me and by my
surgeons at FGPC and our
observations regarding the
surgical sutures are :
1.Sterile packing is good.
2.Tensile strength of sutures
of their appropriate types and
sizes is good.
3.Needle anchorage is fine.
4.Needle quality is good.
5.Tissue reaction to sutures is
according to standard.
Surgical sutures
Nishat Surgical
Sindh
Pakistan
unsatisfactory
specially size of
dispropertmat with
(dia).
Minutes246thMeetingRegistrationBoard
of M/s.
Hyderabad
are
of
quality,
needle is
thread size
Page277
6.No allergic reaction to
suture material.
7.No postoperative infections
nooted.
In light of above observations
I recommend sutures namely;
Propilen, Silk, Pegalak and
Pegalak
Rapi,
Tektel,
Pedesente and Pegesorb and
Pegesorb Rapid.
Decision:
Registration Board deferred the case due to the comments of Lt. Col. Dr.
Farhan Ahmad Majeed, Surgeon, Combined Military Hospital, Rawalpindi as he
mentioned “unsatisfactory quality, specially size of needle is dispropertmat with thread size
(dia)”. The Board decided to send these observations of Lt. Col. Dr. Farhan Ahmad Majeed
to the following experts for further pratical evaluation:


d.
Col. Dr.Bilal Umair, Surgeon, CMH.
Dr.Mamoon Rasheed, Surgeon, Shifa Int Hospital, Islamabad.
Azarga Eye Drop Suspension 5ml - M/s. Ali Gohar & Co. (Pvt) Ltd., Karachi
Registration Board in its 244th meeting deferred following products for expert opinion.
Accordingly products were referred for views. Comments are as under:S.
No.
Name of
Indenter/
Manufacturer
Name of drug (s)/
Composition
& Therapeutic Group
Demanded
Price/Pack
1.
Applicant:
M/s. Ali Gohar &
Co. (Pvt) Ltd.,
Karachi. /
Manufacturer:
M/s. S.A. AlconCouvreur N.V.
Rijksweg 14,
2870 Puurs,
Belgium.
Azarga Eye Drop Suspension
5ml
Each ml contains:Brinzolamide......10mg
Timolol...............4mg
(Beta Blocking agents).
Finished product
specifications are
Manufacturer.
Rs.1400/
5ml Eye
Drops packs
Minutes246thMeetingRegistrationBoard
Shelf
Life
Date of
application
receiving &
fee.
24
02-03-2010
months Rs.50, 000/-
Page278
Prof. Dr. M. Daud Khan,
Principal & Dean,
Pak International Medical
College, Hayatabad,
Peshawar.
Prof.Dr. Ali Raza,
Head of Eye Department,
RMC and Allied Hospitals,
Rawalpindi.
Maj. Gen. Mazhar Ishaq,
Commandant,
Armed Forces Institute of
Opthalmology,
The Mall, Rawalpindi.
(Brinzolamide,
I have reviewed the literature Azarga
& references relating to the Timolol) is already being used
for
the
above mentioned product with internationally
regard to its safety, efficacy & management of Glaucoma &
cost effectiveness. Azarga all references given by them
(Brinzolamide, Timolol) is have been published in peer
international
most comfortable Eye Drops reviewed
preferred by patient then Medical Journals on regular
basis. It has a very good
Dorzolomide/Timolol
combination. I have gone efficacy and is well tolerated
through all references which by the patients.
have been published in
renowned
International Therefore in the light of data
Medical Journals on regular provided I recommend this
intervals. As you all know that drug for registration in
Glaucoma is a second leading Pakistan.
cause of irreversible blindness
worldwide & as well as in
Pakistan & patient has to use
lifelong. So it needs excellent
tolerability & efficacy both.
We need this product in
Pakistan for the preservation
of sight and prevention of
blindness with Glaucoma. I
always trust the quality of
innovative products & Brands.
I highly recommend this drug
for registration & made
available in Pakistan.
Registration Board approved registration of Azarga Eye Drop Suspension
Alcon International is the
leading
international
pharmaceutical
company
dealing with Ophthalmic
drugs and devices. Alcon
drugs are known for quality,
safety and efficacy. Azarga
Eye Drops, which is a
combination of a beta blocker
and
carbonic
anhydrase
inhibitor. It is registered by
FDA and has many studies in
support of its safety, efficacy
and effectiveness. The price
seems to be reasonably
comparable to other antiglaucoma drugs. I therefore
recommend that the drug may
kindly be registered in
Pakistan.
Decision:
5ml as per detail mentioned in the case. The approval is subject to inspection of
manufacturer abroad as per import policy, verification of storage facilities and price
fixation / calculation by the pricing Division etc.
Minutes246thMeetingRegistrationBoard
Page279
e. Hidrasec 10mg, 30mg Sachet and and Hidrasec Capsule 100mg
Registration Board in its 245th meeting deferred following products for expert opinion.
Accordingly products were referred for views. Comments are as under:S.
No.
Name of Indenter/
Manufacturer
Name of drug (s)/
Composition
& Therapeutic Group
1.
M/s. Abbott
Laboratories
(Pakistan) Limited,
Karachi. /
M/s. Laboratoires
SOPHARTEX 21
Rue du Pressoir
Vernouillet,
France.
Hidrasec 10mg Sachet
Each sachet contains:Racecadotril……10mg
(Anti-Diarrheal).
2.
M/s. Abbott
Laboratories (Pakistan)
Limited,
Karachi. /
M/s. Laboratoires
SOPHARTEX 21 Rue
du Pressoir
Vernouillet, France.
Hidrasec 30mg Sachet
Each sachet contains:Racecadotril….30mg
(Anti-Diarrheal).
3.
M/s. Abbott
Laboratories
(Pakistan) Limited,
Karachi. /
M/s. Laboratoires
SOPHARTEX 21
Rue du Pressoir
Vernouillet,
France.
Hidrasec 100mg
Capsules
Each capsule contains:Racecadotril….100mg
(Anti-Diarrheal).
Prof.Dr. Rauf Niazi,
Head of Unit-2
Pakistan Institute of Medical
Sciences,
Islamabad.
I
strongly
recommend
registration of that Raceadotril
(acetorphan), Capsules and
Date of
application
receiving &
fee.
Rs.1046.30/Per
29-04-2013
24
16 Sachets
months Rs.100,000/-
Shelf
Life
Rs.1046.30/Per
29-04-2013
24
16 Sachets
months Rs.100,000/-
Rs.654/
Per 10
Capsules
Prof.Dr. Syed Irfan Ahmed,
Professor of Medicine,
RMC & Allied Hospitals,
Benazir Bhutto Hospital,
Murree Road, Rawalpindi.
Hidrasec is recommended for
registration for the treatment
Minutes246thMeetingRegistrationBoard
Demanded
Price/Pack
29-04-2013
24
months Rs.100,000/-
Brig.Amjad Salamat,
Military Hospital,
Rawalpindi.
Awaited.
Page280
Sachets, however if the price
of the drug can be brought
down, keeping in mind the
economic status of our
population these drugs would
be very useful addition, to
present drugs, available to
treat acute secretory diarrhea
and reduce morbidity of this
common condition. I highly
recommend registration of the
drug, on fast track basis.
Decision:
of diarrhea in conjunction with
ORS. However it should not
be used to treat infections.
Even in Cholera, which
requires
antibiotics
and
intravenous saline, it should
be used with caution as severe
fluid depletion can be a “Prerenal” cause of renal failure.
Hidrasec has a renal mode
excretion. Also no studies
have
been
conducted
comparing its safety profile
with Zinc or probiotics. Hence
it can not be claimed superior
to these modes of treatment.
Registration Board deferred the case for evaluation of clinical data by the
following experts:



Brig.Amjad Salamat MH, Rawalpindi.
Prof.Syed Irfan, BBH.
Prof.Rauf Niazi, PIMS.
Case No. 02. Registration of solvents for Oncodex (Docetaxel) Injection - M/s. PharmEvo
(Pvt) Ltd, Karachi.
Drug Registration Board in 236th meeting held on 20th November, 2012 approved the
registration of following drugs in the name of M/s. PharmEvo (Pvt) Ltd, Karachi manufactured
by M/s. Jiangsu Aosaikang Pharmaceutical Co., Ltd., 699-Kejian Road, Jiangning Science Park,
Nanjing, China subject to inspection of manufacturer abroad:S. No.
1.
2.
Name of drug (s) & composition.
Oncodex 20mg Injection.
Each vial contains:Docetaxel……………20mg.
Oncodex 40mg Injection.
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Page281
3.
4.
Each vial contains:Docetaxel……………40mg.
Oncodex 80mg Injection.
Each vial contains:Docetaxel……………80mg.
Oncotaxel 100mg Injection.
Each vial contains:Paclitaxel……………100mg.
In compliance of Drug Registration Board’s decision, inspection of the manufacturer
M/s. Jiangsu Aosaikang Pharmaceutical Co., Ltd., 699-Kejian Road, Jiangning Science Park,
Nanjing, China has been carried out by the nominated panel comprising Dr. Obaidullah, Deputy
Director General (Registration) and Mr. Abdullah, Deputy Drugs Controller (RRR), Drug
Regulatory Authority of Pakistan. M/s. PharmEvo (Pvt) Ltd, Karachi was advised to submit
separate solvent application for each product. The panel of inspector has recommended the
registration of the above said products. The storage facility of the importer has already been
verified by the area FID.
In response to our latter M/s. PharmEvo (Pvt) Ltd, Karachi have informed that same
solvent with same composition is being used in all three strengths of docetaxel range with final
concentration of the diluted solution equivalent to 10mg/ml. Below is a self-explanatory chart
depicting the fill range, approximate extractable volume and final concentration of the product
i.e. 10mg/ml:CONCENTRATION
OF THE INITIAL
DILUTED
SOLUTION
(MG/ML
DOCETAXEL)
3.88 – 3.08 ml
APPROXIMATE
EXTRACTABLE
VOLUME OF
DILUENT WHEN
ENTIRE
CONTENTS ARE
WITHDRAWN
(ML)
1.8 ml
3.60 – 3.86 ml
3.66 ml
10mg/ml
6.96 – 7.70 ml
7.1 ml
10mg/ml
PRODCUT
NAME
DILUENT 13%
(W/W)
ETHANOL IN
WATER FOR
INJECTION
FILL RANGE
(ML)
DOCETAXEL
20MG INJECTION
DOCETAXEL
40MG INJECTION
DOCETAXEL
80MG INJECTION
Minutes246thMeetingRegistrationBoard
10mg/ml
Page282
M/s. PharmEvo (Pvt) Ltd, Karachi was again advised to submit separate solvent
application for each strength. In response, M/s. PharmEvo (Pvt) Ltd, Karachi has submitted
separate solvent application for each three strengths.
Decision:
Registration Board approved the request of the firm for registration of the
solvents for already registered Docetaxel range of products.
Case No.03. Drugs deferred by Registration Board for submission of documents.
a.
Caflam 50mg Sachets - M/s. Novartis Pharma, Karachi.
Drug Registration Board deferred the following applications for registration of drugs in
its 243rd meeting and decided as mentioned against each. Accordingly, firm was advised to
provide the same information and the firm has submitted the required information as follows:-
S.#
1.
Name of
Manufacturer /
Importer.
Name of Drug (s)
Composition &
Therapeutic
Group.
M/s. Novartis Pharma
(Pakistan) Limited,
Karachi /
M/s. Mipharm S.p.A.,
Milan, Italy.
Caflam 50mg Sachets
Each sachet contains:Diclofenac
potassium……50mg
(Non-steroidal antiinflammatory drug
(NSAID) Analgesic.
Decision:
Demanded
Price &
Pack Size.
Rs.198/
Per packs
of 9’s
Rs.22/Per
Sachet
Shelf
Life
Decision
Reply of
the firm.
02
years
Deferred for
submission
of
COPP
from
regulatory
authority of
Italy
The firm has
provided
COPP
of
Italy attested
by Pakistan
Embassy.
Registration Board approved registration of Caflam 50mg Sachets as per
detail mentioned in the case. The approval is subject to inspection of manufacturer abroad
as per import policy, verification of storage facilities and price fixation / calculation by the
pricing Division etc.
Minutes246thMeetingRegistrationBoard
Page283
b.
Fluimucil A 600mg Effervescent Tablets - M/s. Angelini Pharmaceuticals (Pvt) Ltd.,
Lahore.
Drug Registration Board in its 244th meeting held on 22-23rd July, 2014 considered and
deferred the application of “Fluimucil A 600mg Effervescent Tablets (Acetylcysteine
600mg)” applied by M/s. Angelini Pharmaceuticals (Pvt) Ltd., Lahore imported from M/s.
Zambon Switzerland Ltd., Cadempino, Switzerland for submission of safety and efficacy data of
the drug along with complete clinical trial data of the formulation.
Name of Importer /
Manufacturer.
Demanded
Name
of
Drug
(s)
Composition & Therapeutic
Price & Pack Size.
Group.
Fluimucil
A
600mg
Effervescent Tablets.
Each tablets contains:Acetylcysteine........600mg.
M/s. Zambon Switzerland (Mucolytics).
Ltd., Cadempino,
Switzerland.
M/s. Angelini
Pharmaceuticals (Pvt)
Ltd., Lahore /
Rs.561.41/Per
packs of 10
effervescent
tablets.
Shelf Life
03 years
Rs.56.14/Per
effervescent
tablets.
Accordingly, M/s. Angelini Pharmaceuticals (Pvt) Ltd., Lahore was advised to provide
the same. The firm has submitted the documents safety and efficacy data, which needs
deliberation by the Board.
Decision:
Registration Board deferred the case for evaluation of clinical data by the
following experts:
 Brig. Aslam Khan, Member registration Board
 Abdul Lateef Shaikh, Director Pharmacy, AKUH, Karachi.
 Dr.Shazli Manzoor, Pulmonologist, Quaid-e-Azam Int Hospital, Islamabad.
Minutes246thMeetingRegistrationBoard
Page284
Case No. 04. Registration of imported – Inspections of manufacturing units abroad
thereof.
a.
Withdrawal of registration applications - M/s. Barrett Hodgson Pakistan (Private)
Limited, Karachi.
Drug Registration Board in its 228th meeting held on 12th - 13th October, 2010 approved
the registration of following drugs in the name of M/s. Barrett Hodgson Pakistan (Private)
Limited, Karachi manufactured by M/s. Yangtze River Pharmaceutical (Group) Jiangsu, China,
subject to inspection of manufacturer abroad:S. No.
1.
2.
Name of Drug (s) Composition.
PacliBar Injection 30mg.
Each 5ml vial contains:Paclitaxel………30mg USP Specs.
PacliBar Injection 100mg.
Each 16.7ml vial contains:Paclitaxel………100mg USP Specs.
Dr. Muhammad Khalid Khan, Director, DTL, KPK / Member Drug Registration Board
and Mrs. Rohi Obaid, DDC, DRAP, Karachi was nominated for inspection of M/s. Yangtze
River Pharmaceutical (Group) Jiangsu, China. Accordingly, M/s. Barrett Hodgson Pakistan
(Private) Limited, Karachi was informed for arranging the inspection.
In response, M/s. Barrett Hodgson Pakistan (Private) Limited, Karachi have informed
that their principal M/s. Yangtze River Pharmaceutical (Group) Jiangsu, China is no more
interested in getting these products registered in Pakistan due to much delay in the process.
Therefore, the firm has requested for withdrawing the cases for registration of the above
mentioned products.
Decision:
Registration Board acceded to request of the firm about withdrawl of above
registration applications.
Minutes246thMeetingRegistrationBoard
Page285
b.
Registration of imported drugs – Comments of panel of inspectors.
Drug Registration Board in its 236th meeting held on 20th November, 2012 approved the
registration of following drugs for import in the name of M/s. Sind Medical Stores, Karachi
manufactured by M/s. Boryung Pharmaceutical Co. Ltd., Singil-dong, Wonnam-dong, Chongroku, Seoul, Korea, subject to inspection of manufacturer abroad:S. No.
Name of Drug (s) &
Composition.
Fee
deposited.
Price approved by the Price
Advisory Committee.
1.
A.D. Mycin Injection 10mg.
Each 5ml vial contains:Doxorubicin HCI…….10mg.
Rs.100,000
Rs.430.00/Per vial.
2.
A.D. Mycin Injection 50mg.
Each 25ml vial contains:Doxorubicin HCI…….50mg.
Rs.100,000
Rs.1716.00/Per vial.
3.
E.P. Mycin Injection 10mg.
Each 5ml vial contains:Epirubicin HCI……10mg.
Rs.100,000
Rs.670.00Per vial.
4.
E.P. Mycin Injection 50mg.
Each 25ml vial contains:Epirubicin HCI…....50mg.
Neotabine Injection 1gm.
Each vial contains:Gemcitabine HCI….1.14gm.
Rs.100,000
Rs.2500.00/Per vial.
Rs.100,000
Rs.8330.00/Per vial.
Neotabine Injection 200mg.
Each vial contains:Gemcitabine HCI….228mg.
Rs.100,000
Rs.1675.00/Per vial.
5.
6.
In compliance, inspection of the manufacturer abroad M/s. Boryung Pharmaceutical Co. Ltd.,
Singil-dong, Wonnam-dong, Chongro-ku, Seoul, Korea, has been carried out by the nominated
panel comprising Dr. Saifur-Rehman Khattak, Director, CDL, Karachi and Mr. Salateen Waseem
Philip, ADC (Licensing), Drug Regulatory Authority of Pakistan, Islamabad.
Minutes246thMeetingRegistrationBoard
Page286
The panel of inspectors has recommended the registration of the above said products with the
remarks that registration of the applied products is recommended however import to Pakistan
should be allowed only after confirmation of successful execution of the desired improvement.
The storage facility of the importer has already been verified by the Area FID.
With reference to the inspection report Dr. Saifur-Rehman Khattak, Director, CDL, Karachi
and Mr. Salateen Waseem Philip, ADC (Licensing), Drug Regulatory Authority of Pakistan,
Islamabad were requested to inform about type of short coming pointed out whether these are
critical in nature affecting the quality of the product or suggestive / advisory nature for further
processing the case.
In response, Dr. Saifur-Rehman Khattak, Director, CDL, Karachi have informed that the firm
was thoroughly inspected for facilities regarding the production, quality control and storage of
their products (Anti-Cancer Injections) intended for registration in Pakistan. The risk based
assessment of the facilities of the firm identified a number of critical, major and minor
observations which can adversely affect the quality of the products intended for registration in
Pakistan. They has further clarified that the observation No.1,2,4,6 and 10 are the critical
observations which need be rectified in any stance along with the other stated observations
before importing these products in Pakistan.
The panel informed that the certain observations are very critical and can affect the quality of
the product which is very serious threat for the patients to whom use these products. It should be
the duty of the panel of experts should gave the clear recommendation in light of observation, in
light of these serious observations the panel also recommended these products in final
recommendation, which is not understandable.
Decision:
Registration Board discussed the inspection report in detail and keeping in
view nature of the observations being critical rejected the following applications of M/s.
Sind Medical Stores, Karachi manufactured by M/s. Boryung Pharmaceutical Co. Ltd.,
Singil-dong, Wonnam-dong, Chongro-ku, Seoul, Korea;
S. No.
Minutes246thMeetingRegistrationBoard
Name of Drug (s) &
Composition.
Page287
1.
A.D. Mycin Injection 10mg.
Each 5ml vial contains:Doxorubicin HCI…….10mg.
2.
A.D. Mycin Injection 50mg.
3.
4.
5.
6.
Each 25ml vial contains:Doxorubicin HCI…….50mg.
E.P. Mycin Injection 10mg.
Each 5ml vial contains:Epirubicin HCI……10mg.
E.P. Mycin Injection 50mg.
Each 25ml vial contains:Epirubicin HCI…....50mg.
Neotabine Injection 1gm.
Each vial contains:Gemcitabine HCI….1.14gm.
Neotabine Injection 200mg.
Each vial contains:Gemcitabine HCI….228mg.
c. Registration of imported drug – Issuance of registration letter after inspection of
manufacturer abroad.
i.
M/s. Laderly Bio-Tech Pharma, Karachi
Drug Registration Board in its 244th meeting held on 22-23rd July, 2014 approved the
registration of following drugs in the name of M/s. Laderly Bio-Tech Pharma, Karachi,
manufactured by M/s. CSPC Pharmaceutical Co., Ltd., No. 188 Gongnong Road, Shijiazhuang
City, P R China, subject to inspection of manufacturer abroad, verification of storage facilities
and price fixation / calculation etc as per policy:S.#
Name of drug (s)/Composition.
1.
Meropeon Injection 0.5gm.
Each vial contains: Meropenem USP…… 0.5gm.
Rs.100000
Prices approved by
the Price
Recommendatory
Committee
Rs.600/Per vial
2.
Meropeon Injection 1gm.
Each vial contains: Meropenem USP …… 1gm.
Rs.100000
Rs.1100/Per vial.
Minutes246thMeetingRegistrationBoard
Fee deposited.
Page288
Inspection of the manufacturer abroad M/s. CSPC Zhongnuo Pharmaceutical
(Shijiazhuang) Co., Ltd., 188 Gongnong Road, Shijiazhuang City, Hebei Province, China has
already been carried out by the nominated panel comprising Dr. Obaidullah, Deputy Director
General (Registration) and Mr. Abdullah, Deputy Drugs Controller (RRR), Drug Regulatory
Authority of Pakistan. The panel of inspectors has recommended the registration of the above
said products.
Decision:
Registration Board considered the inspection report of the panel and
approved the registration of above products.
ii.
M/s. Pak China International, Karachi.
Drug Registration Board in its 245th meeting held on 29-30th September, 2014 approved
the registration of following drug in the name of M/s. Pak China International, Karachi
manufacture by M/s. Zheijing Chimin Pharmaceutical Co. Ltd, 888 Beiyuan Road, Huangyan,
Zhejiang, P.R. China and exported by M/s. Ningbo Tisun Biochemi Company Ltd. Ningbo,
China subject to inspection of manufacturer abroad, verification of storage facilities and price
fixation / calculation etc as per policy:S.#
1.
Name of drug (s)/Composition.
Sodium Ringer Lactate Injection.
Each 500ml bottle contains:Sodium Chloride….......................3.0gm.
Sodium Lactate, Anhydrous……1.55gm.
Potassium Chloride .....................0.15gm.
Calcium Chloride............................0.1gm.
Inspection of the manufacturer abroad M/s. Zheijing Chimin Pharmaceutical Co. Ltd, 888
Beiyuan Road, Huangyan, Zhejiang, P.R. China has already been carried out by the nominated
panel comprising Dr. Obaidullah, Deputy Director General (Registration) and Mr. Abdullah,
Deputy Drugs Controller (RRR), Drug Regulatory Authority of Pakistan. The panel of inspectors
has recommended the registration of the above said product.
Minutes246thMeetingRegistrationBoard
Page289
Decision:
Registration Board considered the inspection report of the panel and
approved the registration of above products.
Case No. 05. Change of manufacturing site of imported registered drug.
a.
Duac Gel (Reg. No.043090) - M/s. GlaxoSmithKline Pakistan Limited, Karachi.
M/s. GlaxoSmithKline Pakistan Limited, Karachi have requested to approve the change
of source of manufacturing & supply of their registered imported drug “Duac Gel (Reg.
No.043090)” from M/s. Stiefel Laboratories, Ireland to M/s. Glaxo Operations UK Limited,
Barnard Castle, UK.
The firm has deposited fee Rs.50000/- and submitted following supporting documents:i)
ii)
iii)
iv)
Original legalized CPP from new source.
Supporting letter from endorsing source change.
Copy of initial registration letter.
Copy of transfer of registration letter in the name of M/s. GSK Pakistan Ltd.,
Karachi.
M/s. GlaxoSmithKline Pakistan Limited, Karachi was advised to submit the balance fee
as per revised “Schedule-F” for change of source of Duac Gel (Reg. No.043090) and status of
registration with EMA, US-FDA, Japan & Australia.
In response, M/s. GlaxoSmithKline Pakistan Limited, Karachi has submitted required fee
as per revised fee structure given in SRO 1117 (I) 2012.
The firm M/s. GlaxoSmithKline Pakistan Limited, Karachi has submitted legalized
Certificate of Pharmaceutical Product of “Duac Gel” issued by Australian Regulatory Authority.
The firm has submitted the all document and required fee as per approved policy of the
Drug Registration Board.
Decision:
Registration Board approved request of M/s. GlaxoSmithKline Pakistan
Limited, Karachi for change in manufacturing site of Duac Gel (Reg. No.043090) from M/s.
Stiefel Laboratories, Ireland to M/s. Glaxo Operations UK Limited, Barnard Castle, UK.
Minutes246thMeetingRegistrationBoard
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Case No.06
Transfer of registered drugs.
a. M/s. Getz Pharma (Pvt) Limited, Karachi.
M/s. Getz Pharma (Pvt) Limited, Karachi have requested for transfer of registration of the
under-mentioned registered imported drugs from the name of previous importer M/s. Abbott
Laboratories (Pakistan) Limited, Karachi to their name as a result of agreement between M/s.
AbbVie Inc & M/s. Getz Pharma (Pvt) Limited, Karachi: S. No.
Reg. No.
Name of Drugs.
Name of Manufacturer.
1.
015532
Survanta Suspension 8ml.
2.
059025
Survanta Suspension 4ml.
M/s. Abbvie Inc., North Chicago, IL 60064,
USA.
-do-
3.
011081
Forane Liquid for Inhalation
100ml.
4.
027374
Sevorane Volatile Liquid for
Inhalation 250ml.
M/s.
Getz
Pharma
(Pvt)
Limited,
Manufactured by:M/s. Aescia Queenborough Limited, U.K.
Marketing Authorization Holder:M/s. Abbvie Limited, U.K.
-do-
Karachi
have
deposited
required
fee
Rs.100000x4=400000/- and submitted the following documents:i)
ii)
iii)
iv)
v)
vi)
vii)
viii)
ix)
x)
Decision:
Legalized CoPP / GMP Certificate of Survanta Suspension 4ml.
Legalized CoPP of Forane Liquid for Inhalation 100ml.
Legalized GMP Certificate of Forane Liquid for Inhalation 100ml.
Legalized CoPP of Sevorane Volatile Liquid for Inhalation 250ml.
Legalized GMP Certificate of Sevorane Volatile Liquid for Inhalation 250ml.
Legalized Termination letter from M/s. AbbVie.
Legalized Authorization letter from M/s. AbbVie
No Objection Certificate from M/s. Abbott Laboratories (Pakistan) Limited,
Karachi.
Registration applications on Form-5-A.
Copy of NOC for CRF.
Registration Board decided as follows:

Cancellation of above registrations from M/s. Abbott Laboratories (Pakistan)
Limited, Karachi.

Grant of above registrations in name of M/s. Getz Pharma (Pvt) Limited, Karachi.
Chairman, Registration Board will permit issuance of registration letter after
evaluation / completion of Form 5A as per check list approved by Registration
Minutes246thMeetingRegistrationBoard
Page291
Board, comments of Cost & Pricing Division about MRP of the drug and
compliance of Import Policy for Finished Drugs.
b.
Xenetix 350mg/ml Solution for Injection - M/s. A & Z Health Services, Rawalpindi
M/s. A & Z Health Services, Rawalpindi have requested for transfer of registration of a
registered drug “Xenetix 350mg/ml Solution for Injection (Reg. No.027353)” manufactured by
M/s. Guerbet France from the name of previous agent M/s. Digital Imaging Systems (Pvt) Ltd.,
Lahore to their name for finish import. They have deposited fee Rs.15000/- and submitted their
distribution agreement and previous agent dismissal notice. Since NOC of the former agent M/s.
Digital Imaging Systems (Pvt) Ltd., Lahore was not available. Therefore, as per practice in
vogue M/s. Digital Imaging Systems (Pvt) Ltd., Lahore were asked on 25th May 2009 either to
submit their NOC in this regard or provide their fresh agency agreement (if any) with the
manufacturer abroad. Thereafter a reminder was issued on 01-07-2009 but they did not respond.
Then a show cause notice was issued to them on 29th July 2009 to submit reply within 15 days
but they did not respond at all. Copy of this notice was also endorsed to DDG (E&M) Lahore to
ensure delivery to M/s. Digital Imaging Systems (Pvt) Ltd., Lahore. In response, Federal
Inspector of Drugs, Lahore, Mr. Asim Rauf has informed that despite personal visit of Drugs
Controller Officers to M/s. Digital Imaging Systems (Pvt) Ltd., Lahore on 03-03-2010 and
written reminder thereafter, the firm did not respond to the queries sought.
M/s. A & Z Health Services, Rawalpindi was advised to deposit balance fee as per
revised fee Schedule-F. In response, the firm have deposited the balance fee Rs.35000/-.
The firm has applied for the renewal neither on time nor after the expiry of the time till to
date. Therefore, the registration is not valid and cannot be transferred.
Decision:
Registration Board did not accede to request of firm as registration of the
drug is not valid.
Case No. 07. Transfer of registrations and change of manufacturing site - M/s. Abbott
Laboratories (Pakistan) Limited, Karachi
M/s. Abbott Laboratories (Pakistan) Limited, Karachi have requested for transfer of
registration of the under-mentioned registered imported drugs from the name of previous
importer M/s. Highnoon Laboratories Ltd., Lahore to their name due to an International
Minutes246thMeetingRegistrationBoard
Page292
Acquisition of the Pharmaceutical Section of Solvay with all associated companies has been
acquired by the Abbott group since February 15, 2010: S#
Reg. No.
1.
018552
2.
018551
3.
018550
Name of Drugs.
Existing Name of
New Name of
Manufacturer.
Manufacturer.
Physiotens 0.2mg
M/s. Eli Lilly S.A., Manufactured by:
Tablets.
Spain.
M/s. Rottendrof Pharma
GmbH, Germany.
Packed by: M/s. Abbott Healthcare
SAS, France.
Physiotens 0.3mg
-do-doTablets.
Physiotens
Tablets.
0.4mg
-do-
-do-
They have deposited required fee and following supporting documents: i)
ii)
iii)
iv)
Original NOC of the previous importer M/s. Highnoon Laboratories Ltd., Lahore.
Copy of the acknowledgement of last renewal of registration of the products
applied by the previous importer M/s. Highnoon Laboratories Ltd., Lahore.
Copies of acknowledgement of receipt issued by the German National authority
BfArM & a notification submitted by the Solvay to the Germany authority for the
change in manufacturer name to M/s. Rottendrof Pharma GmbH, Germany.
Copy of NOC for CRF.
Drug Registration Board in its 239th meeting held on 12th September, 2013 approved the
transfer of registration of Physiotens Tablet from M/s. Highnoon to M/s. Abbott Laboratories
(Pakistan) Ltd. Karachi along-with the change in manufacturing site from M/s. Eli Lilly S.A.,
Spain to M/s. Rottendrof Pharma GmbH, Germany, while the packaging site of the finished
products will be M/s. Abbott Healthcare SAS, France. The Board advised to provide site master
file of both sites and panel will inspect the manufacturing sites as well to comply the provisions
of import policy. The Board authorized its chairman to accord approval for issuance of letter
after compliance of aforementioned provisions.
As per decision of the Drug Registration Board M/s. Abbott Laboratories (Pakistan)
Limited, Karachi have submitted site master files of both sites attested by an authorized person
of the company.
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Page293
M/s. Abbott Laboratories (Pakistan) Limited, Karachi was again advised to submit the
Form-5 (A), legalized CoPP’s of both Germany and French sources.
In response, M/s. Abbott Laboratories (Pakistan) Limited, Karachi have submitted Form
5(A) and following documents for an intermediate International Change of Manufacturing from
M/s. Rottendrof Pharma GmbH, Germany to M/s. Abbott Healthcare SAS, France:i)
CoPP of the M/s. Abbott Healthcare SAS, France legalized by Pakistan Embassy.
ii)
GMP of the regulatory authority for the manufacturing site legalized by Pakistan
Embassy.
iii)
Justification of Change.
M/s. Abbott Laboratories (Pakistan) Limited, Karachi have also submitted that both
manufacturing and release site will be M/s. Abbott Healthcare SAS, France.
This case was discussed in 239th meeting of the Drug Registration Board for the change
of manufacturing site from M/s. Eli Lilly S.A., Spain to M/s. Rottendrof Pharma GmbH,
Germany & packaging at M/s. Abbott Healthcare SAS, France. Meanwhile the firm requested
that all the manufacturing and packaging steps will be carried out at “M/s. Abbott Healthcare
SAS, France” and for which they have submitted documents as per SOP. Under the Drugs Act,
1976 there is no provision for transfer of registration from one company to another.
Decision:
Registration Board referred above formulations for c onsideration of Review
Committee.
Case No.08
a.
Change in name of manufacturer.
Rocaltrol Capsules 0.25mcg and 0.5mcg - M/s. Martin Dow Limited, Karachi.
M/s. Martin Dow Limited, Karachi has requested to approve the change of
manufacturer name of their following registered imported drugs as follows:S#
Name of Drug (s)
New Proposed Name
of Manufacturer.
M/s.
Catalent
Germany
Eberbach
GmbH,
Minutes246thMeetingRegistrationBoard
Page294
1.
Reg. No.
015557
Current Name of
Manufacturer.
Rocaltrol Capsules M/s. R.P Scherer GmbH,
0.25mcg.
Germany.
2.
015556
Rocaltrol Capsules
0.5mcg.
-do-
Gammelsbacher
Strasse 2
69412 Eberbach
Baden, Germany.
-do-
/
The firm have deposited required fee Rs.100000x2=200000/- and submitted following
supporting documents:i)
ii)
iii)
iv)
v)
Copy of registration letter.
Copy of transfer of registration letter.
Copy of change in manufacturing site.
Copy of NOC for CRF clearance.
Original and legalized CoPP as per WHO format.
M/s. Martin Dow Limited, Karachi was advised to provide CoPP issued from German
authority as the above said products are being manufactured in Germany and Certificate of Swiss
Medica is irrelevant.
In response, M/s. Martin Dow Limited, Karachi have submitted that Rocaltrol Capsules
0.25mcg & 0.5mcg are imported in finished form from M/s. F. Hoffmann-La Roche Ltd.,
Switzerland, under contract manufacturing arrangement with
M/s. R.P Scherer GmbH,
Germany. M/s. F. Hoffmann-La Roche Ltd., Switzerland holds marketing authorization for
Rocaltrol range and M/s. R.P Scherer GmbH, Germany is just a contract manufacturer of
Rocaltrol. M/s. R.P Scherer GmbH, Germany does not hold marketing authorization of Rocaltrol
in Germany as such German authorities cannot issue CoPP for the product not marketed by the
company in Germany.
The firm has further submitted that they have submitted CoPP of Rocaltrol Capsules
0.25mcg & 0.5mcg issued from Swiss authorities, as the finish product is supplied from
Switzerland which indicates M/s. R.P Scherer (new name Catalaent) as manufacturing site.
The firm has also informed that only the name of manufacturer of Rocaltrol Capsules is
changed from “R.P. Scherer GmbH & Co. KG” to “Catalent Germany Eberbach GmbH”. The
physical address of the facility, the manufacturing process and quality controls for the capsules
as well as the personnel producing & testing of the capsules remains unchanged.
Minutes246thMeetingRegistrationBoard
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The manufacturing site of the product “Rocaltrol Capsules” is located in Germany but the
firm has submitted CoPP of Swiss Medica and not of German Authorities. The same was asked
them but they have not provided the same. The CoPP of country of origin is mandatory for such
approval.
Decision:
The Board deferred the case and advised the firm to submit the legalized
document issued by German regulatory authorities for following confirmations:

Above referred products are being contract manufactured at Catalent Germany
Eberbach GmbH.

It is only change of title / name of the firm and rest of facilities including address is
same as of previous manufacturer.
Case No.09
Exemption from the Drugs (Labeling & Packing) Rules, 1976.
a.
Kytril (Granisetron) Ampoule 3mg/3ml, Reg. No.020691 - M/s. Roche Pakistan
Limited, Karachi.
M/s. Roche Pakistan Limited, Karachi have informed that “Kytril Ampoule 3mg/3ml
(Reg. No.020691)” was registered in the name of M/s. SmithKline & French Pakistan Limited,
Karachi on February 10, 1998 and the registration was subsequently transferred to M/s. Roche
Pakistan Limited, Karachi on July 25, 2001 after the global acquisition of this brand by their
principal M/s. F. Hoffmann La-Roche Basel, Switzerland. Due to the low volumes of the imports
/ sales, (approx 2000 packs / anum) M/s. Roche Pakistan Limited had applied for exemption
from the Drugs (Labeling & Packing) Rules 1986 and the exemption was granted on November
10, 2004. Furthermore, for necessary compliance to the Drugs (Labeling & Packing) Rules 1986,
i.e. (after imports of the consignment) the information, i.e. Pak Reg. No., Price and Urdu
instructions are being overprinted on the secondary carton using an ink-jet printer.
Recently M/s. Roche Pakistan Limited, Karachi have imported a consignment of “Kytril
Ampoules” in Islamabad, (1000 packs) and have been advised by the concerned ADC to paste
stickers for compliance to the Drugs (Labeling & Packing) Rules 1986 on the individual
ampoules of the 5’s pack. Following find few facts which would reveal that individual ampoule
sticker pasting would be detrimental to the 5’s pack and the product:-
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i)
It’s a Neo-top secondary carton, (5’s pack) with perforated seal, and if open once the
temper evident seal / integrity of the pack would be compromised.
ii)
Pasting of stickers is not possible due to the limited space available on the 3ml
ampoule as the sticker would mask the primary label, hiding the critical information
on the primary label, (ampoule photo attached).
iii)
There would be high risk of ampoule breakage during the excessive handling of the
pack after opening it and while carrying out the manual process of sticker pasting.
Considering the above mentioned facts M/s. Roche Pakistan Limited, Karachi have
requested for an exemption of overprinting of the primary label (ampoule), since the secondary
label (carton) is being duly complied with the requirement of the Drugs (Labeling & Packing)
Rules 1986 by ink-jet printing.
M/s. Roche Pakistan Limited, Karachi have deposited required fee Rs.5000/- and
submitted following supporting documents:i)
ii)
iii)
iv)
v)
Copy of transfer of registration letter.
Copy of initial registration letter.
Copy of letter exemption from Drugs (Labeling & Packing) Rules 1986.
Copy of last renewal status.
Copy of labels.
Kytril Ampoules (Reg. No.020691) is an 5HT3-antagonist used as antienetic, available in
3ml ampoule, which cannot be allowed to sell without complying full requirement of the Drugs
(Labeling & Packing) Rules 1986.
Decision:
The Board after detailed deliberations decided that M/s Roche Pakistan Ltd,
Karachi may be permitted for ink-ject printing of Urdu version only of the ampules of
Kytril Ampoules (Reg. No. 020691) in any licensed manufacturing unit having facility for
this purpose. The firm will provide NOC of any licensed manufacturing unit and case will
be processed for approval for issuance of letter. The firm will comply the rest of the
labeling requirements under the Drugs (Labeling & Packaging) Rules, 1986 before import.
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Case No.10
a.
Extension in shelf life of registered drugs.
Alimta 100mg Injection, Regn. No.066174 and Alimta 500mg Injection, Regn.
No.043068.
M/s. Eli-Lilly Pakistan (Private) Limited, Karachi have requested to approve the
extension of shelf life of their following registered imported drugs from 24 months to 36 months.
As the current stability studies conducted on this product confirms that the product is well stable
when tested at 36 months time interval:S. No.
Reg. No.
Name of Product.
1.
066174
Alimta 100mg Injection.
2.
043068
Alimta 500mg Injection.
The firm has deposited required fee Rs.5000x2=10,000/- and submitted following
supporting documents:i)
ii)
Copy of registration letter of Alimta 100mg Injection.
Original CoPP of Alimta 100mg Injection attested by Pakistan Embassy having
approved shelf life of 36 months.
iii)
iv)
Copy of registration letter of Alimta 500mg Injection.
Copy of the acknowledgement of last renewal of registration of Alimta 500mg
Injection.
Original CoPP of Alimta 500mg Injection attested by Pakistan Embassy having
approved shelf life of 36 months.
Copies of Stability Studies.
M/s. Eli-Lilly Pakistan (Private) Limited, Karachi was advised to clarify whether
v)
vi)
stability data conducted for Zone-IV is approved by US-FDA or otherwise. In response, M/s. EliLilly Pakistan (Private) Limited, Karachi have submitted that previously provided stability data
was conducted for Zone-IV and approved by FDA. They have further submitted that original
CPPs issued by the FDA mentioning 36 months shelf life. These CPPs issued by the FDA
specifically for Pakistan for Alimta 100mg & 500mg on the basis of submitted Zone-IV stability
data. Therefore, Zone IV stability data should be considered as approved by the FDA.
As per practice in vogue views of following experts regarding extension of shelf lives of
the products has been obtained:Minutes246thMeetingRegistrationBoard
Page298
S. No.
Name of Expert.
1.
Prof. Dr. Zafar Iqbal,
Chairman, Department of Pharmacy,
University of Peshawar,
Peshawar.
Dr. Farzana Chowdhary,
Director, Department of Pharmacy,
University of Veterinary & Animal
Sciences, Lahore.
2.
3.
Opinion
Recommended
Extension in shelf-lives is recommended
on condition that they will be available
only in hospitals / institutions specialized
for the treatment of cancer.
Jamil Anwar,
Director,
Drugs Testing Laboratory,
Punjab, Lahore.
Recommended
M/s. Eli-Lilly Pakistan (Private) Limited, Karachi was advised to clarify as these
“Pemetrexed” containing products are meant for malignant pleural mesotheliona, which indicate
it is a specialized product for tertiary care institution. The one of the expert indicate these
products should be available only in hospitals / institutions specialized for the treatment of
cancer. Therefore, you are advice to inform this office about mode of sale whether it is selling to
institution / hospitals or also available in retail out lets as well.
In response, M/s. Eli-Lilly Pakistan (Private) Limited, Karachi have confirm that Alimta
(pemetrexed) is indicated for Nonsquamous Non-Small Cell Lung Cancer-NSCLC and
malignant Pleural Mesothelioma. Alimta 500mg and 100mg formulations are registered in
Pakistan since 2006 and 2010 respectively. They would like to inform that at the time of
registration, no restrictions were imposed on the availability of Alimta. They have authorized
their distributor to provide Alimta to hospitals / institutions specialized for the treatment of
Cancer based on tenders / orders and to the very selective licensed outlets in Pakistan.
Decision:
Registration Board after deliberations approved the request of the firm for
increase in shelf life.
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Case No.11. Resemblance of brand name – Personal hearing thereof.
M/s. NovaMed Pharmaceuticals (Pvt) Ltd., Lahore have informed about resemblance of
brand name of imported drug “OZOL-40 Infusion (Reg. No.044854)” imported by M/s. United
International, Karachi with the brand name of their already registered locally manufactured drug
“O-Zole Capsules 40mg (Reg. No.043642)”. M/s. NovaMed Pharmaceuticals (Pvt) Ltd., Lahore
submitted that they are facing problems in marketing the product, time and again, and it will be
even more aggravated if the situation continues. Therefore they have humbly requested to take a
check on the situation and to strictly instruct M/s. United International, Karachi to change their
brand name as early as possible, so that they could continue marketing their product smoothly
and without apprehensions.
Accordingly, M/s. United International, Karachi was advised to propose at least three
distinguished alternate names of their drug other than the existing name. Also, submit an
undertaking that the new proposed brands do not have resemblance with any already registered
drug.
In response, M/s. United International, Karachi have submitted that they had been
granted the registration of product “OZOL-40 Infusion (Reg. No.044854)” on 9th February,
2007, i.e. more than seven years before and the said product is already being marketed by them
for more than seven years, therefore, their product is strongly recognized and accepted by their
prevailing customers in the market with the said name since they have incurred substantial
marketing expenditures to create awareness among the customers about the product with the said
brand name. They have therefore requested to consider the additional fact that the nature of the
products being traded by them and that by M/s. NovaMed Pharmaceuticals (Pvt) Ltd., Lahore is
different, meaning that the product traded by them is an Injection whereas the product traded by
M/s. NovaMed Pharmaceuticals (Pvt) Ltd., Lahore is a capsule. M/s. United International,
Karachi has requested to continue trading of the said product with the same brand name, keeping
in view the these facts.
Registration Board took serious note of firm for not complying the instructions for
change of brand name. The Board decided to suspend the import of “OZOL-40 Infusion (Reg.
No.044854)” imported by M/s. United International, Karachi immediately and call the firm’s
representative in next meeting for personal hearing.
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Accordingly, the importer M/s. United International, Karachi has been advised to suspend
the import of “OZOL-40 Infusion (Reg. No.044854)” imported by them immediately, till the
change of name of the product and called for personal hearing in this meeting.
Decision:
The representative of the firm did not appear before the Board and informed
that they are willing to change the name of their product in light of the directions of the
Board. The Board accepts the request of the firm and authorized its Chairman for decision
on the change of name request of the firm.
Case No.12. Veterinary drugs deferred by Registration Board for expert opinion.
Registration Board in its 243rd meeting held on 08th -09th May, 2014 referred all
veterinary applications to a committed comprises of Dr. Muhammad Arshad, Member
Registration Board, Dr. Muhammad Ashraf, UVAS, Lahore and Head of Pharmacology
Department Arid University Rawalpindi for expert opinion. The recommendations of expert are
as under:S. No.
1.
Name of Importer/
Manufacturer.
Name of Drug (s)/Composition.
M/s. Ghazi Brothers,
Karachi-75350 /
Product License
Holder:M/s. Agrovet Market
S.A., San Luis, Lima,
Peru.
Manufacturer Under
Product License
Holder:M/s. Pharmadix Corp.
S.A.C. Urbanizacion La
Aurora-Ate Lima 3Peru.
Metri-CEF 3 Intrauterine
Suspension
Each 30ml contains:Cephalexin monohydrate
(Base)……………….....600mg
Neomycin sulfate
(Base)…………………1.02gm
Cloxacillin
benzathine...1.50gm
Vitamin A……….....30.000 IU
Minutes246thMeetingRegistrationBoard
Recommendatio Recommendations
ns of Dr.
of Dr. Muhammad
Muhammad
Arshad, Member
Ashraf, UVAS,
R.B
Lahore
Recommended
He endorsed the
recommendations
of
Dr.
Muhammad
Ashraf.
Recommend
ations of
Head of
Pharmacolog
y Department
Arid
University
Rawalpindi
Dr. Mazhar
ul Haq
Wrote
to
this office
“I
am
unable
to
put
my
opinion on
said drugs
due
to
certain
unavoidable
reasons.
Page301
2.
M/s. Ghazi Brothers,
Karachi-75350 /
Product License
Holder:M/s. Agrovet Market
S.A., San Luis, Lima,
Peru.
Manufacturer Under
Product License
Holder:M/s. Pharmadix Corp.
S.A.C. Urbanizacion La
Aurora-Ate Lima 3Peru.
Catofos B9 + B12 Injectable
Solution
Each ml contains:Butaphosphan…………100mg
Vitamin B9 (Folic Acid)..15mg
Vitamin B12
(Cyanocobalamin)…….0.05mg
(Vitamin and Mineral).
Recommended
3.
M/s. Ghazi Brothers,
Karachi. /
M/s. Vetanco S.A.
Buenos Aires,
Argentina.
Recommended
4.
M/s. Ghazi Brothers,
Karachi. /
M/s. Cheilbio Co. Ltd.,
Moknae-Dong, AnsanSi, Gyeonggi-Do,
Korea.
M/s. Ghazi Brothers,
Karachi. /
M/s. Cheilbio Co. Ltd.,
Moknae-Dong, AnsanSi, Gyeonggi-Do,
Korea.
M/s. Ghazi Brothers,
Karachi. /
M/s. Cheilbio Co. Ltd.,
Moknae-Dong, AnsanSi, Gyeonggi-Do,
Korea.
M/s. Ghazi Brothers,
Karachi. /
M/s. Cheilbio Co. Ltd.,
Ketoxilen Injection
Each 100ml contains:Oxytetracycline………...20gm
Ketoprofen………………3gm
(Antibiotic/Antiinflammatory).
Geslong Injection
Each ml of solution contains:Metoclopramide HCI……5mg
(Antiemetic/ Gastroprokinetic).
Cheil Tonocomp Injection
Each ml of solution contains:Toldimfos sodium……200mg
Recommended
Seletoco Injection
Each ml of solution contains:Vitamin E acetate……..100mg
Sodium Selenite…………1mg
(Nutritional additive).
Recommended
Procillin-LA Injection
Each ml contains:Pencillin G
Recommended
5.
6.
7.
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Recommended
Page302
Moknae-Dong, AnsanSi, Gyeonggi-Do,
Korea.
Benzathine ………1,00,000 IU
Penicillin G
Procaine…………1,00,000 IU
Dihydrostreptomycin
sulfate…200mg
(Antibacterial).
8.
M/s. Ghazi Brothers,
Karachi. /
M/s. Cheilbio Co.
Ltd.Gyeonggi-Do,
Korea.
Potential of
misuse on feed
additive & drug
interaction.
9.
M/s. Ghazi Brothers,
Karachi. /
M/s. Cheilbio Co.
Ltd.Gyeonggi-Do,
Korea.
M/s. Ghazi Brothers,
Karachi. /
M/s. Hebei Yuanzheng
Pharmaceutical Co.
Ltd., Shijiazhuang City,
Hebei Province, China.
M/s. Ghazi Brothers,
Karachi. /
M/s. Hebei Yuanzheng
Pharmaceutical Co.
Ltd., Shijiazhuang City,
Hebei Province, China.
M/s. Ghazi Brothers,
Karachi. /
M/s. Hebei Yuanzheng
Pharmaceutical Co.
Ltd., Shijiazhuang City,
Hebei Province, China.
M/s. Ghazi Brothers,
Karachi. /
M/s. Hebei Yuanzheng
Pharmaceutical Co.
Ltd., Shijiazhuang City,
Hebei Province, China.
M/s. Orient Animal
Health (Pvt) Ltd.,
Karachi. /
M/s. Univet Ireland
Ltd. Tullyvin, Cootehill,
Co. Cavan, Ireland.
Oxyneo Powder
Each 1 Kg contains:Oxytetracycline Quaternary
Ammonium Salts………110gm
Neomycin sulfate…...…110gm
(Antibiotic).
Oxyone Powder
Each 1 Kg contains:Oxytetracycline Quaternary
Ammonium Salts……….200g
(Antibiotic).
Cefquin Suspension for
Injection
Each ml contains:Cefquinome (as sulfate)..25mg
(Antibiotic).
Isomedium Powder for
parental administration
Each sachet contains:Isometamedium chloride
hydrochloride…………..…1g
(Antiprotozoal).
Oxybiotic LA 30% Solution
for Injection
Each ml contains:Oxytetracycline (as
dihydrate)…………….300mg
(Antibiotic).
Bupaquone Solution for
Injection
Each ml contains:Buparvaqone…………...50mg
(Antiprotozoal).
Recommended
Unimox LA Injection
Each ml contains:Amoxicillin (as Amoxicillin
Trihydrate) Ph. Eur…...150mg
(Antibacterial).
Recommended
10.
11.
12.
13.
14.
Minutes246thMeetingRegistrationBoard
Potential of
misuse on feed
additive & drug
interaction.
Recommended
Recommended
Recommended
-
Page303
Unicycline LA Injection
15. M/s. Orient Animal
Each ml contains:Health (Pvt) Ltd.,
Oxytetracycline (as
Karachi. /
Oxytetracycline Dihydrate Ph.
M/s. Univet Ireland
Ltd. Tullyvin, Cootehill, Eur)…………………...200mg
(Antibacterial).
Co. Cavan, Ireland.
Recommended
(Stability
Study of
zone IV not
provided)
Multivit Injection
Each 1 ml contains:Vitamin B1…………….10mg
Vitamin B2………...……5mg
Vitamin B6…….………..3mg
Vitamin B12………....0.05mg
Nicotinamide………..…35mg
D-Panthenol…….……...25mg
Vitamin A…………15,000 IU
Vitamin D3………....1,000 IU
Vitamin E…………........10mg
(Multivitamins).
17. M/s. Orient Animal
Promycin-1000 Injectable
Health (Pvt) Ltd.
Solution
Karachi. /
Each ml contains:M/s. V.M.D. N.V,
Colistin
Hoge Mauw, Arendonk- Sulphate………..1,000,000 IU
Belgium.
(Polypeptide Antibiotic).
Recommended
COPP of
Ireland not
provided.
Recommended
(Mnf. In
France then
packaging in
Belgium;
COPP of
France)
Promycin-4800 Water Soluble
18. M/s. Orient Animal
Powder
Health (Pvt) Ltd.,
Each gram contains:Karachi. /
Colistin Sulphate…4,800,000
M/s. V.M.D. N.V,
Hoge Mauw, Arendonk- IU
(Polypeptide Antibiotic).
Belgium.
Recommended
(Mnf. In
France then
packaging in
Belgium;
COPP of
France)
16. M/s. Orient Animal
Health (Pvt) Ltd.,
Karachi. /
M/s. Univet Ireland
Ltd. Tullyvin, Cootehill,
Co. Cavan, Ireland.
19. M/s. Marush (Pvt) Ltd.,
Lahore. /
M/s. Univet Ltd.
Tullyvin, Cootehill, Co.
Cavan, Ireland.
Ubroloxin ® Intramammary
Suspension
Each 1 injector with 10g
(12ml) contains:Cefalexin
monohydrate...................200mg
Kanamycin
monosulfate……………133mg
(Corresponds to 100,000 I.U).
(Pharmaceuticals).
Recommended
20. M/s. U.M. Enterprises,
Karachi-74900/
M/s. Qilu Animal
Health Products Co.
Ltd., Jinan, Shandong,
Flumeglu 5gm Injection
Each 100ml contains:Flunixin Meglumine equivalent
to 5.0g of Flunixin.
(Non-steriod, Ant-
Recommended
Minutes246thMeetingRegistrationBoard
Page304
China.
21. M/s. U.M. Enterprises,
Karachi-74900/
M/s. Qilu Animal Health
Products Co. Ltd., Jinan,
Shandong, China.
22. M/s. U.M. Enterprises,
Karachi-74900/
M/s. Qilu Animal
Health Products Co.
Ltd., Jinan, Shandong,
China.
23. M/s. U.M. Enterprises,
Karachi-74900/
M/s. Qilu Animal
Health Products Co.
Ltd., Jinan, Shandong,
China.
24. M/s. Siddiqui Pharma
(Pvt) Ltd., Multan. /
M/s. KBNP, INC,
Dugok-ri, Sinam,
Yesan, Chungnam,
Korea.
inflammatory drug).
Cefent 1gm Injection
Each 25ml vial contains:Ceftiofur Sodium equivalent to
1.0g Ceftiofur.
(B.Lactum Antibiotics).
Cefent 4gm Injection
Each 100ml vial contains:Ceftiofur Sodium equivalent to
4.0g Ceftiofur.
(B.Lactum Antibiotics).
Recommended
Recommended
Ceftihyde 5gm Injection
Each 100ml contains:Ceftiofur Hydrochloride
equivalent to 5.0g Ceftiofur.
(B.Lactum Antibiotics).
Recommended
Ciroxin 10% Oral Solution
Each Liter contains:Ciprofloxacin…………100g
(Antibiotics).
Recommended
25. M/s. Siddiqui Pharma
(Pvt) Ltd., Multan. /
M/s. KBNP, INC,
Dugok-ri, Sinam,
Yesan, Chungnam,
Korea.
Kenoxin 10% Oral Solution
Each Liter contains:Enrofloxacin……100g
(Antibiotics).
Recommended
26. M/s. Siddiqui Pharma
(Pvt) Ltd., Multan. /
M/s. KBNP, INC,
Dugok-ri, Sinam,
Yesan, Chungnam,
Korea.
27. M/s. Mustafa Brothers
Faisalabad. /
M/s. Laboratorio
Centrovet Santiago,
Chile.
28. M/s. Mustafa Brothers
Faisalabad. /
M/s. Laboratorio
Centrovet Santiago,
Chile.
Noroxin 200 Oral Solution
Each Liter contains:Norfloxacin…………200g
(Antibiotics).
Recommended
Cefalexine Injectable
Suspension 15%
Each 10ml contains: Cefalexine ….150/ml
(Beta lactam Antibiotic)
Ceftiofur Hydrochloride
Injectable Suspension 5%
Contains:
Ceftiofur
Hydrochloride…………...50mg
Recommended
Minutes246thMeetingRegistrationBoard
Recommended
Page305
(Antibiotic)
29. M/s. Ghazi Brothers,
Karachi. /
M/s. CEVASA S.A.
Buenos Aires,
Argentina.
Sulfyvit Water Soluble Powder
Each 100gm contains:Sodium
sulfaquinoxaline………..15gm
Sodium
sulfamethazine………….14gm
Sodium
sulfadimethoxine………...2gm
Trimethoprim …………...6gm
Prednisolone………...0.004gm
Vitamin A……....…300,000IU
Vitamin E……………..200 IU
Vitamin D3……..…..60.000IU
Vitamin C……………….2gm
Vitamin K3……………..1gm
Excipients……..…………..q.s
(Antibiotic, steroids Vitamin).
More chances
of their misuse,
drug interaction
and
development of
resistance. It is
better to have
separate
products for
specific
purpose. Need
experimental
verification for
such
combination,
30. M/s. Fartal
Pharmaceuticals,
Karachi. /
M/s. Laboratorios
Microsules Uruguay
S.A. Canelones,
Uruguay.
Ivermic M.O. Injectable
Suspension
Each ml contains:Ivermectin………..……1,000g
Zinc Sulphate 7H20…...0,043g
Magnesum Chloride
6H20…………………...0,650g
Copper Chloride
2H20…………………...0,004g
Magnesium Hypophosphite
6H20…………………..2,670g
Potassium Iodide……...0.030g
Vitamin B12…………..0,010g
Histidine HCI…………0,420g
Valine……….………..0,420g
Arginine HCI………….0,510g
Methionine……………0,420g
Threonine……………..0,500g
Sodium monobasic
glutamate……………....0,840g
(Endectocide, organic
More chances
of their misuse,
drug interaction
and
development of
resistance. It is
better to have
separate
products
for
specific
purpose.
31. M/s. International
Chempharma (Pakistan)
Lahore. /
CTC Plus Water Soluble
Powder
Contains:-
Minutes246thMeetingRegistrationBoard
More chances
of their misuse,
drug
Page306
M/s. Biopharmachemie
Co Ltd TangNhon Phu
Vietnam.
32. M/s. Better Traders
International,
Faisalabad. /
M/s. Kepro B.V.
Maagdenburgstraat,
Holland.
33. M/s. Ani Cure
Veterinary Services,
Rawalpindi. /
M/s. Interchemie
Werken ”De Adelaar”
B.V. Metaalweg, CG
Venray, Holland.
34. M/s. Ani Cure
Veterinary Services,
Rawalpindi. /
M/s. Interchemie
Werken ”De Adelaar”
B.V. Metaalweg, CG
Chlortetracycline……5500mg
Vitamin A……………2400IU
Potassium Chloride…..760mg
Vitamin B12………...280mcg
Lysine…………………60mg
(Antibiotic)
Thiacol 10% Oral Solution
Each ml contains:Thiamphenicol……….100mg
(Broad Spectrum
Antimicrobial Agent).
Nemovit Water Soluble
Powder
Each gm contains: Neomycin
Sulpahte……………..…40mg
Oxytetracycline HCl…...60mg
Vitamin A……………7500IU
Vitamin D3,
Cholecalciferol………..1500IU
Vitamin E, a-tocopherol
acetate…………………....5mg
Vitamin B1….thiamine
hydrochloride……….....…1mg
Vitamin B2,
riboflavine………….….....2mg
Vitamin B6, pyridoxine
hydrochloride………….....2mg
Vitamin B12,
cyanocobalamin……….....7.5µ
Vitamin C, Ascorbic
acid..25mg
Ca-pantothenate……….7.5mg
Vitamin K3, menadione
sodium bisulfite………….5mg
Nicotinamide…………….5mg
Folic Acid…………..…300µg
DL-Methionine…………30mg
L-Lysine
hydrochloride…………...50mg
Aliseryl Water Soluble Powder
Each gm contains: Erythromycin
thiocyanate…………..…35mg
Oxytetracycline HCl…...50mg
Streptomycin Sulphate…35mg
Minutes246thMeetingRegistrationBoard
interaction and
development
of resistance. It
is better to
have separate
products
for
specific
purpose.
Recommended
More chances
of their misuse,
drug
interaction and
development
of resistance. It
is better to
have separate
products
for
specific
purpose.
More chances
of their misuse,
drug
interaction and
development
of resistance. It
Page307
Colistin
Sulphate……….…..200,000IU
Vitamin A, retinol
acetate…………………3000IU
Vitamin D3,
cholecalciferol………1500IU
Vitamin E, a-tocopherol
acetate…….……………..2mg
Vitamin B1, thiamine
hydrochloride…………….2mg
Vitamin B2,
riboflavine…..4mg
Vitamin B6, pyridoxine
hydrochloride…………….2mg
Vitamin B12,
cyanocobalamin………..10µg
Vitamin C, Ascorbic
Acid..20mg
Capantothenate…………10mg
Vitamin K3, menadione
sodium
bisulfite…………………..2mg
Nicotinamide……….…..20mg
Inositol……………….….1mg
Ceftiofur LPU Injectable
Each 100ml vial contains: Ceftiofur HCL…………50mg
Excipients…………..…100ml
(Antibiotic)
is better to
have separate
products
for
specific
purpose.
36. M/s. Seignior Pharma,
Karachi. /
M/s. Instituto
Rosenbusch S.A. de
Biologia Experimental
Agropecuaria, San Jose
1469 (1136) Buenos
Aires, Argentina.
Florfenicol 30% Rosenbusch
Injectable
Each 100ml vial contains:Florfenicol………...…...30gm
Excipients q.s……....…100ml
(Antibiotic)
Recommended
37. M/s. Bio-Labs (Pvt)
Ltd., Islamabad.
Bio-Enrocol-A Liquid
Each 100ml contains:Enrofloxacin………...…..10%
Colistin Sulphate………..3.5%
Amantadine…………….....4%
Contains
“Amantadine”
which is antiviral
drug for flu and
may have drug
interaction and
Venray, Holland.
35. M/s. Seignior Pharma
Karachi./
M/s. Instituto
Rosenbusch S.A. de
Biologia Experimental
Agropecuaria, San Jose
1469 (1136) Buenos
Aires, Argentina.
Minutes246thMeetingRegistrationBoard
Recommended
Page308
(Antibiotic, Anti-viral).
resistance
problem
so
should not be
used in these
combinations.
38. M/s. Bio-Labs (Pvt)
Ltd., Islamabad.
Coliflox 20% Liquid
Each 100ml contains:Enrofloxacin……………20gm
Colistin Sulphate…50,000,000
i.u.
(Quinolones).
Recommended
39. M/s. Leads Pharma
(Pvt) Ltd., Islamabad.
Virex CRD Powder
Contains:Tylosin Tartrate……….....10%
Doxycycline HCI…….…..22%
Colistin Sulphate……….…4%
Amantadine HCI………….3%
(Antibiotic).
Contains
“Amantadine”
which is
antiviral drug
for flu and may
have drug
interaction and
resistance
problem so
should not be
used in these
combinations.
40. M/s. Elko Organization
(Pvt) Ltd., Karachi.
Fe-Zole SC 5% Oral
Suspension
Each ml contains:Fenbendazole………..….50mg
Elemental Selenium…....1.6mg
Elemental Cobalt.............10mg
(Anthelmintic).
Recommended
41. Noble Pharma Mirpur
Azad Kashmir.
ENTRO-5 Powder
Each 1000gm contains:Tylosin Tartrate BP……..10%
Doxycycline Hyclate USP20%
Colistin Sulphate…...450 MIU
Bromhexine HCI………0.5%
Neomycin SO4…………3.6%
(Antibacterial).
Drug which are
“Me too” like
drugs with
minor
modifications
which may or
may not be
considered.
42. M/s. Mallard
Pharmaceuticals (Pvt)
Centrum Liquid
Each 100ml contains:-
Drug which are
“Me too” like
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Page309
Ltd., Multan.
Enrofloxacin HCI…...7500mg
Sulphamethoxypyridazine……
……………………7500mg
Sulphamethazine……5000mg
Trimethoprim………2500mg
(Antibiotic).
drugs with
minor
modifications
which may or
may not be
considered.
43. M/s. Intervac (Pvt) Ltd,
Sheikhupura Road,
Sheikhpura.
Tilmodox Liquid
Each 100ml contains:Tilmicosin Phosphate….15gm
Doxycycline HCI………15gm
(Antibiotic).
Tissue
resistance.
44. M/s. Intervac (Pvt)
Limited, Lahore.
Amprobit Liquid
Each liter contains:Amprolium HCI………250gm
Ethopabate……………..16gm
(Anticoccidial).
Recommended
45. M/s. Attabak
Pharmaceutical,
Islamabad.
Tylothrodox Powder
Each 1000gm contains:Doxycycline HCl……..…100g
Tylosin tartrate …………..50g
Amantadine HCl ………...40g
Erythromycin thiocyanate..60g
(Antibacterial, Antiviral).
46. M/s. Attabak
Pharmaceutical,
Islamabad.
Spiralinc-B Powder
Each 100gm powder contains:Lincomycin HCI…………..5g
Spectinomycin HCI……..7.5g
Spiramycin adipate...........2.5g
Bromhexine HCI………...0.5g
(Antibacterials).
Contains
“Amantadine”
which is
antiviral drug
for flu and may
have drug
interaction and
resistance
problem so
should not be
used in these
combinations.
Recommended
47. M/s. D-Maarson
Pharmaceuticals,
Rawat, Islamabad.
CRD-555 Water Soluble
Powder
Each 1000g contains:Doxycycline HCl ............200g
Tylosin tartrate ………....100g
Colistin sulphate……500MIU
Minutes246thMeetingRegistrationBoard
Drug which are
“Me too” like
drugs with
minor
modifications
which may or
Page310
48. M/s. Symans
Pharmaceuticals (Pvt)
Ltd. Lahore.
49. M/s. Symans
Pharmaceuticals (Pvt)
Ltd. Lahore.
50. M/s. Jfrin
Pharmaceutical
Laboratories, Hub,
Balochistan.
51. M/s. Biogen Pharma.
8th Km Rawat Chak Beli
Road, Rawat.
Amantadine HCl ………..40g
may not be
considered.
SPZ-Plus Feed Additive Oral
Each 100gm contains:Procaine Penicillin
B.P…1200mg
Streptomycine Sulphate
B.P……………………3600mg
Zinc Bacitracin B.P…5200mg
Colistin Sulphate B.P.500 MIU
(Antimicobial).
Cipro Plus Solution
Each Liter Contains:Ciprofloxacin…………200gm
Colistin Sulphate……400MIU
Amantadine…………….40gm
(Antibiotics).
Recommended
Jfpidox Oral Powder
Each Kg contains:Tylosin Tartrate………100gm
Doxycycline Hcl……...200gm
Phyenylbutazone….……12gm
Bromhexine Hcl…...........5gm
Colistine Sulphate….500 MIU
(Antibacterial/Antibiotic).
Amcocin Liquid
Each 100ml contains:Enrofloxacin………….…10%
Colistin Sulphate…………3%
Amantadine HCI…………4%
(Antibiotic)
Minutes246thMeetingRegistrationBoard
Contains
“Amantadine”
which is
antiviral drug
for flu and may
have drug
interaction and
resistance
problem so
should not be
used in these
combinations.
Drug which are
“Me too” like
drugs with
minor
modifications
which may or
may not be
considered.
Contains
“Amantadine”
which is
antiviral drug
for flu and may
have drug
interaction and
resistance
problem so
should not be
used in these
combinations.
Page311
52. M/s. Biogen Pharma.
8th Km Rawat Chak Beli
Road, Rawat.
Doxytylodine Powder
Each 1000gm contains:Tylosin Tartrate BP…..200gm
Doxycycline HCI BP…100gm
Amantadine HCI……….40gm
Contains
“Amantadine”
which is
antiviral drug for
flu and may
have drug
interaction and
resistance
problem so
should not be
used in these
combinations.
53. M/s. Biogen Pharma,
Rawat.
Advantage Water Soluble
Powder
Each 1000gm contains:Tylosin Tartrate BP..…200gm
Doxycycline HCI BP….40gm
Amantadine HCI……...100gm
Colistin Sulphate…5000 MIU
Contains
“Amantadine”
which is
antiviral drug
for flu and may
have drug
interaction and
resistance
problem so
should not be
used in these
combinations.
(Antibiotic/
Antibacterial/Antiviral).
54. M/s. Wimits
Pharmaceuticals,
Plot No.129, Sunder
Industrial Estate (P.I.E)
Raiwind Road, Lahore.
55. M/s. Wimits
Pharmaceuticals,
Plot No.129, Sunder
Industrial Estate (P.I.E)
Raiwind Road, Lahore.
56. M/s. Wimits
Pharmaceuticals,
Wimtox Injection
Each ml of liquid injection
contains:Novaminsulfon………....40mg
Etilefrin B.P …………...0.2mg
Calcium Gluconate B.P.100mg
Magnesium Gluconate
B.P …………………….10mg
Sodium Salicylate B.P …7mg
Nicotinamide B.P …….0.3mg
Caffeine B.P ………..…10mg
Boric Acid B.P ……..…10mg
(Analgesic and Antipyretic)
Finished product specifications
are Manufacturer.
Stop Spray
Each 100ml of aerosol
contains:Deltamethrin BP……...0.500g
Recommended
(Insecticide)
Defender Spray
Each 30g of aerosol contains:-
Recommended
Minutes246thMeetingRegistrationBoard
Recommended
Page312
Plot No.129, Sunder
Industrial Estate (P.I.E)
Raiwind Road, Lahore.
57. M/s. Wimits
Pharmaceuticals,
Plot No.129, Sunder
Industrial Estate (P.I.E)
Raiwind Road, Lahore.
Neomycin Sulfate BP...150mg
Clostebol Acetate….....150 mg
(Antiseptic)
Methra Spray
Each 100ml of aerosol
contains:Permethrin ……………..0.5 g
Recommended
(Insecticide)
58. M/s. D-Maarson
Pharmaceuticals,
Plot # 17, Street # SS-2,
National Industrial Zone
Rawat, Islamabad.
Decision:
NOVA DM INJECTION
Liquid Injection
Each 100ml contains:Novaminsulfon………..…..4g
Etilefrin………………...0.02g
Calcium Gluconate………10g
Magnesium Gluconate…...1.0g
Sodium salicylate……..0.700g
Nicotinamide…………....0.3g
Caffeine……………….…1.0g
Boric acid………………..1.0g
(Analgesic, Antipyretic)
Recommended
Registration Board deferred the case for the recommendations of Expert
Committee on Veterinary Drugs.
Case No.13. Directions from Drug Appellate Board regarding Nitrofurans.
Drugs Appellate Board in its 140th Sitting held on 20-08-2013 in the appeal of M/s.
Selmore Pharmaceuticals (Pvt.) Ltd., Lahore regarding rejection of their product “UROPessaries” decided as follows:i)
That the said formulation shall be referred to two veterinary experts, by the
defendants, namely: (i) Vice Chancellor, University of Veterinary and Animal
Sciences, Lahore, and (ii) A veterinary expert from Army, to be named by Brig.
Akbar Waheed, Member, Drugs Appellate Board, for their expert opinion.
ii)
The Chairman, Drugs Appellate Board was authorized to take decision on the
aforesaid Appeal in the light of the recommendations of the experts.
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iii)
That the fate of other drug(s) / brand(s) of the same formulation available in the
market shall also be decided by the Registration Board in the light of the
recommendations of the experts and the provisions of law / rules, under
intimation to the Drugs Appellate Board.
Accordingly, opinion of following experts regarding registration of product has been
obtained, which are as follows:S. No. Name of Expert.
Recommendations.
1.
Prof. Dr. Muhammad Ashraf,
Dean, Faculty of Bio-Sciences,
University of Veterinary &
Animal Sciences, Lahore
URO-Pessaries
having
combination
of
Chlorotetracycline,
Furazolidone
and
Metronidazole is not recommended for approval in
animals.
2.
Ltd. Col. Iftikhar Ahmad Anjum, In order to proceed further, following steps be
for DGRV&F, QMG Branch taken up before the product is registered:RV&F
Directorate,
GHQ, a) A fair trial on animals after cultural sensitivity
Rawalpindi.
test, at least on 50 animals which can be provided
by Military Farms located at Lahore or Okara.
b) Deliberate and authentic recording of readings
and fair evaluation be ensured.
c) Post treatment cultural sensitively in an aseptic
environment.
The Drugs Appellate Board in its 142nd Sitting held on 20-06-2014 keeping in view the
fact that Nitrofurans are recognized by FDA as mutagens / carcinogens, decided to dismiss the
appeal with the directions to the respondent Registration Board to decide the fact of similar
formulations accordingly. As per record, there is only one product “Utacare Pessary” (Reg.
No.035062) is registered in the name of M/s. Nawan Laboratories (Pvt) Ltd., Karachi.
Decision:
In compliance to decision of Drugs Appellate Board, Registrstion Board
decided to issue the show cause notice to M/s. Nawan Laboratories (Pvt.) Karachi for
cancellation of registration of Utacare Pessary, (Reg. No.035062). Registration Board
authorized its Chairman for issuance of show cause notice for any other such me too drug.
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Case No.14
Registration of imported veterinary drugs - Correction in minutes.
The Drug Registration Board in its 237th meeting held on 26-02-2013 approved the
registration of following imported veterinary drugs in the name of M/s. Mustafa Brothers,
Faisalabad, manufactured by M/s. Veyx-Pharma B.V, Forellenwegm SJ Raamsdonksveer, The
Netherlands, subject to inspection of manufacturer abroad, verification of storage facilities as per
policy. The firm has deposited the required fee;
S#
Name of Drug (s) /Composition.
1.
Masti Veyxym ® Suspension for
Intramammary.
Each 10gm contains:All-rac-aTocopheryl acetate (Vitamin E
acetate)……120.00mg.
Vitamin A concentrate 100.000 IU.
Chymotrypsin………2400 FIP-U.
Trypsin……………..240 FIP-U.
Papain…………………6-FIP-U.
2.
Veyxyl ® LA 20% Solution.
Each 1ml contains:Amoxicillin trihydrate…229.60mg
(equivalent to 200.00mg Amoxicillin).
Decontrolled /
Pack Size.
Tube of 10ml
Shelf Life
50ml
100ml
03 years
02 years
The applicant M/s. Mustafa Brothers, Faisalabad has requested for issuance of
registration letter of the above said drugs. M/s. Mustafa Brothers, Faisalabad was advised to
provide legalized (CoPP) of M/s. Vexy-Pharma B.V., Forellenweg 16, NL-4941 SJ
Raamsdonksveer, issued by Netherlands as the manufacturing site is located in Netherlands duly
endorsed by the Pakistan Embassy/Consulate office in the country of export.
In response, M/s. Mustafa Brothers, Faisalabad have informed that the production of
“Masti Veyxym ® Suspension for Intramammary & Veyxyl ® LA 20% Solution” is performed
in the Netherlands (as contract manufacturer) by M/s. Vexy-Pharma B.V, the Netherlands for
their principal company M/s. Vexy-Pharma GmbH, Germany. However, this production site only
produces bulk (unlabeled bottles / injections) that is shipped subsequently to their site in
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Germany M/s. Vexy-Pharma GmbH for finalization the production.
At the German site,
the secondary packaging takes place and final batch release is performed. The firm M/s. VexyPharma GmbH (Germany) is the marketing authorization holder and consequently responsible
for the overall quality, the safety and the efficacy of the products.
The firm has disclosed that the products referred above are being manufactured in bulk at
“M/s. Vexy-Pharma B.V, The Netherlands” then these will be labeled and packed at M/s. VexyPharma GmbH, Germany. Now it is clear the firm will import these drugs from Germany.
Therefore, it needs amendment in minutes i.e. name of manufacturer is mentioned from
Netherlands in the minutes of 237th meeting of the Registration Board.
Decision:
Registration Board approved correction in minutes of 237th meeting for
name of manufacturer as M/s. Vexy-Pharma GmbH, Germany for the following products.
S#
Name of Drug (s) /Composition.
1.
Masti Veyxym ® Suspension for
Intramammary.
Each 10gm contains:All-rac-aTocopheryl acetate (Vitamin E
acetate)……120.00mg.
Vitamin A concentrate 100.000 IU.
Chymotrypsin………2400 FIP-U.
Trypsin……………..240 FIP-U.
Papain…………………6-FIP-U.
2.
Veyxyl ® LA 20% Solution.
Each 1ml contains:Amoxicillin trihydrate…229.60mg
(equivalent to 200.00mg Amoxicillin).
Case No.15
Decontrolled /
Pack Size.
Tube of 10ml
Shelf Life
50ml
100ml
03 years
02 years
Registration of veterinary drug.
Drug Registration Board in its 236th meeting held on 20th November, 2012 approved the
registration of following imported veterinary drugs in the name of M/s. Vet Line International,
Lahore manufactured by M/s. Bela-Pharm GmbH & Co.KG Lohner Strasse 19 49377 Vechta,
Germany, subject to inspection of manufacturer abroad, verification of storage facilities as per
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policy. The firm has deposited the required fee.
# No.
Name of Drug (s) /Composition.
1.
Neomycinsulfat Powder.
Each gm powder contains:Neomycin Sulphate……..1000mg.
2.
Belacol 100% Pulver
Each gm powder contains:Colistin Sulphate……….1000mg.
Decontrolled /
Pack Size.
100gm.
500gm.
1kg.
5kg.
100gm.
250gm.
1kg. & 2.5kg
Shelf Life.
3 years
3 years
The storage facility of the importer has also already been verified by the Area FID. The
applicant M/s. Vet Line International, Lahore has requested for issuance of registration letter of
the above said drugs. During processing of case for issuance of registration letter, it was
observed that these products are 100% API and under the Drug Act 1976 the drugs which are
ready to use are registered under the Section 7 of the Act. Then it was deliberated to get opinion
of experts. Accordingly, views of the following experts regarding use of products above in pure
form “100 API” with special reference to efficacy, safety, toxicity and residual effects in food
producing animal has been obtained, which are as follows:-
S.#
1.
Name of Expert.
Dr. Muhammad Ovais Omer,
Chairman,
Department of Pharmacology &
Toxicology,
University of Veterinary and
Animal Sciences, Lahore.
Opinion
i) Based on the pharmacological properties,
Neomycinsulfat is a recommended drug for
treatment of enteric infections in calves, pigs and
chickens.
ii) Based on the pharmacological properties,
Colistin Sulphate is a recommended drug for
treatment of Salmonella, E. coli, Campylobacter,
Pullorum, Paratyphoid infections, Colibacillosis
and Diarrhoea by E.coli in different animal
species.
2.
Brig. Zahid Hussain Abid,
Director Rem & Vet.,
QMG Branch RV & F Dte,
General Headquarters,
As regards efficacy, safety, toxicity and residual
effects in food producing animal, viz a viz both
the products are concerned, in puts of the experts
from University of Veterinary and Animal
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3.
Rawalpindi.
Sciences, Lahore would be more valuable and
pertinent. However, it is suggested that a trial
may be conducted at least on 200 animals for
establishment of all above factors. In this regard
Army Veterinary School can be assigned this
task.
Dr. Farzana Chowdhary,
Director,
Department of Pharmacy,
University of Veterinary &
Animal Sciences,
Lahore.
1. Neomycinsulfat – this drug contains 100mg
Neomycin Sulphate in 1gm indicating that it is a
pure API and not a veterinary finished dosage
form. According to the Drugs Act, 1976 APIs do
not require registration and can only be imported
by manufacturers possessing a valid Drug
Manufacturing License (Formulation) and
registration of the finished drug of which it is an
ingredient.
2. Belacol 100% Pulver contains Colistin
Sulphate 1000mg per 1gm (1000mg) powder and
does not contain any adjuvant or excepient
which is indicative of the fact that it is a pure
API and not a finished dosage form for
veterinary use. Only finished dosage forms
require registration under the Drugs Act, 1976,
whereas, APIs can be imported only by those
who hold a valid DML (Formulation) and
registration of finished drug containing that API.
Decision:
Registration Board deferred the case for the recommendations of Expert
Committee on Veterinary Drugs and list of all such products registered earlier by the
DRAP.
Case No.16. Correction of composition of registered veterinary drug-Neurozoc Injection
Regn. No. 074072.
M/s. Hilton Pharma (Private) Limited, Karachi have requested for correction of
composition of their registered veterinary “Neurozoc Injection (Reg. No.074072)”. They have
informed that they want to apply below composition as “each 1ml contains, pack size of 100ml”
but by typographically mistake it was mentioned in application dossier as “each 100ml contains,
pack size 100ml”. The registration letter received for following composition “each 100ml
contains, pack size 250ml & 500ml”. They have therefore requested for correction of
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composition from “each 100ml contains” to “each 1ml contains” and also change in pack size
from 250ml & 500ml to “100ml”:Approved composition
Neurozoc Injection.
Each 100ml contains:Novaminsulfon …………….. .100mg.
Etilefrin……………………. 0.50mg.
Calcium gluconate …………250mg.
Magnesium gluconate ……… 25mg.
Sodium salicylate ………….17.5mg.
Nicotinamide ………………0.75mg.
Caffeine………………………. 25mg.
Boric acid………………………25mg.
Revised composition.
Neurozoc Injection.
Each ml contains:Novaminsulfon …………….. .100mg.
Etilefrin……………………. 0.50mg.
Calcium gluconate …………250mg.
Magnesium gluconate ……… 25mg.
Sodium salicylate ………….17.5mg.
Nicotinamide ………………0.75mg.
Caffeine………………………. 25mg.
Boric acid………………………25mg.
M/s. Hilton Pharma (Private) Limited, Karachi have deposited required fee Rs.20000/and submitted following supporting documents:i)
ii)
iii)
iv)
Decision:
Copy of registration letter.
Copy of old Form-5.
New Stability data.
Copy of new Form-5.
Registration Board deferred the case for the recommendations of Expert
Committee on Veterinary Drugs.
Case No. 17. Cancellation of registration of drugs and stoppage of production.
Drug Registration Board in its 240th meeting held on 07-11-2013 considered the
inspection report of M/s. Avicenna Laboratories (Pvt) Ltd.,14 Km, Sheikhupura, Faisalabad
Road, Bikhi, District Sheikhupura dated 04-03-2013 conducted by the area FID, wherein the FID
has reported that the firm has registration of following (10) injectable products including
(Penicillin and Steroids) but the Injectable Section is not approved as yet by Licensing Section
and the Registration Section has granted the registration of the same:S. No.
1.
Reg. No.
035001
Name of Drug (s) / composition.
Gentacen 100 Injectable Solution.
Each ml Contains: Gentamycin Sulphate (eq to 100mg
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2.
035002
3.
035003
4.
035004
5.
035005
6.
035006
7.
035127
8.
043166
9.
043167
10.
043168
Gentamycin base).
Moxicol Injectable Suspension.
Each ml contains: Amoxycillin Trihydrate 100mg.
Colistin Sulphate 250,000 IU.
Avimox Injectable Suspension.
Each ml contains: Amoxycillin base (as trihydrate) 150mg.
Tylocen-200 Injectable Solution.
Each ml contains: Tylosin Sulphate 200mg.
Avoxy LA Injectable Suspension.
Each ml contains: Oxytetracycline HCl…200mg.
Dexon-5 Injectable Solution.
Each ml contains: Dexamethasone 5mg.
Oxytocen Injectable Solution.
Each ml contains: Oxytocin 10 I.U.
Predexon Injectable Suspension.
Each ml contains:Dexamethasone ……… 2.5mg.
Prednisolon ………….. 7.5mg.
Lincospec Injectable Solution.
Each ml contains:Spectinomycin Sulphate 100mg base.
Lincomycin Hydrochloride 50mg base.
Avigen-F20 Injectable Solution.
Each ml contains:Gentamycin Sulphate ……. 10mg.
Flumequine ……………… 20mg.
The Drug Registration Board decided that the production of the firm for above mentioned
products should immediately be stopped till the complete investigation of the matter and issue a
show cause notice to the firm for explanation of reasons in their defense. Then place the case
before the Board for further deliberations.
Accordingly, a show cause notice was issued to the firm.
In response to the show cause notice the firm has submitted following documents:Minutes246thMeetingRegistrationBoard
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i)
Approval of layout plan.
ii)
Copies of registration letters.
iii)
Copy of layout plan.
M/s. Avicenna Laboratories (Pvt) Ltd., Sheikhupura was again advised to provide proof
of approval of the Injectable Section and also provide proof of renewal of registration of drugs
above said drugs. The firm have submitted copies of the acknowledgement of last renewal of
registration of above said products and also submitted that on April 15, 2014 the panel
constituted by the Director QA, inspected their Oral Powder, Liquid, Vaccine and Injectable
Sections. The report will be submitted in coming board meeting. The firm have further submitted
that they also want to shift all Penicillin products into toll manufacturing.
DDC (RRR) was also requested to confirm renewal status of the above products. DDC
(RRR) have confirmed the renewal of the drugs.
The Chairman, CLB also resumption of production to the firm only in veterinary oral
powder and veterinary oral liquid sections.
Decision:
Registration Board after detailed deliberations canceled the registrations of
following products of M/s. Avicenna Laboratories (Pvt) Ltd., Sheikhupura as the firm do
not have the approved manufacturing facility for these products;
S. No.
1.
Reg. No.
035001
2.
035002
3.
035003
4.
035004
5.
035005
Name of Drug (s) / composition.
Gentacen 100 Injectable Solution.
Each ml Contains: Gentamycin Sulphate (eq to 100mg
Gentamycin base).
Moxicol Injectable Suspension.
Each ml contains: Amoxycillin Trihydrate 100mg.
Colistin Sulphate 250,000 IU.
Avimox Injectable Suspension.
Each ml contains: Amoxycillin base (as trihydrate) 150mg.
Tylocen-200 Injectable Solution.
Each ml contains: Tylosin Sulphate 200mg.
Avoxy LA Injectable Suspension.
Each ml contains: Oxytetracycline HCl…200mg.
Minutes246thMeetingRegistrationBoard
Page321
Case No.18.
6.
035006
7.
035127
8.
043166
9.
043167
10.
043168
Dexon-5 Injectable Solution.
Each ml contains: Dexamethasone 5mg.
Oxytocen Injectable Solution.
Each ml contains: Oxytocin 10 I.U.
Predexon Injectable Suspension.
Each ml contains:Dexamethasone ……… 2.5mg.
Prednisolon ………….. 7.5mg.
Lincospec Injectable Solution.
Each ml contains:Spectinomycin Sulphate 100mg base.
Lincomycin Hydrochloride 50mg base.
Avigen-F20 Injectable Solution.
Each ml contains:Gentamycin Sulphate ……. 10mg.
Flumequine ……………… 20mg.
Registration of Magnesium Sulphate 15% in veterinary products.
Drug Registration Board in its 243rd meeting held on 08-09th May, 2014 considered and
approved the registration of following drug for import in the name of M/s. BN Pharmaceuticals,
Lahore manufactured by M/s. Laboratories Chaix et Du Marais Lavoisier Head Quarter Paris
France subject to price fixation / calculation:Name of drug (s)/Composition.
Sulphate De Magnesium Lavoisier (1.5G/10ML) 15%
(I.V) Injectable.
Each ampoule contains: Magnesium as Sulphate. 1.5g/10ml (15%).
Demanded Price
/Pack.
Rs.450/Per ampoule.
Rs.4500/Per 10 ampoules.
Meanwhile, the firm M/s. BN Pharmaceuticals, Lahore have submitted the references in
support of above mentioned product which is already under process of registration. The firm has
also submitted the list of countries-organizations in which this product is registered / sponsored
at this time along with the report of WHO Drug Information volume-21/2.2007 WHO Geneva.
Minutes246thMeetingRegistrationBoard
Page322
The Magnesium Sulphate 15% is not approved by any of the reference authorities i.e.
EMA, USFDA, TGA or PDMC, except France.
Decision:
Registration Board referred the case to Review Committee for formulation
review.
Registration-II
Case No.19
Registration of drugs deferred by Registration Board.
a. Cases deferred for expert opinions.
i.
Lurisa Tablet 40mg and 80mg – M/S Helix Pharma, Karachi.
Registration Board in 242nd meeting deferred following products for expert opinion. Accordingly
products were referred to expert for views. Comments are as under.
S.
No
Name of drug(s) & Composition
1
Lurisa Tablets
Each film coated tablet contains:
Lurasidone HCl………..….40 mg
(Antipsychotic for Treatment of Schizophrenia)
Lurisa Oral Tablets
Each tablet contains:
Lurasidone HCl…….80 mg
(Antipsychotic for Treatment of Schizophrenia)
2
Proposed
Pack size
Demanded
Price
10’s,
20’s,
30’s
As per PRC
10’s,
20’s,
30’s
As per PRC
Brig. Saleem Jehangeer
Prof. Dr. Rizwan Taj
Dr. Nadeem Abbas
Armed Forces Institute of
Mental Health,
Psychiatrist,
Fauji Foundation Medical
Centre,
Rawalpindi
Pakistan Institute of Medical
Sciences,
Rawalpindi
Islamabad
Brig for Comdt (Farrukh Hayat
Khan) stated that Maj. Gen
Salim Jehangir, Commandant of
Armed Forces Institute of
Mental Health is not avail due
I have study documents and fee Although Lurasidone salt is not
that this medication should be available / introduced in Pakistan,
available in Pakistan.
In the light of above mentioned
facts & data provided, the drugs
It is a new salt which has shown Lurasidone (Lurisa) 40mg &
promising result as compared to
Minutes246thMeetingRegistrationBoard
Page323
to official commitments
other products in the market it Lurasidone (Lurisa) 80mg are
side effect profile is better also. recommended for Registration
Board
I am recommending its
availability in Pakistan
Decision: Registration Board discussed and agreed to above expert opinions. However,
the Board advised firm to provide data for stability studies conducted under zone IV-A
conditions as per ICH / WHO guidelines for consideration of Registration Board.
ii. Roflumilast 500mcg Tablet.
Registration Board in its various meetings deferred registration of Roflumilast 500mcg Tablet of
various firms for expert opinion. Accordingly products were referred to expert for views. Comments are
as under.
S.
No
Name of firm(s)
Name of drug(s), Composition &
Registration Board Meeting
Proposed
Pack size
Demanded
Price
1.
M/s Macter
International
Karachi
Milast Tablet
Each film coated tablet contains:
Roflumilast …………… 500 mcg
(Phosphodiesterase 4 inhibitors)
Per tab.
Rs.17.36/-
( M-242 )
2.
M/s Hiranis
Pharma, Karachi
Roflu Tablet
Each film coated tablet contains:
Roflumilast…………..500mcg
(Inhibitor of the enzyme PDE-4)
10’s
14’s
Rs.270/Rs.378/-
( M-243 )
3.
M/s Helix
Pharma, Karachi
Raspro 500mcg Tablet
Each tablet contains:
Roflumilast…………...500 mcg
(Anti-Inflammatory)
10’s
As per PRC
( M-243 )
Brig. Dr. Aslam Khan,
Consultant Pulmonologist,
Military Hospital,
Rawalpindi
Dr. Rehana Kauser,
Dr. Shazli Manzoor
Consultant Pulmonologist,
Quaid-e-Azam International
Pakistan Institute of Mecial Hospital, Islamabad
Sciences, Islamabad
Minutes246thMeetingRegistrationBoard
Page324
Regarding expert opinion on
efficacy, safety, quality and
cost
effectiveness
of
Roflumilast
in
the
management of COPD
Roflumilast
is
a
Phosphodiesterase-4 Enzyme
Inhibitor. FDA and EMEA has
approved this drug as an
adjunct
to
bronchodilator
therapy in the maintenance
treatment of severe chronic
obstructive pulmonary disease
(COPD)
associated
with
chronic bronchitis given for the
purpose
of
preventing
exacerbations
Roflumilast
significantly
improved
prebronchodilator
FEV1 and decreased the rate of
moderate
to
severe
exacerbations in a 52 week,
randomized trial of 3091
patients
with
COPD
.
Compared
to
placebo,
roflumilast
decreased
exacerbations (17 percent [95%,
CI 8-25]).
The use of a once daily oral
medication in COPD is
enticing;
however,
the
medication should be used as a
maintenance therapy to prevent
exacerbations rather than to
improve other COPD outcomes
It is a safe drug which is
contraindicated
only
in
moderate or severe hepatic
impairment (Child-Pugh class B
or C)
In view of the above I
recommend this drug for
registration at an affordable
Regarding expert opinion on
efficacy, safety, quality and
cost
effectiveness
of
Roflumilast in the management
of COPD. FDA and EMEA
approved this drug for use in
COPD management in severe
and very severe COPD. This
drug reduce Exacerbations rate
in COPD also included in
GOLD guidelines
However
certain
studies
reported no much beneficial
role in the COPD patients.
Clinical Studies have also
demonstrated
higher
pharmacological activity and
better
tolerability
of
as
compared to earlier PDE-4
inhibitors. In my honest opinion
this drug may be helpful in the
management of COPD in
combination with other drugs
so it should be cost effective
and affordable to the patients.
Minutes246thMeetingRegistrationBoard
Regarding expert opinion on
efficacy, safety, quality and cost
effectiveness of Roflumilast. In
this
connection
I
would
recommend that Roflumilast
(PDE4 inhibitor), is an FDA and
EMEA approved drug with
established
role
in
the
management of COPD. This has
been proven to reduce COPD
exacerbations in various clinical
trials and also included in GOLD
guidelines 2014. Clinical Studies
have also demonstrated higher
pharmacological activity and
better tolerability of Roflumilast
as compared to earlier PDE-4
inhibitors. Therefore, Roflumilast
500mcg orally once a day if made
available in Pakistan especially
from Macter platform due to
quality and cost effectiveness
concern; it can held in reducing
suffering due to exacerbations of
COPD.
Page325
price.
Decision:
Registration Board discussed and agreed to above expert opinions. However,
the Board advised firm to provide data for stability studies conducted under zone IV-A
conditions as per ICH / WHO guidelines for consideration of Registration Board.
iii.
Cocard Plus 75/75MG Tablet – M/S Helix Pharma, Karachi.
Registration Board in 237th meeting approved following product of M/s Helix Pharma,
Karachi subject to reason mentioned in last column. Accordingly provided data was referred to
expert for views. Comments are as under.
S.
No
Name of drug(s) & Composition
1
Cocard Plus 75/75mg Tablet
Each tablet contains:
Clopidogrel bisulfate eq. to
clopidogrel……….75 mg
Aspirin as enteric coated
pellets………….…75 mg
(Anti coagulant anti platelet)
Demand
ed Price
10’s
As per
PRC
Decision
Approved subject to
confirmation
of
Bilayered
tablet
manufacturing facility
Dr. Amanullah Khan,
Director, Drug Testing
Laboratory,
Government of Baluchistan,
Quetta
Mr. Abdul Razzaq,
Director, Drug Testing
Laboratory,
Government of Sindh,
Karachi
Mr. Muhammad Jamil Anwar,
Director, Drug Testing
Laboratory,
Government of Punjab,
Lahore
COCARD PLUS 75/81MG
TABLET dissolution profile is
different from the originator
brand (OGREL PLUS 81
TABLET OF M/S BOSCH
PHARMA,
Karachi)
and
scientifically the dissolution
method applied is incorrect
Tablet COCARD PLUS is a
bilayered
film
coated
(Antiplatelets) having 02
years shelf life is indicated in
different kind of CV diseases.

The
comparative
dissolution profile of
M/s
Helix
Pharma
COCARD PLUS 75/81MG
TABLET
It is observed that necessary
equipment, particularly Bilayered
Tableting Machine is available for
manufacturing of Cocard Plus 75mg
/81mg Tablet.
The accelerated stability studies for
Minutes246thMeetingRegistrationBoard
Proposed
Pack size
Page326
because they use separate tablet
of Cocard for acid and buffer
stages rather replacing the
buffer medium from acid to
buffer stage, hence on scientific
grounds of dissolution profile
the product COCARD PLUS
75/81MG TABLET is not
recommended.




Products “ COCARD
PLUS Tablets” with
originator
Brand
“
OGREL
PLUS
81
TABLETS” by M/s
Bosch Pharmaceuticals,
Karachi” was thoroughly
checked & evaluated.
The stability profile
shows that stability
studies was carried out,
and there was no
significant physical and
chemical changes when
product was kept at 40o
C + 2o C /75% RH +
5%, provided proof of
climatic chamber, also
complies the other tests
performed
such
as
weight variation, Assay,
disintegration
time,
dissolution and other
aspects that meets the
required
quality
specifications.
The data provided
also
reflects
that
manufacturing method /
equipments / instruments
are properly validated
and calibrated.
The
last
panel
inspection
was
conducted on 28-062013 & for verification
of bilayered tablets
manufacturing facilities
was conducted 06-122013 wherein they stated
that the firm has good
facilities provided for
manufacturing
and
quality control and GMP
Compliance was found
good / satisfactory.
The data provided is
sufficient regarding raw
material specification &
Minutes246thMeetingRegistrationBoard
the product has been carried out
with the concluded results of active
ingredient within the limits and also
shows that no significant physical
and chemical change occurred
during accelerated stability study
carried out for six months.
The Dissolution Profile of the
product Batch TF001 has been
studied in acidic and buffer stage
and observed satisfactory. The
comparative study with the other
brand “Ogrel Plus 81mg Tablets of
M/s Bosch Pharma, Karachi was
also carried out with the acceptable
results.
In the light of above and as per
data / information provide the
drug “Cocard Plus 75mg /81mg
(Clopidogrel 75mg + Aspirin
81mg) Tablet is recommended for
registration.
Page327

finished
product
specification
&
analytical
procedures,
labeling, packing is also
available.
So In the light of
above mentioned facts
& data provided the
drug COCARD PLUS
Tablets
is
recommended
for
registration.
It is to mention here that following is correct formulation submitted by the firm and same has
been evaluated by experts. However, erroneously wrong formulation has been mentioned in
agenda and minutes of 245th Registration Board meeting:Cocard Plus 75/81mg Tablet
Each tablet contains:
Clopidogrel bisulfate eq. to clopidogrel…….75 mg
Aspirin as enteric coated pellets………….…81 mg
(Anti coagulant anti platelet)
Decision:
Registration Board decided to forward comments of Director DTL, Quetta to
the manufacturer for clarification.
iv. Dexlansoprazole - M/s OBS Pakistan, Karachi
Registration Board in its 235th meeting deferred following products of M/s OBS Pakistan,
Karachi for reason mentioned in last column.
Name of Drug & Composition
Kapdex 30mg Capsule
Each capsule contains:Dexlansoprazole ………..30mg
(Anti ulcerants)
Minutes246thMeetingRegistrationBoard
Pack
14’s
Demanded
MRP
Rs.840.00
Decision
Deferred.
Not
metoo
product.
May be referred to
expert committee
for new molecule
Page328
Kapdex 60mg Capsule
Each capsule contains:Dexlansoprazole ……...60mg
(Anti ulcerants)
14’s
Rs.1260.00
Deferred.
Not
metoo
product. May be
referred to expert
committee for new
molecule
Registration Board in 245th meeting discussed same formulation and agreed to expert
opinions and advised the firms to provide data for stability studies conducted under zone IV-A
conditions as per ICH / WHO guidelines for consideration of Registration Board.
M/s OBS Pakistan, Karachi has deposited remaining fee (Rs.50000/-) and requested to consider
their above formulations.
Decision:
Keeping in view decision of 245th meeting of registration board regarding same
formulation, the advised firm to provide data for stability studies conducted under zone
IV-A conditions as per ICH / WHO guidelines for consideration of Registration Board.
b. Cases for registration of Tramadol.
Registration Board in its 236th meeting held on 20th November, 2012 had decided
that since Nalbuphine and Tramadol are not controlled drugs as per INCB regulation. So the
Board will not consider these cases in light of controlled drug guidelines. However to avoid
misuse potential, their procurement and manufacturing record shall be strictly maintained and
submitted in quadruplicate under Rule 30 (6) of Drugs (Licensing, Registering and Advertising)
Rules, 1976 to the E&M (Evaluation of Monitoring) Department of DRAP.
In light of above decision for registration of Tramadol containing product of
following firm was pending for decision. Firm has deposited the remaining fee @ Rs.12000/- as
per revised schedule for fees. Details are as under:S. No. Name of firm Name of Drug(s)
Pack
MRP
Decision
1.
10ml
As per PAC
225th RB
M/s Safe
Pharmaceutic
Magadol Drops
Each ml contains:-
Minutes246thMeetingRegistrationBoard
Page329
als, Karachi
Tramadol HCl ………2.5mg
(Non Narcotic Analgesic)
-do-
Magadol Capsule
Each capsule contains:Tramadol HCl ………50mg
(Non Narcotic Analgesic)
2.
Decision:
Deferred for
confirmatio
n of facility
1x10’s
As per PAC
-do-
Registration Board deferred the case for evaluation of registration
application as per approved check list.
c. Registration of Agomelatine Tablet 25mg.
Registration Board in its 227th meetings deferred following products of M/s Nabiqasim
Industries, Karachi and M/s PharmaEvo, Karachi for confirmation of formulation, application on
Form 5D, fee Rs.15, 000.
M/s Nabiqasim Industries, Karachi
Name of Drug & Composition
Modton Tablet 25mg
Each film coated tablet contains:Agomelatine ……25mg
(Antidepressant)
Pack
10’s
Demanded
MRP
Rs.1500.00
M/s PharmEvo, Karachi.
Name of Drug & Composition
Agloda 25mg Tablet
Each tablet contains:Agomelatine ……..25mg
(Anti depressant)
Minutes246thMeetingRegistrationBoard
Pack
10’s
14’s
28’s
Demanded
MRP
Rs.2690/Rs.3750/Rs.7500/-
Page330
Later on scrutiny of registration data reveals that the above formulation is already approved by
the Registration Board in its 236th meeting in favour of M/s Servier Research and Pharmaceuticals
(Pakistan) Ltd, Lahore under the brand name “ Valdoxan 25mg Tablets”
M/s PharmEvo has deposited remaining fee @ Rs.5,000/- and M/s Nabiqasim Industries,
Karachi has also deposited fee @ Rs.15,000/- (dated 10-08-2010) + Rs.52,000/- (dated 2401-2013) + Rs.5,000/- (dated 06-05-2013)
Decision:
Registration Board deferred the case for evaluation of registration
applications as per approved check list.
d. Kaizen Pharmaceutical (Pvt.) Ltd , Karachi
i.
Calcium citrate + Vitamin D.
Registration Board in its 237th meeting deferred following registration application of M/s
Kaizen Pharmaceuticals (Pvt.) Ltd, Karachi for reason mentioned in last column.
Name of drug(s) & Composition
Calvit-D Sachet
Each sachet contains:
Calcium citrate
maleate…………..2500mg
Vitamin D……….400 IU
(Calcium and Vitamin
supplement/replacement preparation)
Proposed
Pack size
10’s
20’s
Demanded
Price
As per PRC
Date of
application,
Diary No. &
Form
28-01-2013
Dy.No.60
Form-5
Rs.20,000/-
Decision
Deferred
submission
application
form-5D
balance fee
for
of
on
with
Now firm has stated that same formulation is already registered in favour of M/s Maple
Pharmaceuticals, Karachi with the brand name “Calcivit Sachet” Reg. No.076051 in 234th
meeting of Registration Board.
Decision:
Registration Board deferred the case for evaluation of registration
application as per approved check list.
Minutes246thMeetingRegistrationBoard
Page331
ii.
Alfacalcidol + Calcium carbonate
Registration Board in its 237th meeting deferred following registration application of M/s
Kaizen Pharmaceuticals (Pvt.) Ltd, Karachi for reason mentioned in last column.
Name of drug(s) & Composition
Alfakal Tablet
Each tablet contains:
Alfacalcidol ………....0.5 mcg
Calcium carbonate….1000 mg
(Calcium and Vitamin Analogue)
Proposed
Pack size
10’s
20’s
30’s
Demanded
Price
As per PRC
Date of
application,
Diary No. &
Form
28-01 -2013
65
Form-5
Rs.60,000/-
Decision
Deferred
for
Clarification
regarding dosage
of calcium
Now firm has stated that same formulation is available / marketed by M/s SchazooZaka
(Pvt.) Ltd, Lahore with the brand name “Bone-Care C Tablet” vide Reg. No.062790.
Decision:
Registration Board deferred the case for evaluation of registration
application as per approved check list.
e. Sodium Polystyrene– M/s PharmaEvo, Karachi.
Registration Board in its 227th meeting deferred following product of M/s PharmaEvo,
Karachi for expert opinion.
S.
No
Name of drug(s) & Composition
1
Klenar Sachet
Each sachet contains:Sodium Polystyrene
Sulphonate …………..…15000mg
(Potassium removing resin)
Proposed
Pack size
15’s
30’s
Demanded
Price
Rs.3000.00
Rs.6000.00
Date of
application,
Diary No. &
Form
02-11-2009
2229
Form-5
Rs.8000/-
Decision
Deferred for
expert
opinion
Now M/s PharmEvo have deposited remaining fee @ Rs.42,000/- being new formulation.
Minutes246thMeetingRegistrationBoard
Page332
Decision:
Registration Board deferred the case for evaluation of registration
application as per approved check list. Moreover, the product will be referred to Prof. Dr.
Ghias Butt, PIMS, Islamabad; Syed Ather Hussain, Head of Nephrology, Agha Khan
University Hospital, Karachi and Uzma Bano, FFH, Rawalpindi for expert opinion.
f. Macter International, Karachi
Following products of M/s Macter International, Karachi was deferred by Registration
Board in 214th meeting for confirmation of atomic absorption spectrophotometer.
Name of Drug & Composition
Mactosin Suspension
Each 5ml contains:Ossien Mineral Complex (Hydroxy Apatite)
800mg equivalent to
Calcium ………….
130mg
Phosphorous …………… 68.8mg
Residual Mineral Salts ….57.5mg
Collagen …………………87.5mg
Other Proteins …………20mg
Trace elements F1,mg,Zn,Fe,Ni,Cu)
Mactosin Tablets
Each tablet contains:Ossien Mineral Complex (Hydroxy Apatite)
250mg equivalent to
Calcium ….53.5mg
Phosphorous …….24.8mg
Residual Mineral Salts ….7.5mg
Collagen …………………87.5mg
Other Proteins …………
Trace elements F1,Mg,Zn,Fe,Ni,Cu)
Pack
60ml
Per tablet
Demanded
MRP
Rs.100.00
Rs.5.33
Later on scrutiny of registration data reveals typographic error in above formulation.
Correct formulation as applied by the firm are as under:Correct Formulation
Mactosin Tablets
Minutes246thMeetingRegistrationBoard
Page333
Each tablet contains:Ossien Mineral Complex (Hydroxy Apatite) 800mg
equivalent to
Calcium ………….
130mg
Phosphorous …………… 68.8mg
Residual Mineral Salts ….57.5mg
Collagen …………………67.5mg
Other Proteins …………..…20mg
Trace elements F1,mg,Zn,Fe,Ni,Cu)
Mactosin Suspension
Each 5ml contains:Ossien Mineral Complex (Hydroxy Apatite) 250mg
equivalent to
Calcium ………….53.5mg
Phosphorous …….24.8mg
Residual Mineral Salts ….7.5mg
Collagen …………………87.5mg
Other Proteins ………… 20mg
Trace elements F1,Mg,Zn,Fe,Ni,Cu)
Federal Inspector of Drug, Karachi in inspection dated 27.09.2012 confirmed atomic
absorption in the Quality Control Laboratory of the firm.
Decision:
Registration Board approved correct formulation for registration.
g. M/s Bosch Pharmaceuticals, Karachi.
Registration Board in 228th & 244th meeting deferred following products of M/s Bosch
Pharmaceuticals, Karachi reason mentioned in last column.
S. No. Name of drug(s) & Composition
1.
Calamox Chewable Tablet 200mg
Each chewable tablet contains:Amoxycillin as Trihydrate ..200mg
Clavulanic Acid as
Potassium ……….….28.50mg
Minutes246thMeetingRegistrationBoard
Proposed
Pack size
Not
mentioned
Demanded
Price
Not
mentioned
Decision
Deferred for confirmation of
international availability &
expert opinion
Page334
(Antibiotics)
Calamox Chewable Tablet 400mg
Each chewable tablet contains:Amoxycillin as Trihydrate ..400mg
Clavulanic Acid as
Potassium ………………….57 mg
(Antibiotics)
Calamox Dispersible Tablet 375mg
Each Dispersible tablet contains:Amoxycillin as Trihydrate ..250mg
Clavulanic Acid as
Potassium ………………...125mg
(Antibiotics)
Calamox ES Oral Suspension
Each ml contains:
Amoxycillin as
Trihydrate……….600 mg
Clavulanic acid as potassium salt……
42.9 gm
(ntibiotic / antibacterial for microbial
diseases)
2.
3.
4.
5.
Calamox-XR Tablet
Each extended release tablet contains:
Amoxycillin as
trihydrate ……….…...1 gm
Clavulanic acid as
potassium…………… 62.5 mg
(Antibiotic / antibacterial for microbial
diseases)
Now firm has stated as under:-
Not
mentioned
Not
mentioned
-Do-
Not
mentioned
Not
mentioned
-Do-
75ml
125ml
200ml
6’s
14’s
28’s
Rs.225.00
Rs.375.00
Rs.600.00
Deferred for confirmation of
me too status
Rs.180.00
Rs.420.00
Rs.840.00
Deferred for confirmation of
me too status.
For products at S. No.1 – 3


Remaining fee @ Rs.35,000/- for each product
Application of Form-5-D
For products at S. No.4 – 5


Remaining fee @ Rs.23,000/- for each product
Application of Form-5-D
Decision:
Registration Board advised firm to provide data for stability studies
conducted under zone IV-A conditions as per ICH / WHO guidelines for consideration of
Registration Board.
Minutes246thMeetingRegistrationBoard
Page335
Case No.20
De-Registration of registered drugs.
M/s Tabros Pharma, Karachi have requested for de-registration of their registered drugs,
as per following details:S. No.
1.
Name of drug(s)
Tabromide Capsule 2mg
Each capsule contains:Loperamide HCl …….2mg
Reason / Justification
Due
to
some
unavoidable
circumstances and unfeasibility in the
market
2.
Evac 100mg Tablets
Each chewable coated tablet
contains:Alpha Tocopherol
Acetate J.P ……………100mg
021801
-do-
3.
Evac 200mg Tablets
Each chewable coated tablet
contains:Alpha Tocopherol
Acetate J.P ……………200mg
021802
-do-
4.
Evac 400mg Tablets
Each chewable coated tablet
contains:Alpha Tocopherol
Acetate J.P ……………400mg
021803
-do-
5.
Evac 600mg Tablets
Each chewable coated tablet
contains:Alpha Tocopherol
Acetate J.P ……………600mg
021804
-do-
6.
Pyrazol 500mg Tablet
Each tablet contains:Pyrazolone Magnesium 500mg
014346
-do-
Decision:
Registration Board deferred the case for presentation before the Board.
Minutes246thMeetingRegistrationBoard
Reg. No.
014296
Page336
Case No.21
Grant of Registration – Mentioning of two MRPs for a formulation.
Registration Board in its 242nd meeting approved following registration in favour of M/s
The Searle Company Ltd, Karachi and accordingly registration letter was issued as per following
details.
S. No
Reg. No.
1
076280
2
076281
3
076282
Name of Drug(s) &
Composition
Peditral-R (Bubble Gum Flavor)
Powder
(Low Osmolar Formulation)
Each sachet contains:Pre-cooked Rice Powder…...6g
Sodium Chloride ……….0.35g
Potassium Chloride ……0.30g
Sodium Citrate ………..0.58g
(Manufacturer’s Specifications)
Peditral-R (Mango Flavor)
Powder
(Low Osmolar Formulation)
Each sachet contains:Pre-cooked Rice Powder…...6g
Sodium Chloride ……….0.35g
Potassium Chloride ……0.30g
Sodium Citrate ………..0.58g
(Manufacturer’s Specifications)
Peditral-R (Orange Flavor)
Powder
(Low Osmolar Formulation)
Each sachet contains:Pre-cooked Rice Powder…...6g
Sodium Chloride ……….0.35g
Potassium Chloride ……0.30g
Sodium Citrate ………..0.58g
(Manufacturer’s Specifications)
Packing
MRP
10’s Sachet
Rs.100.00
10’s Sachet
Rs.100.00
10’s Sachet
Rs.100.00
Later on firm has stated that basically they have filed for pack size of 10’s in registration
dossier including Costing, pack proposed labeling & design but only in Form-5 pack size 20’s
were also mentioned by mistake. Being brand leader they have demanded the MRP Rs.200/- for
10 sachets. While minutes of meeting 242nd of RB shows only pack size of 20’s instead of
10’s.Firm has also submitted that Drug Pricing Committee in its 15th meeting dated 12-04-2011
has already fixed MRP Rs.140/- for pack size of 10’s for same formulation.
Minutes246thMeetingRegistrationBoard
Page337
Case was referred to Evaluation Cell and they explained that firm has applied for both
packs / prices i.e Rs.200/20’s & Rs.200/10’s in the same dossier.
Decision:
Registration Board referred to Cost & Pricing Division, DRAP for their
opinion on the case.
Case No.22
Transfer of registered drugs:
a. Transfer of registration from import to local manufacturing:
M/s The Searle Company Ltd, Karachi have requested for transfer of registration
of following drugs from import to local manufacturing at their own facility i.e M/s The Searle
Company Ltd, F-319, S.I.T.E, Karachi
S. No.
Reg. No.
Name of drug (s)
1
010172
2.
023317
Tramal – 100 Injection
(Tramadol)
Tramal SR100mg Tablet
(Tramadol)
As per SOP, supporting documents were sent for expert opinion to three (03) experts and
now two (02) experts out of three (03) has sent their opinion. Details of comments of experts are
as under:-
Prof. Nadeem Irfan Bukhari,
Faculty of Pharmacy,
University of the Punjab,
Lahore
The report sent for the above
subject shows the results of
ongoing real time stability
studies of Tramal SR Tablets
and
Tramal
100mg/2ml
Injection. It is understood that
the case has been filed for the
transfer of registration from
Director,
Drug
Testing
Laboratory,
Government
of
Bluchistan,
Quetta
After thorough review of
the stability data and
validation of analytical
methods of the products of
Tramal SR Tablets 100mg
and
Tramal
Injection
100mg/2ml Injection is
recommended.
Minutes246thMeetingRegistrationBoard
Director,
Drug Testing Laboratory,
Government of Punjab,
Lahore
Awaited
Page338
import to local manufacturing
this
regard
the
at their local facility. My In
opinion / comments are as undersigned scientifically
and logically comments as
follows:under:The data provided on tablet
formulation indicated that the Stability Studies:
strength (assay) of tramadol
HCl , dissolution test and the The stability studies of
physical characteristics were both Tramal 100 Injection
within
the
limits
and as well as Tramal SR
specifications after the real time 100mg Tablets have been
one year and accelerated carried out against ICH
guidelines.
studies.
The data given on the injection The results of ongoing real
stability
studies
formulation showed that the time
all
physical
tramadol was stable in this showing
formulation during real time as parameters and assay of
well as in the accelerated Tramadol HCl is well
within the specified limits.
stability study.
at
accelerated
The data on real time and Also,
accelerated study
reflected condition the stability data
some variations which were is found satisfactory.
minor and within the acceptable The data given on
Tramadol SR Tablets
limits.
that
the
The HPLC method developed specified
for each formulations was dissolution test, assay of
linear, precise and accurate, Tramadol and physical
of
the
through LOQ and LOD was not characteristics
provided. Meanwhile the drug formulation is within the
peaks were shown to be limits in ongoing stability
resolved
well
without studies (real time and
interference. Furthermore, the accelerated).
drug peaks seem to be
responsive to the changes in Validation data
concentrations of the tramadol
The validation studies of
HCl in the samples.
both products have been
Keeping the general reflection, evaluated the results are
the data on the stability and found satisfactory.
HPLC method of Tramal SR
Tablets 100mg and Tramal Therefore keeping in view
Injection 100mg/2ml Injetion the present data provided
by the firm for both their
seem to be appropriate.
products, the undersigned
Minutes246thMeetingRegistrationBoard
Page339
is of the opinion to
recommend
the
registration of Tramal -100
Injection
(Tramadol)
100mg/2ml
(Reg.
No.010172 and Tramal SR
100mg Tablets (Tramadol)
(Reg.
No.023317)
in
favour of the firm.
As per practice in vogue cases for transfer of registration from import to local
manufacturting are considered at same terms and condition including MRP. Cost & Pricing
Divison was also consulted, who confirmed to proceed as per previous practice. Form 5 has
already been evaluated by PEC as per check list approved by Registration Board.
Decision:
Registration Board decided as follows:
 Cancellation of registrations of Tramal – 100 Injection, Registration No. 010172 and
Tramal SR100mg Tablet, Registration No. 023317 from M/s Serale
Pharmaceuticals, Karcahi.
 Grant of registrations of Tramal – 100 Injection, Registration No. 010172 and
Tramal SR100mg Tablet, Registration No. 023317 in name of M/s The Searle
Company Ltd, F-319, S.I.T.E, Karachi for local manufacturing.
b.
Transfer of registrations from M/s Macter International, Karachi to M/s Ray
Pharma, Karachi.
M/s Ray Pharma, Karachi have requested for transfer of registration of following drugs
from M/s Macter International, Karachi to their name. Registration dossiers were evaluated by
Incharge PEC and DDC (R-II) as per check list approved by the Registration Board and firm has
also rectified shortcomings and following recommendations were framed.
S.
Reg. No.
No.
01 000482
02
004298
Name of Drug(s)
Genticyn Ear / Eye May be approved subject to confirmation
Drops
of renewal status
Genticyn HC Ear / Referred to Review Committee or may be
Eye Drops
discussed in Registration Board due to the
reason that these formulations have not
been found approved in SRA’s (reference
drug agencies)
Minutes246thMeetingRegistrationBoard
Recommendations
Page340
03
000497
Genticyn
0.1% w/w
Cream May be approved subject to confirmation
of renewal status
04
000483
Genticyn HC Cream
05
010186
Genticyn B Cream
06
007701
Multigesic Cream
Referred to Review Committee or may be
discussed in Registration Board due to the
reason that these formulations have not
been found approved in SRA’s (reference
drug agencies)
-doMay be approved subject to confirmation
of renewal status
Renewal status of products are as follows:S.
Reg. No. Name of Drug(s)
No.
Initial date
Aplication
receiving
date
Renewal
status
01
000483
Genticyn HC Cream
06-09-2006
Application
received after
expiry date and
grace period
24-02-2012
Registraion
is not valid
02
03
04
010186
007701
000482
Genticyn B Cream
Multigesic Cream
Genticyn Ear / Eye Drops
-do-do07-06-2012
05
004298
Genticyn HC Ear / Eye
Drops
-do-do24-08-1978
Trasnfer of
regn date
18-06-2007
-do-
-do-doRegistraion
is valid
upto
17-06-2017
-do-
000497
Genticyn Cream 0.1%
w/w
06-09-2006
Application
received after
expiry date
and grace
period
24-02-2012
06
Decision:


Registraion
is not valid
Registration Board decided as follows:
Cancellation of registrations of Genticyn Ear / Eye Drops, Regn No. 010186 from
M/s. Macter International, Karachi.
Grant of registrations of Genticyn Ear / Eye Drops, Regn No. 010186 in name of
M/s. Ray Pharma, Karachi. Chairman, Registration Board will permit issuance of
Minutes246thMeetingRegistrationBoard
-do-
Page341


c.
registration letter after comments of Cost & Price Division.1
Genticyn HC Ear / Eye Drops, Registration No. 004298 referred to review
committee as it’s not found approved in SRA’s (reference drug agencies).
Registrations of Genticyn HC Cream, Genticyn B Cream, Multigesic Cream and
Genticyn Cream 0.1% w/w are not valid.
Transfer of registration from M/s Macter Pharmaceutical (Pvt.) Ltd, Karachi to
M/s Macter International (Pvt.) Ltd, Karachi.
M/s Macter International (Pvt.) Ltd, Karachi has requested for transfer of their following
registered drug from previous name i.e M/s Macter Pharmaceutical (Pvt.) Ltd, Karachi to new
name i.e M/s Macter International (Pvt.) Ltd, Karachi.
Sr.
No.
1.
Registration No.
Brand
Name(s)
Formulation/Generic
Name
011206
Relaxin
Tablets 3mg
Bromazepam
Date of
Registration
06-06-1990
Renewal
Status
Valid up to
05-06-2015
Central Licensing Board in its 238th meeting held on 19-11-2014 approved Tablet
(Psychotropic) / Narcotic) Section as segregated section.
Decision:
Registration Board approved registration of Relaxin Tablets 3mg in name of
M/s Macter International (Pvt.) Ltd, Karachi.
Case No.23
Change of Contract Manufacturer – M/s B. Braun Pakistan (Pvt.) Ltd, Karachi
M/s B. Braun Pakistan (Pvt.) Ltd, Karachi was granted approval for transfer of
registration from Import to Local manufacturing by contract manufacturing at M/s Mac & Rains
Pharmaceuticals (Pvt.) Ltd, Lahore. Now firm has requested for change of contract
manufacturing from M/s Mac & Rains Pharmaceuticals (Pvt.) Ltd, Lahore to M/s Frontier
Dextrose Ltd, Hattar as the M/s Mac & Rains were unable to manufacture their medicine due to
hiring of their plant by M/s Searle Pakistan.
1.
Applicant
Contract
manufacturer
Reg. No.
M/s B.
Braun
M/s Frontier
Dextrose Ltd,
053854
Minutes246thMeetingRegistrationBoard
Name of drug(s) & Composition
B. Braun-RL Infusion
Each 100ml contains:-
Date of
application,
Diary No. &
Form
03-06-2014
537
Category
Import to
local
Page342
Pakistan
(Pvt.) Ltd,
Karachi
Haripur
Sodium Chloride …..0.600gm
Sodium Lactate …..…0.32gm
Potassium Chloride…0.040gm
Calcium
Chloride 2H2O …...0.027gm
Form-5
Rs.50,000/-
contract
2.
-do-
-do-
053855
B. Braun-RLD Infusion
Each 100ml contains:Sodium Chloride …..0.600gm
Sodium Lactate …..…0.32gm
Potassium Chloride…0.040gm
Calcium
Chloride 2H2O …...0.027gm
Dextrose Anhydrous for
Parenteral …………5.5gm
03-06-2014
538
Form-5
Rs.50,000/-
Import to
local
contract
3.
-do-
-do-
053848
B. Braun – Paeds Infusion
Each 100ml contains:Sodium Chloride …..0.45gm
Dextrose Anhydrous for
Parenteral use………5.0gm
03-06-2014
543
Form-5
Rs.50,000/-
Import to
local
contract
4.
-do-
-do-
053849
B. Braun – DS ½ Infusion
Each 100ml contains:Sodium Chloride …..0.45gm
Dextrose Anhydrous for
Parenteral use………5.00gm
03-06-2014
536
Form-5
Rs.50,000/-
Import to
local
contract
5.
-do-
-do-
053850
03-06-2014
541
Form-5
Rs.50,000/-
Import to
local
contract
6.
-do-
-do-
053851
-do-
-do-
053852
03-06-2014
535
Form-5
Rs.50,000/03-06-2014
539
Form-5
Rs.50,000/-
Import to
local
contract
7.
B. Braun – DS Infusion
Each 100ml contains:Sodium Chloride …..0.9gm
Dextrose Anhydrous for
Parenteral use………5.00gm
B. Braun – G5 Infusion
Each 100ml contains:Dextrose Anhydrous for
Parenteral use………5.00gm
B. Braun – G10 Infusion
Each 100ml contains:Dextrose Anhydrous for
Parenteral use………10.00gm
Minutes246thMeetingRegistrationBoard
Import to
local
contract
Page343
8.
-do-
-do-
053856
B. Braun - Mannitol Infusion
Each 100ml contains:Mannitol ………..17.5gm
Sorbitol for Parenteral
use…………….…2.5gm
03-06-2014
540
Form-5
Rs.50,000/-
Import to
local
contract
9.
-do-
-do-
053853
B. Braun - NS Infusion
Each 100ml contains:Sodium Chloride ……0.90gm
03-06-2014
542
Form-5
Rs.50,000/-
Import to
local
contract
The above case was deferred in 245th meeting of Registration Board for confirmation of TOC
analyzer and particle counter in M/s Frontier Dextrose Ltd, Hattar. Federal Inspector of Drugs, DRAP,
Peshawar has reported that that he has checked physically the installation of TOC analyzer and particle
counter in the said firm’s laboratory on 17-11-2014.
Decision:
Registration Board acceded to request of M/s B. Braun Pakistan (Pvt.) Ltd,
Karachi for change of contract manufacturer for above products to M/s Frontier Dextrose
Ltd, Hattar at same terms and conditions. This permission will be valid till 30.06.2015.
Case No: 24 Change of contract manufacturer-M/s Excell Health Care Laboratories
(Pvt.) Ltd, Karachi.
Following products of M/s Excell Health Care Laboratories (Pvt.) Ltd, Karachi
were registered for bulk import from M/s ACTAVIS UK Ltd, United Kingdom and local
repacking at M/s Elko Organization, Karachi.
S. No.
Name of product(s)
Reg. No.
1.
Cyclogest Pessaries 200mg
(Progesterone Pessaries)
Cyclogest Pessaries 400mg
(Progesterone Pessaries)
033181
2.
033182
Now the firm has requested for change of contract manufacturer for above mentioned
product (bulk import and local repacking) from M/s Elko Organization, Karachi to M/s Apex
Pharmaceuticals (Pvt.) Ltd, D-21-A1, S.I.T.E, Super Highway, Karachi. Firm has deposited fee
@ Rs.10, 0000/- for each product for the purpose.
Minutes246thMeetingRegistrationBoard
Page344
Registration Board in 241st meeting discussed and decided as under:The Board deliberated that reapacking is the part of manufacturing and in this case final
quality control release will be granted by local manufacturer, which will be M/s Apex
Pharmaceuticals (Pvt.) Ltd, D-21-A1, S.I.T.E, Super Highway, Karachi. Thus Board
constituted a panel comprising of Director DTL, Peshawar, Director CDL Karachi and
area FID to inspect the premesis for confirmation of repacking and quality control
facilities of the firm. The Board also advised the panel to confirm that status of imported
products whether in pessaries, blister etc. Registration Board will decide the case in light
of report of the panel.
Accordingly panel inspected the premises of M/s Apex Pharmaceuticals, Karachi
and concluded as under:During inspection, it was observed that management has provided adequate facilities for
repacking of above named products and quality control that are being imported from M/s
Actavis, United Kingdom in form of strips and management is intended to repack 15
pessaries in one pack. A room with controlled temperature is also reserved for proper
placement of bulk and repacked products.
Based on the observations made, people met, record reviewed and repacking & QC
facilities provided by the management, panel recommends the transfer of the above name
products from M/s Elko Organization, Karachi to M/s Apex Pharmaceuticals (Pvt.) Ltd,
D-21-A1, S.I.T.E, Super Highway, Karachi
Decision:
Registration Board acceded to request of M/s Excell Health Care
Laboratories (Pvt.) Ltd, Karachi for change of contract manufacturer for repacking and
quality control release of above products to M/s Apex Pharmaceuticals (Pvt.) Ltd, D-21-A1,
S.I.T.E, Super Highway, Karachi. However the firm will provide legalized COPP at WHO
format for both products and authorized its Chairman for issuance of letter. Permission is
at the same terms and conditions will be valid till 30.06.2015.
Case No.25
Issuance of duplicate registration letter.
M/s Johnson & Johnson, Karachi have requested for issuance of duplicate registration of
their following drugs:S. No.
1.
2.
3.
4.
Reg. No.
009078
009084
009083
009082
Name of Drug(s)
Daktarin Oral Gel
Daktacort Cream
Sibelium Capsule
Vermox Tablet 500mg
Minutes246thMeetingRegistrationBoard
Page345
Firm has furnished following documents to support their request:a) Copy of entry in roznamcha from concerned policy station
b) Fee @ Rs.5000/- for each product for the purpose.
Decision:
Registration Board deferred the case for confirmation of renewal status.
Case No.26
Grant of Registration for export purpose - Contract Manufacturing.
Following firm has requested for registration of drug for export purpose only,
on basis of contract manufacturing.
Contract giver
Contract
manufacturer
Name of Drug(s) & Composition
M/s Medisure Labs,
Karachi
M/s Cirin Pharma,
Hattar
Rumaclav Tablet 625mg
Each tablet contains:Amoxicillin as Trihydrate ……500mg
Clavulanic Acid as Potassium…125mg
Date of
application,
Diary No. &
Form
31-12 -2013
Form-5
Rs.50,000/-
Decision:
Registration Board approved grant of above registration on contract
manufacturing basis for export purpose only. In order to boost export, The Board also
authorized Chairman for grant of registration for export purpose on contract
manufacturing basis excluding controlled drugs and new drug as per contract manufacting
policy.
Case No.27
Grant of Registration for export purpose – Controlled Drug.
M/s Pharmatec Pakistan (Pvt.) Ltd, Karachi has requested for registration of following
drug for export purpose only:S.
No.
Date of
application
Diary No.
& Form
30-09-2014
753
Form-5
Rs.20,000/-
Name of drug(s) &
Composition
Flu-Gone C&F
Tablet
Each tablet contains:Paracetamol ...600mg
Pseudoephedrine
HCl…………60mg
Minutes246thMeetingRegistrationBoard
Information required & reply of firm




Application on Form 5 with required fee
as per relevant SRO
NOC for CRF clearance
Copy of approved section from CLB
Copy of last inspection report
An undertaking that applied registration
Page346
Chlorpheniramine
Maleate …….4mg

is exclusively for export purpose and
will not be sold in Pakistan.
If formulation / product is not registered
in Pakistan, then export order from
importing country (Registered in
Pakistan)
Above formulation is registered for local manufacturing as per following details:Applied formulations
Flu-Gone C&F Tablet
Each tablet contains:Paracetamol …….....600mg
Pseudoephedrine HCl..60mg
Chlorpheniramine Maleate..4mg
Registered in Pakistan
Reltus C&F Tab(Reg. No.024908)
Epinol-CF Tab (Reg. No.023982)
Manufacturer
M/s Pharmatec
M/s CCL, Lahore
Decision:
Registration Board discussed that applied drug contains Pseudoephedrine,
which is a precursor chemical and segregated section is required only for Narcotic Drugs
and Psychotropic substances as per Central Licensing Board decision. Thus applied
formulation registered for export purpose only.
Case No.28 Change
in
flavour
–
M/s Sanofi Aventis Pakistan Ltd, Karachi.
Gastrolyte
Rice
(Reg.No.070436)
–
M/s Sanofi Aventis Pakistan Ltd, Karachi has informed that their product
Gastrolyte Rice (Reg. No.070436) is registered in Apricot flavor. Now firm has requested for
change of flavor from Apricot to Raspberry.
Firm has submitted for information to support their request.





O6 months accelerated stability data
Undertaking
Specification & Control Method
Copy of Registration letter
Fee @ Rs.5,000/- for the purpose.
Decision:
Registration Board approved the request. However, Incharge, PEC will
evaluate the stability data and Chairman, Registration Board will authorize issuance of
permission letter on the basis of these recommendations.
Minutes246thMeetingRegistrationBoard
Page347
Case No.29
Change of manufacturing site from Contract to own facility.
Following products of M/s Medisure Labs (Pvt.) Ltd, Karachi were initially registered for
import as per following details and then permitted for local contract manufacturing from M/s
Indus Pharma, Karachi which are valid till 30.06.2015. Now M/s Medisure Labs (Pvt.) Ltd,
Karachi has informed that they have developed facility for Liquid Injectables (Ampoules &
Vials) at their own premises 17/24, Korangi Industrial Area Karachi and requested to permit
manufacturing of products at this facility.
S. No.
Reg. No.
1.
015566
2.
014084
Name of Drug(s)
Date of Registration
Rosiden Injection
Each 1ml ampoule contains:Piroxicam …………….20mg
Neurocoline 250mg/2ml Injection
Each 2ml contains:Citicoline …………….250mg
23-08-1994
01-11-1993
Registration dossiers were evaluated by Incharge PEC and DDC (R-II) as per check list
approved by the Registration Board and firm has also rectified shortcomings. It is pertinent to
mention that citicoline is under consideration of Review Committee.
Decision:
Registration Board approved request of M/s Medisure Labs (Pvt.) Ltd,
Karachi for manufacturing of Rosiden Injection, Registration No.015566 at its own
premesis. However, request of Neurocoline 250mg/2ml Injection, Registration No.014084
will be considered after recommendation of Review Committee and decision of the Board
on Citicoline.
Case No.30
Correction in Minutes:
a. M/s Amarant Pharma, Karachi
Registration Board in 245th meeting approved following registration in favour
of M/s Amarant Pharma, Karachi. Registration letter could not be issued due to following
mistake in minutes. Existing and correct formulation are as under:Minutes246thMeetingRegistrationBoard
Page348
Name of Drug(s) & Composition
Amprexa-F Tablet 12/25mg
Each tablet contains:Olanzapine ………..……12mg
Fluoxetine HCl …….……25mg
Decision:
Correct Composition
Amprexa-F Capsule 12/25mg
Each capsule contains:Olanzapine ……..………12mg
Fluoxetine HCl ………..…25mg
Registration Board approved the correction as Amprexa-F Capsule 12/25mg
instead of tablets.
Registration of Drugs for export purpose-Not me too Drugs.
Case No.31
Following firms have requested for registration of following drugs for export
purpose only which are not me-too. Details are as under:S.
No.
1.
Name of
Company
M/s
Genix
Pharma,
Karachi
2.
-do-
3.
M/s
Tabros
Pharma,
Karachi
M/s Getz
Pharma,
Karachi
4.
Name of product(s)
Sofos Tablet
Each film coated tablet
contains:Sofosbuvir MS ....400mg
Sofopas Tablet
Each film coated tablet
contains:Ledipasvir MS ……90mg
Sofosbuvir MS .......400mg
Vibrenta 400mg Tablet
Each film coated tablet
contains:Sofosbuvir MS ....400mg
Azvira 400mg Tablet
Each film coated tablet
contains:Sofosbuvir ....400mg
Minutes246thMeetingRegistrationBoard
Date of application,
Diary No. & Form
23-11-2014
769
Rs.20,000/-
Export Order
Original Export
Order from
Afghanistan
23-11-2014
770
Rs.20,000/-
Original Export
Order from
Afghanistan
19-11-2014
767
Rs.20,000/-
Copy of Export
Order from
Afghanistan
05-12-2014
771
Rs.20,000/-
Not provided
Page349
Decision:
Mr.A Q Javed Iqbal, Director QA &LT opined that for export purpose only
those formulations should be registered, which are already registered in Pakistan. For new
formulations (which are not registered in Pakistan), manufacturers should first conduct
stability studies and then registration for export purpose be granted. Prof. Muzammil H
Najmi also endorsed it. Registration Board after deliberation decided that inorder to
facilitate export of quality drugs (non-me too drugs), export registration will be granted
and manufacturer will comply following conditions before export of drug:


Manufacturer will export the product after complying all the conditions as required
under Drug Act, 1976 including No objection certificate from concerned DRAP
office. Moreover, Federal Inspector of drugs will take sample from each
consignemnet for analysis from CDL, Karachi.
Manufacturer will also furnish export documents endorsed from custom authorities
in order to ensure the export of the product.
Registration Board approved above products for registration for export purpose only
with aforementioned conditions. These conditions will also be applicable to products
approved for exports (Sofosbuvir) by Chairman, registration Board
Minutes246thMeetingRegistrationBoard
Page350
Registration-III
Case No.32
Registration Board in its 229th meeting approved the following product of M/s Global
Pharmaceutical, Islamabad.
S.No.
1.
Name and Composition of
Product
Tamsol-D Tablets
Each film coated tablet
contains:Tamsulosin Hydrochloride 0.4
mg
(as modified – release tablets)
Dutasteride………………0.5
mg
Pack size
10’s
Demanded
Price
As Per SRO
Fee
Rs:8,000/=
The Registration Board reconsidered the decision of 229th meeting which is as follows:
“Decision: Registration Board after considering the technical opinion by its
members decided to ask the manufacturer to appear before Registration Board
for presentation of his opinion regarding efficacy of the above drug
formulation. The Board further ordered that till final decision, the registration
of above product would remain suspended under section 7(11) (ad) of Drug
Act, 1976.”
Decision:
Registration Board discussed the case and decided to issue show cause notice
to M/s Global Pharmaceutical, Islamabad for cancellation of registration.
Case No.33
M/s. Amgomed, Islamabad has requested to transfer of the following drug from being
imported for local manufacturing on contract basis by M/s. Bio-Lab (Pvt) Limited, Islamabad:S.N
o.
1
Reg.
No.
Name and Composition of
Product
053821 Amgozole Injection
Each vial contains:Omeprazole Sodium
≡ Omeprazole……40 mg
Minutes246thMeetingRegistrationBoard
Pack size
Demanded
Price
Per vial
As Per SRO
Page351
(Proton Pump Inhibitor)
The dossier has been submitted along with fee amounting Rs.50,000 and has been evaluated
with the collaboration of the Incharge Evaluation Cell as per check list.
Decision:
Registration Board approved request of M/s. Amgomed, Islamabad for
contract manufacturing of Amgozole Injection, Registration No. 053821 from M/s. Bio-Lab
(Pvt) Limited, Islamabad. This permission will be valid till 30.06.2015.
Case No. 34.
M/s. Quaper (Pvt) Limited, Sargodha has requested to transfer the manufacturing site from
M/s. Fassgen Pharmaceuticals, Hattar to M/s. Mediate Pharmaceuticals, Karachi on contract
basis:054069
Cefein 250 Injection IV
Each vial contains:Ceftriaxone Sodium
≡ Ceftriaxone……..250
mg
(Cephalosporin)
2. Fassgen
Mediat 054077
e
Cefein 500 Injection IV
Each vial contains:Ceftriaxone Sodium
≡ Ceftriaxone……..500
mg
(Cephalosporin)
3. Fassgen
Mediat 054073
e
Cefein 250 Injection IV
Each vial contains:Ceftriaxone Sodium
≡ Ceftriaxone……..1g
(Cephalosporin)
4. Fassgen
Mediate 054067
Rayxime 400 mg Capsule
Each capsule contains:Cefixime Trihydrate
≡ Cefixime…………400
mg
(Cephalosporin)
1.
From
Fassgen
Hattar
To
Mediat
e
Karachi
Minutes246thMeetingRegistrationBoard
Page352
5. Fassgen
Mediat 054065
e
Rayxime 100 mg Dry
Suspension
Each 5ml contains:Cefixime Trihydrate
≡ Cefixime…………100
mg
(Cephalosporin)
The dossiers have been submitted along with fee of Rs:50,000/each and have been evaluated
with the collaboration of the Incharge Evaluation Cell as per check list.
Decision:
Registration Board approved the request of M/s. Quaper (Pvt) Ltd.,
Sargodha for change in contract manufacturer of above products from M/s.
Fassgen Pharma to M/s. Mediate Pharma, Karachi. Permission is at already
approved terms and conditions.
Case No.35
Registration Board in 242nd meeting approved the registration of following drug
of M/s. Olive Laboratories, Rawat.
S.N
o
1.
Existing name with approved
Correct formulation/Nomenclature
Composition
1. Hepatavir 300 mg Tablets
1. Hepatavir 300 mg Tablets
2.Tablets
2.Tablets
3. Each film coated Tablet
3. Each film coated Tablet contains:
contains:
Tenofovir Disoproxil
Tenofovir Disoproxil Fumarate
Fumarate…300 mg
….30 mg
4. Anti-retroviral / Nucleoside and
4. Anti-retroviral / Nucleoside and Nucleotide Reverse Transcriptase
Nucleotide Reverse Transcriptase
Inhibitors
Inhibitors
The Evaluation Cell stated that the firm had correctly applied for Tenofovir Disoproxil
Fumarate 300 mg film coated tablet but inadvertently incorporated as 30mg in agenda and
minutes of 242nd meeting. The abovementioned inadvertent typographical error of the strength
needs rectification as Tenofovir Disoproxil Fumarate 300 mg.
Decision:
Registration Board approved the correction as Tenofovir Disoproxil
Fumarate 300mg Tablet.
Minutes246thMeetingRegistrationBoard
Page353
Case No.36
Registration Board in 244th meeting deferred the following registration applications of M/s.
Welwink Pharmaceutical, Gujranwala for manufacturing by M/s. Weather Fold Pharmaceuticals,
Hattar on contract basis in view of required GMP inspection as mentioned below:
M/s Welwink
Pharmaceuticals.
G.T Road,
Industrial Estate,
Gujranwala
Cantt.
Gujranwala
Acticef 500 mg Powder
for reconstitution of IM
Injection
Each Vial contains:Ceftriaxone Sodium
≡ Ceftriaxone ……500
mg
(Cephalosporin
Antibiotic)
(USP Specs)
Manufacturing
on Contract
basis by
M/s Weather
Folds
Pharmaceuticals.
Plot 69/2,
Phase-2,
Industrial Estate,
Hattar
-doActicef 250 mg Powder
for reconstitution of IM
Injection
Each Vial contains:Ceftriaxone Sodium
≡ Ceftriaxone…….250
mg
(Cephalosporin
Antibiotic)
-do-
Acticef 250mg Powder
for reconstitution of IV
Injection
Minutes246thMeetingRegistrationBoard
Form 5
18-07-2012
Dy No
7333
21-05-2013
Rs.
150,000/As Per
SRO
1‟s
vial
FDA. (Rocephin
(Roche)
SPORCEF(LOWITT
PHARMACEUTICALS
(PVT) LTD)
Advised for further
improvement in
different sections.
(22-03-2014)
Deferred
for
GMP inspection
of
contract
manufacturer by
panel
comprising of
Dr. Muzammal
H.
Najmi,
Director QA
& LT and Area
FID. Contract
giver will be
inspected
by
Area FID as last
inspection
report is more
than 01 year old
Form 5
18-07-2012
Dy No
7336
21-05-2013
Rs.
150,000/As Per
SRO/1‟s
vial
SPORCEF(LOWITT
PHARMACEUTICALS
(PVT) LTD)
Advised for further
improvement in
different sections. (2203-2014)
Form 5
18-07-2012
Dy No
BNF. (Rocephin
(Roche)
SPORCEF(LOWITT
Deferred
for
GMP inspection
of
contract
manufacturer by
panel
comprising of
Dr. Muzammal
H.
Najmi,
Director QA
& LT and Area
FID. Contract
giver will be
inspected
by
Area FID as last
inspection
report is more
than 01 year old
Deferred
for
GMP inspection
of
contract
Page354
Each Vial contains:Ceftriaxone Sodium
≡ Ceftriaxone
………250 mg
(Cephalosporin
Antibiotic)
USP Specs
Weather Fold
Pharmaceuticals
Hattar
7338
21-05-2013
Rs.
150,000/As Per
SRO
1‟s
vial
Acticef Injection 500mg
(IV)
Each vial contains:
Ceftriaxone sodium
for
≡ Ceftriaxone …500mg
(Cephalosporin
M/s Welwink
Antibiotic)
Pharmaceuticals, USP Specs
Gujranwala
Form 5
18-07-12
Dy No
7341
Rs 8000/21-05-13
Dy
No 3283
1,42,000/As per
SRO/ Pack
of 1‟s
-do-
Form 5
18-07-12
Dy No
7334
Rs 8000/21-05-13
Dy No
3283
1,42,000/As per
SRO/ Pack
of 1‟s
Acticef Injection 1gm
(I.M.)
Each vial contains:
Ceftriaxone sodium
≡ Ceftriaxone …….1g
Cephalosporin
Antibiotic
USP specs
Minutes246thMeetingRegistrationBoard
PHARMACEUTICALS
(PVT) LTD)
Advised for further
improvement in
different sections. (2203-2014)
manufacturer by
panel
comprising of
Dr. Muzammal
H.
Najmi,
Director QA
& LT and Area
FID. Contract
giver will be
inspected
by
Area FID as last
inspection
report is more
than 01 year old
Rociphen of Gentech
Deferred
for
USA
GMP inspection
Rociphen of Roche
of
contract
Karachi
manufacturer by
Inspection of the M/s
panel
Weather Folds
comprising of
Pharmaceuticals, Hattar Dr. Muzammal
was conducted by the
H.
Najmi,
area FID on 22/03/14
Director QA
and advised firm for
& LT and Area
further improvements in FID. Contract
different sections
giver will be
inspected
by
Area FID as last
inspection
report is more
than 01 year old
Rociphen of Gentech
USA
Rociphen of Roche
Karachi
Deferred
for
GMP inspection
of
contract
manufacturer by
panel
comprising of
Dr. Muzammal
H.
Najmi,
Director QA
& LT and Area
FID. Contract
giver will be
inspected
by
Page355
-do-
M/s Weather
Folds
Pharmaceuticals.
Plot 69/2,
Phase-2,
Industrial Estate,
Hattar
For
M/s Welwink
Pharmaceuticals.
G.T Road,
Industrial Estate,
Gujranwala
Cantt.
Gujranwala
Area FID as last
inspection
report is more
than 01 year old
Acticef Injection 1gm(
Form 5
Rociphen of Gentech
Deferred
for
I.V)
18-07-12
USA
GMP inspection
Each vial contains
Dy No
Rociphen of Roche
of
contract
Ceftriaxone sodium
7339
Karachi
manufacturer by
≡ Ceftriaxone …….1gm Rs 8000/panel
Cephalosporin
21-05-13
comprising of
Antibiotic
Dy No
Dr. Muzammal
USP Specs
3283
H.
Najmi,
Rs
Director QA
1,42,000/& LT and Area
As per
FID. Contract
SRO/ Pack
giver will be
of 1‟s
inspected
by
Area FID as last
inspection
report is more
than 01 year old
Deferred
for
Maxoxim 200 mg/5ml
Form 5
International: Suprax
GMP inspection
Dry powder suspension 18-07-2012 for suspension
of
contract
Each 5 ml contains:
Dy No
200mg/5ml (FDA)
manufacturer by
Cefixime Trihydrate
7330
Local: Biozil Dry
USP
panel
Rs.
Suspension 200 mg/5
≡ Cefixime ……200 mg 150,000/comprising of
ml by M/s BioLabs
Dr. Muzammal
(Cephalosporin
As per SRO According to report of
Najmi,
antibiotics)
inspection dated 22-10- H.
Director QA
USP Specs
2014 of M/s Weather f
& LT and Area
old, firm is advised to
rectify shortcomings in FID. Contract
giver will be
various sections.
inspected
by
According to report of
inspection dated 13-06- Area FID as last
2013 of M/s Welwink,
inspection
inspection book was not report is more
than 01 year old
available at time of
inspection and firm was
once again directed to
submit their validation
data of areas and
processes before
starting of their
production.
Minutes246thMeetingRegistrationBoard
Page356
-do-
Maxoxim 100 mg/5ml
Dry Powder Suspension
Each 5 ml contains:
Cefixime Trihydrate
USP
≡ Cefixime ………100
mg
(Cephalosporin
antibiotics)
USP Specs
Maxoxim 400 mg
Capsule
Each capsule contains:
Cefixime trihydrate
≡ Cefixime …….. 400
mg
(Cephalosporin
antibiotics)
Finished product
Manufacturing
specifications
-do-
1.Form 5
2.18-072012
Dy No
7335
3. 21-052013
Rs.
150,000/-
-do-
-do-
1.Form 5
2.18-072012
Dy No
7335
3. 21-052013
Rs.
150,000/-
-do-
-do-
The panel of Central Licensing Board inspected Weather Fold Pharmaceuticals, on 18-112014 and recommended the Renewal of DML. The Federal Inspector of Drugs Lahore also
inspected the M/s. Welwink Pharmaceutical Gujranwala and stated that the firm possesses the
relevant facility of quality control.
Decision:
Registration Board approved the request of M/s. Welwink Pharmaceuticals
for contract manufacturing of above products by M/s. Weather Ford Pharmaceuticals,
Hattar. Permission will be valid till 30.06.2015.
Case No.37
Registration Board in 245th meeting considered the following new molecule of M/s. Global
Pharmaceutical, Islamabad
Dlanz 30mg Capsules
Each capsule contains:Dexlansoprazole …. 30 mg
(Proton Pump Inhibitor)
Minutes246thMeetingRegistrationBoard
30‘s
As Per Registration Board discussed and
SRO
agreed to above expert opinions.
However, the Board advised firm
to provide data for stability
studies conducted under zone IVPage357
A conditions as per ICH / WHO
guidelines for consideration of
Registration Board.
Dlanz 60mg Capsules
Each capsule contains:Dexlansoprazole …. 60 mg
(Proton Pump Inhibitor)
30‘s
As Per
SRO
-do-
Zaprin SR 15mg Capsules
Each capsule contains:Cyclobenzaprine HCl (USP)
≡ Cyclobenzaprine ……15
mg (Skeletal Muscle
Relaxant)
60‘s
As Per
SRO
-do-
Now the firm has submitted the stability report of quality control for period of 12, 9, 6, 3
(months) and initial QC about Dexlansoprazole. Moreover, Cyclobenzaprine has been already
approved in favour of CCL, Lahore in 242nd meeting of DRB. The firm has requested to grant of
registration of above mentioned drugs in view of the relevant explanation.
Decision:
Registration Board approved the products. However, the Board advised
concerned P E & R Division and Incharge, PEC to evaluate submitted stability studies of
Zone IVA of Dexlansoprazole 30 & 60mg Capsule. Registration Board authorized its
Chairman for subsequent approval for issuance of registration letter.
Registration Board approved Cyclobenzaprine HCl 15mg Capsule, being me too
product.
Case No.38
Registration Board in 245th meeting deferred the following application of M/s. Global
Pharmaceuticals Islamabad for evaluation of dossier with the collaboration of Evaluation Cell as
per check list:Anarob Infusion
Each 100 ml contains:Metronidazole
B.P…500 mg
026985 1x100
ml
Ofloquin Infusion
Each 100 ml contains:
Ofloxacin HCl
026980 1x100
ml
Minutes246thMeetingRegistrationBoard
M/s. Mac &
M/s. Vision
Rains
Pharmaceuticals,
Pharmaceuticals,
-do-
-do-
Page358
≡ Ofloxacin….. 200
mg
Nafcin Injection
Each 100 ml contains:
Ciprofloxacin Lactate
≡ Ciprofloxacin…..200
mg
026979 100
ml
-do-
-do-
The dossiers have been evaluated with the collaboration of Incharge Evaluation Cell as per
check list.
Decision:
Registration Board approved request of M/s Global Pharmaceuticals,
Islamabad for change of contract manufacturer of above products from the M/s. Mac &
Rains Pharmaceuticals to M/sVision Pharmaceuticals, Islamabad. Permission is at same
terms and conditions.
Case No.39
M/s. Vision Pharmaceutical, Kahuta Road, Islamabad has requested for transfer of
registration of following drugs from M/s. Vision Pharmaceutical, I-10/3, Islamabad. Previously,
these products were contract manufactured by m/s Mac & Rains Pharmaceuticals, Lahore:Levovis IV Infusion
Each 100 ml contains:Levofloxacin hemihydrate
032160 1x100ml
≡
Levofloxacin………
500ml
Medicip IV infusion
Each 100 ml contains:Ciprofloxacin lactate
030701 1x100ml
≡ Ciprofloxacin ......200
mg
M/s. Mac &
Rains
Pharmaceuticals,
M/s. Vision
Pharmaceuticals,
-do-
-do-
M/s. Vision Pharmaceutical, Kahuta Road, Islamabad has developed the relevant
manufacturing facilities and submitted complete dossier along with fee amounting
Rs:50000/dossier. The dossiers have been evaluated with the collaboration of Incharge of the
Evaluation Cell as per check list.
Minutes246thMeetingRegistrationBoard
Page359
Decision:
Registration Board decided as follows:

Cancellation of above registrations from M/s. Vision Pharmaceuticals, I-10/3,
Islamabad.

Grant of above registrations in name of M/s. Vision Pharmaceutical, Kahuta Road,
Islamabad. Chairman, Registration Board will permit issuance of registration letter
after comments of Cost & Pricing Division about MRP of the drug.
Case No.40
M/s. Metro Pharmaceutical, Islamabad has requested for correction of nomenclature and label
claim of the following drugs as mentioned below:Existing /approved formulation
Myzinc Syrup
Each 5ml contains:Zinc Sulfate Monohydrate…. 20
mg
(USP Specs)
Correct
formulation/Nomenclature
Myzinc Syrup
Each 5ml contains:Zinc Sulphate Monohydrate
≡ Zinc (element)……..…. 20 mg
(USP Specs)
Reg No.
075253
The management has deposited fee of Rs:5000/- for this purpose. It is pointed out that the
strength of the API is calculated on the basis of content of zinc element.
Decision:
Registration Board approved the correction as Zinc Sulphate Monohydrate
equivalent to Zinc (element) 20mg/5ml syrup.
Registration-IV
Case No.41
M/s. Genome Pharmaceutical, Hattar has requested for correction in formulation of
following drugs. Initially these drugs were registered on 2nd August, 2003 and 4th February,
2006 with M/s. Silver Oak Corporation Hattar. The management was changed and the unit was
renamed and registrations of the products approved for Silver Oak Corporation Hattar were
transferred in favour of M/s. Genome Pharmaceuticals. It is pointed out that at the time of
transfer of registration of the products, the brand name was also changed but the strengths of
Minutes246thMeetingRegistrationBoard
Page360
active pharmaceutical ingredient in the below-mentioned formulations were inadvertently typed
as:
S.N
o
1.
2.
Previous name /
Formulation
Tick-Nil Tablets
Each tablet contains:Cetirizine 2HCl…..10
mg
Existing name / Incorrect
Formulation
Citgen Tablets
Each tablet contains:Cetirizine
Dihydrate….10 mg
Solifen Tablets
Each tablet contains:Ketoprofen…………10
0 mg
Proket Tablets
Each tablet contains:Ketoprofen………30 mg
Reg No.
030815
042511
It is pointed out that it was inadvertently written as Cetirizine Dihydrate 10 mg per tablet
while transferring the registration from M/s. Silver Oak to M/s. Genome. Similarly, the strength
of Ketoprofen was wrongly mentioned as 30mg/tablet. The correct formulation is mentioned
below in the right column of table.
S.N
o
1.
2.
Existing name with
Composition
Citgen Tablet
Each tablet
contains:Cetirizine
Dihydrate…..…..10
mg
Proket Tablet
Each tablet
contains:Ketoprofen……30m
g
Correct Formulation/
Nomenclature
Citgen Tablet
Each film coated tablet
contains:Cetirizine Dihydrochloride…
10 mg
Proket Tablet
Each film coated tablet
contains:Ketoprofen……… 100 mg
Reg
No.
03081
5
04251
1
Decision:
Registration Board approved the correction as Cetirizine Dihydrochloride
10mg film coated tablet and Ketoprofen 100mg film coated tablet of the above mentioned
products.
Minutes246thMeetingRegistrationBoard
Page361
Case No.42
Registration Board approved the application of M/s. Genome Pharmaceuticals, Hattar for
Tablets containing combination of Domperidone Maleate and Cinnarizine in Drug Registration
meeting 214th as mentioned below:1.
2.
Approved formulations in
214th meeting
Domenome Tablets
Each tablet contains:Domperidone Maleate…19.48
mg
Cinnarizine………20.40mg
The formulation issued
in the Registration letter)
Zinom Tablets
Each tablet contains:Domperidone
Maleate......19.10 mg
Cinnarizine ...........25mg
(Genome’s Specs)
It is pointed out that Domperidone Maleate and Cinnarizine were inadvertently approved as
19.48 mg and 20.4mg respectively. Moreover, the certificate of registration also contained
typographical error regarding Domperidone maleate 19.10mg and Cinnarizine 25mg. The firm
provided the copy of the dossier and requested to correct the Minutes of 214th meeting as well as
the typographical error of the respective formulation along with the correction in certificate of
registration as mentioned below.
Decision:
Reg No
Correct formulation /Nomenclature
053580
Domenome Tablets
Each tablet contains:Domperidone Maleate……19.1mg
≡ Domperidone…………..15 mg
Cinnarizine………………..20 mg
(Approved formulations in 214th meeting
)
Registration Board deferred and referred above formulations to Review
Committee.
Minutes246thMeetingRegistrationBoard
Page362
Case No.43
Registration Board in 243rd meeting approved the registration of following drug of M/s.
Wnsfeild Pharmaceutical Hattar.
S.N
o
1.
Existing name with Composition
1. Alfa-Block
2. Capsule
3. Each capsule contains:Tamsulosin Hydrochloride SR
pellets……50mg
4. (Selective Alpha-a Adrenergic
Blocking Agents)
Correct
formulation/Nomenclature
1. Alfa-Block Capsule
2. Each capsule contains:3.Tamsulosin Hydrochloride SR
pellets 0.2%w/w
≡ Tamsulosin HCl……….0.4mg
4. (USP Specification)
Now the firm has informed that the strength of Tamsulosin HCl pellets is incorrectly
mentioned as 50 mg per capsule. Incharge Evaluation Cell stated that above mentioned error had
been pointed to the firm and it was rectified subsequently and prior to the 243-Meeting. But the
agenda and minutes of 243rd meeting could not be amended. The management has requested for
the appropriate correction and issuance of the certificate of registration accordingly.
Decision:
Registration Board approved the correction as Tamsulosin Hydrochloride
SR pellets 0.2%w/w equivalent to Tamsulosin Hydrochloride 0.4mg/Capsule.
Case No.44
M/s. Wisdom Pharmaceuticals Industries, Peshawar requested for issuance of registration
letter of Zoramid (Domperidone) Suspension which was approved in 243rd meeting of
Registration Board with the following formulation:Zoramid Suspension
Each 5ml contains:Domperidone Maleate eq. to Domperidone….5mg
The registration letter was not issued due to inappropriate active pharmaceutical ingredient
and the ambiguous label claim. With reference to Motilium Suspension (brand leader Johnson &
Johnson) and BNF 66 it is evident that Suspension contains Domperidone 5mg/5ml instead of
Domperidone maleate equivalent to Domperidone 5mg/5ml.
Minutes246thMeetingRegistrationBoard
Page363
The management was informed that the inappropriate description of active pharmaceuticals
ingredient and label claim needs verification by the Incharge Pharmaceutical Evaluation Cell
because the dossier was evaluated by the PEC and the management has to apply formally for this
rectification.
Mr. Tahir CEO M/s. Wisdom Pharmaceuticals, Peshawar verbally informed, “The
management corrected the formulation and claim of Zormid Suspension and submitted the same
to the PEC before the commencement of DRB meeting-243rd. The correction was neither
incorporated in agenda nor in the relevant minutes and the ambiguity prevailed the approved
minutes”. Instead of proceeding in the proper way, ironically, Mr. Tahir CEO wrote in the letter
No.WPI/DRAP/40/14 dated 11-11-2014, “but due to unknown reason registration letter of our
product has not been issued till to date it is requested to issue registration letter of our product as
soon as possible. If the registration letter is not issued up to 30-11-2014 the case will be sent to
the Honourable Wafaqi Mohtasib (Ombudsman) of Pakistan Islamabad.,” Moreover, the
management forwarded the copies to Honourable Wafaqi Mohtasib (Ombudsman) of Pakistan,
C.E.O DRAP and Director PE&R without waiting for the response of the department according
to the stipulated period of 30-11-2014.
Resultantly the Incharge Evaluation Cell was asked to verify the in appropriation in
formulation and the proclaimed rectifications of Wisdom Pharmaceuticals. The Evaluation Cell
confirmed from the record that stance of firm is true i.e.Wisdom Pharmaceuticals has corrected
the composition as per reference product but the same could not be reproduced into the agenda
and minutes of 243rd meeting of DRB.
Decision:
Registration Board deferred the formulation and referred the case to Review
Committee in conformity of decision of 244th meeting.
Case No. 45
Registration Board in 227th meeting held on 26th & 27th August, 2010 deferred the following
registration application of M/s Cherwel Pharmaceuticals, Hattar for manufacturing on basis of
contract till the finalization of contract policy:1.
M/s. Cherwel
Pharmaceutic
Cherzone 250 mg Injection
I.V
Minutes246thMeetingRegistrationBoard
Per
vial
As Per
SRO
3-10- Deferred till
2009 the
Page364
als, Hattar
Manufacturin
g on Contract
basis by
M/s.Wise
Pharma,
Islamabad
Each vial contains:Ceftriaxone Sodium
≡ Ceftriaxone…….…….250
mg
(Cephalosporin)
2.
-do-
Per
vial
As Per
SRO
-do-
-do-
3.
-do-
Per
vial
As Per
SRO
-do-
-do-
4.
-do-
Cherzone 500 mg Injection
I.V
Each vial contains:Ceftriaxone Sodium
≡ Ceftriaxone…….…….500
mg
(Cephalosporin)
Cherzone 1 g Injection
Each vial contains:Ceftriaxone Sodium
≡ Ceftriaxone ………….1 g
(Cephalosporin)
Getxime 400 mg Capsules
Each capsule contains:Cefixime Trihydrate
≡ Cefixime………….….400
mg
(Cephalosporin)
5’s
As Per
SRO
-do-
-do-
5.
-do-
Getxime 100 mg Dry
Suspension
Each 5 ml contains:Cefixime Trihydrate
≡ Cefixime
…..…….….100mg
(Cephalosporin)
30ml
As Per
SRO
-do-
-do-
6.
-do-
Getxime200mg Dry
Suspension
Each 5 ml contains:Cefixime Trihydrate
≡Cefixime …..…….….200
mg
(Cephalosporin)
30ml
As Per
SRO
-do-
-do-
Minutes246thMeetingRegistrationBoard
finalization of
contract
policy
Page365
7.
-do-
Welpime 500mg Injection
Each vial contains:Cefepime HCl with LAginine
≡ Cefepime (anhydrous)
500mg
(Cephalosporin)
Per
vial
As Per
SRO
-do-
-do-
8.
-do-
Welpime 1gm Injection
Each vial contains:Cefepime HCl with LAginine
≡ Cefepime (anhydrous) 1 g
(Cephalosporin)
Per
vial
As Per
SRO
-do-
-do-
9.
-do-
Biset 1 g Injection
Each vial contains:Cefoperazone Sodium
≡ Cefoperazone.…… 500 mg
Sulbactam Sodium
≡ Sulbactam…………. 500
mg
(Cephalosporin)
Per
vial
As Per
SRO
-do-
-do-
10.
-do-
Biset 2g Injection
Each vial contains:Cefoperazone Sodium
≡ Cefoperazone……… 1g
Sulbactam Sodium
≡ Sulbactam…………… 1g
(Cephalosporin)
Per
vial
As Per
SRO
-do-
-do-
Now contract manufacturing policy has been finalized and the management of the firm has
deposited the fee of Rs. 50,000/each and requested to change the manufacturer from M/s. Wise
Pharmaceuticals Rawat to M/s. Bloom Pharmaceuticals, Hattar and also to change the brand
name of some product. The Dossiers have been evaluated with the collaboration of Incharge
Evaluation Cell as per check list.
Decision:
Registration Board registered above products
Pharmaceuticals, Hattar on contract manufacturing basis
Pharmaceuticals, Hattar. Permission will be valid till 30.06.2015
Minutes246thMeetingRegistrationBoard
of M/s. Cherwell
from M/s. Bloom
Page366
Case No.46
M/s. Maxi Care International, Lahore has requested for transfer of following drug from
import for local manufacturing on contract basis by M/s. Welwrd Pharmaceuticals Hattar:S.N
o.
1
Reg.
No.
Name and Composition of
Product
059263 PE-40 Lyophilized Injection
Each vial contains:Pantoprazole Sodium
≡Pantoprazole……… 40 mg
(Proton Pump Inhibitor)
Pack size
Demanded
Price
Per vial
Rs.250.00
They have submitted the complete dossier along with fee of Rs. 50,000/- for this purpose.
The dossier has been evaluated by the Incharge Evaluation Cell as per check list.
Decision:
Registration Board approved request of Maxi Care International, Lahore for
contract manufacturing of above product from M/s. Welwrd Pharmaceuticals, Hattar.
Permission is at same terms and conditions except that firm will not claim the product as
lyophilized.
Case No.47
M/s. Aries Pharmaceuticals, Peshawar has requested for registration of following drugs
for the export only:S.N
Name and Composition of
o.
Product
Xanek Tablets
1
Each tablet contains:Alprazolam……….0.5 mg
(USP Spec)
Lexonil Tablets
2
Each tablet contains:Bromazepam…………3 mg
(Aries Specs)
The management of the firm provide the complete dossier, Fee of Rs,20000/- original export
order and requested for registration of drugs for export purpose only. The dossiers have been
evaluated accordingly.
Decision:
Registration Board approved grant of registration of above mentioned
products for the purpose of export only.
Minutes246thMeetingRegistrationBoard
Page367
Case No. 48
Registration Board in 243rd meeting deferred the following application of M/s. Genome
Pharmaceuticals, Hattar for opinion of experts but the panel of experts has not been proposed :1.
M/s. Genome Genozal Tablets
Pharmaceutical Each tablet contains:, Hattar.
Balsalazide Disodium
Dihydrate………750 mg
(Genome Spec)
(Anti-inflammatory drug)
2.
-do-
Rebon-X Tablets
Each film coated tablet
contains:Strontium citrate………680
mg
(Bone stabilizer)
10’s
As Per
SRO
Deferred for
expert opinion.
10’s
As Per
SRO
 Deferred due
to Methylene
Chloride.
 Inspection
report nil
 Form 5/ file
partially
signed.
Now the case is again included in the agenda for constitution of panel of expert for expert
opinion. The dossier has been evaluated and rectified by the Evaluation Cell as per check list.
Decision:
Registration Board referred above products to following panel for expert
evaluation:
 Genozal Tablets (Balsalazide Disodium Dihydrate………750 mg)
o Brig Dr. Aslam Khan, Member Registration Board.
o Dr. Rauf Niazi, PIMS, Islamabad.
o Dr.Irfan Ahmad, BBH, Rawalpindi

Rebon-X Tablets (Strontium citrate………680 mg)
o Mr. Abdul Latif Sheikh, AKUH.
o Prof Dr. Rafi-uz-Zaman, Member Registration Board.
o Prof. Dr. Zafar Iqbal, University of Peshawar
Minutes246thMeetingRegistrationBoard
Page368
Case No. 49
M/s. Swat Pharmaceutical, Swat has requested to transfer the manufacturing site from
M/s. Medera Pharmaceuticals (toll manufacturer) to their own manufacturing unit in view of the
existence of the manufacturing facility:
1.
2.
3.
4.
5.
Baxib 250mg Tablets
Each film coated tablet contains:Ciprofloxacin HCl
≡ Ciprofloxacin……....250 mg
(Quinolone)
Baxib 500mg Tablets
Each film coated tablet contains:Ciprofloxacin HCl
≡ Ciprofloxacin……....500 mg
(Quinolone)
Baxib 750 mg Tablets
Each film coated tablet contains:Ciprofloxacin HCl
≡ Ciprofloxacin……....750 mg
(Quinolone)
Sanlevo 250 mg Tablets
Each film coated tablet contains:Levofloxacin Hemihydrate
≡ Levofloxacin…………….250 mg
(Quinolone)
Sanlevo 500 mg Tablets
Each film coated tablet contains:Levofloxacin Hemihydrate
≡ Levofloxacin…………….500 mg
(Quinolone)
030449
030450
030451
029883
029884
The management of the firm has deposited the fee of Rs. 20,000/each and requested to
transfer the above mentioned drugs to their own manufacturing site M/s. Swat Pharmaceutical,
Swat. The Dossiers have been evaluated with the collaboration of incharge Evaluation Cell as
per check list.
Decision:
Registration Board approved request of M/s. Swat Pharmaceuticals, Swat for
manufacturing of the above products at its own facility. Permission is at same terms and
conditions.
Minutes246thMeetingRegistrationBoard
Page369
Case No. 50
M/s. Usawa Pharmaceutical, Rislapur has requested to transfer the manufacturing site
from M/s. Caraway Pharmaceuticals (toll manufacturer) to their own manufacturing unit in view
of the existence of the manufacturing facility:
1.
Afixim 400 mg Capsule
Each capsule contains:Cefixime Trihydrate
≡ Cefixime……………… 400 mg
060248
2.
Durixil Capsule 500 mg
Each capsule contains:Cefadroxil Monohydrate
≡ Cefadroxil……………… 500 mg
060249
The management of the firm has deposited the fee of Rs. 20,000/each and requested to
transfer the above mentioned drugs to their own manufacturing site M/s. Usawa Pharmaceutical,
Rislapurt. The Dossiers have been evaluated with the collaboration of Incharge Evaluation Cell
as per check list.
Decision:
Registration Board approved request of M/s. Usawa Pharmaceuticals,
Risalpur for manufacturing of the above products at its own facility.
Permission is at same terms and conditions.
Case No. 51
Registration Board in 228th meeting and 238th meeting deferred the following drugs of
M/s. Genome Pharmaceuticals, Hattar for the reasons mentioned below:
1.
Perilone Tablets
Each tablet contains:Paliperidone……….1.5 mg
(Ant-psychotropic)(Genome Spec)
10’s
As Per
SRO
Deferred for expert
opinion being a new
chemical entities.
(M-228
2.
Lanso-SR Capsules
Each SR capsule contains:Dexlansoprazole enteric coated
Pellets
14’s
As Per
SRO
Deferred
till
submission
of
application
on
FORM 5-D along
Minutes246thMeetingRegistrationBoard
Page370
≡ Dexlansoprazole….30 mg
(Proton Pump Inhibitor)
with prerequisite fee
(M-238)
Now the firm has informed that the same formulations and same strength has been registered
by the Registration Board in favour of Pharmatec. The firm deposited the differential fee and
dossiers have been evaluated by the collaboration of Evaluation Cell as per check list.
Decision:
Registration Board approved Lanso-SR Capsules. However, the Board
advised concerned P E & R Division and Incharge, PEC to evaluate submitted stability
studies of Zone IVA of Dexlansoprazole 60mg Capsule. Registration Board authorized its
Chairman for subsequent approval for issuance of registration letter.
Registration Board approved Tablets Paliperidone 1.5mg
Case No.52
The following anomaly cases drugs of M/s. Wnsfeild Pharmaceuticals, Hattar were deferred
in 245th meeting as mentioned below:1.
Somac 40 mg Injection
Each vial contains:Pantoprazole Sodium
Sesquihydrate
≡ Pantoprazole…..40 mg
(Proton pump inhibitor)
Per
vial
2.
Winomax 500 mg injection
Each vial contains:Azithromycin monohydrate
≡ Azithromycin ……..40 mg
(Anti-infective)
Per
vial
3.
Lantex 30 mg injection
Each vial contains:Lansoprazole sodium
≡ Lansoprazole ……..30 mg
(Proton pump inhibitor)
Per
vial
4.
Kalwin 500 mg Injection
Each vial contains:Clarithromycin
Per
vial
Minutes246thMeetingRegistrationBoard
AsAs per
perSRO
SR
29-1-13
O
29113
AsAs per
perSRO
SR
29-1-13
O
29113
AsAs per
perSRO
SR
29-1-13
O
29113
AsAs per
perSRO
SR
29-1-13
Registration Board
deferred above
products for
scrutinization of
registration application
as per check list.
-do-
-do-
-do-
Page371
≡ Clarithromycin …..500 mg
(Proton pump inhibitor)
O
29113
The dossiers have been evaluated by with the collaboration of Evaluation Cell as per check
list and the term lyophilized will not be claimed by the manufacturer.
Decision:
Registration Board approved the registration of above mentioned products.
Case No.53
The following anomaly cases of M/s. Welmark Pharmaceuticals, Hattar were deferred in 237th
meeting of the Drug Registration Board as mentioned below:1.
M/s. Welmark
Pharmaceuticals,
Hattar
New Section
Carimark 500 mg Injection
Each vial contains:Clarithromycin
≡ Clarithromycin …500 mg
(Macrolide)
Per
vial
As
per
SRO
16-08- Deferred
for
11
clarification
weather
Lyophilization
procedure
is
mandatory/required
for
such
formulation or not.
2.
-do-
Ezi-mark 500 mg Injection
Each injection contains:Azithromycin dihydrate
≡ Azithromycin ….500 mg
(Macrolide)
Per
vial
As
Per
SRO
19-82011
do
Now the firm has removed the word Lyophilized from the formulation and the dossiers have
been evaluated with the collaboration of Evaluation Cell as per check list.
Decision:
Registration Board approved the registration of above mentioned products.
Minutes246thMeetingRegistrationBoard
Page372
Case No.54.
The following registration application of M/s. Navegal Pharmaceuticals, Hattar were considered
in 225th meeting and approved on the ground that the firm develop new separate Psychotropic
Section. The registration letter was not issued.
1.
2.
3.
4.
5.
6.
7.
8.
9.
Zocin 25 mg Tablets
Each tablet contains:Pentazocine HCl
≡ Pentazocine base.. 25 mg
(Benzomarphan derivative)
Fenotal 30mg Tablets
Each tablet contains:Phenobarbital……. 30 mg
(Barbiturate)
Buprex 0.2mg Tablets
Each tablet contains:Buprenorphine HCl
≡ Buprenorphine base0.2
mg
(Thebaine derivative)
Gytil 3 mg Tablets
Each tablet contains:Bromazepam……3 mg
(Benzodiazepine)
Gytil 6mg Tablets
Each tablet contains:Bromazepam……6 mg
(Benzodiazepine)
Xafil 0.25mg Tablets
Each tablet contains:Alprazolam………0.25 mg
(Benzodiazepine)
Xafil 0.5mg Tablets
Each tablet contains:Alprazolam……… 0.5 mg
(Benzodiazepine)
Xafil 1mg Tablets
Each tablet contains:Alprazolam………1 mg
(Benzodiazepine)
Xolpi 10mg Tablets
Each tablet contains:Zolpidem
Minutes246thMeetingRegistrationBoard
10x10’s
REs.2.50
per tablet
Approved
2x15’s
Rs.2.70
per tablet
Approved
50’s
Rs.0.68
per tablet
Approved
3x10’s
Rs.3.50
per tablet
Approved
3x10’s
Rs.7.50
per tablet
Approved
3x10’s
Rs.4.00
per tablet
Approved
3x10’s
Rs.10.00
per tablet
Approved
3x10’s
Rs.10.00
per tablet
Approved
2x10’s
Rs.16.00
Approved
Page373
Hemitartrate….10mg
(Imidazopyridine)
10. Dilamid 1mg Tablets
Each tablet contains:Lormetazepam ………1mg
(Short Acting
Benzodiazepine)
100’s
Rs.1.70
per tablet
Approved
Now the firm deposited the differential fee of Rs:12000/- each and complete the dossiers.
The dossiers have been evaluated with the collaboration of Evaluation Cell as per check list.
Decision:
Registration Board approved the registration of above mentioned products.
Registration-V
Case No.55: M/S. CCL Pharmaceuticals (Pvt.) Ltd, Lahore- Export Registrations.
M/s. CCL Pharmaceuticals (Pvt.) Ltd; Lahore has requested for registration of following
products for export purpose only:S. No
1.
2.
Name of Products
Cef-OD Chewable Tablet 100mg
Each chewable tablet contains:Cefixime trihydrate equivalent to
Cefixime ……………………….. 100mg
Bicarb Capsule 600mg
Each capsule contains:Sodium Bicarbonate ………………… 600mg
The above mentioned products are not available locally. However, product at Sr. No. 1 is
FDA approved and product at Sr. 2 is available in Sri-Lanka. The firm has submitted the
following documents:a.
b.
c.
d.
e.
f.
Fee of Rs. 20000/- for this purpose.
Form-5.
Under taking stamp paper.
Copy of GMP inspection.
CRF clearance certificate.
Export orders.
Minutes246thMeetingRegistrationBoard
Page374
Decision: Registration Board approved the products with following conditions:


Manufacturer will export the product after complying all the conditions as required
under Drug Act, 1976 including No objection certificate from concerned DRAP
office. Moreover, Federal Inspector of drugs will take sample from each
consignemnet for analysis from CDL, Karachi.
Manufacturer will also furnish export documents endorsed from custom authorities
in order to ensure the export of the product.
Case No. 56:
M/s. Wilshire Labs Lahore - Case deferred for expert opinion
Registration Board in its 237th deferred the following registration application of M/s.
Wilshire Laboratories, Lahore for expert opinion by Brig.(R).Prof. Dr. Muzammil Hasan Najmi,
member Registration Board and submission of differential fee. Initially the case was deferred for
expert opinion and two experts have already been given their opinions as follows. Now
Brig.(R).Prof. Dr. Muzammil Hasan Najmi has also give expert opinion:Name of Product
Tripoli 400 mg & 800 mg
Each tablet contains:Metaxalone….400 mg & 800 mg
S. No.
1.
Name of Expert
Prof. Dr.
Mohammad Hanif
Head Deptt. of
Medicine,
Rawalpindi
Medical College,
Rwp.
2.
Dr. Mughees
Sherani, Agha
khan Hospital
Karachi
MRP
15% less
brand leader
Opinion
The mode of action of this drug has not been clearly identified,
absolute bioavailability is not known. Impact of age, gender,
hepatic and renal disease on the pharmacokinetics, carcinogenic
potential, safety in pregnancy, safety and effectiveness in
children under age of 12 has not determined. Leucopenia and
haemolytic anemia are among the side effects. The drug is not
cost-effective.
“Tripoli tablets cannot be recommended for registration for the
adjunctive treatment of acute, painful, musculo-skeletal
conditions”
“I have personal experience of writing this medication as this is
an FDA approved medication and is available in the United State
by the name of “Skelaxin”. Before moving to Pakistan in 2002, I
was practicing in Midland Texas, USA and use to prescribe this
medication”.
“It is used as an adjunctive treatment of acute, painful
musculoskeletal conditions and provides earlier relief.”
“It major side effects include drowsiness. It should be given with
caution in older patients and in patients with chronic disease,
Minutes246thMeetingRegistrationBoard
Pack Size.
10’s
100’s
500’s
Page375
3.
Brig.(R).Prof. Dr.
Muzammil Hasan
Najmi
especially in liver and kidney diseases.”
“I think this medication can be approved as this has long track
record without major complications or problems.”
“Metaxalone is a skeletal muscle relaxant used in treatment of
painful muscle spasm/sprains. The exact mechanism of action of
the drug is not known but it produce generalized CNS
depression, which is also responsible for its side effects. It has
significant interactions with other centrally acting drugs like
benzodiazepines and antidepressants. It is considered to be
unsafe in elderly. Safety in pregnancy and location has bot been
determined. The drug is available in USA.
Metaxalone may be registered as a prescription drug to be
marketed with precautions as outlined above”.
The firm has also deposited remaining fee of Rs. 35,000/- for this purpose.
Decision:
Registration Board discussed and agreed to above expert opinions.
However, the Board advised firm to provide data for stability studies conducted under zone
IV-A conditions as per ICH / WHO guidelines for consideration of Registration Board.
Case No.57 : M/s. Highnoon Labs, Lahore- Case deferred for submission of clinical data
The Registration Board in its 245th meeting deferred the following product of M/s.
Highnoon Labs; Lahore for submission of safety and efficacy data of the drugs along with
complete clinical trial data of these formulations:Sr.No.
Product Name with
composition
Pack size
Demanded
price
1.
Ebernet 1% Cream
Each gram contains:Eberconazole (as
nitrate)….10mg
(anti fungal)
10gm
Rs.320.00
Minutes246thMeetingRegistrationBoard
Date of
submission
and fee
21-06-2011
Rs. 8000/27-06-2011
Rs. 7000/10-7-2013
135000/(Total: Rs.
150000/-)
Form-5D
Remarks
Not available
in FDA,
EMA,
Australia and
Japan.
Page376
In compliance to the decision of registration board, M/s. Highnoon Labs; Lahore has
submitted clinical trial data of the above mentioned product.
Decision: Board deferred above products for expert opinion of following experts on
submitted clinical studies data:



Dr.Fareed ur Rehman, FFH, Rawalpindi.
Dr.Afaq, PIMS, Islamabad.
Mr.Abdul Lateef Shaikh, AKUH
Case No.58 : Permission for Contract Manufacturing due to renovation.
M/s. Highnoon Laboratories Ltd; Lahore has applied for contract manufacturing of their
following products on toll manufacturing basis through M/s. Titlis Pharma, Lahore. Due to
continuous improvement and capacity enhancement program of their manufacturing plant, they
have planned for renovation/up gradation of their granulation-I area while granulation-II area
will remain operational. Therefore they have applied for contract manufacturing of the products
manufactured in granulation-I to avoid shortage of these products:S. No.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
Name of Drug(s)
Cyrocin Tablet 250mg
Ciprofloxacin
Cyrocin Tablet 500mg
Ciprofloxacin
Hilin Capsule 100mg
Pregabalin
Hilin Capsule 150mg
Pregabalin
Hilin Capsule 50mg
Pregabalin
Hilin Capsule 75mg
Pregabalin
Oxaquin Tablet 400mg
Moxifloxacin
Aria Tablet 1mg
Ketotfen (Fumarate)
Inhibitol Capsule 30mg
Lansoprazole (pellets)
Neupentin Capsule 100mg
Gabapentin
Neupentin Capsule 300mg
Gabapentin
Minutes246thMeetingRegistrationBoard
Reg. No.
011406
011407
048917
048834
048916
047833
043660
014742
020613
035763
035764
Page377
12.
13.
14.
Voxiquin Tablet 250mg
Levofloxacin Hemihydrate
Voxiquin Tablet 500mg
Levofloxacin Hemihydrate
Senegy-OD Tablet 10mg
Loratidine
038991
038992
017672
They have deposited fee of Rs. 50,000/- for each product and have furnished application
dossiers along with toll agreement.
It is submitted that in total there are 83 registered in tablet and capsule sections, however
firm has applied for 14 products only i.e. for products of granulation-I area. Orders are solicited,
whether such cases can be processed as per new toll policy.
Decision: Registration Board deferred the case and advised firm to provide complete
renovation plan with time frame for consideration of the Board. Form-5 will be checked as
per check list approved by Registration Board.
Case No. 59: M/s. Phamrawise Labs (pvt.) Ltd; Lahore - Transfer of registration due to
change of name of the firm without change in manufacturing site.
The name of M/s. Fakma Pharma, Lahore was changed from M/s. Fakma Pharma, Lahore
to M/s. Pharmawise Labs (Pvt.) Ltd; Lahore in 2000 on their request. The firm had requested that
either to change all letters regarding registrations with new name or issue a letter to reflect the
said change in each of the registration letter. However, they had not deposited any fee for this
purpose. The case was presented in Board meeting No. 164th on 30-07-2001 and the Registration
Board had decided as under:“The request of the firm was not acceded to and the firm was directed to deposit the
requisite fee of Rs. 8000/- for each product for transfer of registration in the new name”.
It is submitted that as per practice in vogue, in case a company changes their name / title apply
for transfer of registration from previous name to new name with full registration fee. However,
the owner of the firm has the view that there is no provision in law for transfer of registration on
same premises.
Minutes246thMeetingRegistrationBoard
Page378
The case was also referred to Law Division for comments. Law Division in their reply
referred to the case of change of name of M/s. Breeze Pharma, Islamabad to M/s. ICI, Pakistan
Ltd; due to change in management. The issue was as to whether M/s. ICI Pakistan Ltd; require a
fresh license for manufacturing of drugs on leased premises or license of M/s. Breeze Pharma,
Islamabad would be a valid one for manufacturing of drugs.
In this regard, Law Division was of the opinion that license issued by competent
authority was issued to drug manufacturing facility/plant/premises and inspection was done for
drug manufacturing facility, plants, its premises and also of the qualifications of the management
under rule 15, 16 of Drug (Licensing Registering & Advertising) Rules 1976. It would therefore,
be wrong to state that license was issued to the premises and not the management. Law Division
has further referred to Section 196 of the Companies ordinance 1984 which states that business
of a company is run and managed by the Directors of a company. Therefore, lease agreement
between Breeze Pharma, & M/s. ICI amounts to transfer of license which is un-authorized under
the said rules.. It is also been suggested that referring Division (DRAP) shall suitable amend the
rules, so that such like complications due to silent position of rules can be averted in future.
Decision: Registration Board decided to seek opinion of Legal Affairs Division, DRAP in
the matter.
Case No. 60: M/s Servier Research & Pharmaceuticals (Pakistan) (Pvt.) Ltd; Lahore- Case
deferred for confirmation of registration in France
Registration Board in its 245th meeting deferred the following products of M/s. Servier
Research and Pharmaceuticals (Pakistan) Limited Lahore till confirmation of registration status
of Nartrilam 5 and 10 mg tablets in France:S.
No.
1
Name of Drug(s) with
formulation
Natrilam 10mg Tablets
Each tablet contains:Indapamide SR…..1.5mg
AmlodapineBesilate…..10mg
(Antihypertensive diuretic +
Calcium antagonist)
Minutes246thMeetingRegistrationBoard
Pack
size
30‘s
Demande
d price
Rs.72.52/
Tablet
Fee & form
20-6-2012
Rs.8000/30-04-13
Rs. 130,000/Total Fee Rs. 150,000/Form 5-D
Page379
2
Natrilam 5 mg Tablets
Each tablet contains:Indapamide SR…..1.5mg
Amlodapineas
Besilate…..5mg
(Antihypertensive diuretic +
Calcium antagonist)
30‘s
Rs.36.26/
Tablet
05-04-2011 Rs.8000/30-04-13
Rs. 130,000/Total Fee Rs. 150,000/Form 5-D
The management of the firm has provided legalized free certificate of the products in
France and have requested to grant them registration of above mentioned products.
Decision: Board decided to defer the product for expert opinion of following experts on
clinical studies data:



Brig(R). Dr. Muzamil H. Najmi, Member Registration Board
Dr. Shahid Nawaz, PIMS, Islamabad.
Brig. Dr. Sohail Aziz, AFIC, Rawalpindi.
Case No. 61: M/s. English Pharma, Lahore- Case Deffred For Expert Opinion
Registration Board in its 243rd meeting deferred the following product of M/s. English
Pharma, Lahore for expert opinion of Prof. Dr. Ghias Butt; Prof. Mumtaz Ahmad, Benazir
Bhutto hospital and Prof. Muzamil Tahir, Sh Zayed Hospital, Lahore:S. No.
1.
Name of Drug(s)
Ucholin 10mg Tablet
Each tablet contains:Bethanechol Chloride equivalent to Bethanechol ……………. 10mg
Two experts have provided their opinion as under:Name of expert
Prof. Ghias-ud-Din Butt,
PIMS, Islamabad
Comments
Bethanechol chloride is indicated for the treatment of acute
postoperative and postpartum non obstructive (functional) urinary
retention and for neurogesic atony of the urinary bladder with
retention. It works by helping the bladder muscle to squeeze better,
thereby improving your ability to urinate.
Because of the selective action of bethanechol, nicotinic symptoms of
cholinergic stimulation are usually absent or minimal when orally or
subcutaneously administered in therapecutic doses, while muscarinic
effects are prominent.
Special care is required if this drug is given to patients receiving
Minutes246thMeetingRegistrationBoard
Page380
ganglion blocking compounds because a critical fall in blood pressure
may occur. Usually, severe abdominal symptoms appear before there is
such a fall in the blood pressure. Safety and effectiveness in pediatric
patients have not been established.
Price is a matter of regulator authorities but considering the
effectiveness of Molecule or patients Bethanechol HCl availability
in Pakistan must be assured at affordable price. The maximum
price should not exceed Rs. 30 for 10mg tablet.
Prof. Dr. Mumtaz Ahmad
This medicine is used to treat certain bladder problems such as the
Benazir Bhutto Shaheed inability to urinate or empty the bladder completely due to certain
Hospital, Rawalpindi
causes (e.g surgery, bladder muscle problems). It works by helping the
bladder muscle to squeeze better, thereby improving your ability to
urinate.
Synthetic choline ester with effects similar to those of acetylcholine
(ADh). Acts directly on postsynaptic receptor, and since it is not
hydrolyzed by cholinesterase, its actions are more prolonged than those
of Ach.
Dosage must be individualized, depending on the type and severity of
the condition to be treated. Preferably gives the drug when the stomach
is empty. If taken soon after eating, nausea and vomiting may occur.
Due to non availability of local brand price is at a high and
different prices are charged by patients in different areas. I
therefore recommended the immediate allocation of local
manufacturing of the drug so that the patients can also benefit from it.
There also have been incidents reported for high rates and over
charging of drug due the smuggled version of the drug.
Decision:
Registration Board discussed and agreed to above expert opinions.
However, the Board advised firm to provide data for stability studies conducted under zone
IV-A conditions as per ICH / WHO guidelines for consideration of Registration Board.
Case No. 62:
Case deferred for confirmation of storage facilities
Registration Board in its 245th meeting deferred the following product of M/s. Rasco
Pharma, Lahore for further deliberation on storage condition of the Misoprostol API. Chairman,
Registration Board advised members and stakeholders to forward their scientific comments on
storage condition of the Misoprostol API for consideration of Registration Board:-
Minutes246thMeetingRegistrationBoard
Page381
Name of Drug(s)
Aerotec-75 Tablet
(Inner core is enteric coated with outer
core as immediate release)
Each tablet contains:Diclofenac Sodium ….. 75mg
Misoprostol …….. 200mcg
NSAID + mucosal protective
Form & demanded MRP.
1. Form 5
2. Fast Track
3. As per SRO/blister of 2×10
tablets
4. 29.06.2011/Rs.8000
5.21.05.2013/Rs.52000/4237
Competitor & specification
Arthrotec (Pfizer)
Manufacturers‘s Specs
The firm has now provided assessment report (EMA) of misoprostol API which is reproduced as
under:Misoprostol, as described in the Ph.Eur., is an only liquid which is very unstable and
difficult to be process into a drug product in liquid form. The stability of misoprostol is
significantly enhanced when it is dispersed in hypromellose. Hence, misoprostol dispersed in
hypromellose is used as an intermediate in the manufacture of misoprostol tablet. The
dispersion consists of a powder that can be stored at 5+3 °C, whereas the actual active
substance is an oily liquid that needs to be stored at -20 °C.
The certificate of analysis of the misoprostol API of the firm shows that the product is
Misoprostol 1% HMPC dispersion (White to off-white powder) and it is to be stored at 2-8 °C.
The panel of inspectors has already been recommended the storage facility of the firm for above
mentioned product. They have requested to grant them registration of above mentioned products.
A panel of inspectors comprising DDG (E & M), Lahore & area FID inspected the firm on
18-06-2014 for verification of manufacturing and storage facilities for misoprostol raw material.
The panel had recommended as under:-
“the management had provided cold cabinet to maintain temperature range from 2 to 8 C° at the
time of inspection. The panel member physically inspected the cabinet and found that the
conditions for storage were maintained. The overall sanitation and hygienic in this area was
satisfactory. SOPs for handling the raw material during sampling and dispensing were
available. The panel was satisfied with storage and production facilities at the time of inspection
to manufacture the Aerotec-75 Tablet”.
Minutes246thMeetingRegistrationBoard
Page382
Decision: Keeping in view discussion regarding requirement of storage facility for
Misoprostol and inspection report of the firm, the Board approved the product
(Misoprostol with 1% dispersion HPMC) and with change in brand name.
RRR Section
Case No. 63: Applications for Re-Registration of drugs
Following firms have applied for registration of drug as they failed to apply for renewal of
registration in time:M/s. Ambrosia Pharmaceuticals, Islamabad
S.
Reg.
Name of Drugs with
Date of
No.
No.
composition
Initial Reg.
Renewal
Application
Application Receiving
Due Date
Date for
Re-Reg.
17-12-2009 17-10-2012
Documents
Provided
by the firm
1.
035357
Ambrocillin
250mg
Tablets
Each tablets contains:Amoxicillin
(as
Trihydrate)…….250mg
18-12-2004
2.
035358
-do-
-do-
-do-
3.
041411
04-10-2005
03-10-2010
-do-
-do-
4.
041412
-do-
-do-
-do-
-do-
5.
041414
Ambrocillin
500mg
Tablets
Each tablets contains:Amoxicillin
(as
Trihydrate)…….500mg
Micozole N Ointment
Contains:Miconazole
Nitrate……………2%
Isozole Vag Cream
Contains:Isoconazole
Nitrate…………..1%
Sexatin N Cream
Each
gm
cream
contains:-
(i). Form-5
(ii). Initial
Reg. Letter
(iii). CRF
NOC
(iv). Fee
Rs.20,000/-do-
-do-
-do-
-do-
-do-
Minutes246thMeetingRegistrationBoard
Page383
Bufexamac………50mg
Neomycin
Sulphate……….2500IU
Nystatin……100,000IU
6.
042917 Monorate Ointment
Contains:Mometasone
Furoate…….0.1% w/w
M/s. Woodward Pakistan (Private) LTD., Karachi.
S.
Reg.
Name of Drugs with
Date of
No.
No.
composition
Initial Reg.
-do-
-do-
Documents
Provided
by the firm
055717
Renewal
Application
Application Receiving
Due Date
Date for
Re-Reg.
06-04-2014 24-06-2014
Documents
Provided
by the firm
1.
000483
Genticyn HC Cream
Each gm contains:Gentamicin
Sulphate
Hydrocotisone Acetate
06.9.2006
Renewal
Application
Application Receiving
Due Date
Date for
Re-Reg.
05.9.2011
24-11-2014
2.
010186
-do-
-do-
-do-
3.
007701
-do-
-do-
-do-
-do-
4.
000497
Genticyn B Cream
Each gm contains:Gentamicin
Sulphate
Betamethasone Valerate
Multigesic Cream
Each gm contains:Diethylamine Salicylate
Genticyn Cream
Each gm contains:-
(i). Form-5
(ii). Initial
Reg. Letter
(iii). CRF
NOC
(iv). Fee
Rs.20,000/-do-
-do-
-do-
-do-
-do-
1.
Bactizith 500mg Capsule 07-04-2009
Each capsule contains:Azithromycin
(as
Dihydrate)……..500mg
(USP Specification)
M/s. Macter International Limited, Karachi.
S.
Reg.
Name of Drugs with
Date of
No.
No.
composition
Initial Reg.
Minutes246thMeetingRegistrationBoard
(i). Form-5
(ii). Initial
Reg. Letter
(iii). Fee
Rs.20,000/-
Page384
Gentamicin Sulphate
Decision: Registration Board decided to defer the case till opinion of stake holders in the
matter as decided in Item No. IV(c).
Minutes246thMeetingRegistrationBoard
Page385
Item No. VII Registration of Biological Drugs – Biological Evaluation & Research Division
Case No. 01. Expert Committee for Biological Drugs
The Drug Registration Board in its 241st Meeting decided to strength the expert
committees on biological drugs for the technical evaluation of biological drugs. The earlier
committee was not functional due to resignation of 01 member and absence of another member
due to tour abroad. The proposal of constitutions of new expert committees on biological drugs
was floated with draft notifications for separate expert committees for human and veterinary
biological drugs and were processed as per law with the approval of Federal Government.
However, the Law, Justice and Human Rights Divisions raised certain queries/ legal aspects
regarding composition of committees and role of secretariat officers in the committees, which
needed to be rectified before the notifications are finalized. The notifications were re-visited and
necessary amendments were made in consultation with the Law, Justice and Human Rights
Division. The process of official notification of expert committees is in final stages. However,
due to non functional ECBD, no fresh cases can be placed before the Registration Board.
However, miscellaneous cases of already registered biological drugs are placed before the Board
for its consideration in this meeting.
Decision:
Registration Board noted the information.
Case No. 02. Change of manufacturing site for already registered drugs of M/s. R.G.
Pharmaceutica (Pvt), Ltd., Karachi.
M/s R.G. Pharmaceutica (Pvt) Ltd., Karachi has submitted the following
applications for change in manufacturing site of their already registered drugs;
S.#
1.
2.
Product &
Registration No.
Ferti-C 5000IU
Chorionic
gonadotrophin for
Injection
(Reg. No070931)
Ferti-C 1000IU
Chorionic
gonadotrophin for
Existing Manufacturing
site
Livzon (Group)
Pharmaceutical Zhohai,
Guangdong, China
Livzon (Group)
Pharmaceutical Zhohai,
Guangdong, China
Minutes246thMeetingRegistrationBoard
New Manufacturing Site
Livzon (Group) Pharmaceutical
Factory.
Address: No.38, Chuangye Road
North, Liangang Industrial Zone,
Zhuhai, Guangdong, China.
Livzon (Group) Pharmaceutical
Factory.
Address: No.38, Chuangye Road
Page386
3.
4.
Injection
(Reg. No 070930)
Ferti-M 150IU
Menotropin for
Injection
(Reg. No 070929)
Ferti-M 75IU
Menotropin for
Injection
(Reg. No 070928)
Livzon (Group)
Pharmaceutical Zhohai,
Guangdong, China
Livzon (Group)
Pharmaceutical,
Zhohai, Guangdong,
China
North, Liangang Industrial Zone,
Zhuhai, Guangdong, China.
Livzon (Group) Pharmaceutical
Factory.
Address: No.38, Chuangye Road
North, Liangang Industrial Zone,
Zhuhai, Guangdong, China.
Livzon (Group) Pharmaceutical
Factory.
Address: No.38, Chuangye Road
North, Liangang Industrial Zone,
Zhuhai, Guangdong, China.
As per SOP defined by the Drug Registration Board in its 240th Meeting, the firm has
provided following documents;
1. Application with required fee as per SRO (Rs.100, 000/- per product).
2. Copy of registration letter and last renewal status.
3. NOC for CRF clearance (Not required for Importer)
4. Original legalized CoPP, having address of new manufacturing site.
The source is from China, which falls under category, where the inspection abroad is mandatory.
Decision: Registration Board approved the request of the firm. Inspection of the foreign
manufacturer shall be conducted as per Import Policy. The Board authorized its Chairman
for issuance of letter for change in manufacturing site on the recommendation of inspection
report if it is of recommendation. If inspection report is of not recommendation, then case
will be placed before Registration Board.
Case No. 03. Request for change of importer and manufacturing site for already
registered drugs by m/s. Avior Pharmaceuticals (Pvt) Ltd., Karachi.
M/s. Avior Pharmaceuticals (Pvt) Ltd., Karachi has submitted applications for transfer of
products from M/s Global Pharmaceuticals (Pvt) Ltd. The firm has also informed that the
manufacturing site is also changed by the foreign principal. The details are as under: S.#
1.
Product &
Registration No.
Tropin 2000iu Inj
Each vial contains: Recombinant Human
Erythropoietin
Existing
Manufacturing site
M/s Harbin
Pharmaceutical Group
of Bioengineering Co.
Ltd., Harbin China
Minutes246thMeetingRegistrationBoard
New Manufacturing Site
M/s Harbin Pharmaceutical Group
Bioengineering Co., Ltd., No.99
Zhuhai Road Limin Development
Zone Hulan District, Harbin,
Page387
2.
2000iu
Reg No. 062218
Tropin 4000iu Inj
Each vial contains: Recombinant Human
Erythropoietin
4000iu
Reg No. 62219
Tropin 6000iu Inj
Each vial contains: Recombinant Human
Erythropoietin
6000iu
Reg No.066152
M/s Harbin
Pharmaceutical Group
of Bioengineering Co.
Ltd. China
M/s Harbin
Pharmaceutical Group
of Bioengineering Co.
Ltd. China
4.
Auspogen 300ug per
vial
Recombinant Human
G.CSF
Reg No. 062217
M/s Harbin
Pharmaceutical Group
of Bioengineering Co.
Ltd. China
5.
Refron 3 MIU Inj
Each vial contains
Recombinant Human
Interferon Alpha 2b
3MIU
Reg No. 047665
M/s Harbin
Pharmaceutical Group
of Bioengineering Co.
Ltd. China
Heilongjiang Province, P.R. of
China
M/s Harbin Pharmaceutical Group
Bioengineering Co., Ltd., No.99
Zhuhai Road Limin Development
Zone Hulan District, Harbin,
Heilongjiang Province, P.R. of
China
M/s Harbin Pharmaceutical Group
Bioengineering Co., Ltd., No.99
Zhuhai Road Limin Development
Zone Hulan District, Harbin,
Heilongjiang Province, P.R. of
China
M/s Harbin Pharmaceutical Group
Bioengineering Co., Ltd., No.99
Zhuhai Road Limin Development
Zone Hulan District, Harbin,
Heilongjiang Province, P.R. of
China
M/s Harbin Pharmaceutical Group
Bioengineering Co., Ltd., No.99
Zhuhai Road Limin Development
Zone Hulan District, Harbin,
Heilongjiang Province, P.R. of
China
M/s Avior Pharmaceuticals (Pvt) Ltd, Karachi has provided following documents as per SOP
defined by the Drug Registration Board in its 240th Meeting;
i)
Application on Form 5 A along with fee as defined under SRO (Rs.
100,000 per product).
ii)
Copy of registration letters and last renewal status.
iii)
NOC for CRF clearance (Not applicable to importers)
iv)
Termination letter (Original) of previous importer M/s. Global
Pharmaceuticals (Pvt) Ltd
v)
Authority letter/sole agent letter (original) from manufacturer in favour of
M/s Avior Pharmaceuticals (Pvt) Karachi.
vi)
No objection letter from Global Pharmaceuticals in favor of M/s. Avior
Pharmaceuticals for transfer of Registration.
vii)
Original and legalized CoPP of all above products.
viii) Site Master file.
The source is from China, which falls under category, where the inspection abroad is mandatory.
Minutes246thMeetingRegistrationBoard
Page388
Decision: Registration Board approved the request of the firm. Inspection of the foreign
manufacturer shall be conducted as per Import Policy. The Board authorized its Chairman
for issuance of letter for change in manufacturing site on the recommendation of inspection
report if it is of recommendation. If inspection report is of not recommendation, then case
will be placed before Registration Board.
Case No. 04. Change of manufacturing site for already registered drugs of M/s.
Pharmaevo (Pvt) Ltd, Karachi.
M/s. PharmaEvo (Pvt) Ltd., Karachi has submitted application for change of
manufacturing site of their already registered drugs. The details are as under: Product / Registration
No.
EPOSINO 4000IU/ML
Each pre-filled syringe
contains: Recombinant Human
Erythropoietin…4000IU
(Reg No. 045690)
EPOSINO 2000IU/ML
Each pre-filled syringe
contains: Recombinant Human
Erythropoietin…2000IU
Erythropoietin
Reg No. (045689)
Previous Name of
Manufacturing Site
Sandong Kexing
Bioproducts Co., Ltd.,
China
New Name of Manufacturing
site
Shandong Kexing Bioproducts
Co., Ltd. No.2666, Chuangye
Road, Mingshui development
Zone, Zhangqiu, Shandong,
China.
Sandong Kexing
Bioproducts Co., Ltd.,
China
Shandong Kexing Bioproducts
Co., Ltd. No.2666, Chuangye
Road, Mingshui development
Zone, Zhangqiu, Shandong,
China.
M/s PharmaEvo (Pvt) Ltd, Karachi has provided following documents to support their request as
per SOP decided by the DRB in its 240th Meeting:1.
2.
3.
4.
5.
Application with required fee as per SRO (Rs.100, 000/- per product).
Copy of registration letter and last renewal status.
NOC for CRF clearance.
Original legalized CoPP for new manufacturing site.
Site Master file
The source is from China, which falls under category, where the inspection abroad is mandatory.
Decision: Registration Board approved the request of the firm. Inspection of the foreign
manufacturer shall be conducted as per Import Policy. The Board authorized its Chairman
for issuance of letter for change in manufacturing site on the recommendation of inspection
Minutes246thMeetingRegistrationBoard
Page389
report if it is of recommendation. If inspection report is of not recommendation, then case
will be placed before Registration Board.
Case No. 05. Change of manufacturing site for already registered drugs by M/s. Roche
Pakistan, Ltd, Karachi.
M/s. Roche Pakistan Ltd., Karachi has submitted application for change of manufacturing
site. The details are as under: Product / Registration
No.
Avastin 100mg/4ml
injection
Each ml contains:
Bevacizumab 25mg
Reg No. 043004
Avastin 400mg/16ml
injection
Each ml contains:
Bevacizumab 25mg
Reg No. 043005
Previous Name of
Manufacturing Site
M/s F. Hoffmann- La
Roche Ltd., Basel,
Switzerland
New Name of Manufacturing
site
M/s F. Hoffmann La-Roche Ltd.,
Wurmisweg 4303, Kaiseraugst,
Switzerland.
M/s F. Hoffmann- La
Roche Ltd., Basel,
Switzerland
M/s F. Hoffmann La-Roche Ltd.,
Wurmisweg 4303, Kaiseraugst,
Switzerland.
M/s Roche Pakistan Ltd, Karachi has provided following documents to support their claim:1.
2.
3.
4.
Application on Form 5-A with required fee as per SRO (Rs.50, 000/- per product).
Copy of registration letter and last renewal status.
NOC for CRF clearance (Not required for Importer)
Original CoPP provided for new manufacturing site, however the CoPP is not
notarized and legalized from Embassy of Pakistan
5. Site Master file
The drugs is used for Matastatic Carcinoma of the Colon are rectum breast cancer and other
types of cancers. The site falls under category of Stringent Regulatory Authorities. It is proposed
that the request of the firm may be approved with condition that change of site letter shall be
issued after submission of legalized CoPP through permission from Chairman Registration
Board.
Decision: Registration Board approved request of the firm. The firm will provide legalized
CoPP of the product and authorized its Chairman for issuance of letter in light of Import
Policy for Finished Drugs.
Minutes246thMeetingRegistrationBoard
Page390
Case No. 06. Request for exemption of printing of registration and MRP on vial M/s.
Popular International (Pvt) Limited, Karachi
M/s Popular International (Pvt) Ltd., Karachi has submitted the following requests for
exemption of printing of Registration Number & MRP on inner vials as exemption for Urdu
Version granted to them vide letter No. F.1-19/95-Reg-I (Pt) dated 11th July, 2007. The firm has
informed that their principal print lot number, date of manufacturing and date of expiry on each
vial and outer box and finally print registration number on each box before shipment whereas
MRP is printed locally by us on outer box. However due to limited space on the inner vial the
principal cannot print registration and MRP. Further the company has informed that laser
printing may denature the products. The details of their request are as under: S.#
Product Name
1.
KOATE – DVI
Registration
No.
007965
2.
HyperRAB S/D
007972
3.
HyperHEP B S/D
4.
5.
PLASBUMIN
UMAN
ALBUMIN
IMMUNORHO
012835 &
007971
007967
059249
6.
GAMMARAAS
059296
059297
031350
Generic Name
Antihemophilic Factor –
VIII(Human)
Rabies Immune Globulin
(Human)
Hepatitis B Immune Globulin
(Human)
Albumin (human)
Rho (D) Immune Globulin
(Human)
Intravenous Immune Globulin
(Human)
Decision: Registration Board decided to call firm,s representative in its forthcoming
meeting for presentation of their case along with labeling/ printing status/ evidence of
similar products available in the market.
Minutes246thMeetingRegistrationBoard
Page391
Case No. 07 Request for additional pack size by M/s. Snam Pharma, Lahore
M/s Snam Pharma, Lahore has requested to approve additional pack against their
already registered products. The firm has deposited an amount of Rs.5,000/- as prescribed fee for
each product. The detail is as under with justification: S.#
Product Name
1.
Regn
No.
Biocan R Injection ad 057167
us vet
Existing
pack size
10x5ml.
5x20ml
Additional
Pack
(1m1)x20
single dose
2.
Ornipet lyof.ad.us.vet
059171
5000 x 10 Large dose pack size in
doses
poultry is convenient in the
large poultry formers and
dose of 5000 bird packing is
demanded by the market.
3.
Ornibron
lyof.ad.us.vet
057169
4.
Orniprim
lyof.ad.us.vet
057170
200doses.
500 doses.
1000 doses.
2500 doses.
10x200 doses
10x500 doses
10x1000
doses
10x2500
doses
10x200 doses
10x500 doses
10x100 doses
10x2500
doses
10x200 doses
10x500 doses
10x100 doses
10x2500
doses
5.
Ornibur intermediate 059172
lyof.ad.us.vet
The single dose of Biocan R
is necessary as it will be
used
in
single
dog
vaccination, and it is
demanded by the market.
5000 x 10 Large dose pack size in
doses
poultry is convenient in the
large poultry formers and
dose of 5000 bird packing is
demanded by the market.
5000 x 10 Large dose pack size in
doses
poultry is convenient in the
large poultry farmers and
dose of 5000 bird packing is
demanded by the market.
500 doses
2500 x 10 Large dose pack size in
1000 doses
doses.
poultry is convenient in the
1000 doses
large poultry farmers and
2000 doses
dose of 2500 bird packing is
5000 doses
demanded by the market.
10x500 doses
10x1000
doses
10x2000
Minutes246thMeetingRegistrationBoard
Justification
Page392
doses
10x5000
doses
Decision: Registration Board deferred the request and advised the firm to provide legalized
CoPP of the product for confirmation of availability of applied packs.
Case No. 08 Request for additional pack size by M/s Marush (Pvt) Ltd, Lahore
M/s Marush (Pvt) Ltd, Lahore with the request to approve additional pack against
their already registered products. The firm has deposited an amount of Rs.5,000/- prescribed fee.
The detail is as under with justification: S.#
1.
Product Name
CEVAC
TRANSMUNE
IBD VACCINE
Regn
No.
039910
Existing
pack size
1000 doses.
Additional Pack
Justification
2000 vial
4000 vial
8000 vial
More recently market trends
and demand of formers have
changed due to initiation of
multiple
large
sized
commercial
farms
and
integrated units which,
demands
medium
and
bigger packs keeping in
view their convenience and
economy in usage.
To demonstrate the benefits
for
users
regarding
introduction of additional
packs a detailed study as per
DRA’s format.
Decision: Registration Board deferred the request and advised the firm to provide legalized
CoPP of the product for confirmation of availability of applied packs.
Minutes246thMeetingRegistrationBoard
Page393
Case No. 09 Withdrawal of applications for registration of finished drugs by M/s. Sami
Pharmaceuticals, Karachi.
M/s Sami Pharmaceuticals (Pvt) Ltd, Karachi has requested for surrender of
applications for registration of finished drugs to be imported from M/s Xiamen Amoytop Biotech
Co. Ltd, Xiamen, Fujian, P.R. China. These drugs were considered favourable in meeting No. M225 dated 15.05.2010 and registration for the same were to be granted after satisfactory
inspection of the manufacturer’s facility abroad which could not be done till to date. However,
the firm was voluntarily withdrawn these long outstanding applications and will have no
objection if registrations for the same are granted either to M/s Xiamen Amoytop Biotech Co.
Ltd and/or to any other party so authorized by them. The details of withdrawn applications are
as under: Sl.#
1.
2.
Name of company
Drug name with
composition
M/s Sami
Relkin 1.5mg Injection
Pharmaceutical(Pvt) Each vial contains: Ltd, Karachi./M/s
Oprelvekin Recombinant
Xiamen Amoytop
Human Interleukin-11
Biotech Co., Ltd.,
(rHulL-11)…..1.5mg
Xiamen, Fujian,
(Immunostimulants)
P.R. China
M/s
Sami Relkin 3mg Injection
Pharmaceutical(Pvt) Each vial contains: Ltd, Karachi./M/s Oprelvekin Recombinant
Xiamen Amoytop Human Interleukin-11
Biotech Co., Ltd., (rHulL-11)…..3mg
Xiamen,
Fujian, (immunostimulants)
P.R. China
MRP
Shelf life
Remarks
As per latest
decision
taken by
PAC
24 months
Approved
As per latest
decision
taken by
PAC
24 months
Approved
Decision: The request of the firm was acceded to and the Board rejected the above
registration applications.
Minutes246thMeetingRegistrationBoard
Page394
Case No. 10 Grant of registration of solution for injection - M/s. Macter International
Limited, Karachi
M/s. Macter International Limited, Karachi has requested for registration of
solution for injection for local manufacturing. The firm has deposited an amount of Rs. 50,000/-.
The composition detail is as under: Name of Company
Raw Material
M/s Macter International Sodium Chloride
Limited, Karachi
Glycine
Polysorbate 80
Water for Injection
Quantity/0.6Ml
3mg
0.225mg
0.06mg
Qs to 0.6mL
The solvent is required to be co-packed with the product free of cost. The case of manufacturing
of locally manufactured biological product was decided in the 244th Meeting of the Drug
Registration Board including lyophilized pegylated interferon products of the company which is
under implementation process.
Request of the company for grant of registration of solvent is submitted for the approval of
Registration Board.
Decision: The request of the firm for grant of registration of solvent was approved.
Case No. 11. Change of manufacturing site for already registered drugs by M/s. Hospital
Services & Sales, Karachi and change of brand name.
M/s Hospital Services & Sales, Karachi has submitted the applications for change of
manufacture site and brand name of their already registered vaccine for below mentioned
product;
Sl.No. Reg.
No.
1.
Previous Brand
Name
and
composition.
053813 EASYFIVE –
Pentavalent
Vaccine
Each dose 0.5ml
contains: Diphtheria
Toxoid: 20Lf
(30IU)
Tetanus Toxoid:
Proposed
Name
Brand Existing
Manufacturing
Site
EASYFIVE – TT
M/s. Panacea
Pentavalent Vaccine Biotech Ltd.,
Each dose 0.5ml
New Delhi,
contains: India.
Diphtheria Toxoid:
20Lf (30IU)
Tetanus Toxoid:
7.5Lf(40IU in guinea
pig and 60 IU in
Minutes246thMeetingRegistrationBoard
New
proposed
manufacturing
site
M/s. Panacea
Biotech Limited,
Malpur, Baddi,
Distt. Solan
(H.P.) 173 205,
Inda.
Page395
7.5Lf(40IU in
guinea pig and
60 IU in mice)
Pertussis
Vaccine: 12OU
(4IU)
r-Hepatitis B
surface antigen
(HBsAg):
10mcg
Haemophilus
type b conjugate
vaccine: 10mcg.
mice)
Pertussis Vaccine:
12OU (4IU)
r-Hepatitis B surface
antigen (HBsAg):
10mcg
Haemophilus type b
conjugate vaccine:
10mcg.
M/s Hospital Services & Sales, Karachi has provided following documents to support their
request:1. Application on Form 5-A with required fee as per SRO (Rs.100, 000/- per
product).
2. Copy of registration letter and last renewal status.
3. NOC for CRF clearance (Not required for Importer)
4. Original CoPP provided for new manufacturing site.
5. Site Master file
6. The firm has also provided evidence of WHO prequalification of EASYFIVE –
TT vaccine.
Decision: Request of the firm for grant of registration of solvent exclusively to be used with
EASYFIVE – Pentavalent Vaccine, Regn No. 053813 was approved.
Case No. 12. Case of import of interferon from Cuba instead of China by M/s. Macter
International
(Pvt) Ltd., Karachi.
The case was discussed in the 244th Meeting of Drug Registration Board. The decision of the
case was as below:
Decision: Registration Board discussed the matter in detail and advised
investigation officer to further clarify following points:
a) On which documents the firm obtained clearance of Heberon Alfa R-2b Registration No.047675 from DRAP, Karachi along with dates of
invoice, airway bill/BL, LC date and other relevant information.
b) After grant of approval of change of source, what is legal status of
renewal application submitted by the firm from previous source?
Minutes246thMeetingRegistrationBoard
Page396
c) What is the status of recall of stocks, the legal course of
holding/restricting the stocks from sale was followed or otherwise,
after “not to dispose of order” on Form-1 dated 28.10.2013?
The decision of the Board was communicated to DDG (E&M) with request to clarify the points
raised by the Drug Registration Board. In response to Directorate of Biological’s letter dated 5th
November, 2014. The Deputy Director General (E&M), DRAP, Karachi has stated that.
a) The documents on which the firm obtained clearance of Heberon Alpha R 2-b,
Registration No. 047675 from DRAP, Karachi are follows: i. Attested invoices.
ii. Copy of Airway bill/Bill of lading.
iii. Copy of L.C. dated 23.05.2013 as swift of M/s. Meezan Bank, Karachi
Pakistan.
b) The lyophilized source from Cuba; Product name: Heberon Alpha 3MIU injection
(interferon Alpha 2b3 MIU) Registration No. 022820 vide letter No.F. 3-6/98-Reg-II
(M-137).
2.
The liquid source from china product name: Heberon Alpha 3 MIU (Interferon R 2-b
3MIU) Registration No. 047675 vide letter No.F.3-1/2008-Reg-I (M-212).
3.
The legal status with justification as I understand is the change of dosage form for
another Registration No.047675 which becomes legal as source was changed only for
Registration No. 047675 of the same product. The first source relates to the Heberon Alpha
3MIU (Interferon R 2-b 3MIU) (Registration No. 022820) but the change of source from Cuba to
China is for Heberon Alpha 3MIU (Inteferon R 2-b 3MIU) (Registration No. 047675) in liquid
form. T he former dosage form was lyophilized. Hence, it is concluded that M/s. Changchun
Heber Biological Technology Co. Ltd., China is the sister concern of M/s. Heber Biotech S.A.
La Havana, Cuba the basic approved site and the product release authority of both the sources
Cuba and China is same. Hence, there is no product Safety, Quality, Efficacy and Economic
value related issued found. As the lot was released by NCLB, Islamabad also the importer (M/s.
Macter International Pvt. Ltd.) applied for the renewal of the said product on form 5-B of the
rule 26 of the Drug renewal for registration on 18.07.2013 and also deposited the required fee
under SRO 1117(I)/2012 which is pending with RRR section, DRAP. Therefore there is no harm
to allow them to market the aforesaid lot in favour of the importer in public interest so required
as protected under rule 27 of the Drugs (Licensing, Registering & Advertising) Rules, 1976
(copies of both the application for registration renewal are enclosed.
Minutes246thMeetingRegistrationBoard
Page397
As far as the grant of approval of change of source is also valid under rule 26 of
the Drugs renewal for registration dosage form of which is physically different as described
above. On the other hand, the legal status of renewal application submitted by the firm from
previous source is also legal as there is no legal embargo if the previous source is rejuvenated by
the applicant that is valid under SRO 145(I)/1976 if pending with the board concerned and
1117(i)/2012.
(i)
(ii)
The status of recall of stocks is laying hold in the cold storage area of the
importer.
The legal course of holding/restriction of the stocks were followed by the
firm. Through, they are now not bound to sell after the expiration of the
period of the order on Form-I dated 28.10.2013 which is only for the
period of 14 days by the undersigned.
Conclusion:
After having sufficient documents evidences for both the sources of same product, having
different registration for different sources and renewal also pending though applied well in time
under rules, suffice the need of legal protection to import from the either source being the
custodian of two registrations originally and subsequently renewed as per law enacted under
condition of registration under Drug Act 1976.
The intention of the importer depicts that the change of source of one registration from Cuba to
China is positive for the adequate / free availability of life saving drugs in public interest.
Concluding all pros and corns of this investigation the contention and intention of the importer
was found positive professional approach and no evidence was found to contravene the Drugs
Act 1976 and rules prevails thereunder.
Hence the DDG (E&M) has recommended to allow the importer M/s Macter International (Pvt)
LTd, to make this life saving drug available and restriction as imposed after lot release may also
be withdrawn.
Decision:
Registration Board discussed that the firm has violated the Drug Act, 1976
and rules framed there under and decided to issue show cause notice to the company, as
why not the consignment be re-exported or legal action be taken as per procedure, after
giving opportunity of personal hearing to the firm in the next meeting.
Minutes246thMeetingRegistrationBoard
Page398
Case No. 13. Import of Insulatard Penfill Syringe from the previous source by M/s N o v o
Nordisk Pharma (Pvt), Clifton Karachi.
The case of the firm was discussed in 244th Meeting of Drug Registration Board. The
case details are as below: M/s Novo Nardisk has applied for the change of source of their registered product
namely Insulatard Penfill 100iu/ml 5x3ml (Registration No.010341). The decision of the
Registration Board in its 242nd meeting is as follows: S.No. Product &
API
Existing
Proposed
Regn.No.
Manufacture
secondary
secondary
Site
packaged
packaged
import site
import site
1
Insulatard
Novo
Novo Nordisk
Novo Nordisk
Penfill ®
Nordisk A/S
A/S
Production S.A.S.
100 IU/ml 5x3
Novo Alle
Novo Alle
5 bis, rue Edmond
ml
DK-2880
DK-2880
Poillot
(R.No. 010341)
Bagsvaerd
Bagsvaerd
28000 Chartres
Denmark
Denmark
France
Past Decision: The Board approved the new EMA approved site mentioned above for import
of the above mentioned products subject to COPP from new site.
Accordingly the change of source letter was issued to the firm on 7th April, 2014 clearly
mentioning that the previous source of import stands cancelled. The Assistant Drugs Controller,
Karachi has informed that M/s Novo Nordisk, Karachi has imported Insulatard Penfil 100IU/M
(Reg NO. 010341) from Denmark on 20th May, 2014 which is the earlier source of import. The
ADC, Karachi was requested to submit complete case along with his recommendations. The
ADC Karachi has stated that he is of the opinion to revoke the orders of sales restrictions as the
safety, quality and economic value of drug in question. The officer has also stated that sale of the
drug may be allowed in the public interest so required.
It is submitted that the source of import was cancelled by the Drug Registration Board vide letter
No. 2-1/2014-DDC (BD)(M-242), dated 7th April, 2014. Under section 23 subsection 1(a) (vii)
“no person shall himself or by any other person on his behalf export, import or manufacture for
sale or sell any drug which is not registered or is not in accordance with the conditions of
registration”. The firm has violated the Drugs Act, 1976.
Minutes246thMeetingRegistrationBoard
Page399
The case of the firm was decided as under: “DECISION: Registration Board approved request of the firm. However the
Board advised firm to provide/submit copy of L/C (original or duly certified) for
establishing the fact that the import order was placed well before the date of
grant of change of manufacture site by DRAP and authorized its Chairman for
permission to issue the letter for sale of drug”.
The firm was asked to provide the documents as per decision of the Drug Registration Board,
however, the company has provided following documents: i)
ii)
Signed distribution Agreement between Novo Nordisk A/S Novo Alle
2880 Bagsveard Denmark and Novo Nordisk Pharma (Pvt) Ltd, 113,
Shahrah-e-Iran, Mian Clifton Karachi by indicating that in place of L/C
the term of payment is 360 days from the date of invoice, which is also
mentioned on custom invoice.
Customs Invoice.
The firm informed that they have not established L/C as per their own system. The case was
submitted to the Chairman Registration Board for decision. The Chairman has desired to place
the case before the Drug Registration Board for decision.
Decision:
Registration Board discussed that the firm has violated the Drug Act, 1976
and rules framed there under and decided to issue show cause notice to the company for
not providing the copy of L/C with opportunity of personal hearing, as per procedure of
Drug Registration Board.
Case No. 14. Deferred case of 241st meeting for Poulvac ® SE Vaccine by M/s. Hi-tech
Pharmaceutical, Lahore.
The following case of M/s. Hi-Tech Pharmaceutical, Lahore was deferred in 241st Meeting of Drug
Registration Board reasons mentioned in the last column below: Sl.# Applicant
Name and Specs
ECBD
6.
Poulvac ® SE
Vaccine
Each 0.5ml dose
contains: Salmonella enteritidis
Phase Type
Recomme
nded
M/s
Hi-Tech
Pharmaceutical,
Lahore
Manufactured
by:
M/s Pfizer
Minutes246thMeetingRegistrationBoard
Committee
Recommendation
More data is
required
Decision
Deferred
for
clarification
from the
application
regarding
Page400
Animal Health
(Pfizer Inc),
2000 Rockford
Road, Charles
City, Iova, USA
4….RP…> 1.0/dose at
release.
Salmoella enteritidis
Phase Type
8…RP….>1.0/dose at
release.
Salmonella enteritidis
Phase Type
13a…RP…> 1.0/dose
at release 37%
Formaldehyde.
Solution…..0.0006ml
White oil….0.1995ml
Arlacel-83…0.1105ml
Tween80…0.001105ml
Saline….q.s to 0.3ml
(For Veterinary Use)
use of
formalin
concentrati
on and
review by
already
constituted
committee
and
veterinary
expert of
ECBD.
The firm has submitted application to Animal Husbandry Commissioner Dr. Qurban Ali and
submitted clarification to Director Biological Drugs, DRAP, Islamabad. Clarification submitted to
DRAP and comments of Animal Husbandry Commissioner are tabulated below: -
Clarification submitted by the firm to DRAP



For inactivation, formalin is added to the
total volume of the bacterial suspension,
not over 1%
Source of formalin brand used holds 37%
formaldehyde solution, of this 37%
branded formaldehyde stock solution,
maximum upto 1% of formalin is used in
total volume of the bacterial suspension.
Dose of Poulvac SE is 0.3mL/bird and
each dose contains 0.0006mL i.e. 0.2% of
37% formaldehyde solution.
Comments of Animal Husbandry
Commissioner
“Formalin is used to produce inactive bacter
vaccines. For this purpose, 37% formalindehy
gas is added to water to produce reage
commonly known as formaline, which is th
used in a very small concentration (as is used
the subject product “Poulvac SE” at the rate
1% to the total volume of bacterial suspension
Therefore, 37% formaldehyde solution
formalin at the rate of 1% is part of norm
procedure to produce such inactivated vaccines”
Decision: Registration Board referred the case to Expert Committee on Biological Drugs
(Vet) for its consideration.
Minutes246thMeetingRegistrationBoard
Page401
Case No. 15. Change of manufacturing site for already registered drugs of M/s. Pfizer
Pakistan, Karachi.
M/s Pfizer Pakistan, Karachi had submitted the following application along with
prescribed Fee Rs. 50,000/- for the product as well as CoPP from new manufacturing site. The
details are as under: S.#
1.
Product &
Registration No.
Prevenar 13
Suspension for
injection
(Reg # 066110)
Existing
Manufacturing site
Baxter Pharmaceutical
Solutions LLC 927
South City Curry Pike,
Bloomington IN, USA
New Manufacturing
Site
Pfizer
Ireland
Pharmaceuticals
Grange
Castle
Business
Park,
Clondalkin, Dublin 22
Ireland.
M/s Pfizer Pakistan Ltd, Karachi has provided following documents to support their claim:1. Application with required fee as per SRO (Rs.50, 000/- per product) being the
innovative.
2. Copy of registration letter and last renewal status.
3. NOC for CRF clearance.
4. Original legalized CoPP for new manufacturing site.
5. GMP of manufacturing site.
6. Site Master file
Decision: The request of the company was acceded by the Board as per CoPP issued by the
EMA.
Case No. 16
M/s Novo Nordisk, Karachi had requested for registration of Histidine solvent in
Prefilled Syringe for already registered drugs NovoSeven 50KIU (1mg) Powder for solution for
Injection (Reg No. 066157) each vial contains: Eptacog alfa (activated)1mg and NovoSeven
100KIU (2mg) Powder for Solution for Injection (Reg No. 66158) alongwith Hisitidine 2ml each
vial contains Eptacog alfa (Activated) 2mg. The firm has deposited an amount of Rs. 50,000/- for
each product. The composition detail is as under: Name of Company
Novo Nordisk, Karachi
Minutes246thMeetingRegistrationBoard
Raw Material
Powder and solvent
Quantity/0.6mL
01mg/vial
Page402
Novo Nordisk, Karachi
for solution for
injection
Powder and solvent
for injection for
injection
(50KIU/vial)
02mg/vial
(1000KIU/vial
Decision: Registration Board deferred the case for confirmation of status of solvent in
CoPP.
Case No. 17. Extension in exemption for the biological drugs imported from M/s Ferring
Germany.
Atco Laboratories Limited, Karachi have submitted that they are importing
following Biological drugs from M/s Ferring Pharmaceutical, Germany since 1994 that are in the
process of shifting their manufacturing facility and it would not be possible for them during this
period to incorporate all requirements according to their local labeling rules on the packaging
material. As these products are rare/ already in the market and patient needs them, therefore, M/s
Atco Laboratories Limited, Karachi has requested for extension in exemption in Labeling and
Packing Rules for the Biological Imported Drugs for at least twenty months are more: Sl. #
1.
2.
3.
4.
Reg.
Name of
No.
Drug(s)
016110 Decapeptyl
0.1mg injection
016111 Decapeptyl
3.75mg
injection
032143 Menogon
Injection
016153 Glypressin 1mg
Injection
Exemption requested
Quantity
i) Generic Name not in bracket.
ii) Drug registration number to be printed
locally.
iii) MRP to be printed locally.
iv) Urdu instruction to be printed locally.
v) Pharmaceutical specification.
vi)
-do-
924 units.
2638 units.
-do-
6106 units.
-do-
3438 units.
Minutes246thMeetingRegistrationBoard
Page403
This case has been discussed in 243 Meeting of Drug Registration Board and deferred for
confirmation of pharmacological group. The firm has provided the pharmacological group as per
following details: Sl. #
Product name
Generic Name
Pharmacological Group
1.
Decapeptyl 0.1mg injection
Triptorelin Acetate Eq.
Triptorelin is synthetic form
to 95.6UG
of Gonaderelin. Triptorelin
Triptorelin/ml
causes an increase in the
amount of FSH and LH
release from the Pituitary
gland.
2.
Decapeptyl 3.75mg injection
Triptorelin Acetate
Triptorelin is synthetic form
Corresponding to
of Gonaderelin. Triptorelin
3.75mg/Single Dose
causes an increase in the
amount of FSH and LH
release from the Pituitary
gland.
3.
Menogon Injection
Menotrophin 75IU
Gonadotrophic
Hormone
(used in infertility).
4.
Glypressin 1mg Injection
1mg Terlipressin
Terlinpressin is an analog of
Acetate Pentahydrate
vasopressin used for Bleeding
In 11mg Dry Substance of esophageal varices, spactic
shock
and
hepato-renal
syndrome.
Decision:
Registration Board acceded to the request of the firm for relaxation for the
Urdu version at the time of import for the products referred above subject to local printing
at the licensed premises of M/s. Atco Laboratories Ltd. Karachi for one year. The firm will
comply with all the rest of conditions as per rules for labeling, before importing to
Pakistan.
Case No. 18. Change of manufacturing name for already registered drug of M/s. Allmed
Laboratories, Karachi
M/s Allmed Laboratories, Karachi has submitted the following application for change of
name of manufacturer along with CoPP from new manufacturer as well as fee of Rs. 50,000. The
detail is as under: S.#
1.
Product &
Registration No.
ATG – Fresenius S
Concentrate for
solution for
Minutes246thMeetingRegistrationBoard
Existing name of
manufacturer
M/s Fresenius Biotech
GmbH Germany
New Manufacturer
name
M/s Neovii Biotech
GmbH, AM Haag 6-7,
82166 Grafelfing
Page404
infusion.
Each ml contains:Rabbit
Immunoglobulin
20mg
(Reg No. 033134)
M/s Allmed
claim:1.
2.
3.
4.
Germany,
Laboratories, Ltd, Karachi has provided following documents to support their
Application with required fee as per SRO (Rs.50, 000/- per product).
Copy of registration letter and last renewal status.
NOC for CRF clearance (Not required for Importer)
Original legalized CoPP for new manufacturing site.
Decision: The request of the firm was approved as per CoPP provided by the firm.
Case No. 19. Change of name of manufacturing site for already registered drug of M/s.
Wyeth Pakistan Limited, Karachi.
M/s Wyeth Pakistan Limited, Karachi has submitted the following application for change of
name of manufacture site for their already registered product along with copy of CoPP from new
manufacturer as well as fee of Rs. 100,000/-. The detail is as under: S.#
1.
1.
2.
3.
4.
5.
6.
Product &
Registration No.
Premarin 0.3mg
tablet Conjugated
Estropgens USP
(Desiccated with
Lactose at
4.29%)…0.3mg.
Existing name of
manufacturer
M/s. Wyeth Medica
Ireland
Little Connell New
bridge Country Kildare,
Ireland
New Manufacturer
name
Pfizer
Ireland
Pharmaceuticals
Little Connell New
Bridge
Country
Kildare, Ireland.
Application with required fee as per SRO (Rs.100,000/- per product).
Copy of registration letter and last renewal status.
NOC for CRF clearance.
Original legalized CoPP for new name of manufacturer.
GMP of manufacturing site.
Site Master file
Decision: The request of the company was approved as per CoPP.
Minutes246thMeetingRegistrationBoard
Page405
Case No. 20. Extension in shelf life of Poliomyelitis Vaccine of M/s. Hospital Services &
Sales, Karachi.
M/s. Hospital Services & Sales, Karachi has submitted the following application for
extension in shelf life of already registered drug from 24 months to 36 months: Sl.
No.
1.
Name of Drug with Registration No.
Existing Shelf Life
Demanded Shelf Life
Poliomyelitis Vaccines Inactivated,
Suspension for Injection 0.5ml
vial/dose (IM/SC)
24 months (02 years)
36 months (03 years)
The firm has submitted for following documents: a.
b.
c.
d.
e.
Application on Form 5A with required fee as per relevant SRO (Rs. 5000/-).
Copy of registration letter and last renewal status.
NOC for CRF clearance (not required in case of importer).
Justification for proposed change.
Approval of regulatory body of country of origin / Original and legalized
Certificate of Pharmaceutical Product as per WHO format indicating shelf life 36
months.
f. Free sale certificate and GMP certificate
g. Stability studies for product 2-80C.
h. The firm has also provided WHO prequalification evidence indicating the shelf
life from 24month to 36 month at 2-80C.
Usually extension of shelf life case is placed before the Drug Registration Board after
getting the experts opinion from different experts. However considering the polio emergency in
the country and WHO prequalified data of the said drug, the case is placed before the board for a
decision.
Decision:
The request of the firm was approved. WHO status shall be checked from
WHO website before issuance of letter to the company. It shall also be mentioned in the
registration letter that incase of any change in WHO status, the company shall immediately
report to the Board and decision of the Board shall stand cancelled.
Minutes246thMeetingRegistrationBoard
Page406
Case No. 21. Local manufacturing of Allergen vaccines by M/s. Pakcure Pharma, Rawat.
The case of manufacturing of Allergen vaccines by M/s. Pakcure Pharma, Rawat was
under consideration of Board. The following products were discussed in different meetings of the
Board.
Applicant
M/s Pakcure
Pharma, Rawat,
Islamabad.
Registration No. of Decision
similar product
already in the
market as
manufactured by
NIH, Islamabad
016742
Deferred for
Allergex-MP
Product specific
Each ml contains:
inspection by the
Beef protein extract…….10mcg
panel.
Chicken protein extract. 10mcg
Egg protein
extract……...10mcg
Fish protein
extract……..10mcg
Mutton protein extract..10mcg
Product specifications
Shelf Life: 6 months when
stored at +2 to +8˚C
M/s Pakcure
Pharma, Rawat,
Islamabad.
Allergy vaccine,
immunostimulant
Allergex-Px1
Each ml contains:
Cannabis sativa protein extract
10mcg
Acacia niloticaa protein extract
10mcg
Eucalyptus globulus protein
extract 10mcg
Pininus longfolia protein
extract 10mcg
House dust extract 10mcg
-do-
Deferred for
Product specific
inspection by the
panel.
Shelf Life: 6 months when
stored at +2 to +8˚C
Allergy vaccine,
immunostimulant
Minutes246thMeetingRegistrationBoard
Page407
M/s Pakcure
Pharma, Rawat,
Islamabad.
Allergex-Px2
-do-
Deferred Product
specific inspection
by the panel.
-do-
Deferred for
Product specific
inspection by the
panel.
Each ml contains:
Cannabis sativa protein extract
10mcg
Acacia niloticaa protein extract
10mcg
Eucalyptus globulus protein
extract 10mcg
Pininus longfolia protein
extract 10mcg
Mixed grass extract of Lolim
temulentum + Cynodon
dactylon …10mcg
House dust extract ..10mcg
Shelf Life: 6 months when
stored at +2 to +8˚C
M/s Pakcure
Pharma, Rawat,
Islamabad.
Allergy vaccine,
immunostimulant
Allergex-Px3
Each ml contains:
Cannabis sativa protein extract
10mcg
Acacia niloticaa protein extract
10mcg
Eucalyptus globulus protein
extract 10mcg
Pininus longfolia protein
extract 10mcg
House dust extract ..10mcg
Paper mulberry extract…10mcg
Thrasher extract…10mcg
Raw cotton extract…10mcg
Shelf Life: 6 months when
stored at +2 to +8˚C
Allergy vaccine,
immunostimulant
Minutes246thMeetingRegistrationBoard
Page408
M/s Pakcure
Pharma, Rawat,
Islamabad.
Allergex-Px4
Each ml contains:
Cannabis sativa protein extract
10mcg
Acacia niloticaa protein extract
10mcg
Eucalyptus globulus protein
extract 10mcg
Pininus longfolia protein
extract 10mcg
House dust extract ..10mcg
Paper mulberry extract…10mcg
Thrasher extract…10mcg
-do-
Deferred for
Product specific
inspection by the
panel.
Shelf Life: 6 months when
stored at +2 to +8˚C
Allergy vaccine,
immunostimulant
The product specific inspection of the company was conducted and presented before the board in
its 243rd Meeting wherein the deficiencies of the facility were discussed and the board decided as
under;
Past Decision: The Board decided to defer the case till removal of deficiencies. Reference
may also be sent to the Licensing Board to ensure compliance as per requirement of Biological
Drugs.
The firm after making improvements, approached again for the inspection. The inspection of the
company was again carried out by the panel. The panel observed that the firm has not made
substantial improvements. However, the panel was also of the opinion that the company may be
allowed trial manufacturing to ensure that all necessary requirements are met by the company.
The trial manufacturing is not for utilization of allergy vaccines for human use.
In the light of inspection report and recommendations of the panel, the case is placed before the
Board for a decision.
Decision: The Board offered personal hearing to Mr. Agha Sadrad ud Din, CEO of the
company. The applicant explained his status of improvements and assured the Board for
its compliance. The Board decided to conduct the inspection of the company by already
approved panel as and when the firm informs for compliance and will be ready for
inspection. The report of panel shall be considered in the next meeting of Board.
Minutes246thMeetingRegistrationBoard
Page409
Case No. 22. Court case of M/s Forward Solution V/S DRAP.
The case of M/s Forward Solution was discussed in 243rd Meeting of the Drug Registration
Board. The board decided that since the case is sub judice and under the consideration of the
Honorable Court. The firm M/s. Well Pharma, Lahore will be asked to substantiate their claim of
sole agent of the manufacturer in order to satisfy the legal procedure.
The decision of the board was communicated both the companies. M//s Well Pharma, Lahore has
not provided any sole agent agreement.
The firm M/s Forwarded Solution filed a writ petition in the Honourable Islamabad High
Court, Islamabad on 13.09.2014 on the grounds that the Drug Regulatory Authority of Pakistan
is not granting the Registration due to inaction of the functionary of the Drug Regulatory
Authority of Pakistan (CEO, DRAP, Director, Registration and Director Biological Products).
Parawise comments have been prepared and submitted to the Lawyer of DRAP for finalization
and submission to Honourable Court. Meanwhile, Federal Investigation Agency (FIA) has also
directed to appear before them to provide the details of the case, probably on the complain of
aggrieved company for non grant of registrations. The matter is submitted for information of the
Honorable Drug Registration Board and necessary instruction/orders if any.
Decision: The information was noted by the Board.
Minutes246thMeetingRegistrationBoard
Page410
Item No: VIII Quality Control Cases – Quality Assurance & Lab Testing Division
Case No. 01:
Sr.
No
Name of
Drugs
1
Deferred Cases
Firm
CDL Report
M/s Kohs
Pharmaceuticals
(Pvt) Ltd
Substandard
regard to :-
Mfg. Sep-13
with Firm challenged
the report after 30
days as per record
Assay
for provided by FID
Artemether:
so the request was
Found:- 80.256% not valid for re
testing by the
Appellate
Lab
NIH
Islamabad
Limit:
90% to
under
Section
110%
22(5) of Drugs Act
1976
Exp. Aug-15
Does not comply
(F. No. 0363/2013)
Remarks:The
sample
is
of
substandard
quality under the
Drugs Act 1976.
Kohsar DS
Tablets
(Artimether &
Lumifantrin)
Hyderabad.
Tablets
Batch No.001
Test report
852/2013
Minutes246thMeetingRegistrationBoard
Appellate Testing
No.
Detail / Decision
The
Board
was
apprised about the
background of
the
case as under: The
Sample
of
Kohsar DS Tablets
Batch
No.
001
manufacture by M/s
Kohs
Pharmaceuticals
(Pvt)
Ltd
Hyderabad, drawn
on 10-10-2013 from
manufacturer’s
premises by FID
Hyderabad,
was
declared substandard
by
Federal
Government Analyst
CDL, Karachi vide
Test report No.
852/2013 dated 1012-2013. The firm
did not respond
FID’s explanation
letter dated 17-122013 so reminder
letters dated 06-012014 and 30-012014 were issued by
the FID. The firm
vide its response
dated
11-02-2014
disagreed
and
challenged the CDL
report. As per record
provided by the FID
Page411
the
report
was
conveyed to the firm
by the FID vide
letter dated 17th
December
2013,
while
the
firm
challenged the report
vide its letter dated
11th February 2014.
The FID nominated
following
as
responsible persons.
i.
Owner of the
firm, M/s Kohs
Pharmaceuticals
(Pvt) Ltd.,
ii. Quality Control
Incharge of M/s
Kohs
Pharmaceuticals
(Pvt) Ltd
iii. Mirza
Saleemullah,
Production
Manager,
M/s
Kohs
Pharmaceuticals
(Pvt) Ltd

Minutes246thMeetingRegistrationBoard
The FID has not
given
any
recommendations
nor
made
any
comments
regarding validity
of the act of
challenging
the
CDL report by the
firm. However, as
Page412
per record provided
by the FID, it
appears that firm
has challenged the
report after the 30
days
period
prescribed
under
Section 22(4) of
Drugs Act 1976,
therefore,
the
request was not
valid for retesting
by Appellate Lab.

As
per
responsibility fixed
by the FID, show
cause notices dated
05-05-2014 were
issued to the firm
and the accused
persons of the firm.
 The
case
was
placed before Drug
Registration Board
in its 244th meeting
held on 23-24th July
2014. The accused
of the firm were
also called for
personal hearing in
the said meeting of
the Board but they
could not appear
before the Board.
The Board decided
to defer the case
and provide a final
opportunity
of
personal hearing to
the accused.
 The case was
again
placed
before
Drug
Registration Board
in its 245th meeting
Minutes246thMeetingRegistrationBoard
Page413
held on 29-30th
September 2014.
The accused of the
firm were also
called for personal
hearing in the said
meeting of the
Board but they
could not appear
before the Board.
The Board decided
to defer the case
and provide a final
opportunity
of
personal hearing to
the accused.
The
case
was
presented before the
registration board in
its 246th meeting on
11-12-2014.
The
Board decided the
case as under in the
light
of
personal
hearing
of
Mr.
Pardeep
Kumar
Director of the firm:Decision:The Board took the
following decision
i.
ii.
iii.
Minutes246thMeetingRegistrationBoard
Cancellation of
Kohsar
DS
Tablets
Registration
No 070898.
Panel
Inspection for
PSI.
The panel will
be constituted
by
Director
Page414
QA&LT.
2.
Dozabitol
(Paracetamol
Syrup.
M/s Kohs
Pharmaceuticals
(Pvt) Ltd
Hyderabad
Batch No. DB
110
Mfg-Jul -13
Exp. Jun-15
Firm challenged
the report after 30
With regard to days as per record
assay
for provided by FID
Paracetamol
so the request was
Found :-82.2984% not valid for re
testing by the
Appellate
Lab,
NIH
Islamabad
Limit:- 90% to
under
section
110%
22(5) of Drugs Act
1976
Sub-Standard:-
Does not comply
(F.No. 0312/2014)-QC
Remarks:The
sample
is
of
substandard
quality under the
Drugs Act 1976.
Test report
848/2013
Minutes246thMeetingRegistrationBoard
No.
The
Board
was
apprised about the
background of
the
case as under: The Samples of
Dozabitol
Syrup,
Batch No. DB110
manufacture by M/s
Kohs
Pharmaceuticals
(Pvt)
Ltd
Hyderabad, drawn
on 10-10-2013 from
manufacturer’s
premises by FID
Hyderabad,
were
declared substandard
by
Federal
Government Analyst
CDL Karachi vide
Test report No.
848/2013 dated 2711-2013.
.
In
response to FID’s
explanation letter,
the firm disagreed
and challenged the
CDL report. As per
record provided by
the FID the report
was conveyed to the
firm by the FID vide
letter dated 03rd
December 2013 and
reminder was issued
vide letter dated 30Page415
01-2014 for firm’s
response in the
matter. The firm
challenged the report
vide
its
letter
received in DRAP
Karachi office on
13-02-2014. so the
request for retesting
was not valid as the
same was received
by FID office after
30 days The FID has
nominated following
as
responsible
persons.
i. Owner of the
firm, M/s Kohs
Pharmaceutical
s (Pvt) Ltd.,
ii. Quality Control
Incharge, M/s
Kohs
Pharmaceutical
s (Pvt) Ltd
iii. Mirza
Saleemullah,
Production
Manager, M/s
Kohs
Pharmaceutical
s (Pvt) Ltd

Minutes246thMeetingRegistrationBoard
The FID has not
given
any
recommendations
nor
made
any
comments
regarding validity
of the act of
challenging
the
Page416
CDL report by the
firm. However, as
per record provided
by the FID, it
appears that firm
has challenged the
report after the 30
days
period
prescribed
under
Section 22(4) of
Drugs Act 1976,
therefore,
the
request was not
valid for retesting
by Appellate Lab.
 As
per
responsibility fixed
by the FID, show
case notices dated
05-05-2014 were
issued to the firm
and the accused
persons of the firm.
 The case was
placed before Drug
Registration Board
in its 244th meeting
held on 23-24th
July 2014. The
accused of the firm
were also called
for
personal
hearing in the said
meeting of the
Board but they
could not appear
before the Board.
The Board decided
to defer the case
and provide a final
opportunity
of
personal hearing to
the accused.
 The case was
again
placed
Minutes246thMeetingRegistrationBoard
Page417
before
Drug
Registration Board
in its 245th meeting
held on 29-30th
September 2014.
The accused of the
firm were also
called for personal
hearing in the said
meeting of the
Board but they
could not appear
before the Board.
The Board decided
to defer the case
and provide a final
opportunity
of
personal hearing to
the accused.
The
case
was
presented before the
registration board in
its 246th meeting on
11-12-2014.
The
Board decided the
case as under in the
light
of
personal
hearing
of
Mr.
Pardeep
Kumar
Director of the firm:Decision:The Board took the
following decision
i..
Minutes246thMeetingRegistrationBoard
Cancellation of
Registration of
Dozabitol
(Paracetamol
Syrup
Page418
Registration
No.006201.
ii.
iii.
3.
Dozabitol
(Paracetamol
Syrup.
M/s Kohs
Pharmaceuticals
(Pvt) Ltd
Hyderabad
Batch No. DB
089
Mfg- Jan-13
Exp- Dec-14
(F.No. 0331/2013)-QC
The
Board
was
Sub-Standard with Sub-Standard
apprised about the
regard to:With regard to:- background of
the
Assay
for i. Assay for
case as under:Paracetamol:paracetamol:Found:- 88.62%
 The
Sample
of
Dozabitol
Syrup
85.52%
Batch No. DB089
manufacture by M/s
Limit:- 95.0% to Does not comply
Kohs
with BP 2011.
105%
Pharmaceuticals
(Pvt)
Ltd
ii.
Description
Hyderabad, drawn
pink colored syrup
on 21-03-2013 from
un
Does not comply having
manufacturer
dissolved masses
with BP 2011
premises by FID
which
do
not
Hyderabad,
was
declared substandard
disperse even on
by
Federal
Remarks:The shaking
Government
sample
is
of
Analyst,
CDL
substandard
Karachi vide Test
quality under the Does not comply
report No. 535/2013
dated 06-05-2013.
Drugs Act 1976.
with BP 2011,
On explanation letter
which states that
issued by the FID,
suspension
may
the firm requested
show
a
Appellate
testing
sedimentation
under section 22(5)
Test report No. which is readily
of Drugs Act 1976.
535/2013
dispersed
on
The
Appellate
Laboratories
also
Minutes246thMeetingRegistrationBoard
Panel
Inspection
for PSI.
The panel
will be
constituted
by Director
QA&LT
Page419
declared the sample
sub-standard
vide
test report No.08MNHRS/2013 dated
Test report No.0806th August 2013.
MNHRS/2013
The
repot
of
Appellate
Laboratories
was
forwarded to the FID
for sending complete
case along with
recommendation and
name
of
the
responsible persons.
The FID in response
has
nominated
following
as
responsible person
with request for
permission
for
prosecution
and
cancellation
of
registration.
i.
Owner of the
firm,
M/s
Kohs
Pharmaceuticals (Pvt)
Ltd., Hyderabad.
shaking.
ii.
Miss
Rakhshanda
(Quality
Manger).
Perveen
Control
iii.
Production
Manager of the firm
 As per responsibility
fixed by the FID,
show cause notices
dated
07-05-2014
were issued to the
firm and the accused
persons of the firm..
 The case was
Minutes246thMeetingRegistrationBoard
Page420
placed before Drug
Registration Board
in its 244th meeting
held on 23-24th
July 2014. The
accused of the firm
were also called
for
personal
hearing in the said
meeting of the
Board but they
could not appear
before the Board.
The Board decided
to defer the case
and provide a final
opportunity
of
personal hearing to
the accused. They
have been called
for
personal
hearing
again
accordingly.
 The case was
again
placed
before
Drug
Registration Board
in its 245th meeting
held on 29-30th
September 2014.
The accused of the
firm were also
called for personal
hearing in the said
meeting of the
Board but they
could not appear
before the Board.
The Board decided
to defer the case
and provide a final
opportunity
of
personal hearing to
the accused.
The
case
was
Minutes246thMeetingRegistrationBoard
Page421
presented before the
registration board in
its 246th meeting on
11-12-2014.
The
Board decided the
case as under in the
light
of
personal
hearing
of
Mr.
Pardeep
Kumar
Director of the firm:Decision:The Board took the
following decision
i..
Cancellation of
Registration of
Dozabitol
(Paracetamol
Syrup
Registration
No.006201.
ii.
4.
Stearox 1ml
Injection
Batch No.
H110112
Mfg:-01-12
Exp:-01-14
M/s Gyton
Pharmaceutical
Lahore
Panel
Inspection for
PSI.
iii. The panel will
be constituted
by
Director
QA&LT.
Sub-Standard
Not Challenged
The Brief about the
background of
the
With regards to:Batch
No. case is as under:H110112,
i. pH
The
samples
of
Stearox
Injection
Determined 5.94
Batch No. H110112,
Limit 7.0 to 8.5
Manufactured by M/s
Guyton
Does not comply
Pharmaceutical
with USP 34
Lahore drawn by FID
Minutes246thMeetingRegistrationBoard
Page422
(F.No.0325/2013 QC)
ii.
Assay
for
Dexamethasone
Phosphate 14.59%
Limit 90% to 115%
Does not comply
with USP 34
Karachi from Central
Pharmacy of JPMC,
Karachi on 26-022013, was declared
Substandard vide test
report
No.261/2013
dated 03-04-2013 by
Federal Government
Analyst. The FID has
identified following
persons responsible in
the case.
.
Mr.
Ahmad
(Q.C
charge)
Talat
Anjum
In-
.Muhammad
Khalil
Imran
(Production In-charge)
 As per procedure
show cause notices
was issued to the
firm 20th February
2014 and above
accused,
offering
opportunity
of
personal
hearing
before the Drug
Registration Board.
They have also
been called for
personal
hearing
accordingly.
 The case was
placed
before
244th meeting of
Registration
Board
which
decided the case
Minutes246thMeetingRegistrationBoard
Page423
as under:“The accused of the
firm were called for
personal hearing, but
they could not appear
before the Board. The
Board decided to defer
the case and a final
opportunity
of
personal hearing shall
be given in next
meeting of the Board”
Accused as identified
by FID Lahore has
also been called for
personal
hearing
accordingly. The case
was again placed
before 245th meeting
of Refistration Board
which decided the
case as under:Decision:Mr.
Muhammad Salman
Ali, Advocate High
Court appeared on
behalf of M/s Guyton
Pharmaceutical
Lahore. The Board did
not accept power of
Attorney on behalf of
the firm. The Board
decided the case as
under:i. The production of
the injection Stearox
1ml Registration No.
Minutes246thMeetingRegistrationBoard
Page424
040336
shall
be
stopped. One more
opportunity
of
personal hearing is
granted
with
the
direction that the
Management
and
Technical Personnel
shall appear before the
Board failing which
the ex-parte decision
shall be taken.
ii. The Board further
decided that the firm
will recall all the
marketed batches of
sub-standard
drugs
from distribution / sale
outlets / institutional
supplies if any and
area FID shall take
report from the firm
and
submit
a
compliance report to
Chairman Registration
Board.
In the light of decision
taken in 245th meeting
of Registration Board
The
One
more
opportunity
of
personal hearing is
granted
with
the
direction that the
Management
and
Technical Personnel
shall appear before the
Board failing which
Minutes246thMeetingRegistrationBoard
Page425
the ex-parte decision
shall be taken.
The
case
was
presented before the
registration board in
its 246th meeting on
11-12-2014.
The
Board decided the
case as under in the
light
of
personal
hearing of Mr. Bilal
Khurshid
Chief
Executive
of the
firm:Decision:The Board took the
following decision:i.
ii.
Minutes246thMeetingRegistrationBoard
Area FID Mr.
Abdul Rasool
Shiekh to take
the samples of
the batch and
submit
the
investigation
report of the
case again as
the firm has
disowned the
supply
of
specific Batch.
The
production of
the firm in the
steroidal
Injectable
section shall
be
stopped
along
with
suspension of
registration of
Page426
iii.
iv.
Case No. 02
New Cases.
Minutes246thMeetingRegistrationBoard
Stearox 1ml
Registration
No.
040336
which
had
already been
suspended in
245th meeting
till
investigation
of the case is
finalized.
The firm will
be asked to
provide
on
stamp paper
regarding
their
statement of
disownership
of supply of
this batch.
The case will
be submitted
before
the
Registration
Board after
the
completing
the
investigation.
Page427
Sr.
No
1.
Name of Drugs
Rehumetic 50
Tablets
(Diclofenac
Potassium)
Batch No. RT012
Mfg Date:-03-14
Exp Date:- 03-16
(F.No.03-42/2014QC)
Firm
CDL Report
M/s Rehmat
Pharma
Lahore.
Sub-Standard
regard to:-
Appellate Testing
with No Challenged
i. Assay for diclofenac
Potassium:Determined
amount/tablet:- 48.44mg
Stated
50mg
amount/tablet:-
Percentage:- 96.88%
Fail on Dissolution test
as under:-
The background of
the case is as under:-
The
FID
has
submitted
the
investigation report.
The FID has fixed
the
responsibility
and submitted the
name of Directors,
Production Incharge,
Quality
Control
Incharge as under:i.
Mr. Bashir
Ahmed, Chief
Executive,
Tablet No:- (%)age
M/s
Rehmat
Pharma,
Sheikhupura
Road,
1.
17.25
Lahore.
2.
14.37
3.
17.82
4.
13.5
5.
12.94
6.
16.10
ii. Dissolution test:-
Minutes246thMeetingRegistrationBoard
Detail / Decision
ii.
Mr. Muzaffar
Bashir
Production
Incharge
M/sp
Rehmat
Pharma,
Sheikhupura
Road
Page428
Lahore.
Limits: Not less than
75.0%
Does not comply with
USP 37
Remarks:- The sample
is
of
substandard
quality under the Drugs
Act 1976.
Test
Report
LHR.136/2014
No.
iii. Mr. Muhammad
Sarwar, Quality
Control Incharge,
M/s Rehmat Pharma,
Sheikhupura Road,
Lahore.
The
FID
has
concluded that the
firm has violated
Section 23(1)(a)(v)
of the Drug Act,
1976
and
rules
framed there under.
The tablet Rehumetic
50 was declared
substandard by CDL
on the basis of
dissolution test. The
firm vide its reply
dated 18-08-2014 to
FID
did
not
challenge the report
and requested to
drop the proceeding
against them in the
interest of justice.
The
FID
has
submitted the copies
of recall of the
product from market
by M/s Rehmat
pharma, Lahore.
Keeping in view
above since the firm
has not challenged
Minutes246thMeetingRegistrationBoard
Page429
the report of CDL
therefore the report
dated 21st July, 2014
is
the
adducing
evidence under the
law.
As per procedure a
show cause notice
was issued to the
firm
and
other
accused,
offering
opportunity
of
personal
hearing
before the Drug
Registration Board.
The
case
was
presented before the
registration board in
its 246th meeting on
11-12-2014.
The
Board decided the
case as under in the
light of personal
hearing of Mr. Abid
Hussain
Awan
Technical Advisor
and Mr. Muhammad
Sarwar QC Incharge
of the firm:Decision:The Board took the
following decision
i.
ii.
Minutes246thMeetingRegistrationBoard
Warning to
the firm.
Destroy the
Page430
iii.
3.
D. Dron
(Dexamethason)
Injection
(IM/IV)
M/s Epharm
Laboratories,
Karachi.
Adulterated
& Not challenged
Substandard
with
regards to Description:Finding of Lab:-
The
Board
was
apprised about the
background of the
case as under:
Batch No.
DF.137
Mfg:- 06-13
EXP:- 06-15
Colorless solution in
clear glass ampoule. Out
of 25 ampoules (referred
portion of sample) one
ampoule contain black
particles and another
ampoule contains white
fibers.
&
Minutes246thMeetingRegistrationBoard
recalled
quantity
(1,34000) of
Rehumetic
50mg tablets
in presence
of area FID
Lahore. The
area FID will
submit the
report of
destruction
to the
Directorate
of QA/LT.
The firm will
submit the
measures
taken to
overcome
such
incidence in
future.
The samples of DDron
Injection
Batch No DF.137
&
DF-138
manufactured by
M/S
Epharm
Laboratories,
Karachi
were
taken by FID
Hyderabad
at
Karachi on 29-012014
from
manufacturer’s
premises.
The
samples
were
Page431
Does not comply with
Description
Remarks:-
The sample is of
“Adulterated
&
Substandard” under the
Drugs Act 1976.
Adulterated
&
Substandard
with
regards to Description:Finding of Lab:-
Clourless solution in
clear glass ampoule. Out
of 15 ampoules (referred
portion of sample) two
ampoules contain black
particles.
Batch No.
DF.138
Mfg:- 07-13
Does not comply with
Description
EXP:- 07-15
Minutes246thMeetingRegistrationBoard

declared
Adulterated
&
Substandard
by
Federal
Government
Analyst vide test
reports
No.KQ.60/2014 &
KQ.61/2014 dated
18th
February
2014 respectively.
The
FID
communicated the
test reports to the
firm vide his letter
No.05-10/2014FID-H (K) 255257 dated 19-022014. The firm in
their
reply
mentioned about
their
right
of
exercise the power
under subsection
(4) of Section 22
of Drugs Act 1976
for retesting of
their samples from
appellate
lab
Islamabad. As per
submission
of
complete case by
the FID, the firm’s
reply was received
in the office of
DRAP Karachi on
08-04-2014 which
was well after the
expiry of time
allowed
under
section 22(4) of
the Drugs Act
1976 and hence
not valid as per
FID’s remarks.
Page432
Remarks:-
(F.No.0310/2014-QC)

The sample is of
“Adulterated
&
Substandard” under the
Drugs Act 1976.
The
FID
has
furnished
the
names of the
following persons
of
the
firm
responsible
for
committing
the
offence under the
law.
i.
M/S Epharm
Laboratories
Karachi.
ii.
Mr.
Asad
Ilyas
Nainitalwala
,
Director,
iii.
Mr. Ahmed
Nadeem
Qasmi,
QC
Manager,
iv
Dr.
Mohammad
Khokhar
Production
Manager,

Minutes246thMeetingRegistrationBoard
Show
cause
notices
were
issued to the firm
and other accused,
offering
opportunity
of
personal hearing
before the Drug
Registration
Board after the
approval of the
competent
authority.
They
have been also
Page433
called for personal
hearing
accordingly.
The
case
was
presented before the
registration board in
its 246th meeting on
11-12-2014.
The
Board decided the
case as under in the
light of personal
hearing of Mr. Asad
Ilyas Director of the
firm and Mr. Ahmed
Nadeem Qasmi QC
Manager of the firm.
Decision:The Board took the
following decision
Minutes246thMeetingRegistrationBoard
i.
The Board
decided
to
suspended
the
registration of
D-Dron
Injection
Registration
No.058424
(IM/IV) for a
period of three
months.
ii.
PSI Inspection
by
a
panel
comprising
of
Director
DTL
Quetta and area
FID
will
be
conducted and
Page434
they will submit
the report to the
Registration
Board
3.
i. Loose pink
cloured tabletsRumin
(Ibuprofen)
400mg Tablets
Batch No. Nil
M/s Ankaz
Pharmex
(Pvt) Ltd
Karachi
Substandard with regard Substandard with
to “Assay”
regard to “Assay”
for Ibuprofen (BP)
for Ibuprofen:
Determined amount/Tab
=49.512mg
Stated:400mg/Tab
Stated
amount/tab
=400mg
Mfg Date:- Nil
Exp Date:- Nil
Found:- 313mg/tab.
Percentage:- 12.378%
Limit: 95% to 105%
Does not comply
Percentage:78.29%
Limit:
105%
95% to
Remarks:- The sample
Does not comply
is
of
substandard
with BP 2011
quality under the Drugs
Act 1976.
Conclusion:Test
Report
RKQ.212/2014.
Minutes246thMeetingRegistrationBoard
No. The sample is of
substandard
quality on the basis
The
Board
was
apprised about the
background of the
case as under:
The
Federal
Inspector of Drug,
Karachi-III vide
his letter dated 2104-2014 informed
that he alongwith
Dr.
Shahid
Hussain,
FID
Karachi and others
raided
the
premises of M/s
Ankaz Pharmax
(Pvt) Ltd., Karachi
on 19-04-2014 at
07.45 AM. The
raid
was
conducted on the
source
information
of
FIA Crime Circle
Karachi. Deputy
Director FIA Mr.
Fakeer
Muhammad
headed the raid
alongwith
his
team. Ten samples
of
different
products
were
taken from the
manufacturers
premises
for
Page435
of tests performed.


Minutes246thMeetingRegistrationBoard
test/analysis
on
the
prescribed
Form-3.
The FID vide his
investigation
report of the case
intimated
that
eight samples of
the drugs taken
have
been
declared to be
substandard by the
Federal
Government
Analyst,
CDL
Karachi. In the
light of the same,
the FID issued
explanation letter
regarding
the
matter
of
manufacture and
sale
of
substandard drugs
to the firm. As per
documents
provided by the
FID, the firm
challenged the test
reports
and
requested to get
the
samples
retested from the
Appellate
Laboratory, NIH
Islamabad.
The
Appellate
Laboratory
also
declared the drug
sample
under
reference
as
Substandard.
The
FID
concluded that the
manufacturer
is
Page436
guilty
of
manufacturing
substandard drugs
and de-registered
drug in violation
to the provisions
of Drugs Act 1976
and rules framed
there under. He
has requested for
cancellation DML
of the firm or
permission
to
lodge
the
prosecution
against the firm.
 Following persons
of the firm have
been
held
responsible
for
committing
the
offence by the
FID.
i. Ali
Abbass,
Managing
Director of the
firm.
ii. Akbar
Production
Incharge.
Ali
iii. Safdar Alam,
Quality
Control
Incharge.
 As per procedure
Show
cause
notices
were
issued to the firm
and other accused,
in the light of the
test reports of the
Minutes246thMeetingRegistrationBoard
Page437
Appellate Lab and
report of the FID,
offering
them
opportunity
of
personal hearing
before the Drug
Registration
Board.
 They have also
been called for
personal hearing
accordingly.

Minutes246thMeetingRegistrationBoard
The
Federal
Inspector
of
Drugs, Karachi-III
vide his letter
dated 21-04-2014
informed that he
alongwith
Dr.
Shahid Hussain,
FID Karachi and
others raided the
premises of M/s
Ankaz Pharmax
(Pvt) Ltd., Karachi
on 19-04-2014 at
07.45 AM. The
raid
was
conducted on the
source
information
of
FIA Crime Circle
Karachi. Deputy
Director FIA Mr.
Fakeer
Muhammad
headed the raid
alongwith
his
team.
Page438
Minutes246thMeetingRegistrationBoard

The FID vide his
investigation
report of the case
intimated
that
eight samples of
the drugs taken
have
been
declared to be
substandard by the
Federal
Government
Analyst,
CDL
Karachi. In the
light of the same,
the FID issued
explanation letter
regarding
the
matter
of
manufacture and
sale
of
substandard drugs
to the firm. As per
documents
provided by the
FID, the firm
challenged the test
reports
and
requested to get
the
samples
retested from the
Appellate
Laboratory, NIH
Islamabad.
The
Appellate
Laboratory
declared the drug
sample
under
reference
as
Misbranded.

The
FID
concluded that the
manufacturer
is
guilty
of
Page439
manufacturing
substandard drugs
and de-registered
drug in violation
to the provisions
of Drugs Act 1976
and rules framed
there under. He
has requested for
cancellation DML
of the firm or
permission
to
lodge
the
prosecution
against the firm.
 Following persons
of the firm have
been
held
responsible
for
committing
the
offence by the
FID.
i. Ali
Abbass,
Managing
Director of the
firm.
-do.
Substandard with regard
to :Assay for Ibuprofen:
Determined
amount/Tablet
=24.756mg
Stated
=200mg
amount/tablet
Percentage:- 12.378%
Limit: 95% to 105%
Substandard with
regard to “Assay”
for Ibuprofen (BP)
ii. Loose pink
cloured tabletsRumin
(Ibuprofen)
200mg Tablets
Does not comply
Batch No. Nil
Remarks:- The sample
is of substandard quality
under the Drugs Act Found:1976.
153.38mg/tab.
Mfg Date:- Nil
Minutes246thMeetingRegistrationBoard
Report
Ali
iii. Safdar Alam,
Quality Control
Incharge.
Stated:200mg/tab
Test
ii. Akbar
Production
Incharge.
No.
 As per procedure
Show
cause
notices
were
issued to the firm
and other accused,
in the light of the
test reports of the
Appellate Lab and
Page440
Exp Date:- Nil
RKQ.213/2014
Percentage:76.69%
Limit:
105%
90% to
Does not comply
with BP 2011
Conclusion:The sample is of
substandard
quality on the basis
of tests performed.
-do-
Test Report
No.09Substandard with regard MNHSR/2014
to :Assay for Ibuprofen:
Determined
amount/Tablet
=350.71mg
Stated
=400mg
Minutes246thMeetingRegistrationBoard
amount/tablet
Substandard with
regard to “Assay”
for Ibuprofen (BP)
report of the FID,
offering
them
opportunity
of
personal hearing
before the Drug
Registration
Board.
 They have also
been called for
personal hearing
accordingly.
The FID vide his
investigation report
of the above case
also reported that the
firm was
found
manufacturing
its
one of de-registered
product
namely
syrup
Rumin
mentioning the old
manufacturing date
on the label. It has
been intimated that
Syrup Rumin was
found stored in bulk
in big vessel placed
in
liquid
manufacturing areas
of the firm. A huge
quantity of finished
goods of same deregistered syrup was
also seen placed in
finished good wear
house
Page441
Percentage:- 87.6775%
Limit: 95% to 105%

Stated:400mg/tab
iii. Tablet
Rumin
(Ibuprofen)
400mg
Does not comply
(Blister packing)
Remarks:- The sample Percentage:is of substandard quality 79.81%
under the Drugs Act
1976.
Batch No. 1105
Mfg Date:- 1-12
Test
Report
RKQ.215/2014
Found:319.24mg/tab.
No. Limit:
105%
95% to
Exp Date:- 12-14
Does not comply
with BP 2011

The
FID
concluded that the
manufacturer
is
guilty
of
manufacturing
substandard drugs
and de-registered
drug in violation
to the provisions
of Drugs Act 1976
and rules framed
there under. He
has requested for
cancellation DML
of the firm or
permission
to
lodge
the
prosecution
against the firm.
Following persons
of the firm have
been
held
responsible
for
committing
the
offence by the
FID.
Conclusion:The sample is of
substandard
quality on the basis
of tests performed.
i. Ali
Abbass,
Managing
Director of the
firm.
Test Report
No.08MNHSR/2014
ii. Akbar
Production
Incharge.
Substandard with regard
to :Assay for Ibuprofen:
Determined
amount/Tablet
=30.945mg
Stated
Minutes246thMeetingRegistrationBoard
amount/tablet
Ali
iii. Safdar Alam,
Quality Control
Page442
-do-
Incharge.
=200mg
Percentage:- 15.4725%
Limit: 95% to 105%
Substandard with
regard to “Assay”
for Ibuprofen (BP)
Stated:200mg/tab
Does not comply
Found:145.60mg/tab.
Remarks:- The sample
is
of
substandard
quality under the Drugs Percentage:Act 1976.
72.80%
Test
Report
RKQ.206/2014
iv. Tablet
Rumin
(Ibuprofen)
200mg
No. Limit:
105%
95% to
Does not comply
with BP 2011
Batch No. 640
(Jar Packing)
Conclusion:The sample is of
substandard
quality on the basis
of tests performed.
Mfg Date:- 2-13
Exp Date:- 01-16
Substandard with regard
Minutes246thMeetingRegistrationBoard
 As per record of
Quality
Control
Section,
registration of this
product
was
cancelled by DRB
in
its
237th
meeting held on
26-02-2013,
which
was
communicated of
the firm vide their
officer
letter
bearing
No.0316/2012-QC,
dated 22-03-2013.
 As per procedure
Show
cause
notices
were
issued to the firm
and other accused,
in the light of
report of the FID,
and record of QC
Section regarding
the de-registration
of the product
offering
them
opportunity
of
personal hearing
before the Drug
Registration
Board.
They have also been
called for personal
hearing accordingly
Test Report
Page443
to :Assay
for
Sulphamethoxazole:
No.012NHSR/2014
The
Board
was
apprised about the
background of the
case as under:-
Determined
amount/Tablet =101.328
mg
Stated
=800mg
amount/tablet
Misbranded with
the following
remarks:-
Percentage:- 12.666%
Does not comply
-do-
Remarks:- The sample
is
of
substandard
quality under the Drugs
Act 1976.
Test
Report
RKQ.207/2014
No.
“Labeling on the
immediate pack is
not legible. More
over
batch
number
and
expiry date is
printed
with
removable ink and
some strips found
without
batch
numbers
and
expiry date which
is violation of the
labeling
and
packing rules of
Drugs Act 1976.
Conclusion:- The
sample
is
misbranded.
Test Report
No.06Minutes246thMeetingRegistrationBoard

The
Federal
Inspector of Drug,
Karachi-III vide
his letter dated 2104-2014 informed
that he alongwith
Dr.
Shahid
Hussain,
FID
Karachi and others
raided
the
premises of M/s
Ankaz Pharmax
(Pvt) Ltd., Karachi
on 19-04-2014 at
07.45 AM. The
raid
was
conducted on the
source
information
of
FIA Crime Circle
Karachi. Deputy
Director FIA Mr.
Fakeer
Muhammad
headed the raid
alongwith
his
team. Ten samples
of
different
products
were
taken from the
manufacturers
premises
for
test/analysis
on
the
prescribed
Page444
Form-3.
MNHSR/2014
v.. Biprim (CoTrimoxazole) DS
Tablets
Batch No. 305
(Blister packing)
Mfg Date:- 11-13
Exp Date:- 10-16

The FID vide his
investigation
report of the case
intimated
that
eight samples of
the drugs taken
have
been
declared to be
substandard
by
the
Federal
Government
Analyst,
CDL
Karachi. In the
light of the same,
the FID issued
explanation letter
regarding
the
matter
of
manufacture and
sale
of
substandard drugs
to the firm. As
per
documents
provided by the
FID, the firm
challenged
the
test reports and
requested to get
the
samples
retested from the
Appellate
Laboratory, NIH
Islamabad. The
Appellate
Laboratory
declared the drug
sample
under
reference as of
standard quality.
 As per Section 22
Minutes246thMeetingRegistrationBoard
Page445
vi. Rumin
(Iburofen)
Suspension
Batch No.408
(5) of the Drugs
Act 1976 and the
report
of
conclusive
evidence so in the
light of the same
the present case
with regard to
drug
under
reference may be
filed.
The sample is of
standard quality with
regard
to
tests
performed.
Test
report
RKQ.210/2014.
.

Submitted
for
Information of the
Board please.
No.
Mfg Date:-03-13
-Do-
Exp Date:-02-16
vii. Biprim DS
(CoTrimoxazole)
Tablets
Batch No. 305
(Jar packing)
Substandard with regard
to :Assay
for
Sulphamethoxazole:
Determined
amount/Tablet =101.328
mg
Stated
=800mg
amount/tablet
Mfg Date:- 11-13
Exp Date:- 10-16
Percentage:- 12.666%
Does not comply
Minutes246thMeetingRegistrationBoard
-DoThe
case
was
presented before the
registration board in
its 246th meeting on
11-12-2014.
The
Board decided the
case as under in the
light of personal
hearing of Mr. Salim
Isharat
Husain,
Page446
viii. Biprim
(CoTrimoxazole)
Tablets
Batch No. 524
Remarks:- The sample
is
of
substandard
quality under the Drugs
Act 1976.
Test
Report
RKQ.209/2014
No.
(Blister packing)
Substandard with regard
to :-
Mfg Date:- 01-13
Assay
for
Sulphamethoxazole:
Exp Date:- 12-15
ix. Loose white
cores
claimed/suspecte
d of TabletsRumin
(Ibuprofen)
200mg
Batch No. Nil
Mfg Date:- Nil
Exp Date:- Nil
(F.No.0317/2014-QC)
Determined
amount/Tablet =101.328
mg
Stated
=800mg
amount/tablet
Percentage:- 12.666%
Decision:The Board in view
of personal hearing
of Mr Saleem Isharat
Hussain on behalf of
Managing Director
Ankaz Pharmex and
available
record/facts of the
case decided as
under:1.
The Board
decided to cancel
the registration of
the
following
products as per its
consideration:-
Substandard with regard
to :-
i. Loose
Pink
Colored TabletsRumin
(Ibuprofen)
400mg Tablets.
Registration No.
007545
ii.
Loose
Pink
colored TabletsRumin
(Ibuprofen)
200mg Tablets,
Reg. No. 007543.
Assay for Ibuprofen:
iii.
Does not comply
Remarks:- The sample
is of substandard quality
under the Drugs Act
1976.
Test
Report
RKQ.208/2014
Determined
amount/Tablet
Minutes246thMeetingRegistrationBoard
Technical Consultant
on behalf of M.D of
the firm.
No.
Tab. Rumin
400mg. (Blister
Packing) Reg.
Page447
=30.945mg
Stated
=200mg
No. 007545
amount/tablet
iv. Tab. Rumin
200mg
(Jar
Packing) Reg. No.
007543.
Percentage:- 15.4725%
v. Tab. Biprim (CoTrimoxazole)
DS
(Blister
Packing)
Reg.
No. 008409
Limit: 95% to 105%
vi.
Does not comply
Remarks:- The sample
is
of
substandard
quality under the Drugs
Act 1976.
Test
Report
RKQ.214/2014
-Do-
N.A
No.
The Sample has
been declared of
Standard Quality
on the basis of tests
performed.
Test Report
No.013MNHSR/2014
Rumin
(Ibuprofen)
Suspension, Reg.
No. 008526
2.
The Board
further decided to
recommend to the
Central Licensing
Board
for
cancellation of the
Drug
Manufacturing
License of the firm
on the violation of
manufacturing of
already
Deregistered product
i.e.
Rumin
Suspension
Reg.
No. 008526.
The Sample has
been declared of
Standard Quality of
the basis of tests
performed
Minutes246thMeetingRegistrationBoard
Page448
Test Report No.07MNHSR/2014
The Sample has
been declared of
Standard Quality
on the basis of tests
performed by the
Appellate
Lab,
NIH, Islamabad.
(Test Report
No.010MNHSR/2014)
4.
Kemycillin
(Ampicillin)
Syrup
M/s Alkemy
Pharmaceutica
l Laboratories
Hyderabad.
Batch No. A1028
Mfg. Oct-13
Exp. Use with in
three years
(F. No. 0334/2014)
Substandard with regard Sub-Standard
to :With regard
Assay for Ampicillin
Assay for
Determined
amount/5ml:=103.32mg
Ampicillin:-
The
Sample
of
Kemycillin
Syrup
Stated 125mg/5ml
Batch No A-1028,
i.
First
day
Found
manufactured by M/s
Stated amount /5ml
Alkemy
=101.14mg/5ml
=125mg
Pharmaceutical
Laboratories
P/9,
SITE
Hyderabad
Percentage:Sindh was taken by
Percentage:- 82.66%
80.91%
FID Hyderabad at
Karachi on 24-042014
from
Limit: 90% to 120%
manufacturer’s
premises. It was
i.
On
07th declared substandard
Day Found
Does not comply
by
Federal
=
Government
Analyst
78.53mg/5
vide Test report No.
ml
Remarks:- The sample
KQ.230/2014 dated
is
of
substandard
27th May 2014. In
quality under the Drugs Percentage:-
Minutes246thMeetingRegistrationBoard
The
Board
was
apprised about the
to:- background of the
case as under:-
Page449
Act 1976.
Test
report
KQ.230/2014
response
to
the
explanation
letter
issued by the FID,
the firm challenged
No.
the CDL report and
Limit:- 80-120%
requested
for
Appellate
Testing
under Section 22(5)
Does not comply of Drugs Act, 1976.
The
Appellate
with BP 2011.
Laboratory
also
declared the sample
as Substandard vide
Conclusion:test report No. 015MNHSR/2014 dated
The sample is of
08th August 2014.
substandard
quality on the basis The FID in response
of tests performed. to this office letter
dated 29th August
2014 concluded that
Test report No. the firm has violated
015-MNHSR/2014 Section 23(1)(a)(v)
of Drugs Act 1976.
FID
has
recommended
immediate
action
under Section 7(11)
of the Drugs Act
1976
and
has
furnished the names
of the following
persons of the firm
responsible for the
offence.
62.82%
i. M/s
Alkemy
Pharmaceutical
Laboratories
Minutes246thMeetingRegistrationBoard
Page450
(Pvt.)
Ltd
Hyderabad,
ii. Mr.Fraz Ahmed
Sheikh,
Managing
Director,
iii. Mr. Asif Najeeb
Laghari,
QC Manager,
iv. Mr.Abid Ali
Khoso
Production
Incharge,

As
per
responsibility
fixed by the FID,
show case notices
dated 05-05-2014
were issued to the
firm
and
the
accused persons
of the firm.

The
case
was
presented before the
registration board in
its 246th meeting on
11-12-2014.
The
Board decided the
case as under in the
light of personal
hearing of Mr. Asif
Najeeb Laghari QC
Manager of the firm.
Decision:The Board took the
following decision:
Minutes246thMeetingRegistrationBoard
Page451
i.
ii.
iii.
5.
Empoir 500mg
(Ciprofloxacin)
Tablets.
M/s Alkemy
Pharmaceutica
l Laboratories
Hyderabad.
Batch No. 283
Mfg Date- 03-14
Exp Date. 02-17
(F.No. 0333/2014)-QC
Sub-Standard:With regard to
Dissolution test
Tablet 01= 38.23%
Determined:59.9%
The
Board
was
apprised about the
background of the
case as under:-
The
Sample
of
Empoir
500mg
Tablet 02= 48.94%
57.71% (repeated)
Tablets Batch 283
Tablet 03= 39.30%
manufactured by M/s
Limit:- Not less
Alkemy
than 80% of the
Tablet 04= 32.26%
Pharmaceutical
stated amount
Laboratories (Pvt.)
Tablet 05= 39.15%
Ltd,
P/9,
SITE
Tablet 06= 39.15%
Hyderabad was taken
Does not Complies
by FID Hyderabad at
with USP 32
Karachi on 24-042014
from
Limit:- Not less than
manufacturer’s
80%
premises.
The
Sample was declared
Conclusion:substandard
by
Does not comply with
Minutes246thMeetingRegistrationBoard
Substandard with
regard to
Dissolution test
Suspended
the
registration
of
Kemycillin
(Ampicillin)
Syrup, Reg.
No. 022520
for a period
of six (06)
months.
Panel
Inspection
for PSI.
The panel
will be
constituted
by Director
QA&LT
Page452
Federal Government
Analyst
CDL
Karachi vide Test
report
No.
KQ.228/2014 dated
15th May 2014. In
response
to
the
explanation
letter
Test report No. issued by the FID,
014-MNHSR/2014 the firm challenged
No.
the CDL report and
requested
for
Appellate
Testing
under Section 22(5)
of Drugs Act, 1976.
The
Appellate
Laboratory
also
declared the sample
as Substandard vide
test report No. 014MNHSR/2014 dated
12th August 2014.
The FID in response
to this office letter
dated 18th September
2014 has concluded
that the firm has
violated
Section
23(1)(a)(v) of Drugs
Act 1976. FID has
furnished the names
of the following
persons of the firm
responsible for the
offence.
The sample is of
substandard
quality on the basis
Remarks:- The sample of tests performed.
is
of
substandard
quality under the Drugs
Act 1976.
USP 35.
Test
report
KQ.228/2014
i.
M/s
Alkemy
Pharmaceutical
Minutes246thMeetingRegistrationBoard
Page453
Laboratories (Pvt.)
Ltd Hyderabad,
ii.
Mr.Fraz
Ahmed Sheikh,
Managing Director,
iii.
Mr.
Asif Najeeb Laghari,
QC Manager,
iv.
Mr.Abid Ali
Khoso
Production Incharge,

.As
per
responsibility
fixed by the FID,
show case notices
have been issued
to the firm and
other
accused
persons of the
firm.
The
case
was
presented before the
registration board in
its 246th meeting on
11-12-2014.
The
Board decided the
case as under in the
light of personal
hearing of Mr. Asif
Najeeb Laghari QC
Manager of the firm.
The
case
was
presented before the
registration board in
its 246th meeting on
Minutes246thMeetingRegistrationBoard
Page454
11-12-2014.
The
Board decided the
case as under in the
light of personal
hearing of Mr. Asif
Najeeb Laghari QC
Manager of the firm.
Decision:The Board took the
following decision
i. Suspended
the
registration
of Empoir
500mg
(Ciprofloxaci
n) Tablets
Reg. No.
039367 for a
period of six
(06) months.
ii. Panel
Inspection
for PSI.
iii. The panel
will be
constituted
by Director
QA&LT
Case No. 03 Substandard Rifacin (Rifampicin Suspension BP 60ml) manufactured by M/s
Pharmawise Labs Pvt Ltd Lahore
Brief Background
The FID Islamabad-II on 03-04-2012 drew samples of Rifacin Suspension Batch No.152
of M/s Pharmawise Labs (Pvt) Lahore, from T.B Center, Asghar Mall Road Rawalpindi for
Minutes246thMeetingRegistrationBoard
Page455
test/analysis. The samples were declared substandard by the F.G Analyst vide test report
No.T.B.64/2012 dated 01-08-2012.
The firm did not challenge the report and case was
accordingly processed and decided by the Registration Board in its 237th meeting, held on 26-022013 and cancelled the registration of the product under reference. The firm filed an appeal
before Appellate Board against the decision of DRB vide appeal No.04/2013, dated 06-09-2013,
which was dismissed by the Appellate Board in its 140th sitting.
.
.The firm filed a writ petition No.4442-2013, before Honorable Islamabad High Court,
Islamabad against the decision of Appellate Board but the Court upheld the decision of Appellate
Board. The firm filed a C.P.L.A No. 2/2014 before the Honorable Supreme Court of Pakistan
which in its order dated 22-08-2014 the directed to retest the sample in accordance with law.
Accordingly the sample was sent to Appellate Lab (NIH) for retesting which also declared the
sample is of Sub-standard quality.
S.No. CDL Test Report No.
TB.64/2012 & Findings
1.
i. pH Determined 5.18
ii. Limits:- 4.2 to 4.8 Does not
comply with BP 2011
Appellate Test Report No.016MNHSR/2014 & Findings
i. pH Determined 4.75
ii. Limits:- 4.2 to 4.8 Comply with
BP 2011 .
iii. Volume Determined 60ml
Complies with volume stated on the
Assay for Rifampicin
i. Determined amount per ml label
=15.514mg/ml
Assay for Rifampicin
i.
Determined amount per ml
ii.
Stated amount / ml= =17.31mg/ml
20mg/ml
ii. Stated amount / ml= 20mg/ml
iii. Percentage:- 77.57%
iv. Limits:- 90% to 110%
iii. Percentage:- 86.63%
Does not comply with BP iv. Limits:- 90% to 110%
2011
Does not comply with BP 2011
Remarks
The sample is of
Substandard
quality on the
basis
of
test
performed
by
FGA
CDL
Karachi
and
Appellate Testing
Lab Islamabad.
The case is submitted of the consideration / decision of Registration Board under
intimation to Assistant Registrar motion for Deputy Registrar Judicial in the light of brief
background please.
Decision:Minutes246thMeetingRegistrationBoard
Page456
The Board after through celebration decided as under:1.
Up held the decision of cancellation of registration of substandard Rifacin
(Rifampicin Suspension BP60ml), Regn. No. 037528 manufactured by M/s
Pharmawise Labs (Pvt) Ltd., Lahore taken in 237th meeting, Registration
Board.
2.
The Board further decided that the case with brief background shall be
intimated to Assistant Registrar motion for Deputy Registrar Judicial in the
light of decision of the Board and substandard test report by the Appellate
Lab NIH Islamabad and Medical Superintended T.B Hospital Asghar Mall
Road Rawalpindi for their further necessary action if any.
The firm will recall all its supplied batches to T.B Hospital Asghar Mall Road
Rawalpindi under intimation to area FID-II Islamabad.
3.
Case No. 04 Deaths of persons allegedly due to consumption of cough syrup
manufactured by M/S Ethical Laboratories (Pvt) Ltd and M/S Reko Pharmecal
Laboratories Lahore
The Registration Board in its 245th meeting decided the case as under:Decision:- Registration Board decided that Mr. Jamil Anwar Member of the Registration Board, Deputy
Director General (E&M) Lahore & Islamabad will furnish the pending status of these petitions filed by
M/s Ethical laboratories Pvt Ltd and M/s Reko Pharmacal Lahore for consideration of the Board in its
up-coming meeting
The pending status of the petitions filed by M/s Reko and Ethical Laboratories pvt Ltd Lahore
have not yet been received from the Honorable member Mr. Jamil Anwar, and DDG (E&M) Lahore and
Islamabad as communicated to them.
Decision:
Registration Board again decided that that Mr. Jamil Anwar Member,
Registration Board, Deputy Director General (E&M) Lahore & Islamabad will furnish
the pending status of these petitions filed by M/s Ethical laboratories Pvt Ltd and M/s
Reko Pharmacal Lahore for consideration of the Board in its up-coming meeting
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Case No. 05
Damage Samples for Board Portion
Board portion of sealed samples from ADC Quetta and FID Peshawar were received in damage
conditions
S.
No.
1.
2.
3.
4.
5.
6.
7.
.
(File No.13-09/2013-QC)
Product & Batch No.
Manufacturer
Condition
Canrce Tablets
Q18
Optifam Tablets
38
Naproxen Imported Raw
Material
Metformin-Hcl Imported
Raw Material
Tablet Klaribact 250mg
Q64
Liquid Glucose
014270-Bulk
Liquid Serbetol
00470114
M/s Merck (Pvt) Ltd
Quetta
M/s Merck (Pvt) Ltd
Quetta
M/s Merck (Pvt) Ltd
Quetta
M/s Merck (Pvt) Ltd
Quetta
M/s Merck (Pvt) Ltd
Quetta
Rafhan Maiz Pakistan
Badly damaged, broken carton
and seal.
Badly damaged, broken carton
and seal.
Badly damaged, glass broken
bottle and seal.
Badly damaged, glass broken
bottle and seal.
Badly damaged, broken carton
and seal.
Badly damaged, leaked bottles
and torn memorandum.
Badly damaged, leaked bottles
and torn memorandum
Made in China
The Board portions of the samples at serial No. 1-5 have been sent by ADC Quetta
whereas the samples at serial No.6-7 have been sent by FID Peshawar. Both officers had been
informed telephonically about the status of these samples.
.
The Registration Board in its 238th meeting allowed the QC Section to get fresh samples
from the inspectors if they are received in damage conditions. In view of above following
proposal is submitted.
i.
The FID Peshawar and ADC Quetta may be advised to take special care for
packing and transportation of the Boards portion of samples in future all the
DDGs in the field offices may also be advised to instruct FIDs/ADCs to
ensure appropriate packing and sealing of such samples.
ii.
FID Peshawar and ADC Quetta may be advised to draw fresh samples, of the same
batches/raw materials, of damaged drugs for test analysis.
Decision:The Board approved the proposals of QC Section and Directed that all
DDGs, FIDs and ADCs be asked to send the Board Portion intact form and ensure
appropriate packing and sealing of such samples before sending. In future such
approvals will be taken from Director QA/LT on file.
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Case No. 06
Manufacture and supply of sub-standard Hepaferon Injection by M/s Pharmedic,
Lahore to Govt of Khyber Pakhtoonkhawa
BRIEF BACK GROUND:
The case of M/s Pharmedic Laboratories (Pvt) Ltd was discussed with
reference to the decision taken in also 243rd & 244th meeting of Registration Board which is reproduced
as under.
Decision taken in 243rd Meeting of Registration Board
i
The Federal Inspector of Drugs Peshawar is advised to get the case completed
covering details of findings, conclusion fixation of responsibilities with his
recommendations.
ii.
The Board further decided to get update regarding Suo Moto notice taken by
Hounrable Peshawar High Court Peshawar and fate of case referred to NAB
Khyber Pakhtoon Khawa.
The FID Peshawar has submitted the investigation of the case fixing the responsibility of name of
persons accused & co accused in manufacture and sale of substandard Hepaferon Injection Batch No 8087 which are involved directly or indirectly. The FID has also submitted the suo moto judgment a copy of
Honorable High Court Peshawar but did not submitted the report regarding investigation by NAB.
Name of accused persons.
i.
ii.
iii.
Mr. Iftikhar Ahmed Shiekh
Mr. Mazhar Hussain
Mr. Asim Mehmood
Director/C.E.O
Production Incharge.
Quality Control Inchage
Name of Co-accused persons.
Dr. Chuhan Director
Dr. Sharif, Director
Dr. Ghulam Subhani Director Hapatitis Program
Mubarik Shah, Store Keeper LRH Hapatitis Program
Dr. Nigar Ahmed, Ms DHQ Mardan.
Mr. Aurengzaib, Store Incharge, DHQ Mardan.
The case was again presented before 244th meeting of the Board in the light of recommendations of
the FID Peshawer as above which decided the instant case as under:-
Decision:- The Board decided to issue show cause notices to accused of M/s Pharmadic
Laboratories (Pvt) Ltd Lahore regarding manufacture and supply of substandard Injection
Hepaferon (3MIU) Interferon Alpha 2a to government of KhyberPakhtoonKhawa.
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The The FID Peshawar has submitted the complete investigation of the case fixing the
responsibility of name of persons accused / co-accused in manufacture and sale of substandard Hepaferon
Injection Batch No 80-87and proposed their names for prosecution under Section 23(1)(a)(v)(vii) and 23
(1)(a)(vii), 23(1)(b)(f) which are involved directly or Indirectly in this case some of the co-accused are
employees of Government of Khyber Pakhtoon Khawa.
As directed by Chairman Registration Board the case is again submitted for consideration of the
Registration Board keeping in view of the Public health at large, Suo Moto Notice by Peshawar High
Court, & NAB investigation in instant case please.
Decision:The Board decided that Federal Inspector of Drugs Peshawar will be asked
to submit the certified copies of decisions of Drug Court Peshawar and Peshawar High
Court, Peshawar in the instant case with in 07 days. Reference will be sent to Law division
to ascertain whether government officials under provincial governments can be issued
show cause notice for violations any provision of Drug Act, 1976 or otherwise.
The Show Cause Notice to the accused of firms will be issued after the receipt of the
letter from the FID and approval from Chairman, Registration Board. However, show
cause to government officials will be served after clarification from Law Division.
Case No.07 Supply of substandard /adulterated injection of cil 100ml to DHQ hospital
Hafizabad (25000 vials) and M/s Medisearch Pharma (Pvt) Ltd., 5-km, Raiwind Manga
Road, Lahore which supplied Almajax 250ml Suspension to DHQ Hospital Hafizabad
(35600 bottles).
The Secretary Provincial Quality Control Board (PQCB) Punjab Mr. Tallat Farooq Ahmad
has forwarded two recommendations to DRAP as under:i.
The Federal Government Cancel the Drug Manufacturing License of M/s
Mediceena Pharma, (Pvt) Ltd., 27-KM Raiwind Road Lahore on supply of Substandard / Adulterated injection Ofcil 100ml to DHQ Hospital Hafizabad (25000
vials) and M/s Medisearch Pharma (Pvt) Ltd., 5-KM, Raiwind Manga Road, Lahore
which supplied substandard Almajax 120ml Suspension to DHQ Hospital
Hafizabad (35600 bottles).
ii.
The Federal Government Cancel the Registrations of the said drugs of M/s
Mediceena Pharma, (Pvt) Ltd., 27-KM Raiwind Road Lahore and M/s Medisearch
Pharma (Pvt) Ltd., 5-KM, Raiwind Manga Road, Lahore.
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Brief Background
The Provincial Quality Control Board (PQCB) after scrutiny of the report of Government
analyst i.e report Nos. TRA. 22863 & 22864 dated 21-11-2014 Batch No. JX168 of Almajax
suspension, and statement of the Drug Inspector observed that this is a criminal negligence on
the part of manufacturers and gross loose in GMP compliance. The Punjab Government (PQCB)
observed that there is a dire need to take quick action against the said firms to safeguard the
public health at large and submitted the above mentioned recommendations.
The case is placed before Registration Board for decision on the recommendations of
(PQCB) Punjab by Registration Board regarding cancellation of Registrations of Drugs of these
firms as per law with the proposal that recommendations may also be send to Division of
Licensing for further necessary action at their end so that public health may be saved from risk.
Decision:-
The Board decided as under:a. To get the complete investigation along with all the reports and case
background from the Secretary Provincial Quality Control Board Health
Department Government of Punjab Lahore through the DDG (E&M)
Lahore.
b. The area FID Lahore will be asked to submit the case background in
writing along with all relevant reports for perusal of the Registration
Board for decision.
The Board further decided the case shall be forwarded to Directorate of Licensing for
further necessary action in the light of recommendation of the Provincial Quality Control
Board (PQCB) Punjab.
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Page461
Item No.IX
Registration of Medical Devices – Medical Devices Division
Case No.01.
Applications for registration of medical devices for import.
Registration Board considered the following applications of medical
devices for import and decided as mentioned against each. Approved applications have already
been recommended by Expert Committee on Medical Devices and are subject to inspection of
manufacturer abroad, verification of storage facilities etc as per policy:A)
Cannulas:
S.No Name of Importer and
.
Manufacturer/Exporter.
M/s Kaf Surgical &
Disposable Equipments,
GF-116, Panorama Centre,
Plot No.248, Staff Lines,
Fatima Jinnah Road,
Karachi/
1.
Name of Medical
Device
JRZ Intravenous
Canula without
Wings without
Injection Port
(Pencil Type).
Price
Pack size
Shelf
life
Decision
Decontrolled till
policy decision
by the Policy
Board/ Federal
Government.
(14G,
16G, 18G,
20G,
22G, 24G,
26)
5
years
Approved.
5
years
Approved.
Manufactured by
50 per box
M/s Plasti Lab S.A.R.L,
Roumieh El Metn,
Industrial Area, Main
Road, Khoury Bldg,
P.O.Box 70407, Beruit,
Lebanon.
M/s Kaf Surgical &
Disposable Equipments,
GF-116, Panorama Centre,
Plot No.248, Staff Lines,
Fatima Jinnah Road,
Karachi/
2.
JRZ Intravenous
Canula without
Wings without
Injection Port
(Pen Type)
-do-
(14G,
16G, 18G,
20G,
22G, 24G,
26)
Manufactured by
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Page462
M/s Plasti Lab S.A.R.L,
Roumieh El Metn,
Industrial Area, Main
Road, Khoury Bldg,
P.O.Box 70407, Beruit,
Lebanon.
3.
M/s Lab Link Enterprises,
192-N, Block-II, PECHS,
Karachi.
50 per box
Nipro Safelet
Cath (I.V
Cannula Pen
Type)
Manufactured by:
Decontrolled till (16G,18G,
policy decision
20G,
by the Policy
22G, 24G)
Board/ Federal
Government
M/s Lab Link Enterprises,
192-N, Block-II, PECHS,
Karachi.
Approved.
5
years
Approved.
5
years
Approved.
50 per box
M/s PT Nipro Indonesia
Jaya, Kawaran Industri
Suryacipta, JI Surya Utama
Kav, 122B, 23 & 24, Desa
Kutamekar, Kec, Ciampel,
Karawang, Jawa Barat,
Indonesia.
4.
5
years
Nipro Wing Cath
(I.V Cannula with
Injection Port &
Wing)
-do-
(16G,
18G, 20G,
22G, 24G)
Manufactured by:
50 per box
M/s PT Nipro Indonesia
Jaya, Kawaran Industri
Suryacipta, JI Surya Utama
Kav, 122B, 23 & 24, Desa
Kutamekar, Kec, Ciampel,
Karawang, Jawa Barat,
Indonesia.
5.
M/s. A. Feroz & Co.,
Medicine Street No.1,
Marriot Road, Karachi
Star IV. Catheter
with Injection
Port.
Minutes246thMeetingRegistrationBoard
-do-
(14G,
16G, 18G,
20G, 22G,
24G)
Page463
Manufactured by
M/s. Engineering
Technical Plastic Industries
(Enteplin-Egypt) 10th of
Ramadan City, Industrial
Zone, A-1 Part 41/3.
Sharqia, Egypt.
B:
100 per
box
Infusion Set:
S.No Name of Importer and
.
Manufacturer/Exporter.
1. M/s Lab Link Enterprises,
192-N, Block-II, PECHS,
Name of Medical
Device
Nipro Infusion
Set
Karachi.
Manufactured by:
(with needle)
Price
Decontrolled till
policy decision
by the Policy
Board/ Federal
Government
Pack
size
Shelf
life
Decision
1’s
5
years
Approved.
M/s PT Nipro Indonesia
Jaya, Kawaran Industri
Suryacipta, JI Surya Utama
Kav, 122B, 23 & 24, Desa
Kutamekar, Kec, Ciampel,
Karawang, Jawa Barat,
Indonesia.
C:
Syringes:
S.No Name of Importer and
.
Manufacturer/Exporter.
Name of Medical
Device
Price
M/s Lab Link Enterprises,
192-N, Block-II, PECHS,
Nipro Disposable
Syringe (with
needle)
Decontrolled till
policy decision
by the Policy
Board/Federal
1.
Karachi.
Minutes246thMeetingRegistrationBoard
Pack
size
1ml
3ml
Shelf
life
5
years
Decision
Deferred
for
clarification
from
the
Page464
Government
Manufactured by:
M/s PT Nipro Indonesia
Jaya, Kawaran Industri
Suryacipta, JI Surya Utama
Kav, 122B, 23 & 24, Desa
Kutamekar, Kec, Ciampel,
Karawang, Jawa Barat,
Indonesia.
M/s Lab Link Enterprises,
192-N, Block-II, PECHS,
2.
Karachi.
5ml
applicant
regarding
nonpermanent
marking of
10ml
&
20ml
syringes
with delible
ink.
10ml
20ml
Nipro Disposable
Syringe
(without needle)
-do-
Nipro Disposable
Syringe U-100
Insulin with
needle
-do-
30ml
50ml
5
years
Deferred
for
clarification
from
the
applicant
regarding
nonpermanent
marking of
30ml
&
50ml
syringe with
delible ink.
5
years
Approved.
Manufactured by:
M/s PT Nipro Indonesia
Jaya, Kawaran Industri
Suryacipta, JI Surya Utama
Kav, 122B, 23 & 24, Desa
Kutamekar, Kec, Ciampel,
Karawang, Jawa Barat,
Indonesia.
M/s Lab Link Enterprises,
192-N, Block-II, PECHS,
3.
Karachi.
1 ml
Manufactured by:
M/s PT Nipro Indonesia
Jaya, Kawaran Industri
Suryacipta, JI Surya Utama
Kav, 122B, 23 & 24, Desa
Kutamekar, Kec, Ciampel,
Karawang, Jawa Barat,
Indonesia.
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Case No.02.
Withdrawal of registration applications of medical devices.
The following importing firms are withdrawing their registration applications of
medical devices as mentioned against each. The firms have also not deposited differential fee as
per revised fee schedule for their products:S.No
Name of Importer and
Manufacture/Exporter.
Name of Medical
Device (s)
1.
M/s Otsuka Pakistan Ltd.
30-B Sindhi Muslim
Cooperative Housing
Society, Karachi.
Manufactured by
M/s Micro Port Medical
(Shanghai) Co. Ltd.,
China.
M/s Otsuka Pakistan Ltd.
30-B Sindhi Muslim
Cooperative Housing
Society, Karachi.
Manufactured by
M/s Micro Port Medical
(Shanghai) Co. Ltd.,
China.
M/s Otsuka Pakistan Ltd.
30-B Sindhi Muslim
Cooperative Housing
Society, Karachi.
Manufactured by
M/s Micro Port Medical
(Shanghai) Co. Ltd.,
China.
Jive Stent (PTCA
Balloon Catheter)
M/s Otsuka Pakistan Ltd.
30-B Sindhi Muslim
Cooperative Housing
Society, Karachi.
Manufactured by
M/s Micro Port Medical
2.
3.
4.
Demanded
price & Pack
size
Decontrolled till
policy decision
by the Policy
Board/ Federal
Government.
Shelf
life
Remarks
2
years
Reference
No.27/12/
Stent-Reg.
Decontrolled till
policy decision
by the Policy
Board/ Federal
Government.
12
month
s
Firebird-2 (Rapamycin Decontrolled till
Cobalt Chromium
policy decision
Coronary Stent
by the Policy
System)
Board/ Federal
Government.
09
month
s
Mustang Stent
(Stainless Steel
Coronary Stent
System)
2
years
Firebird (Rapamycin
Eluting Stainless Steel
Coronary Stent
System)
Minutes246thMeetingRegistrationBoard
Decontrolled till
policy decision
by the Policy
Board/ Federal
Government.
Dated:
26-12-2011.
Reference
No.26/12/
Stent-Reg.
Dated:
26-12-2011.
Reference
No.30/12/
Stent-Reg.
Dated:
26-12-2011.
Reference
No.28/12/
Stent-Reg.
Dated :
26-12-2011.
Page466
(Shanghai) Co. Ltd., China.
5.
M/s. Intek Corporation,
Rawalpindi. /
Manufacturer:
M/s. OrbusNeich
Medical B.V. Drs, W.
Van Royenstraat, AN
Hoevelaken, The
Netherlands.
Shipped From:M/s. Asia Cardiovascular
Products Ltd., Kwai
Chung, N.T. Hong Kong.
Blazer CoCr Alloy
Coronary Stent
Delivery System
(Cobalt Chromium
Stent).
(Medical Device).
Decontrolled till
24
policy decision months
by the Policy
Board/ Federal
Government.
The
firm
has
informed
that further
action
on
this product
is no more
required.
Decision: Registration Board considered the request of the firms for withdrawal of their
applications for registration of above mentioned medical devices and approved
the request.
Case No.03.
Cancellatiuon of sole agency agreement.
M/s. A.H Distributors, Kh-1183, Lane No.5, Peshawar Road, Rawalpindi had
applied for registration of Primum Guiding Catheter and Pointer Angiographic Catheter for
import from foreign manufacturer i.e. Pendra Care International B.V Van der Waalspark 22 9351
VC
leek
the
Netherlands.
The
importing
firm
was
advised
to
complete
the
documents/information including fresh authorization letter and differential fee as per revised fee
schedule but the importing firm has not responded till now. The authorization letter of principal
manufacturer in respect of importer M/s A.H Distributors, Rawalpindi was expired on 31-122011. The manufacturer M/s Pendra Care International B.V Netherlands, has sent a termination
letter in respect of M/s A.H Distributors for the above mentioned products directly to Drug
Regulatory Authority of Pakistan. In the aforementioned letter the manufacturer has confirmed
that they terminated the business relationship with A.H Distributors, Rawalpindi.
Decision:
The Board after thorough discussion decided that final reminder should be
issued to the firm for submission of all deficient documents including fresh
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Page467
authorization letter from the principal manufacturer, attested by the
Embassy of Pakistan in the country of origin and the prescribed differential
fee. If the applicant fails to provide the aforesaid documents and prescribed
differential fee within 15 days, the above mentioned applications shall not be
entertained for registration.
Case No.04.
Case remanded back by the Appellate Board.
The Registration Board in its 240th meeting held on 7th November, 2013 considered and
rejected the following medical device of M/s Mana & Co, Karachi due to the reason mentioned
below against the product:S.No.
Name of Importer and
Manufacturer/Exporter.
1.
M/s Mana & Co,
204 New Medicine Market, Near
Densohall, Karachi.
Manufactured by
M/s Jiangxi Huali Medical
Instrument Co.Ltd. Yudu
Industrial Zone,Ganzhou, Jiangxi,
China.
Name of Medical Demanded
Device
price &
Pack size
Medicare IV
Decontrolled
Catheter with
(14G, 16G,
Injection Port.
18G, 20G,
22G, 24G )
Shelf
life
5
years
Decision
Rejected
due to
incomplete
and
unsatisfact
ory
stability
profile.
Rejection letter was issued to the importing firm. The said firm filed an appeal against the
decision of Registration Board before Appellate Board.
The Appellate Board in its 142nd
meeting held on 24th June, 2014 decided as under:“The Board in light of the stability data submitted before it and taking a lenient view
decided to remand the case to the Registration Board for decision under the rules.”
Decision:
Registration Board decided to ask the importing firm to submit complete
stability profile for the above mentioned device for review.
Minutes246thMeetingRegistrationBoard
Page468
Case No.05
a.
Miscellaneous Cases.
Relaxation in the condition of Drug (Labeling & Packaging) Rules, 1986. (Deferred
in 245th meeting of Registration Board).
M/s Johnson & Johnson Pakistan (Pvt) Ltd, Karachi has requested for relaxation in
condition of Drug (Labeling & Packaging) Rules, 1986 i.e. Urdu version, Pak Registration
Number and MRP of their already registered imported Prowler Micro Catheters (Registration
No.074692).
The firm has submitted that Prowler family of Micro Catheters being labeled as
per the requirement of Medical Device directives 93/42, GHTF labeling recommendation. As
Prowler Micro Catheters belongs to sterile sensitive class of medical device and it is supplied in
sterile peel open packages after carrying out all recommended package integrity and sterility
validation tests. To ensure the sterility of product till it is received by key user, packaging
qualification testing is performed on all Prowler Micro Catheters which are packaged in a
preformed tray, sealed in packaging pouch and placed in a folding carton. The same sterilized
pack being supplied in all International countries. The firm has deposited the required fee for
above mentioned product.
The firm has further submitted that the demand forecast of Prowler Micro Catheters in
Pakistan is only 1% of the global supply, so it is not viable for their Principal manufacturer to
produce country specific packs for such a small volume. Therefore, the firm requested for the
following approval:“That they may be allowed to import Prowler Micro Catheters in international
packs provided that company will perform ink jet printing of Urdu version, Pak
Registration No. and maximum retail price at their locally licensed premises.”
The case was placed before Registration Board in its 245th meeting and the Board
deferred the case and decided to call the firm M/s Johnson and Johnson Pakistan (Pvt) Ltd,
Karachi for personal hearing alongwith samples of the product in the forthcoming meeting of the
Board. Accordingly letter was issued to the firm for personal hearing alongwith provision of
samples.
Minutes246thMeetingRegistrationBoard
Page469
Decision: Registration Board deferred the case and decided to call the firm M/s Johnson
and Johnson Pakistan (Pvt) Ltd, Karachi for personal hearing alongwith
samples of the product in the next meeting of the Board.
b.
Inspection of Manufacturer Abroad M/s Biosensors Interventional Technologies Pte
Ltd., Kampong Ubi, Industrial Estate, Singapore.
The Registration Board in its 238th meeting held on 5TH & 6TH August, 2013
considered and approved the following medical devices of M/s Promed International, Islamabad
subject to inspection of manufacturer abroad, local storage facility etc:S.
No
1.
Name of Importer and
Manufacturer/Exporter
M/s. Promed International,
Ground Floor, Jamil Mohsin
Mansion, G-6 Markaz,
Islamabad.
Manufacturer:
Biosensors Interventional
Technologies Pte Ltd.,
Kampong Ubi, Industrial
Estate, Singapore.
Name of Medical Device Demanded
(s)
Price &
Pack Size
TM
Power Line PTCA
Decontrolled
Catheter
1’s
Balloon Dia (mm):
1.5, 2.0, 2.5, 2.75, 3.0,
3.5, 4.0.
Shelf
Life
36
months
Balloon Length (mm):
10,15, 20, 25, 30.
(Many product codes)
2.
M/s. Promed International,
Ground Floor, Jamil Mohsin
Mansion, G-6 Markaz,
Islamabad
Legal Manufacturer:
Biosensors Europe SA, Ch1110 Morges, Switzerland.
Manufacturing Site:
Biosensors Interventional
Technologies Pte Ltd.,
Kampong Ubi, Industrial
Estate, Singapore.
Bio Matrix TM Drug
Eluting Coronary Stent
System.
19
months
1’s
Stent Inner Dia (mm):
2.25, 2.5, 2.75, 3.0, 3.25,
3.50, 4.0.
Stent Length (mm):
8, 11, 14, 18, 23, 24, 28.
(Many product codes)
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Decontrolled
Page470
3.
4.
M/s. Promed International,
Ground Floor, Jamil Mohsin
Mansion, G-6 Markaz,
Islamabad
Legal Manufacturer:
Biosensors Europe SA, Ch-1110
Morges, Switzerland.
Manufacturing Site:
Biosensors Interventional
Technologies Pte Ltd., Kampong
Ubi, Industrial Estate,
Singapore.
M/s. Promed International,
Ground Floor, Jamil Mohsin
Mansion, G-6 Markaz,
Islamabad
Legal Manufacturer:
Biosensors International Pte.
Ltd, 21 Kallang Avenue,
Singapore Manufacturing
Site:
Biosensors Interventional
Technologies Pte Ltd.,
Kampong Ubi, Industrial
Estate, Singapore.
BioMetrix Flex TM Drug
Eluting Coronary Stent
System
Decontrolled
24
months
1’s
Stent Inner Dia (mm):
2.25, 2.5, 2.75, 3.0, 3.50,
4.0.
Stent Length (mm):
8, 11, 14, 18, 24, 28, 33,
36.
(Many product codes)
Gazelle Coronary Stent
System
Decontrolled
24
months
1’s
Stent Dia (mm):
2.25, 2.5, 2.75, 3.0, 3.25,
3.50, 4.0.
Stent Length (mm):
8, 11, 14, 18, 23, 24, 28.
(Many product codes)
Accordingly the inspection of manufacturer abroad has been carried out by the panel
comprising Mr. Sayyad Hussain Khan, DDC (LA) and Ms. Sara Mehreen, ADC, DRAP,
Islamabad on 1st and 2nd September, 2014. The panel has not recommended the products for
registration on the basis of following major concerns:(i)
(ii)
(iii)
Firm is importing stents in finish form either from Germany or from China. So
there was no way to verify their manufacturing standard.
Sterility testing is outsourced and either performed in Malaysia or Germany. So
the panel was not able to check the process of sterilization for the applied
products. However, final release of the products is firm itself.
As the firm was shifting to their own constructed new premises and few
operations including microbiological testing had already been shifted to the new
premises. So the panel was not able to check their microbiological testing
process as inspection of new premises was not the mandate of the panel.
Minutes246thMeetingRegistrationBoard
Page471
(iv)
Decision:
One of the applied products namely BioMatrix Flex Drug Eluting Coronary Stent
is not on free sale in the country of origin, which is one of the conditions for
registration of imported drugs in Pakistan.
Regiastration Board discussed the inspection report in detail and keeping in
view nature of the observations being critical rejected the above applications of M/s.
Promed International, Iislamabad manufactured by M/s. Biosensors Interventional
Technologies Pte Ltd., Kampong Ubi, Industrial Estate, Singapore.
Minutes246thMeetingRegistrationBoard
Page472
Item No.X:
Local Manufacturing of Biological Drugs.
The following cases for the local manufacturing biological drugs were decided in the
244th Meeting of the Drug Registration Board. The details of the cases and decisions taken by the
Drug Registration Board in its 242nd, 243rd and 244th Meeting are as below: Sl.#
1.
Applicant
Getz Pharma, Karachi.
Product Specifications
Eptifib Solution for Infusion 75mg/100ml
2.
Getz Pharma, Karachi
Eptifib Solution for Injection 20mg/10ml
3.
Getz Pharma, Karachi
4.
Getz Pharma, Karachi
Enoxa Injection
20mg/0.2ml Injection Each Pre-filled
syringe
Enoxa 40mg/0.4ml Injection
Each Pre-filled syringe
5.
Getz Pharma, Karachi
6.
Getz Pharma, Karachi
7.
Getz Pharma, Karachi
8.
Getz Pharma, Karachi
9.
Getz Pharma, Karachi . Menocon
Lyophilized Powders for Injection 1000 IU
USP
10.
Getz Pharma, Karachi
11.
Getz Pharma, Karachi
12.
Getz Pharma, Karachi
13. Getz Pharma, Karachi
Minutes246thMeetingRegistrationBoard
Enoxa
60mg/0.6ml Injection
Each Pre-filled syringe
Enoxa
80mg/0.8ml Injection
Each Pre-filled syringe
Gilia solution for injection
Glatiramer acetate 20mg/ml
Lira Solution for injection
6mg/ml Solution for Injection in Cartridge
Menocon
Lyophilized Powders for Injection 5000 IU
USP
Menoget
Menotropins 75IU /2ml vial
Menoget
Menotropins 150IU / 2ml vial
Neupeg injection
Page473
14. Getz Pharma, Karachi
15. Getz Pharma, Karachi
16. Getz Pharma, Karachi
17. Getz Pharma, Karachi
18. Getz Pharma, Karachi
19. Getz Pharma, Karachi
20. Getz Pharma, Karachi
21. Getz Pharma, Karachi
22. Getz Pharma
23. Getz Pharma
24. Getz Pharma
25. Getz Pharma
Getiferon
Solution for Injection
5 MIU in Pre-Filled Syringes
Uniferon Solution for Injection
3 MIU in Vials
Uniferon Solution for Injection
5 MIU in Vials
Uniferon Solution for Injection
3MIU in Pre-Filled Syringe
Uniferon Solution for Injection
5MIU in Pre-Filled Syringes
Unipeg 80 Solution injection 180mcg/mL
in vial
Unipeg 40 Solution injection 180mcg/0.5
mL in Prefilled Syringe
Unipeg Solution injection 180mcg/mL in
vial
Unipeg Solution injection 180mcg/0.5mL
in Prefilled syringe
Applicant
26. Macter International
Limited, Karachi
Product Specifications
Heberon 2a Injection 3MIU/0.3ml.
(Liquid Solution)
27. Macter International
Limited, Karachi
28. Macter International
Limited, Karachi
Heberon 2a Injection 5MIU/0.5ml.
(Liquid Solution)
Heberon 2a Injection 3MIU/ml
(Lyophilized Powder)
29. Macter International
Limited, Karachi
Heberon 2a Injection 5MIU/ml
(Lyophilized Powder)
Minutes246thMeetingRegistrationBoard
Getiferon
Solution for Injection
3 MIU in Vials
Getiferon
Solution for Injection 5MIU in Vials
Getiferon
Solution for Injection
3 MIU in Pre-Filled Syringes Each PreFilled
Page474
30. Macter International
Limited, Karachi
31. Macter International
Limited, Karachi
32. Macter International
Limited, Karachi
33. Macter International
Limited, Karachi
Peg-In Injection
100mcg /0.5ml
(Lyophilized Powder)
Peg-In Injection
120mcg /0.5ml
(Lyophilized Powder)
34. Macter International
Limited, Karachi
Peg-In Injection
150mcg /0.5ml
(Lyophilized Powder)
35. Macter International
Limited, Karachi
36. Macter International,
Karachi.
Neupeg
6mg/ml Injection Each vial
Prance Injection
Recombinant Human Basic Fibroblast
growth factor.
Macgrastim Injection
Pre-filled Syringe
Granulocyte colony stimulating factor.
37.
Macter International,
Karachi.
Applicant
Hilton Pharma (Pvt)
Ltd., Karachi.
Hilton Pharma (Pvt)
Ltd., Karachi.
Hilton Pharma (Pvt)
Ltd., Karachi.
Product specifications
Xiro Injection
Filgrastim 300ug
Lameo Injection 3MIU
Interferon alfa 2a
Lameo Injection 5MIU
Interferon alfa 2a
Applicant
M/s Nextar Pharma
(Pvt) Ltd., Karachi
Product specifications
Nexfil 150 Injection
42.
M/s Nextar Pharma
(Pvt) Ltd., Karachi
Nexfil 300 Injection
Each Prefilled syringe
43.
M/s Nextar Pharma
(Pvt) Ltd., Karachi
Pegaron Injection
38.
39.
40.
41.
Minutes246thMeetingRegistrationBoard
Peg-In Injection
50mcg /0.5ml
(Lyophilized Powder)
Peg-In Injection 80mcg /0.5ml
Page475
44.
45.
M/s Nextar Pharma
(Pvt) Ltd., Karachi
M/s Nextar Pharma
(Pvt) Ltd., Karachi
NP-POETIN 2000 INJECTION
NP-POETIN 4000 INJECTION
Decision of 242nd Meeting of Drug Registration Board. Product Approved, however, cGMP /
COPP is required of the finished Drug manufactured using this particular drug substance in the
country of origin. Biosimilarity data of locally manufactured drug needs to be disclosed by the
local manufacturer. However the minutes of the meeting were quarantine due to observation of
members of Drug Registration Board.
Decision of 243rd Meeting of Drug Registration Board: - Decision recorded in 242nd Meeting
upheld. Further, all firms will submit Bio-comparability data followed by regular Pharmacovigilance report.
Final Decision of the Drug Registration Board in its 244th Meeting: “ a) Biosimiliarity is the principal requirement for the registration of biological
drugs, as it is part of requirements of DRAP Act, 2012 mainly focusing on
patient safety and also to promote biological production and availability of
biological products.
b) All those manufacturing units which have been approved by Central
Licensing Board for manufacturing of biological drugs and also had
qualified product specific inspection by panel of Registration Board, are
allowed registrations of applied biological drugs for local manufacturing on
case to case basis. Item for which product specific inspection is required,
then it will be conducted by already constituted panel of Registration Board.
c) Local manufacturer will provide legalized documents from concerned
regulatory body confirming the status of licensed manufacturer of
concentrate/bulk source in its country of origin. Moreover manufacturer
will provide legalized documents for confirmation that finished product is
also available in market from the same biological material. Case will be
processed for issuance of registration letter after fulfillment of above
mentioned requirements, with following conditions:
i.
Registration is exclusively for trial manufacturing of the drug and
manufacturer shall not be allowed in any way to sale/utilize these
trial manufactured drugs. Manufacturer will perform biosimilarity
studies as per WHO guidelines confirming the biosimilarity of
applied product to original innovator product.
ii)
Manufacturer will submit actual result of conducted biosimilarity
studies to the Biological Division for its scientific evaluation
through Expert Committee on Biological Drugs (ECBD).
Moreover manufacturer will also provide sufficient quantity of
these trial manufactured drugs to Biological Division for testing by
Minutes246thMeetingRegistrationBoard
Page476
d)
National Control Laboratory for Biological (NCLLB) as per WHO
guidelines.
iii)
Recommendation of ECBD and report of NCLB will be submitted
to Registration Board for permission of commercial manufacturing
of the product or otherwise.
This decision supersedes all the already taken decisions so far in the
earlier meetings of Registration Board on the subject cases”.
The decision of the Board was communicated to the concerned companies. In response to
which the companies have submitted documents. The documents of M/s Nextar, Karachi were
complete and inspections of the company already conducted supported the trial manufacturing of
biological products. Accordingly trial production of 04 products out of 05 products (for one
product COPP was missing) was allowed to the company. Product specific inspection of the
company has not been conducted. The Board may decide the requirement of product specific
inspection of the company.
The documents of M/s Getz Pharma, Karachi required further support (COPP not provided) of
their case and under process while M/s Hilton has not responded yet. Two products of M/s
Macter Pharma, Karachi i.e., Prance and Macgrastim are to be imported in the form of
labelled finished vial and repacked locally which may be dealt as per procedures of import policy
for finished drugs. For rest of the products the documents submitted by the company are under
review.
The case of local manufacturing of biological drugs was also under examination of
Honourable Ombudsman on the complaint of M/s Macter International, Karachi. The
findings/recommendations of the Honourable Wafaqi Mohtasib are as below: The record of DRAP showed that more than 300 drugs of similar formulation
were freely available in the market. Moreover, DRAP had already
registered/approval more than 500 vaccines. The complainant’s case was
approved in 243rd board meeting with certain conditions which the complainant’s
fulfilled. He was never informed as to why without assigning any reason new
conditions were imposed. It was surprising to note that although the decision of
243rd meeting had become final and the minutes were displayed on DRAP Website
yet again the earlier decision was revised in 244th Board meeting and fresh
stringent requirements were proposed. The record also indicates that the drugs
registration board did not work in a systematic and organized manner. The
complainant’s case was examined and scrutinized by an expert committee and
cleared by the drug registration board which included technical experts and
eminent health professionals. It was noteworthy that the conditions prevalent at
the time of submission of application by the complainant were met and
subsequently additional conditions were applied retrospectively which was an
unfair practice. New conditions could only have been applied to fresh application.
After finalization of the decision of the 243rd Drug Registration Board Meeting,
imposition of a new condition by DRAP tantamount to mal-administration in
Minutes246thMeetingRegistrationBoard
Page477
terms of Article 2(2) of the President’s Order No.1 of 1983. It is therefore,
recommended that: 1) The complainant’s product be registered in line with the decision of
243rd board meeting and already done in the case of more than 300
registered biological products which are already being manufactured
in accordance with previous requirements.
2) There should be no discrimination and the complainant be allowed a
time frame as had been granted to other manufacturers of registered
biological products to bring their products in conformity with the new
requirements.
Compliance should be reported within 30 days of the receipt of a copy of these
findings or the reasons for not doing so be submitted in terms of Article 11(2) of
the President’s Order No 1 of 1983. Under provision of Article 11(2A) of P.O. 1
of 1983 read with section 13 of Federal Ombudsmen Institutional Reforms Act,
2013 and Article 32 of P.O. 1 of 1983 under which any person, aggrieved by a
decision or an order by the Wafaqi Mohtasib may also, within thirty days: (a) File a review petition before the Wafaqi Mohtasib; or
(b) Make a representation to the President.
Discussion:
On the direction of the Honorable Ombudsman, the case was taken up by the Drug
Registration Board on priority.
The matter related to local manufacturing of biological drugs was discussed on 10th
December, 2014 in the meeting. The Board discussed / examined in detail its earlier decisions
taken in 243rd and 244th Registration Board meeting regarding registration of biological drugs.
The Board observed that there is no difference in both decisions and in later meeting (244th), the
Board only devised implementation process for decision taken in 243rd meeting. The members of
the Board also examined the decision of Honorable Ombudsman and the whole matter of local
manufacturing of biological drugs was re-examined with holistic approach, keeping in view
ensuring the public health and safety, efficacy, quality of locally manufactured biological drugs.
It was also agreed by the Board that these local manufacturers (M/s. Macter International
Karachi, M/s. Getz Pharma Karachi, M/s. Nextar Pharma, Karachi and M/s. Hilton Pharma,
Karachi) will be provided an opportunity for appraising their views with the Registration Board
on next day.
Following representatives of four manufacturers attended the meeting for presentation of
their case.
Minutes246thMeetingRegistrationBoard
Page478
i.
ii.
iii.
iv.
v.
vi.
vii.
viii.
Mr. Abdur Jabbar Saya (M/s. Nextar, Karachi)
Syed Asghar Abbass Alve (M/s. Nextar, Karachi)
Mr. Saleem Riaz (M/s. Hilton Pharma, Lahore)
Dr. Salman Ahmad (M/s. Macter Pharma, Karachi)
Mr. Farooq Mustafa (M/s. Macter Pharma, Karachi)
Mr. Zeeshan Ahmad (M/s. Getz Pharma, Karachi)
Mr. Ayub Malik (M/s. Getz Pharma, Karachi)
Mr.Shamim Ahmad, PPMA representative for the meeting
The firms unanimously presented / argued that Registration Board previously did not implement/
demand CoPP/ Free sale certificate from local manufacturer of biological drugs. But now only
GMP certificate of the foreign manufacturer can be provided which should be accepted by the
Drug Registration Board. Moreover, the condition of providing bio-similarity data should not be
imposed as per previous practice of the Registration Board for already registered locally
manufactured drugs as this condition will result in further delay which can be very damaging to
new biopharmaceutical units. Condition of clinical studies should not be imposed. The
manufacturer shall ensure the quality, safety and efficacy of locally manufactured biological
drugs by them.
Representatives of the firms, PPMA and Pharma Bureau re-iterated that already
registered biological drugs may be re-assessed in light of safety, efficacy and quality parameters.
Decision: After all detailed discussion and directions of the Ombudsman, Registration
Board decided as follows:
1. As the Registration Board in 244th meeting has already approved registration of
biological drugs for four manufacturers (M/s. Macter International Karachi, M/s.
Getz Pharma Karachi, M/s. Nextar Pharma, Karachi and M/s. Hilton Pharma,
Karachi) for local manufacturing. In order to issue registration letter, the Board
advised these manufacturers to provide following document as discussed and agreed
during the deliberations with manufacturers:
a. The firms shall provide legalized GMP certificate of biological drug
manufacturer abroad (who will provide concentrate / ready to fill bulk of
biological drug to Pakistani manufacturers for further processing) as an
evidence that the manufacturer is an authorized manufacturer of that
particular biological drug in its country of origin.
Minutes246thMeetingRegistrationBoard
Page479
b. The firm shall provide studies conducted by manufacturer abroad (dully
verified with statement for correctness / genuineness of data) regarding
structural similarity of subject biological drug product (concentrate/ ready to
fill bulk for further processing) with reference biological product
(innovator).
c. The local manufacturer shall be authorized to manufacture the finished
biological product and then perform bio-comparability studies including
identity testing to parent molecule, purity testing, in vitro biological activity,
potency and toxicity with support of iso-electro focusing data, gel
electrophoresis, Western-Blot and other analytical techniques) and stability
studies of finished biological product. Data provided by the local
manufacturer shall be evaluated by the Expert Committee on Biological
Drugs. Recommendation of the committee shall be considered by the
Registration Board for issuance of registration letter.
d. The firms shall conduct parallel bio-similarity studies as per WHO
guidelines immediately after grant of registration and shall submit complete
studies with in two (2) years in any case. Manufacturer will provide progress
report to this effect to Directorate of Biological Drugs on quarterly basis.
e. Regular monitoring through pharmacovigilance reporting system shall be
observed through proper pharmacovigilance cell of the manufacturer and
report will be forwarded to the National Pharmacovigilance Centre, Division
of Pharmacy Services and Biological Division of DRAP. In case of any severe
adverse event, immediate mandatory reporting procedure shall be followed.
f. If any of the conditions is not fulfilled or public health risk reported at any
stage, the drug registration shall stand cancelled with immediate effect.
g. All the provisions as contained in the Drugs Act, 1976 and rules made there
under including provisions of Lot Release certification from National
Control Laboratory for Biologicals shall be strictly adhered to.
2.
Already registered biological drugs shall be reviewed in the same manner.
3.
New applications for registration of biological drugs shall be considered after
compliance of above point.
Minutes246thMeetingRegistrationBoard
Page480
Item No.XI: Applications for transfer of registrations
Various firms (column II) have applied for transfer of registrations. Registration Board
on 10.12.2014 advised P E & R Division to bring such applications for its consideration. Various
applications were considered as per following details:
S. No.
Name of
applicant(s)
Name of
existing
manufacturer
II
M/s
GlaxoSmithKlin
e Pakistan Ltd,
Kara
III
M/s Akhai
Pharmaceutical
s, Karachi
2.
-do-
-do-
20-06-2014
Dy.No.595
Form-5
Rs.40000/-
017890
3.
-do-
-do-
20-06-2014
Dy.No.596
Form-5
Rs.40000/-
017891
Traxon 250mg IM/IV
Injection
Each vial contains:Ceftriaxone
Sodium
…………..250mg
4.
M/s Martin Dow
Ltd, Karachi
10-02-2014
Dy.No.113
Form-5
Rs.20,000/-
027216
Biprofin Tablets
Each tablet contains:Flurbiprofen
…………..50mg
5.
-do-
M/s Martin
Dow
Pharmaceutical
s (Pakistan)
Ltd, 45-KM,
Multan Road,
Lahore
-do-
10-02-2014
Dy.No.112
Form-5
Rs.20,000/-
027216
Biprofin Tablets
Each tablet contains:Flurbiprofen
…………..100mg
6.
-do-
-do-
10-02-2014
Dy.No.111
Form-5
049189
Fexinol-D Tablet
Each tablet contains:Pseudoephedrine
HCl
I
1.
Minutes246thMeetingRegistrationBoard
Date of
application,
Diary No . &
Form
IV
20-06-2014
Dy.No.594
Form-5
Rs.40000/-
Registration
No.
V
017889
Name of product with
composition
VI
Traxon 1gm IM/IV
Injection
Each vial contains:Ceftriaxone
Sodium
…………..1gm
Traxon 500mg IM/IV
Injection
Each vial contains:Ceftriaxone
Sodium
…………..500mg
Page481
Rs.20,000/-
…….120mg
Fexofenadine
………. 60mg
HCl
7.
-do-
-do-
10-02-2014
Dy.No.110
Form-5
Rs.20,000/-
018485
Covatine Coated Tablet
Each tablet contains:Captodiamine
HCl
……….50mg
8.
-do-
-do-
14-04-2014
Dy.No.341
Form-5
Rs.20000/-
042810
Fexinol Tablets 30mg
Each tablet contains:Fexofenadine
HCl
……30mg
9.
-do-
-do-
14-04-2014
Dy.No.342
Form-5
Rs.20000/-
024311
Fexinol capsule
Each capsule contains:Fexofenadine
HCl
……80mg
10.
-do-
-do-
14-04-2014
Dy.No.340
Form-5
Rs.20000/-
024312
Fexinol Tablets 120mg
Each tablet contains:Fexofenadine
HCl
……120mg
11.
-do-
-do-
14-04-2014
Dy.No.343
Form-5
Rs.20000/-
024313
Fexinol Tablets 180mg
Each tablet contains:Fexofenadine
HCl
……180mg
12.
M/s Novartis
Pharma
(Pakistan) Ltd,
(DML
No.000193),
West Wharf
Road, Karachi
M/s Novartis
Pharma
(Pakistan) Ltd,
(DML
No.000010),
Jamshoro.
24-06-2014
Dy.No.636
Form-5
Rs.20,000/-
022204
Lozal 20mg Capsule
Each capsule contains:Omeprazole
…………..20mg
M/s Elko
Organization
(Pvt.) Ltd,
Karachi
M/s Macquin’s
International,
Karachi
12-11-2013
Dy.No.1003
Form-5
Rs.20,000/-
048507
Aqua Teas Eye Drops
Each ml contains:Dextran………1mg
HPMC……….3mg
13.
Minutes246thMeetingRegistrationBoard
18-09-2014
Dy.No.800
Rs.80,000/-
Page482
Glycerin……...2mg
(Manufacturer’s
Specification)
14.
-do-
-do-
12-11-2013
Dy.No.1003
Form-5
Rs.20,000/-
044457
MetaDex Eye / Ear
Drop
Each ml contains:Ciprofloxacin…..3mg
Dexamethasone..1mg
(Manufacturer’s
Specification)
15.
-do-
-do-
12-11-2013
Dy.No.1003
Form-5
Rs.20,000/-
044449
Blepharite Eye Drop
Each ml contains:Sulfacetamide…0.10g
Prednisolone
Acetate.…..2mg
Phenyephrine
HCl……..1.2mg
(Manufacturer’s
Specification)
16.
M/s AGP (Pvt.)
Ltd, Karachi
26-06-2013
Dy.No.1084
Form-5
Rs.20,000/-
015027
Atarax Syrup
Each 5ml contains:Hydroxyzine
Dihydrochloride..10mg
17.
M/s
GlaxoSmithKlin
e Pakistan Ltd,
F-268, S.I.T.E,
(DML
No.000233)
Karachi
-do-
-do-
26-06-2013
Dy.No.1084
Form-5
Rs.20,000/-
007591
Atarax Tablet 10mg
Each tablet contains:Hydroxyzine
Dihydrochloride..10mg
18.
-do-
-do-
26-06-2013
Dy.No.1084
Form-5
Rs.20,000/-
002287
Navidoxine Tablet
Each tablet contains:Meclozine
Dihydrochloride..25mg
Pyridoxine
Hydrochloride..50mg
19.
-do-
-do-
26-06-2013
034675
Xyzal Tablet
Minutes246thMeetingRegistrationBoard
Page483
Dy.No.1084
Form-5
Rs.20,000/-
Each film coated tablet
contains:Levocetirizine
Dihydrochloride………
…….5mg
20.
-do-
-do-
26-06-2013
Dy.No.1084
Form-5
Rs.20,000/-
016937
Zyrtec Syrup
Each ml contains:Cetirizine 2HCl
………….1mg
21.
-do-
-do-
26-06-2013
Dy.No.1084
Form-5
Rs.20,000/-
011020
Zyrtec Tablet 10mg
Each tablet contains:Cetirizine 2HCl
………….1mg
22.
M/s Bosch
Pharmaceuticals
(Pvt.) Ltd,
(DML
No.000707),
Karachi (PlantII)
M/s Bosch
Pharmaceutical
s (Pvt.) Ltd,
(DML
No.000350),
Karachi (PlantI)
12-03-2014
Dy.No.190
Form-5
Rs.20,000/-
037306
Ambac Injection 0.75gm
Each vial contains:
Ampicillin sodium USP
eq. to
Ampicillin…….500 mg
Sulbactam Sodium USP
eq. to
Sulbactam……250 mg
23.
-do-
-do-
12-03-2014
Dy.No.188
Form-5
Rs.20,000/-
037629
24.
-do-
-do-
12-03-2014
Dy.No.189
Form-5
Rs.20,000/-
042424
Ambac Injection 1.5gm
Each vial contains:
Ampicillin sodium USP
1.06gm eq. to
Ampicillin………1gm
Sulbactam Sodium USP
0.545gm eq. to
Sulbactam……500 mg
Bactamox Plus 0.75gm
Injection
Each vial contains:
Amoxicillin Sodium (as
Amoxicillin Sodium
Anhydrous)B.P …0.50
gm
Sulbactam Sodium USP
….0.25gm
Minutes246thMeetingRegistrationBoard
Page484
(USP Specification)
Bactamox Plus 1.5gm
Injection
Each vial contains:
Amoxicillin Sodium (as
Amoxicillin Sodium
Anhydrous)B.P …1.0
gm
Sulbactam Sodium USP
….0.5gm
(USP Specification)
25.
-do-
-do-
12-03-2014
Dy.No.187
Form-5
Rs.20,000/-
042425
26.
-do-
-do-
12-03-2014
Dy.No.186
Form-5
Rs.20,000/-
042426
Bactamox Plus 3gm
Injection
Each vial contains:
Amoxicillin Sodium (as
Amoxicillin Sodium
Anhydrous) B.P …2.0
gm
Sulbactam Sodium USP
….1.0gm
(USP Specification)
27.
-do-
-do-
12-03-2014
Dy.No.185
Form-5
Rs.20,000/-
015906
Boschoclox Injection
250mg
Each vial contains:
Cloxacillin Sodium USP
eq. to 250mg
Cloxacillin Base
28.
M/s
GlaxoSmithKlin
e Pakistan Ltd,
Korangi Plant
Karachi
M/s
GlaxoSmithKli
ne Pakistan
Ltd,
West Wharf,
Karachi
14-06-2012
Dy.No.315
Form-5
Rs.8,000/29-04-2013
Rs.12000/-
0001859
Kenacomb Cream
Each gram contains:Triamcinolone
Acetonide USP …1mg
Nystatin
USP
………….100,000 units
Gramidicin
USP
………...0.25mg
29.
-do-
-do-
14-06-2012
Dy.No.314
Form-5
005026
Kenacomb Ointment
Each gram contains:Triamcinolone
Minutes246thMeetingRegistrationBoard
Page485
Rs.8,000/29-04-2013
Rs.12000/-
30.
-do-
31.
M/s Hilton
Pharma, Karachi
32.
-do-
33.
-do-
Acetonide USP ….1mg
Nystatin
USP
………….100,000 units
Gramidicin
USP
……………...0.25mg
Neomycin Sulphate eq.
to 2.5mg base
14-06-2012
Dy.No.316
Form-5
Rs.8,000/29-04-2013
Rs.12000/-
009452
Kenalog
Orabase
Ointment
Each gram contains:Triamcinolone
Acetonide USP ….1mg
11-07-2013
Dy.No.692
Form-5
Rs.20,000/-
021661
Zinum 250mg Injection
Each vial contains:Ceftazidim
Sodium
……….250mg
-do-
11-07-2013
Dy.No.693
Form-5
Rs.20,000/-
021662
Zinum 500mg Injection
Each vial contains:Ceftazidim
Sodium
……….500mg
-do-
-do-
11-07-2013
Dy.No.697
Form-5
Rs.20,000/-
021663
Zinum 1gm Injection
Each vial contains:Ceftazidim
Sodium
……….1gm
34.
-do-
-do-
11-07-2013
Dy.No.696
Form-5
Rs.20,000/-
021664
Axone 250mg Injection
Each vial contains:Ceftriaxone
Sodium
…….250mg
35.
-do-
-do-
11-07-2013
Dy.No.699
Form-5
Rs.20,000/-
021665
Axone 500mg Injection
Each vial contains:Ceftriaxone
Sodium
…….500mg
36.
-do-
-do-
11-07-2013
Dy.No.695
021666
Axone 1gm Injection
Each vial contains:-
M/s Brookes
Pharma,
Karachi
Minutes246thMeetingRegistrationBoard
Page486
Form-5
Rs.20,000/-
Ceftriaxone
…….1gm
Sodium
37.
M/s Indus
Pharma, Karachi
M/s Nimrall
Laboratories,
Islamabad
05.11.2014
Dy.No.394
Form-5
Rs.20,000/-
054553
Rudra 5mg Tablet
Each tablet contains:Rosuvastatin
(as
Calcium) …….5mg
38.
-do-
-do-
05.11.2014
Dy.No.395
Form-5
Rs.20,000/-
054554
Rudra 10mg Tablet
Each tablet contains:Rosuvastatin
(as
Calcium) …….10mg
39.
M/s Sante (Pvt.)
Ltd, Karachi
M/s
Elko
Organization
(Pvt.)
Ltd,
Karachi
18-09-2014
Dy.No.657
Form-5
Rs.20,000/-
070516
Dequsan Throat / Mouth
Spray Solution
Each 100ml contains:Dequalinium Chloride
BP………15mg
Benzalkonium Chloride
BP………..35mg
40.
M/s Pfizer
Pakistan Ltd,
DML
No.000025
(Formulation) at
B-2, SITE,
Karachi
M/s
wyeth
Pakistan Ltd.,
Karachi
contract
manufactured
by M/s Spencer
&
Co
(Pakistan) Ltd,
Karachi.
06-02-2014
Dy.No.68
Form-5
Rs.20,000/-
000083
Ativan 1mg Tablets
(Lorazepam)
41.
-do-
-do-
000084
Ativan 2mg Tablets
(Lorazepam)
42.
M/s Ambrosia
Pharmaceuticals
, Rawat
M/s Spencer &
Co, Karachi
06-02-2014
Dy.No.68
Form-5
Rs.20,000/29-10-2014
Dy.No.634
Form-5
Rs.20,000/-
006348
Calcipan-T
50
mg
Tablet
Each tablet contains:Calcium
Pantothenate……..50
mg
43.
-do-
-do-
29-10-2014
067454
Infacol 40 mg Drops
Each ml contains:-
Minutes246thMeetingRegistrationBoard
Page487
44.
-do-
-do-
Dy.No.635
Form-5
Rs.20,000/29-10-2014
Dy.No.633
Form-5
Rs.20,000/-
45.
M/s Glitz
Pharma,
Islamabad
M/s Caraway
Pharmaceutical
, Rwat
46.
M/s Focus &
Rulz, Islamabad
47.
Simethicone
…………40 mg
008801
Infacol Suspension
Each 5 ml contains:Dicyclomine
HCl
……….5 mg
Simethicone
………
…50 mg
784; 09.12.2014
Rs.50000/Form 5
066362
G-Cal 5 mg Injection
Each ampoule contains:Cholecalciferol eq. to
Cholecalciferol
……………. 5 mg
M/s Highnoon
Labs, Lahore
970; 10.12.2014
Rs.20000/Form 5
027104
Helezol 20 mg Capsule
Each
delayed-release
capsule contains:Omeprazole
enteric
coated pellets 8.5%
≡ Omeprazole……. 20
mg
-do-
-do-
976; 10.12.2014
Rs.20000/Form 5
051054
Helezol 40 mg Capsule
Each
delayed-release
capsule contains:Omeprazole
enteric
coated pellets 8.5%
≡ Omeprazole……. 40
mg
48.
-do-
-do-
971; 10.12.2014
Rs.20000/Form 5
025098
Angiocard
2.5mg
Capsule
Each sustained-release
capsule contains:Nitroglycerin SR Pellets
≡ Nitorglycerin……..2.5
mg
49.
-do-
-do-
969; 10.12.2014
Rs.20000/Form 5
025099
Angiocard SR 6.5 mg
Capsule
Each sustained-release
capsule contains:Nitroglycerin SR Pellets
≡ Nitorglycerin……..6.5
mg
Minutes246thMeetingRegistrationBoard
Page488
50.
51.
-do-
-do-
-do-
-do-
974; 10.12.2014
Rs.20000/Form 5
972; 10.12.2014
Rs.20000/Form 5
024929
024930
Artonec 50 mg Capsule
Each delayed-release
capsule contains:Diclofenac
Sodium
enteric coated pellets
≡ Diclofenac Sodium
…... 50 mg
Artonec SR-100 Capsule
Each sustained-release
capsule contains:Diclofenac Sodium
sustained release coated
pallets
≡ Diclofenac Sodium
….100 mg
52.
-do-
-do-
973; 10.12.2014
Rs.20000/Form 5
027105
Neopres 5 mg Tablet
Each tablet contains:Amlodipine Besylate eq.
to
Amlodipine……….5mg
53.
-do-
-do-
968; 10.12.2014
Rs.20000/Form 5
027106
Neopres 10 mg Tablet
Each tablet contains:Amlodipine Besylate eq.
to Amlodipine…10 mg
54.
-do-
-do-
975; 10.12.2014
Rs.20000/Form 5
051057
Delergic 5 mg Tablet
Each film coated tablet
contains:Desloratidine……..5 mg
05-06-2013
926
Form-5
05-06-2013
5549
Form-5
059991
05-06-2013
5548
Form-5
054157
Obdin Tablet 5mg
Each tablet contains:Desloratadine…. 5mg
Azrocin Suspension
Each 5ml contains:Azithromycin
dihydrate
eq.
to
Azithromycin.. 200mg
Obflox Tablet
Each tablet contains:Levofloxacin
Hemihydrate
equivalent to
55.
56.
57.
M/s. Synchro M/s. Obsons
Pharmaceutical Pharmaceutic
s Lahore
als, Lahore
-do-do-
-do-
-do-
Minutes246thMeetingRegistrationBoard
025404
Page489
58.
-do-
-do-
05-06-2013
5547
Form-5
030488
59.
-do-
-do-
05-06-2013
5554
Form-5
054166
60.
-do-
-do-
05-06-2013
5552
Form-5
029834
61.
-do-
-do-
025406
62.
-do-
-do-
05-06-2013
5551
Form-5
05-06-2013
5553
Form-5
63.
-do-
-do-
05-06-2013
5550
Form-5
054153
64.
-do-
-do-
05-06-2013
5555
Form-5
054165
22-04-2014
780
Form-5
018632
65.
M/s. Searle IV M/s.
the
Solutions
Searle
(Pvt.)
Ltd; Company,
Minutes246thMeetingRegistrationBoard
025403
Levoflocaxin
…………. 500mg
Obflox Tablet
Each tablet contains:Levofloxacin
Hemihydrate
equivalent to
Levoflocaxin
…………. 250mg
Obpra Capsule 40mg
Each
capsule
contains:Enteric coated pellets
of
Esomeprazole
magnesium trihydrate
eq. to Esomeprazole
…………… 40mg
Vincam Capsule 20mg
Each
capsule
contains:Piroxicam…… 20mg
Rubinol Tablet
Each tablet contains:Flurbiprofen.. 100mg
Azrocin Capsule
Each
capsule
contains:Azithromycin
dihydrate….. 250mg
LevortizinTablet
Each tablet contains:Leocetirizine
dihydrate 5mg
Obpra Capsule
Each
capsule
contains:Esomeprazole
magnesium trihydrate
enteric coated pellets
equivalent
to
Esomeprazole
…………. 20mg
Metronzine Injection
Each
100
ml
Page490
Lahore
Karachi
66.
-do-
-do-
22-04-2014
783
Form-5
044077
67.
-do-
-do-
22-04-2014
790
Form-5
047384
68.
-do-
-do-
22-04-2014
778
Form-5
047391
69.
-do-
-do-
22-04-2014
782
Form-5
014408
70.
-do-
-do-
22-04-2014
779
Form-5
047383
71.
-do-
-do-
22-04-2014
797
Form-5
067114
72.
-do-
-do-
22-04-2014
781
Form-5
067113
Minutes246thMeetingRegistrationBoard
contains:Metronidazole
……….. 500 mg
Vaptor 20 mg Tablets
Each tablet contains:Rosuvastatin
(as
Calsium) 20 mg
Searl-α
0.5
mcg
Tablets
Each tablet contains:Alfacalcidol
……………0.5 mcg
Rhulef 20 mg Tablets
Each film coated
tablet contains:Leflunomide
…………. 20 mg
Gravinate Injection
Each ml contains:Dimenhydrinate
………… 50 mg
Searl- α 1 mcg Tablet
Each tablet contains:Alfacalcidol
……………….. 1 mcg
Peditral Liquid
Each 5 ml contains:Sodium
Chloride
…...... 17.50 mg
Potassium
Chloride
…… 7.50 mg
Trisodium Citrate
Dihydrate .. 14.5 mg
Dextrose… 100.00 mg
(Flavour: Orange)
Peditral Liquid
Each 5 ml contains:Sodium Chloride ......
17.50 mg
Page491
73.
-do-
-do-
22-04-2014
787
Form-5
047390
74.
-do-
-do-
22-04-2014
789
Form-5
047382
75.
-do-
-do-
22-04-2014
791
Form-5
058022
76.
-do-
-do-
22-04-2014
792
Form-5
044075
77.
-do-
-do-
22-04-2014
793
Form-5
050736
78.
-do-
-do-
22-04-2014
794
Form-5
050737
79.
-do-
-do-
22-04-2014
795
Form-5
067116
Minutes246thMeetingRegistrationBoard
Potassium
Chloride
…… 7.50 mg
Trisodium Citrate
Dihydrate .... 14.5 mg
Dextrose… 100.00 mg
(Flavour: Regular)
Rhulef 10 mg Tablets
Each
film
tablet
contains:Leflunomide…. 10 mg
Searl- α 0.25 mcg
Tablet
Each tablet contains:Alfacalcidol….0.25
mcg
Co-Olesta Tablet
Each tablet contains:Olmesartan…... 20 mg
Hydrochlorothiazide
….. 12.5 mg
Vaptor Tablets
Each tablet contains:Rosuvastatine
(as
Calcium) 5 mg
Olesta 20 mg Tablet
Each tablet contains:Olmesartan
Medoxomil … 20 mg
Olesta 40 mg Tablet
Each tablet contains:Olmesartan
Medoxomil … 40 mg
Peditral Liquid
Each 5 ml contains:Sodium Chloride ……
17.50 mg
Potassium
Chloride
….. 7.50 mg
Page492
80.
-do-
-do-
22-04-2014
796
Form-5
067115
81.
-do-
-do-
22-04-2014
798
Form-5
058023
82.
-do-
-do-
22-04-2014
783
Form-5
044048
83.
-do-
-do-
22-04-2014
783
Form-5
044076
84.
-do-
-do-
22-04-2014
786
Form-5
044049
85.
-do-
-do-
22-04-2014
788
Form-5
047389
86.
-do-
-do-
22-04-2014
876
Form-5
060631
Requested for
change of
name
Minutes246thMeetingRegistrationBoard
Trisodium Citrate
Dihydrate .. 14.5 mg
Dextrose… 100.00 mg
(Flavour: Banana)
Peditral Liquid
Each 5 ml contains:Sodium Chloride ……
17.50 mg
Potassium
Chloride
….. 7.50 mg
Trisodium Citrate
Dihydrate….. 14.5 mg
Dextrose...100.00 mg
(Flavour: Bubble gum)
Co-Olesta Tablet
Each tablet contains:Olmesartan ... 40 mg
Hydrochlorothiazide
….. 12.5 mg
Simbex Tablets
Each tablet contains:Simvastatin …. 10 mg
Ezetimibe …… 10 mg
Vaptor Tablet
Each tablet contains:Rosuvastatin
(as
Calcium) 10 mg
Simbex Tablets
Each tablet contains:Simvastatin.. 20 mg
Ezetimibe …… 10 mg
Rhulef 100 mg Tablets
Each tablet contains:Leflunomide
…………… 100 mg
Levomac Infusion
Each
100
ml
contains:Levofloxacin.. 500 mg
Page493
87.
-do-
-do-
22-04-2014
781
Form-5
060632
Requested for
change of
name
88.
M/s. The
Searle
Company
Limited F319, S.I.T.E,
Karachi
(DML #
000016)
-do-
23-10-2013
487
Form-5
018627
89.
M/s. The
Searle
Company
Limited 32Km Multan
Road, Lahore
(DML #
000647)
-do-
23-10-2013
486
Form-5
018628
90.
-do-
-do-
23-10-2013
488
Form-5
018629
91.
M/s. Allmed
(Pvt.) Ltd;
Lahore at same
premises
21-02-2013
469
Form-5
052455
92.
-do-
M/s. Ever
Green
Pharmaceutic
als (Pvt.) Ltd;
Plot No. 509
Sundar
Industrial
Estate, Lahore
-do-
-do-
052434
93.
-do-
-do-
-do-
059964
Minutes246thMeetingRegistrationBoard
Moxirains Infusion
Each
250
ml
contains:Moxifloxacin as HCl
…… 400 mg
(Mac & Rains Specs)
Sermol Suspension
Each 5ml contains:Paracetamol…..120mg
Sermol
Forte
Suspension
Each 5ml contains:Paracetamol
………….. 250mg
Sermol Tablet
Each tablet contains:Paracetamol ………..
500mg
Hemfil Syrup
Each 5ml contains:Iron
Polymaltose
complex
eq.
to
Elemental
Iron
…………….. 50mg
Hemifim-F Tablet
Each tablet contains:Iron
hydroxide
Polymaltose complex
…. 100mg
Folic Acid … 0.35mg
Uriflow Capsule
Each
capsule
contains:Tamsulosin
Page494
94.
-do-
-do-
-do-
052462
95.
-do-
-do-
-do-
052460
96.
-do-
-do-
-do-
052422
97.
-do-
-do-
-do-
063136
98.
-do-
-do-
-do-
063135
99.
-do-
-do-
-do-
052424
100.
-do-
-do-
-do-
052440
101.
-do-
-do-
-do-
067918
Minutes246thMeetingRegistrationBoard
Hydrochloride
…………….. 0.4mg
Protx 20mg Capsuel
Each
capsule
contains:Esomeprazole
……………… 20mg
Protx 40mg Capsuel
Each
capsule
contains:Esomeprazole
……………… 40mg
Everlom-400 Tablet
Each tablet contains:Lomefloxacin as HCl
….. 400mg
Ichunil D Syrup
Each 10ml contains:Pseudeophedrine
(HCl) . 13.3mg
Phlocodine ... 3.33mg
Paracetamol … 200mg
Ichunil D Syrup
Each 10ml contains:Pseudeophedrine
(HCl) . 13.3mg
Phlocodine . 3.33mg
Paracetamol… 200mg
Diphenhydramine
…….. 3.33mg
Okcin-200 Tablet
Each tablet contains:Ofloxacin …. 200mg
Meamin Capsule
Each
capsule
contains:Mecobalamin..500mcg
Everlose Syrup
Page495
102.
-do-
-do-
-do-
067898
103.
-do-
-do-
-do-
052444
104.
-do-
-do-
-do-
052461
Decision:


Each 5ml contains:Lactulose …. 3.35mg
Methemin Injection
Each ml contains:Mecobalamin..
500mcg
Itrdym Capsule
Each
capsule
contains:Itraconazole ... 100mg
Sopra-Praz Capsule
Each
capsule
contains:Lansoprazole… 30mg
Registration Board decided as follows:
Cancellation of above registrations from name of manufacturer (column II) except
item at S.No.45 as it is case for change of contract manufacturer, which is deferred
for processing in light of contract manufacturing policy.
Grant of above registrations in name of manufactyrer (column III). Chairman,
Registration Board will permit issuance of registration letter after evaluation /
completion of Form 5A as per check list approved by Registration Board, renewal
status and comments of Cost & Pricing Division about MRP of the drug.
Meeting ended with a vote of thanks to and from the chair.
______________________________________________________________________________
End of the Document
PE&
R
Minutes246thMeetingRegistrationBoard
Digitally signed
by PE&R
DN: cn=PE&R, o,
ou=DRAP,
email=drobaid@
yahoo.com, c=US
Date: 2015.01.09
12:28:11 +05'00'
Page496