Download Recommendations: I approve the minutes of 32 SEC (Antimicrobial

Recommendations:
I approve the minutes of 32nd SEC (Antimicrobial, Antiviral, Antiparasitic and Antifungal)
held on 11.04.2017 at CDSCO HQ New Delhi and recommended the following:
Agend
a no.
File no./Drug Name
Name of firm/
Institute
Recommendations
New Drugs Division
1
12-34/12-DC ArbekacinSulphate Injection
200mg/4ml
M/s. Alkem
The firm did not turn
up for presentation.
Fixed Dose Combination Division
2
04-58/2016-DC(Pt. Maneesh) Rifampicin
IP+Isoniazid IP (450mg+225mg)
The firm presented the
BE protocol for the
FDC of Pyridoxine
(vit B6) 10 mg with
Rifampicin
450mg,
Isoniazid
225mg,
Pyrazinamide
1200
mg and Ethambutol
Hcl 825mg Sachet
with the Reference
product Rimstar (3
tablets) of Sandoz
Denmark (Each tab.
containing Rifampicin
150mg,
Isoniazid
75mg, Pyrazinamide
400mg
and
Maneesh
Ethambutol
Hcl
Pharmaceuticals 275mg).The firm also
informed that the BE
data for the proposed
4 drug FDCs will be
extrapolated to 2
drugs and 3 drugs
FDCs. The Committee
deliberated
and
recommended
for
conduct of proposed
BE study. After the
submission of BE
report the proposal for
Phase III Clinical trial
will be considered as
already recommended
in
the
previous
meeting
held
on
Page 1 of 6
32nd
SEC (Antimicrobial, Antiviral, Antiparasitic and Antifungal) 11.04.2017
Agend
a no.
File no./Drug Name
Name of firm/
Institute
Recommendations
8.12.2016.
3
04-17/2016-DC Daclatasvir+Sofosbuvir
( 60mg+400mg)
M/s NATCO
Pharma
4
04-87/2000-DC(Pt.Cipla)
Lopinavir+Ritonavir ( 40mg+10mg)
M/s. Cipla Ltd.,
The firm presented the
BE
study
data
conducted for export
purpose
as
recommended by the
Committee in the
previous meeting held
on 22.09.2016. The
committee reviewed
and found the BE data
satisfactory. Further
the
firm
also
requested for the CT
waiver based on the
recent circular issued
by
DCG(I)
on
20.03.2017.The
Committee did not
recommended for the
CT waiver as the
proposed drug does
not fall under the
category of extreme
urgency.
The firm was directed
by the Committee to
conduct
the
acceptability
and
feasibility study in
Indian
pediatric
population
in
its
meeting
held
on
18.12.2015. However
the firm expressed its
inability to conduct
such study. Further
the
firm
also
requested for the
study waiver based on
the recent circular
issued by DCG(I) on
20.03.2017.The
Committee
opined
that the above circular
is not applicable for
the proposed study
and has insisted to do
Page 2 of 6
32nd
SEC (Antimicrobial, Antiviral, Antiparasitic and Antifungal) 11.04.2017
Agend
a no.
File no./Drug Name
Name of firm/
Institute
5
04-38/2009-DC(Pt. EM)
DarunavirEthanolateeq .to
Darunavir+Ritonavir IP (600mg+100mg)
6
04-43/2016-DC
Each Combikit contains: Part A: two film
coated tablets of darunavirEthanolate eq. to
Darunavir 600mg and Part B: two film coated
tablets of Ritonavir IP100mg
Recommendations
the study as proposed
in earlier meeting held
on 18.12.2015.
The Firm presented
the Pharmacokinetic
Interaction
Study
report before the
Committee.
The
Committee
recommended for the
approval
of
manufacturing
and
marketing of FDC of
Darunavir Ethanolate
eq. to Darunavir +
Ritonavir
IP
M/s. Emcure
(600mg+100mg) for
Pharmaceuticals
the indication “ for the
treatment of Human
immunodeficiency
virus (HIV) infection
in
antiretroviral
treatment experienced
adult patients, such as
those patients with
HIV-1 strains resistant
to more than one
protease inhibitor and
with
other
antiretroviral agents”.
The Firm presented
the Pharmacokinetic
Interaction
Study
report for FDC of
Darunavir Ethanolate
eq. to Darunavir +
Ritonavir
IP
(600mg+100mg)
before the Committee.
M/s. Emcure
The
Committee
Pharmaceuticals recommended for the
approval
of
manufacturing
and
marketing of proposed
combikit of Part A:
two
film
coated
tablets of Darunavir
Ethanolate eq. to
Darunavir 600mg and
Part B: two film
Page 3 of 6
32nd
SEC (Antimicrobial, Antiviral, Antiparasitic and Antifungal) 11.04.2017
Agend
a no.
7
8
File no./Drug Name
Name of firm/
Institute
Recommendations
coated
tablets
of
Ritonavir IP 100mg
Combikit for the
indication “for the
treatment of Human
immunodeficiency
virus (HIV) infection
in
antiretroviral
treatment experienced
adult patients, such as
those patients with
HIV-1 strains resistant
to more than one
protease inhibitor and
with
other
antiretroviral agents”.
04-12/2017-DC Part A: One film coated
The firm presented the
tablets of
proposal
for
the
EmtricitabineIP+TenofovirDisoproxilFumara
proposed combikit of
te IP & Part B: One Uncoated tablets of
Part A: One film
Nevirapine Extended release tablets
coated
tablets
of
(Nevirapine USP)(200mg+300mg &
Emtricitabine IP +
400mg)Combikit
Tenofovir Disoproxil
Fumarate IP & Part B:
One Uncoated tablets
M/s. Emcure
of
Nevirapine
Pharmaceuticals Extended
release
tablets
(Nevirapine
USP) (200mg+300mg
&
400mg).
The
committee
after
detailed deliberation
did not recommend
the proposed combikit
as it will not provide
any additional benefit.
Medical Devices
4-MD/CT-105/2013-DC (Part-2) Application
in Form 44 for permission to conduct Clinical
Trial titled of product i.e., “Hinglact Prime
(Absorbable, antibacterialchlorhexidineacetate surgical PGA-PLAsuture)”
M/s. HLL
Lifecare
Ltd,Trivandrum
-695017, Kerala
The firm could not
present the adequate
safety and efficacy
data of the product.
However the firm
presented protocol for
conducting
clinical
trial in India. The
committee observed
that the protocol has
many
limitations/inadequacy
Page 4 of 6
32nd
SEC (Antimicrobial, Antiviral, Antiparasitic and Antifungal) 11.04.2017
Agend
a no.
File no./Drug Name
Name of firm/
Institute
Recommendations
.
a) Sample
size
not calculated
scientifically.
b) Trial
sites
selected
are
inappropriate
(small nursing
homes)
and
without
Institutional
Ethics
Committee.
c) Inclusion
criteria were
not defined.
d) The
study
methodology
lacks clarity.
Hence,the protocol in
the present form is not
acceptable.
Page 5 of 6
32nd
SEC (Antimicrobial, Antiviral, Antiparasitic and Antifungal) 11.04.2017
S.No SEC –Experts Name & Designation
Signature
1. Dr.Archna Thakur, Dir. Prof. Department of Microbiology,
G. B Pant Hospital, New Delhi.
2. Dr. B. Gupta Prof & Head Dept of Medicine, NDMC
Medical college & Hindu Rao Hospital, New Delhi
3. Dr.Subhash C. Parija, Sr. Prof & HOD, Microbiology,
JIPMER, Puducherry
4. Dr.Varsha Gupta, Prof. Department of Microbiology, Govt.
medical college and Hospital (GMCH), Chandigarh
5. Dr.Amita Jain, Prof. Department of Microbiology, KGMU,
Lucknow
6. Dr. C.D. Tripathi , Department of Pharmacology VMMC
&Safdarjung Hospital, New Delhi
7. DrPratipKundu, MD Professor of Microbiology & Medical
Superintendent cum Vice Principal, School of Tropical
Medicine ChittaRanjan Avenue Kolkata
8. Dr. AbhishekAgrawal (Associate Professor) Dept. of
Medicine SMS Medical College, Jaipur 2744555
Page 6 of 6
32nd
SEC (Antimicrobial, Antiviral, Antiparasitic and Antifungal) 11.04.2017