Download Guidance Document For Reporting Individual Case Safety Report

Guidance Document For Reporting Individual Case Safety Report
National Coordination Centre
Indian Pharmacopoeia Commission, Ghaziabad is an autonomous institution of the Ministry
of Health and Family Welfare, Govt. of India, which sets standards for drugs that are
manufactured, sold and consumed in India.IPC is functioning as a National Coordination
Centre for Pharmacovigilance Programme of India.The basic function of IPC is to publish
official documents for improving quality of medicines by way of adding new and updating
existing monographs in the form of Indian Pharmacopoeia. It further promotes rational use of
generic medicines by publishing National Formulary of India. IP prescribes standards for
identity, purity and strength of drugs essentially required from healthcare perspective of
human beings and animals. IPC also provides IP Reference Substances which act as a finger
print for identification of an article under test and its purity as prescribed in IP. The IP
standards are legally acceptable during quality assurance and at the time of dispute in the
court of law. IPC administers the Second Schedule of the Drugs and Cosmetics Act, 1940
(the act) and Rules 1945, applying a risk management approach designed to set standards of
drugs in India to meet acceptable standards of quality, safety and efficacy of drugs commonly
required for treatment of diseases prevailing in the region.
NCC is operating under the supervision of steering committee which recommends procedures
and guidelines for regulatory interventions.The main responsibility of NCC is to monitor all
the adverse reactions of medicines being observed in the Indian population. It aims to
develop and maintain its own Pharmacovigilance database for patient safety with respect to
use of medicine.
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Introduction
Adverse reactions of drugs continue to remain as an important public health issue. Safety
monitoring of medicines is the responsibility of all stakeholders of the healthcare system
since globally it continues to be an important cause of morbidity and mortality. In some
countries adverse drug reactions are among the ten leading causes of mortality. The safety of
patients and the safe use of medicines are crucial for health policy development and delivery
of the best healthcare. To prevent or reduce harm to patients thereby improving public health,
the safety of medicines in clinical use must be monitored and evaluated through specialised
systems. This requires a need to establish a well-organised pharmacovigilance system. Thus,
a pharmacovigilance system is defined as a system used by an organisation to monitor the
safety of authorised medicinal products and detect any change to their risk-benefit balance. A
pharmacovigilance system is characterised by its structures, processes and outcomes. To run
an effective pharmacovigilance system a protocol is required for reporting adverse reactions
associated with drug use. Therefore NCC aims to ensure the systematic and effective
functioning of PvPI by publishing its guidance document.
This Guidance Document lays down requirements and guidance for reporting of adverse drug
reactions and significant safety issues related to drugs regulated by the Central Drugs
Standard Control Organization. This document does not establish legally enforceable
responsibilities. This has been prepared by the NCC and approved by Working Group. The
purpose of this document is to present the importance of pharmacovigilance in India, to
record the growth and potential as a significant discipline within medical science, and to
describe its impact on patient welfare and public health. This document also highlights the
importance of collaboration and communication at local, regional and international levels to
ensure that pharmacovigilance delivers its full benefits. It also provides guidance to
stakeholders on good pharmacovigilance practices, assessment of data regarding drugs
including vaccines, herbal and biological products (blood and blood components) and dietary
supplements.
Scope of Guidance Document
This document helps to expand the role and scope of PvPI to identify, analyse and minimise
the risk associated with drugs. Further it promotes better and broader use of existing
pharmacovigilance data for patient safety by spontaneous reporting system.
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The document is intended for the following wide-ranging readership:
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Policy makers at all levels of healthcare, particularly those concerned with drug
policy
Staff and consultants in CDSCO
Healthcare practitioners including clinicians, dentists, pharmacists, nurses and other
healthcare professionals
Pharmaceutical industry and scientists
Professional staff at NCC
Representatives of Adverse Drug Reaction Monitoring Centre
Medical and scientific journals
Health epidemiologists
Health economists
National Health Programs under MoHFW, Government of India
Professional staff at poison and drug information centres
Health administrators
Consumer groups, civil societies and patient support groups
Institutes of medical, dental, pharmacy and nursing
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Chapter 1: Pharmacovigilance Programme of India
1.0 Background
The Pharmacovigilance Programme of India was initiated by the Government of India on 14th
July 2010in AIIMS, New Delhi as the NCC for monitoring ADRs in the country for safeguarding public health. The NCC was shifted from AIIMS, New Delhi to IPC, Ghaziabad on
15th April 2011.
1.1 Overview
Before registration and marketing of medicine in the country, its safety and efficacy
experience is based primarily on the use of the medicine in clinical trials. These trials mainly
detect common adverse reactions. Some important reactions, such as those, which take a long
time to develop, or those, which occur rarely, may not be detected in clinical trials. In
addition, the controlled conditions under which medicines are used in clinical trials do not
necessarily reflect the way they will be used in practice. For a medicine to be considered
safe, its expected benefits should be greater than any associated risks of harmful reactions. So
in order to gain a comprehensive safety profile of medicine, a continuous post-marketing
monitoring system is essential. PvPI is to collate the data and use the inferences to
recommend regulatory interventions, besides communicating risks to healthcare professionals
and the public.
The robust database will play a vital role in analysing and detecting new signals and updating
the status of existing information on drug profile. The larger is the data for any drug, the
higher will be the likelihood of saying with confidence that the conclusions or inferences
being drawn from that data are meaningful and significant. The Medical Colleges and
hospitals are the corner stone of the PvPI. They act as AMCs which are responsible for
collecting the individual case safety reports and performing the follow up with the patient to
check completeness of the reports as per SOPs. The ICSRs data is then uploaded in the
VigiBase by using VigiFlow software which is sent to NCC. The quality assessment will be
performed at NCC and the data is further sent to WHO-UMC which maintains the global
drug safety database.
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1.2 Mission
Safeguard the health of the Indian population by ensuring that the benefits of use of medicine
outweigh the risks associated with its use.
1.3 Vision
To improve patient safety and welfare in Indian population by monitoring drug safety and
thereby reducing the risk associated with use of medicines.
1.4 Objectives
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To create a nation-wide system for patient safety reporting
To identify and analyse new signal from the reported cases
To analyse the benefit - risk ratio of marketed medications
To generate evidence based information on safety of medicines
To support regulatory agencies in the decision-making process on use of medications
To communicate the safety information on use of medicines to various stakeholders to
minimise the risk
To emerge as a national centre of excellence for pharmacovigilance activities
To collaborate with other national centres for the exchange of information and data
management
To provide training and consultancy support to other national pharmacovigilance
centres across globe
1.4.1 Short term goals
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To develop and implement pharmacovigilance system in India
To enrol, initially, all MCI approved medical colleges in the program covering north,
south, east and west of India
To encourage healthcare professionals in reporting of adverse reaction to drugs,
vaccines, medical devices and biological products
Collection of case reports and data
1.4.2 Long term goals
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To expand the pharmacovigilance programme to all hospitals (govt. & private) and
centres of public health programs located across India
To develop and implement electronic reporting system (e-reporting)
To develop reporting culture amongst healthcare professionals
To make ADR reporting mandatory for healthcare professionals
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1.5 Organogram under Pharmacovigilance Programme of India
1.5.1 Organogram of NCC
Advisor
Secretary-CumScientific Director,
IPC
Senior Scientific Officer
Director, National
Institute of
Biologicals
Finance & Account Officer
Scientific Assistant
Technical Associate
1.5.2 Committees under NCC
The following committees and panels are constituted by MoHFW, Government of India to
give proper direction for efficient functioning of the programme.
Steering Committee
PvPI is administered and monitored by Steering Committee to supervise and give proper
direction to the programme.
PvPI Working Group
It is constituted to approve major technical issues related to establishment, implementation of
programme and giving technical inputs to CDSCO for regulatory intervention of medicine.
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Quality Review Panel
It is constituted to review quality, causality assessment and completeness of ICSRs. The
panel also makes recommendations to PvPI working group after data analysis and will devise
formats and guidance documents for follow up actions after implementation of
recommendations.
Signal Review Panel
It is constituted of experienced scientists and clinical experts affiliated to government and
non-government academic institutions, hospitals and pharmaceutical industries to collate and
analyze information from ICSRs submitted to NCC. This panel assesses the results of the
regular computerized screening of ICSRs in NCC database for the occurrence of signals of
possible importance of public health, drug regulation and science. It also defines biostatical
methods to be followed for analysis and creates standardized post analytical reports that will
help in understanding the information that is derived from ADRs. It is also responsible to
decide on actionable indicators.
Core Training Panel
The Core Training Panel of PvPI identifies trainers and zone wise training centres for
imparting training under pharmacovigilance training programme. Core training panel
interacts with international agencies for participation and implementation of training
programmes related to pharmacovigilance. It organizes training and projects budgetary
requirements. Training modules and training schedules are also develop by this panel.
1.6
PvPI - Programme Communication
Effective communication channels are the key to successful functioning of PvPI. The
following chart depicts the movement of information between the key stakeholders and
ensures the continuous transfer of data, information, and knowledge.
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PvPI - Programme Communication
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Chapter 2: Responsibilities of Stakeholders under
PvPI
2.0 Roles and Responsibilities of Personnel at AMC
Each AMC under PvPI is assigned with a coordinator and a technical associate responsible
for its functioning. Their roles and responsibilities are:
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The designated coordinator is responsible for the proper functioning of respective
AMC. In absence of the coordinator, the designed deputy coordinator is responsible
for the smooth functioning of the centre.
Other important responsibilities of coordinator checking completeness of a valid case,
causality assessment and scrutinizing the ADR reports as per SOPs.
The technical associate is responsible for collecting and follows up ICSRs. All the
scrutinized and signed ADR reports should be entered in VigiFlow by TA. Every
report has to be sent for the central assessment at NCC.
The centre coordinator is responsible for sending the monthly reports of their AMC to
NCC.
The centre coordinator is also responsible for sensitization of the physicians/healthcare
professionals/medical students/patient of the catchment hospital for spontaneous ADR
reporting by various modes (lectures on ADR reporting, emails, telephone, pamphlets
& newsletters).
Feedbacks to all healthcare professionals involved in reporting are to be sent by the
AMC coordinator.
2.1 Roles and Responsibilities of Personnel at NCC
NCC is responsible for:
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Preparing standard operating procedures, guidance documents &training manuals.
Enrolment of new AMC.
Reviewing and analyzing ICSRs received from AMCs and commit them to WHOUMC.
Organising Continuous Medical Education on pharmacovigilance at various zones.
Conducting periodic training and workshops for all enrolled AMCs.
Publishing the newsletter (PvPI Newsletter) on timely basis.
Reporting all concerned issues to CDSCO Headquarters.
Providing procurement, financial and administrative support to all AMCs enrolled
under PvPI.
Collaborating with WHO-UMC, Sweden.
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2.2 Roles and Responsibilities of Personnel at Zonal/Sub-zonal CDSCO
office
The Zonal/Sub-zonal is responsible for:
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Reporting all drug related issues to the CDSCO headquarter.
Providing administrative and logistic supports to the AMC at their zone.
Auditing/inspecting AMC in their respective zonal and submitting the inspection
report to CDSCO HQ.
2.3 Roles and Responsibilities of Personnel at CDSCO HQ
The CDSCO HQ is responsible for:
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Taking appropriate regulatory decision and actions on the basis of recommendations
made by NCC.
Propagating medicine safety related decisions to stakeholders.
Providing administrative support to run PVPI.
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Chapter 3: Reporting of Adverse Drug Reactions
Monitoring of ADRs in a pharmacovigilance involves both active and passive surveillance
system. Passive surveillance means that no active measures are taken to look for adverse
effects other than the encouragement of health professionals and others to report safety
concerns. Reporting is entirely dependent on the initiative and motivation of the potential
reporters. Spontaneous or voluntary reporting is a type of passive surveillance. Active
surveillance, in contrast to passive surveillance, seeks to ascertain completely the number of
adverse events via a continuous pre-organised process. An example of active surveillance is
the follow-up of patients treated with a particular drug through a risk management program.
3.0 Spontaneous Reporting
As per WHO definition, a spontaneous report is an unsolicited communication by healthcare
professionals or consumers, pharmaceutical company to regulatory authority that describes
one or more suspected adverse drug reactions in a patient given one or more medicinal
products. Globally spontaneous reporting is adopted as the most common method of passive
surveillance since it is easiest to establish and the convenient to run. In spontaneous
reporting, reporting rates are generally very low and subject to bias and there is no database
of all users or information on overall drug utilization. These problems prevent the accurate
assessment of risk, risk factors or comparisons between drugs. Underreporting is also a
problem of spontaneous reporting systems for suspected adverse drug reactions. Underreporting may delay signal detection and cause underestimation of a serious problem.
Nevertheless spontaneous reporting has played a major role in the identification of safety
signals throughout the marketed lifetime of medicines in general. PvPI is following
spontaneous reporting system to collect data on drug safety.
3.1 Reporting Form
The NCC has designed a Suspected Adverse Drug Reaction Reporting Form to record
adverse reactions related to drugs. Separate forms are available to record adverse reactions
associated with transfusion of blood and blood products and Adverse Event Following
Immunization. A report that contains information describing a suspected adverse drug
reaction related to the administration of one or more medicinal products to an individual
patient is termed as individual case safety report. An ICSR must contain information on the
following items:
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A. Patient Information
1. Patient initials: A reporter should only write the initials of a patient instead of full
name. For e.g.: Madhu Gupta should be written as MG
2. Age at time of event or date of birth: A reporter must report either the date of birth or
age of the patient at the time event or reaction occurred
3. Sex: A reporter must mention the gender of the patient.
4. Weight: The weight of the patient should be in kilograms
B. Suspected Adverse Reaction
5. Date of reaction started: A reporter must report the date on which the reaction first
observed.
6. Date of recovery: If the reaction recovered, the date on which the reaction recovered
should be report.
7. Describe reaction: A reporter must describe the event in terms of nature, localization
etc. For e.g.: patient developed erythematous maculopapular rash over upper and
lower limp.
C. Suspected Medications
8. The details of suspected medication(s) such as drug name (brand or generic name),
manufacturer, batch no/lot no, expiry date, dose used, route used, frequency, dates of
therapy started and stopped, and indication of use must be provided by the reporter.
9. De-challenge details: A reporter must report the status on de-challenge as:
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‘Yes’- if reaction abated after de-challenge
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‘Reduced dose’- If dose at which the reaction occurred is reduced
Note: Also mention the reduced dose
‘No’- if reaction does not abated after de-challenge
‘Unknown’- if information on de-challenge is not confirmed
‘Not Applicable’ or ‘NA’- if de-challenge is not applicable as in case of
vaccines, anaesthesia or where single dose is given
10. Re-challenge details: A reporter must report the status on re-challenge as:
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‘Yes’- if reaction reappeared after re-challenge
‘No’- if reaction does not reappeared after re-challenge
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‘Unknown’- if information on re-challenge is not confirmed
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‘Re-introduced dose’- If the reduced dose is increased to dose at which adverse
‘Not Applicable’ or ‘NA’- if re-challenge is not applicable as in case of
injections.
event occurred
11. Concomitant drugs: A reporter should include all the details of concomitant drugs
including self-medication, OTC medication, herbal remedies with therapy dates
12. Relevant tests/ laboratory data: The reporter must report any laboratory data (if
available) relevant to the event occurred.
13. Other relevant history: A reporter must mention any relevant history persistent to
patient including pre-existing medical conditions (e.g. allergies, pregnancy, smoking,
alcohol use, hepatic/renal dysfunction).
14. Seriousness of the reaction: If any event is serious in nature, a reporter must tick the
appropriate reason for seriousness as:
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‘Death’- if the patient died due to adverse event
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‘Life-threatening’- if patient was at substantial risk of dying at the time of the
adverse event
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‘Hospitalisation/prolonged’- if the adverse event cause hospitalisation or
increased the hospital stay of the patient
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‘Disability’- if adverse event resulted in a substantial disruption of a person's
ability to conduct normal life functions
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‘Congenital anomaly’- if exposure of drug prior to conception or during
pregnancy may have resulted in an adverse outcome in the child.
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‘Required intervention to prevent permanent impairment/damage’- if
medical or surgical intervention was necessary to preclude permanent impairment
of a body function, or prevent permanent damage to a body structure
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‘Other’ -when the event does not fit the other outcomes, but the event may put
the patient at risk and may require medical or surgical intervention to prevent one
of the other outcomes. Examples include serious blood dyscrasias (blood
disorders) or seizures/convulsions that do not result in hospitalization,
development of drug dependence or drug abuse
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15. Outcomes: The reporter must tick the outcome of the event as:
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‘Fatal’- if the patient dies due to adverse event
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‘Continuing’- if the patient is continuing with the event occurred
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‘Recovering’- if the patient is recovering from the existing event occurred
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‘Recovered’- if the patient is recovered from the event occurred
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‘Unknown’- if the outcome is not known
D. Reporter
16. Name and Professional address: A reporter must mention his/her name and
professional address on the form. The identity of the reporter will be maintained
confidential
17. Causality assessment: The reporter (if trained) must perform the causality assessment.
18. Date of report: A reporter must mention the date on which he/she reported the adverse
event.
For quality reporting of ICSRs all the above mentioned fields are essential. In case of
incomplete information, the reporter must take care that at least mandatory fields are present.
Following are the mandatory fields for a valid case report:
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Patient information: initials, age at onset of reaction, gender.
Suspected adverse reaction: A reaction term(s), date of onset of reaction
Suspected medication: Drug(s) name, dose, date of therapy started, indication of use,
seriousness, outcome, de-challenge and re-challenge details
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Reporter: Name and address, causality assessment, date of report
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3.2 Who can Report?
Under PvPI healthcare professionals (clinician, dentist pharmacist nurses and others) can
report suspected adverse drug reaction. Pharmaceutical companies can also send ICSRs
specific for their product to NCC.
3.3 What to Report?
In order to foster the habit of reporting PvPI encourages reporting of all types of suspected
ADRs- irrespective of whether they are known or unknown, serious and non-serious, frequent
or rare. Although pharmacovigilance is primarily concerned with pharmaceutical medicines,
adverse reactions associated with drugs used in traditional medicine (e.g. herbal remedies)
should also be considered. Special fields of interest are drug use in pregnancy, lactation,
paediatric and geriatric. In addition, the reporting of lack of efficacy and suspected
pharmaceutical defects is recommended, especially when there is the possibility of
manufacturing problems, counterfeit pharmaceuticals or of the development of resistance e.g.
antibiotics.
3.4 Whom to Report?
Use the ‘Suspected Adverse Drug Reaction Reporting Form’ which is available on the
official website of IPC (www.ipc.gov.in) as well as CDSCO (www.cdsco.nic.in) to report any
ADR. A reporter who is not a part of AMC can submit the ICSR to the nearest AMC or
directly to the NCC. A reporter can also mail the ICSR at [email protected] or
[email protected]
Contact details for AMCs under PvPI are included in Annexure I.
3.5 Establishment of an AMC
A ‘letter of Intent’ is required to submit by the Heads of the Institutions to participate in this
nationwide programme to monitor drug safety. After examining the suitability, the concerned
centre may be inducted as AMC under PvPI. Subsequently NCC communicates the AMC
details to WHO-Uppsala Monitoring Centre (UMC), Sweden to obtain VigiFlow (WHOUMC owned online software) login details to upload ADRs.
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3.5.1 Data Flow
Once the Medical institute enrolled as AMC, the AMC starts reporting ADRs to NCC.
Following chart explains the flow of data at regional, national and international level.
Following chart explains the flow of data at regional, national and international level.
3.6 Assessment of Individual Case Safety Reports
The quality of the ICSR will be assessed for completeness of information and it will be
reviewed by:
1. Quality of documentation: e.g. completeness and integrity of data, quality of diagnosis,
follow-up.
2. Coding: Drug names should be registered in a systematic way, for example by using the
WHO Drug Dictionary (which is based on the ATC classification). For the coding of the
adverse events the WHO Adverse Reaction Terminology (WHOART) and internationally
recognised terminology (e.g. MedDRA) should be used.
3. Relevance with regard to the detection of new reactions, drug regulation, or scientific or
educational value. The following questions especially may be asked:
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New drug - a new drug shall continue to be considered as new drug for a period of
four years from the date of its first approval or its inclusion in IP, whichever is
earlier.
Unknown reaction- Not included in the approved Summary of Product
Characteristics
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Serious reaction- Results into either death, life-threatening condition,
hospitalisation or prolonged hospitalisation, disability, congenital anomaly,
required intervention to prevent permanent impairment/damage or any other
medically important condition
4. Identification of duplicate reports: Certain characteristics of a case (sex, age or date of
birth, dates of drug exposure, etc.) may be used to identify duplicate reporting.
5. Causality assessment: With few exceptions, case reports describe suspected adverse drug
reactions. The likelihood of a causal relationship between drug exposure and adverse
events must be validated.
3.7 Utilization of the Data
Data collected in pharmacovigilance can be used in a variety of ways.
1. Signal generation and strengthening: A major aim of pharmacovigilance is the early
detection of signals with regard to possible adverse reactions. A signal may be
strengthened by further analysis can help the regulatory system in performing regulatory
activities.
2. Drug regulation: After approval of a medicinal product, all available domestic and
international safety information is continuously monitored by the drug regulatory
authority and MAH. The PvPI data can be useful in resolving the problems by adaptation
of the approved product information (inclusion of new adverse effects and warnings).
3. Education: The information from PvPI data is useful in updating the knowledge of
healthcare
professionals
during
continuous
medical
education
programme
on
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3.8 Reporting Requirements in Special Population
3.8.1 Pregnancy and Breastfeeding
Pregnancy
The clinical trial program of a medicinal product under development rarely includes pregnant
women, unless the product is intended specifically for use during pregnancy. All pregnant
women coming for routine pre-natal check-ups at various categories of health system must be
monitored for any suspected ADR by the healthcare professional. They must be followed-up
to collect information on the outcome of the pregnancy and development of the child after
birth. At present NCC database contains a limited number of ICSRs related to parent-child
case. Intensive monitoring is required to draw any conclusion to upgrade/downgrade
pregnancy category of drugs use during pregnancy.
Breastfeeding
All lactating mother exposed to medicinal product should be monitored to collect information
on outcome of lactation on neonates and infants.
3.8.2 Paediatric and Geriatrics
The collection of safety information in the paediatric and geriatric population is important as
ADRs can lead to significant morbidity and death among these populations. Immunisation is
one of the most common and widely used public health interventions in paediatric population.
On other hand geriatric population is at higher risk of developing ADRs due to factors like
polypharmacy and co-morbidities. The paediatric and geriatric population can be considered
to be more vulnerable to some adverse reactions. Therefore, data collected from this program
will provide a national database for drug safety information in this vulnerable population. To
ensure safe and effective medicines for children and elderly, efforts are needed at different
levels (governments, drug regulatory agencies, pharmaceutical industries, health care
professionals, and parents).NCC database contains ICSRs reported for paediatric population
and geriatric population but more number of case reports are required for monitoring drug
safety in these populations.
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3.8.3 Reporting in the Event of a Public Health Emergency
A public health emergency is a public health threat duly recognised either by the WHO or
MoHFW, Government of India. In the event of a public health emergency, regular reporting
requirements may be amended.
3.8.4 Reports of overdose, abuse, off-label use, misuse or OTC
Reporting of ADRs encountered with overdose, abuse, off-label use, misuse or occupational
exposure is not currently included in PvPI, however physician judgement shall be final.
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Chapter 4: Haemovigilance
4.0 Introduction
Haemovigilance is a process of data collection and analysis of transfusion -related adverse
reactions in order to investigate their causes and outcomes, and prevent their occurrence or
recurrence. Indian Pharmacopoeia Commission in collaboration with National Institute of
Biologicals has launched Haemovigilance across the country under PvPI with following
terms of references:
1. To track Adverse Reactions/ Events and incidence associated with Biologicals,
Blood transfusion and Blood product administration (Haemovigilance) as well as
tissue organ and cell therapy transplantation.
2. To help in identifying trends, recommend best practices and interventions required
to improve patient care and safety, while reducing overall cost of the healthcare
system.
Haemovigilance Programme was launched on 10th Dec 2012 as an integral part of PvPI. NIB
is the Coordinating Centre to collate & analyze data for Haemovigilance.
Further information on Haemovigilance is available on http://nib.gov.in/haemovigilance.
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4.1
Transfusion Reaction Reporting Form(TRRF)
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Chapter 5: Adverse Event following Immunization
5.0 Introduction
AEFI is defined as a medical event that takes place after immunization, causes concern and is
believed to be caused by immunization. The AEFI should be handled effectively in order to
maintain/restore public faith in immunization program. AEFI Surveillance System in India
has come a long way since its inception in 1986.
To ensure their safety and efficacy, vaccines are subjected to release a lot at Central Research
Institute, Kasauli before release for public use. AEFIs may occur due to the intrinsic property
of vaccines and constituents like stabilizers, adjuvant, antibiotics, diluents etc. added to the
vaccines or hypersensitivity of some individuals to vaccine component(s). Such incidents are
rare but may become apparent in terms of number when vaccinating a large cohort. AEFI
may also result from programmatic errors as a result of inappropriate storage, improper
handling, preparation and administration etc. of vaccines. AEFI surveillance and timely
management will build public confidence and prevent additional clustering of cases if they
occur due to a programmatic error.
AEFI surveillance monitors immunization safety, detects and responds to adverse events;
corrects unsafe immunization practices, reduces the negative impact of the event on health
and contributes to the quality of immunization activities. Operational Guidelines of AEFI
mainly relate to vaccines included in the National Immunization Program and issues of
vaccine manufacturing, safety & quality control of AEFI cases are handled by CDSCO
headed by DCGI. Intensive efforts are being made by MoHFW, Government of India to
strengthen surveillance and monitoring of AEFI in the country. In India, the safety of vaccine
is monitored by the division of AEFI, MoHFW, Government of India and PvPI.
AEFI cases submitted to PvPI are further coordinated with national level committee AEFI for
reporting & investigation. Subsequently AEFI committee will follow with local AEFI team to
completely furnish FIR/PIR/DIR to do the causality assessment.
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5.1 Adverse events following immunization- Reporting Form
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Chapter 6:Causality Assessment of Adverse Event
6.0 Definition
Causality Assessment is defined as the evaluation of the likelihood that a medicine was the
causative agent of an observed adverse reaction.
6.1 Why causality assessment?
An inherent problem in pharmacovigilance is that most case reports concern suspected
adverse drug reactions. Adverse reactions are rarely specific for the drug, diagnostic tests are
usually absent and a Re-challenge is rarely ethically justified. In practice few adverse
reactions are ‘certain’ or ‘unlikely’; most are somewhere in between these extremes, i.e.
‘Possible’ or ‘Probable’. In an attempt to solve this problem many systems have been
developed for a structured and harmonised assessment of causality but none of these systems,
have shown to produce a precise and reliable quantitative estimation of relationship.
Nevertheless, causality assessment has become a common routine procedure in
pharmacovigilance.
AMC is responsible for performing causality assessment of reports which shall be reviewed
at NCC. The PvPI follows WHO-UMC causality assessment scale for establishing the
relation between the suspected drug and suspected adverse drug event. The WHO-UMC scale
is used as a practical tool for the assessment of case reports. It is basically a combined
assessment taking into account the clinical-pharmacological aspects of the case history and
the quality of the documentation of the observation.
6.2 Advances and limitations of standardised case causality assessment
What causality assessment can do
What causality assessment cannot do
Decrease disagreement between assessors Give accurate quantitative measurement of
Relationship likelihood
Classify relationship likelihood
Distinguish valid from invalid cases
Mark individual case reports
Prove the connection between drug and event
Improvement of scientific evaluation;
Educational



Pharmacovigilance Programme of India
Quantify the contribution of a drug to the
Development of an adverse event
Change uncertainty into certainty
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6.3 WHO-UMC Causality Assessment Scale
Causality term
Certain
Assessment criteria





Probable/
Likely

Possible







Event or laboratory test abnormality, with plausible time
relationship to drug intake
Cannot be explained by disease or other drugs
Response to withdrawal plausible (pharmacologically,
pathologically)
Event definitive pharmacologically or phenomenological
(i.e. an objective and specific medical disorder or a
recognised pharmacological phenomenon)
Re-challenge satisfactory, if necessary
Event or laboratory test abnormality, with reasonable time
relationship to drug intake
Unlikely to be attributed to disease or other drugs
Response to withdrawal clinically reasonable
Re-challenge not required
Event or laboratory test abnormality, with reasonable time
relationship to drug intake
Could also be explained by disease or other drugs
Information on drug withdrawal may be lacking or unclear

Event or laboratory test abnormality, with a time to drug
intake that makes a relationship improbable (but not
impossible)
Disease or other drugs provide plausible explanations
Conditional/
Unclassified



Event or laboratory test abnormality
More data for proper assessment needed, or
Additional data under examination
Unassessable/
Unclassifiable


Report suggesting an adverse reaction
Cannot be judged because information is insufficient or
contradictory
Data cannot be supplemented or verified
Unlikely

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Chapter 7: Signal Detection and Evaluation
Signal detection and its clinical assessment is an important domain of pharmacovigilance.
The WHO has defined a Signal as “Reported information on a possible causal relationship
between an adverse event and a drug, the relationship being unknown or incompletely
documented previously.” It is worth mentioning that a signal does not imply causation but it
can only provide preliminary information about postulating a hypothesis and not for testing it.
Analysis of any pharmacovigilance database can be used for signal detection but it is
reviewed by clinicians and other experts to arrive at decision making.
Signal detection process in a spontaneous ADR database is based on different statistical
methodology - either the Bayesian or Frequentist statistical approach. Whichever method is
employed, basically it involves computation of measures of disproportionality i.e.
determination to what extent the number of observed cases differs from the number of
expected cases. All disproportionality algorithms despite having operational technique
variability actually calculate surrogate observed to expected ratios in which the reporting
experience of each reported drug-adverse event combination is compared to the background
reporting experience across all drugs and events in the database using an independence
model.
The WHO UMC uses the BCPNN – (Bayesian Confidence Propagation Neural Network)
while US FDA uses the MGPS- (Multi item Gamma Poisson Shrinker) methodologies. Other
disproportionality analyses methods are ROR (Reporting Odds Ratio), PRR (Proportional
Reporting Ratio) are employed by some national reporting centres (MHRA, UK) and drug
safety research units.
In the BCPNN methodology computation of the Information Component is based on prior
and posterior probabilities. As per the WHO-UMC, the IC measures the disproportionality in
the reporting of a drug-ADR pair in an ICSR database, relative to the reporting expected
based on the overall reporting of the drug and the ADR. Positive IC values indicate higher
reporting than expected. However, review of signals generated by using such tools must be
analysed by clinicians and drug safety experts before arriving at a conclusion.
Whichever method is used for signal detection, each has its advantages and disadvantages
and therefore is no single method which can be considered as the gold standard. The PVPI is
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currently analysing its own national database and a signal review panel will shortly formulate
its strategy for signal detection and its assessment.
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Chapter 8: PvPI and WHO-UMC Collaboration
IPC-NCC has free access to the databases provided by WHO-UMC which helps in achieving
the objectives of PvPI in a more efficient way.
8.0 VigiFlow
VigiFlow is a web-based ICSR management system that is specially designed for use by
national centres in the WHO Programme for International Drug Monitoring. VigiFlow is
based on and compliant with the ICH E2B standard and is a trademark of the UMC and
maintained by the UMC in Uppsala, Sweden. It offers a simple, fast and secure web-based
solution that improves all aspects of ADR reporting. ICSR data can be manually entered into
VigiFlow with support from the latest versions of terminologies such as the WHO-DD and
WHO-ART or MedDRA. Once a report is complete and committed the first version of the
ICSR is considered to be finalized. It is easy to retrieve reports to amend the contents or add
follow-up information. ICSRs will automatically be flagged for being copied to VigiBase, the
WHO Global ICSR database when they are committed.
8.1 VigiMed
VigiMed is a web-based forum for those working at national centres in the WHO Programme
to have easy access to safety concerns in other countries, to check regulatory status, and to
expedite the sharing of drug information. VigiMed is part of the UMC collaboration portal, a
web-based platform managed by the UMC.
8.2 VigiSearch
VigiSearch is a powerful search tool that provides access to all case reports in VigiBase.
VigiSearch allows for report searching across multiple drugs and ADRs simultaneously, as
well as incorporating a range of filters. Drugs can be searched on a generic substance level or
a specific trade name. VigiSearch also supports browsing the ATC structure. The results can
be accessed on an overview level and viewed from a number of aspects (country, year,
reaction term) or at the level of individual case report. For members of the WHO Programme,
VigiSearch enables an international comparison of national spontaneous reporting data, as
well as giving access to ADR information on drugs that are not yet on the national market.
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8.3 VigiLyze
VigiLyze is a powerful search and analysis tool that provides access to more than 8 million
ICSRs in VigiBase, submitted from over 100 countries. VigiLyze includes data on
conventional medicines, traditional medicines as well as biological medicines including
vaccines. VigiLyze can be used to have a global, regional or national view of an ADR
identify or monitor international patient safety data. It can be useful to find supporting
evidence while assessing Indian case reports or to see how Indian data support global
pharmacovigilance. VigiLyze enables international comparison with national spontaneous
reporting data, as well as giving access to ADR information on drugs that are not yet on our
national market. Results from VigiLyze are instantly available as graphics as well as in
tabular format.
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VigiFlow- Demo Chart
User ID
Password
LOG-IN DETAIL
Change Password
Retrieve Unsaved Report
Language
Quick Start
Main Menu
Mandatory Fields: Report Title, Patient Initials, Patient Age, Gender, Reaction term, Onset Date of Reaction, Drug Name, date of therapy started, indication of use,
seriousness, outcome, de-challenge , re-challenge details, reporter details
1
2
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4
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5
6
7
THE CAUSALITY ASSESSMENT
SAVE REPORT
SEND REPORT TO NCC
COMMIT REPORT
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Chapter 9: Risk Management, Communication and
Publications
9.0 Risk Management
Risk management is the identification, assessment, and prioritization of risks followed by
coordinated and economical application of resources to minimize, monitor, and control the
probability and impact of unfortunate events. It is the discipline within pharmacovigilance
that is responsible for signal detection and the monitoring of the risk-benefit profile of drugs.
At the time of marketing authorisation, the benefit-risk balance is judged to be positive for
the target population. A medicinal product is associated with multiple risks and individual
risks will vary in terms of severity, effect on individual patients and public health impact.
However, at the time when an initial authorisation is sought all the risks (actual or potential)
have not been identified and many of the risks associated with the use of a medicinal product
will only be discovered and characterised during post-authorisation.
Risk management has three stages which are inter-related as mentioned below:
1. Characterisation of the safety profile of the medicinal product including what is
known and not known.
2. Planning of pharmacovigilance activities is to characterise and identify new risks and
increase the knowledge in general about the safety profile of the medicinal product.
3. Planning and implementation of risk minimisation, mitigation and assessment of the
effectiveness of these activities.
Risk management is a global activity. However the benefits and risk of a medicinal product
may also vary between regions as they differ in disease prevalence, severity, population
genetics (South Indian, North Indian, East Indian and West Indian). The overall aim of risk
management is to ensure that the benefits of a particular medicinal product exceed the risks
by the greatest achievable margin for the individual patient and for the target population as a
whole.
9.1 Communication
Communicating safety information to patients and healthcare professionals is a public health
responsibility and is essential for achieving the objectives of pharmacovigilance in terms of
promoting the rational, safe and effective use of medicine, preventing harm from adverse
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reactions and contributing to the protection of public health. Communication in PvPI
improves patient care, understanding, promotes transparency and accountability. All the
communications with WHO-UMC will be managed by NCC. All the issues associated with
drug safety are reported to CDSCO which will further take appropriate regulatory decision
and action on the basis of recommendation of NCC. The objective of communication in PvPI
aims to provide evidence based information on the safe and effective use of medicine and
regulatory status of medicines in India as well as globally. For this PvPI is using different
modes of communications as follow:
Press communication
It includes press release and press briefings which are primarily intended for journalists. The
Secretary-Cum-Scientific Director, IPC is the only designated authority to correspond with
media, related to all activities and issues of PvPI.
Website
A website is a key tool for the stakeholders including patients and health professionals. NCC
and CSDCO shall ensure that all important safety information should be published on the
websites under their control.
Newsletter
To communicate the findings and regulatory status of medicine in India as well as globally to
the stakeholders, IPC-NCC publishes newsletter i.e. “PvPI Newsletter” three issues in a year.
This newsletter is for everyone concerned with the issues of pharmacovigilance which
provides practical information and advice on drug safety and information about emerging
safety issues. The newsletter can also be downloaded from IPC website www.ipc.gov.in
under Pharmacovigilance Program of India.
9.2 Publications
IPC publishes Indian Pharmacopoeia, a book of standards for drugs in India as per Drugs and
Cosmetics Act, 1940 (the act) and Rules 1945. Also IPC publishes National Formulary of
India which is a guidance document for rational use of medicines.
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Chapter 10: Audit of PvPI
To ensure the PvPI operates effectively and achieves its objectives, the center will establish
key indicators to measure the efficiency of (i) process (ii) outcome and (iii) impact of
the PvPI.
The following indicators will be measured:
A. Personnel’s details:
1. Personnel prior education and GVP experience.
2. Whether GVP training provided by the Zone/NCC
3. Do personnel know the job descriptions/responsibilities?
B. Administrative Responsibility:
1. Whether infrastructure is sufficient for PV?
2. Whether sufficient working place?
3. Whether logistic support provided by NCC such as Computer system, internet connection
are work properly?
4. Storage of hard copies as well as soft copies of documents.
5. Whether co-operation by other dept. to PV section?
C. Documents Review:
1. Verify version number and effective date of SOPs provided to NCC with AMC’s SOPs.
2. Verify Training Records/Certificates.
3. Randomly verify the data of source documents with entreated ICSRs.
D. Quality Assurance:
1. Does the source document mentions Essential Required Item such as patient information/
division/ reaction with date/ suspected drug with date/ outcome and sender information?
2. Determine whether data entry by TA in VigiFlow is same with source documents.
3. Whether all ADRs were reported in Suspected ADR Reporting Form.
4. Verify the timeline for reporting the SAE to NCC and CDSCO.
E. Data collection and its security:
1. Use of electronic data capture or data transcription from Suspected ADR Reporting into an
electronic record (VigiFlow).
2. Record retention.
3. Data security in case of disasters, e.g., power failure.
4. Contingency plans and backup files.
5. Determine whether personnel has Access methods e.g., User ID/password for the security
of electronic data.
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F. Competence of Technical Associate:
1.
2.
3.
4.
He/She is conversant with the drug for which he/she is sending the report?
Is he/she conversant with the Rechallenge and Dechallenge process?
Is this a side effect or ADR?
Any SAE reported from the centre? How quickly it was forwarded.
G. Authenticity of Data:
1. Mechanism of identifying the patient from the registration number of the case report –
random check should be done by the inspecting team
2. How many times TA visits various wards.
3. How quickly he/she sends the report to NCC.
4. Is he/she taking interest in reporting drugs of current interest i.e. from CVS, Psychiatry,
Oncology and Diabetes?
5. Interaction with coordinator – frequency and documentation for the same.
H. Core Structural Indicators:
1.
2.
3.
4.
5.
6.
7.
8.
Does the AMC have standard accommodation?
Whether NCC has given acceptance letter?
A regular financial provision for the AMC?
Human resources to carry out its functions properly?
A standard ADR reporting form?
A process in place for collection, recording and entering of ADRs in VigiFlow?
Newsletters/NFI/Information bulletin/website for PV information dissemination?
A PV advisory committee or expert committee in the setting?
I. Core Process Indicators:
1.
2.
3.
4.
5.
6.
Total number of ADR reports reported to NCC last calendar year.
Percentage of total annual reports acknowledged by NCC.
Percentage of reports subjected to causality assessment in the year.
Percentage of reports on therapeutic ineffectiveness.
Percentage of reports on medication error.
Number of active surveillance activities initiated, on-going or completed, the last 5 years.
J. Core Outcome/Impact Indicators:
1.
2.
3.
4.
5.
6.
Number of medicine related hospital admissions/1000 admissions.
Number of medicine related deaths/1000 persons served by hospital.
Number of medicine related deaths/100000 in the population.
Average cost of treatment of medicine-related illness.
Average duration of extension of medicine-related hospital stay.
Average cost of medicine related hospitalization.
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Annexure 1: Contact details of AMC reporting under PvPI
LIST OF 90 ADR MONITORING CENTRES UNDER PHARMACOVIGILANCE PROGRAMME OF INDIA (PvPI)
S. No
1.
2.
3.
4.
5.
State
Centre Name
Andhra
Pradesh
Andhra Medical College King George Hospital
(KGH), Visakhapatnam
Guntur Medical College, Guntur
Kakatiya Medical College, Warangal
Nizam Institute of Medical Sciences, Hyderabad
Department of Pharmacology, Govt. Medical
College, Guwahati
Silchar Medical College & Hospital, Ghungoor,
Silchar
Indira Gandhi Institute of Medical Sciences,
Shekhpura, Patna
Goa Medical College & Hospital, Bambolim
Assam
6.
7.
Bihar
8.
Goa
9.
Gujarat
10.
SMT NHL Municipal Medical
Ahmadabad
BJ Medical College, Ahmadabad
Coordinator name
Dr. J. Sudha
[email protected]
Dr. Zaheda Bano
Dr. Raju Devde
Dr. Shobha Udutha
Dr. Mangala Lahkar
[email protected]
[email protected]
[email protected]
[email protected]
Dr.Pinaki Chakravarty
[email protected]
Dr. Harihar Dikshit
[email protected]
Dr. Padmanabh V. Rataboli
[email protected]
m
[email protected]
College, Dr. Varsha J Patel
Dr. R.K. Dikshit
13.
Government Medical College, Bhavnagar
Dr. C B Tripathi
Surat Municipal Institute of Medical Education & Dr. Sachendra Ku. Srivastava
Research, Surat
M.P. Shah Medical College, Jamnagar
Dr. Hiren R. Trivedi
14.
PDU Medical College, Rajkot
11.
12.
Pharmacovigilance Programme of India
Email
Dr. S. T. Hotchandani
[email protected]/ramdiksh
[email protected]
[email protected]
[email protected]/drarvi
[email protected]
[email protected]/
[email protected]
[email protected]
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Medanta-The Medicity Sector-38, Gurgaon
PanditBhagwatDayal Sharma, Post Graduate
Institute of Medical Sciences, Rohtak
Dr. Himanshu Baweja
Dr MC Gupta
[email protected]
[email protected]/
[email protected]
Dr. Vishal Tandon
Dr. ZA Wafai
[email protected]
[email protected]
Dr. Janardan Sharma
[email protected]
Dr. C. R. Jayanthi
[email protected]
21.
22.
23.
24.
Govt. Medical College, Bakshi Nagar, Jammu
Sher-i-Kashmir Institute of Medical Sciences,
Srinagar
Rajendra Institute of Medical Sciences (RIMS),
Ranchi
Bangalore Medical College and Research
Institute, Bengaluru
Belgaum Institute of Medical Sciences, Belgaum
Bidar Institute of Medical Sciences, Bidar
JSS Medical College Hospital, Mysore
Karnataka Institute OF Medical Sciences, Hubli
Dr. Basavaraj Kotintot
Dr. B.O. Hanumanthappa
Dr. Parthasarathi G
Dr. Janaki. R. Torvi
25.
Kasturba medical College, Manipal
Dr. K. L. Bairy
26.
Mandya Institute of Medical Sciences (MIMS), Dr. Nagabushan
District Hospital Campus, Mandya
SDS Tuberculosis Research Centre & Rajiv Dr. Shashidhar Buggi
Gandhi Institute of Chest Disease, Bengaluru
[email protected]
[email protected]
[email protected]
[email protected]/kims_hubl
[email protected]
[email protected]/klbairy@yah
oo.com
[email protected]
15.
16.
Haryana
17.
18.
J&K
19.
Jharkhand
20.
Karnataka
27.
28.
29.
St. John’s Medical College, Bengaluru
Vijaynagar Institute of Medical Sciences, Bellary
Dr. Padmini Devi
Dr. C. Lakshmi Narayana
30.
Vydehi Institute of Medical Sciences
Research Centre, Bengaluru
Govt. Medical College Kozhikode
Dr. P.V. Narayanan
31.
32.
Kerala
Govt. Medical College, Kottayam
Pharmacovigilance Programme of India
and Dr. Pratibha Nadig
Dr. Kala Kesavan
[email protected]/direct
[email protected]
[email protected]
[email protected]/blydrkln
@gmail.com
[email protected]
[email protected]
.in
[email protected]
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33.
34.
35.
36.
37.
Madhya
Pradesh
Maharashtra
38.
39.
40.
41.
42.
43.
44.
45.
46.
47.
48.
49.
50.
Odisha
Pushpagiri Institute of Medical Sciences and
Research centre, Pushpagiri Medical College
Hospital, Tiruvalla
Gandhi Medical College, Bhopal
RD Gardi Medical College, Ujjain
SAIMS Medical College, Indore
BJ Medical College & Sassoon General Hospital,
Pune
Government Medical College & Hospital, Nagpur
Dr. Santosh Pillai
[email protected]
Dr. Arun Srivastav
Dr. S.P. Dhaneria
Dr. Chhaya Goyal
Dr. Pradeep Deshpande
Grant medical college & Sir JJ Group of Hospital,
Mumbai
Indira Gandhi Government Medical College,
Nagpur
LokmanyaTilak municipal Medical College &
General Hospital, Mumbai
Mahatma Gandhi Institute of Medical Sciences,
Nagpur
MGM Medical College and Hospital, Kalamboli,
Navi Mumbai
Pd. Dr. D.Y. Patil Medical College, Pimpri, Pune
Seth GS Medical College & KEM Hospital, Parel,
Mumbai
Swami Ramanand Teerth Rural Govt Medical
College, Ambajogai
TN Medical College &Byl Nair Hospital, Mumbai
Central, Mumbai
VSS Medical College, Burla
M. K. C. G Medical College, Berhampur
SCB Medical College and Hospital, Cuttack
Dr. S. B. Patel
[email protected]
[email protected]
[email protected]
pradeepdeshpande.deshpande69@g
mail.com
[email protected]/gndakhle
@rediffmail.com
[email protected]/dr.sbpat
[email protected]
[email protected],/am1
[email protected]
[email protected]
Pharmacovigilance Programme of India
Dr. Ganesh N. Dakhle
Dr. Vandana Avinash Badar
Dr. Sudhir R. Pawar
Dr. Sushil Kumar Varma
Dr. Daniel Joseph
Dr. P.S. Worlikar
Dr. Urmila Thatte
[email protected]/varmasushil9
@gmail.com
[email protected]
Dr. V.M. Motghare
[email protected]
[email protected]/urmilathatt
[email protected]
[email protected]
Dr. Renuka Kulkarni-Munshi
[email protected]
Dr. Sabita Mohapatra
Dr. Bandana Rath
Dr. Srikanta Mohanty
[email protected]
[email protected]
[email protected]/adr.sc
[email protected]/
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51.
Punjab
52.
53.
54.
Rajasthan
55.
56.
57.
58.
59.
60.
61.
62.
63.
64.
65.
66.
67.
68.
69.
Christian Medical College and Hospital, Brown
Road, Ludhiana
Dayanand Medical College and Hospital,
Ludhiana
Govt. Medical College Patiala
Sardar Patel Medical College, Bikaner
Dr. Dinesh Kumar Badyal
[email protected]
[email protected]
Dr. Sandeep Kaushal
[email protected]
Dr. Anita Gupta
Dr. Kiran Barar
SMS Medical College, Jaipur
Dr. Mukul Mathur
Dr. Supratim Datta
[email protected]
[email protected]/kiran
[email protected]
[email protected]/co
[email protected]
[email protected]
Dr. Dr. J.V. peter
Dr. C. Ramachandra Bhat
Dr. R Nandini
Dr. S. Ramalingam
peterjohnvictor @yahoo.com.au
[email protected]
[email protected]
[email protected]
Dr. Jamuna Rani
[email protected]
Dr. Debasis Ray
Dr. T.N. Sharma
[email protected]
[email protected]
Dr. P.P. Gupta
[email protected]
Dr S.P. Singh
Dr. B.L. Pandey
[email protected]
[email protected]
Dr. Mohammad Nasiruddin
[email protected]
Dr.Sadhna Kaushik
Dr. Rakesh Chandra Chaurasia
[email protected]
[email protected]
Sikkim Manipal Institute of Medical Sciences,
Tadong, Gangtok
Tamil Nadu Christian Medical College, Vellore
Govt. Kilpauk Medical College, Chennai
Madras Medical College, Chennai
PSG Institute of Medical Sciences & Research,
Coimbatore
SRM Medical College Hospital & Research
Centre, kattankulathur, Chennai
Agartala Govt. Medical College, Agartala
Tripura
Tripura Medical College & Dr. BRAM Teaching
Hospitals, Hapania, Agartala
Uttar Pradesh B.R.D Medical College & Nehru Hospital,
Gorokhpur
GSVM Medical College, Swaroop Nagar, Kanpur
Institute of Medical Sciences Banaras Hindu
University, Varanasi
JN Medical College Aligarh Muslim University ,
Aligarh
M.L.B. Medical College, Jhansi
M.L.N Medical College, Allahabad
Sikkim
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70.
71.
72.
73.
Uttarakhand
74.
75.
West Bengal
76.
77.
78.
79.
80.
81.
82.
83.
84.
85.
86.
87.
88.
Chandigarh
Delhi
Santosh Medical University, Santosh Nagar,
Ghaziabad
U.P Rural Institute of Medical Sciences and
Research, Safai, Etwah
Govt Medical College, Haldwani
Himalayan Institute of Medical Sciences,
Dehradun
Veer Chandra Singh Garhwali Medical Science
and Research Institute, Srinagar, Garhwal
School of Tropical Medicine, Chittaranjan
Avenue, Kolkata
R.G. Kar Medical College, Kolkatta
Calcutta National Medical College, Kolkata
Institute of Postgraduate Medical Education &
Research, Kolkata
Burdwan Medical college, Burdwan
BankuraSammilani Medical College, Bankura
Dr. VC Chopra
[email protected]
Dr. Asha Pathak
[email protected]
Dr. Bhavana Srivastava
Dr. DC Dhasmana
[email protected]
[email protected]
Dr. Vijay Thawani
Dr. Santanu Tripathi
[email protected]
om/[email protected]
[email protected]
Dr. Anjan Adhikari
Dr. Syed Mohammad Naser
Dr. Suparna Chatterjee
[email protected]
[email protected]
[email protected]
Dr. Swati Bhattacharyya
Dr. Santanu Munshi
NilratanSircar Medical College, Kolkata
PGIMER, Chandigarh
All India Institute of Medical Sciences (AIIMS)
Prof. Nina Das
Dr. Bikash Medhi
Dr. Y.K. Gupta
Indraprastha Apollo Hospital
Lady Hardinge Medical College (LHMC)
University College of Medical Sciences, Dilshad
Garden
Vallabhbhai Patel Chest Institute (VPCI) University of Delhi
VMMC &Safdarjung Hospital
Dr. Lalit Kanodia
Dr. H.S. Rehan
Dr. S. K. Bhattacharya
[email protected]
[email protected]/
[email protected]
[email protected]
[email protected]
[email protected]/
[email protected]
[email protected]
[email protected]
[email protected]
Dr. A. Ray
[email protected]
Dr. C.D. Tripathi
[email protected]
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89.
90.
Puduchery
Indira Gandhi Medical College & Research Dr. G. Sivagnanam
Institute, Kadirkamam.
JIPMER, Pondicherry
Dr. C Adithan
Pharmacovigilance Programme of India
[email protected]/adigaisc
[email protected]
[email protected]
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Annexure
2:
Pharmacovigilance
Terminologies
used
in
Absolute risk
Risk in a population of exposed persons; the probability of an event affecting members of a
particular population (e.g. 1 in 1,000). Absolute risk can be measured over time (incidence)
or at a given time (prevalence).
Adverse event
Any untoward medical occurrence that may present during treatment with a pharmaceutical
product but which does not necessarily have a causal relationship with this treatment.
Adverse (drug) reaction (ADR)
A response which is noxious and unintended, and which occurs at doses normally used in
humans for the prophylaxis, diagnosis, or therapy of disease, or for the modification of
physiological function. (WHO, 1972).
An adverse drug reaction, contrary to an adverse event, is characterized by the suspicion of a
causal relationship between the drug and the occurrence, i.e. judged as being at least possibly
related to treatment by the reporting or a reviewing health professional.
Association
Events associated in time but not necessarily linked as cause and effect.
Attributable risk
Difference between the risk in an exposed population (absolute risk) and the risk in an
unexposed population (reference risk). Also referred to as excess risk.
Attributable risk is the result of an absolute comparison between outcome frequency
measurements, such as incidence.
Examples: If the exposed persons with a particular outcome are A, the exposed persons
without the outcome are B, the unexposed persons with the outcome are C and the unexposed
persons with the outcome are D, then the attributable risk is calculated as : [A / (A+B)] - [C /
(C+D)]. If, during the same time period, the incidence of rash in a population treated with
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medicine X is 20/1,000=0.02, and the incidence of rash in a population not treated with X is
5/2,000=0.0025, the attributable risk is (20/1,000) - (5/2,000) = 0.0175.
Benefit
An estimated gain for an individual or a population. See also Effectiveness/Risk.
Benefit - risk analysis
Examination of the favourable (beneficial) and unfavourable results of undertaking a specific
course of action. (While this phrase is still commonly used, the more logical pairings of
benefit-harm and effectiveness-risk are slowly replacing it).
Biological products
Medical products prepared from biological material of human, animal or microbiologic origin
(such as blood products, vaccines, insulin).
Causal relationship
A relationship between one phenomenon or event (A) and another (B) in which A precedes
and causes B. In pharmacovigilance; a medicine causing an adverse reaction.
Causality assessment
The evaluation of the likelihood that a medicine was the causative agent of an observed
adverse reaction. Causality assessment is usually made according established algorithms.
CIOMS
The Council for International Organizations of Medical Sciences (CIOMS) is a body set up
under World Health Organization and UNESCO. It has developed a series of guidelines on
pharmacovigilance, drawn up by a committee of volunteers from Industry, regulatory
authorities, WHO and others.
The main guidelines concern the international reporting form (CIOMS I); periodic safety
update reports (CIOMS II); core data sheets (CIOMS III); benefit-risk assessments (CIOMS
IV); practical issues in pharmacovigilance (CIOMS V); clinical trial safety data (CIOMS VI);
and development safety update reports (CIOMS VII).
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Clinical trial
A systematic study on pharmaceutical products in human subjects (including patients and
other volunteers) in order to discover or verify the effects of and/or identify any adverse
reaction to investigational products, and/or to study the absorption, distribution, metabolism
and excretion of the products with the objective of ascertaining their efficacy and safety.
Cohort Event Monitoring
Cohort Event Monitoring (CEM) is a prospective, observational study of events that occur
during the use of medicines, for intensified follow-up of selected medicinal products phase.
Patients are monitored from the time they begin treatment, and for a defined period of time.
See also Prescription Event Monitoring.
Common Epidemiology
In pharmacovigilance, an event with a frequency between 1 in 100 and 1 in 10.
Co-morbidities
Two or more coexisting medical conditions or disease processes that are additional to an
initial diagnosis.
Compliance
Faithful adherence by the patient to the prescriber's instructions.
Congenital Anomalies
Morphological, functional and/or biochemical developmental disturbance in the embryo or
foetus whether detected at birth or not. The term congenital anomaly is broad and includes
congenital abnormalities, foetopathies, genetic diseases with early onset, developmental
delay, etc.
Control group
The comparison group in drug-trials not being given the studied drug.
Critical terms
Some of the terms in WHO-ART are marked as "Critical Terms". These terms either refer to
or might be indicative of serious disease states, and warrant special attention, because of their
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possible association with the risk of serious illness which may lead to more decisive action
than reports on other terms.
Data-mining
At the UMC, the use of an automated tool, based on Bayesian logic, for the scanning of the
WHO database (VigiBase) in the process of detecting drug-adverse reaction associations: the
BCPNN. Knowledge-detection is the preferred term for the process.
De-challenge
The withdrawal of a drug from a patient; the point at which the continuity, reduction or
disappearance of adverse effects may be observed.
Disproportionality analysis
Screening of ICSR databases for reporting rates which are higher than expected. For drugADR pairs, common measures of disproportionality are the Proportional Reporting Ratio
(PRR), the Reporting Odds Ratio (ROR), The Information Component (IC), and the
Empirical Bayes Geometrical Mean (EBGM). There are also disproportionality measures for
drug-drug-ADR triplets, such as Omega (Ω).
Drug Abuse
It is a patterned use of a drug in which the user consumes the substance in amounts or with
methods neither approved nor supervised by medical professionals.
Effectiveness/risk
The balance between the rate of effectiveness of a medicine versus the risk of harm is a
quantitative assessment of the merit of a medicine used in routine clinical practice.
Comparative information between therapies is most useful. This is more useful than the
efficacy and hazard predictions from pre-marketing information that is limited and based on
selected subjects.
Efficacy
The ability of a drug to produce the intended effect as determined by scientific methods, for
example in pre-clinical research conditions (opposite of hazard).
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Epidemiology
The science concerned with the study of the factors determining and influencing the
frequency and distribution of disease, injury and other health-related events and their causes
in a defined human population for the purpose of establishing programs to prevent and
control their development and spread (Dorland's Illustrated Medical Dictionary).
Essential medicines
Essential medicines are those that satisfy the priority health care needs of the population.
They are selected with due regard to public health relevance, evidence on efficacy and safety,
and comparative cost-effectiveness.
EVMPD
The EudraVigilance Medicinal Product Dictionary (EVMPD) has been developed by the
European Medicines Agency in collaboration with the EudraVigilance Joint Implementation
Group. The main objective of the EVMPD is to assist the pharmacovigilance activities in the
European Economic Area.
EUDRAGENE
Eudragene is a European collaboration that established a collection of DNA samples as a
resource for studying genes which influence serious or adverse drug reactions (ADRs).
Identifying genes that influence susceptibility to adverse reactions will advance
understanding of the basis of adverse drug reactions and may also lead to the development of
tests that can predict individual susceptibility to adverse reactions.
Excipients
All materials included to make a pharmaceutical formulation (e.g. a tablet) except the active
drug substance(s).
Formulary
A listing of medicinal drugs with their uses, methods of administration, available dose forms,
side effects, etc., sometimes including their formulas and methods of preparation.
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Generic (multisource product)
The term "generic product" has somewhat different meanings in different jurisdictions.
Generic products may be marketed either under the non-proprietary approved name or under
a new brand (proprietary) name. They are usually intended to be interchangeable with the
innovator product, which is usually manufactured without a license from the innovator
company and marketed after the expiry of patent or other exclusivity rights.
Harm
The nature and extent of actual damage that could be caused by a drug. Not to be confused
with risk.
ICH
The International Conference on Harmonization of Technical Requirements for the
Registration of Pharmaceuticals.
ICD
International Classification of Diseases (ICD) is the standard diagnostic tool for
epidemiology, health management and clinical purposes.
Incidence
The extent or rate of occurrence, especially the number of new cases of a disease in a
population over a period of time.
Individual Case Safety Report
A report that contains information describing a suspected adverse drug reaction related to the
administration of one or more medicinal products to an individual patient.
MedDRA
MedDRA or Medical Dictionary for Regulatory Activities is a clinically-validated
international medical terminology used by regulatory authorities and the regulated
biopharmaceutical industry. The terminology is used through the entire regulatory process,
from pre-marketing to post-marketing, and for data entry, retrieval, evaluation, and
presentation.
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Medical error
"An unintended act (either of omission or commission) or one that does not achieve its
intended outcomes." Leape, Lucien. Error in Medicine. Journal of the American Medical
Association 272(23):1851-57 (Dec. 21, 1994).
Over the counter (OTC)
Medicines which are available for purchase without prescription.
Off-label-use
When the medicinal product is intentionally used for a medical purpose not in accordance
with the authorised product information.
Overdose
Administration of a quantity of a medicinal product given per administration or cumulatively,
which is above the maximum recommended dose according to the authorised product
information.
Pharmacoepidemiology
Study of the use and effects of drugs in large populations.
Pharmacology
Pharmacology is the science of drugs (Greek: Pharmacon-drug; logos-discourse in) . In a
broad sense, it deals with interaction of exogenously administered chemical molecules
(drugs) with living systems. It encompasses all aspects of knowledge about drugs, but most
importantly those that are relevant to effective and safe use for medicinal purposes.
Pharmacovigilance
The science and activities relating to the detection, assessment, understanding and prevention
of adverse effects or any other drug-related problem.
Phocomelia
Characteristic deformity caused by exposure to thalidomide in the womb, also very rarely
occurring spontaneously. Meaning: limbs like a seal.
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Placebo
An inactive substance (often called a sugar pill) given to a group being studied to compare
results with the effects of the active drug.
Polypharmacy
The concomitant use of more than one drug, sometimes prescribed by different practitioners.
Post-authorization safety study (PASS)
A pharmacoepidemiological study or a clinical trial carried out in accordance with the terms
of the Marketing Authorisation, with the aim of identifying or quantifying a safety hazard
relating to an authorized medicinal product.
Post-marketing
The stage when a drug is generally available on the market.
Predisposing factors
Any aspect of the patient’s history (other than the drug) which might explain reported adverse
events (for example, genetic factors, diet, alcohol consumption, disease history,
polypharmacy or use of herbal medicines).
Pre-marketing
The stage before a drug is available for prescription or sale to the public.
Prescription event monitoring (PEM)
System created to monitor adverse drug events in a population. Prescribers are requested to
report all events, regardless of whether they are suspected adverse events, for identified
patients receiving a specified drug. Also more accurately named "cohort-event monitoring".
Prescription only medicine (POM)
Medicinal product available to the public only on prescription.
Prophylaxis
Prevention or protection.
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PSUR
The Periodic Safety Update Report (PSUR) is a stand-alone document that allows a periodic
but comprehensive assessment of the worldwide safety data of a marketed drug or biological
product.
QPPV
Qualified Person responsible for Pharmacovigilance.
Rare
In pharmacovigilance an event with a probability between 1 in 10,000 and 1 in 1,000.
Rational drug use
An ideal of therapeutic practice in which drugs are prescribed and used in exact accordance
with the best understanding of their appropriateness for the indication and the particular
patient, and of their benefit, harm effectiveness and risk.
Re-challenge
The point at which a drug is again given to a patient after its previous withdrawal (see dechallenge).
Reference risk
Risk in a population of unexposed persons. Also called baseline risk. Reference risk can be
measured over time (incidence) or at a given time (prevalence). The unexposed population
refers to a reference population, as closely comparable to the exposed population as possible,
apart from the exposure.
Regulatory authority
The legal authority in any country with the responsibility of regulating all matters relating to
drugs.
Relative risk
Ratio of the risk in an exposed population (absolute risk) and the risk in an unexposed
population (reference risk). Relative risk is the result of a relative comparison between
outcome frequency measurements, e.g. incidences.
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Example: If the exposed persons with an outcome are A, the exposed persons without the
outcome are B, the unexposed persons with the outcome are C, and the unexposed persons
without the outcome are D, the relative risk is calculated as [A / (A+B)] / [C / (C+D)].
If the incidence of rash in a population treated with medicine X is 35/1,500=0.023, and the
incidence of rash in a population which is not treated with X, during the same time period, is
5/2,000=0.0025, the relative risk is (35/1,500) / (5/2,000) = 9.3.
Risk
The probability of harm being caused; the probability (chance, odds) of an occurrence.
SAEC
The International Serious Adverse Events Consortium (SAEC) is a non-profit consortium
formed in October 2007 between industry, academia, the Wellcome Trust, and the US Food
and Drug Administration to identify genetic variants associated with serious adverse events.
Serious Adverse Event or Reaction
A serious adverse event or reaction is any untoward medical occurrence that at any dose:






results in death
results in life-threatening condition
requires inpatient hospitalization or prolongation of existing hospitalization
results in persistent or significant disability/incapacity
causes congenital abnormality
requires any intervention to prevent the occurrence of any of the above
To ensure no confusion or misunderstanding of the difference between the terms "serious"
and "severe", the following note of clarification is provided:
The term "severe" is not synonymous with serious. In the English language, "severe" is used
to describe the intensity (severity) of a specific event (as in mild, moderate or severe); the
event itself, however, may be of relatively minor medical significance (such as severe
headache). Seriousness (not severity) which is based on patient/event outcome or action
criteria serves as guide for defining regulatory reporting obligations.
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Side effect
Any unintended effect of a pharmaceutical product occurring at normal dosage which is
related to the pharmacological properties of the drug.
Signal
Reported information on a possible causal relationship between an adverse event and a drug,
the relationship being unknown or incompletely documented previously. Usually more than a
single report is required to generate a signal, depending upon the seriousness of the event and
the quality of the information. The publication of a signal usually implies the need for some
kind of review or action.
Spontaneous reporting
System whereby case reports of adverse drug events are voluntarily submitted from health
professionals and pharmaceutical manufacturers to the national regulatory authority.
SUSAR (Suspected Unexpected Serious Adverse Drug Reaction)
A serious adverse drug reaction whose nature, severity or frequency is not identified
previously in the risk information provided to the clinical investigator’s brochure (CIB) or on
the drug label.
Summary of Product Characteristics
A regulatory document attached to the marketing authorization which forms the basis of the
product information made available to prescribers and patients.
Teratogen
Environmental factors which can cause congenital abnormalities.
Traditional Medicines
Traditional medicine is the sum total of the knowledge, skills, and practices based on the
theories, beliefs, and experiences indigenous to different cultures, whether explicable or not,
used in the maintenance of health as well as in the prevention, diagnosis, improvement or
treatment of physical and mental illness.
Uncommon
In pharmacovigilance an event with a frequency between 1 in 1.000 and 1 in 100.
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Unexpected adverse reaction
An adverse reaction, the nature or severity of which is not consistent with domestic labeling
or market authorization, or expected from characteristics of the drug.
VigiBase
The name of the WHO Global ICSR Database.
WHO-ART
Terminology for coding clinical information in relation to drug therapy. WHO-ART is
maintained by UMC.
WHO Drug Dictionary (WHO-DD)
The WHO Drug Dictionary is an international classification of drugs providing proprietary
and on-proprietary names of medicinal products used in different countries, together with all
active ingredients.
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Annexure 3: Organisations, societies, regulators &
useful websites
1. The Central Drugs Standard Control Organisation Headquarters
CDSCO is the national regulatory body for Indian pharmaceuticals and medical devices, and
serves parallel function to the European Medicines Agency of the European Union,
the PMDA of Japan and the Food and Drug Administration of the United States. Within the
CDSCO, the DCG (I) regulates pharmaceutical and medical devices. The DCGI is advised by
the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC). It
is divided into zonal offices which do pre-licensing and post-licensing inspections, postmarket surveillance, and recalls when needed.
Official website: www.cdsco.nic.in
2. Indian Pharmacopoeia Commission
IPC is an autonomous institution of the Ministry of Health and Family Welfare, Government
of India. IPC is created to set standards of drugs in the country. Its basic function is to update
regularly the standards of drugs commonly required for treatment of diseases prevailing in
this region. It publishes official documents for improving quality of medicines by way of
adding new and updating existing monographs in the form of IP. It further promotes rational
use of generic medicines by publishing NFI. IPC also acts as a NCC for PvPI, thereby
coordinating all the activities related to PV in India.
Official website: www.ipc.gov.in
3. WHO Collaborating Centre for International Drug Monitoring: The Uppsala
Monitoring Centre
The WHO is a specialized agency of the UN that is concerned with international public
health. The UMC is an independent foundation and a centre for international service and
scientific research.
The operational responsibility for the ADR monitoring programme rests with the WHO
Collaborating Centre for International Drug Monitoring, UMC, in Sweden. The system
started with 10 countries that had already established national systems for spontaneous
adverse reaction reporting and who agreed to contribute data. For an effective international
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system to become operative, a common reporting form was developed, agreed guidelines for
entering information formulated, common terminologies and classifications prepared and
compatible systems for transmitting, storing and retrieving and disseminating data were
created. The ADRs database in Uppsala currently contains over eight million reports of
suspected ADRs.
Official website: www.who-umc.org
4. WHO Country office for India
Envisioning better health for all Indians, Mr Ghulam Nabi Azad, Hon’ble Minister for Health
& Family Welfare, Government of India launched WHO’s new Country Cooperation Strategy
(CCS), 2012-17with India along with Dr Nata Menabde, WHO representative to India on 29
June 2012. The WHO Country Office for India is headquartered in Delhi with country-wide
presence. Its areas of work are enshrined in its new CCS, 2012-2017.The key aim of this pathbreaking strategy is to contribute to improving health and equity in India. It also provides the
blueprint for unleashing India’s role on the global health arena alongside the continued pursuit
of health improvement in the country. In this context, it distinguishes and addresses the
challenges to India’s potential globally as well as impediments in solving long-standing health
and health service delivery internally.
The WHO Country Office for India also coordinates pharmacovigilance training programmes
to the PV professionals, preparation and updating of PV toolkit and other regulatory
documents for PvPI.
Official website: www.whoindia.org
5. National Institute of Biologicals
National Institute of Biologicals is an autonomous institution under the MoHFW,
Government of India and is a premier scientific organization and a centre of excellence to
ensure quality of biological and vaccines in the country. The institute responsibly assures
and reviews the quality of number of biological products available through domestic
manufacturers or imports. The operations are carried out in the state of the art facility of the
institute and in close coordination with regulatory authorities.
Official website: www.nib.gov.in
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6. International Conference on Harmonization of Technical Requirements
for Registration of Pharmaceuticals for Human Use (ICH)
ICH is a project that brings together the regulatory authorities of Europe, Japan and the
United States and experts from the pharmaceutical industry in the three regions to discuss
scientific and technical aspects of pharmaceutical product registration.
Official website: www.ich.org
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Annexure
4:
Literature
resources
for
pharmacovigilance
Following literature resources can provides further information to NCC and AMCs under
PvPI, regarding drug safety monitoring and other aspects of pharmacovigilance.
Books
1. Alesso, L. (2007) Farmacovigilancia: HaciaUna Mayor Seguridad en el Uso de
Medicamentos, Los talleresgráficos de Alejandro Graziani S.A. (2nd edition planned)
2. Aronson, JK. (ed.) (2006) Meyler's Side Effects of Drugs, 15th edition, Elsevier
Science.
3. Aronson, JK. (ed.) (2010) Side Effects of Drugs Annual (36), Elsevier.
4. Baxter, K. (ed.) (2010) Stockley's Drug Interactions, 9th edition, Pharmaceutical Press.
5. Begaud, B. (2000) Dictionary of Pharmacoepidemiology, John Wiley & Sons Ltd.
6. Bennett, P., Calman, K., Curtis, S. and Fischbacher-Smith, D. (2010) Risk
Communication and Public Health, 2nd edition, Oxford University Press, USA.
7. BMJ. (2007) Clinical Evidence Handbook: The International Source of the Best
Available Evidence for Effective Healthcare, BMJ Publishing Group.
8. CIOMS. (1999) Benefit-Risk Balance for Marketed Drugs: Evaluating Safety
Signals (Report of CIOMS Working Group IV), WHO.
9. CIOMS. (2010) Practical Aspects of Signal Detection in Pharmacovigilance (Report
of CIOMS Working Group VIII), WHO.
10. Cobert, B. (2011) Cobert’s Manual of Drug Safety and Pharmacovigilance,
2nd edition, Jones & Bartlett Learning.
11. Cobert, B. and Biron, P. (2008) Practical Drug Safety from A to Z, Jones & Bartlett
Publishers.
12. Cohen, MR. (2006) Medication Errors, 2nd edition, American Pharmacists
Association.
13. Dukes, G., Mildred, M. and Swartz, B. (1998) Responsibility for Drug-Induced Injury:
A Reference Book for Lawyers, the Health Professions and Manufacturers, IOS Press.
14. Gupta, SK. (ed.) (2011) Textbook of Pharmacovigilance, Jaypee Brothers Medical
Publishers (P) Ltd.
15. Hugman, B. (2009) Healthcare Communication, Pharmaceutical Press.
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16. Klepper, MJ. andCobert, B. (2010) Drug Safety Data: How to Analyze, Summarize,
and Interpret to Determine Risk, Jones & Bartlett Learning.
17. Klincewicz, SL., Yap, YY., Thomas, A. with Taylor, JL. (ed.) (2009) Global
Pharmacovigilance: Laws & Regulations, the Food and Drug Law Institute.
18. Mann, RD. and Andrews, EB. (ed.) (2007) Pharmacovigilance, 2nd edition, John
Wiley & Sons Ltd.
19. MHRA. (2008) Good Pharmacovigilance Practice Guide, Pharmaceutical Press.
20. Slovic, P. (2000) The Perception of Risk, Earthscan Publications Ltd.
21. Strom, BL. (2005) Pharmacoepidemiology, 4th edition, John Wiley & Sons Ltd.
22. Sweetman, SC. (ed.)(2011) Martindale: The Complete Drug Reference, 37th edition,
Pharmaceutical Press.
23. Talbot, J. and Waller, P. (ed.) (2003) Stephen’s Detection of New Adverse Drug
Reactions, 5th edition, John Wiley & Sons Ltd.
24. Van Boxtel, CJ.,Santoso, B. and Edwards, IR. (ed.) (2008) Drug Benefits and Risks:
International Textbook of Clinical Pharmacology, 2nd edition, IOS Press.
25. Vincent, C. (2010) Patient Safety, 2nd edition, Wiley-Blackwell.
26. Waller, P. (2009) An Introduction to Pharmacovigilance, Wiley-Blackwell.
Journals
1. ADR Newsletters from National Centres
2. BMJ (British Medical Journal)
3. Drug Information Journal
4. Drug Safety
5. Indian Heart Journal
6. Indian Journal of Pathology & Microbiology
7. Indian Journal of Cancer
8. Indian Journal of Clinical Medicine
9. Indian Journal of Dentistry
10. Indian Journal of Dermatology
11. Indian Journal of Gastroenterology
12. Indian Journal of Health & Wellbeing
13. Indian Journal of Medicine
14. Indian Journal of Oncology & Radiation Biology
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15. Indian Journal of Ophthalmology
16. Indian Journal of Pharmaceutical Sciences
17. Indian Journal of Pharmacology
18. Indian Journal of Pharmacy Practice
19. Indian Journal of Psychiatry
20. Indian Journal of Public Health
21. Indian Journal of Sexually Transmitted Diseases and AIDS
22. Indian Journal of Transfusion Medicine
23. JAMA (Journal of the American Medical Association)
24. Journal of Indian Medical Association
25. Pharmacoepidemiology & Drug Safety
26. Pharmacoepidemiology and Drug Safety
27. Prescrire
28. Reactions Weekly
29. The Indian Journal of Hospital Pharmacy
30. The Indian Journal of Medical Research
31. The Indian Journal of Paediatrics
32. The International Journal of Risk & Safety in Medicine
33. The Journal of Family Welfare
34. The Lancet
35. The New England Journal of Medicine
36. The Nursing Journal of India
Publications
1. PvPI Newsletters
2. Safer Medicines, Safer Use of Medicines, Safer Patients (leaflet)
3. Aide Memoire - For a National Strategy for Safe Drugs and Their Appropriate Use
4. WHO Policy Perspectives on Medicines no. 9 - PV: Ensuring the Safe Use of
Medicines
5. Viewpoint (part 1)
6. Viewpoint (part 2)
7. The Importance of Pharmacovigilance - Safety Monitoring of Medicinal Products
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8. Safety Monitoring - Guidelines for Setting Up and Running a Pharmacovigilance
Centre
9. Safety of Medicines - A Guide to Detecting and Reporting Adverse Drug Reactions
10. Being a Member of the WHO Programme
11. Uppsala Reports (Newsletter)
12. Vigiflow - when time is crucial (leaflet)
13. VigiSearch/VigiMine (leaflet)
14. CemFlow (leaflet)
15. SIGNAL
16. WHO Pharmaceuticals Newsletter
17. WHO Drug Information
18. WHO: Pharmaceuticals: Restrictions in Use and Availability
19. Effective Communications in Pharmacovigilance - The Erice Report
20. Dialogue in Pharmacovigilance - More Effective Communication
21. Expecting the Worst (2nd Edition 2010)
22. The Safety of Medicines in Public Health Programmes - Pharmacovigilance an
Essential Tool
23. A Practical Handbook on the Pharmacovigilance of Antimalarial Medicines
24. A Practical Handbook on the Pharmacovigilance of Antiretroviral Medicines
25. WHO Guidelines on Safety Monitoring of Herbal Medicines
26. Accepted Scientific Names of Therapeutic Plants and their Synonyms
27. Herbal ATC Guide
28. Writings on Pharmacovigilance - Selected articles by David J Finney
29. A Lifetime in Safety - Selected articles by Ed Napke
30. Promoting Safety of Medicines for Children
31. The world medicines situation 2011 –Pharmacovigilance and safety of medicines
Pharmacovigilance Programme of India
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70