Pharmacovigilance Programme of

Pharmacovigilance
WHO defines pharmacovigilance as the science and activities relating to the detection, assessment,
understanding and prevention of adverse effects or any other medicine-related problem.
The aims of pharmacovigilance

Events such as the thalidomide tragedy highlight the extreme importance of effective drug monitoring
systems for all medicines. The principal aims of pharmacovigilance programmes are:
• to improve patient care and safety in relation to the use of medicines, and all medical and paramedical
interventions;
• to improve public health and safety in relation to the use of medicines;
• to contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their
safe, rational and more effective (including cost-effective) use;
• to promote understanding, education and clinical training in pharmacovigilance and its effective
communication to health professionals and the public.
Over the last decade, it has been increasingly recognized that the scope of pharmacovigilance needs to be
extended beyond the strict confines of detecting new signals of safety concerns. Globalization,
consumerism, the resulting explosion in free trade and communication across borders, and increasing use of
the Internet have all contributed to a change in the way people access medicinal products and information
about them. These changing patterns in drug use require a shift in the approach to pharmacovigilance, more
specifically, towards one that is more closely linked, and thus better able to respond, to the prevailing
patterns of drug use within society.
Pharmacovigilance Programme of India (PvPI)
The Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services under
the aegis of Ministry of Health & Family Welfare, Government of India in collaboration with Indian
Pharmacopeia commission, Ghaziabad is initiating a nation-wide Pharmacovigilance programme for
protecting the health of the patients by assuring drug safety. The programme shall be coordinated by the
Indian Pharmacopeia commission, Ghaziabad as a National Coordinating Centre (NCC). The centre will
operate under the supervision of a Steering Committee.
www.revolutionpharmd.com
3. Steering Committee
Pharmacovigilance Programme of India
Chairman
Drugs Controller General (India), New Delhi, ex- officio

Members
1. Scientific Director, Indian Pharmacopoeia Commission, Ghaziabad, ex-officio
2. Head of Department, Pharmacology, AIIMS, ex - officio
3. Nominee of Director General, ICMR, ex-officio
4. Assistant Director General ( Extended Programme of Immunization [ ADG(EPI)] as representative of

Directorate General Health Services
5. Under Secretary (Drugs Control) as representative of The Ministry of Health & family Welfare.
6. Nominee of Vice Chancellor of Medical/Pharmacy University, ex-officio
7. Nominee of the Medical Council of India, ex-officio
8. Nominee of Pharmacy Council of India, ex-officio

Member Secretary
Officer-in-Charge (New Drugs), CDSCO, New Delhi, ex-officio
Goal and Objectives
Goals
To ensure that the benefits of use of medicine outweighs the risks and thus safeguard the health of the
Indian population.
Objectives
 To monitor Adverse Drug Reactions (ADRs) in Indian population

 To create awareness amongst health care professionals about the importance of ADR reporting in India
 To monitor benefit-risk profile of medicines

 Generate independent, evidence based recommendations on the safety of medicines
 Support the CDSCO for formulating safety related regulatory decisions for medicines
 Communicate findings with all key stakeholders
 Create a national centre of excellence at par with global drug safety monitoring standards
4.3 Programme governance and reporting structures
The Pharmacovigilance Programme of India will be administered and monitored by the following two
committees.
I. Steering Committee
II. Strategic Advisory Committee
Technical support will be provided by the following committees:
I. Signal Review Panel

II. Core Training Panel
III. Quality Review Panel
ADR MONITORING CENTRES

 MCI Approved Medical Colleges & Hospitals
 Private Hospitals
 Public Health Programmes
 Autonomous Institutes (ICMR etc.)
Collaboration with World Health Organization-Uppsala Monitoring Centre (UMC)
WHO and UMC work with and/or provide technical support to more than 94 countries worldwide. The long
term objective of the PvPI is to establish a ‘Centre of Excellence’ for Pharmacovigilance in India. To
achieve this objective, the PvPI National Coordinating Centre will collaborate with the WHO Collaborating
Centre - Uppsala Monitoring Centre (UMC) based in Sweden.

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Pharmacovigilance

The aims of pharmacovigilance

• to improve public health and safety in relation to the use of medicines;

Pharmacovigilance Programme of India (PvPI)

Pharmacovigilance Programme of India

Drugs Controller General (India), New Delhi, ex- officio

2. Head of Department, Pharmacology, AIIMS, ex - officio

3. Nominee of Director General, ICMR, ex-officio

4. Assistant Director General ( Extended Programme of Immunization [ ADG(EPI)] as representative of

6. Nominee of Vice Chancellor of Medical/Pharmacy University, ex-officio

7. Nominee of the Medical Council of India, ex-officio

8. Nominee of Pharmacy Council of India, ex-officio

Goal and Objectives

 To monitor Adverse Drug Reactions (ADRs) in Indian population

 To monitor benefit-risk profile of medicines

4.3 Programme governance and reporting structures

Technical support will be provided by the following committees:

I. Signal Review Panel

ADR MONITORING CENTRES

 Public Health Programmes

 Autonomous Institutes (ICMR etc.)

Collaboration with World Health Organization-Uppsala Monitoring Centre (UMC)

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