Pharmacovigilance

Definition:
According to WHO, Pharmacovigilance (PV) is the science and activities relating to the detection,
assessment, understanding and prevention of adverse effects or any other drug related problem.

Aims of pharmacovigilance:

Its aims are to enhance patient care and patient safety and to support public health programmes by providing
reliable, balanced information for the effective assessment of the benefit-risk profile of medicines and
vaccines.

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.

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. 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

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.

Scope of pharmacovigilance:

 Improve patient care and safety in relation to the use of medicines, and all medical and paramedical
interventions.
 Improve public health and safety in relation to the use of medicines.
 Contribute to the assessment of benefit, harm, effectiveness and risk of medicines.
 Encourage their safe, rational and more effective (including cost effective) use.
 Promote understanding, education and clinical training in pharmacovigilance and its effective
communication to the public.
 Monitor Adverse Drug Reactions (ADRs) in population.
 Create awareness amongst health care professionals about the importance of ADR reporting.
 Monitor benefit-risk profile of medicines.
 Generate independent, evidence based recommendations on the safety of medicines.
 Support the regulatory agencies for formulating safety related regulatory decisions for medicines.
 Create centre of excellence at par with global drug safety monitoring standards.