Pharmacovigilance Program of India

1. Pharmacovigilance Program Of India (PvPI)
Name :- Kharat Pranit Yashwant
Year :- Final Year
Roll no :- 21

2. Introduction :
Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), under the guidance of
Ministry of Health & Family Welfare, Government of India in collaboration with Indian Pharmacopeia commission,
Ghaziabad initiated a nation-wide Pharmacovigilance Programme (PvPI) for the protection of patient’s health by providing
safety from the drugs. However, Indian Pharmacopeia commission (IPC), Ghaziabad coordinates these Programs as a
National Coordinating Centre (NCC).
Initiated with AIIMS, New Delhi as National Coordination Centre (NCC) for monitoring ADR’s in country July 2010, shifted
to Indian Pharmacopoeia Commission (IPC), Ghaziabad on 15th April 2011.
Mission :
To protect the health OF Indian population by emsuring that the benefits of medicine used overshadow the risks
associated with its use.
Vision :
To improve patient safety and welfare in Indian population by monitoring the drug safety and thereby reducing the risk
associated with use of medicines.

3. Pharmacovigilance as “science and activities relating to the detection, assessment, understanding and prevention of
adverse effects or any other possible drug related problems.”
Background :
1986 - Formal ADR monitoring system of 12 regional centres was proposed for india.
1989 - Six regional centres were set up under the guidance and support of the Drug Controller of India.
1997 - India joined the WHO programme for International Drug Safety Monitoring.
1998 - Pharmacovigilance initiated in India.
2004 - 05 - National Pharmacovigilance Programme launched in India.
2009 - 10 - PvPI was initiated.

4. Objectives :
1) A nation-wide system must be formed for reporting of patient safety.
2) Identification and analysis of new ADR (signal) from the reported cases.
3) Analysis of benefit - risk ratio of marketed pharmaceutical products.
4) Evidence based information must be generated on safety of medicines.
5) Supporting the regulatory agencies in the process of decision making on use of medicines.
6) Emerging as a national center of excellence for pharmacovigilance activities.
7) Communicating over the safety information on use of medications to different stakeholders for minimizing the risk.
8) Collaborating with other national centers for data management and exchange of information.
9) Providing consultancy and training support to other National Coordination Centre for Pharmacovigilance Programme
in India located across the world.
Pv methods
Spontaneous Reporting .
Targeted Spontaneous Reporting.
Cohort Event Monitoring.

5. Spontaneous Reporting :
An unsolicited communication by the health care expert or consumers that describes one or more ADR in a patient who
was administered one or more medical products that is not derived form a study or any organisation data collected
scheme is called a spontaneous report.
Targeted Spontaneous Reporting :
To evaluate the mechanism of action for the adverse reaction clinical studies are called in, in case the significant risks are
identified from pre-approval clinical trials. To define whether specific dosing instructions can put patients at an increased
risk of adverse events PK and PD studies can be carried out.
Cohort Event Monitoring :
A population at risk for the disease (or event) is observed over time to record the occurrence of the disease (or event) in a
cohort study. Exposure status information is available during the follow-up period for each patient. A patient might be
exposed to a medicine at one time during follow-up, but not exposed at another time. Meanwhile the population
exposure during follow-up is acknowledged, incidence rates can be calculated, concerning medicine exposure, appraisal
cohorts of interest are selected on the basis of medicine use and monitored over time in many cohort studies.