Pharmacovigilance Program of India (PvPI)

The Central Drugs Standard Control Organisation (CDSCO), New Delhi, under the aegis of Ministry of Health & Family Welfare, Government of India has initiated a nation-wide pharmacovigilance programme in July, 2010, with the All India Institute of Medical Sciences (AIIMS), New Delhi as the National Coordinating Centre (NCC) for monitoring Adverse Drug Reactions (ADR) in the country to safe-guard Public Health. In year 2010, 22 ADR monitoring centres (AMCs) including AIIMS, New Delhi had been set up under this Programme. To ensure implementation of this programme in a more effective way, the National Coordinating Centre was then shifted from the All India Institute of Medical Sciences (AIIMS), New Delhi to the Indian Pharmacopoeia Commission (IPC), Ghaziabad, (U.P.) in April, 2011.

The mission of PvPI is to safeguard the health of the Indian population by ensuring that the benefit of use of medicine outweighs the risks associated with its use. Since there exist considerable social and economic consequences of adverse drug reactions and the positive benefit/cost ratio of implementing appropriate risk management – there is a need to engage healthcare professionals and the public at large, in a well structured programme to build synergies for monitoring adverse drug reactions in the country.

The purpose of the PvPI is to collate data, analyze it and use the inferences to recommend informed regulatory interventions, besides communicating risks to healthcare professionals and the public. The broadened patient safety scope of pharmacovigilance includes the detection of medicines of substandard quality as well as prescribing, dispensing and administration errors. Counterfeiting, antimicrobial resistance, and the need for real time surveillance in mass vaccinations are other pharmacovigilance challenges which need to be addressed.

The vision of PvPI is to improve patient safety and welfare in Indian population by monitoring drug safety and thereby reducing the risk associated with use of medicines.The ultimate safety decisions on medicines may need considerations of comparative benefit/risk evaluations between products for similar indications, so the complexity is great.

Scope and Objectives

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
To promote rational use of medicine

Short Term Goals

To develop and implement pharmaco-vigilance 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

Long Term Goals

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

Functions of a National Pharmacovigilance System

To create a nation-wide system for patient safety reporting
To identify and analyse the new signal (ADR) from the reported cases
To analyse the benefit – risk ratio of marketed medications
To generate the 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 located across globe

Minimum requirements for a functional Pharmacovigilance system

Pharmacovigilance activities may be undertaken by several organizations, individuals and agencies. The Pharmacovigilance Programme of India fulfills the minimum requirements that should be present in any functional national pharmacovigilance system, as per WHO, which include the following:

A national pharmacovigilance centre with designated staff (at least one full time), stable basic funding, clear mandates, well defined structures and roles and collaborating with the WHO Programme for International Drug Monitoring (The National Coordinating Centre for PvPI being The Indian Pharmacopoeia Commission, Ghaziabad, under Ministry of Health & Family Welfare, Government of India)
The existence of a national spontaneous reporting system with a national individual case safety report (ICSR) form i.e. an adverse drug reaction (ADR) reporting form
A national database or system for collating and managing ADR reports (Vigibase database and Vigiflow software for PvPI)
A national ADR or pharmacovigilance advisory committee able to provide technical assistance on causality assessment, risk assessment, risk management, case investigation and where necessary, crisis management including crisis communication (Steering Committee provides technical assistance in PvPI)
A clear strategy for routine and crisis communications

Organogram

Reference: https://ipc.gov.in/PvPI

Pharmacovigilance Program of India (PvPI)