Adverse event reporting tools and regulatory measures in India through outcome of Pharmacovigilance Programme of India.

Abstract

The primary care medical practitioners as well as common public must be made aware of the importance and benefits of reporting adverse drug reactions (ADRs). The reporting of ADRs through periodic safety update reports is a regulatory requirement in many countries including India, however, the importance of ADR reporting through spontaneous reporting system cannot be ignored. After the initiation of Programme for International Drug Monitoring, WHO-Uppsala Monitoring Centre (UMC), Sweden, succeeded in establishing a worldwide pharmacovigilance (PV) network in >150 countries. As a full member of this program, India also has developed a robust PV system through Pharmacovigilance Programme of India (PvPI) involving its various ADR Monitoring Centers and after due quality check of Individual Case Safety Reports (ICSRs), submits this information to UMC through a web-based tool VigiFlow®. This information is then stored into VigiBase® which is the repository of worldwide ICSRs. Based on the drug safety information collected, PvPI issues alerts, recommends label change (if any), and identifies signals thereby supporting National Regulatory Authority. At national level, PvPI has developed several tools for reporting of ADRs by the stakeholders. This article provides an overview of adverse events reporting tools in India vis-a-vis selected countries around the world, based on a comparative literature search. This article also throws light upon the regulatory aspects of PV in India, findings of PvPI and its recommendations to Central Drugs Standard Control Organization, collaboration of PvPI with Public Health Programmes, future prospects of reporting ADRs in India and how it will help enhance the quality of ADR-reporting by citizens of India.