Pharmacovigilance: An Overview

Pharmacovigilance (PV) plays a key role in the healthcare system through assessment, monitoring & discovery of interactions amongst drugs and their effects in human being. Pharmaceutical and biotechnological products are designed to diagnose, prevent or cure diseases. India is the world’s second most populated country with over 1 billion potential drug consumers. Although, India is participating in the Uppsala Monitoring Center (UMC) programme, its contribution to that database is relatively small. Signal assessment is mainly performed to analyse the cause and effect by using World Health Organization (WHO) scale & Naranjo scale of probability. Signal detection and its assessment is very vital and complex process. This article gives a systematic review of the PV in India from its origin to the current scenario and also discusses the various strategies and proposals to build, maintain and implement a robust PV system and to improve the process of ADR reporting in the country. Keywords: Adverse drug reactions; pharmacovigilance; spontaneous reporting system; Uppsala monitoring centre; causality assessment system