Become A Member

Pharmacovigilance is defined as the science and activities relating to the detection, assessment, monitoring, and prevention of ADR in humans.  Pharmacovigilance has been known to play an important role in the rational use of drugs, by providing information about the adverse effects possessed by the drugs in the general population. India is the world’s second-largest populated country with over 1 billion potential drug consumers. India has participated in the Uppsala Monitoring Centre program; it is a contribution to that database is relatively small. Signal assessment is mainly performed to analyze the cause and effect by using the World Health Organization (WHO) scale & Naranjo scale of probability. Signal detection and its assessment are a 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, needs, objectives, and proposals to build, maintain and implement a robust PV system and to improve the process of ADR reporting in the country.

KEYWORDS:  Pharmacovigilance; Adverse Drug Reactions; spontaneous reporting system;  Uppsala monitoring center; causality assessment system;