Pharmacovigilance: History and development in india

Abstract

Pharmacovigilance (PV) is the science dedicated to detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems to ensure medication safety and protect public health. It gained prominence after incidents like the thalidomide tragedy, which emphasized the need for systematic monitoring of adverse drug reactions (ADRs). PV primarily focuses on post-marketing surveillance to identify unrecognized side effects, evaluate real-world drug performance, and reduce drug-related morbidity and mortality. Historically, its development was marked by key milestones such as the Vaccine Act (1813), the Pure Food and Drug Act (1906), and the establishment of the WHO Programme for International Drug Monitoring in 1968. In India, pharmacovigilance evolved through initiatives like the National Pharmacovigilance Programme and the Pharmacovigilance Programme of India (PvPI) launched in 2010. The history of pharmacovigilance in India began with a proposal for a formal system in 1986, but it wasn't until 1998 that India joined the WHO program, though this was unsuccessful. A more successful National Pharmacovigilance Programme was launched in 2005, and it was later renamed the Pharmacovigilance Programme of India (PvPI) in 2010, with the Indian Pharmacopoeia Commission as its National Coordinating Centre. The program has since expanded to include a large network of Adverse Drug Reaction Monitoring Centers and has been recognized by the WHO