Pharmacovigilance in India: Evolution and Change in Scenario in India

Dr. Siddhartha Dutta

Abstract: In healthcare medicines play a crucial role in therapeutics, diagnostics and also in prophylaxis of diseases. Drugs sometimes acts as a dual edged sword. At one end it heals and cures diseases at other end it comes with adverse drug reactions (ADRs). Monitoring of ADRs is very essential as it has significant effect on the morbidity, mortality and economic status of a patient. National Coordinating Centre (NCC) at Indian Pharmacopeia Commission started the Pharmacovigilance programme of India (PvPI) with an aim to monitor, assess and report the suspected ADRs to them. Healthcare professionals (HCPs) forms the cornerstone for the ADR reporting and key persons for PvPI. Even after continuous efforts the ADR reporting was not up to the mark. Prime reason for underreporting was attributed to lack of knowledge and awareness regarding pharmacovigilance among the HCPs. NCC-PvPI has taken multiple steps to hasten the ADR reporting from all stakeholders and is continuously working to keep the tempo going. With these continuous efforts we can hope a new horizon in the future where India will stand as one of the leading nations in promoting safe, effective and rational usage of drugs.

Keywords: Pharmacovigilance, Adverse drug reactions, PvPI, ADR reporting

Edition: Volume 7 Issue 10, October 2018,

Pages: 976 - 978