Pharmacovigilance in India and its Impact in Patient Management

Abstract

ABSTRACT Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding, and prevention of adverse effects, particularly the long-term and short-term adverse effects of drugs or treatment. The World Health Organization (WHO) established pharmacovigilance Programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. India joined the WHO adverse drug reaction (ADR) monitoring program based in Uppsala, Sweden, in 1998. The Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, under the aegis of the Ministry of Health and Family Welfare, Government of India, in collaboration with Indian Pharmacopoeia Commission, Ghaziabad, is a National Coordinating Centre (NCC). Adverse drug reaction monitoring centers (AMCs) under the Pharmacovigilance Programme of India (PvPI) play a vital role in the collection and follow-up of ADR reports from the patients, as drug trials in animals and humans (Phase I–III) do not predict accurately the adverse drug events. Patients with chronic kidney disease (CKD)/liver disease are at risk of enhanced drug-related events. These patients should be closely monitored for any adverse events and it should be reported. Thus, inculcating the habit of ADR reporting will help in generating data specific to Indian population and will contribute toward patient safety. This will also help in modifying the treatment given to the patients, as early identification of ADRs will help in reducing morbidity and mortality in patients. How to cite this article Sharma G, Kumar R, Singh J, Bhandari V, Singh N. Pharmacovigilance in India and its Impact in Patient Management. Curr Trends Diagn Treat 2017;1(1):27-33.