PHARMACOVIGILANCE SYSTEM IN INDIA IN COMPARISON WITH USA, EUROPEAN UNION AND FEW ASIAN COUNTRIESAbstract
Though the anesthesia-related death of a 15-year-old Hannah Greener marked the beginning of pharmacovigilance 160 years ago, the science of pharmacovigilance was not established as a separate field until the wake of the thalidomide tragedy in 1960’s. The World Health Organization (WHO) instituted International Drug Monitoring Program to internationalize the act of drug safety monitoring. Inspite of this, many countries, particularly the low and middle-income developing countries, found it difficult to implement a robust drug safety monitoring system in their country due to various technical and financial snags. India was able to establish its own pharmacovigilance system called Pharmacovigilance Program of India (PVPI) only in 2005. This article analyzes the hurdles and challenges faced by India during the implementation phase of the Pharmacovigilance program, and this article also compares the pharmacovigilance system of India with few other developed and developing countries.
T. Muthukumaran, J. S. J. U. Chander * and K. A. Kumar
Department of Pharmacology, College of Pharmacy, Sri Ramakrishna Institute of Paramedical Sciences, Coimbatore, Tamil Nadu India.
08 June 2020
03 November 2020
05 May 2021
01 June 2021