History, Current Status And Future Aspects Of pharmacovigilance In India

Abstract

Pharmacovigilance(PV) is defined by the World Health Organization (WHO) as "the research and practices associated to the detection, evaluation, comprehension, and prevention of adverse effects or other important issues caused by drugs."Pharmacovigilance is primarily concerned with the detection of Adverse drug reactions (ADRs) of drugs.Safety of medications is one of the important factors for success of any therapy, along with therapeutic efficacy, in the ever-increasing range and potency of medicines. India is currently a desirable clinical testing locationfor to be launched drug entities.The PV activity is regulated in India by the Indian Pharmacopoeia Commission (IPC) and the National Coordination Committee (NCC) through the Central Drug Standard Control Organization (CDSCO). The Indian government planned and launched the Pharmacovigilance Programme of India in 2010 to establish a potential PV system in India.To enhance regulatory compliance, clinical trial safety, and post-marketing surveillance, the Drugs Controller General of India (DCGI) should act fast to improve PV by implementing Good Pharmacovigilance Practice (GPP) into processes and procedures. If medicines are to be used safely, a well-functioning PV system is essential.This article summarized introduction, history, current status and future aspects of Pharmacovigilance in India.