Authors and affiliation (s):
Ansuman Sahu, Nihar Ranjan Das*
Department of Pharmacology, Roland Institute of Pharmaceutical Sciences, Berhampur, Odisha, INDIA.
Abstract
Adverse drug reaction monitoring are crucial parts of drug use. India’s grandeur, surrounding diverse sociocultural, biotic regions and healthcare environment influence its own disease patterns and expose its population to potential Adverse Drug Reactions (ADRs). This demands a well-planned and culturally-responsive pharmacovigilance system. This study examines the current system for tracking Adverse Drug Reactions (ADRs) in India. The goal is to provide a clear and detailed picture of the ADR monitoring system highlighting its strengths and weaknesses along with its key features. It was observed that the Central Drugs Standard Control Organization (CDSCO) is regulating the safety, efficacy and quality of pharmaceutical products having more than two hundred Adverse Drug Monitoring Centres (AMCs) operational nationwide. Within the Pharmacovigilance Programme of India (PvPI), these centres report ADRs to National Coordination Centres (NCC) at the Indian Pharmacopoeia Commission (IPC) located in Ghaziabad. Reporting ADRs involves a standardized form available in various languages accessible to both health professionals and every citizen of India for reporting to NCC if they experience ADRs. While electronics software called Vigiflow owned by World Health Organization Uppsala Monitoring Centre (WHO UMC) plays a crucial role in reporting the ADRs to NCC by AMCs. India contributes to global ADR monitoring through its national program and WHO collaboration. As a vast country, India has a systematic and structured programme on ADR monitoring to tackle the ADRs. India also contributes to Global ADR monitoring by providing necessary data to WHO UMC.
Keywords: AMCs, CDSCO, PvPI, National Coordination Centres.