Pharmacovigilance System in India

This chapter provides an overview of the pharmacovigilance system in India, concentrating on history, development, functions, different pharmacovigilance programs, framework, and current scenario. This chapter aims to offer insights to readers seeking a deeper understanding of the pharmacovigilance system in India. In 2010, the Pharmacovigilance Programme of India (PvPI) was launched by the Ministry of Health and Family Welfare, Government of India, after recognizing the need to improve ADRs reporting system in India. PvPI plays a significant role in collecting drug safety-related data and submitting it to World Health Organization (WHO) database. IPC, Ghaziabad is the national coordination centre (NCC) under the PvPI responsible for collecting, analyzing, and suggesting regulatory actions to Central Drugs Standard Control Organization (CDSCO). There are 760 Adverse Drug Monitoring Centres (AMCs) in India. Globally, India is now considered as a hub of clinical trials and research studies. Furthermore, there is a thrust need to a robust pharmacovigilance system in India to ensure patient safety.