Evaluating The Functioning and Significance of The Pharmacovigilance Programme of India

Pharmacovigilance (PV) is very important in safety surveillance of drugs and Adverse Drug Reaction (ADRs) with greater public health benefits. According to WHO, pharmacovigilance is a branch of pharmacoepidemiology concerned with the epidemiology of adverse effects or other drug related problems. The current demand for improved health and extended access to needed medical care and the steadily rising global consumption of drugs demonstrate the need for durable PV systems. In 2010, Pharmacovigilance Programme of India, PvPI was started under the Ministry of Health & Family Welfare, initially run by AIIMS and then migrated to Indian Pharmacopoeia Commission (IPC). PvPI is concerned with reporting, documentation, assessment, and sharing of ADR information to enhance drug safety and hence supportive authorities’ decision making. The paper assesses the relevance and performance of PvPI employing the context analysis approach, where data have been obtained from the 2012–2023 scientific production database. They quote that within three years of its operation, PvPI has recorded vital progress in ADR monitoring with 256 Adverse Drug Reaction Monitoring Centres (AMCs). Nevertheless, threats like under-representation, training of healthcare workers, and structural difficulties are still there. All the same, the displayed problems do not overshadow the efforts made in the PvPI framework to improve the situation concerning drug safety, for example, training, creating public awareness, and performing technological developments. Comparing the situation with other PV systems, existing in the USA and EU, it can be stated that India ranks lower in integration and ADR reporting statutory requirements. Solutions proposed for future studies are independent ADR reporting, integrating artificial intelligence and electronic records, extension of network coverage, and international cooperation. Improving the understanding of PvPI’s framework may improve patient safety, consonant regulations and approach to rational use of drugs. Therefore, with its compliance to the best practices globally, PvPI has the potential to elevate India’s pharmacovigilance system to international standards, ultimately contributing to safer pharmaceutical practices and improved healthcare outcomes.