Role of Pharmacovigilance Programme of India (PvPI) in Adverse Drug Event Monitoring for medication safety in patient

A pharmacovigilance system is a specialized domain within the pharmacological sciences that pertains to the reporting of Adverse Event Reactions associated with medical devices and pharmaceuticals. An adverse event represents a potential public health concern that necessitates continuous documentation, evaluation, and surveillance. Regulatory measures about pharmaceuticals have been enhanced and fortified since the catastrophic sulphanilamide incident of 1937 and the thalidomide tragedy of 1960. In response to these historical events, a Pharmacovigilance System was established, designed to receive, diagnose, assess, monitor, and mitigate the detrimental effects associated with medical products.(1) The Central Drug Standard Control Organization (CDSCO) oversees the pharmacovigilance framework in India. Within India, the pharmacovigilance initiative is tasked with the oversight of adverse drug responses. India has instituted a comprehensive Pharmacovigilance Program to monitor and document adverse drug reactions. Similarly, the United States has implemented stringent regulations to fortify the pharmacovigilance requirements set forth by the Food & Drug Administration (FDA). The World Health Organization (WHO) has established an International Monitoring System in cooperation with the Uppsala (1–3)Monitoring Centre (UMC). Improving patient safety and welfare in the Indian population by monitoring drug safety & thereby reducing the risk associated with the use of medicines is the primary mission of the pharmacovigilance program in India. Advocating for safe drug use may become a top focus for the Indian Pharmacopoeia Commission, which also functions as the National Coordination Centre for India's Pharmacovigilance Program. The risk of adverse reactions necessitated the pharmacovigilance system for patient safety. A literature search documented better health literacy of patients through intervention. (3) KEYWORDS: