ABSTRACT:
Pharmacovigilance (PV) is the science dedicated to detecting, assessing, understanding, and preventing adverse effects or other drug-related issues, with a primary focus on adverse drug reactions (ADRs). ADRs, defined as harmful and unintended responses to medications, can pose significant health risks, including morbidity and mortality. Despite rigorous pre-clinical and clinical testing, some ADRs only emerge post-marketing when drugs are used by larger populations. Pharmacovigilance systems, therefore, play a crucial role in ongoing drug safety monitoring, utilizing methods such as data mining and case report analysis. Historically, PV originated in response to major drug-related incidents, such as the 1937 sulfanilamide disaster in the U.S., which spurred the development of the first regulatory system for drug safety. In India, PV efforts began in 1997 when the country joined the WHO Adverse Drug Reaction Monitoring Program. However, the establishment of the National Pharmacovigilance Program in 2005 marked a significant step forward, with further developments through the Pharmacovigilance Program of India (PvPI) launched in 2010.PV aims to improve patient safety by identifying new ADRs, assessing risk factors, and enhancing the benefit-risk ratio of marketed drugs. It also promotes education and awareness on safe drug use. The Drug Controller General of India (DCGI) plays a vital regulatory role, ensuring drug safety through post-marketing surveillance and compliance. As India continues to grow as a hub for clinical trials, a robust PV system is essential for ensuring public health and safety.