Vol. 8, Issue 1, Part A (2026)

Pharmacovigilance (PV) is an essential scientific discipline focused on the detection, assessment, understanding, and prevention of adverse drug reactions (ADRs) and other medicine-related problems. It ensures continuous post-marketing surveillance and contributes to the safe, rational, and effective use of medicines at the population level. Over the decades, both India and the United States (U.S.) have developed structured pharmacovigilance frameworks aligned with global regulatory expectations. However, notable differences exist in regulatory mechanisms, reporting infrastructure, and implementation efficiency. This review provides an updated, comprehensive, and comparative analysis of PV guidelines in India and the U.S., highlighting regulatory principles, reporting requirements, data-management systems, and quality frameworks.