COMPARATIVE ANALYSIS OF THE EUROPEAN UNION'S PHARMACOVIGILANCE FRAMEWORK WITH INDIA'S DRUG SAFETY REGULATIONS

Pharmacovigilance (PV) is the science and set of activities concerned with detecting, assessing, understanding and preventing adverse drug reactions (ADRs) and other medicine-related problems throughout a product's life cycle. The European Union (EU) operates one of the most comprehensive and integrated PV systems in the world, built on common legislation, Good Pharmacovigilance Practices (GVP), the EudraVigilance database and the Pharmacovigilance Risk Assessment Committee (PRAC). India's Pharmacovigilance Programme of India (PvPI), launched in 2010 and coordinated by the Indian Pharmacopoeia Commission (IPC) under the Central Drugs Standard Control Organisation (CDSCO), is a younger system that has expanded rapidly through a network of ADR Monitoring Centres (AMCs). This article reviews the historical and conceptual background of PV, describes the EU and Indian frameworks, and compares them across seven domains: legal and institutional structure, ADR/individual case safety report (ICSR) reporting, signal detection and management, risk management planning, post-authorisation safety surveillance, stakeholder and patient engagement, and regulatory capacity and workforce. Both systems share the same fundamental principles; the main differences lie in institutional integration, reporting volume and completeness, the use of active surveillance, stakeholder participation and the link between safety signals and regulatory action. Practical, resource-sensitive areas for strengthening the Indian system are proposed.