An overview of the pharmacovigilance in India: From ADR reporting to regulatory action

Abstract

Pharmacovigilance (PV) is the science and activities concerned with detection, assessment, understanding, and prevention of adverse drug reactions(ADRs) and other drug-related problems, playing an important role in promoting patient safety and rational use of medicines. This review provides an overview of the development and current status of pharmacovigilance in India, from major historical drug-safety events that highlighted the need for systematic ADR monitoring to the development of the present pharmacovigilance system. It discusses the classification of ADRs, the short, medium, and long-term objectives of PV, and the Pharmacovigilance Programme of India (PvPI), including the role and ADR Monitoring Centers in collecting, assessing, and monitoring safety information. The review further describes method of reporting ADR through reporting forms, mobile applications, and helpline along with roles of the Indian Pharmacopoeia Commission (IPC), Central Drugs Standard Control Organization (CDSCO), healthcare professionals, and pharmacists in drug-safety monitoring. Data collection, signal detection, Vigiflow, and regulatory actions based on pharmacovigilance data are also discussed. Despite these developments, challenges such as under-reporting, lack of awareness, shortage of trained personnel, limited resources, inadequate infrastructure, poly-pharmacy, and drug interactions continue to affect effective pharmacovigilance. Recent developments in digitalization and the use of artificial intelligence may support improved data analysis and earlier identification of potential safety concerns. Strengthening collaboration among regulatory authorities, pharmaceutical industries, healthcare professionals, and patients, together with improved training and reporting practices, is essential for enhancing pharmacovigilance and promoting the safe and rational use of medicine in India.