Ensuring the safety of medicines is a crucial responsibility of healthcare systems worldwide. In a country like India, which has a large population and a rapidly expanding pharmaceutical industry, monitoring the safety of drugs throughout their lifecycle is an important public health priority. Adverse drug reactions (ADRs) can significantly affect patient health and treatment outcomes, making it essential to establish a systematic mechanism for identifying and evaluating such reactions. To address this need, the Government of India launched the Pharmacovigilance Programme of India (PvPI) on 14 July 2010 under the Central Drugs Standard Control Organization (CDSCO). The programme aims to monitor the safety of medicines, collect information related to adverse drug reactions, and support regulatory decisions that ensure safer use of drugs.PvPI operates through a nationwide network of Adverse Drug Reaction Monitoring Centers (AMCs) located in hospitals and medical colleges across the country. These centers play a key role in collecting and reporting ADR data, which is then analyzed by the National Coordination Centre at the Indian Pharmacopoeia Commission (IPC). Since its inception, the programme has expanded significantly, growing from 22 monitoring centers in 2010 to more than 400 centers across India by 2023. Through this expansion, the programme has strengthened Indias capacity to detect drug safety issues and contribute to global pharmacovigilance efforts. India is also an active contributor to the World Health Organizations international drug monitoring programme, with a large number of Individual Case Safety Reports submitted to the global database, VigiBase. Data generated through PvPI has supported several regulatory actions, including updates to drug labels, safety alerts, prescribing restrictions, and withdrawal of potentially harmful medicines from the market. Additionally, related initiatives such as the Materiovigilance Programme of India and the Haemovigilance Programme of India have further expanded the scope of safety monitoring in the healthcare system.Despite these achievements, challenges such as under-reporting of adverse drug reactions, variations in reporting quality, limited awareness among healthcare professionals and patients, and infrastructural limitations in certain regions still persist. Strengthening digital reporting systems, improving awareness, and encouraging active participation from healthcare professionals and patients will be essential for the continued growth and effectiveness of pharmacovigilance in India.
maurya et al. (Sun,) studied this question.