India launched the Biovigilance Programme of India (BvPI) in New Delhi on 21 September 2026. The programme was announced during the 6th National Pharmacovigilance Week and is linked to patient safety in the use of medicines and biological products.
Biovigilance in Health Regulation
Biovigilance is a safety-monitoring system for adverse reactions associated with biological products. In the Indian context, the programme covers medicines and biological products used in organ and tissue transplants.
Institutional Framework
The Indian Pharmacopoeia Commission (IPC) will lead the monitoring of adverse events linked to organ and tissue transplantation under the Biovigilance Programme. The IPC is the national body associated with standards for drugs and related health products in India.
Existing Safety-Monitoring Systems
India already has Pharmacovigilance and Materiovigilance programmes for monitoring drug-related and medical-device-related safety issues. The Biovigilance Programme extends this framework to biological products used in transplantation medicine.
Important Facts for Exams
- The National Pharmacovigilance Week is observed in India as a professional awareness event linked to drug safety.
- The National Formulary of India provides standard information on medicines used in the country.
- The 7th Edition of the National Formulary of India and its digital version were released on 21 September 2026.
- Organ and tissue transplantation involves biological materials that require specialised safety monitoring.
National Formulary of India
The 7th Edition of the National Formulary of India and its digital version were released on 21 September 2026. The formulary is used as a reference document for medicines and their standard use in India.
