India Approves Biovigilance Programme to Strengthen Safety Monitoring in Organ and Tissue Transplants

The Government of India has approved the Biovigilance Programme of India, expanding the country’s existing safety-monitoring system to cover medicines and biological products used in organ and tissue transplantation. The programme will be led by the Indian Pharmacopoeia Commission (IPC) and will focus on identifying, assessing, monitoring and preventing adverse events associated with products used during transplantation.

The announcement was made by Union Minister of State for Health and Family Welfare Anupriya Patel during the 6th National Pharmacovigilance Week programme in New Delhi on 21 September. The programme will cover products administered to both donors and recipients involved in organ and tissue transplantation.

The new initiative adds another layer to India's patient-safety framework. It will work alongside the country's existing Pharmacovigilance Programme of India (PvPI), which monitors adverse drug reactions, and the Materiovigilance Programme of India (MvPI), which focuses on safety issues associated with medical devices. Together, these programmes are intended to provide a broader system for monitoring safety concerns across different areas of healthcare.

During the programme, the minister also highlighted the need for greater participation from healthcare professionals and patients in reporting adverse events. Around 1,150 adverse drug reaction reporting centres are currently operating across India, and the government plans to expand the reporting network further, including at the primary healthcare level.

The initiative comes as transplantation services become increasingly dependent on medicines and biological products administered to donors and recipients. Systematic collection of information about unexpected or harmful events can help regulators identify safety signals and take appropriate action.

The government has also encouraged the use of digital platforms, artificial intelligence and advanced data analytics to improve the collection and assessment of safety information. 

21-09-2026