The Indian government has approved the Biovigilance Programme of India, establishing a dedicated framework to monitor adverse events associated with medicines and biological products used in organ and tissue transplantation. The Indian Pharmacopoeia Commission will lead the initiative, which will cover products administered to both donors and recipients. The move is expected to extend systematic safety surveillance into an area where patients may be exposed to multiple medicines and biological products during the transplantation journey.

The new program will operate alongside the Pharmacovigilance Programme of India, which tracks adverse drug reactions, and the Materiovigilance Programme of India, which monitors adverse events involving medical devices. Together, the three surveillance systems are intended to provide broader coverage of safety signals involving medicines, devices and…