India Approves Biovigilance Programme for Drug Safety in Transplants

The Ministry of Health and Family Welfare approved the Biovigilance Programme of India on September 21, 2026. Under this programme, the Indian Pharmacopoeia Commission (IPC) will lead the monitoring, assessment, and prevention of adverse events associated with biological products used in organ and tissue transplantation. The programme will strengthen the country’s safety-monitoring framework alongside existing pharmacovigilance and medical-device vigilance programmes.

The programme focuses specifically on adverse events related to medicines and biological products used in organ and tissue transplants. This initiative aims to extend the IPC's work alongside existing pharmacovigilance efforts, which already include 1,150 monitoring centres across public and private hospitals.

The Indian government has tasked the Indian Pharmacopoeia Commission (IPC) with proactive drug safety monitoring to align pharmacovigilance with global norms. This follows an assessment of India against global health standards by the World Health Organization.