Biovigilance Programme of India

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Key takeaways

The Government of India approved the Biovigilance Programme of India to improve safety monitoring for transplant medicines.
The program is coordinated nationwide by the Indian Pharmacopoeia Commission (IPC).
It covers biological products given to both organ donors and recipients to prevent adverse events.
It connects with existing safety frameworks like PvPI and MvPI to build a strong patient safety network.

The Government of India approved the Biovigilance Programme of India to improve safety monitoring for medicines and biological products used in organ and tissue transplantation.

This is a national patient safety surveillance programme designed to systematically report, assess, monitor, and prevent bad reactions linked to medicines and biological products used in transplants.
The Indian Pharmacopoeia Commission (IPC) manages this organization.
The main aim is to identify, assess, and prevent adverse events related to transplant products, which improves safety for both donors and recipients.

It systematically tracks adverse events linked to medicines and biological products used during organ and tissue transplantation, enabling timely safety interventions.
It covers biological products given to both donors and recipients, extending safety surveillance across the entire transplantation process.
The Indian Pharmacopoeia Commission (IPC) coordinates reporting, assessment, monitoring, and prevention of transplant related adverse events nationwide.
It complements PvPI for adverse drug reactions and MvPI for medical device events, creating a broader and interconnected patient safety framework.
It builds domestic capacity to collect, analyze, and generate evidence from adverse event data, supporting safer clinical practices and regulatory decisions.

Early identification and assessment of adverse events enable timely corrective measures, reducing risks to transplant donors and recipients.
It integrates pharmacovigilance and biovigilance, extending surveillance across medicines, medical devices, and transplant related biological products.