Organ transplantation is a growing area of Indian healthcare, yet safety monitoring has lagged behind drug safety monitoring. Critically evaluate the need for a dedicated Biovigilance Programme.

India's organ transplants grew nearly fourfold — from under 5,000 in 2013 to about 20,000 in 2025 [3] — yet adverse events after transplantation had no national reporting system until the Biovigilance Programme of India (BvPI) was announced on 21 September 2026 [1]. The need is genuine; the design is still incomplete.

Why a dedicated programme is justified

• A different shape of harm: one deceased donor supplies organs and tissues to several recipients across hospitals, so an undetected infection or donor-origin cancer becomes a cluster, not a single reaction. Such systems rest on traceability from donor to recipient and back [4].
• Delayed manifestation: transmitted infection and malignancy surface months later, and delayed reactions are globally the least recognised and reported [4]. The ADR model of PvPI, built for conventional medicines [2], cannot capture this.
• Institutional gap: NOTTO runs the retrieval-and-transplant network [3] while IPC coordinates the vigilance verticals [1]; neither alone owned transplant safety surveillance.
• Trust as a policy asset: over 4.8 lakh donor pledges since 17 September 2023 [3] — one unexplained transmission can set back donation for years.

Critical limitations

• BvPI is presently an announcement, not a legal duty — no notified list of reportable events, obligation on hospitals, or timeline [1].
• PvPI, running since July 2010 [2], still requires annual awareness weeks to elicit routine reporting; voluntarism's record is the honest baseline.
• Reports flow to IPC, itself the statutory standards body [2], lacking the arm's-length confidentiality of the UK's SHOT scheme; France mandates confidential reporting of serious events with fixed classification [4].
• Living donors — roughly 82% of Indian transplants [3] — risk falling outside a recipient-focused scope.

BvPI is therefore a necessary correction to a long-standing asymmetry, not a surplus vertical. Anchoring a mandatory reporting duty in the THOTA, 1994, a shared NOTTO–IPC donor identifier, scheduled long-term follow-up and feedback to reporters would convert intent into assurance, advancing patient safety as the quality pillar of universal health coverage (SDG-3).