Context: Despite nearly three decades of the Transplantation of Human Organs and Tissues Act (THOTA), 1994, India’s deceased organ donation ecosystem remains underdeveloped. According to The Hindu, the deceased donor rate continues to be critically low, highlighting systemic, legal, and operational constraints.
Organ Donation Performance in India
India’s deceased organ donation rate stood at 0.77 per million population (pmp) in 2023, starkly lower than Spain’s 49.38 pmp, the global leader. An estimated 5 lakh Indians die annually due to non-availability of organs. Although over 50,000 Brainstem Death (BSD) cases are medically eligible each year, only 700–900 deceased donors are realised.
Further, 85% of transplants rely on living donors, unlike developed countries where 70–80% are from deceased donors. Alarmingly, only 2–3% of ICU deaths undergo BSD certification. The apnea test is mandatory for confirming irreversible loss of brainstem function and is central to BSD determination.
Legal and Institutional Framework
The THOTA, 1994 provides the statutory backbone for organ transplantation in India. It:
- Recognises Brainstem Death as legal death, enabling deceased donation.
- Regulates living donations, transplant hospitals, and penalises organ trade.
- Prescribes certification and consent norms (Form 10 for BSD declaration; Form 8 for consent).
Institutional mechanisms include:
- NOTTO: National apex body for organ allocation, registry, and coordination.
- ROTTO: Regional coordination across States.
- SOTTO: State nodal agencies for training, hospital networking, and awareness.
Key Challenges
- Low BSD Utilisation: Massive gap between eligible and certified BSD cases.
- Dual Death Certificate Ambiguity: Issuance of both BSD and cardiac death certificates causes legal uncertainty and delays.
- Restricted Certification Locations: BSD certification allowed only in registered transplant centres, excluding over 90% of public ICU hospitals.
- Doctor Approval Bottleneck: Less than 8% of government doctors are authorised for BSD certification.
- Consent Timing Errors: Families often approached before formal BSD certification, leading to 60–70% refusal rates in major public hospitals.
Way Forward
- Universal BSD Certification: Permit all ICU-equipped hospitals to certify BSD, as practiced in Spain.
- Single Death Certificate Rule: Recognise BSD as the final legal time of death; Kerala’s 2020 order is a best practice.
- Trained Transplant Coordinators: Deploy certified counsellors in ICUs; Tamil Nadu’s model increased donations by over 400%.
- Digital BSD Registry: Establish a real-time, integrated BSD and organ availability platform linked with NOTTO and SOTTO.