Organ Transplantation in India

India’s organ transplantation framework, governed by the Transplantation of Human Organs and Tissues Act (THOTA), 1994, continues to face legal and procedural bottlenecks, particularly around brainstem death (BSD) certification.

These gaps are hindering deceased organ donation, contributing to India’s extremely low donation rate of 0.77 donations per million population.

About Organ Transplantation

Organ transplantation is a critical intervention for end-stage organ failure, involving grafting organs from living or deceased donors.
India now ranks third globally, after the U.S. and China, in the annual number of transplants performed.
An estimated 5 lakh Indians die each year due to the non-availability of suitable organs.
Around 85% of transplants in India are still from living donors, unlike developed nations, where deceased donations account for 70-80% of all transplants.

Removal of the 65-year age limit for registration for deceased donor organs.
Scrapping the requirement of state domicile for patients registering for organ transplant.
Expansion of the National Organ Transplant Programme (NOTP) across all States/UTs.

Transplantation of Human Organs and Tissues Act (THOTA), 1994, covers both deceased donations (following BSD) and living donor transplants.
The Act legally recognises Brainstem Death as a valid form of death and prescribes the certification procedure through a four-member medical board.
Deaths from BSD and cardiac arrest are legally equivalent, since both fall under “permanent disappearance of all evidence of life” as defined in THOTA (1994) and the Registration of Births and Deaths Act (1969).
THOTA regulates organ retrieval, storage and transplantation and prohibits commercial dealings in human organs and tissues.
Form 4 (under the 1969 Act) differentiates cause and mode of death, allowing BSD to be recorded as a valid mode.

NOTTO (National Organ and Tissue Transplant Organisation), the national apex body for coordination, data management, organ allocation and awareness.
5 ROTTO (Regional Organ and Tissue Transplant Organisation), eegional coordination centres.
14 SOTTO (State Organ and Tissue Transplant Organisation): State-level bodies for local oversight.

One Nation One Policy: Launched in 2024 to standardise age limits, domicile criteria, and registration fees for organ transplants across states.
Aadhaar-Linked Portal: Introduced in 2023 to facilitate digital donor pledges through Aadhaar-based identity verification.
Angdaan Jan Jagrukta Abhiyan: Started in 2024 to raise public awareness and dispel social myths.
NOTP Programme: National initiative expands capacity, trains staff, and upgrades hospital infrastructure.
Green Corridors: Priority routes enable timely organ transport, improving transplant survival rates.
Campaigns: Angdaan Mahotsav & Organ Donation Day counter myths and mobilize participation.
Insurance Coverage: AB-PMJAY includes transplants, reducing catastrophic costs for poor households.
Air Ambulances: Kerala’s state model demonstrates faster retrieval from remote and coastal regions.

Confusion Over Equivalence of BSD: Many practitioners and hospitals remain unsure whether BSD can be registered as death if families withhold consent for donation.
- This leads to unnecessary extension of life support, straining ICU ventilator capacity.
Dual death certificates: Many transplant centres issue an additional cardiac death certificate after organ retrieval, leading to inconsistencies and potential legal disputes.
Consent-related Gaps: Law requires BSD to be diagnosed before approaching the family for consent (Rule 5 and Form 8).
- Lack of clarity results in inconsistent practices across hospitals.

Only registered transplant hospitals or Non-Transplant Organ Retrieval Centres (NTORCs) currently certify BSD. This contradicts Rule 5, which requires BSD certification in any hospital with ICU facilities.
Requirement that two out of four certifying doctors must be approved by the Appropriate Authority (AA) has become a bureaucratic hurdle.
- No special eligibility criteria exist; this makes approval redundant.
Form 10 for BSD certification does not include the time of death, creating registration difficulties.
- Kerala addressed this by defining the time of death as the moment when arterial pCO₂ hits target levels during the second apnoea test.

Amend THOTA to explicitly allow BSD identification, certification, and organ retrieval in all ICU-equipped hospitals, not just registered transplant centres.
Remove the requirement for AA-approved doctors; mandate that certifying doctors be registered specialists.
Update Form 10 to include the time of death for seamless registration.
Standardise BSD certification protocols across states and strengthen doctor training.
Improve hospital-level systems to ensure that BSD is consistently recognised and certified, regardless of eventual organ donation.