Supreme Court calls for national policy to address inconsistencies in organ transplantation

The Supreme Court on Tuesday issued a series of directions to the Union and State governments, aimed at strengthening India’s organ transplantation framework and addressing the inconsistencies between States when it comes to regulation and procedure for organ donation [Indian Society of Organ Transplantation v. Union].

A bench of Chief Justice of India BR Gavai and Justice Vinod Chandran highlighted critical inconsistencies in the implementation of the Transplantation of Human Organs and Tissues Act, 1994 (THOTA), particularly its 2011 amendments.

The Court pointed out that although the 1994 Act, which was passed following extensive consultations, was listed under Entry 6 of the State List of the Constitution and was later ratified by every State, some States are yet to adopt the important 2011 amendments and associated regulations that were meant to expedite the transplant procedure.

The CJI noted that Karnataka, Tamil Nadu, and Manipur have not yet adopted the revised rules while Andhra Pradesh was yet to implement the 2011 amendments.

On August 21, 2025, Karnataka had passed a resolution, indicating progress on the matter.

"We therefore request all the States who have not implemented the rules to take into consideration importance of the issue and adopt the act and the rules," said the court.

The Bench expressed concern that a number of regions, including Manipur, Nagaland, the Andaman & Nicobar Islands and Lakshadweep, still operate without State Organ and Tissue Transplant Organisations (SOTOs), vital bodies mandated under the national framework.

"We request Union to take on board all States and evolve guidelines for donor welfare including live donors and to ensure they are cared for. To ensure commercialization and exploitation of donors does not happen," said the court.

The bench also stressed the necessity of consistent allocation criteria across the country.

The Court observed that current regional discrepancies in allocation norms result in differences, including those based on caste and gender.

“It is submitted that in the absence of a national policy, transplants cannot be done even if donors are available,” observed the court.

The Court ordered the Union to establish SOTOs in Manipur and Nagaland and directed the Secretary of Public Health to personally supervise compliance.

It further ordered the development of model allocation criteria that address caste and gender-based disparities, along with uniform donor criteria across all states.

It also directed the Union government to draft guidelines protecting live donors and preventing exploitation, after consulting with National Organ and Tissue Transplant Organisation (NOTTO) and the petitioner organisation.

In order to document brain death and whether families were given the choice to donate their organs, the Bench also demanded changes to birth and death certificate forms.

"We request Union in consultation with NOTTO and petitioner organisation to amend forms 4 and 4A of birth and death so that it shows if death was due to brain death and if yes then if option to donate organ was given or not," the Court directed.

Lastly, the Court directed all State governments to impose strict penalties on hospitals that fail to provide the necessary information.

The Court also expressed appreciation for the cooperation between the petitioner, SOTO and the Union government.

Interestingly, the hearing was also privy to a discussion on organised crime surrounding organ procurement.

CJI Gavai remarked that Justice Chandran had warned him about “mafias operating when roadside accidents happen.”

Solicitor General Tushar Mehta concurred, referencing Malayalam film Joseph and its Hindi remake Apne, both of which depict organ trafficking rings exploiting accident victims.

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