The Supreme Court issued a set of significant directions to the Union and State governments to strengthen India’s organ donation and transplantation system. The Court noted that despite the Transplantation of Human Organs and Tissues Act, 1994 (THOTA) and its 2011 amendments forming a unified national framework, several States continue to follow outdated rules, resulting in procedural inconsistencies across the country.

A Bench comprising the Chief Justice of India BR Gavai and Justice Vinod Chandran observed that although all States had endorsed the 1994 law, which falls under Entry 6 of the State List, many have still not adopted the revised 2011 rules meant to streamline and expedite transplant processes. The Court recorded that Karnataka, Tamil Nadu, Manipur and Andhra Pradesh were among the States where the updated amendments or corresponding regulations had not yet been brought into force, though Karnataka has recently initiated steps toward compliance.

Emphasising the importance of uniformity, the Bench urged all remaining States to immediately adopt the amended rules, calling the issue one of national importance.

The Court also expressed concern over the absence of State Organ and Tissue Transplant Organisations (SOTOs) in several regions, including Manipur, Nagaland, Lakshadweep and the Andaman & Nicobar Islands, despite SOTOs being essential bodies under the statutory scheme. The Union government was directed to ensure that SOTOs are established in these jurisdictions without delay, with the Secretary of Public Health instructed to personally oversee implementation.

Addressing disparities in how organs are allocated across States, the Bench noted reports of regional variations influenced by factors such as caste and gender. It stressed the need for clear national criteria to eliminate such inequities. The Union government was therefore directed to devise model allocation norms and standardised donor criteria, in consultation with the National Organ and Tissue Transplant Organisation (NOTTO) and the petitioner association.

To safeguard live donors from exploitation, the Court further ordered the framing of comprehensive guidelines addressing donor welfare, preventive safeguards and monitoring mechanisms. It underlined that lack of uniform protection leaves room for commercial exploitation in the absence of cohesive national policy.

Additionally, the Court called for amendments to the statutory birth and death certificate formats (Forms 4 and 4A), directing that they must record whether a death was classified as brain death and whether the family was given the option to donate organs. States were asked to impose strict penalties on hospitals that fail to supply mandatory donor-related information.

The Bench also acknowledged coordinated efforts between the petitioner body, the Union government and various SOTOs during the proceedings. At one point, the Court referred to concerns regarding organised criminal networks linked to illegal organ procurement, noting that such exploitation often surfaces in accident-related cases.

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Siddharth Raghuvanshi