Many States/UTs Still Non-Compliant with Organ Transplant Framework, SC Issues Detailed Directions
The National Organ and Tissue Transplant Organization must come forward with a national policy also for the health of a live donor, says SC
Supreme Court issues directions on organ transplant framework, urging states to adopt 2011 amendment and 2014 Rules for a national organ donation policy
The Supreme Court has asked all States and Union Territories that have not yet adopted the 2011 amendment and the 2014 Rules to the Transplantation of Human Organs Act, 1994, to take into consideration the importance of the issue and adopt them at the earliest.
A bench of Chief Justice of India B R Gavai (since retired) and Justice K Vinod Chandran noted that the primary purpose of the 2011 amendment was to bring ‘tissue’ transplants within the ambit of the 1994 Act. The amendment also introduced Section 9(3A), enabling swap transplantation for the first time, broadened the definition of ‘near relatives,’ set up the National Human Organs and Tissues Removal and Storage Network, and created the National Registry for Transplants. The Transplantation of Human Organs and Tissue Rules, 2014, were subsequently framed in line with these changes.
Court was hearing a writ petition filed by the Indian Society of Organ Transplantation, which sought to highlight issues of uniformity, equality and access in organ donation for both donors and recipients.
During the proceedings, the bench found that Andhra Pradesh has still not adopted the 2011 amendment, while Karnataka, Telangana, Andhra Pradesh and Manipur have not adopted the 2014 Rules. “Such a non-adoption till now severely impedes the possibility of a uniform national policy and national grid and reduces the chances of transplantation in the concerned States as well as the rest of the country,” the bench observed.
Court further noted that Meghalaya, Nagaland and three Union Territories i.e. Andaman and Nicobar Islands, Lakshadweep, and Ladakh, are functioning without a State Organ and Tissue Transplant Organization (SOTTO), without which organ or tissue transplant work cannot be performed.
Concurring with the Kerala High Court’s judgment in Moideen v. State of Kerala (2017), the bench reiterated that while the life of a recipient must be protected, the life of a live donor who parts with a valuable part of their body must equally be safeguarded and adequately cared for after the procedure. “We find it appropriate that the National Organ and Tissue Transplant Organization must come forward with a national policy which also addresses concerns with regard to the maintenance of the health of a live donor after the operation is carried out,” court said.
The bench issued the following directions:
i. The UoI to persuade Andhra Pradesh to adopt the 2011 amendment by explaining to them the importance of such adoption.
ii. The UoI to persuade Karnataka, Telangana, Andhra Pradesh and Manipur to adopt the 2014 Rules.
iii. The Secretary, Health and Family Welfare to personally monitor the twin points.
iv. The UoI to constitute a SOTTO for Meghalaya and Nagaland under the aegis of National Organ Transplant Program after due consultation with the concerned States.
v. The Uof through NOTTO to evolve model allocation criteria in consultation with all the States so as to ensure a uniform national policy for transplantation.
vi. The Uof through MHA in consultation with NOTTO, MoF&FW and the petitioner organization to consider amending Form 4 and Form 4A of the Registration of Births and Deaths Rules, 1999 so as to include a column on whether the deceased was a case of brain-stem death and if that be the case to indicate whether the option to donate organs was given to the relatives of the deceased.
vii. The UoI through NOTTO to evolve national swap transplantation guidelines in consultation with all States to implement Section 9(3) of the 1994 Act.
viii. The UoI through NOTTO in consultation with all the States/Union Territories to develop transplantation facilities where there are inadequate public health facilities. Further, the Union of India through the NOTTO is requested to develop a five-year plan mapping the course for development of transplantation facilities in India.
ix. The UoI to take on board all the States/Union Territories through the NOTTO and evolve guidelines for welfare of live donors, including measures to ensure an informed and voluntary consent, maintenance of a portal, mandatory follow-up with the doctors and to ensure they are cared for.
x. All the States/Union Territories to ensure that data related to organ donation and transplantation along with the details of donors and recipients of organs and tissues is reported by the concerned hospitals to the national registry maintained by the NOTTO as mandated under Section 13D of the 1994 Act.
xi. All the State Governments/Union Territory Administrations to ensure that strict action is taken against the defaulting hospitals, who fail to furnish the data as has been directed.
Court fixed the matter for consideration after six months.
Case Title: Indian Society of Organ Transplantation Vs Union of India & Ors
Order Date: November 19, 2025
Bench: Chief Justice of India B R Gavai (since retired) and Justice K Vinod Chandran