The state government has widened access for those who cannot undergo a kidney transplant due to biological incompatibility and issued detailed administrative guidelines to allow for multi-pair kidney swap transplants. Karnataka is the first state in the country to frame such guidelines, officials said.
A Government Order (GO), issued on April 4, operationalizes the provisions of the Transplantation of Human Organs and Tissues Act (THOTA) 1994, which allow kidney exchanges involving three or more donor-recipient pairs, while establishing a structured regulatory and procedural framework.
Officials said a significant number of patients in Karnataka are unable to undergo transplant due to incompatibility factors such as ABO blood group mismatch, positive cross-test or HLA incompatibility. Kidney Paired Exchange (KPE), an internationally recognized and scientifically proven approach, allows such incompatible couples to exchange donors with other couples to achieve compatible matches.
“While section 9(3A) of THOTA expressly allows exchange transplants between two couples, it does not directly address multi-couple exchanges. The absence of any prohibition, along with the 2025 judgment of the Supreme Court in the case of Indian Society of Organ Transplantation vs. Union of India and supporting legal opinion obtained by the state,” the government said to allow official three-way exchanges and above.
Eligibility and Warranties
The guidelines state that multi-pair swaps will only be allowed under strict conditions. Each donor must be a “close relative” of the intended recipient, and each couple must have documented medical evidence of incompatibility. At the same time, cross-swap group compatibility must be ensured through cross-testing and HLA reports certified by NABL-accredited laboratories.
All donors and recipients are required to enter into a single joint exchange consent agreement. The regulation mandates that all clinical, immunological, psychological and legal evaluations prescribed by law and regulations be carried out to the satisfaction of the relevant authority and authorization committee. It also expressly prohibits any form of commercial transactions.
Approval and supervision
Any multi-pair exchange transplant will require prior authorization committee approval, with the state-level authorization committee having jurisdiction over all such cases, including those involving multiple hospitals or districts.
The committee was tasked with additional scrutiny, including verifying that the swap pool contained only close-related pairs, ensuring that no participant was replaced by agreement without new approval, and conducting individual interviews with all donors and recipients, which must be videotaped.
The guidelines also prescribe a timeline that requires the authorization committee to make a decision within 24 hours of convening its meeting.
Documentation and procedure
Hospitals must submit extensive documentation, including Form 11 applications prepared jointly by donors and recipients, proof of relationship, medical fitness certificates, incompatibility reports and declarations confirming the absence of financial transactions.
A single joint agreement signed by all participants together with certification by the authorization committee is mandatory. Surgical procedures should be performed simultaneously if possible to avoid failure of the replacement device. Where this is not possible, transplants can be done in a closely coordinated sequence with prior approval, the GO said.
In multi-hospital cases, a detailed inter-hospital coordination plan must be submitted in advance and organ transport must be in accordance with THOTA 2014 protocols. The process will be overseen by a designated transplant coordinator.
Monitoring and reporting
Guidelines emphasize post-transplant monitoring and reporting. All participating hospitals must report details of such transplants to the State Organ Transplantation Organization (SOTTO) and the national registry in prescribed formats, while maintaining long-term donor and recipient follow-up data. The state will compile consolidated data and submit regular reports.
Recognizing that multi-pair swaps are relatively new in Karnataka, the government directed that initial cases be treated as special cases, with decisions subject to further review or guidance if necessary.
The CC clarifies that the guidelines are administrative in nature and are in line with the provisions of THOTA and the Supreme Court judgment of 2025 and will remain in force until formal changes are made to the Central Act.
Published – 06 Apr 2026 19:42 IST
