Karnataka frames guidelines for multi-pair kidney swap transplants

Expanding access for those unable to undergo renal transplantation due to biological incompatibility, the State government has issued detailed administrative guidelines enabling multi-pair kidney paired exchange (swap) transplants. Karnataka is the first State to frame such guidelines in the country, officials said.

A Government Order (GO), issued on April 4, operationalises provisions under the Transplantation of Human Organs and Tissues Act (THOTA), 1994, to permit kidney swaps involving three or more donor-recipient pairs, while laying down a structured regulatory and procedural framework.

Officials said a significant number of patients in Karnataka are unable to undergo transplantation due to incompatibility factors such as ABO blood group mismatch, positive crossmatch, or HLA incompatibility. Kidney Paired Exchange (KPE), an internationally accepted and scientifically validated approach, allows such incompatible pairs to exchange donors with other pairs to achieve compatible matches.

“While Section 9(3A) of THOTA explicitly allows swap transplants between two pairs, it does not directly address multi-pair exchanges. However, the absence of any prohibition, along with the Supreme Court’s 2025 judgment in Indian Society of Organ Transplantation vs. Union of India and a supporting legal opinion obtained by the State, has enabled the government to permit three-way and higher-order swaps,” officials said.

Eligibility and safeguards

The guidelines stipulate that multi-pair swaps will be allowed only under strict conditions. Each donor must be a ‘near relative’ of the intended recipient, and each pair must have documented medical evidence of incompatibility. At the same time, compatibility must be established across the swap group through cross-match and HLA reports certified by NABL-accredited laboratories.

All donors and recipients are required to enter into a single joint agreement consenting to the exchange. The order mandates that all clinical, immunological, psychological and legal evaluations prescribed under the Act and Rules be completed to the satisfaction of the Appropriate Authority and the Authorisation Committee. It also explicitly prohibits any form of commercial transaction.

Approval and oversight

Every multi-pair swap transplant will require prior approval from the Authorisation Committee, with the State-Level Authorisation Committee vested with jurisdiction over all such cases, including those involving multiple hospitals or districts.

The Committee has been tasked with additional scrutiny, including verifying that the swap group comprises only near-relative pairs, ensuring that no participant is substituted after the agreement without fresh approval, and conducting individual interviews of all donors and recipients, which must be video-recorded.

The guidelines also prescribe a timeline, requiring the Authorisation Committee to take a decision within 24 hours of convening its meeting.

Documentation and procedure

Hospitals must submit extensive documentation, including Form 11 applications jointly executed by donors and recipients, proof of relationship, medical fitness certificates, incompatibility reports, and declarations affirming the absence of financial transactions.

A single joint agreement signed by all participants is mandatory, along with certification from the Authorisation Committee. Surgical procedures are to be conducted simultaneously, as far as possible, to prevent breakdown of the swap arrangement. Where this is not feasible, transplants may be carried out in a closely coordinated sequence with prior approval, stated the GO.

In cases involving multiple hospitals, a detailed inter-hospital coordination plan must be submitted in advance, and organ transport must comply with protocols under the THOTA Rules, 2014. A designated transplant coordinator will oversee the process.

Monitoring and reporting

The guidelines emphasise post-transplant monitoring and data reporting. All participating hospitals must report details of such transplants to the State Organ Transplant Organisation (SOTTO) and the national registry in prescribed formats, while also maintaining long-term follow-up data for donors and recipients. The State will compile consolidated data and submit periodic reports.

Recognising that multi-pair swaps are relatively new in Karnataka, the government has directed that initial cases be treated as special cases, with decisions subject to additional review or guidance, if required.

The GO clarifies that the guidelines are administrative in nature and consistent with the provisions of THOTA and the 2025 Supreme Court judgment, and will remain in force until any formal amendments are made to the central law.

Published – April 06, 2026 07:42 pm IST