The Karnataka High Court on Wednesday permitted a 52-year-old bachelor to donate one of his kidneys altruistically to an unrelated recipient. The state government informed the court that it is framing guidelines to lay down a mechanism for handling cases of altruistic organ donation, Bar and Bench reported.

 

The case raises questions about how organ donation is regulated in India, whether altruistic donation to an unrelated person is permitted and what safeguards are in place to prevent commercial organ trading.

 

What law regulates organ donation in India?

 

Organ donation in India is primarily regulated by the Transplantation of Human Organs and Tissues Act (THOTA), 1994, along with its 2011 amendments and the 2014 national rules.

  

Its broad purposes are to regulate the removal, storage and transplantation of human organs and tissues for therapeutic purposes, regulate living and deceased donation, and prevent commercial dealing in human organs and tissues.

 

How does the organ donation system work in India?

 

The National Organ and Tissue Transplant Organisation (NOTTO) functions at the national level to manage registries, set protocols and oversee fair organ distribution. NOTTO is the apex organisation under the Directorate General of Health Services and is responsible for implementing the National Organ Transplant Programme and maintaining the national registry of donors and recipients.

 

There are also Regional Organ and Tissue Transplant Organisations (ROTTOs) and State Organ and Tissue Transplant Organisations (SOTTOs). This three-tier system coordinates procurement, waiting lists and awareness at the regional and state levels.

 

Who can donate an organ in India?

 

THOTA allows transplantation of human organs and tissues from living donors, and from cadavers after cardiac or brain death. Living donors are classified as either near relatives or non-related donors.

 

A near relative includes the spouse, children, grandchildren, siblings, parents and grandparents. A near-relative donor needs the permission of the doctor in charge of the transplant centre to donate his or her organ. A non-related donor needs the permission of an authorisation committee established by the state to donate an organ.

 

Is altruistic organ donation allowed in India?

 

Altruistic donation essentially means that the donor gives an organ without expecting monetary payment or another prohibited benefit.

 

Altruistic organ donation is legally permitted in India under the Transplantation of Human Organs and Tissues Act (THOTA), 1994, though implementation and formal guidelines vary by state. Section 9(3) of THOTA allows living donations to non-relatives if they are motivated by “affection or attachment” or other special reasons, provided there is no commercial transaction.

 

Unrelated donations require strict clearance from an authorisation committee, which examines whether the donation is entirely voluntary and free from financial motives. The 2014 Rules also contain forms for such cases, requiring the donor and recipient to state the reason for the proposed donation and affirm that the decision was made without undue pressure, inducement, influence or allurement.

 

The framework is intended to prevent a genuine attempt to help a stranger from being used to disguise a commercial transaction. THOTA specifically criminalises false documentation or false affidavits used to establish that an organ donation is being made as a near-relative donation or because of affection or attachment when it is actually part of an illegal arrangement.

 

High courts, including in Kerala and Karnataka, have ruled that genuine altruistic and anonymous donations to strangers are valid under the law and cannot be arbitrarily rejected by authorities based on vague suspicions. Among states, Kerala has established formal guidelines for altruistic donations, while other states such as Karnataka are actively implementing structured protocols.

 

How is illegal organ trading regulated in India?

 

THOTA prohibits commercial dealings in human organs. Section 19 covers making or receiving payment for supplying a human organ, seeking someone willing to supply an organ for payment, offering an organ for payment, initiating or negotiating arrangements involving payment, managing or controlling an organisation involved in such arrangements, advertising offers or requests involving paid organ supply, and helping create or submit false documents to portray an otherwise commercial donation as one between near relatives or based on affection or attachment.

 

THOTA also regulates who can remove organs and under what circumstances. Unauthorised removal of a human organ can attract imprisonment of up to 10 years and a fine of up to ₹20 lakh. Commercial dealings in human organs can attract 5-10 years’ imprisonment and a fine ranging from ₹20 lakh to ₹1 crore.

 

What does international law say about organ donation?

 

The World Health Organisation’s (WHO) Guiding Principles on Human Cell, Tissue and Organ Transplantation, endorsed by the World Health Assembly, provide the main international framework for organ donation and transplantation. They apply to organs obtained from both living and deceased donors and emphasise voluntary, non-remunerated donation, informed consent, protection of donors and equitable allocation of organs.

 

Altruistic donation is recognised as an important principle under the WHO framework. WHO encourages countries to develop systems for voluntary and non-remunerated donation of organs from living and deceased donors. However, the specific rules for altruistic donation are determined by individual countries through their national laws.