Organ donation in India — who can donate, and the legal process
Organ and tissue donation in India runs on a single statute and one rulebook — the Transplantation of Human Organs and Tissues Act, 1994 (THOTA), the THOTA (Amendment) Act, 2011 which added tissues, swap transplants and stiffer penalties to the original frame, and the THOT Rules, 2014 which set out the forms, the Authorisation Committee composition, the brain-stem-death board and the NOTTO allocation procedure. The Act recognises four donor routes — the near-relative living donor under Section 9 read with Section 2(i), the unrelated living donor whose donation must be cleared by an Authorisation Committee under Section 9(3), the cadaveric donor whose organs are retrieved after brain-stem death is certified by a four-member board under Section 3(6), and the swap-transplant donor under Section 9(3A) where two near-relative pairs exchange. Commercial dealing in organs is a non-compoundable offence under Section 19 punishable with five to ten years' imprisonment and a fine between rupees twenty and one crore. The constitutional frame — body autonomy as a facet of Article 21 — is supplied by Common Cause v Union of India, (2018) 5 SCC 1 and Aruna Shanbaug v Union of India, (2011) 4 SCC 454. This guide sets out the donor categories, the authorisation chain, the brain-stem-death procedure and the swap route — the four legal gates a transplant has to clear.
India's transplant programme is built on a single statute that combines three distinct decisions in one frame — who may donate while alive, who may donate after death, and what the State will do to those who buy or sell an organ. The Transplantation of Human Organs and Tissues Act, 1994 was enacted to end an unregulated kidney trade that had taken root in the south Indian cities in the late 1980s; it was amended substantially in 2011 to add tissues, swap transplants and a sharper penalty regime; and it has been operationalised since 2014 by the THOT Rules, which set out the Authorisation Committee composition, the four-member brain-stem-death board, the NOTTO registry architecture and the consent forms in their statutory form. The Supreme Court's decision in Common Cause v Union of India, (2018) 5 SCC 1 — which constitutionalised the advance directive — and its earlier decision in Aruna Shanbaug v Union of India, (2011) 4 SCC 454 — which laid the foundation for the brain-stem-death framework — supply the constitutional architecture into which the Act fits. This article sets out the donor categories, the procedural gates and the offence regime, in the form a researcher needs to follow a typical living-donor or cadaveric-donor file.
The Act, the Amendment and the Rules — the statutory frame
The Transplantation of Human Organs Act, 1994 was enacted to provide for the regulation of removal, storage and transplantation of human organs for therapeutic purposes and to prevent commercial dealings in human organs. The 2011 amendment renamed the Act to add "and Tissues" — extending the regulatory frame to bone, skin, cornea, heart valves and other tissues that had become transplantable in the intervening years — and added swap-transplants under Section 9(3A), modified the Authorisation Committee composition, mandated tissue banks, introduced a transplant coordinator in every hospital registered for transplantation, and substantially raised the penalty for commercial dealings. The THOT Rules, 2014 — which superseded the 1995 Rules — operationalise the amended Act through 36 Forms covering everything from the near-relative donor's affidavit (Form 1) to the cadaveric-donor consent (Form 8) to the Authorisation Committee proceedings (Form 11) to the brain-stem-death certification (Form 10).
Section 2 supplies the definitional vocabulary the rest of the Act runs on. Section 2(f) defines "human organ" as any part of a human body consisting of structured arrangement of tissues which, if wholly removed, cannot be replicated by the body. Section 2(i) defines "near relative" — the category whose donation is procedurally simplest — as the spouse, son, daughter, father, mother, brother, sister, grandfather, grandmother, grandson or granddaughter of the recipient. The 2011 amendment expanded the list by adding grandparents and grandchildren to the original five-member spouse-son-daughter-father-mother-brother-sister set; aunts, uncles, cousins, parents-in-law and other affines are not "near relatives" within Section 2(i) and have to take the unrelated-donor route through the Authorisation Committee. Section 2(c) defines "brain-stem death" — the trigger for cadaveric donation — as the stage at which all functions of the brain-stem have permanently and irreversibly ceased; the certification mechanism is in Section 3(6).
The four donor routes
The Act recognises four routes by which an organ or tissue may lawfully be removed for transplantation. Each runs through a different procedural gate.
Route one — the near-relative living donor. Section 9(1) read with Section 9(1A) permits a living donor who is a near relative within Section 2(i) to authorise the removal of an organ for transplantation into the body of another near relative. The authorisation is in writing in Form 1 of the THOT Rules, 2014, executed before two witnesses and a Notary; the donor must also produce documentary proof of the near-relative relationship — passport, birth certificate, ration card showing both names, family tree certified by a Sub-Divisional Magistrate, and so on. Once the relationship is documented to the satisfaction of the registered medical practitioner who is to perform the transplant, the donation proceeds without reference to the Authorisation Committee. This is the procedurally simplest route, and accounts for the great majority of living-donor transplants in India — typically a parent or sibling donating a kidney or a portion of liver to a child or sibling.
Route two — the unrelated living donor. Section 9(3) permits a living donor who is not a near relative within Section 2(i) — a friend, a parent-in-law, a more distant relation, or any other person — to donate an organ to the recipient, but only with the prior approval of the Authorisation Committee constituted under Section 9(4) read with Rule 7 of the THOT Rules, 2014. The Committee is to satisfy itself, recording reasons, that there is no commercial transaction between the donor and the recipient — that the donor is not being paid, in money or in kind, beyond reasonable reimbursement of expenses. The Committee, in a State-level configuration under Rule 7(1), consists of a Director of Medical Education or his nominee, a Government Secretary not below Joint Secretary rank, a Director of Health Services or his nominee, two senior medical practitioners drawn from a panel maintained by the State Government, and two non-medical persons "of high standing and integrity" in society. The Committee personally interviews both the donor and the recipient under Rule 7(3), examines the documentary evidence of the affection-and-attachment basis claimed for the donation, and either approves the donation in Form 11 or refuses it with reasons.
Route three — the cadaveric donor. Section 3 read with Section 6 governs removal of organs from a deceased donor. Two sub-categories exist. Where the donor, before death, had authorised the removal in writing in the presence of two witnesses, the organs may be removed without the consent of the family — Section 3(1). Where no such authorisation exists, the person lawfully in possession of the dead body — typically the next-of-kin — may grant or withhold consent under Section 3(2), and the consent extends only to organs in respect of which it is granted. The authorisation procedure for brain-stem-death cadaveric donation is in Section 3(6) — the certification must be by a board of four medical experts consisting of the registered medical practitioner in charge of the hospital where brain-stem death has occurred, a medical practitioner nominated from a panel by the in-charge, a neurologist or neurosurgeon nominated from a panel similarly, and a registered medical practitioner attending on the deceased; the certification is in Form 10 of the THOT Rules, 2014, recorded twice at an interval of six hours.
Route four — the swap transplant. Section 9(3A), introduced by the 2011 amendment, permits a "swap transplant" — where the donor of one near-relative pair is medically incompatible with the recipient of that pair but compatible with the recipient of a second near-relative pair, and the donor of the second pair is correspondingly compatible with the recipient of the first. The Act permits the two donor-recipient pairs to exchange — each donor donates to the other pair's recipient. The exchange must still pass through the Authorisation Committee under Section 9(3A) read with Rule 7(2A), with the Committee required to satisfy itself that the two pairs are bona fide near-relative pairs and that the exchange is not a disguised commercial transaction. The swap route has come into substantial use after 2014, particularly for kidney exchanges across HLA-mismatched pairs.
The Authorisation Committee — composition, procedure and standard of review
The Authorisation Committee is the operational heart of the unrelated-donor regime. Its composition and procedure are set out in Section 9(4) of the Act read with Rules 7 and 24 of the THOT Rules, 2014. A State-level Committee, constituted under Rule 24, sits in the State capital and handles cases from State-run hospitals and from private hospitals that do not have their own Hospital-Based Committee. A Hospital-Based Authorisation Committee, constituted under Rule 7 for any hospital that performs more than 25 transplants per year, sits within the hospital and consists of three medical practitioners on the hospital staff (the Medical Director or Medical Superintendent as Chair, a Senior Medical Practitioner and an Anaesthesiologist), two senior medical practitioners not connected with the hospital nominated by the appropriate authority, and two non-medical persons of high standing.
The procedure under Rule 7(3) is the Committee personally interviewing both donor and recipient, separately and together, with a transplant coordinator present; examining the documents tendered — Affidavit of donor in Form 2, recipient's affidavit in Form 6, photographs of donor and recipient together, evidence of the long-standing affection-and-attachment relationship claimed (joint photographs, joint financial transactions, evidence of cohabitation or shared life-events, certificates from local authorities or community leaders); recording the proceedings in Form 11; and either approving the donation or refusing it with reasons. The Committee's order is appealable under Section 17 to the appropriate State or Central authority within thirty days; in practice, refusals are also challenged by way of writ petition before the High Court under Article 226.
The standard the Committee applies is whether the donation is "by reason of affection or attachment towards the recipient or for any other special reasons" rather than for any commercial consideration — the formulation in Section 9(3). The Madras High Court in a line of decisions following Kuldip Singh v State of Tamil Nadu, (2003) 12 SCC 528 (a habeas-corpus case decided in a different context but cited for the THOTA frame) and subsequent High Court rulings has insisted that the Committee record reasons for both approval and refusal, that the donor and recipient be heard separately and given an opportunity to explain the relationship, and that the Committee not refuse approval merely because the donor and the recipient are not blood-related — friendship, gratitude, long-standing co-residence and similar attachments are valid foundations for an unrelated donation if the Committee is satisfied that there is no commercial transaction. The Committee's discretion is wide, but it is structured discretion — exercisable on reasons, on evidence, and subject to judicial review.
Brain-stem death and the cadaveric route — Section 3(6) and Form 10
The cadaveric-donor route opens once brain-stem death has been certified under Section 3(6). The procedure is exacting and is the operational gateway to the national organ-pool that the NOTTO registry administers. The four-member board of experts identified in Section 3(6) — the registered medical practitioner in charge of the hospital, a medical practitioner nominated from a panel of experts by the in-charge, a neurologist or neurosurgeon nominated from a panel by the in-charge, and the treating physician of the deceased — performs the certification by examining the deceased for the clinical criteria of brain-stem death (absent brain-stem reflexes, fixed and dilated pupils, no response to painful stimuli, no spontaneous respiration on apnoea testing, absent oculo-cephalic and vestibulo-ocular reflexes). The certification is in Form 10 of the THOT Rules, 2014, and must be done twice at an interval of six hours. Once both certifications are complete, the patient is declared brain-stem dead and organ retrieval may proceed in accordance with the consent given by the family under Section 3(2) or by the deceased before death under Section 3(1).
The legal architecture for withdrawal of life support — distinct from but adjacent to brain-stem death — is the architecture laid down by the Constitution Bench in Common Cause v Union of India, (2018) 5 SCC 1 read with the simplification order of 24 January 2023 in M.A. 1699 of 2019. Brain-stem death is not "withdrawal of treatment" in the Common Cause sense — it is the legal death of the patient, after which there is no patient left to whom treatment is being given. Aruna Shanbaug v Union of India, (2011) 4 SCC 454 — though decided on the different question of passive euthanasia for a patient in a persistent vegetative state — laid the foundation for the recognition of brain-stem-death as a legally distinct category from cardiopulmonary death, a recognition formalised by the THOTA framework. The two doctrines now operate in tandem — the brain-stem-death certification under Section 3(6) opens the cadaveric donation; the advance-directive doctrine under Common Cause opens the withdrawal-of-treatment route in cases where brain-stem death has not occurred but the patient cannot benefit from continued treatment.
NOTTO and the national allocation framework
The National Organ and Tissue Transplant Organisation (NOTTO) is the apex coordinating body under the Directorate General of Health Services, Ministry of Health and Family Welfare. It administers the National Organ Transplantation Programme and operates the NOTTO registry — the national waiting list to which every transplant centre in India must report. The Regional Organ and Tissue Transplant Organisations (ROTTOs) coordinate at the regional level; the State Organ and Tissue Transplant Organisations (SOTTOs) operate at the State level. The allocation guidelines issued by NOTTO under Rule 31 of the THOT Rules, 2014 — most recently revised in 2024 — set out the priority criteria for cadaveric organ allocation: medical urgency, waiting-time on the national list, blood-group and HLA matching, geographic proximity, and the principle that paediatric recipients have priority for paediatric donors.
The 2024 NOTTO guideline change removed the earlier domicile requirement — under which a recipient could be on the waiting list only of the State in which he or she was resident — and made the national registry the single waiting list, with allocation following the medical-and-temporal priority criteria irrespective of State of residence. The change followed a number of representations from out-of-State patients who had been excluded from in-State cadaveric pools despite higher medical urgency. The change does not affect the procedural aspects of donor authorisation under Section 9 — those remain State-level, with the appropriate Authorisation Committee being the one in the State where the donor and recipient are located.
Consent, capacity and the constitutional frame
The consent architecture for organ donation operates on two distinct planes. For the living donor, the consent is to undergo surgery and to part with an organ — a consent governed by the general law of informed consent for medical procedures laid down by the Supreme Court in Samira Kohli v Dr Prabha Manchanda, (2008) 2 SCC 1 (which articulated seven propositions on informed consent), read with the seven good-faith exceptions in Sections 26 to 31 of the Bharatiya Nyaya Sanhita, 2023 [Sections 88 to 93 of the IPC] under which a surgical procedure done with the patient's consent in good faith for the patient's benefit is not an offence. Section 11 read with Section 14 of the Indian Contract Act, 1872 supplies the contractual capacity framework — a donor below 18 years is not a competent donor under Section 2(j) read with Section 9(1A) of the Act; a donor of unsound mind is not a competent donor; a donor whose consent was obtained by coercion, undue influence, fraud or misrepresentation is not a freely-consenting donor and the donation is liable to be set aside.
For the cadaveric donor, the consent is either the pre-mortem authorisation under Section 3(1) (the donor signed a pledge in his lifetime, witnessed by two persons), or the post-mortem consent of the person lawfully in possession of the body under Section 3(2). The Mental Healthcare Act, 2017 — Sections 4 and 5 — supplies the capacity framework for an advance directive (which is not, in itself, an organ-donation pledge, but which may include one); the constitutional foundation is Article 21 read with the privacy doctrine of KS Puttaswamy v Union of India, (2017) 10 SCC 1, under which decisions about one's body — including the decision to donate an organ during life or after death — fall within the constitutional protection of personal autonomy. Common Cause v Union of India, (2018) 5 SCC 1 read this autonomy doctrine into the medical context.
Commercial dealings — the Section 19 offence regime
The Act treats commercial dealing in organs as a criminal offence of substantial gravity. Section 19, as amended in 2011, punishes any person who makes or receives any payment for the supply of, or for an offer to supply, a human organ or tissue with imprisonment for a term not less than five years which may extend to ten years and with a fine not less than rupees twenty lakh which may extend to rupees one crore. The offence covers the donor, the recipient, the middleman, the doctor and the hospital — anyone who participates in the commercial transaction. Section 20 punishes contraventions of the other provisions of the Act — running an unregistered transplant centre, failing to maintain records, removing an organ without authorisation under Section 9 — with imprisonment up to five years and fine up to rupees twenty lakh. Section 22 makes a doctor who has been convicted under the Act liable to have his registration suspended or cancelled by the State Medical Council.
Sections 13 and 14 of the Act constitute the regulatory architecture — Section 13 establishes the Appropriate Authority that registers transplant centres and inspects them, Section 14 sets out the registration procedure. A transplant performed in an unregistered centre is not a defence to a commercial-dealing prosecution; it is an additional offence. The 2011 amendment also introduced Section 18A — making it mandatory for every hospital registered for transplantation to appoint a transplant coordinator under Rule 5(b), whose function is to identify potential donors, counsel families, and liaise with NOTTO. The transplant coordinator is the operational hub of the cadaveric-donor pipeline; the registered medical practitioner remains the legal-decision-maker.
What the framework permits and what it does not
The THOTA framework permits four things — near-relative donation on documentary proof of relationship, unrelated donation on Authorisation-Committee clearance, cadaveric donation on brain-stem-death certification, and swap donation on dual-Committee clearance. It does not permit — and treats as a Section 19 offence — any donation in which payment passes between the donor and the recipient or any other person involved in the transaction. The line between reimbursement of expenses (which the Act permits) and commercial consideration (which the Act criminalises) is the line the Authorisation Committee must police on the facts before it. Reasonable medical expenses, travel costs, post-operative care for the donor, loss of wages during the recovery period — these are permitted reimbursements. Payment for the organ itself, in money or in kind, is the offence.
The contested operational questions — whether the Authorisation Committee is bound to approve a donation where the documentary evidence of affection-and-attachment is strong but the Committee suspects an undisclosed commercial dimension (the answer is no — the Committee retains discretion to refuse on reasons), whether a refusal by a Hospital-Based Committee can be reviewed by the State Committee or only by writ petition (the answer varies by State), whether the brain-stem-death certification under Section 3(6) can be challenged by the family who disagrees with the diagnosis (the answer is yes, by writ petition; courts have been reluctant to interfere where the four-member board has followed the Form 10 procedure), and whether the swap-transplant route under Section 9(3A) can be used for three-way or four-way exchanges (the Act contemplates pair-wise exchange; multi-way exchanges have been approved in some States by extending the Section 9(3A) framework, but the practice is not uniform across States) — continue to work themselves out at the State-Authorisation-Committee and High-Court level.
The practical takeaway for a researcher reading the THOTA file is that the Act is procedurally dense but doctrinally clear. The four routes are the four routes; the Authorisation Committee is the gate; the brain-stem-death board is the gate for cadaveric donation; the Section 19 offence is the line. A transplant that clears the relevant gate is lawful; a transplant that does not clear the gate is unlawful and exposes everyone involved to the Section 19 or Section 20 offence. The constitutional frame in Common Cause and Aruna Shanbaug supplies the autonomy backdrop; the statutory frame in THOTA supplies the operational machinery; the Authorisation Committee supplies the case-by-case judgment.