The Transplantation of Human Organs Act 1994, Act 42 of 1994, was written to do two things that pull against each other, and the friction between them explains almost everything about how Indian transplant law behaves in practice. Its long title promises, in one breath, to regulate the removal, storage and transplantation of human organs for therapeutic purposes and to prevent commercial dealings in human organs. The first promise is enabling: before this statute, a surgeon who removed a heart or a liver from a person whose brain had died but whose heart still beat had no legal foundation for the act, because Indian law recognised death only when the heart stopped, and an organ taken after the heart stops is usually an organ already lost. The second promise is prohibitory: by the early 1990s India had become a destination in a global trade in kidneys, in which poor sellers, brokers and willing hospitals formed a market that Parliament intended to extinguish. A statute that opens a lawful channel for donation while sealing every channel through which money might flow is a statute built around suspicion of its own subject, and that design choice, generosity and suspicion in the same text, is the key to the whole Act.

The result is a law that is simultaneously permissive and restrictive in a way that confuses families at the worst moment of their lives. A wife may give a kidney to her husband as a matter of course. A friend of thirty years may not give one to the same man without persuading a statutory committee that the gift is affection and not commerce. A young man killed on a motorcycle may save six strangers, but only if a four-member board certifies his death in a prescribed form, only if his family is asked the right question by the right doctor in the right sequence, and only if the hospital holding his body is registered for the purpose. Every one of those conditions is a considered legislative choice, and each has a history. This article works through the statute as a pillar of Indian health law: what it replaced, the constitutional oddity that decides where each version of it applies, the definition of death on which deceased donation rests, the near relative rule and the committee that polices its boundary, the swap donation route added in 2011, the registration machinery for hospitals and tissue banks, the penalty ladder, the enforcement record, and an honest account of where the statute succeeds and where it does not.

What existed before, and why it failed

The law that the 1994 Act displaced was a patchwork written for single organs and single places. In Delhi, which as a Union territory could be legislated for directly, Parliament had enacted the Eyes (Authority for Use for Therapeutic Purposes) Act, 1982 and the Ear Drums and Ear Bones (Authority for Use for Therapeutic Purposes) Act, 1982, two narrow statutes that authorised removal of corneas and ear bones from the dead. Maharashtra had its own Maharashtra Kidney Transplantation Act, 1982 and the older Bombay Corneal Grafting Act, 1957. Between them, these statutes covered eyes, ears and kidneys in fragments of the country, and said nothing at all about the heart, the liver, the lungs or the pancreas, the organs whose transplantation was becoming technically routine in Indian operating theatres. A heart transplant programme could not be built on a corneal grafting statute. The Statement of Objects and Reasons appended to the 1994 Bill records the position plainly: there was no comprehensive legislation to regulate the removal of organs from living and deceased persons, and in the absence of legal sanction the removal of organs from persons suffering brain-stem death had not been possible, which impeded transplantation of organs like the liver and the heart for which the technology existed in the country.

The second failure was worse than the first. While deceased donation had no legal channel at all, living donation had a thriving illegal one. Through the 1980s and into the 1990s, investigative reporting and official inquiry documented a trade in which kidneys moved from poor donors in India to wealthy recipients from India and abroad, arranged by brokers who took the largest share of the price. The Statement of Objects and Reasons notes the persistent demand in Parliament and from medical, legal and social experts for legislation, particularly as reports about commercial dealing in human organs, especially kidneys, increased. A committee of medical and legal experts headed by Dr L. M. Singhvi prepared a report that fed into the consensus-building process, and seminars were held in the four metropolitan cities before the Bill was settled. The statute that emerged therefore had to answer two different scandals at once: organs that could have saved lives were being buried and cremated for want of a lawful route, and organs that should never have been sold were being bought through an unlawful one.

The sequence of the first heart transplant shows how close the technology ran ahead of the law. The Bill was passed by Parliament in May 1994 and received the President’s assent on 8 July 1994. On 3 August 1994, a team led by Dr P. Venugopal at the All India Institute of Medical Sciences in New Delhi performed the first successful heart transplant in India, on a patient named Devi Ram, using the heart of a woman who had died of a brain haemorrhage in the same hospital. The operation that the statute existed to make lawful was performed weeks after assent but months before the Act was actually brought into force, a detail that captures the transitional oddity of the period: the medical capacity, the parliamentary will and the ethical argument had all arrived, and only the commencement notification lagged behind.

What changed in the law on 4 February 1995?

On 4 February 1995 the Act was brought into force in Goa, Himachal Pradesh, Maharashtra and all the Union territories, and from that date Indian law recognised brain-stem death as death for organ removal, living donation was confined within statutory channels, and commercial dealing in organs became a criminal offence.

Commencement mattered because the Act changed the legal meaning of death itself for transplant purposes. Before it, death in Indian law was marked by the permanent disappearance of all evidence of life in a cardio-pulmonary sense, and by the time that test was met the heart, liver and lungs of the deceased were generally unusable. The Act added a second, carefully fenced definition of death, certified by a board of medical experts, which allowed retrieval while circulation continued. Everything else in the statute, the near relative rule, the committees, the registration of hospitals, the penalties, is machinery built around that definitional move and around the prohibition that accompanied it.

The pre-1994 position repays one more pass, because the Act’s severity is unintelligible without the market it displaced. Kidney transplantation had spread through Indian private hospitals during the 1980s faster than any regulatory idea could follow, and the supply side of the practice organised itself around paid donors recruited from poverty: labourers, rickshaw pullers and indebted villagers whose kidneys were purchased for sums that bore no relation to the fees the full transplant package commanded, and who received little of the follow-up care the surgery required. Investigative reporting and the Singhvi committee’s work documented the pattern in terms Parliament could not ignore: brokers holding donors in lodgings near hospitals, donors discharged into the same poverty that had sold the kidney, and a recipient traffic that included foreign patients drawn by price, the original transplant tourism. The fragmentary statutes of the period, the corneal and ear Acts for Delhi and the Maharashtra kidney and corneal statutes, regulated slivers of the field for slivers of the country and left the kidney trade in the private hospitals of the major cities effectively unpoliced, since no offence of selling an organ existed for a prosecutor to charge. The 1994 Act’s design, prohibition first, authorisation machinery second, is the imprint of that experience: Parliament legislated as a body that believed the market was the emergency and the donation system the construction project, and the ordering explains choices that puzzle readers who meet the Act as a donation statute, including the breadth of the Section 19 negotiation and advertisement limbs and the depth of the documentary suspicion built into the committee route.

The Article 252 foundation and the compounding map

The strangest feature of this statute is not in its operative sections at all. It is in its preamble, and it decides the question every reader should ask first about any Indian health statute: where does this law actually apply? Public health and hospitals sit in the State List of the Seventh Schedule, so Parliament had no ordinary power to legislate on organ transplantation for the states. The Act’s own preamble says so in terms: Parliament has no power to make laws for the states with respect to any of the matters in the Act except as provided in Articles 249 and 250 of the Constitution. The route used was Article 252, the consent route, under which the legislatures of two or more states may resolve that Parliament should regulate a state subject for them, and other states may adopt the resulting Act later by their own resolutions. This places the transplantation statute inside the small family of consent-built health and land statutes mapped in the complete guide to health laws in India, alongside the other Article 252 exercises traced in the repeal of the urban land ceiling law and the Water Act 1974, and the transplantation Act is the member of that family in which the mechanism’s compounding effect is easiest to see.

The resolutions that produced the 1994 Act were passed by the legislatures of Goa, Himachal Pradesh and Maharashtra. Section 1(2) of the Act therefore provides that it applies, in the first instance, to the whole of those three states and to all the Union territories, and to any other state which adopts it by resolution under Article 252(1). Adoption proceeded state by state through the 1990s and afterwards, on each adopting state’s own timetable. The Statement of Objects and Reasons of the 2011 amendment records the end position for the parent Act: it had been adopted by all states except Jammu and Kashmir and Andhra Pradesh, which had enacted their own legislation on the subject. Andhra Pradesh had passed its own transplantation statute in 1995, which continues to govern in Andhra Pradesh and, after bifurcation, in Telangana as well. So even at its widest, the central Act’s map never became the map of India; it became the map of India minus the states that had chosen to write their own version of the same law.

The amendment then did the thing that makes this statute the series’ clearest exhibit of Article 252 compounding. When Parliament amended the Act in 2011, it could amend it only on the strength of fresh resolutions, because an Article 252 statute can be amended by Parliament only for the states that consent to the amendment. The preamble to the Transplantation of Human Organs (Amendment) Act, 2011, Act 16 of 2011, recites resolutions passed by the legislatures of Goa, Himachal Pradesh and West Bengal, asking that the Act be amended by Parliament. West Bengal, which was not among the original three, appears; Maharashtra, which was, does not. Section 1(2) of the amending Act applies it, in the first instance, to Goa, Himachal Pradesh and West Bengal and to all the Union territories, and to any other state only on adoption. The amendment received assent on 27 September 2011 but was brought into force in its initial territories only on 10 January 2014. Other states adopted it at their own pace, some slowly, and a state that had adopted the parent Act but not the amendment continued to be governed by the unamended text: the pre-2011 near relative list, the pre-2011 penalties, and no tissues, no swap donation and no required request.

The consequence deserves to be stated as the general rule it is. Under Article 252, a statute does not accumulate amendments the way an ordinary central Act does, uniformly and at once. It accumulates maps. Each parliamentary intervention, the original enactment and every amendment, carries its own initial territory and its own adoption history, and the law in force in a given state is a function of the sequence of resolutions that state’s legislature has passed, not simply of what Parliament last enacted. A lawyer advising on a transplant in a particular state must therefore answer a prior question that arises under no ordinary central statute: which vintage of this Act is the law here? The land cluster showed a repeal whose territorial reach differed from the enactment it repealed, and the environment cluster showed an amendment whose reach differed from its parent Act. The transplantation cluster shows the mechanism at its most developed, because here the two resolution sets differ from each other as well as from the original, and the layering is three deep once the 2014 central Rules, framed under the amended text, are added to the picture.

The courts have had to notice the map because litigants keep tripping over it. When the question reached the Orissa High Court in litigation over a transplant proposed in Odisha under Andhra Pradesh’s own statute, the argument turned on the fact that Andhra Pradesh had not adopted the central Act and that its 1995 state Act governed instead, an illustration of how the consent map decides real cases and not merely footnotes. The most authoritative snapshot of the unfinished map came from the Supreme Court on 19 November 2025, in public interest proceedings brought by the Indian Society of Organ Transplantation, when a bench of Chief Justice B. R. Gavai and Justice K. Vinod Chandran directed the Centre to frame a national policy with model allocation criteria and uniform criteria for donors, asked the Centre to persuade Andhra Pradesh to adopt the 2011 amendments, and directed states named in the order, including Karnataka, Tamil Nadu and Manipur, to adopt the 2014 Rules expeditiously. A direction from the Supreme Court asking a state to adopt an amendment passed fourteen years earlier is the compounding map photographed from above: the law Parliament made in 2011 was still not the law everywhere a generation later.

The mechanism is worth stating precisely, because it is frequently garbled in accounts of the Act. A resolution under Article 252 is the legislature of a state requesting Parliament to legislate on a matter in the State List for that state; the resulting Act applies to the resolving states and may be adopted by any other state by a later resolution, and, critically, such an Act can thereafter be amended or repealed only by Parliament in like manner, which means the consenting states surrender their own power to vary the text. That surrender is what makes the compounding possible: a state that adopted the 1994 Act could not itself modernise the near relative list or raise the penalties, and Parliament could modernise them only on fresh resolutions, so reform required two legislatures to move in sequence, first the states by resolution and then Parliament by amendment, for every change. States that declined the second round of resolutions were not being obstructive about a detail; they were exercising the only control the design leaves them, control over whether the new text enters their territory at all. The same structure explains why the 1994 commencement was staggered even in the resolving states’ favour, assent in July 1994 and commencement on 4 February 1995, since the machinery of Appropriate Authorities, committees and registration had to be notified into existence before the prohibition could bite.

The definitions that carry the weight

Statute pillars stand or fall on their definitions, and five definitions in Section 2 of this Act do most of its work. The first is “human organ” itself: any part of a human body consisting of a structured arrangement of tissues which, if wholly removed, cannot be replicated by the body. The definition explains why the kidney, liver, heart and lungs are inside the Act while blood, which the body replenishes, is outside it. The 2011 amendment inserted a definition of “tissue” as a group of cells, except blood, performing a particular function in the human body, and added “Tissue Bank” as a facility registered under the new Section 14A for the recovery, screening, testing, processing, storage and distribution of tissues, blood banks expressly excluded. With those two definitions the Act’s centre of gravity widened: corneas, skin, bone, heart valves and other tissues, which are retrieved in far larger numbers than solid organs and stored rather than transplanted within hours, came inside the regulatory perimeter, with their own registration track and their own, lighter penalty provisions.

The definition of “donor”, a person not less than eighteen years of age who voluntarily authorises removal, sets the age floor for living donation and embeds voluntariness in the concept itself. The definition of “payment” is the most carefully drawn line in the statute, because it decides where generosity ends and commerce begins. Payment means payment in money or money’s worth, but it expressly does not include payment defraying or reimbursing the cost of removing, transporting or preserving the organ, or any expenses or loss of earnings incurred by a person so far as reasonably and directly attributable to supplying the organ. A recipient’s family may therefore lawfully meet a donor’s travel costs, hospital expenses and lost wages without crossing into purchase; what may not be paid for is the organ. That carve-out is the statute’s acknowledgment that donation is not costless to the donor, and it is the provision on which lawful reimbursement practice rests.

Two further definitions structure everything that follows. “Near relative” is defined in Section 2(i), and its contents are examined below, because the category is the gate through which most living donation passes. “Brain-stem death” is defined in Section 2(d) as the stage at which all functions of the brain-stem have permanently and irreversibly ceased, and is so certified under Section 3(6). The definition is short, but note its two-step character: the stage must have occurred in fact, and it must be certified in the prescribed manner. An uncertified brain-stem death is a clinical event; a certified one is a legal death on which retrieval may lawfully proceed. The 2011 amendment also inserted definitions of “Human Organ Retrieval Centre”, a hospital with adequate facilities for treating seriously ill patients who can be potential donors and registered for retrieval, of “minor”, and of “transplant co-ordinator”, a person appointed by the hospital for coordinating all matters relating to removal and transplantation and for assisting the authority for removal. Each of those definitions marks a point where the 2011 legislature reached into hospital organisation, not merely into offences.

The remaining definitions deserve a slower reading than they usually receive, because several recurring confusions in public discussion of the Act are definition errors. A “hospital” for the Act’s purposes includes a nursing home, clinic, medical centre, medical or teaching institution for therapeutic purposes, or another like institution, which means the registration obligation in Chapter III reaches well beyond the large multi-speciality hospitals that dominate the public image of transplantation; a small nursing home that associates itself with retrieval or transplantation without registration offends Section 10 just as a corporate hospital would. A “recipient” is simply a person into whose body an organ or tissue of another person is transplanted, and the symmetry between the donor and recipient definitions, both turning on transplantation for therapeutic purposes, explains why removal for research, however valuable, is not authorised by this Act at all and must find its authority, if anywhere, in the separate consent and ethics framework governing anatomical gifts and research. The word “therapeutic” is doing quiet but decisive work throughout the statute: it is the condition that separates the transplant programme from experimentation, and it appears in the authorisation provisions, the registration provisions and the savings alike.

The definition of “registered medical practitioner” is borrowed from the Indian Medical Council Act, 1956, tying competence under this Act to registration under the general medical framework rather than creating a parallel licensing of transplant surgeons; the specialisation requirements enter through the Rules and the registration conditions instead, which prescribe the qualifications and experience a hospital’s transplant team and its coordinator must hold. That drafting choice has a consequence worth noting for the health cluster this article belongs to: the transplant statute does not define who is fit to practise medicine, it presupposes the answer given by the medical education and registration statutes and builds its own controls at the level of the institution, the team and the file. A reader tracing the cluster will find the same instinct in the penalties, where the professional consequence of conviction, removal from the State Medical Council register, is executed through the machinery of the medical councils legislation rather than through any register this Act maintains.

The payment definition merits one further observation, because it is the provision through which the Act speaks to the ethics debate taken up later in this article. By excluding reimbursement from the concept of payment, Parliament declined the purist position that any money changing hands in connection with a donation corrupts it, and equally declined the market position that the organ itself may be priced. The line drawn is between compensating a donor for what donation costs him, which the Act treats as consistent with altruism, and rewarding him for the organ, which it treats as purchase whatever the label. Committees apply the line through the financial scrutiny in Rule 7(3), comparing the parties’ means over three financial years, since a reimbursement proportionate to a poor donor’s costs looks different in the file from a transfer proportionate to a rich recipient’s gratitude, and the gross disparity inquiry exists to catch the second dressed as the first. The definition thus does double duty, as a shield for legitimate practice in Section 2(k) and as the conceptual core of the offence in Section 19, and its drafting, specific exclusions rather than a general altruism test, is a large part of why the prohibition has proved administrable for three decades.

Brain-stem death: the definition on which deceased donation rests

Deceased donation of solid organs is possible only because the Act recognises a form of death that occurs while the heart is still beating. When the brain-stem, which drives respiration and the basic reflexes, has permanently and irreversibly ceased to function, the patient cannot breathe unaided and cannot recover, but ventilation can maintain circulation for a period, keeping organs perfused and viable. Section 3(5) obliges the registered medical practitioner, before removing any organ from a deceased person, to satisfy himself by personal examination that life is extinct, or, where it appears to be a case of brain-stem death, that the death has been certified under Section 3(6). Section 2(e) completes the architecture by defining “deceased person” to include a person in whom permanent disappearance of all evidence of life occurs by reason of brain-stem death or in a cardio-pulmonary sense. The statute thus recognises two routes to legal death, and the brain-stem route is the one that carries heart, liver, lung and pancreas transplantation.

Certification is entrusted not to a single doctor but to a Board of medical experts of specified composition, and the composition is itself an anti-abuse device. Under Section 3(6), the board consists of the registered medical practitioner in charge of the hospital in which the brain-stem death has occurred; an independent registered medical practitioner, being a specialist, nominated from the panel of names approved by the Appropriate Authority; a neurologist or neurosurgeon, likewise nominated from the approved panel; and the registered medical practitioner treating the person whose brain-stem death has occurred. A proviso added in 2011 addresses the scarcity of neurologists outside large centres: where no neurologist or neurosurgeon is available, the board may include an independent surgeon or physician together with an anaesthetist or intensivist, subject to the condition that they are not members of the transplantation team for the concerned recipient. The conflict-of-interest logic runs through the whole provision. The people who will benefit institutionally from the retrieval, the transplant team, do not certify the death on which retrieval depends, and at least two members of the board come from a panel the regulator approves rather than from the treating hospital’s own staff alone.

The manner and form of certification are prescribed by the Rules, and under the Transplantation of Human Organs and Tissues Rules, 2014 the certificate is given in Form 10, signed by all the members of the board, after the clinical examinations the form records, conducted in two sets separated by an interval of at least six hours. The two-stage examination, the panel composition and the signed form are the statute’s answer to the objection families most often voice, that a patient might be declared dead too early or for the wrong reason. The certification is a finding about the brain-stem, not a prediction about survival prospects, and it is deliberately insulated from the transplant decision that follows it. Where the deceased is under eighteen, Section 3(7) provides that, notwithstanding the general authority provisions, any of the parents may give authority for removal after brain-stem death has been certified, in the form and manner prescribed.

The distinction between brain-stem death and the conditions families confuse it with matters to the working of the Act. A patient in a coma retains brain-stem function; a patient in a vegetative state breathes unaided. Neither is dead in law, and neither can be a deceased donor under the Act. Brain-stem death is the irreversible cessation of all functions of the brain-stem, tested by the absence of the reflexes the brain-stem mediates and by the apnoea test, in a patient whose condition is explained by a known and irremediable cause. The Patna High Court, in observations noted in the legal literature on the Act, has pointed to the awareness deficit here: public confusion between brain death and coma suppresses consent, and wider understanding that the two are different states would reduce the need to take organs from living persons at all. That judicial observation captures why the certification ritual is so elaborate. The board, the panel and the form are not bureaucracy laid over a medical fact; they are the means by which a contested medical fact is converted into a social and legal fact that a grieving family, a coroner and a court can each rely on.

The interval between the two examinations deserves emphasis, because it is the feature of the Indian scheme families most often ask about and commentators most often misdescribe. The six-hour separation is not a waiting period imposed out of caution after death has occurred; it is part of the proof that the cessation is irreversible, a demonstration that the absent brain-stem reflexes do not return across a clinically significant span in a patient under continued ventilation. The board’s certificate in Form 10 records the examinations on which that conclusion rests, and the signatures of all members attach individual professional responsibility to the finding. Where the death is also a medico-legal case, an accident, an assault, a poisoning, the retrieval must be worked through the procedure the Rules prescribe with the police and the doctor conducting the post-mortem examination, so that organs needed as evidence are not removed and the cause of death can still be determined; Section 4’s bar on authority where an inquest may be required and the post-mortem provision in Section 6 meet at exactly this point, and in practice the medico-legal case is where the deceased programme loses donors to delay, as permissions move between the hospital, the police and the forensic department while viability windows close.

Certification also has an institutional geography the statute builds in without stating. The panel from which the independent specialist and the neurologist or neurosurgeon must come is approved by the Appropriate Authority, which means the regulator holds a roster of certifiers independent of any single hospital’s transplant ambitions, and a hospital cannot assemble a compliant board entirely from its own staff. The 2011 proviso relaxing the neurology requirement where no neurologist or neurosurgeon is available, substituting an independent surgeon or physician with an anaesthetist or intensivist, was a concession to the district reality that the original text described a board only a metropolitan hospital could reliably convene; the condition attached to the concession, that the substitute members must not belong to the transplant team for the concerned recipient, preserves the conflict screen that is the board’s reason for existing. The pattern repeats the statute’s general method: a strict rule drawn for the ideal case, a stated relaxation for the hard case, and the anti-abuse condition carried across into the relaxation.

One member of the board deserves separate attention, the registered medical practitioner treating the person whose death is to be certified. His presence anchors the certificate in the clinical history: he can speak to the cause of the catastrophe, the course of treatment, the exclusion of reversible conditions such as drug intoxication or metabolic disturbance that can mimic brain-stem failure, and the family’s understanding of events. His presence is also the board’s acknowledged tension, since he belongs to the hospital that will host the retrieval, and the statute manages the tension rather than denying it, surrounding him with the hospital’s head, an independent specialist and a neurologist or neurosurgeon drawn from the regulator’s panel, so that the finding requires concurrence across institutional loyalties. Certification concludes with communication, and although the Act does not script the conversation, the sequence it constructs, certificate first, authority and request after, protects the family from the corrosive suspicion that the declaration of death was influenced by the wish to retrieve. A family told of death by a board that has already completed and signed its certificate, and only then approached about donation by a coordinator, receives the two facts in the order the statute intends, and programme experience across jurisdictions records that the order, and the separation of the messengers, materially affects consent. The legal text and the bedside practice here are the same insight at different altitudes: trust in the certificate is the foundation, and everything in Section 3(6) is engineered to deserve it.

Authority to remove organs after death

Once death has occurred and, in a brain-stem case, been certified, the Act must answer a second question: whose authority makes removal lawful? Section 3 builds a ladder of authorities, and the rungs matter because most Indian deceased donation travels down the second and third rungs rather than the first. The first rung is the donor’s own prior authorisation. Under Section 3(2), if a donor had, in writing and in the presence of two or more witnesses, at least one of whom is a near relative, unequivocally authorised before death the removal of organs after death for therapeutic purposes, the person lawfully in possession of the body must, unless he has reason to believe the authority was later revoked, grant the registered medical practitioner all reasonable facilities for removal. The pledge, as this authorisation is popularly known, may be recorded in the form prescribed under the Rules, Form 7, and the Rules contemplate its incorporation into documents such as driving licences.

The second rung covers the far commoner case in which the deceased left no recorded wish. Under Section 3(3), where no authority was given but the deceased also expressed no objection to organs being used after death, the person lawfully in possession of the body may authorise removal, unless he has reason to believe that any near relative of the deceased objects. The structure is a qualified silence regime: objection by the deceased bars donation outright, silence permits it, but a near relative’s objection known to the person in possession removes the permission. The Rules then add the working reality that dominates Indian practice. Rule 5 of the 2014 Rules requires the medical practitioner, before removal from a deceased donor, to ascertain whether a prior authorisation exists, and provides that the consent of the near relative or the person lawfully in possession shall also be required notwithstanding an authorisation made by the deceased donor, recorded through the declaration in Form 8. In practice, therefore, the family is asked in every case, pledge or no pledge, and a family’s refusal at the bedside ends the matter even where the deceased had signed a pledge card in life. The statute’s first rung gives the donor’s wish legal force; the Rules and hospital practice give the family a concurrent voice, and the friction between the autonomy of the donor and the grief of the family is managed, case by case, by transplant coordinators at the bedside rather than by any hierarchy the Act lays down.

Who may authorise removal of organs after brain-stem death?

Authority follows a ladder in Section 3: the deceased’s own written authorisation made before two witnesses, or, where none exists and no objection was expressed in life, the person lawfully in possession of the body, which in practice means the family; for a deceased minor, either parent may authorise removal after certification.

The 2011 amendment inserted the provision that tries to make this ladder operate in real intensive care units rather than only in the statute book. Section 3(1A) makes it the duty of the registered medical practitioner working in a hospital, in consultation with the transplant coordinator where one is available, to ascertain from the patient admitted to the intensive care unit or from the near relative whether the patient had authorised donation before death; where no such authority was given, to make the patient or the near relative aware of the option to authorise or decline donation; and to require the hospital to inform the Human Organ Retrieval Centre in writing so that removal, storage or transplantation can follow. Section 3(1B) extends the same duties to practitioners in intensive care units of hospitals that are not themselves registered under the Act, from a prescribed date. This is the required request: a statutory duty, placed on the treating side, to raise donation with every family of a patient who dies in intensive care, instead of leaving the subject to chance, to the family’s initiative or to a doctor’s discomfort. It is the provision through which the 2011 legislature tried to change the conversion rate, the proportion of certified brain-stem deaths that become donations, which is the number on which the entire deceased programme depends.

The remaining provisions of Chapter II are guardrails. Section 4 bars the grant of facilities or authority where the person concerned has reason to believe an inquest may be required into the death, and bars authority from a person to whom the body was entrusted solely for interment, cremation or other disposal. Section 5 deals with unclaimed bodies in hospitals and prisons: if the body is not claimed by near relatives within forty-eight hours of death, the person in charge of the institution may authorise removal, but not if he has reason to believe a near relative is likely to claim the body even after the period runs. Section 6 permits removal from bodies sent for post-mortem examination, for medico-legal or pathological purposes, where the organ will not be required for the examination and the deceased neither objected nor revoked an authorisation, a provision that must be worked alongside the inquest bar and the medico-legal procedure in the Rules, which requires the retrieving hospital to involve the police and the post-mortem doctor so that the determination of the cause of death is not jeopardised. Section 7 requires prescribed steps for preservation of the removed organ. Section 8 saves other lawful dealings with a dead body and provides that a removal made under the Act is not the offence of indignity to a human corpse under Section 297 of the Indian Penal Code, a small provision that removes a real chill: without it, every lawful retrieval would also have been a prima facie interference with a corpse.

The required request is worth a closer look, because it is the provision through which the 2011 legislature chose to fight the shortage, and its design reveals what the legislature believed the binding constraint to be. The duty in Section 3(1A) is not cast on the Authorisation Committee, the Appropriate Authority or any programme official; it is cast on the registered medical practitioner working in the hospital, the clinician at the bedside, acting in consultation with the transplant coordinator. Three distinct acts are required: ascertaining whether the patient authorised donation in life, which sends the hospital back to pledge records and to the family as the source of that knowledge; making the patient or the near relative aware of the option to authorise or decline, which is the request itself, framed so that refusal is as lawful an answer as consent; and informing the Human Organ Retrieval Centre in writing, which converts a private conversation into a trigger for the retrieval and allocation machinery. A duty structured this way cannot be discharged by a poster on a corridor wall. It presupposes that intensive care staff can recognise a potential donor, that a coordinator exists to conduct or support the conversation, and that a retrieval centre is close enough to act on the intimation, which is why the provision’s effectiveness tracks hospital organisation so closely and why states with strong coordinator networks convert a far higher share of certified deaths into donations than states where the duty exists on paper alone.

Section 7’s preservation duty and the transport practice built around it complete the deceased pathway. A removed organ is a perishable thing measured in hours, and the statute’s laconic direction that prescribed steps be taken for preservation is the hook on which the programme’s cold chain, perfusion fluids, packaging standards and transport coordination hang. Where an organ is allocated across institutions or across a city, the movement is arranged through the state organisation and the police-assisted transport corridors that metropolitan programmes have developed, so that the statutory sequence of certification, authority, allocation and retrieval is matched by a logistics sequence running in parallel. None of that logistics appears in the Act, and its absence from the text is instructive: the statute secures the legality of each step, and leaves the speed of the whole to the programme built beneath it, which is one more reason the same Act yields such different donation rates in different states.

Living donation and the near relative rule

Living donation is governed by Section 9, and its first sub-section states the rule around which the whole living programme is organised: save as otherwise provided in Section 9(3), no organ removed from a living donor shall be transplanted into a recipient unless the donor is a near relative of the recipient. The near relative is the person whose love for the recipient the law treats as self-explanatory, and whose donation therefore needs no external validation of motive. As enacted in 1994, Section 2(i) defined near relative as spouse, son, daughter, father, mother, brother or sister. The 2011 amendment added grandfather, grandmother, grandson and granddaughter, closing a gap that had produced real hardship and artificial litigation: a grandmother willing to give a kidney to a grandchild was, under the original text, a stranger in law, routed to a committee to prove affection for her own grandchild. The error that many secondary accounts still make, repeating the pre-2011 list of six relations as though it were the law, is one this statute’s amendment history exists to correct: the list has had ten entries in the territories where the amendment applies since January 2014.

The spousal case is worth separating from the general category, because in practice the spouse is the commonest living donor in India and the Rules treat the spousal application as its own track, with its own authorisation form, Form 2, distinct from Form 1 for other near relatives and Form 3 for donors outside the category. The 2014 Rules route near relative applications through a joint application in Form 11 and approval by the competent authority, defined in Rule 2(c) as the head of the institution or hospital carrying out the transplantation or a committee constituted by that head, with the relationship certified in Form 5 and medical tests used, where required, to establish the fact of the relationship. The design is deliberate: the near relative track is an intra-hospital verification of identity, relationship, fitness and consent, not an inquisition into motive, because the statute presumes the motive. Section 12 reinforces the consent quality on this track and every other: no practitioner shall undertake removal or transplantation unless he has explained, in the prescribed manner, all possible effects, complications and hazards to donor and recipient respectively.

Three boundary provisions complete the living scheme, each inserted or sharpened in 2011. Where the donor or the recipient, being a near relative, is a foreign national, Section 9(1A) requires the prior approval of the Authorisation Committee even inside the family track, and forbids the committee from approving a case in which the recipient is a foreign national and the donor an Indian national unless they are near relatives. Section 9(1B) bars removal from a living minor except in the manner prescribed, and the Rules confine it to exceptional medical grounds, recorded in detail with full justification and the prior approval of the Appropriate Authority and the state government concerned; in ordinary practice, a child cannot be a living organ donor. Section 9(1C) bars removal from a mentally challenged person altogether, defining that expression to include a person with mental illness or mental retardation, a categorical exclusion which sits at the boundary of the transplant statute and the capacity framework that the Mental Healthcare Act 2017 constructs for persons with mental illness, and which prefers a bright protective line over case-by-case assessment of understanding in a setting where money and family pressure can both distort consent.

The competent authority track for near relatives is frequently misunderstood as no scrutiny at all, and the distinction between the two living tracks is better stated as a difference in the question asked than in the rigour applied. The committee asks whether the donation is what it claims to be; the competent authority asks whether the papers, the relationship, the fitness and the consent are what they claim to be. On the family track the hospital must still verify identity and relationship, with Form 5 certification and, where documents leave doubt, the medical evidence of relationship that genetic testing can supply; it must still satisfy itself of the donor’s medical fitness and of the absence of the conditions that make donation unsafe; and it must still record the donor’s authorisation in the prescribed form, Form 1 for near relatives generally and Form 2 for a spouse, with the joint application in Form 11 and the recipient’s documentation in Form 19 completing the file. A file that fails these checks fails the transplant, and hospitals that treat the family track as a formality expose their registration to Section 16 action, because every racket prosecution of the last two decades has featured family track paperwork that a hospital accepted without the verification the Rules demand. The spousal predominance within living donation also has a paperwork expression: the separate spousal form exists because the spouse is at once the commonest donor and the donor whose relationship proof, a marriage certificate, a joint photograph, shared records, is the most standardised, and whose consent the system is most anxious to test for the quiet coercion that a family crisis can exert on the partner with the matching blood group.

Section 12’s explanation duty, finally, applies with equal force on both tracks and is the Act’s principal substantive protection of the living donor as a patient rather than as a source. The practitioner must explain the possible effects, complications and hazards of the surgery to the donor, and to the recipient, before proceeding, in the manner the Rules prescribe, and the explanation is owed to the donor independently of the recipient’s wishes or the family’s enthusiasm. Read with the definition of donor, which builds voluntariness into the status itself, Section 12 completes a consent architecture in which the donor’s agreement must be informed, documented and given by an adult, and in which the system’s residual anxiety is not about the donor who refuses but about the donor whose agreement the file records and the bedside reality contradicts, which is precisely the gap the committee’s family interview and the coordinator’s counselling exist to patrol.

The living donor’s story does not end at discharge, and the statute’s treatment of the period after donation is one of its quieter strengths, distributed across provisions a quick reading misses. Section 13(3) charges the Appropriate Authority, in its periodic inspections of registered hospitals, with examining the follow-up care of donors and recipients, which makes the donor’s aftercare a registration concern and not merely a clinical courtesy: a hospital whose donors disappear from its records unexamined is a hospital whose file the regulator is directed to open. The registry function in Section 13D, framed as ongoing evaluation of the scientific and clinical status of organs, supplies the programme level counterpart, the possibility of knowing, across the system, what becomes of living donors over time. Programme practice and the Supreme Court’s 2025 engagement with donor welfare press in the same direction, toward structured long-term follow-up, insurance and support for living donors, on the reasoning that a system asking healthy people to accept surgery for another’s benefit owes them more than a successful discharge summary. The contrast with the paid donor of the pre-1994 trade, discharged into invisibility, is the measure of the distance travelled: the lawful donor is a person the system is obliged to keep seeing, and the unlawful trade’s defining cruelty was that its donors were designed to be unseen, by the brokers who profited from them and, too often, by the hospitals that operated on them. Where follow-up fails in the lawful system, it fails against a statutory expectation, which gives donors, authorities and courts something to enforce; that is the practical difference a definition and an inspection clause can make in a life.

The Authorisation Committee: function, inquiry and judicial review

For the donor who is not a near relative, the statute substitutes scrutiny for trust. Section 9(3) provides that where a donor authorises removal before death for transplantation into a recipient who is not a near relative, the donation being made by reason of affection or attachment towards the recipient or for any other special reasons, the organ shall not be removed and transplanted without the prior approval of the Authorisation Committee. Section 9(4) leaves the composition of the committees to be prescribed by the Central Government and obliges state governments and Union territory administrations to constitute one or more committees by notification. On a joint application by donor and recipient, Section 9(5) requires the committee to hold an inquiry and, after satisfying itself that the applicants have complied with all the requirements of the Act and the Rules, to grant approval. Section 9(6) requires that a rejection be by reasons recorded in writing, after giving the applicants an opportunity of being heard.

What the committee is to satisfy itself about is specified in Rule 7(3) of the 2014 Rules, and the rule repays reading because it defines the institution better than any commentary. The committee must evaluate that there is no commercial transaction between recipient and donor and that no payment has been made or promised; prepare an explanation of the link between them and the circumstances in which the offer was made; examine the reasons why the donor wishes to donate; examine documentary evidence of the link, such as proof that they have lived together; examine old photographs showing donor and recipient together; evaluate that there is no middleman or tout involved; evaluate the financial status of donor and recipient from evidence of vocation and income for the previous three financial years, with any gross disparity assessed against the objective of preventing commercial dealing; ensure the donor is not a drug addict; and ensure that a near relative or other adult relative of the donor is interviewed about the donor’s intention and the authenticity of the link. The list is a portrait of the fraud the statute fears: a stranger recruited by a broker, coached in a false biography, whose poverty is the real consideration. It is also, read from the other side, a demanding audit of a genuine friendship, in which two people must document a relationship that life rarely documents. The account in this section states the general legal position; it is not advice on an individual application, and a family facing a refusal should take advice promptly, because the thirty-day appeal window under Section 17 runs from receipt of the committee’s order.

The courts have drawn the committee’s constitutional boundary with unusual consistency. The leading authority is the Supreme Court’s decision in Kuldeep Singh v. State of Tamil Nadu, (2005) 11 SCC 122, arising from a refusal of permission for a kidney donation outside the near relative circle, in which the Court located the object of the approval requirement in the prevention of commercial dealing and held, in substance, that the committee’s satisfaction must rest on material: where a donor asserts an altruistic motive, the assertion is not to be disbelieved without credible reason, and unless there is definite material showing a financial transaction, permission ought not to be withheld on speculation. High Courts have applied that standard in a long line of writ decisions setting aside refusals. The Madras High Court has repeatedly held that a rejection unsupported by material showing the donation is not altruistic is arbitrary, and has in some cases directed that permission be granted within a fixed period or be deemed granted. The Kerala High Court, in proceedings concerning a donor asked to produce a certificate of altruism from the district police chief, an extra-statutory demand, quashed serial rejections of a genuine altruistic donation and directed approval. The Calcutta High Court, setting aside a refusal in which the committee had fastened on a discrepancy between the donor’s account and a driving licence, restated the Kuldeep Singh position: the burden cannot be made so heavy that applicants must prove a negative, and a mismatch on a collateral detail is not definite material of a financial dealing. The Delhi High Court, for its part, has pressed the temporal dimension, directing the health ministry to prescribe timelines for the stages of the approval process so that a complete application is ordinarily decided in a matter of weeks, on the footing that for a patient in organ failure, delay by committee is not a neutral act.

The pattern in this jurisprudence is not that courts distrust committees; it is that courts enforce the statute’s own allocation of function. The committee is a screen against commerce, not a tribunal on the worthiness of human attachment, and a refusal that travels beyond the commerce question, into judgments about whether the donor’s reasons are good enough, whether the relationship is long enough or documented enough to deserve belief, exceeds the power Section 9 confers. At the same time, the courts have not dismantled the screen: where investigations have disclosed brokers, payments or fabricated relationships, approvals have been refused and prosecutions upheld, and no line of authority holds that Section 9(3) approval is a formality. The doctrine as it stands is therefore a calibration, trust but verify, and it holds the committee to evidence in both directions.

The committee’s institutional weaknesses are of a different order from its legal mandate, and they explain much of the litigation’s volume. Committees are state and district level bodies whose members are drawn from the medical, administrative and legal services; they sit at intervals that vary widely between jurisdictions, they inherit no uniform template for recording their satisfaction beyond the Rule 7(3) checklist, and the quality of the inquiry, how searching the interview is, how the financial evidence is read, whether the donor’s family is actually heard, depends on the membership in a way the statute cannot standardise. A single application may therefore pass through preliminary scrutiny by the hospital, scrutiny by the committee, and, where police verification of the parties’ circumstances is sought, a third layer whose statutory basis is administrative practice rather than the Act, a layer the Kerala High Court’s altruism certificate ruling marks as the point where verification hardens into obstruction. The reform proposals that recur in the case law and in programme commentary respond to this picture rather than to the mandate: prescribed timelines for each stage, of the kind the Delhi High Court directed the ministry to frame; standardised documentation lists, so that applicants are not asked serially for papers no rule requires; and reasoned orders that engage the Rule 7(3) factors expressly, so that judicial review can proceed on the committee’s actual reasoning instead of reconstructing it. None of these requires amendment of Section 9. They are governance repairs to a sound provision, and the distinction matters to the verdict this article reaches at the end.

One further feature of the committee system is easy to miss and explains several reported controversies. The committee that approves a case is ordinarily the committee of the state where the transplant is to occur, and the parties before it may belong to another state or another country, with documents issued elsewhere and a shared history lived elsewhere. Verification across that distance is the committee’s hardest task, and it is the setting in which forged relationship papers have most often succeeded, because a committee in one state has limited means of testing a family book, a ration card or a village record from another jurisdiction. The foreign national cases under Section 9(1A) present the same difficulty at international scale, which is why the ministry’s later administrative response included circulation of the Act’s requirements to Indian missions abroad and embassy verification channels: the statute assigns the judgment to the committee, and the surrounding administration has had to build the committee an evidence supply chain worthy of the judgment.

Swap donation: the 2011 exchange route

Incompatibility is the quiet tragedy inside family donation: a willing, healthy near relative whose blood group or tissue type does not match the patient. Before 2011, two such families could solve each other’s problem only awkwardly, and paired exchange, in which the donor of one incompatible pair gives to the recipient of the other, had no express place in the statute. Section 9(3A), inserted by the 2011 amendment, gives it one. It applies where a donor has agreed to donate to a recipient who is his near relative but is not biologically compatible, and a second donor stands in the same position toward a second recipient, and the first donor is compatible with the second recipient and the second donor with the first, and all four, both donors and both recipients, have entered into a single agreement to donate and receive according to that compatibility within the group. Removal and transplantation under such an agreement require the prior approval of the Authorisation Committee.

The design choices in Section 9(3A) are instructive. Swap is not treated as two ordinary donations that happen to coincide; it is a single four-party transaction, authorised as a whole, so that the committee can see the entire exchange and neither side can withdraw after receiving while refusing to give, the classic vulnerability of paired exchange. Both underlying relationships must be near relative relationships, so swap widens the usefulness of family donors without opening the stranger route any further than Section 9(3) already does. And the route runs through the committee not because commerce is suspected in the ordinary way, the consideration each family receives is an organ for its own patient, given openly and in kind, but because the four-party structure needs a single point of verification that the agreement is genuine, simultaneous and uncoerced. Published transplant literature records paired exchanges taking place in India before the amendment on case-by-case approvals, and a growing series afterwards; the statutory recognition mattered less as permission than as standardisation, since a route that exists in the Act can be applied for, processed and, if refused, appealed, in ways an ad hoc practice cannot.

The limits of the swap route are as instructive as its existence. It solves blood group incompatibility elegantly, the common case being a pair in which the donor’s blood cannot go to his own recipient but matches the stranger recipient whose donor matches his, and it can be extended in programme practice to chains and larger pools where several incompatible pairs are matched against each other, though the statutory text is written for the two-pair exchange and larger configurations are assembled from committee approvals of the constituent donations. What swap cannot solve is the shortage itself: it multiplies the yield of family donors who have already come forward, it creates no new donors, and it depends on a matching infrastructure, registries of incompatible pairs with their blood groups and sensitisation profiles, that only organised programmes maintain. Its under-use in much of the country is therefore a programme fact rather than a legal one. The provision sat in the Act from January 2014 in the adopting territories, waiting for hospitals to build pair registries and for committees to develop a routine practice for four-party files, and the gap between the provision’s availability and its use is a small, precise instance of the article’s larger claim, that this statute’s text has consistently run ahead of the institutions meant to operate it.

Which donation route applies: the decision table

The sections so far describe the statute; the table below is the statute as a family or a hospital coordinator actually meets it, as a routing problem. Every lawful donation in India travels down exactly one of these routes, and most failures in practice are routing failures: the wrong form, the wrong approver, a committee approached for a case it does not decide, or a family that discovers late that its case belonged to a slower track. The timelines given are the ordinary administrative experience of the routes rather than statutory deadlines, because the Act prescribes almost no decision deadlines, which is itself one of the findings of the implementation record discussed later in this article.

Donation route	Who the donor is	What is required	Who approves	Typical timeline	Commonest reason a case fails at this step
Living near relative	Spouse, son, daughter, father, mother, brother, sister, grandfather, grandmother, grandson or granddaughter of the recipient	Joint application in Form 11; donor authorisation in Form 1 or Form 2 for a spouse; relationship certified in Form 5; medical fitness and compatibility tests; explanation of effects under Section 12	The competent authority of the hospital, the head of the institution or a committee constituted by that head	Days to a few weeks once tests and documents are complete	The relationship cannot be documented, or documents disagree on names, ages or parentage
Living donor outside the near relative list	A friend, distant relative, in-law outside the list, colleague or other person donating by reason of affection or attachment or other special reason	Joint application in Form 11; donor authorisation in Form 3; evidence of the link, including photographs and proof of shared history; income and vocation evidence of both parties for three financial years; interviews of donor, recipient and the donor’s family	The Authorisation Committee constituted by the state or Union territory, after inquiry under Section 9(5)	Weeks to months, depending on committee sittings, police or field verification and document gaps	The committee finds the link unproven or suspects a commercial transaction, and rejects with reasons recorded in writing
Swap or paired exchange	Two near relative donors, each incompatible with his or her own recipient and compatible with the other’s	A single agreement among both donors and both recipients under Section 9(3A); the full near relative documentation for each pair; compatibility testing across the two pairs	The Authorisation Committee	Weeks, since both pairs must clear together and surgery must be coordinated	One of the four parties fails a medical or documentary step, collapsing the whole exchange
Living donation involving a foreign national	A near relative where donor or recipient is a foreign national, or a foreign recipient with an Indian donor	Authorisation Committee approval even within the family; identity and relationship documents verified through the embassy channel where required	The Authorisation Committee; no approval is possible where a foreign recipient and an Indian donor are not near relatives	Weeks to months	Forged or unverifiable relationship documents, the pattern at the centre of the foreigner transplant investigations
Deceased donation after brain-stem death	A person whose brain-stem death is certified, whose family authorises removal	Certification in Form 10 by the Board of medical experts under Section 3(6); the deceased’s prior authorisation in Form 7 if any; family consent recorded in Form 8; intimation to the Human Organ Retrieval Centre	No committee; authority comes from Section 3 itself, through the donor’s prior authorisation or the person lawfully in possession of the body	Hours; organ viability windows govern every step after certification	The family declines, or brain-stem death is never identified, certified or raised with the family in time
Deceased donation from an unclaimed body	A person who dies in a hospital or prison and whose body is unclaimed	Forty-eight hours must pass without a claim by near relatives under Section 5; authorisation by the person in charge of the institution in Form 9; no reason to believe a near relative is likely to claim the body	The person in charge of the hospital or prison, under Section 5	Not before forty-eight hours from death	A near relative appears, or the institution declines the responsibility the section casts on it

Read the table’s last column as a map of the statute’s stress points. The living routes fail on paper: identity, relationship, proof. The deceased route fails on time and on conversation: certification that never happens, a request that is never made, a family that refuses because the subject arrives unannounced at the worst hour. The committee route fails on judgment, which is why it generates the litigation. A reformer who wants more lawful transplants has to decide which column to work on, because the fixes are entirely different: documentation support for the first, sittings and standards for the second, intensive care identification and coordinator staffing for the third.

Two rows of the table conceal subtleties that litigation has exposed. The foreign national row reads as a single route, but it contains a hard statutory edge: the bar on approving a foreign recipient with an Indian donor who are not near relatives is not a matter of committee discretion at all, so a file of that description should never reach the stage of evidence, and its appearance in approval records was among the irregularities that programme reporting flagged. The unclaimed body row conceals the opposite subtlety, a power almost never exercised: institutions are reluctant to authorise removal from unclaimed bodies even after the statutory forty-eight hours, because the provision casts a personal responsibility on the officer in charge and the medico-legal overlay in Section 4 excludes a large share of hospital deaths from the route in any event, so a route that looks generous in the table contributes very few organs in practice. The table’s purpose is orientation, and these two rows mark its limits: one route is narrower than it looks because a prohibition hides inside it, and one is wider than it looks on paper and narrower in the world, because institutional caution hides inside it.

Hospitals, retrieval centres and tissue banks: the registration machinery

Transplantation under the Act is a licensed activity in a registered place. Section 10 provides that no hospital, unless registered under the Act, shall conduct, associate with or help in the removal, storage or transplantation of any organ, and no practitioner or other person shall conduct any such activity at a place other than a registered place; a registered place may be used for these activities only for therapeutic purposes. Two relaxations keep the scheme workable at its edges: eyes and ears may be removed at any place from a dead body by a registered medical practitioner, an acknowledgment that corneal retrieval cannot wait for a registered theatre, and a prescribed technician may enucleate a cornea under the proviso to Section 3(4). Section 14 makes registration substantive rather than formal. No hospital, including a Human Organ Retrieval Centre, may commence activity relating to removal, storage or transplantation unless duly registered, and the Appropriate Authority must be satisfied that the hospital can provide the specialised services and facilities, skilled manpower and equipment, and maintain the standards prescribed. Section 14(4), inserted in 2011, adds the organisational condition that has done more to change hospital behaviour than any penalty in the Act: no hospital shall be registered unless the Authority is satisfied that it has appointed a transplant coordinator with prescribed qualifications and experience. Registration is granted by certificate under Section 15 after inquiry, is renewable, and may be suspended or cancelled under Section 16 after a show cause notice and hearing for breach of the Act or Rules; where the Authority considers it necessary in the public interest, it may suspend a registration without prior notice, for reasons recorded in writing, a power used when a registered hospital is found at the centre of a racket.

What is a Human Organ Retrieval Centre?

A Human Organ Retrieval Centre is a hospital with adequate facilities for treating seriously ill patients who can become potential donors, registered under Section 14 for retrieval of organs rather than for transplantation itself, so that a brain-stem death in a non-transplant hospital can still yield organs for patients elsewhere.

The retrieval centre category is the statute’s answer to a structural waste: most brain-stem deaths occur in hospitals that cannot transplant, trauma units, district hospitals and general intensive care units, and without a retrieval registration those deaths could never become donations. In programme practice such centres, including hospitals that only retrieve, are commonly described as non-transplant organ retrieval centres, and their registration, together with the Section 3(1B) duties cast on practitioners in unregistered intensive care units, is meant to wire the whole hospital system into the donation network rather than only its transplant apex. Tissue banks stand on a parallel track: Section 14A, inserted in 2011, requires a tissue bank to be registered before it carries on recovery, screening, testing, processing, storage or distribution of tissues, on the same satisfaction of the Appropriate Authority as to facilities, manpower and standards, and Section 10 bars an unregistered tissue bank from those activities in terms. Appeals against refusal of approval by an Authorisation Committee, and against refusal, suspension or cancellation of registration, lie under Section 17 to the Central Government or the state government, as the case may be, within thirty days of receipt of the order, a short fuse that practitioners in this field learn to respect.

Registration practice under the Rules fills out what the certificate means in a hospital’s life. The application is made to the Appropriate Authority in the prescribed form with the particulars of the institution, its facilities, its equipment, its surgical and support manpower and its coordinator, and the Authority’s inquiry under Section 15 extends to the standards the 2014 Rules prescribe for transplant centres, intensive care support, laboratory and imaging back-up, infection control and record keeping. The certificate specifies what the hospital is registered to do, and the distinction between a centre registered for transplantation, a centre registered for retrieval and a centre registered for both is the working expression of the retrieval centre concept in the definition clause. Renewal is periodic and inspection based, and Section 13(3) obliges the Authority to inspect registered hospitals periodically to examine not only the transplants performed but the follow-up care of recipients and donors, which gives the registration regime a clinical audit dimension unusual among Indian licensing statutes of its generation: the regulator is directed to look at outcomes and aftercare, not merely at premises and papers. When the Authority finds a breach, Section 16 offers a ladder of response, show cause, hearing, suspension or cancellation, with the unannounced suspension power reserved for cases the Authority records as implicating public interest, and the use of that power against hospitals implicated in the 2016 Mumbai proceedings showed the ladder being climbed in the circumstances it was designed for, a registered institution whose licence had become the racket’s cover.

The retrieval centre registration has a programme significance beyond its licensing function, and it connects the registration chapter back to the consent chapter’s central problem. A deceased donation is a relay run across institutions that may have no other relationship: the hospital where the donor dies and is certified, the retrieval team that travels or receives, the state organisation that allocates, and the hospital where the recipient waits. Registration is what makes the relay lawful at each hand-off, since Section 10 confines every stage, removal, storage, transplantation, to registered places and registered activity, and the retrieval centre category exists so that the first hand-off, in the hospital that can certify a death but cannot transplant, is a registered act rather than an improvisation. Metropolitan programmes have built their deceased donation growth on exactly this wiring, enrolling trauma and general hospitals as retrieval points feeding a smaller set of transplant centres, and the corollary is diagnostic: a state whose hospital map contains few registered retrieval centres will underperform in deceased donation whatever its consent law says, because potential donors die, in the main, in hospitals that do not transplant. The Section 3(1B) duty cast on practitioners in unregistered intensive care units is the statute’s bridge across the same gap from the other side, obliging the unregistered hospital to raise the question and notify the retrieval system rather than letting the death close unexamined. Read together, the registration category and the notification duty describe a system designed to hunt for donors where deaths actually occur; read against the donation map, they describe a system whose design has been implemented unevenly enough that the hunt still depends on the accident of which state’s intensive care unit a patient reaches.

The Appropriate Authority and the national network

Registration has to be policed by someone, and the Act’s policeman is the Appropriate Authority, appointed under Section 13 by the Central Government for the Union territories and by each state government for the state. Its functions under Section 13(3) run the full regulatory cycle: granting and renewing registration, suspending or cancelling it, enforcing prescribed standards for hospitals and tissue banks, investigating complaints of breach and taking action, inspecting hospitals periodically to examine the quality of transplantation and the follow-up care of recipients and donors, inspecting tissue banks, and undertaking other prescribed measures. The 2011 amendment equipped this office with two instruments the original Act lacked. Section 13A requires the constitution of Advisory Committees, chaired by an administrative expert not below the rank of Secretary to the state government and including medical experts, a legal expert who has held office as an Additional District Judge or equivalent, social workers, an organ donation or human rights representative and a transplantation specialist who is not a member of a transplant team, to aid and advise the Authority. Section 13B gives the Authority the powers of a civil court for summoning persons, requiring discovery and production of documents, and issuing search warrants for places suspected of unauthorised removal, procurement or transplantation, which converts the Authority from a licensing clerk into an investigator with compulsory process.

Above the state level, the amended Act reaches toward a national architecture in two enabling provisions whose modesty is the point. Section 13C empowers the Central Government, by notification, to establish a National Human Organs and Tissues Removal and Storage Network at one or more places, and regional networks, in the manner and for the functions prescribed. Section 13D obliges the Central Government to maintain a national registry of donors and recipients, with such information as may be prescribed, for ongoing evaluation of the scientific and clinical status of organs and tissues. What the Act does not do is create the organisations the public knows by their acronyms. The National Organ and Tissue Transplant Organisation, NOTTO, was established in 2014 by executive action of the Directorate General of Health Services in the Ministry of Health and Family Welfare, housed at Safdarjung Hospital in New Delhi, under the National Organ Transplant Programme, and it operates through the two arms its structure gives it, the national removal and storage network envisaged by Section 13C and a National Biomaterial Centre for tissues. Five Regional Organ and Tissue Transplant Organisations, at Chandigarh, Mumbai, Chennai, Kolkata and Guwahati, coordinate across groups of states, and State Organ and Tissue Transplant Organisations carry the waiting lists within states. The same relationship between a licensing statute and the public bodies built under it appears in the Drugs and Cosmetics Act 1940, where the operative machinery likewise lives substantially in rules, laboratories and programme structures rather than in the parent text.

The distinction between the Act’s enabling sections and the executive organisations matters for accountability. NOTTO maintains the national registry, frames allocation guidelines and coordinates inter-state sharing, but its authority over a defaulting hospital or a state programme is programme authority, exercised through the Appropriate Authorities and the state organisations, not a statutory power of command conferred by the Act. Allocation itself, the decision about which waiting patient receives a deceased donor’s organ, is made under allocation guidelines framed within this network on criteria of medical urgency, waiting time, matching and geography, administered through the state and regional lists, and not by the treating hospital’s choice. The guidelines were materially liberalised by the health ministry in February 2023, when the domicile condition that had confined a patient to the waiting list of the state of residence was removed so that a patient may register in any state, the upper age limit of sixty-five years for registering to receive a deceased donor organ was dropped, and states that had charged registration fees, reported at between five thousand and ten thousand rupees in Gujarat, Telangana, Maharashtra and Kerala, were asked not to charge them. The domicile question, which the brief for this article rightly flags, was never a creature of the Act: the statute says nothing about domicile for registration, the restriction grew up in state allocation practice, and it was dismantled administratively, through the national guidelines, rather than by any court holding it unconstitutional. That is the accurate statement of the position, and it is also a measure of how much of this field’s real law lives below the statute.

The registry function in Section 13D deserves a word of its own, because the registry is where the Act’s evaluation ambition lives. A national registry of donors and recipients, maintained for ongoing evaluation of the scientific and clinical status of organs and tissues, is the instrument by which graft survival, donor outcomes and centre performance become visible as system facts rather than as anecdotes traded between hospitals, and the annual reports through which NOTTO publishes the programme’s numbers are the registry’s public face. The allocation system the registry supports has a further feature that repays attention: the unique identification issued to a registered patient follows the patient across hospitals and states, so that registration is an entry in a single national queue logic rather than a place in a hospital’s private list, and the February 2023 removal of the domicile condition completed that logic by letting the patient register where treatment is actually available. The Supreme Court’s directions of November 2025 for a national policy with model criteria for organ allocation, and for uniform criteria for donors, were addressed to precisely this layer of the system, the guidelines layer, and their premise is the same as this section’s: the Act supplies the frame and the values, but the fairness a patient experiences is produced by allocation criteria, registry discipline and state organisations, which is why the Court directed its orders at governments and programme bodies rather than at the statute.

The Appropriate Authority itself, on which so much of this architecture depends, is the least visible office in the system and repays a closing word. It is ordinarily headed by a senior health administrator of the state or, for the Union territories, of the Centre, supported by the Advisory Committee’s mixed expertise, and it works without the public profile of a NOTTO or the bedside presence of a coordinator. Yet every protection in the Act passes through its hands at some point: it approves the panels from which brain-stem death boards are drawn, registers and inspects the hospitals and tissue banks, receives the complaints and conducts the investigations that Section 22 makes the gateway to prosecution, reports convicted practitioners to the medical councils, and advises, through its inspections, whether the standards the Rules prescribe exist in fact. The variance between states in transplantation outcomes is, to a degree the programme literature acknowledges, variance in the energy and staffing of this office. An Authority that inspects on schedule, publishes its register and acts on complaints makes the Act a working system in its territory; an Authority that exists as a notification and a part-time charge makes the same text a paper one. The statute cannot manufacture administrative capacity, and its framers knew it, which is why they built the 2011 reinforcements, advisory committees, civil court powers, search warrants, around the office rather than around any new tribunal: the design bet everything on strengthening the regulator it had.

The prohibition and the penalty ladder

Chapter VI of the Act contains the offences, and their arrangement shows what the legislature feared most. Section 19, the commercial dealings offence, is the core. It catches whoever makes or receives any payment for the supply of, or for an offer to supply, an organ; whoever seeks to find a person willing to supply an organ for payment; whoever offers to supply one; whoever initiates or negotiates an arrangement involving such a payment; whoever takes part in the management or control of a body whose activities include initiating or negotiating such arrangements; and whoever publishes or distributes an advertisement inviting supply for payment, offering supply for payment, or indicating willingness to negotiate. The 2011 amendment added a seventh limb aimed at the documentary fraud on which the modern trade runs: abetting the preparation or submission of false documents, including giving false affidavits to establish that a donor is a near relative or is donating by reason of affection or attachment. The offence is complete at the stage of negotiation and advertisement; no surgery need occur, because the legislature intended to break the market’s formation, not merely to punish its completed sales.

As enacted in 1994, Section 19 carried imprisonment of not less than two years and up to seven, with a fine of not less than ten thousand rupees and up to twenty thousand, and a proviso allowed a court, for adequate and special reasons recorded in the judgment, to go below even that modest floor. Those were the prices Parliament initially set on a kidney market in which a single transplant package could be sold for sums counted in lakhs: the maximum fine was a rounding error in the trade’s economics. The 2011 amendment rebuilt the ladder. Commercial dealing in organs carries imprisonment of not less than five years and up to ten, and a fine of not less than twenty lakh rupees and up to one crore, and the indulgent proviso is gone. Section 19A, inserted for tissues, carries one to three years and a fine of five lakh to twenty-five lakh rupees for the parallel tissue offences. Section 18 punishes removal of an organ without authority with imprisonment up to ten years and a fine up to twenty lakh rupees, and, where the offender is a registered medical practitioner, requires the Appropriate Authority to report the conviction to the State Medical Council for removal of the practitioner’s name from the register for three years for a first offence and permanently for a subsequent one; unauthorised removal of tissues carries up to three years and a fine up to five lakh rupees. The residuary offence in Section 20, contravention of any provision for which no separate punishment is provided, rose in 2011 from three years or a five thousand rupee fine to five years or a fine up to twenty lakh rupees. Section 21 attributes offences by companies to the persons in charge of the business, subject to a due diligence defence, and reaches directors, managers and officers who consented to or connived at the offence.

The ladder has a gate at its foot that practitioners regard as its weakest joint. Under Section 22, no court shall take cognizance of an offence under the Act except on a complaint made by the Appropriate Authority concerned or an officer authorised by the government or the Authority, or by a person who has first given not less than sixty days’ notice to the Appropriate Authority of the alleged offence and of the intention to complain. Trials are confined to Metropolitan Magistrates and Judicial Magistrates of the first class. The gate has a defensible purpose, to screen a highly technical field against vexatious prosecution, but its cost is structural: the official who licenses the hospitals is also the gatekeeper of prosecutions arising from their conduct, and a private victim of the trade, typically a poor donor in no position to serve two months’ notice and litigate, depends entirely on official initiative. When the enforcement record is examined, this is the provision to keep in view.

Two design judgments inside the penalty chapter reward scrutiny. The first is the decision to make the advertisement and negotiation limbs of Section 19 complete offences in themselves. A trade that must recruit donors and solicit recipients in semi-public space, through brokers, touts, newspaper and online advertisements and hospital corridors, is vulnerable at the point of solicitation in a way that a purely surgical offence would not be, and the 1994 legislature’s inclusion of the offering, seeking and advertising limbs shows it understood the trade as a market with a marketing function. The second judgment is the professional penalty in Section 18(2), which converts a practitioner’s conviction into removal from the medical register, for three years on a first offence and permanently thereafter, on the Authority’s report to the State Medical Council. For a transplant surgeon, exclusion from the register is exclusion from the profession, and the provision aligns the Act’s incentives with its analysis: the trade cannot operate without surgical participation, so the surgeon is made the person with the most to lose. Set against these strengths is the sentencing reality the numbers expose. The original fine ceiling of twenty thousand rupees for commercial dealing, against transplant packages priced in lakhs, meant that for seventeen years the financial deterrent was negligible and the 2011 correction, a ceiling of one crore with a floor of twenty lakh, was less an enhancement than the repair of an obvious drafting economy. The imprisonment floor of five years, with the below-minimum proviso deleted, similarly signals that the amended Parliament intended convictions to carry consequences a hospital’s balance sheet and a broker’s business plan both had to price in.

Section 21’s attribution of company offences completes the ladder’s institutional reach. A transplant racket conducted through a hospital is, in corporate form, an offence by a company, and the section deems every person who was in charge of and responsible for the conduct of the business at the time liable, subject to the defence that the offence occurred without his knowledge or despite his due diligence, while separately reaching any director, manager, secretary or officer whose consent, connivance or neglect the prosecution proves. The provision matters because the trade’s modern form is institutional: it requires theatres, laboratories, records departments and billing systems, and a liability rule confined to the individual broker or surgeon would leave the organisation that profited untouched. Read with the registration sanctions in Section 16, which can end the institution’s transplant business altogether, Section 21 gives the enforcement system two distinct grips on a culpable hospital, the licence and the prosecution, and the reported proceedings against hospitals in the racket cases have characteristically used both, suspension of the transplant programme alongside criminal process against individuals. The trial forum rule, confining trials to Metropolitan Magistrates and Judicial Magistrates of the first class, is the chapter’s remaining antique: offences carrying ten years sit in courts whose ordinary sentencing remit was designed for lesser matters, a mismatch between the amended penalties and the unamended forum that commentators on the Act have noted and that the legislature has not revisited.

The enforcement record: rackets, documents and the gender of donors

The trade the Act was passed to kill did not die; it changed its paperwork. The pattern that investigators have exposed in successive rackets is consistent: the surgery is competent and takes place in known hospitals, the donors are poor and recruited through brokers, and the fraud is located in the authorisation file, in fabricated proof of relationship or affection that routes a paid donor through the near relative track or past a committee. The Gurgaon racket exposed in 2008, run by Amit Kumar and associates across clinics in Haryana, Uttar Pradesh and Delhi, was reported to have performed several hundred paid kidney transplants over years, with donors lured from labour lines and some held and operated on against effective resistance; prosecutions by the Central Bureau of Investigation produced convictions in the principal case, and the exposure of the racket was the immediate political backdrop against which the amendment Bill that became the 2011 Act was pressed forward. In 2016, Mumbai police uncovered a kidney racket operating through a prominent private hospital in the city, built on forged documents presenting paid donors as relatives, and the hospital’s transplant authorisations became the subject of criminal and regulatory proceedings. NOTTO’s annual reporting has itself recorded allegations of irregular approvals for transplants involving foreign nationals in Delhi and Rajasthan, including allegations that nationals of Myanmar had purchased kidneys from poor persons in their own country and had the surgeries performed in Delhi, and the health ministry in 2024 circulated the Act’s foreigner provisions to Indian missions abroad and sought a nodal coordination mechanism, an administrative response to a vulnerability in the Section 9(1A) screen.

Two conclusions follow from this record, and the article’s verdict depends on holding both at once. The first is that the prohibition is not futile: the trade survives at the margin of a regulated system, disguised as compliance, at volumes far below the open kidney bazaars of the early 1990s, and every racket prosecution proceeds under the Act’s offences. The second is that the system’s defensive energy concentrates on the documentary surface, because documents are what committees and authorities can check, and the trade has adapted to exactly that surface, so enforcement becomes a contest over affidavits between brokers who forge them professionally and committees who meet them occasionally. The gender data in NOTTO’s reporting is a quieter exhibit of the same pressure: of the 15,436 living donors recorded in 2023, 9,784 were women, nearly two-thirds, while recipients were predominantly men, a distribution the Supreme Court’s 2025 directions on donor welfare and gender bias expressly engaged. A system that channels most living donation through families will reproduce the family’s internal economics, in which the kidney that can be spared is disproportionately a woman’s, and any honest assessment of the near relative rule has to count that as one of its costs alongside its protection against strangers bearing brokers.

The enforcement picture also has an investigative asymmetry that the cases display. A racket’s victims divide into the recipients, who have no incentive to complain, the donors, who are poor, frequently from another state or country, and dependent on the broker network that recruited them, and the hospitals, whose exposure is regulatory and reputational rather than testimonial. Discovery therefore tends to arrive from outside the transaction, from a donor who was cheated of the promised payment or abandoned after surgery, from a police investigation running on another trail, from a committee or authority that notices a pattern across files, or from a journalist. The Gurgaon exposure followed that pattern, as did the Mumbai discovery, and NOTTO’s recording of the foreign national allegations shows the programme itself acting as a sensor. The statutory design anticipates detection difficulty in one respect, the Section 22 gate channels complaints through the Authority, concentrating expertise, but pays for it in another, since a gatekeeper model suppresses exactly the spontaneous private complaints through which hidden trades are usually surfaced. Reform discussion in the field returns repeatedly to this tension, and the considered position taken in the implementation literature is not that the gate should be abolished, a technical field does need screening against malicious prosecution of hospitals, but that the Authority’s own inspection and complaint machinery must be active enough to substitute for the private enforcement the gate displaces. Where authorities inspect periodically and publish their actions, as Section 13(3) directs, the gate is a filter; where they do not, it approaches a wall.

The 2011 amendment and the second map

Gathered in one place, the amendment of 2011 was the largest single revision the statute has undergone. It renamed the Act the Transplantation of Human Organs and Tissues Act, 1994 and brought tissues and tissue banks inside it. It expanded the near relative definition to include grandparents and grandchildren. It inserted swap donation in Section 9(3A) and the foreign national controls in Section 9(1A), the living minor restriction in Section 9(1B) and the mentally challenged bar in Section 9(1C). It inserted the required request and the retrieval centre duties in Sections 3(1A) and 3(1B), defined the transplant coordinator and made a coordinator a condition of hospital registration in Section 14(4). It created Advisory Committees in Section 13A, gave the Appropriate Authority civil court powers and search warrants in Section 13B, authorised the national network in Section 13C and the national registry in Section 13D, and inserted the tissue bank registration track in Section 14A. And it multiplied the penalties, most sharply for commercial dealing, where the fine ceiling rose from twenty thousand rupees to one crore.

How many versions of this Act are in force across India at once?

Several, layered by consent: the unamended 1994 text where a state adopted the parent Act but not the amendment; the amended text where the amendment was adopted; the central Rules of 2014 where states have taken them up; and, in Andhra Pradesh and Telangana, a separate state Act of 1995 altogether.

That layered position is not a transitional embarrassment that time has cured. The amendment was brought into force in its initial territories, Goa, Himachal Pradesh, West Bengal and the Union territories, on 10 January 2014, more than two years after assent, and the Transplantation of Human Organs and Tissues Rules, 2014, which superseded the Transplantation of Human Organs Rules, 1995, were notified on 27 March 2014. States then took up the amendment at different speeds, and the Supreme Court’s order of November 2025 records the position a decade on: Andhra Pradesh still to be persuaded to adopt the 2011 amendments, named states still to adopt the 2014 Rules, and State Organ and Tissue Transplant Organisations still unconstituted in Manipur, Nagaland, the Andaman and Nicobar Islands and Lakshadweep. For the researcher, the lesson is methodological: a statement about what the transplantation Act provides is incomplete without a territorial qualifier, and the commonest professional error in this field, after the stale near relative list, is to state the amended law as though it were uniformly in force.

The 2014 Rules, which the amendment’s commencement set in motion, are the statute’s operating manual and deserve recognition as the third layer of the map. Across their provisions and their nineteen forms, the Rules convert the Act’s concepts into artefacts a hospital can process: the pledge in Form 7, the post-mortem family declaration in Form 8, the unclaimed body authorisation in Form 9, the brain-stem death certificate in Form 10, the joint application in Form 11, the donor authorisations in Forms 1 to 3, the relationship certificate in Form 5 and the recipient documentation in Form 19, together with the committee’s evaluation discipline in Rule 7 and the coordinator’s duties in Rule 5. A practitioner who knows the Act but not the Rules knows why each decision is taken but not how, and the adoption question therefore matters at this layer too: a state that has taken the amendment but works to older state rules, or delays taking the 2014 Rules, operates the amended text through outdated machinery, which is why the Supreme Court’s 2025 directions addressed the Rules by name and set named states to adopt them expeditiously. The three layers, Act, amendment, Rules, each with its own territorial history, are the full answer to the deceptively simple question of what the law of organ transplantation in a given Indian city is.

The tissue half of the amended title has its own economy, and it operates at a scale the organ figures conceal. Corneas are retrieved from a large share of hospital deaths where retrieval is organised, because enucleation is quick, does not require brain-stem certification machinery of the same intensity and can be performed by a trained technician under the Section 3(4) proviso; skin, bone and heart valves are retrieved from deceased donors and processed by tissue banks into grafts that wait in storage for recipients whose need is planned rather than desperate. The 2011 decision to regulate this economy inside the transplantation statute, with registration under Section 14A, a dedicated unauthorised removal offence in Section 18(3) and the commercial dealing offence for tissues in Section 19A at a lower tariff than for organs, reflects a judgment that tissue banking had commercialised quietly and at volume, with private banks selling processed grafts into a surgical market, and that the altruistic donation frame required statutory protection there too. The lower tariff is itself a considered choice: tissue offences carry one to three years and fines between five and twenty-five lakh rupees, against five to ten years and up to a crore for organs, a gradation that prices the difference between a graft that can be stored, screened and replaced and a solid organ whose trade the legislature regarded as the graver corruption. Readers of the public debate miss most of this, because tissue transplantation rarely makes news; the registry counts it, the banks conduct it, and the amended Act’s double title is the trace of its importance.

Consent, presumed consent and the argument about shortage

Underneath the machinery sits a values dispute that the stance of this series requires be stated in its strongest forms on both sides. The prohibition’s defence is the one Parliament enacted. A market in organs, its defenders argue, cannot be a market among equals: the sellers will be the poor, the buyers the rich, the consent of a person who sells a kidney to clear a debt or feed a family is consent in form only, and the long-term health costs fall on the seller, who disappears from the system’s statistics after discharge. On this view, associated internationally with the World Health Organization’s guiding principles on human cell, tissue and organ transplantation and the Declaration of Istanbul on organ trafficking and transplant tourism, both of which insist on altruistic donation and the prohibition of payment, the criminal ban is not a policy preference but the minimum content of treating the body as outside commerce. The Indian debate adds a domestic strand: the living donor programme works at all because families trust that the system is not a bazaar, and a legalised market would corrode the deceased programme’s moral foundation.

The contrary argument is made with equal seriousness in the academic literature on organ markets, and its strongest form is empirical rather than libertarian. Prohibition, the critics observe, has not produced supply: India performs one of the largest numbers of transplants in the world yet overwhelmingly from living donors, deceased donation remains below one donor per million population, and patients die on waiting lists while a black market operates at the margin anyway, so the ban’s practical achievement is to make the trade criminal rather than to end it, and to deny compensation to the one party, the donor, who bears the risk. Writers in this tradition, including the proponents of a regulated incentive model associated with proposals by economists and transplant physicians over several decades, argue that a state-regulated system of compensation, with screening, lifelong follow-up and a fixed price, would protect donors better than a ban that drives them to brokers. The honest common ground, and it is genuinely common, is that both sides measure the system by the deceased donation rate: prohibition’s defenders concede that a ban without a functioning cadaveric programme leaves the field to living donation and its pressures, and the market’s proponents concede that a developed deceased programme would dissolve most of their case. Spain is the exhibit both sides cite, with the highest deceased donation rates in the world achieved under a system that pairs presumed consent in law with, in practice, an intensive care coordinator network and routine family approach, which is why Dr Sunil Shroff of the MOHAN Foundation and other Indian programme builders caution that an opt-out statute transplanted without the coordinator infrastructure and public trust that make the Spanish system work would change the text without changing the numbers.

Presumed consent itself, the proposal that every adult be treated as a donor after death unless he or she opted out in life, has been urged on India by senior clinicians, among them Dr M. C. Misra, a former director of the All India Institute of Medical Sciences, who proposed it for road accident fatalities in particular, and it surfaces in expert commentary whenever the shortage is debated. Its parliamentary fate is simply stated: no Indian statute adopts it. The 2011 amendment, Parliament’s one full reconsideration of the consent architecture, kept the opt-in structure intact and legislated instead for the required request, the duty to ask, which is the policy midpoint between opt-in silence and presumed consent: nobody is deemed to consent, but nobody’s family is left unasked. A reader should therefore treat any statement that India has adopted, or is on the point of adopting, an opt-out system as a claim about a proposal, never about the law.

The academic critique of presumed consent in Indian conditions adds a register the clinician debate sometimes misses, and it appeared in considered form in a review in the Indian Journal of Community Medicine examining the proposal against India’s social structure. The objection is not squeamishness: it is that presumed consent operates justly only where the population is uniformly informed, uniformly served by the health system whose agents will act on the presumption, and able to register an objection with equal ease across class, language and literacy, and that in a society stratified on each of those axes the presumption will fall in practice on those least equipped to record a refusal, converting an opt-out statute into a taking from the poor by default. Proponents answer that an accessible registry of objections, linked to documents citizens already carry, can answer the fairness point, and that the families who refuse at the bedside under the opt-in system frequently refuse from shock and unfamiliarity rather than conviction, a refusal the presumption would treat as the accident it is. The exchange is genuinely balanced, which is why the article’s position rests where the evidence rests: the comparative record attributes high deceased donation rates less to the consent formula on the statute page than to coordinator density, intensive care referral discipline and public trust in the fairness of allocation, the variables the Spanish system built over decades, and India invested its 2011 amendment in exactly those variables through the required request and the coordinator mandate. The consent debate will continue, and proposals will recur in expert committees and private members’ initiatives; the law to be applied in any given hospital on any given night remains the opt-in ladder of Section 3.

The debate has a further Indian dimension that neither the market nor the presumption literature fully captures, the claims of the family. Indian donation practice, as the authority provisions showed, is familial in its working even where the text is individual: the pledge is the donor’s, but the family is asked; the definition of donor is personal, but the committee interviews the donor’s relatives; the recipient’s need is individual, but the living donor who answers it is usually produced by a family’s internal deliberation about whose health, whose earnings and whose care work can be risked. A consent philosophy for India therefore has to answer not only the liberal question, what may a person do with his own body, and the market question, what will increase supply, but the sociological question of which institution actually decides, and on the evidence of the registry’s own numbers the answer is the family, deciding under pressure, with women disproportionately supplying the organ and men disproportionately receiving it. Reform proposals that ignore that deciding institution fail in predictable ways: an opt-out register presumes an individual decision-maker the bedside rarely presents, and a compensation scheme paid to an individual donor enters a household economy whose distribution it cannot control. The Act’s actual philosophy, visible across its provisions rather than declared in any preamble, is to work through the family while fencing it, presuming its donations genuine, testing the stranger cases it cannot presume, protecting its weakest members, the minor and the person with mental illness, by categorical exclusion, and surrounding its decisions with coordinators, committees and courts. Whether that philosophy is a wise accommodation to Indian social reality or a failure to assert individual autonomy against it is the deepest question the statute poses, and reasonable readers of this pillar will divide on it; the statute’s durability suggests the accommodation, at least, was honestly made.

The record in numbers

The figures in this field are quoted loosely in public argument, so the ones used here are tied to their sources and kept in their own series. The Ministry of Health and Family Welfare, answering in the Rajya Sabha, put the deceased organ donation rate at 0.27 donors per million population in 2013 and 0.81 per million in 2024, with deceased donors rising from 340 to 1,128 over the same period and deceased donor transplants from 837 to 3,403; total transplants of all kinds rose from 4,990 in 2013 to 18,910 in 2024. NOTTO’s annual report for 2023 records 18,378 transplants in that year, 1,099 deceased donors, the first year above one thousand, 2,935 transplants from deceased donors against 837 in 2013, and 15,436 living donors, of whom 9,784 were women and, among deceased donors, 844 were men and 255 women. The two series measure the same climb at different points and agree on its shape: steep growth from a very low base, with deceased donation remaining a small minority of all transplantation.

Why do most Indian transplants still come from living donors?

Because the deceased pipeline leaks at every stage: brain-stem deaths in intensive care are identified and certified in only a fraction of cases, the statutory request reaches families unevenly, coordinators are scarce outside large centres, and refusal is common, so families supply the organs the cadaveric system does not.

State variation within those totals repeats the statute’s federal lesson in programme form. The organised deceased donation programmes of the southern and western states, Tamil Nadu’s cadaver transplant programme being the longest established state system, built on government orders, a state transplant authority and a culture of intensive care referral, produce a disproportionate share of the nation’s deceased donors, while states whose adoption of the amendment and the Rules lagged, and which lack state organisations altogether, contribute few. The waiting list side of the ledger is harder to state with precision, because India has no single audited count of deaths on waiting lists, and estimates of annual need, for kidneys alone commonly placed above two lakh patients against a transplant count a small fraction of that, are constructions from disease incidence rather than registry counts. The durable statement is directional: need exceeds transplantation by an order of magnitude, most transplantation is living donor transplantation, and deceased donation, though growing at the rates the ministry’s figures show, supplies a minority of organs in every year for which the registry reports.

The growth rates themselves contain a lesson in reading programme statistics. A deceased donation rate rising from 0.27 to 0.81 per million across a decade is, proportionally, a trebling, and it is also true that a rate below one donor per million leaves India far beneath the levels of the mature deceased programmes against which it is conventionally compared, where rates are counted in tens per million. Both statements are honest, and the choice between them in public argument is a choice of framing rather than of fact. The transplant totals tell the complementary story: the rise from 4,990 transplants in 2013 to 18,910 in 2024 in the ministry’s series is a real expansion of surgical capacity and of living donor transplantation alongside the deceased programme, since living donors supplied the large majority in every year of the series. A reader who wants to know whether the Act’s deceased architecture is working should therefore watch the deceased share and the conversion behaviour behind it, identifications, certifications, requests, consents, rather than the headline transplant count, which can grow handsomely on living donation alone while the cadaveric system stagnates. The registry’s gender figures perform a similar diagnostic service for the living programme, as the enforcement section noted: a living donor pool that is nearly two-thirds women, donating into a recipient pool that is predominantly men, is a datum about family economics that no reading of Section 9’s neutral text would predict, and it is the kind of fact the evaluation purpose in Section 13D exists to surface.

The state pattern inside the national totals deserves a final word, because it converts the article’s federal argument into programme evidence. Organised state programmes built patiently over years, with a state authority or organisation holding the waiting list, government orders standardising brain-stem death certification and family approach in public hospitals, and coordinators posted where deaths occur, produce deceased donation rates several times the national average from within the same statute. The causation runs through institutions rather than through culture in any simple sense: the states that lead are the states that built the machinery earliest and funded it longest, and the states that trail are disproportionately those whose adoption of the amendment and the 2014 Rules came late or whose state organisations the Supreme Court found still unconstituted in 2025. For a policy reader, the implication cuts both ways. The statute cannot be blamed for outcomes its machinery was never built to deliver, and it cannot be credited where the machinery, once built, performs: the honest unit of analysis in this field is the state programme, and the Act is best understood as the common legal chassis on which programmes of very different quality have been assembled.

Assessment and verdict

The statute’s architecture, separated from its operation, is well designed. It solved the definitional problem completely: brain-stem death, certified by a conflict-screened board, is a stable legal fact on which a national programme can rest. It drew the commerce line at a defensible place, permitting reimbursement of costs and lost earnings while criminalising payment for the organ itself, and it surrounded the two pressure points of the system, the stranger donation and the foreign recipient, with committee scrutiny calibrated by the courts to evidence of dealing rather than suspicion of motive. Its 2011 revision shows a legislature learning from its own statute: the gaps it closed, grandparents, swap, required request, coordinators, tissues, trivial fines, were the gaps the first seventeen years had actually exposed. A reader who doubts the design should be asked which provision he would repeal, and the honest answers are few.

The operation is a different matter, and the failures cluster where this article has located them. The consent-based map means the statute’s protections and permissions vary by state in ways no clinical consideration justifies, a defect the Supreme Court’s 2025 directions acknowledged from the bench. The committees, the system’s hinge, vary in sitting frequency, documentation culture and fidelity to the Kuldeep Singh standard, so that the same application is a fortnight’s formality in one district and a year’s litigation in another. The deceased pipeline, on which everything ultimately depends, remains thin outside a handful of states and large hospitals, not for want of law, Section 3(1A) has imposed the duty to ask for over a decade in the amendment’s territories, but for want of the coordinators, retrieval registrations and intensive care habits that turn a duty into a routine. And the enforcement gate in Section 22 leaves prosecution of the trade dependent on the same authorities whose licensing the trade’s existence embarrasses.

Judged as a study object, which is this series’ purpose, the Act also teaches a transferable method for reading any Indian regulatory statute of the federal era. Begin with the preamble and the extent clause, because they tell you where the law is; read the definitions as operative law, because in this statute they carry the commerce line, the death line and the family line; follow the money in the penalty chapter against the prices of the thing regulated, because a fine below the market price of compliance failure is an invitation printed in the statute book; and end with the institutions, asking of each body the Act names whether the Act created it or merely imagined it, because the answer decides where accountability can actually be demanded. Applied to the transplantation Act, that method produces the findings this article has organised itself around: a consent-built map that compounds with every amendment, a definitional core of unusual quality, a penalty ladder that took seventeen years to reach deterrent scale, and a national organisation that arrived by executive action two decades after the enabling text. The method will serve the reader again in the mental healthcare and surrogacy pillars that follow in this cluster, where the same questions, where does it apply, what do the definitions carry, do the penalties price the offence, and who actually runs it, separate the statute as enacted from the statute as experienced.

The verdict of this pillar is therefore a divided one. As a text, the Transplantation of Human Organs and Tissues Act is among the more carefully constructed Indian statutes of its decade, and its central choices, brain-stem death, the near relative rule, the committee screen, the absolute ban on payment, have each withstood thirty years of pressure, litigation and amendment without surrendering their logic. As an operating system for organ donation in India, it remains unfinished in the specific way Article 252 statutes tend to remain unfinished: its map is incomplete, its newest text is not yet the law everywhere, and the organisations that give it life were built a generation after it, by executive action, on an enabling section. The series’ namable claim for this cluster bears repeating as the closing note: the parent Act and its amendment do not apply in the same places, because each was requested by a different set of states, and the version of transplantation law in force for a given patient is a function of resolutions passed by legislatures, not of the date on the statute book. Readers preparing teaching or seminar material from this article can work through the route table above with a presentation viewer for the donation routes table, which is also the fastest way to test the table’s routing against a real case.

Frequently Asked Questions

Q: What does the Transplantation of Human Organs Act prohibit?

The Act prohibits the removal of any human organ from a donor, living or deceased, without authority in the manner the Act prescribes, and it prohibits commercial dealing in organs altogether. Section 19 makes it an offence to make or receive payment for the supply of an organ, to seek or offer an organ for payment, to negotiate such an arrangement, or to advertise one, and the 2011 amendment added abetting false documents to establish a false relationship. It also prohibits unregistered hospitals from conducting, associating with or helping in removal, storage or transplantation under Section 10, and removal from a living donor who is not a near relative without the prior approval of the Authorisation Committee.

Q: Who counts as a near relative for organ donation?

Section 2(i) defines a near relative as the spouse, son, daughter, father, mother, brother, sister, grandfather, grandmother, grandson or granddaughter of the recipient. The original 1994 definition listed only six relations, spouse, son, daughter, father, mother, brother and sister, and the 2011 amendment added the four grand relations, so accounts repeating the shorter list state the pre-amendment law. A near relative may donate without Authorisation Committee approval, through the hospital’s competent authority, on a joint application in Form 11 with the relationship certified in Form 5. In-laws, cousins, uncles, aunts, nephews and nieces are not near relatives under the definition, however close the family bond, and their donations travel the committee route.

Q: What happens when a donor is not a near relative?

The donation is not barred, but it cannot proceed on the family’s word alone. Section 9(3) requires the prior approval of the Authorisation Committee where the donor donates by reason of affection or attachment towards the recipient or for any other special reasons. Donor and recipient apply jointly in Form 11, the committee holds an inquiry under Section 9(5), and under Rule 7(3) of the 2014 Rules it examines the link between them, documentary and photographic evidence, their financial status over three financial years, the absence of a middleman or payment, and interviews the donor’s family. A rejection must record reasons in writing after hearing the applicants, and an appeal lies to the state or central government under Section 17 within thirty days.

Q: How does Indian law define brain stem death?

Section 2(d) defines brain-stem death as the stage at which all functions of the brain-stem have permanently and irreversibly ceased, and is so certified under Section 3(6). Certification is by a Board of medical experts consisting of the practitioner in charge of the hospital, an independent specialist from the panel approved by the Appropriate Authority, a neurologist or neurosurgeon from that panel, with a statutory substitute where none is available, and the practitioner treating the patient. The certificate is given in Form 10 under the 2014 Rules after two sets of clinical examinations separated by at least six hours. Brain-stem death is legally distinct from coma or a vegetative state, in which brain-stem function continues, and only a certified brain-stem death makes a person a deceased person for organ retrieval.

Q: Why was the organ transplant law enacted under Article 252?

Public health and hospitals are state subjects, so Parliament could not legislate a transplantation law for the whole country on its own authority. Article 252 of the Constitution allows Parliament to legislate on a state subject for states whose legislatures pass resolutions requesting it, and Goa, Himachal Pradesh and Maharashtra passed such resolutions for this Act, with other states then free to adopt it by resolution. The Act therefore applied in the first instance to those three states and to all Union territories, and spread state by state as legislatures adopted it. The same route was needed again for the 2011 amendment, whose own resolutions came from Goa, Himachal Pradesh and West Bengal, which is why the parent Act and its amendment do not apply in identical territory.

Q: What did the 2011 transplantation amendment add?

The Transplantation of Human Organs (Amendment) Act, 2011, Act 16 of 2011, renamed the Act the Transplantation of Human Organs and Tissues Act and brought tissues and tissue banks inside it. It added grandparents and grandchildren to the near relative definition, created swap donation in Section 9(3A), imposed the required request duty in Section 3(1A), created foreign national approval controls, the living minor restriction and the bar on removal from mentally challenged persons, required every registered hospital to appoint a transplant coordinator, created Advisory Committees, civil court powers for the Appropriate Authority, the national network and registry provisions in Sections 13C and 13D, and raised commercial dealing punishment to five to ten years with fines between twenty lakh rupees and one crore.

Q: What is swap donation and when is it allowed?

Swap donation, or paired exchange, is the arrangement Section 9(3A) authorises for two families each of which has a willing near relative donor who is biologically incompatible with his or her own recipient. The first donor is compatible with the second recipient and the second donor with the first, and all four, both donors and both recipients, enter into a single agreement to donate and receive on that basis. Removal and transplantation under the agreement require the prior approval of the Authorisation Committee. Swap does not widen who may donate, since both donors must still be near relatives of their own recipients; it widens the usefulness of family donors by letting incompatibility be solved across two families instead of within one.

Q: Can a state require domicile for transplant registration?

The Act itself says nothing about domicile. The restriction grew up in state allocation practice under the national programme, under which a patient registered for a deceased donor organ on the waiting list of the state of domicile, and some states also charged registration fees and applied an upper age limit of sixty-five. In February 2023 the health ministry’s modified national guidelines removed the domicile requirement, so a patient may register for a transplant in any state, dropped the age ceiling, and asked states not to charge registration fees. The change was administrative, made through the guidelines administered by NOTTO and the state organisations, and no court held a domicile condition unconstitutional; the position rests on programme policy rather than on the statute or a judgment.

Q: Can a person pledge their organs before death, and is the pledge enough on its own?

A person may authorise removal of organs after death under Section 3(2), in writing and in the presence of two or more witnesses, at least one of whom is a near relative, and the Rules provide Form 7 for recording the pledge. The authorisation has legal force: the person lawfully in possession of the body must grant all reasonable facilities for removal unless the authority was revoked. In practice, though, Rule 5 of the 2014 Rules requires the consent of the near relative or the person in possession to be taken as well, recorded in Form 8, so hospitals ask the family in every case and a family’s refusal at the bedside normally ends the matter. A pledge is therefore best understood as a strong instruction that the family is asked to honour, not as a self-executing order.

Q: What does an Authorisation Committee check before approving a donation?

Under Rule 7(3) of the 2014 Rules, the committee evaluating a donation by a person who is not a near relative must satisfy itself that there is no commercial transaction and no payment made or promised, prepare an explanation of the link between donor and recipient and how the offer arose, examine the donor’s reasons, study documentary evidence of the link such as proof of having lived together, look at old photographs of donor and recipient together, check that no middleman or tout is involved, compare the financial status of both from income and vocation evidence for the previous three financial years, confirm the donor is not a drug addict, and interview a near relative or other adult relative of the donor about the intention to donate and the authenticity of the link.

Q: What is the punishment for buying or selling a human organ in India?

Commercial dealing in human organs is punishable under Section 19 with imprisonment of not less than five years and up to ten years, and a fine of not less than twenty lakh rupees which may extend to one crore rupees, figures substituted by the 2011 amendment for the original two to seven years and fines measured in thousands of rupees. The offence covers making or receiving payment, seeking or offering an organ for payment, negotiating such an arrangement, advertising it, and, since 2011, abetting false documents or affidavits to fake a near relative relationship or an altruistic motive. Separate penalties apply to unauthorised removal under Section 18, up to ten years and twenty lakh rupees, and a convicted practitioner faces removal from the medical register for three years for a first offence and permanently thereafter.

Q: Can a foreign national get an organ transplant in India?

Yes, within controls designed to keep India from becoming a destination for purchased organs. Where the donor or the recipient, being a near relative, is a foreign national, Section 9(1A) requires the prior approval of the Authorisation Committee even inside the family track, and the committee cannot approve a case in which the recipient is a foreign national and the donor an Indian national unless the two are near relatives. Applications are tested on identity and relationship documents, with verification through diplomatic channels where the papers require it. The controls exist because investigations, including allegations recorded in NOTTO’s own annual reporting of irregular approvals involving foreign nationals in Delhi and Rajasthan, showed the foreigner route being used to launder paid donation into apparent family donation.

Q: Can organs be removed from an unclaimed body in a hospital or prison?

Yes, under Section 5, but only after time has been allowed for a claim. If a person dies in a hospital or a prison and the body is not claimed by any near relative within forty-eight hours of death, the authority for removal may be given by the person in charge of managing and controlling the hospital or prison, in Form 9 under the Rules. The power is withheld if that person has reason to believe a near relative is likely to claim the body even after the forty-eight hours have run. Section 4 adds a separate bar: no authority may be granted where there is reason to believe an inquest may be required into the cause of death, so medico-legal cases travel a distinct procedure.

Q: What is a transplant coordinator and why does the law require one?

A transplant coordinator is a person appointed by a hospital, as defined in Section 2(q), for coordinating all matters relating to the removal and transplantation of organs and tissues and for assisting the authority for removal. Section 14(4), inserted in 2011, makes the appointment a condition of registration: the Appropriate Authority must be satisfied that the hospital has appointed a coordinator with the prescribed qualifications and experience before it registers or renews the hospital. The coordinator is the human hinge of the deceased donation system, counselling families at the point of brain-stem death, running the required request under Section 3(1A), and liaising with retrieval centres and the state network, which is why programme experience treats coordinator strength, rather than the consent text, as the variable that moves donation rates.

Q: Why do Andhra Pradesh and Telangana have their own organ transplant law?

Because the central Act’s Article 252 design never reached them in the ordinary way. When the 1994 Act was enacted for the resolving states and adopted elsewhere, Andhra Pradesh, like Jammu and Kashmir, had its own legislation on the subject, the Andhra Pradesh Transplantation of Human Organs Act of 1995, and the statement of objects of the 2011 central amendment records that position. On the state’s bifurcation, that state Act continued in both Andhra Pradesh and Telangana. The practical consequence, which the Supreme Court’s directions of November 2025 addressed by asking the Centre to persuade Andhra Pradesh to adopt the 2011 amendments, is that the amended central text, with swap donation, the required request and tissue regulation, does not supply the governing law there in the same form as in the adopting states.

Q: Can a child donate an organ to a parent or sibling?

In ordinary practice, no. Section 9(1B) provides that no organ shall be removed from the body of a living minor except in the manner prescribed, and the 2014 Rules confine the exception to cases where medical grounds are so exceptional that the removal is justified, with the grounds recorded in detail and the prior approval of both the Appropriate Authority and the state government obtained. The definition of donor in Section 2(g) itself speaks of a person not less than eighteen years of age. The bar protects a person who cannot weigh a permanent surgical sacrifice, and it applies within the family as much as outside it: parental consent does not convert a child into an ordinary donor, and a hospital proposing such a case faces the exceptional grounds procedure, not the routine near relative track.

Q: What can a patient do if the Authorisation Committee rejects the donation?

The first protection is built into Section 9(6): a committee cannot reject an application without giving the applicants an opportunity of being heard, and the rejection must record reasons in writing. An appeal then lies under Section 17 to the Central Government or the state government, as the case may be, and it must be filed within thirty days of receipt of the order, a short window that makes prompt action essential. Patients have also approached the High Courts in writ jurisdiction, and the courts have set aside rejections that rest on speculation rather than material showing a commercial dealing, applying the Supreme Court’s decision in Kuldeep Singh v. State of Tamil Nadu, (2005) 11 SCC 122, under which a donor’s altruistic account is not to be disbelieved without credible reason and permission ought not to be withheld absent definite material of a financial transaction.

Q: Who decides which patient receives a deceased donor’s organ?

Not the treating hospital acting alone. Organs from a deceased donor are allocated through the waiting lists maintained within the network the 2011 amendment authorised in Sections 13C and 13D, operated by NOTTO at the national level, the five regional organisations and the state organisations, under allocation guidelines framed by the health ministry and NOTTO. The guidelines rank patients on criteria of medical urgency, waiting time, blood group and tissue matching and the geography of retrieval, so that an organ is offered to the listed patient it fits rather than to the patient whose hospital retrieved it. The treating team’s role is clinical, certifying fitness and performing the transplant; the choice among waiting patients is an administrative allocation under the guidelines, open to scrutiny precisely because it is rule based.

Q: Is it legal to reimburse a living donor’s expenses and lost wages?

Yes. The definition of payment in Section 2(k) excludes payment for defraying or reimbursing the cost of removing, transporting or preserving the organ, and any expenses or loss of earnings incurred by a person so far as reasonably and directly attributable to his supplying the organ. A recipient or the recipient’s family may therefore lawfully meet the donor’s travel, hospital and recovery costs and compensate earnings lost through the donation and convalescence, without committing the commercial dealing offence. What may not be paid for is the organ itself, and the line is policed by proportion and documentation: reimbursement must answer to real costs reasonably incurred, and a payment dressed as expenses but bearing no relation to them is capable of being treated as consideration for the organ, which Section 19 punishes with five to ten years’ imprisonment.

Q: What is NOTTO, and was it created by the Act itself?

NOTTO, the National Organ and Tissue Transplant Organisation, is the apex body of the national programme, established in 2014 by executive action of the Directorate General of Health Services in the Ministry of Health and Family Welfare under the National Organ Transplant Programme, and housed at Safdarjung Hospital, New Delhi. It was not created by the Act. The Act, through Sections 13C and 13D inserted in 2011, empowers the Central Government to establish a national removal and storage network and requires it to maintain a national registry of donors and recipients, and NOTTO is the organisation built within that enabling frame, working through five regional organisations at Chandigarh, Mumbai, Chennai, Kolkata and Guwahati and the state organisations below them. Its powers over hospitals and states are programme powers, exercised through the Appropriate Authorities, not statutory powers conferred by the Act’s text.