Transplantation of Human Organs Act

Transplantation of Human Organs Act, 1994AIMTo provide for the regulation of RemovalStorage of human organstransplantation for therapeutic purposes For the prevention of commercial dealings in human organsFor matters connected therewithbrain-stem death means the stage at which all functions of the brain stem have permanently and irreversibly ceased deceased person means a person in whom permanent disappearance of all evidence of life occurs, by reason of brain-stem death or in a cardio-pulmonary sense, at any time after live birth has taken placedonor means any person, not less than eighteen years of age, who voluntarily authorizes the removal of any of his human organs for therapeutic purposesnear-relative means spouse, son, daughter, father, mother, brother or sisterAUTHORITY FOR REMOVAL OF ORGANSAny donor can authorize the removal for therapeutic purposes BEFORE DEATHIf any donor in writing in presence of 2 witnesses (at least 1 is near relative) authorizes the removal person who is in lawful possession of body grant all reasonable facilities to R.M.P. for removal of human organ from the dead body of donor UNLESS person believes that the donor has revoked the authority If no authority is given by donor prior to death BUT no objection was also expressedOnly RMP can remove human organsRMP must satisfy thatDeath has occurredBrain stem death has occurred Brain stem death certified byRMP in charge of hospitalRMP treating the personAn independent specialist RMP, nominated by in charge RMP from panel approved by Appropriate Authority Neurosurgeon or neurologist, nominated by in charge RMP from panel approved by Appropriate AuthorityIn case of minor, authority by parents is to be given

NO AUTHORISATIONIf inquest required to be heldNo authority given by person who is entrusted for its cremation, interment or disposal

UNCLAIMED BODIESIn hospital and prisonIf not claimed by WITHIN 48 hours by nearest relatives authority can be given by person in charge of hospital or prisonNo authority if it is likely that nearest relative will claim the body even AFTER 48 hoursBODY SENT FOR POSTMORTEM EXAMINATIONAuthority given by person in charge ifThe organ to be removed is not required for aforementioned purposeNo objection expressed prior to death by donor for removal of organThe donor has given authority for removalThe donor has not revoked the given authority before death

PRESERVATION OF ORGANSAfter the removal of any human organ from the body of any person, the registered medical practitioner shall take such steps for the preservation of the human organ so removed as may be prescribed.RESTRICTIONS TO TRANSPLANTTransplantation before death of donorRecipient must be near relative Transplantation after death of donorRecipient who is in need of human organ

Transplant before death not in near relativeBy reason of attachmentBy reason of affectionOr any other reasonAuthorization Committee approval neededCentral and State Government, by notificationconstitute one or more Authorisation Committees Application by donor and recipient to Authorisation CommitteeRequirements and rules complied ApproveNot complied No appovalREGULATIONS OF HOSPITALSRegistration for hospitals undertaking removal, storage and transplantation is mustNo R.M.P. aid/conduct any activity in hospital for transplantation unless registeredRegistered hospitals should conduct removal, storage and transplantation only for therapeutic purposeR.M.P. can remove eyes and ears any place after the death of donor, for therapeutic purposePROHIBITION OF REMOVALNo authority should be given for removal unless therapeutic purposeNo authority UNLESS all possible effects, complications and hazards of the removal and transplantation explained to the donor and the recipient respectively

APPROPRIATE AUTHORITYCentral Govt. appoint one or more officers as Appropriate Authority in Union TerritoriesState Govt. appoint one or more officers as Appropriate Authority

Functions of Appropriate AuthorityTo grant or renew registration of hospitalsTo suspend or cancel registration of hospitalsTo enforce standards in hospitalsTo investigate complaints against breach of this Act or rules made thereunderTo inspect hospitalsFor examination of quality of transplantationFollow up care of donor and recipientTo undertake such other measures as prescribedREGISTRATION OF HOSPITALSNo hospital shall be registered under this Act unless the Appropriate authority is satisfied that such hospital is in a position to provideSpecialised servicesFacilitiesPossess such skilled manpower and equipments Maintain such standards as may be prescribed.Registration after application with prescribed feesCERTIFICATE OF REGISTRATIONGiven by Appropriate AuthorityAfter inspection for standardsRejection if hospital does not complyPeriodic renewal in such manner and after payment of fees as prescribedSUSPENSION/CANCELLATIONNotice by Appropriate Authority to hospitalsShow cause why registration should not be cancelledAfter hearing, if there is breach in provisions of this Act or rules under this Act Suspension/CancellationWhere Appropriate authority is of the opinion that it is necessary to do in the public interest, it may, for reasons to be recorded in writing, suspend the registration of any hospital without issuing any notice.APPEALSAny person aggrieved by decision of Authorisation Committee appeal to Central or State Govt. as necessary within 30 days of that order, in prescribed mannerAny hospital aggrieved by decision of Appropriate Authority appeal to Central or State Govt. as necessary within 30 days of that order, in prescribed manner

PUNISHMENTSRemoval of organs without authority by RMPimprisonment for a term which may extend to five years and with fine which may extend to ten thousand rupees.Removal of name from register for 2 years for first offence and permanently for subsequent offence

Commercial dealings in human organsWhoever for removal, storage and transplantation of organsMakes/receive paymentSeeks to find person for this purposeOffers supply of the organMakes arrangement for supply or paymentPublishes advertisement for this purposeImprisonment for a term which shall not be less than two years but which may extend to seven years and shall be liable to fine which shall not be less than ten thousand rupees but may extend to twenty thousand rupeesWhoever contravenes any provision of this Act or any rule made or any condition of the registration granted thereunderfor which no punishment is separately provided in this Actshall be punishable with imprisonment for a term which may extend to three years or with fine which may extend to five thousand rupees.OFFENCES BY COMPANIESThe officer in charge of the company shall be deemed to be guilty of the offence and shall be liable to be proceeded against and punished accordinglyEXCEPT if he proves that the offence was committed without his knowledge or that he had exercised all due diligence to prevent the commission of such offenceCOGNIZANCE OF OFFENCENo court shall take cognizance of an offence under this Act except on a complaint made by(a) the Appropriate Authority concerned, or any officer authorised in this behalf by the Central Government or the State Government or, as the case may be OR(b) a person who has given notice of not less than sixty days, in such manner as may be prescribed, to the Appropriate Authority concerned, of the alleged offence and of his intention to make a complaint to the court.No court other than that of a Metropolitan Magistrate or a Judicial Magistrate of the first class shall try any offence punishable under this Act.Where a complaint has been made by the person as above, the court may, on demand by such person, direct the Appropriate Authority to make available copies of the relevant records in its possession to such person.THE TRANSPLANTATION OF HUMAN ORGANS (AMENDMENT) ACT, 2011 No.16 OF 2011 [28th September, 2011]AdditionsHuman organs is replaced by human organs and tissuesHospital Human Organ Retrieval Centrenear relative means spouse, son, daughter, father, mother, brother, sister, grandfather, grandmother, grandson or granddaughter Defines tissue a group of cells, except blood, performing a particular function in the human bodyDefines Tissue Bank a facility registered for carrying out any activity relating to the recovery, screening, testing, processing, storage and distribution of tissues, but does not include a Blood Bank

transplant co-ordinator a person appointed by the hospital for co-ordinating all matters relating to removal or transplantation of human organs or tissues or both and for assisting the authority for removal of human organsNo Registration until transplant co-ordinator appointedRMP in charge shall work in consultation with transplant co-ordinatorTo ascertain the authority for removal, storage and transplantation of human organs and tissuesTo make aware the patient or near relative to authorise or decline the donationTo inform in writing Human Organ Retrieval Centre for the removal, storage and transplantation of human organs and tissues

A technician possessing such qualifications and experience, as may be prescribed, may enucleate a cornea.

Where a neurologist or a neurosurgeon is not availableRMP may nominate an independent RMP surgeon/ physician/anaesthetist/intensivist subject to the condition that they are not members of the transplantation team for the concerned recipient

Where the donor or the recipient being near relative is a foreign national prior approval of the Authorisation Committee shall be required before removing or transplanting human organ or tissue or bothAuthorisation Committee shall not approve such removal or transplantation if the recipient is a foreign national and the donor is an Indian national unless they are near relatives. No human organs or tissues or both shall be removed from the body of a minor before his death for the purpose of transplantation except in the manner as may be prescribedNo human organs or tissues or both shall be removed from the body of a mentally challenged person before his death for the purpose of transplantation. Where(a) any donor has agreed to make a donation of his human organ or tissue or both before his death to a recipient, who is his near relative, but such donor is not compatible biologically as a donor for the recipient(b) the second donor has agreed to make a donation of his human organ or tissue or both before his death to such recipient, who is his near relative, but such donor is not compatible biologically as a donor for such recipientThen(c) the first donor who is compatible biologically as a donor for the second recipient and the second donor is compatible biologically as a donor of a human organ for human organs and tissue for the first recipient and both donors and both recipients in the aforesaid group of donor and recipient have entered into a single agreement to donate and receive such human organ or tissue or both according to such biological compatibility in the group the removal and transplantation of the human organ or tissue of both, as per the agreement referred to above, shall not be done without prior approval of the Authorisation Committee

No Tissue Bank, unless registered under this Act, shall carry out any activity relating to the recovery, screening, testing, processing, storage and distribution of tissues The Central and the State Governments, shall constitute an Advisory Committee For a period of two years To aid and advise the Appropriate Authority to discharge its functions.The Advisory Committee shall consist of- one administrative expert not below the rank of Secretary to the State Government, to be nominated as Chairperson of the Advisory Committeetwo medical experts having such qualifications as may be prescribedone officer not below the rank of a Joint Director to represent the Ministry or Department of Health and Family Welfare, to be designated as Member-Secretarytwo eminent social workers of high social standing and integrity, one of whom shall be from amongst representatives of womens organisationone specialist in the field of human organ transplantation, provided he is not a member of the transplantation team.The Appropriate Authority shall for the purposes of this Act have all the powers of a civil court trying a suit under the Code of Civil Procedure The Central Government may establish a National Human Organs and Tissues Removal and Storage Network at one or more places and Regional NetworkThe Central Government shall maintain a national registry of the donors and recipients of human organs and tissue having information as may be prescribed to an ongoing evaluation of the scientific and clinical status of human organs and tissues

Removal of human organs for the purpose of transplantation without authority by RMP imprisonment for a term which may extend to ten years and with fine which may extend to twenty lakh rupeesRemoval of name from register for three years for first offence and permanently for subsequent offenceRemoval of human tissues without authority, shall be punishable with imprisonment for a term which may extend to three years and with fine which may extend to five lakh rupees.

Commercial dealings in human organsWhoever for removal, storage and transplantation of organsMakes/receive paymentSeeks to find person for this purposeOffers supply of the organMakes arrangement for supply or paymentPublishes advertisement for this purposeImprisonment for a term which shall not be less than five years but which may extend to ten years and shall be liable to fine which shall not be less than twenty lakh rupees but may extend to one crore rupees

Commercial dealings in human tissuesWhoever for removal, storage and transplantation of tissuesMakes/receive paymentSeeks to find person for this purposeOffers supply of the organMakes arrangement for supply or paymentPublishes advertisement for this purposeShall be punishable with imprisonment for a term which may extend to three years and which shall be liable to fine not to be less than five lakh rupees but which may extend to twenty-five lakh rupees

Whoever contravenes any provision of this Act or any rule made or any condition of the registration granted thereunderfor which no punishment is separately provided in this Actshall be punishable with imprisonment for a term which may extend to five years or with fine which may extend to twenty lakh rupees Thank You