Transplantation of Human Organs and Tissues Rules, 2014
(1) These rules may be called the Transplantation of Human Organs and Tissues Rules, 2014.
(2) They shall come into force on the date of their publication in the Official Gazette.
In these rules unless the context otherwise requires,--
(a) "Act" means the Transplantation of Human Organs Act, 1994;
(b) "cadaver(s)", "organ(s)" and "tissue(s)" means human cadaver(s), human organ(s) and human tissue(s), respectively;
(c) "competent authority" means the Head of the institution or hospital carrying out transplantation or committee constituted by the head of the institution or hospital for the purpose;
(d) "Form" means a Form annexed to these rules;
(e) National Accreditation Board for Testing and Calibration Laboratories (NABL) means the autonomous body established under the aegis of Department of Science and Technology, Government of India with the objective to provide Government, Regulators and Industry with a scheme of laboratory accreditation through third-party assessment for formally recognising the technical competence of laboratories and the accreditation services are
Subject to the provisions of Section 3 of the Act, a living person may authorise the removal of any organ or tissue of his or her body during his or her lifetime as per prevalent medical practices, for therapeutic purposes in the manner and on such conditions as specified in Form 1, 2 and 3.
For the purpose of certifying the brain-stem death, the Appropriate Authority shall maintain a panel of experts, in accordance with the provisions of the Act, to ensure efficient functioning of the Board of Medical Experts and it remains fully operational.
(1) The registered medical practitioner of the hospital having Intensive Care Unit facility, in consultation with transplant coordinator, if available, shall ascertain, after certification of brain stem death of the person in Intensive Care Unit, from his or her adult near relative or, if near relative is not available, then, any other person related by blood or marriage, and in case of unclaimed body, from the person in lawful possession of the body the following, namely:--
(a) whether the person had, in the presence of two or more witnesses (at least one of who is a near relative of such person), unequivocally authorised before his or her death as specified in Form 7 or in documents like driving license, etc. wherein the provision for donation may be incorporated after notification of these rules, the removal of his or her organ(s) or tissue(s) including eye, after his or her death, for therapeutic purposes and there is no reason to believe that the person had su
(1) After the authority for removal of organs or tissues, as also the consent to donate organs from a brain-stem dead donor are obtained, the registered medical practitioner of the hospital shall make a request to the Station House Officer or Superintendent of Police or Deputy Inspector General of the area either directly or through the police post located in the hospital to facilitate timely retrieval of organs or tissue from the donor and a copy of such a request should also be sent to the designated post mortem doctor of area simultaneously.
(2) It shall be ensured that, by retrieving organs, the determination of the cause of death is not jeopardised.
(3) The medical report in respect of the organs or tissues being retrieved shall be prepared at the time of retrieval by retrieving doctor (s) and shall be taken on record in postmortem notes by the registered medical practitioner doing postmortem.
(4) Wherever it is possible, attempt should be made to request t
(1) The medical practitioner who will be part of the organ transplantation team for carrying out transplantation operation shall not be a member of the Authorisation Committee constituted under the provisions of clauses (a) and (b) of sub-section(4) of section 9 of the Act.
(2) When the proposed donor or recipient or both are not Indian nationals or citizens whether near relatives or otherwise, the Authorisation Committee shall consider all such requests and the transplantation shall not be permitted if the recipient is a foreign national and donor is an Indian national unless they are near relatives.
(3) When the proposed donor and the recipient are not near relatives, the Authorisation Committee shall,-
(i) evaluate that there is no commercial transaction between the recipient and the donor and that no payment has been made to the donor or promised to be made to the donor or any other person;
(ii) prepare an explanation of the link
The removal of the organ(s) or tissue(s) shall be permissible in any registered retrieval or transplant hospital or centre and preservation of such removed organ(s) or tissue(s) shall be ensured in registered retrieval or transplant centre or tissue bank according to current and accepted scientific methods in order to ensure viability for the purpose of transplantation.
The cost for maintenance of the cadaver (brain-stem dead declared person), retrieval of organs or tissues, their transportation and preservation, shall not be borne by the donor family and may be borne by the recipient or institution or Government or non-Government organisation or society as decided by the respective State Government or Union territory Administration.
(1) The donor and the recipient shall make jointly an application to grant approval for removal and transplantation of a human organ, to the competent authority or Authorisation Committee as specified in Form 11 and the papers for approval of transplantation would be processed by the registered medical practitioner and administrative division of the Institution for transplantation.
(2) The competent authority or Authorisation Committee shall take a decision on such application in accordance with the rule 18.
(3) If some State wants to merge Form 11 with Form 1, Form 2 or Form 3, they may do so, provided the content of the recommended Forms are covered in the merged Form and the same is approved by the State Government concerned.
(1) There shall be one State level Authorisation Committee.
(2) Additional Authorisation Committees in the districts or Institutions or hospitals may be set up as per norms given below, which may be revised from time to time by the concerned State Government or Union territory Administration by notification.
(3) No member from transplant team of the institution should be a member of the respective Authorisation Committee.
(4) Authorisation Committee should be hospital based if the number of transplants is twenty five or more in a year at the respective transplantation centres, and if the number of organ transplants in an institution or hospital are less than twenty-five in a year, then the State or District level Authorisation Committee would grant approval(s).
The hospital based Authorisation Committee shall, as notified by the State Government in case of State and by the Union territory Administration in case of Union territory, consist of,--
(a) the Medical Director or Medical Superintendent or Head of the institution or hospital or a senior medical person officiating as Head - Chairperson;
(b) two senior medical practitioners from the same hospital who are not part of the transplant team -Member;
(c) two persons (preferably one woman ) of high integrity, social standing and credibility, who have served in high ranking Government positions, such as in higher judiciary, senior cadre of police service or who have served as a reader or professor in University Grants Commission approved University or are self-employed professionals of repute such as lawyers, chartered accountants, doctors of Indian Medical Association, reputed non-Government organisation or renowned social worker - Membe
The State or District Level Authorisation Committee shall, as notified by the State Government in case of State and by the Union territory Administration in case of Union territory, consist of,--
(a) a Medical Practitioner officiating as Chief Medical Officer or any other equivalent post in the main or major Government hospital of the District - Chairperson;
(b) two senior registered medical practitioners to be chosen from the pool of such medical practitioners who are residing in the concerned District and who are not part of any transplant team- Member;
(c) two persons (preferably one woman) of high integrity, social standing and credibility, who have served in high ranking Government positions, such as in higher judiciary, senior cadre of police service or who have served as a reader or professor in University Grants Commission approved University or are self-employed professionals of repute such as lawyers, chartered accounta
When the living donor is unrelated and if donor or recipient belongs to a State or Union territory, other than the State or Union territory where the transplantation is proposed to be undertaken, verification of residential status by Tehsildar or any other authorised officer for the purpose with a copy marked to the Appropriate Authority of the State or Union territory of domicile of donor or recipient for their information shall be required, as per Form 20 and in case of any doubt of organ trafficking, the Appropriate Authority of the State or Union territory of domicile or the Tehsildar or any other authorised officer shall inform police department for investigation and action as per the provisions of the Act.
The quorum of the Authorisation Committee should be minimum four and the quorum shall not be complete without the participation of the Chairman, the presence of Secretary (Health) or nominee and Director of Health Services or nominee.
The format of the Authorisation Committee approval should be uniform in all the institutions in a State and the format may be notified by the respective State Government as per Form 18.
(1) Secretariat of the Authorisation Committee shall circulate copies of all applications received from the proposed donors and recipients to all members of the Committee along with all annexures, which may have been filed along with the applications.
(2) At the time of the meeting, the Authorisation Committee should take note of all relevant contents and documents in the course of its decision making process and in the event any document or information is found to be inadequate or doubtful, explanation should be sought from the applicant and if it is considered necessary that any fact or information requires to be verified in order to confirm its veracity or correctness, the same be ascertained through the concerned officer(s) of the State Government or Union territory Administration.
(1) Where the proposed transplant of organs is between near relatives related genetically, namely, grandmother, grandfather, mother, father, brother, sister, son, daughter, grandson and granddaughter, above the age of eighteen years, the competent authority as defined at rule 2(c) or Authorisation Committee (in case donor or recipient is a foreigner) shall evaluate;
(i) documentary evidence of relationship e.g. relevant birth certificates, marriage certificate, other relationship certificate from Tehsildar or Sub-divisional magistrate or Metropolitan Magistrate or
Sarpanch of the Panchayat, or similar other identity certificates like Electors Photo Identity Card or AADHAAR card; and
(ii) documentary evidence of identity and residence of the proposed donor, ration card or voters identity card or passport or driving license or PAN card or bank account and family photograph depicting the proposed donor and the proposed recipient along with another
Where the proposed transplant is between other than near relatives and all cases where the donor or recipient is foreign national (irrespective of them being near relative or otherwise), the approval will be granted by the Authorisation Committee of the hospital or if hospital based Authorisation Committee is not constituted, then by the District or State level Authorisation Committee.
When the proposed donor or the recipient are foreigners;
(a) a senior Embassy official of the country of origin has to certify the relationship between the donor and the recipient as per Form 21 and in case a country does not have an Embassy in India, the certificate of relationship, in the same format, shall be issued by the Government of that country;
(b) the Authorisation Committee shall examine the cases of all Indian donors consenting to donate organs to a foreign national (who is a near relative), including a foreign national of Indian origin, with greater caution and such cases should be considered rarely on case to case basis:
Provided that the Indian living donors wanting to donate to a foreigner other than near relative shall not be considered.
In the course, of determining eligibility of the applicant to donate, the applicant should be personally interviewed by the Authorisation Committee which shall be videographed and minutes of the interview shall be recorded.
In case where the donor is a woman, greater precautions ought to be taken and her identity and independent consent should be confirmed by a person other than the recipient.
(1) The Authorisation Committee (which is applicable only for living organ or tissue donor)should state in writing its reason for rejecting or approving the application of the proposed living donor in the prescribed Form 18 and all such approvals should be subject to the following conditions, namely:--
(i) the approved proposed donor would be subjected to all such medical tests as required at the relevant stages to determine his or her biological capacity and compatibility to donate the organ in question;
(ii) the physical and mental evaluation of the donor has been done to know whether he or she is in proper state of health and it has been certified by the registered medical practitioner in Form 4 that he or she is not mentally challenged and is fit to donate the organ or tissue:
Provided that in case of doubt for mentally challenged status of the donor the registered medical practitioner or Authorisation Committee may get the donor
(1) An application for registration shall be made to the Appropriate Authority as specified in Form 12 or Form 13 or Form 14 or Form 15, as applicable and the application shall be accompanied by fee as specified below, payable to the Appropriate Authority by means of a bank draft, which may be revised, if necessary by the Central or State Government, as the case may be:--
(i) for Organ or Tissue or Cornea Transplant Centre: Rupees ten thousand;
(ii) for Tissue or Eye Bank: Rupees ten thousand;
(iii) for Non-Transplant Retrieval Centre: Nil.
(2) The Appropriate Authority shall, after holding an inquiry and after satisfying itself that the applicant has complied with all the requirements, grant a certificate of registration as specified in Form 16 and it shall be valid for a period of five years from the date of its issue and shall be renewable.
(3) Before a hospital is registered under the provisions of this rule, it
(1) An application for the renewal of a certificate of registration shall be made to the Appropriate Authority at least three months prior to the date of expiry of the original certificate of registration and shall be accompanied by a fee as specified below, payable to the Appropriate Authority by means of a bank draft, which may be revised, if necessary by the Central or State Government, as the case may be,--
(i) for Organ or Tissue or Cornea Transplant Centre: Rupees five thousand;
(ii) for Tissue or Eye Bank: Rupees five thousand;
(iii) for Non-Transplant Retrieval Centre: Nil.
(2) A renewal certificate of registration shall be as specified in Form 17 and shall be valid for a period of five years.
(3) If, after an inquiry including inspection of the hospital or tissue bank and scrutiny of its past performance and after giving an opportunity to the applicant, the Appropriate Authority is satisfied that the applic
(a) Cornea Transplantation:
M.D. or M.S. or Diploma (DO) in ophthalmology or equivalent qualification with three months post M.D. or M.S or DO training in Corneal transplant operations in a recognised hospital or institution;
(b) Other tissues such as heart valves, skin, bone, etc.:
Post graduate degree (MD or MS) or equivalent qualification in the respective specialty with three months post M.D. or M.S training in a recognised hospital carrying out respective tissue transplant operations and for heart valve transplantation, and the qualification and experience of expert shall be MCh degree in Cardiothoracic and Vascular Surgery (CTVS) or equivalent qualification with three months post MCh training in a recognised hospital carrying out heart valve transplantation;
(c) the Hospital registered under Clinical Establishment (Registration and Regulation) Act, 2010(23 of 2010) shall also follow the minimum standards prescribed in respect of manpower, equipment,
(1) The retrieval center shall be registered only for the purpose of retrieval of organ from deceased donors and the organ retrieval centre shall be a hospital having Intensive Care Unit (ICU) facilities along with manpower, infrastructure and equipment as required to diagnose and maintain the brain-stem dead person and to retrieve and transport organs and tissues including the facility for their temporary storage.
(2) All hospitals registered as transplant centres shall automatically qualify as retrieval centres.
(3) The retrieval centre should have linkages with nearby Government hospital designated for post-mortem, for retrieval in medico-legal cases.
(4) Registration of hospital for surgical tissue harvesting from deceased person and for surgical tissue residues, that are routinely discarded, shall not be required.
(1) Facilities must conform to the standards and guidelines laid down for the purpose and the States and Union territories may have separate registration fee and procedure to keep track of their tissue bank activities.
(2) The respective State or Union territory Appropriate Authority may constitute an expert committee for advising on the matter related to tissue specific standards and related issues.
(3) The tissue bank must have written guidelines and standard operating procedures for maintenance of its premises and facilities which include-
(a) controlled access;
(b) cleaning and maintenance systems;
(c) waste disposal;
(d) health and safety of staff;
(e) risk assessment protocol; and
(f) follow up protocol.
(4) Equipments as per scientific requirements specific to tissue (s) being procured, processed, stored and distributed and the tissue bank should en
(8) Complete screening of donor must be conducted including medical or social history and serological evaluation for medical conditions or disease processes that would contraindicate the donation of tissues and the report of corneas or eyes not found suitable for transplantation and their alternate use shall be certified by a committee of two Ophthalmologists.
(9) Facility for relevant Laboratory tests for blood and tissue samples shall be available and testing of blood and tissue samples shall begin at Donor Screening and continue during retrieval and throughout processing.
(10) Procurement of tissue must be carried out by registered health care professionals or technicians having necessary experience or special training.
(11) Consent for the procurement shall be obtained.
(12) Procurement records shall be maintained.
(13) Standard operating procedure for following shall be followed, namely :-
(a) procurement or Retrieval and transplantation;
(b) processing and sterilisation;
(c) packaging, labeling and storage;
(d) distribution or allocation;
(e) transportation; and
(f) reporting of serious adverse reactions.
(14) A log of tissue received and distributed shall be maintained to enable traceability from the donor to the tissue and the tissue to the donor and the records shall also indicate the dates and the identities of the staff performing specific steps in the removal or processing or distribution of the tissues.
(15) A unique donor identification number shall be used for each donor, and access to donor records shall be restricted.
(16) The Quality Management System shall define quality control procedures that include the following, namely:-
(a) environmental monitoring;
(b) quipment maintenance and monitoring;
(c) in -process controls monitoring;
(d) internal audits including reagent and supply monitoring;
(e) compliance with reference standards, local regulations, quality manuals or documented standard operating procedures; and
(f) monitoring work environment.
(17) All tissue recipients shall be followed up and prompt and appropriate corrective and preventive actions taken in case of adverse events.
(1) The transplant coordinator shall be an employee of the registered hospital having qualification such as:
(a) graduate of any recognised system of medicine; or
(b) Nurse; or
(c) Bachelor's degree in any subject and preferably Master's degree in Social work or Psychiatry or Sociology or Social Science or Public Health
(2) The concerned organisation or institute shall ensure initial induction training followed by retraining at periodic interval and the transplant coordinator shall counsel and encourage the family members or near relatives of the
deceased person to donate the human organ or tissue including eye or cornea and coordinate the process of donation
and transplantation.
(3) The transplant coordinator or counselor in a hospital registered for eye banking shall also have qualification specified in sub-rule (1).
(1) The Central Government and the State Government, as the case may be, shall constitute by notification an Advisory Committee under Chairpersonship of administrative expert not below the rank of Secretary to the State Government for a period of two years to aid and advise the Appropriate Authority and the two medical experts referred to in clause(b) of sub-section(2) of section 13A of the Act shall possess a postgraduate medical degree and at least five years' experience in the field of organ or tissue transplantation.
(2) The terms and conditions for appointment to the Advisory Committee are as under:
(a) the Chairperson and members of the Committee shall be appointed for a period of two years;
(b) the Chairperson and members of the Committee shall be entitled to the air fare and other allowances to attend the meeting of the Committee equivalent to the officer of the level of the Joint Secretary to the Government of India;
(
(1) There shall be an apex national networking organisation at the centre, as the Central Government may by notification specify.
(2) There shall also be regional and State level networking organisations where large number of transplantation of organ(s) or tissue (s) are performed as the Central Government may by notification specify.
(3) The State units would be linked to hospitals, organ or tissue matching laboratories and tissue banks within their area and also to regional and national networking organisations.
(4) The broad principles of organ allocation and sharing shall be as under,-
(a) The website of the transplantation center shall be linked to State or Regional cum State or National networks through an online system for organ procurement, sharing and transplantation.
(b) patient or recipient may get registered through any transplant centre, but only one centre of a State or region (if there is no centre in the State)
(1) The Organ Transplant Registry shall include demographic data about the patient, donor, hospitals, recipient and donor follow up details, transplant waiting list, etc., and the data shall be collected from all retrieval and transplant centers.
(2) Data collection frequency, etc., will be as per the norms decided by the Advisory Committee which may preferably be through a web-based interface or paper submission and the information shall be maintained both specific organ wise and also in a consolidated format.
(3) The hospital or Institution shall update its website regularly in respect of the total number of the transplantations done in that hospital or institution along with reasonable detail of each transplantation and the same data should be accessible for compilation, analysis and further use by authorised persons of respective State Governments and Central Government.
(4) Yearly reports shall be published and also shared with the contributing units and ot
(5) The Organ Donation Registry shall include demographic information on donor (both living and deceased), hospital, height and weight, occupation, primary cause of death in case of deceased donor, associated medical illnesses, relevant laboratory tests, donor maintenance details, driving license or any other document of pledging donation, donation requested by whom, transplant coordinator, organs or tissue retrieved, outcome of donated organ or tissue, details of recipient, etc.
(6) The Tissue Registry shall include demographic information on the tissue donor, site of tissue retrieval or donation, primary cause of death in case of deceased donor, donor maintenance details in case of brain stem dead donor, associated medical illnesses, relevant laboratory tests, driving license or any other document pledging donation, donation requested by whom, identity of counsellors, tissue(s) or organ(s) retrieved, demographic data about the tissue recipient, hospital conducting transplantation, transplant waiting list and priority list for critical patients, if these exist, indication(s) for transplant, outcome of transplanted tissue, etc.
(7) Yearly reports in respect of National Registry shall be published and also shared with the contributing units and other stakeholders
Pledge for organ or tissue donation after death:
(8) Those persons, who, during their lifetime have pledged to donate their organ(s) or tissue(s) after their death, shall in Form 7 d
(1) Any person aggrieved by an order of the Authorisation Committee under sub-section (6) of Section 9 or by an order of the Appropriate Authority under sub-section (2) of Section 15 or sub-section (2) of Section 16 of the Act, may, within thirty days from the date of receipt of the order, prefer an appeal to the Central Government in case of the Union territories and respective State Government in case of States.
(2) Every appeal shall be in writing and shall be accompanied by a copy of the order appealed against.
| FORM 1 | |||
| For organ or tissue donation from identified living near related donor | |||
| (to be completed by him or her) | |||
| (See rules 3 and 5(3)(a)) | |||
| My full name (proposed donor) is ……………………………………………………&# |
MINISTRY OF HEALTH AND FAMILY WELFARE NOTIFICATION New Delhi, the 6th November, 2025 | |
G.S.R. 821(E).-In exercise of the powers conferred by section 24 of the Transplantation of Human Organs and Tissues Act, 1994 (42 of 1994), the Central Government hereby makes the following rules to amend the Transplantation of Human Organs and Tissues Rules, 2014, namely:— 1. (1) These rules may be called the Transplantation of Human Organs and Tissues Rules, 2025. (Amendment) (2) They shall come into force on the date of their publication in the Official Gazette. 2. In the Transplantati |
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