CHAPTER VI
TRANSPLANTATION OF HUMAN ORGANS AND TISSUES RULES, 2014
Transplantation of Human Organs and Tissues Act, 1994
[42 OF 1994]1
An Act to provide for the regulation of removal, storage and transplantation of 2[human organs and tissues for therapeutic purposes and for the prevention of commercial dealings in human organs and tissues] and for matters connected therewith or incidental thereto.
WHEREAS it is expedient to provide for the regulation of removal, storage and transplantation of 3[human organs or tissues or both] for therapeutic purposes and for the prevention of commercial dealings in 3[human organs or tissues or both];
AND WHEREAS in Parliament has no power to make laws for the States with respect to any of the matters aforesaid except as provided in articles 249 and 250 of the Constitution;
AND WHEREAS in pursuance of clause (1) of article 252 of the Constitution, resolutions have been passed by all the Houses of the Legislatures of the States of Goa, Himachal Pradesh and Maharashtra to the effect that the matters aforesaid should be regulated in those States by Parliament by law;
BE it enacted by Parliament in the Forty-fifth Year of the Republic of India as follows:—
CHAPTER I PRELIMINARY
Short title, application and commencement.
1. (1) This Act may be called the Transplantation of 4[Human Organs and Tissues] Act, 1994.
(2)It applies, in the first instance, to the whole of the States of Goa, Himachal Pradesh and Maharashtra and to all the Union territories and it shall also apply to such other State which adopts this Act by resolution passed in that behalf under clause (1) of article 252 of the Constitution.
1. Dated 8-7-1994.
2.Substituted for “human organs for therapeutic purposes and for the prevention of commercial dealings in human organs” by the Transplantation of Human Organs (Amendment) Act, 2011, w.e.f. 27-9-2011.
3. Substituted for “human organs”, ibid.
4. Substituted for “Human Organs” ibid.
(3) It shall come into force in the States of Goa, Himachal Pradesh and Maharashtra and in all the Union territories on such date5 as the Central Government may, by notification, appoint and in any other State which adopts this Act under clause (1) of article 252 of the Constitution, on the date of such adoption; and any reference in this Act to the commencement of this Act shall, in relation to any State or Union territory, means the date on which this Act comes into force in such State or Union territory.
COMMENTS
SECTION NOTES
Applicability of the Act
Initially, the Act applies to the States of Goa, Himachal Pradesh, Maharashtra, and all Union Territories.
For other States:
The Act applies if adopted by a State Legislature through a resolution under Article 252(1) of the Constitution. Such adoption indicates State consent to a Central law on a subject otherwise within State jurisdiction.
Definitions.
2. In this Act, unless the context otherwise requires,—
(a) “advertisement” includes any form of advertising whether to the public generally or to any section of the public or, individually to selected persons;
(b) “Appropriate Authority” means the Appropriate Authority appointed under section 13;
(c) “Authorisation Committee” means the committee constituted under clause (a) or clause (b) of sub-section (4) of section 9;
(d) “brain-stem death” means the stage at which all functions of the brainstem have permanently and irreversibly ceased and is so certified under sub-section (6) of section 3;
(
e) “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 place;
(f) “donor” means any person, not less than eighteen years of age, who voluntarily authorises the removal of any of his 6[human organs or tissues or both] for therapeutic purposes under sub-section (1) or sub-section (2) of section 3;
5. With effect from 4-2-1995, vide S.O 80(E), dated 4-2-1995. Extended to the Union territory of Jammu and Kashmir and Union territory of Ladakh by the Jammu and Kashmir Reorganisation Act, 2019, w.e.f. 31-10-2019.
6. Substituted for “human organs” by the Transplantation of Human Organs (Amendment) Act, 2011, w.e.f. 27-9-2011.
(g) “hospital” includes a nursing home, clinic, medical centre, medical or teaching institution for therapeutic purposes and other like institution;
(h) “human organ” means any part of a human body consisting of a structured arrangement of tissues which, if wholly, removed, cannot be replicated by the body;
7[(ha) “Human Organ Retrieval Centre” means a hospital,—
(i) which has adequate facilities for treating seriously ill patients who can be potential donours of organs in the event of death; and
(ii) which is registered under sub-section (1) of section 14 for retrieval of human organs;
(hb) “minor” means a person who has not completed the age of eighteen years;]
8[(i) “near relative” means spouse, son, daughter, father, mother, brother, sister, grandfather, grandmother, grandson or granddaughter;]
(j) “notification” means a notification published in the Official Gazette;
(k) “payment” means payment in money or money’s worth but does not include any payment for defraying or reimbursing—
(i) the cost of removing, transporting or preserving the 9[human organ or tissue or both] to be supplied; or
(
ii) any expenses or loss of earnings incurred by a person so far as reasonably and directly attributable to his supplying any 9[human organ or tissue or both] from his body;
(l) “prescribed” means prescribed by rules made under this Act;
(m) “recipient” means a person into whom any 9[human organ or tissue or both] is, or is proposed to be, transplanted;
(n) “registered medical practitioner” means a medical practitioner who possesses any recognised medical qualification as defined in clause (h) of section 2 of the Indian Medical Council Act, 1956 (102 of 1956), and who is enrolled on a State Medical Register as defined in clause (k) of that section;
(o) “therapeutic purposes” means systematic treatment of any disease or the measures to improve health according to any particular method or modality; 10[***]
7[(oa) “tissue” means a group of cells, except blood, performing a particular function in the human body;
7. Inserted by the Transplantation of Human Organs (Amendment) Act, 2011, w.e.f. 27-9-2011.
8. Substituted, ibid. Prior to substitution, clause (i) read as under:
‘(i) “near relative” means spouse, son, daughter, father, mother, brother or sister;’
9. Substituted for “human organ”, ibid.
10. Word “and” omitted, ibid
( ob) “Tissue Bank” means a facility registered under section 14A for carrying out any activity relating to the recovery, screening, testing, processing, storage and distribution of tissues, but does not to include a Blood Bank;]
(p) “transplantation” means the grafting of any 10a[human organ or tissue or both] from any living person or deceased person to some other living person for therapeutic purposes;
11[(q) “transplant co-ordinator” means 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 organs in accordance with the provisions of sections 3.]
COMMENTS
SECTION NOTES
2.1 Transplantation [Section 2(p)]
“transplantation” means the grafting of any human organ from any living person or deceased person to some other living person for therapeutic purposes.
2.2 Human Organ [Section 2(h)]
Any part of the human body, composed of tissues arranged in a structured form, which, if completely removed, cannot regenerate naturally.
2.3 Tissue [Section 2(oa)]
“tissue” means a group of cells, except blood, performing a particular function in the human body.
2.4 Therapeutic Purposes [Section 2(o)]
“therapeutic purposes” means systematic treatment of any disease or the measures to improve health according to any particular method or modality.
2.5 Brain-Stem Death [Section 2(d)]
Defined as the permanent and irreversible cessation of all brain-stem functions, confirmed by a certification under section 3(6).
2.6 Deceased Person [Section 2(e)]
A person declared dead due to: Brain-stem death, or Cardio-pulmonary cessation, occurring anytime after live birth.
2.7 Donor [Section 2(f)]
An individual 18 years or older, who voluntarily consents to the removal of his human organs for therapeutic purposes under Section 3(1) or 3(2).
2.8 Human Organ Retrieval Centre [Section 2(ha)]
A hospital with adequate facilities to treat critically ill patients who could potentially become organ donors upon death, registered under Section 14(1) for organ retrieval.
10a. Substituted for “human organ” by the Transplantation of Human Organs (Amendment) Act, 2011, w.e.f. 27-9-2011.
11. Inserted, ibid.
TRANSPLANTATION OF HUMAN ORGANS AND TISSUES ACT
1994 WITH TRANSPLANTATION OF HUMAN ORGANS AND TISSUES RULES
2014 – BARE ACT WITH SECTION NOTES
AUTHOR : TAXMANN’S EDITORIAL BOARD
PUBLISHER : TAXMANN
DATE OF PUBLICATION : FEBRUARY 2025
EDITION : 2025 EDITION
ISBN NO : 9789364556286
NO. OF PAGES : 96
BINDING TYPE : PAPERBACK
DESCRIPTION
Transplantation of Human Organs and Tissues Act 1994 with Transplantation of Human Organs and Tissues Rules 2014 [Bare Act with Section Notes] by Taxmann is a focused legal reference on the regulation of human organ and tissue removal, storage, and transplantation in India. It presents the updated text of the Principal Act (as amended) and the Rules, serving as a single resource. Its purpose is to clarify statutory requirements, procedures, and penal provisions for donations from living or deceased donors, detailing the responsibilities of medical personnel, institutional guidelines, and safeguards against unethical practices.
This book is intended for the following audience:
• Legal Practitioners & Judges
• Medical Professionals & Hospitals
• Academics & Students
• Policy Makers & Government Officials
• NGOs & Social Workers
The Present Publication is the 2025 Edition, covering the amended and updated text of the Transplantation of Human Organs and Tissues Act [Act No. 42 of 1994] and Rules, with the following noteworthy features:
• [Complete Legal Text] Incorporates the unabridged Act with all relevant amendments, plus the full Rules
• [Updated & Authoritative] Reflects the latest legal position as of 2025
• [Pre-amendment Provisions] Retains earlier provisions in footnotes, aiding historical and transitional understanding
• [Section-wise Notes] Concise explanations under each section for clarity on intent and scope
• [User-friendly Format] Structured presentation of Rules, with corresponding forms (e.g., consent forms)
• [Compliance & Procedures] Covers licensing, hospital and tissue bank registration, and transplantation standards
• [Penal Provisions] Summaries of offences and penalties, including those for unauthorised removal and commercial dealings