THE TRANSPLANTATION OF HUMAN ORGANS AND TISSUES ACT, 1994

An Act to provide for the regulation of removal, storage and transplantation of                  

^[1][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 ^[2][human organs or tissues or both] for therapeutic purposes and for the prevention of commercial dealings in ²[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

1. Short title, application and commencement._—(1) This Act may be called the Transplantation of ^[3][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.

3. It  shall  come into force in the States  of  Goa,  Himachal Pradesh and Maharashtra and in all the Union territories on such  date^[4] 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.

2. Definitions.—In  this  Act,  unless  the   context   otherwise requires,—

   1. “advertisement”  includes  any  form  of   advertising whether  to  the public generally or to any  section  of  the public or, individually to selected persons;

   2. “Appropriate Authority” means the Appropriate Authority appointed under section 13;

   3. “Authorisation Committee” means the committee constituted under clause (a) or clause (b) of                   sub-section (4) of section 9;

   4. “brain-stem  death”  means  the  stage  at  which   all functions of the brain-stem have permanently and irreversibly ceased  and is so certified under sub-section (6) of  section 3;

   5. “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;

   6. “donor” means any person, not less than eighteen  years of age, who voluntarily authorises the removal of any of his human  organs for therapeutic purposes under sub-section (1) or                     sub-section (2) of section 3;

   7. “hospital” includes  a nursing home,  clinic,  medical centre,  medical  or  teaching  institution  for  therapeutic purposes and other like institution;

   8. “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;

 ^[5][(ha) “Human Organ Retrieval Centre” means a hospital,—

1. 1. 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;]

            ^[6][(i) _“near relative” means spouse, son, daughter, father, mother, brother, sister, grandfather, grandmother, grandson or granddaughter;]

1. 10. “notification”  means a notification  published  in  the Official Gazette;

   11. “payment”  means payment in money or money’s worth  but does not include any payment for defraying or reimbursing—

       1. the cost of removing, transporting or  preserving the ^[7][human organ or tissue or both] to be supplied; or

       2. any  expenses  or loss of earnings incurred by a person so far as reasonably and directly  attributable to his supplying any human organ from his body;

1. 50. “prescribed” means prescribed by rules made under  this  Act;

1. 1000. “recipient”  means a person into whom any  ³[human  organ or tissue or both] is, or is proposed to be, transplanted;

   14. “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;

   15. “therapeutic purposes” means systematic  treatment  of any  disease or the measures to improve health  according  to any particular method or modality; ^[8]***

^[9][(oa) “tissue” means a group of cells, except blood, performing a particular function in the human body;

(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;]

1. 16. “transplantation” means the grafting of any human organ from  any  living  person or deceased person  to  some  other living person for therapeutic purposes;

 ⁵[(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.]

 

CHAPTER II

AUTHORITY FOR THE REMOVAL OF ^[10][HUMAN ORGANS OR TISSUES OR BOTH]

3. Authority  for removal of ¹[human organs or tissues or both]._—(1) Any donor may, in such  manner  and  subject to such conditions as  may  be  prescribed, authorise  the  removal, before his death, of any ^[11][human organ or tissue or both]  of  his body for therapeutic purposes.

 ^[12][(1A) For the purpose of removal, storage or transplantation of such human organs or tissues or both, as may be prescribed, it shall be the duty of the registered medical practitioner working in a hospital, in consultation with transplant co-ordinator, if such transplant co-ordinator is available,_—

1. 1. to ascertain from the person admitted to the Intensive Care Unit or from his near relative that such person had authorised at any time before his death the removal of any human organ or tissue or both of his body under sub-section (2), then the hospital shall proceed to obtain the documentation for such authorisation;

   2. where no such authority as referred to in sub-section (2) was made by such person, to make aware to that person or near relative for option to authorise or decline for donation of                     human organs or tissues or both;

   3. to require the hospital to inform in writing to the Human Organ Removal Centre for removal, storage or transplantation of human organs or tissues or both of the donor identified in                 clauses (i) and (ii) in such manner as may be prescribed

(1B) The duties mentioned under clauses (i) to (iii) of sub-section (1A) from such date, as may be prescribed, shall also apply in the case of a registered medical practitioner working in an Intensive Care Unit in a hospital which is not registered under this Act for the purpose of removal, storage or transplantation of human organs or tissues or both.]

2. If  any donor had, in writing and in the presence of two  or more  witnesses                     (at  least one of whom is a  near  relative  of  such person),  unequivocally authorised at any time before his  death,  the  removal  of  any  human  organ  of his  body,  after  his  death,  for therapeutic  purposes, the person lawfully in possession of  the  dead body of the donor shall, unless he has any reason to believe that  the donor  had  subsequently revoked the authority aforesaid, grant  to  a registered  medical  practitioner all reasonable  facilities  for  the removal,  for therapeutic purposes, of that ²[human organ or tissue or both] from the  dead body of the donor.

3. Where  no  such authority as is referred to  in  sub-section (2), was made by any person before his death but no objection was also expressed  by such person to any of his ¹[human organs or tissues or both]  being used  after his death for therapeutic purposes, the person lawfully in  possession of  the dead body of such person may, unless he has reason to  believe that any near relative of the  deceased person has objection to any of the  deceased  person’s  ¹[human  organs or tissues or both] being  used  for   therapeutic purposes, authorise the removal of any ²[human organ or tissue or both] of the deceased person for its use for  therapeutic purposes.

4. The authority given under sub-section (1) or sub-section (2) or,  as the case may be,                     sub-section (3) shall be  sufficient  warrant for the removal, for therapeutic purposes, of the ²[human organ or tissue or both]; but  no such  removal  shall be made by any person other than  the  registered medical practitioner:

 ³[Provided that a technician possessing such qualifications and experience, as may be prescribed, may enucleate a cornea.]

5. Where  any ²[human organ or tissue or both] is to be removed from the body  of  a deceased  person,  the registered medical practitioner  shall  satisfy himself,  before such removal, by a personal examination of  the  body from  which any ²[human organ or tissue or both] is to be removed, that life is extinct  in such body or, where it appears to be a case of brain-stem death,  that such death has been certified under  sub-section (6).

6. Where  any ²[human organ or tissue or both] is to be removed from the body  of  a  person in the event of his brain-stem death, no such removal shall  be undertaken  unless such death is certified, in such form and  in  such manner and on satisfaction of such conditions and requirements as  may be  prescribed,  by  a  Board of medical  experts  consisting  of  the following, namely:—

   1. the registered medical practitioner in charge  of  the hospital in which brain-stem death has occurred;

   2. an independent registered medical practitioner, being a specialist,  to  be  nominated  by  the  registered   medical practitioner specified in clause (i), from the panel of names approved by the Appropriate Authority;

   3. a  neurologist or a neurosurgeon to be  nominated  by the registered medical practitioner specified in clause  (i), from   the  panel  of  names  approved  by  the   Appropriate  Authority: ^[13]***

 ^[14][Provided that where a neurologist or a neurosurgeon is not available, the registered medical practitioner may nominate an independent registered medical practitioner, being a surgeon or a physician and an anaesthetist or intensivist subject to the condition that they are not members of the transplantation team for the concerned recipient and to such conditions as may be prescribed;]

6. 4. the registered medical practitioner treating the person whose brain-stem death has occurred.

7. Notwithstanding anything contained in sub-section (3), where  brain-stem  death  of  any person, less than eighteen  years  of  age, occurs  and is certified under sub-section (6), any of the parents  of the  deceased  person  may give authority, in such form  and  in  such manner  as may be prescribed, for the removal of any ^[15][human organ or tissue or both]  from the body of the deceased person.

4. Removal of ^[16][human organs or tissues or both] not to be authorised in certain cases._—(1) No facilities shall be granted under sub-section (2) of section 3 and no authority shall be given under                  sub-section (3) of that  section for the removal of any ³[human organ or tissue or both] from the body of a deceased person, if the person required to grant such facilities, or empowered to  give such authority, has reason to believe that an inquest may be  required to be held in relation to such body in pursuance of the provisions  of any law for the time being in force.

(2) No authority for the removal of any ³[human organ or tissue or both] from the body of a deceased person shall be given by a person to whom such body has been entrusted solely for the purpose of interment, cremation or other disposal.

5. Authority for  removal of ⁴[human organs or tissues or both] in  case  of  unclaimed bodies in hospital or  prison._—(1) In the case of a dead body lying in a  hospital or prison and not claimed by any of the near relatives  of the  deceased  person within forty-eight hours from the  time  of  the death  of the concerned person, the authority for the removal  of  any ³[human  organ or tissue or both] from  the dead body which so remains  unclaimed  may  be given,  in the prescribed form, by the person in charge, for the  time being,  of the management or control of the hospital or prison, or  by an  employee of such hospital or prison authorised in this  behalf  by the person in charge of the management or control thereof.

(2)  No authority shall be given under sub-section (1) if the person empowered to give such authority has reason to believe that any near relative of the deceased person is likely to claim the dead body even though such near relative has not come forward to claim the body of the deceased person within the time specified in sub-section (1).

6. Authority for removal of ⁴[human organs or tissues or both] from bodies sent for                     post-mortem examination for medico-legal or pathological purposes._—Where the body of a person has been sent for post-mortem examination—

1. for medico-legal purposes by reason of the death of  such person having been caused by accident or any other  unnatural cause; or

2. for pathological purposes, 

the person competent under this Act to give authority for the  removal of  any  ^[17][human  organ or tissue or both] from such dead body may, if  he  has  reason  to believe that such ¹[human organ or tissue or both] will not be required for the purpose for which  such body has been sent for post-mortem  examination,  authorise the  removal,  for therapeutic purposes, of that ¹[human  organ or tissue or both]  of  the deceased person provided that he is satisfied that the deceased person had  not expressed,  before his death, any objection to any  of  his ^[18][human organs or tissues or both] being used, for therapeutic purposes after his death  or, where  he  had granted an authority for the use of any  of  his  ²[human organs or tissues or both] for therapeutic purposes, after his death, such authority  had not been revoked by him before his death.

7. Preservation  of ²[human organs or tissues or both]._—After the removal of  any ¹[human organ or tissue or both] from  the  body  of  any  person,  the   registered   medical practitioner  shall take such steps for the preservation of the  ¹[human organ or tissue or both] so removed as may be prescribed.

8. Savings._—(1) Nothing in the foregoing provisions of   this Act shall be construed as rendering unlawful any dealing with the body or with   any part of the body of a deceased person if such dealing would have been lawful if this Act had not been passed.

(2)  Neither  the  grant  of any facility or  authority  for  the removal  of  any  ¹[human organ or tissue or both] from the body of a  deceased  person  in accordance  with  the provisions of this Act nor the removal  oil  any ¹[human  organ or tissue or both] from the body of a deceased person in pursuance  of  such authority  shall be deemed to be an offence punishable  under  section  297 of the Indian  Penal Code (45 of 1860).

9. Restrictions on removal and transplantation of ²[human organs or tissues or both]._—(1) Save as otherwise provided in sub-section (3), no ¹[human organ or tissue or both] removed from the body of a donor before his death shall be transplanted into a recipient unless the donor is a near relative of the recipient.

 ^[19][(1A) 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 both:

Provided that the Authorisation 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.

(1B) 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 prescribed.

(1C) No human organs or tissues or both shall be removed from the body of a mentally challenge person before his death for the purpose of transplantation.

Explanation.—For the purpose of this sub-section,—

1. the expression “mentally challenged person” includes a person with mental illness or mental retardation, as the case may be;

2. the expression “mental illness” includes dementia, schizophrenia and such other mental condition that makes a person intellectually disables;

3. the expression “mental retardation” shall have the same meaning as assigned to it in               clause (r) of section 2 of the Persons With Disabilities (Equal Opportunities, Protection of Right  and

Full Participation) Act, 1995 (1 of 1996).]

2. Where  any donor authorises the removal of any of his  ²[human organs or tissues or both]   after  his  death under sub-section (2) of section 3 or  any person competent or empowered to give authority for the removal of any  ¹[human organ or tissue or both]  from the body of any deceased person authorises  such  removal, the  ¹[human organ or tissue or both] may be removed and transplanted into the body of  any recipient who may be in need of such ¹[human organ or tissue or both].

3. If  any  donor authorises the removal of any  of  his  ²[human organs or tissues or both] before  his  death  under  sub-section (1)  of  section  3  for transplantation  into  the body of such recipient, not  being  a  near relative,  as  is  specified by the donor by reason  of  affection  or attachment  towards  the recipient or for any other  special  reasons, such  ¹[human  organ or tissue or both] shall not be removed and transplanted  without  the prior approval of the Authorisation Committee.  ²[(3A) Notwithstanding anything contained in sub-section (3), where—

   1. 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; and 

   2. 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 recipient; then

   3. 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 or tissue or both 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 or both, as per the agreement referred to above, shall not be done without prior approval of the Authorisation Committee.]

³[(4) (a)   The composition of the Authorisation Committee shall be such as may be prescribed by the Central Government from time to time.

 (b) The State Government and the Union territories shall constitute, by notification, one or more Authorisation Committee consisting of such members as may be nominated by the State Government and the Union territories on such terms and conditions as may be specified in the notification for the purposes of this section.]

5. On  an  application jointly made, in such form and  in  such manner  as  may  be prescribed, by the donor and  the  recipient,  the Authorisation  Committee  shall, after holding an  inquiry  and  after satisfying  itself  that  the applicants have complied  with  all  the requirements of this Act and tile rules made thereunder, grant to  the applicants  approval for the removal and transplantation of the human organ.

6. If, after the inquiry and after giving an opportunity to the applicants  of being heard, the Authorisation Committee  is  satisfied that  the applicants have not complied with the requirements  of  this Act  and  the  rules  made thereunder, it shall,  for  reasons  to  be recorded in writing, reject the application for approval.

CHAPTER III

REGULATION OF HOSPITALS

10. Regulation of hospitals conducting the removal, storage or transplantation of                   

⁴[human organs or tissues or both].—(1) On and from the commencement of this Act,— 

1. no hospital, unless registered under this  Act,  shall conduct, or associate with, or help in, the removal,  storage or transplantation of any ¹[human organ or tissue or both;]

2. no  medical  practitioner  or any  other  person  shall conduct,  or cause to be conducted, or aid in  conducting  by himself or through any other person, any activity relating to the removal, storage or transplantation of any ¹[human organ or tissue or both] at a place other than a place registered under this Act; ⁵***

                                                          

1. Subs. by Act 16 of 2011, s. 4, for “human organ” (w.e.f. 10-1-2014).

2. Ins. by s. 7, ibid. (w.e.f. 10-1-2014).

3. Subs. by s. 7, ibid., for sub-section (4) (w.e.f. 10-1-2014).

4. Subs. by s. 4, ibid., for “human organs” (w.e.f. 10-1-2014).

5. The word “and” omitted by s. 8, ibid. (w.e.f. 10-1-2014)

 

 

 

(c)   no  place  including a hospital registered  under  sub-section (1)   of  section 15 shall be used or cause  to  be used   by   any   person  for   the   removal,   storage   or transplantation  of  any ^[20][human organ or tissue or both] except  for  therapeutic purposes; ^[21][and]

 ^[22][(d) no Tissues Bank, unless registered under this Act, shall carry out any activity relating to the recovery, screening, testing, processing, storage and distribution of tissues.]

(2)  Notwithstanding anything contained in sub-section (1), the eyes or the ears may be removed at any place from the dead body of any donor, for therapeutic purposes, by a registered medical practitioner.

Explanation.—For the purposes of   this sub-section, “ears” includes ear drums and ear bones.

1. 11. Prohibition of removal or transplantation of ^[23][human organs or tissues or both] for any  purpose other than the rapeatic purposes._— No donor and no  person empowered  to give authority for the removal of any human organ  shall authorise  the removal of any ¹[human organ or tissue or both] for any purpose  other  than therapeutic purposes.

   12. Explaining   effects,   etc.,  to  donor  and   recipient._— No registered  medical  practitioner  shall  undertake  the  removal   or transplantation  of any ¹[human organ or tissue or both] unless he has explained,  in  such manner  as may be prescribed, all possible effects, complications  and hazards  connected with the removal and transplantation to  the  donor and the recipient respectively. 

CHAPTER IV

APPROPRIATE AUTHORITY

13. Appropriate  Authority._—(1)  The  Central  Government   shall appoint,  by  notification,  one  or  more  officers  as   Appropriate  Authorities for each of the Union territories for the purposes of this  Act.

2. The State Government shall appoint, by notification, one or more officers as Appropriate Authorities for the purposes of this Act.

3. The Appropriate Authority shall perform the following functions, namely:_—

   1. to grant registration under sub-section (1) of  section 15  or  renew  registration under               sub-section  (3)  of  that section;

   2. to suspend or cancel registration under sub-section (2) of section 16;

 ^[24][(iii) to enforce such standards, as may be prescribed,_—

1. 3. 1. for hospitals engaged in the removal, storage or transplantation of any human organ:

      2. for Tissue Banks engaged in recovery, screening, testing, processing, storage and distribution of tissues;]

   4. to  investigate any complaint of breach of any  of  the provisions  of this Act or any of the rules  made  thereunder and take appropriate action;

 ^[25][(iva) to inspect Tissue Banks periodically;]

1. 5. to  inspect hospitals periodically for  examination  of the quality of transplantation and the   follow-up medical care to  persons  who have undergone transplantation  and  persons from whom organs are removed; and

   6. to undertake such other measures as may be prescribed.

 ^[26][13A. Advisory Committees to advise Appropriate Authority._—(1) The Central Government and the State Governments, as the case may be, by notification, shall constitute an Advisory Committee for a period of two years to aid and advise the Appropriate Authority to discharge its functions.

(2) The Advisory Committee shall consist of—

1. 1. 1. one administrative expert not below the rank of Secretary to the State Government, to be nominated as Chairperson of the Advisory Committee;

      2. two medical experts having such qualifications as may be prescribed;

      3. one 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-Secretary;

      4. two eminent social workers of high social standing and integrity, one of whom shall be from amongst representatives of women’s organisation;

      5. one legal expert who has held the position of an Additional District Judge or equivalent;

      6. one person to represent non-governmental organisations or associations which are working in the field of organ or tissue donations or human rights;

      7. one specialist in the field of human organ transplantation, provided he is not a member of the transplantation team.

(3) The terms and conditions for appointment to the Advisory Committee shall be such as may be prescribed by the Central Government.

13B. Powers of Appropriate Authority._—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, 1908 (5 of 1908) and, in particular, in respect of the following matters, namely:—

1. summoning of any person who is in possession of any information relating to violation of the provisions of this Act or the rules made thereunder;

2. discovery and production of any document or material object;

3. issuing search warrant for any place suspected to be indulging in unauthorised removal, procurement or transplantation of human organs or tissues or both; and

4. any other matter which may be prescribed.

13C. National Human Organs and Tissues Removal and Storage Network._—The Central Government may, by notification, establish a National Human Organs and Tissues Removal and Storage Network at one or more places and Regional Network in such manner and to perform such functions, as may be prescribed.

13D. National registry._—The Central Government shall maintain a national registry of the donors and recipients of human organs and tissues and such registry shall have such information as may be prescribed to an ongoing evaluation of the scientific and clinical status of human organs and tissue.]

CHAPTER V

REGISTRATION OF HOSPITALS

14. Registration  of  hospitals  engaged  in  removal,  storage  or transplantation of                     ^[27][human organs or tissues or both]._—(1) ^[28][No hospital (including Human Organ Retrieval Centre)] shall  commence  any activity  relating to the removal, storage or transplantation  of  any ^[29][human  organ or tissue or both] for therapeutic purposes after the commencement  of  this Act unless such hospital is duly registered under this Act:

Provided   that   every  hospital  engaged,  either   partly   or exclusively,  in  any  activity relating to the  removal,  storage  or transplantation   of   any ³[human  organ or tissue or both]  for   therapeutic   purposes immediately  before  the  commencement of this Act,  shall  apply  for registration within           sixty days from the date of such commencement: 

Provided  further  that every hospital engaged  in  any  activity relating to the removal, storage or transplantation of any ³[human organ or tissue or both] shall  cease  to engage in any such activity on the  expiry  of  three months from the date of commencement of this Act unless such  hospital  has  applied  for registration  and is go  registered  or  till  such application is disposed of, whichever is earlier.

2. Every application for registration under sub-section (1) shall be made to the Appropriate Authority in such form and in such manner and shall be accompanied by such fees as may be prescribed.

3. No  hospital shall be registered under this Act  unless  the  Appropriate Authority is satisfied that such hospital is in a position to  provide  such specialised services and facilities, possess) such skilled manpower and equipments and maintain such standards as may  be prescribed.

 ^[30][(4) No hospital shall be registered under this Act, unless the Appropriate Authority is satisfied that such hospital has appointed a transplant coordinator having such qualifications and experience as may be prescribed.]

 ^[31][14A. Registration of Tissue Bank.—(1) No Tissue Bank shall, after the commencement of the Transplantation of Human Organs (Amendment) Act, 2011 (16 of 2011), commence any activity relating to the recovery, screening, testing, processing, storage and distribution of tissues unless it is duly registered under this Act:

Provided that any facility engaged, either party or exlusively, in any activity relating to the recovery, screening, testing, processing, storage and distribution of tissues immediately before the commencement of the Transplantation of Human Organs (Amendment) Act, 2011 (16 of 2011), shall apply for registration as Tissues Bank within sixty days from the date of such commencement:

Provided further that such facility shall cease to engage in any such activity on the expiry of three months from the date of commencement of the Transplantation of Human Organs (Amendement)               Act, 2011 (16 of 2011), unless such Tissue Bank has applied for registration and is so registered, or till such application is disposed of, whichever is earlier.

2. Every application for registration under sub-section (1) shall be made to the Appropriate Authority in such form and in such manner and shall be accompanied by such fees as may be prescribed.

3. No Tissue Bank shall be registered under this Act unless the Appropriate Authority is satisfied that such Tissue Bank is in a position to provide such specialised service and facilities, possess such skilled manpower and equipments and maintain such standards as may be prescribed.]

15. Certificate of  registration._—(1) The  Appropriate  Authority shall,  after holding an inquiry and after satisfying itself that  the applicant  has complied with all the requirements of this Act and  the  rules  made  thereunder, ^[32][grant to the hospital or to the tissue Bank, as the case may be,]  a  certificate  of registration  in  such  form,  for such period  and  subject  to  such conditions as may be prescribed.

2. If, after the inquiry and after giving an opportunity to the applicant of being heard, the Appropriate Authority is satisfied that the applicant has not complied with the requirement of this Act  and the  rules  made thereunder, it shall, for reasons to be  recorded  in writing, reject the application for registration. 

3. Every certificate of registration shall be renewed in such manner and on payment of such fees as may be prescribed.

16. Suspension   or   cancellation   of   registration._—(1)   The  Appropriate Authority may,                suo motu or on complaint, issue a notice to any ^[33][hospital or Tissue Bank, as the case may be,] to show cause why its registration under this Act  should not be suspended or cancelled for the reasons mentioned in the notice.

(2)  If, after giving a reasonable opportunity of being heard  to the  ⁴[hospital or Tissue Bank, as the case may be,] the Appropriate Authority is satisfied that  there  has been  a breach of any of the provisions of this Act or the rules  made thereunder,  it may, without prejudice to any criminal action that  it may  take  against such ⁴[hospital or Tissue Bank, as the case may be,] suspend its registration  for  such period as it may think fit or cancel its registration:

Provided that where the Appropriate Authority is of the opinion that it is necessary or expedient so to do in the public interest, it may,  for reasons to be recorded in writing, suspend the  registration of any ^[34][hospital or Tissue Bank, as the case may be,] without issuing any notice. 

17. Appeals._—Any person aggrieved by an order of the Authorisation  Committee rejecting an application for approval under sub-section (6) of section 9, or any hospital ^[35][or Tissue Bank, as the case may be,] aggrieved by an order of the Appropriate  Authority rejecting an application for registration under  sub-section  (2)  of  section  15  or an order of  suspension  or  cancellation  of registration  under sub-section (2) of section 16, may, within  thirty days  from the date of the receipt of the order, prefer an appeal,  in such manner as may be prescribed, against such order to—

1. the Central Government where the appeal is against  the order of the Authorisation Committee constituted under clause  (a)  of sub-section (4) of section 9 or against the order  of the Appropriate Authority appointed under sub-section (1)  of section 13; or

2. the State Government, where the appeal is against  the order of the Authorisation Committee constituted under clause (b)  of sub-section (4) of section 9 or against the order  of the Appropriate Authority appointed under sub-section (2)  of section 13.

CHAPTER VI

OFFENCES AND PENALTIES

18. Punishment for removal of human organ without authority._—(1) Any person who renders his services to or at any hospital and who, for purposes of transplantation, conducts, associates with, or  helps  in any manner in, the removal of any human organ without authority, shall be  punishable with imprisonment for a term which may extend  to ^[36][ten years and with fine which may extend to twenty lakh rupees].

(2)  Where  any  person  convicted under  sub-section  (1)  is  a registered  medical  practitioner, his name shall be reported  by  the Appropriate  Authority  to the respective State  Medical  Council  for taking  necessary  action including the removal of his name  from  the register  of  the  Council for a period of ^[37][three years] for  the  first offence and permanently for the subsequent offence.

 ^[38][(3) Any person who renders his services to or at any hospital and who conducts, or associates with or helps in any manner in the removal of human tissue 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.]

19. Punishment for commercial dealings in human organs.—Whoever—

1. makes or receives any payment for the supply of, or for an offer to supply, any human organ;

2. seeks  to find a person willing to supply  for  payment any human organ;

3. offers to supply any human organ for payment; or

4. initiates or negotiates any arrangement involving  the making  of any payment for the supply of, or for an offer  to supply, any human organ;

5. takes  part  in the management or control of a body  of persons, whether a society, firm or company, whose activities consist of   or  include  the  initiation  or  negotiation  of   any arrangement referred to in clause (d); or

6. publishes or distributes or causes to be  published  or distributed any advertisement,_—           

   1. inviting  persons  to supply for payment of  any  human organ;

   2. offering to supply any human organ for payment; or

   3. indicating that the advertiser is willing to  initiate or negotiate any arrangement referred to in clause (d);

^[39][(g) abets in the preparation or submission of false documents including giving false affidavits to establish that the donor is making the donation of the human organs, as a near relative or by reason of affection or attachment towards the recipient,

shall  be punishable with imprisonment for a term which shall  not  be less  than ^[40][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].

       ^[41]*                          *                                  *                                  *                           *

^[42][19A. Punishment for illegal dealings in human tissues.—Whoever—

1. makes or receives any payment for the supply of, or for an offer to supply, any human tissue; or

2. seeks to find a person willing to supply for payment and human tissue; or

3. offers to supply any human tissue for payment; or

4. initiates or negotiates any arrangement involving the making of any payment for the supply of, or for an offer to supply, any human tissue; or

5. takes part in the management or control of a body of persons, whether a society, firm or company, whose activities consist of or include the initiation or negotiation of any arrangement referred to in clause (d); or 

6. publishes or distributes or causes to be published or distributed any advertisement—

   1. inviting persons to supply for payment of any human tissue; or

   2. offering to supply any human tissue for payment; or 

   3. indicating that the advertiser is willing to initiate or negotiate any arrangement referred to in clause (d); or

7. abets in the preparation or submission of false documents including giving false affidavits to establish that the donor is making the donation of the human tissues as a near relative or by reason of affection or attachment towards the recipient,

shall be punishable with imprisonment for a term which shall not be less than one year but which may extend to three years and shall be liable to fine which shall not be less than five lakh rupees but which may extend to twenty-five lakh rupees.]

20. Punishment  for contravention of any other provision  of  this  Act._—Whoever contravenes any provision of this Act or any rule made, or any condition of the registration granted, thereunder for which  no punishment  is  separately provided in this Act, shall  be  punishable with  imprisonment for a term which may extend to ^[43][five years or  with fine which may extend to twenty lakh rupees].

21. Offences by companies._—-(1) Where any offence punishable under this  Act  has been committed by a company, every person who,  at  the time  the offence was committed was in charge of, and was  responsible to,  the  company for the conduct of the business of the  company,  as well  as the company, shall be deemed to be guilty of the offence  and shall be liable to be proceeded against and punished accordingly:

Provided that nothing contained in this sub-section shall  render any  such  person  liable to any punishment, if  he  proves  that  the offence  was committed without his knowledge or that be had  exercised all due diligence to prevent the commission of such offence.

(2)  Notwithstanding anything contained in sub-section (1), where any offence punishable under this Act has been committed by a  company and it is proved that the offence has been committed with the  consent or  connivance of, or is attributable to any neglect on the part  of, any director, manager, secretary or other officer of the company, such director, manager, secretary or other officer shall also be deemed  to be guilty of that offence and shall be liable to be proceeded  against and punished accordingly. Explanation.—For the purposes of this section,—

1. “company” means any body corporate and includes a  firm or other association of individuals; and

2. “director” in relation   to a firm, means a partner  in the firm.

 22. Cognizance of offences._—(1) No court shall take cognizance of an offence under this Act except on a complaint made by—

1. 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,  the  Appropriate  Authority; or;

2. 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.

2. 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.

3. Where  a  complaint has been made under clause (b)  of  sub-section  (1),  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.

CHAPTER VII

MISCELLANEOUS

 23. Protection  of  action  taken  in  good  faith._—(1)  No suit, prosecution or other legal proceeding shall lie against any person for  anything  which  is  in  good faith done or intended  to  be  done  in pursuance of the provisions of this Act.

(2)  No  suit  or other legal proceeding shall  lie  against  the Central  Government or the State Government for any damage  caused  or likely  to  be  caused for anything which is in  good  faith  done  or intended to be done in pursuance of the provisions of this Act.

      24. Power to make rules._—(1) The Central Government may, by notification, make rules for carrying   out the purposes of this Act.

2. In particular, and without prejudice to the generality of the foregoing power, such rules may provide for all or any of the following matters, namely:—

   1. the manner in which and the conditions subject to which any  donor  may authorise removal, before his death,  of  any ^[44][human organ or tissue or both] of  his body under sub-section (1A) of section 3;

^[45][(aa) the human organ or tissues or both in respect of which duty is cast on registered medical pracitioner the manner of obtaining documentation of authoirsation under clause (i) of sub-section 3;

(ab) the manner of informing the Human Organ Retrieval Centre under clause (iii) of                  sub-section (1A) of section 3;

(ac) the date from which duties mentioned in sub-section (1A) are applicable to registered medical practitioner working  a unregistered hospital under sub-section (1B) of section 3;

(ae) the qualification and experience of a technician under the proviso to sub-section (4) of

section 3;]                                        

1. 2. the form and the manner in which a brain-stem death  is to be certified and the conditions and requirements which are to  be  satisfied for that purpose under sub-section  (6)  of section 3;

^[46][(ba) the conditions for nomination of a surgeon or a physician and an anaesthetist or intensivist to be included in the Board of medical experts under the proviso to clause (iii) of sub-section (6) of section 3;]

1. 3. the form and the manner in which any of the parents may give  authority, in the case of    brain-stem death of a  minor, for  the removal of any ^[47][human organ or tissue or both] under                     sub-section (7)  of section 3;

   4. the form  in which authority for the  removal  of  any ²[human organ or tissue or both] from an, unclaimed dead body may be given by  the person incharge of the management or control of the  hospital or prison under sub-section (1) of section 5;

   5. the steps to be taken for the preservation of the ²[human organ or tissue or both] removed from the body of any person, under section 7;

 ¹[(ea) the manner of removal of human organs or tissues or both from the body of a minor before his death for transplantation under sub-section (1B) of section 9;

(eb) the composition of the Authorisation Committees under sub-section (4) of section 9;]

1. 6. the form and the manner in which an application may  be jointly made by the donor and the recipient under sub-section (5) of section 9;

   7. the manner in which all possible effects, complications and hazards connected with the removal and transplantation is to be explained by the registered medical practitioner to the donor and the recipient under section 12;

   8. the standards as are to be enforced by the  Appropriate Authority  for hospitals engaged in the removal,  storage  or transplantation of any ²[human organ or tissue or both] under clause (iii) of sub-section (3) of section 13;

   1. the other measures as the Appropriate Authority  shall undertake  in performing its functions under clause  (vi)  of sub-section (3) of section 13;

 ¹[(ia) the qualifications of medical experts and the terms and conditions for appointment to

Advisory committee under sub-sections (2) and (3) of section 13A;

(ib) the power of the Appropriate Authority in any other matter under clause (d) of section 13B;

(ic) the manner of establishment of a National Human Organs and Tissues Removal and Storage

Network and Regional Network and functions to be performed by them under section 13C;

(id) the information in the national registry of the donors and recipients of human organs and tissues and all information under section 13D;]

1. 10. the  form  and the manner in which an  application  for registration  shall  be  made  and the  fee  which  shall  be accompanied, under sub-section (2)  of section 14;

   11. the  specialised  services  and the  facilities  to  be provided, skilled manpower and the equipments to be possessed and  the  standards  to  be  maintained  by  a  hospital  for registration, under sub-section (3) of section 14;

 ¹[(ka) the qualifications and experience of a transplant co-ordinator under sub-section (4) of section 14;

(kb) the form and the manner in which an application for registration shall be made and the fee which shall be accompanied, under sub-section (2) of section 14A;

(kc) the specialised service and the facilities to be provided, skilled manpower and the equipment to be possessed and the standards to be maintained by a Tissue Bank, under sub-section (3) of            section 14A;]

1. 50. the  form  in  which,  the period  for  which  and  the conditions subject to which certificate of registration is to be  granted to a ^[48][hospital or Tissue Bank], under sub-section (1)  of  section 15;

2. 1000. the  manner  in which and the fee on payment  of  which certificate  of  registration  is to be  renewed  under  sub-section (3) of section 15;

   14. the   manner in which an appeal may be  preferred  under section 17;

   15. the manner in which a person is required to give notice to  the Appropriate Authority of the alleged offence  and  of his intention to make a complaint to the court, under  clause (b) of                     sub-section (1) of section 22; and

   16. any other matter which is required to be, or  may  be, prescribed.

3. Every rule made under this Act shall be laid, as soon as may be  after it is made, before each House of Parliament, while it is  in session,  for a total period of thirty days which may be comprised  in one session or in two or more successive sessions, and if, before  the expiry  of  the  session  immediately following  the  session  or  the successive  sessions  aforesaid,  both  Houses  agree  in  making  any modification in the rule or both Houses agree that the rule should not be made, the rule shall thereafter have effect only in such  modified form  or be of no effect, as the case may be; so, however, that  any such  modification or annulment shall be without  prejudice  to  the validity of anything previously done under that rule.

25. Repeal and savings._—(1) The Ear Drums and Ear Bones (Authority for Use for Therapeutic Purposes) Act, 1982 (28 of 1982) and the Eyes (Authority for Use for Therapeutic Purposes) Act, 1982 (29 of 1982) are hereby repealed.

(2)  The repeal shall, however, not affect the previous operation of the Acts so repealed or anything duly done or suffered thereunder.