2. INTRODUCTION
āTo provide the regulation of removal, storage and
transplantation of human organs for therapeutic
purposes and for the prevention of commercial
dealings in human organsā
4. (1). This Act may be called the Transplantation of Human
Organs 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
States
5. Definitions
a) Advertisement
b) Appropriate authority
c) Brain stem death
d) Deceased person
e) Donor
f) Hospital
g) Human organ
h) Near relative Notification
i) Payment
j) Recipient
k) Registered medical practitioner
l) Therapeutic purpose
m) transplantation
7. Authority for removal of human organs
1) Any donor can authorize the removal, before his death, of any human organs of
his body for therapeutic purposes.
2) Any donor in writing in presence of two or more witness authorized at any time
before his death, the removal of his organs after his death for therapeutic
purpose.
3) If any near relative of deceased person has no objection for removal of his organ
for therapeutic purpose.
4) Authority is given to registered medical practitioner.
8. Continueā¦.
5) Registered medical practitioner shall satisfy himself before removal, by personal
examination of body from which organ is to be removed that the is extinct it is
in case brain stem death.
6) Authority for removal of organ is given only if death is certified medical experts
(neurologist or neurosurgeon RMP in charge)
7) Any of the parents of deceased person may give authority if brain stem death of
person less than 18 age has occurred
9. Removal of human organs not be authorized in certain cases:
ļ¶Authority of removal of human organs in cases of
unclaimed bodies in hospital or prison:
1. If any unclaimed body lying in hospital or prison is not identified
by near relative within 48hru, authority is given for removal of
human organs by person in charge of management or control of
hospital or prison.
2. No authority is given if the person empowered to give such
authority has reason that any near relative of the deceased is likely
to claim dead body
10. ļ¶Authority for removal of human organs from bodies sent
for postmortem examination for medico legal or
pathological purpose:
ļ¶Preservation of human organs: after removal of any organ from
human body registered medical practitioner shall take prescribed steps
for preservation.
ļ¶Restriction on removal & transplantation of human organs:
No human organ shall be removed from body of donor before his death &
transplantation into recipient unless donor is near relative of recipient.
12. Regulations of hospital
ļ¶ Regulation of hospital conducting the removal, storage or
transplantation of human organs:
1) No hospital shall commence any activity relating to removal,
storage or transplantation of any human organ unless it is
registered under this act.
2) No medical practitioner or any other person shall conduct or aid in
conducting removal, storage or transplantation of any human
organ at place other than registered.
3) No place including of any human organ except for therapeutic
purpose.
13. ļ¶ Prohibition of removal or transplantation of human organs for any
purpose other than therapeutic purpose:
No person & no donor give authority for transplantation of organ
for any purpose other than therapeutic.
ļ¶ Explaining ,effects etc, to donor & recipient:
No registered medical practitioner shall undertake removal or
transplantation unless he has explained prescribed manner, all
possible effect & complications to donor & recipient respectively.
15. Appropriate authority
Central & state govt. Shall appoint 1 or more officers as
appropriate authorities for this act.
Function
1) To grant registration & suspend or cancel registration.
2) To enforce such standards as may be prescribed, for hospitals
engaged in the removal, storage or transplantation of any human
organ.
3) To investigate any complaint.
4) 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.
17. Registration of hospitals
ļ¶Registration of hospitals engaged in removal, storage or
transplantation of human organs:
ā¢ No hospital shall commence any activity relating to removal, storage or
transplantation of any human organ unless it is registered under
ļ¶Certificate of registration:
ā¢ Appropriate authority shall grant certificate to hospital such from, for such
period & subject to such conditions.
ā¢ Every certificate of registration shall be renewed such manner & on payment
of fees as prescribed.
ļ¶Suspension or cancellation of registration:
19. ļ¶Punishment for removal of human organ without authority:
ā¢ Imprisonment for term which may extend to 5yrs fine up
to 10,000 or more
ā¢ If a person is registered medical council for taking
necessary action including removal of his name from
council for period of 2yrs first offence and permanently for
the subsequent offence.
20. Punishment for commercial dealings in human organs:
ā¢ Makes or receives any payment for the supply of or for an offer to supply any
human organs.
ā¢ Seeks to find a person willing to supply any human organ for payment
ā¢ Offers to supply any organ for payment.
ā¢ Initiates or negotiates any arrangement involving the making of any payment for
supply of human organs
ā¢ Takes part in management or control of body of persons, either a society, firm or
company in initiation or negotiation any arrangement making of any payment for
supply of human organ.
ā¢ Publishes or distributes any advertisement
-Inviting persons to supply for payment of any human organ;
21. ā¢ Imprisonment for term which may extend to 2yrs to
5years fine up to 10,000 to 20,000 rupees.
ā¢ If any contravenes ,Imprisonment for term which may
extend to 3yrs fine up to 10,000 or more.
ā¢ offence by company ,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.
ā¢ Cognizance of offence
25. ā¢ The Transplantation of Human Organs (Amendment) Bill,
2013 ā Drafted by Ministry of Health.
ā¢ THO Act to cover both organs & tissues
ā¢ Human Organ Retrieval Centre
ā¢ Hospital with adequate ICU facilities, but not registered under the
THO Act
ā¢ Hospital registered under the THO Act
ā¢ Transplant Coordinator
A person appointed by a hospital to coordinate all matters relating
to removal or transplantation of human organs/tissues
26. ļ¶ Duties of the registered medical practitioner
ā¢ Mandatory for ICU doctor, in consultation with transplant coordinator to request
relatives of brain dead patients for organ donation.
ā¢ The registered medical practitioner (rmp)shall before removing any human organ
and/or tissue from the body of a donor before his/her death, shall satisfy himself
-The donor has given his/her authorization appropriate form 1(a) or 1(b) or 1(c).
ļ¶ AUTHORISATION COMMITTEE
ļ¶ Foreign nationals
ā¢ Authorization committee to prohibit organ transplantation where recipient is a foreign
national and donor is an Indian national.
ā¢ Approval of authorization committee required - donor and / or recipient being near
relatives are foreign nationals.
ļ¶ Mentally challenged
ā¢ No human organ or tissue to be removed from the body of a mentally challenged
person before his death for the purpose of transplantation.
27. ļ¶Swap Donations
ā¢ Two different willing but incompatible ānear relativeā
donors (vis-Ć -vis their intended related recipient) permitted
to donate their organs.
ā¢ Authorization committee will evaluate on a case-to-case
basis.
ļ¶Procedure for donation in medicolegal cases
ļ¶Removal and preservation of organs and/or tissues
ļ¶ Cost for maintenance of cadaver or retrieval or
transportation or preservation of organs or tissues:
28. ļ¶Application for live donor transplantation
ā¢ āAuthorization committeeā as specified in form 10
ā¢ The guidelines in rule 6-F
ļ¶Composition of authorisation committees
A. There shall be one State level Authorisation Committee.
B. Composition of hospital based authorisation committees.
C. Composition of state or district level authorisation committees.
29. REGISTRATION OF HOSPITAL/TISSUE BANK
ā¢ The appropriate authority as specified in form 11 or 11A or 11B.
ā¢ 1000rs fees payable at bank draft or postal order
ā¢ Grant a certificate of registration as specified in form 12 and it shall be valid for a
period of five years from the date of its issue and shall be renewable.
ā¢ Mandatory for the hospital to nominate a transplant coordinator.
RENEWAL OF REGISTRATION
ā¢ A period of three months prior to the date of expiry.
ā¢ A fee of rupees five thousand payable to the appropriate authority by means of
a bank.
ā¢ A renewal certificate of registration shall be as specified in Form 13 and shall be
valid for a period of five years.
30. Conditions/standards for grant of certificate of registration for organ and/
or tissue transplantation centers
1. General Manpower Requirement Specialised Services and Facilities(24hr ICU,
NURSE,DR & LAB ETC)
2. Equipment.
3. Experts and their qualifications
a. kidney transplantation: (M.S. (Gen.) Surgery )
b. Transplantation of liver and other abdominal organs
c. Cardiac, pulmonary, cardio-pulmonary transplantation.(M.Ch. Cardio-thoracic and
vascular surgery )
d. Cornea Transplantation(MS /MD OPTHO)
e. Other Tissues: Heart Valves, Skin, Bone etc.
31. ļ¶Transplant coordinator ā qualification, rĆ“le etc.
ā¢ Graduate of any recognized system of medicine
ā¢ Nurse, as defined in the Indian Nursing Council Act
ā¢ Masterās degree in Public Health/Social Work/Psychology
ā¢ Qualified counselor
ļ¶Advisory committee.
ļ¶Information to be included in national registry regarding
donors and recipients of human organ and tissue:
ļ¶Power to amend the rules
- central government