Transplantation of

Human Organ Act 1994

(THOA ACT)

Presented by

Pavitra Ibrahimpur

MHA 3RD SEM

INTRODUCTION

“To provide the regulation of removal, storage and

transplantation of human organs for therapeutic

purposes and for the prevention of commercial

dealings in human organs”

CHAPTER- I

Short title

Application

Commencement and definitions

(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

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

Authority for removal of human organs

CHAPTER-II

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.

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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

Removal of human organs not be authorized in certain cases:

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

Authority for removal of human organs from bodies sent

for postmortem examination for medico legal or

pathological purpose:

Preservation of human organs: after removal of any organ from

human body registered medical practitioner shall take prescribed steps

for preservation.

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.

REGULATIONS OF HOSPITAL

CHAPTER -III

Regulations of hospital

Regulation of hospital conducting the removal, storage ortransplantation of human organs:

1) No hospital shall commence any activity relating to removal,storage or transplantation of any human organ unless it isregistered under this act.

2) No medical practitioner or any other person shall conduct or aid inconducting removal, storage or transplantation of any humanorgan at place other than registered.

3) No place including of any human organ except for therapeuticpurpose.

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.

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.

APPROPRIATE AUTHORITY

CHAPTER-IV

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.

5) To undertake such other measures as may be prescribed.

REGISTRATION OF HOSPITALS

CHAPTER -V

Registration of hospitals

Registration of hospitals engaged in removal, storage or transplantation of human organs:

• No hospital shall commence any activity relating to removal, storage or transplantation of any human organ unless it is registered under

Certificate of registration:• Appropriate authority shall grant certificate to hospital such from, for such

period & subject to such conditions.

• Every certificate of registration shall be renewed such manner & on payment of fees as prescribed.

Suspension or cancellation of registration:

Offences & Penalties

CHAPTER VI

Punishment for removal of human organ without authority:

• Imprisonment for term which may extend to 5yrs fine up

to 10,000 or more

• 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.

Punishment for commercial dealings in human organs:

• Makes or receives any payment for the supply of or for an offer to supply any

human organs.

• Seeks to find a person willing to supply any human organ for payment

• Offers to supply any organ for payment.

• Initiates or negotiates any arrangement involving the making of any payment for

supply of human organs

• 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.

• Publishes or distributes any advertisement

-Inviting persons to supply for payment of any human organ;

• Imprisonment for term which may extend to 2yrs to

5years fine up to 10,000 to 20,000 rupees.

• If any contravenes ,Imprisonment for term which may

extend to 3yrs fine up to 10,000 or more.

• 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.

• Cognizance of offence

MISCELLANEOUS

CHAPTER VII

Miscellaneous

• Protection of action in taken good faith

• Power to make rules

-Central government

• Repeal and save

Amendments

• The Transplantation of Human Organs (Amendment) Bill, 2013 – Drafted by Ministry of Health.

• THO Act to cover both organs & tissues

• Human Organ Retrieval Centre

• Hospital with adequate ICU facilities, but not registered under the THO Act

• Hospital registered under the THO Act

• Transplant Coordinator

A person appointed by a hospital to coordinate all matters relating to removal or transplantation of human organs/tissues

Duties of the registered medical practitioner

• Mandatory for ICU doctor, in consultation with transplant coordinator to request relatives of brain dead patients for organ donation.

• 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).

AUTHORISATION COMMITTEE

Foreign nationals

• Authorization committee to prohibit organ transplantation where recipient is a foreign national and donor is an Indian national.

• Approval of authorization committee required - donor and / or recipient being near relatives are foreign nationals.

Mentally challenged

• No human organ or tissue to be removed from the body of a mentally challenged person before his death for the purpose of transplantation.

Swap Donations

• Two different willing but incompatible ‘near relative’ donors (vis-à-vis their intended related recipient) permitted to donate their organs.

• Authorization committee will evaluate on a case-to-case basis.

Procedure for donation in medicolegal cases

Removal and preservation of organs and/or tissues

Cost for maintenance of cadaver or retrieval or transportation or preservation of organs or tissues:

Application for live donor transplantation

• “Authorization committee” as specified in form 10

• The guidelines in rule 6-F

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.

REGISTRATION OF HOSPITAL/TISSUE BANK

• The appropriate authority as specified in form 11 or 11A or 11B.

• 1000rs fees payable at bank draft or postal order

• 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.

• Mandatory for the hospital to nominate a transplant coordinator.

RENEWAL OF REGISTRATION

• A period of three months prior to the date of expiry.

• A fee of rupees five thousand payable to the appropriate authority by means of

a bank.

• A renewal certificate of registration shall be as specified in Form 13 and shall be

valid for a period of five years.

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.

Transplant coordinator – qualification, rôle etc.

• Graduate of any recognized system of medicine

• Nurse, as defined in the Indian Nursing Council Act

• Master’s degree in Public Health/Social Work/Psychology

• Qualified counselor

Advisory committee.

Information to be included in national registry regarding

donors and recipients of human organ and tissue:

Power to amend the rules

- central government

FORMS

Thank you