The document discusses organ transplantation in India. It notes that there is a large need for organ transplants but limited availability of organs, resulting in over 100,000 deaths per year. The Transplantation of Human Organs Act was passed in 1994 to regulate organ donation and transplants and prevent commercialization. It established two authorities - the Authorization Committee to approve transplants and the Appropriate Authority to regulate hospitals performing transplants. The Act placed restrictions on organ removal and donation to prevent exploitation and only allow transplants for therapeutic purposes.

2.  Organ Transplantation is a boon to
medical industry as it has helped in
saving the lives of those who would
have died otherwise.
 In a country like India, there is a
great need for human organs for
transplantation.
 Unofficial statistics from India
indicate that there are nearly 300
deaths every day due to failure of
organ. That is more than one lac
deaths per year.

3.  In fact, the need far exceeds the supply of transplantable
organs.
 This disparity has led to the formulation of various
legislations, attempting to regulate the scare resources
(transplantable human organs) and to help establish an
equitable system to allocate the organs where they can do
the most good.

4.  Organ transplantation is the moving of
an organ from one body to another or
from a donor site on the patient's own
body, for the purpose of replacing the
recipient's damaged or absent organ.
 The person who is donating the organ (
i.e. donor) could either be a living or a
deceased or a cadaver.
 The human organs that can be
transplanted are:
Heart , Kidney, Eyes, Liver, Lungs,
Pancreas, Intestine, Thymus.
Tissues include
bones, tendons, cornea, skin, heart
valves, and veins.

5. “An Act to provide for the regulation of removal,
storage and transplantation of human organs for
therapeutic purposes and for the prevention of
commercial dealings in human organs and for
matters connected therewith or incidental
thereto.”
-CENTRAL ACT NO 42 , 1994

6. At present ONLY 95% kidney and
Gross imbalance 1% of all
between the new liver
donations are transplants are
patients being cadaver.
added for from living
transplant and donors
available donors.
The list of
Organ donation Need for potential
recipients is
from dead
bodies is a the act mounting day
miniscule 0.5 by day and year
per one lakh
Around 3,000 95% kidney
patients die 5,500 kidney and liver
every year due to transplants in 180 transplants
lack of timely centres, 400 livers in are from
organ transplant 25 centres and 10-15 living
surgeries. hearts in very few donors
centres are done
annually.

7. A vast
impoverished
population.
Enterprising
Lack of
middlemen who
appropriate
could arrange for
laws regulating
any and
organ donation.
everything.
Need for the Act
Readily available
trained doctors
Good
willing to do the
infrastructure.
needful for a
consideration.

8.  The THOA was Passed by
 The Houses of Parliament
Rajya Sabha on 5th May, 1993
 Lok Sabha on 14th June 1994
 Amendments made by the
Lok Sabha agreed to by the
Rajya Sabha on 15th June 1994
 Assented to on 8th July 1994
 1995- Transplantation of
Human Organ Rules
 2009-Transplantation of
Human Organs (Amendment)
Bill

9.  Chapter I – Preliminary
 Chapter II- Authority for Removal of Human
Organ
 Chapter III- Regulation of Hospitals
 Chapter IV- Appropriate Authority
 Chapter V- Registration of Hospitals
 Chapter VI- Offences and Penalties
 Chapter VII- Miscellaneous

10.  To regulate hospitals involved in the transplantation of
human organs and to prevent commercialization, two
authorities were formed under the Act,
1. Authorization Committee (AC)
2. Appropriate Authority (AA)

11. Establishes that the unrelated donors
are not under any coercion or unduly
Approves the transplants between influenced by monetary considerations
unrelated donors and recipients to donate their
organs.
Functions of AC
Seeks NOC from respective domicile In case of a Foreign National, approval
states, if donor, recipientand place of from the AC is required over the NOC
transplantation are in differentstates. from their respective country

12.  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.
 The State Government shall
appoint, by notification, one or
more officers as Appropriate
Authorities for the purposes of
this Act.

13.  to grant registration or renew registration
 to suspend or cancel registration
 to enforce standards for hospitals
 to investigate any complaint of breach
 to inspect hospitals periodically for examination of the
quality of transplantation and the follow-up medical
care to persons

14.  Any donor may, in such manner
and subject to such condition
as may be prescribed, authorize
the removal before his death of
any human organ of his body
for therapeutic purposes.
•If any donor had in writing and in
the presence of two or more
witnesses unequivocally
authorized at any time before his
death, the removal of any human
organ of his body after his death
for therapeutic purposes

15. - The authority given shall be sufficient
warrant for the removal for therapeutic
purposes of the human organ but no
such removal shall be made by any
person other than the registered
medical practitioner.
- Where any human organ 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 where it appears to be a case of
brain-stem death, that such death has
been certified .

16.  Where any human organ 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 maybe prescribed by
a Board of medical experts
 Where brainstem death of any person less than eighteen
years of age occurs and is certified 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
human organ from the body of the deceased person.

17.  No authority for the removal of any human organ 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
 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 authority for the removal of any human
organ 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.

18. • No hospital, unless registered
under this act, shall conduct or
associate with, or help in the
removal, storage or
transplantation of any human
organ.
 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 human organ at a place other than a place
registered under this Act

19.  No donor and no person empowered to give authority for the
removal of any human organs shall authorise the removal of any
human organ for any purpose other than therapeutic purposes.
•No registered medical practitioner shall
undertake the removal or transplantation of any
human organ 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.

20.  Every application for registration shall be made to the
Appropriate Authority
 No hospital shall be registered under this Act unless the
Appropriate authority is satisfied that the applicant has
complied with all the requirements of this Act
 The AA issues a license to a hospital for a period of 5 years at a
time and can renew the license after that period. Each organ
requires a separate license.
 Any hospital aggrieved by an order of the Appropriate Authority
rejecting/cancelling/suspending an application for registration
may, within thirty days from the date of the receipt of the order,
prefer an appeal to Central/State Government.

21. Whosoever Carries
out removal or Now enhanced to
transplantations 10 years and 5
without authority is lacs in
punishable for up Transplantation of
to five years and a Human Organs Bill
fine of up to Rs 2011.
10,000.

22. Offending registered medical
practitioner is liable to be
removed from the state medical council
roll for two years
for the first offence and permanently for
any subsequent
offence.

23. Commercial dealings, like Enhanced to 5-10
indulging in monetary years and a fine
transaction for trading in between 20 lakh
human organs, brokering to 1 crore in
human organ trade deals, and Transplantation of
advertising to solicit clients, Human Organs Bill
are punishable with 2011.
imprisonment ranging from
two to seven years, and a
fine of Rs 10,000 to Rs
20,000

24. Punishment For Contravention Of Other Provision
For provisions where no punishment has been
prescribed
Imprisonment of up to 3 years
Fine up to Five Thousand Rupees.

25.  No court has shall take cognizance
unless complaint has been made by
a) Appropriate authority or on behalf
of central / state government
b) Notice of not less than 60 days to
Appropriate authority
 Metropolitan Magistrate or a
Judicial Magistrate of the first
class .

26.  FOR RELATED DONARS:
The relatives who are allowed to donate include
mother, father, brothers, sisters, son, daughter,
grandparents and spouse. These first relatives are
required to provide proof of their relationship by
genetic testing and/or by legal documents.
 In the event of there being no first relatives, the
recipient and donor are required to seek special
permission from the government appointed
authorization committee.

27. FOR UNRELATED DONARS:
File an affidavit in the court of a magistrate stating that
the organ is being donated out of affection.
Undergo number of tests before the actual transplant
takes place.
The Authorization Committee set up for the purpose
ensures that all the documents required under the act
have been supplied.
If it is found that the money has been exchanged in the
process then both the recipient as well as the donor are
considered as prime offenders under the law.

28. 1. To rename the Act as the “Transplantation of Human Organs
and Tissues Act”
2. To expand the definition of the term ‘near relatives’ to include
grandparents and grandchildren
3. To provide for the enucleation of corneas by a trained
technician
4. To enable a surgeon/physician and an anaesthetist/ intensivist
to be included in the medical board in the event of non
availability of a neurosurgeon/neurologist for certification of
brain death
5. To make it mandatory for the ICU/Treating Medical Staff to
request relatives of brain dead patients for organ donation

29. 6. To provide for Swap Donations of organs
7. To empower the Central Government to prescribe the
composition of Authorisation Committees and to empower Union
Territories to set up their own authorization committees
8. To regulate the transplantation of organs for foreign nationals
9. To prevent the exploitation of minors
10. To provide for the establishment of Advisory Committees for
Appropriate Authorities
11. To vest in Appropriate Authorities, the power to summon
persons, seek production of documents, issue search warrants etc

30. 12. To establish a National Organ Retrieval, Banking &
Transplantation Network
13. To provide for the development and maintenance of a
national registry of the recipients of organ transplants
14. To create the position of a ‘Transplant Coordinator’ in all
hospitals registered for organ retrieval and or
transplantation
15. To provide for the registration of Non Government
Organizations working in the field of organ retrieval and or
transplantation in any manner whatsoever
16. To enhance the penalties under the act
17. To expand the rule making powers of the Central
Government.

31. 18. The current age limit of 60-years should be removed for cadaver donors.
Improved health and longer life expectancy means some older people
could be suitable donors, upping the organ donor count to an extra 10 or
12 a year.
19. It has also been proposed that paired matching should be permitted i. e.
if patient A's donor does not match A and likewise for patient B, then
donor switch should be allowed, if it results in a match. Swaps or
exchanges between families unable to fulfil the need of their family
member in need of a transplant due to incompatibility, are known to
take place. However, this is not legal and is mostly done under cover. The
proposed amendment seeks to convert the de facto into de jure,
encouraging more families to swap organs amongst themselves, to be
vetted by an authorisation committee.

32. 20. The law will also make it easier for a spouse to donate an
organ. Although the 1994 Act included spouse in the
definition of ‘near relative’, a spousal donation was next to
impossible because of strictures. But the fact and duration of
marriage will still be needed to be established in the new law
to protect women from being exploited.

33.  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.
 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.

34.  Case: Unrelated donor..Vs Authorization
Committee
 Issue
 AC had rejected the application for organ
donation by the sister-in-law. petition
 The prospective recipient filed a writ
before the High Court of Karnataka against the
order of the AC.
 Petitioners seek direction to the respondents
(AC) "to give clearance for the transplant
operation .“

35.  Reasons Recorded by AC for refusal
 Donor being sister-in-law was not genetically related to the
recipient.
 Other near relatives were not being considered as donors by
the family
 Final Court Direction
 Direction was issued to the first respondent to consider the
applications of the petitioners afresh.
 The Committee had to ascertain from the 2nd petitioner
whether she would be donating the kidney out of "affection
and attachment

36.  Outcome
 When presented with the provisions of the law,the AC
concludes that if the recipient and donor
 pledge affection in front of them, they should not
object unless there is a complaint or some gross
oversight.
 Finally permission was granted by the AC for the transplant.

37.  Control illegal organ transplant &
trafficking
 To stop commercial dealing in organs
especially kidneys.
 Accept Brain death as a definition of
death.
 Define donor eligibility.
 Prevent manipulation of lower
socio-economic class.
 Regulate and respect self willing
donors wishes.