INDIAN ORGAN AND TISSUE TRANSPLANT ACT

1. The Transplantation of Human Organs and Tissue
Act, (TOHOTA)

2. • There is huge shortage of Organs available for carrying out Transplants as
compared to the number of patients who require Organ transplants.
• There is huge Gap between demand and supply of organs.
• There is a need to promote deceased organ donation, rather than relying
on living donors, because of risk of commercial trading and inherent risk
to the health of living donor.
• Cadaveric organ donor transplant can be done from “brain stem dead”
persons before the heart stops beating.
• About 1.5 lakhs deaths happen annually due to road traffic accidents in
India – a large number of these cases could be harvested for organs.

3. ThisAct was enacted for the
Regulation of removal, storage and transplantation of human organs
for therapeutic purposes only
For the prevention of commercial dealings in human organs.

4. Till 1994 there was no comprehensive nationwide legislation to
regulate the removal of organs from deceased or living persons.
There were only some state level legislation and that pertaining only
to specified organ
In Delhi
The eye act 1982
The ear drum and ear bone act 1982
In Maharashtra
The Bombay corneal grafting act 1957
The Maharashtra kidney transplantation act 1982

5. Human Organ retrieval centre
Means a hospital
Which has adequate facilities for treating seriously ill patients who can be
potential donors of organs in the events of death
Which is registered U/s 141 for retrieval of human organs
Near relatives
In the original act there were following seven relations
Father
Mother
Spouse
Brother
Sister
Son
Daughter

6. By the 2011 amendment following four relations were added
Grand father
Grand mother
Grand sons
Grand daughter
Tissue- means of a group of cells except blood performing a particular
functions in human body. This sub section has been added by 2011
amendment and brings bone marrow within the purview of the act.
Tissue bank- means a facility registered u/s 14A for caring out any
activity relating to the recovery, screening, testing processing, storage and
distribution of tissues, but dose not include blood bank (added by 2011
amendment)

7. Transplant coordinator- 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 authorities for removal of
human organs in accordance with the provisions ofAct.
Appropriate authority(AA)
Central government and state governments should appoint AA
comprising of one or more persons and functions ofAAare-

8. To grant registration and renew registration to hospital.
To suspend and cancel registration.
Enforce high standard for hospital and tissue bank.
To investigate complaints into irregularities take action.
To periodically inspect hospitals and tissue bank.

9. NETWORK
NOTTO: National Organ and Tissue
Transplant Organization
ROTTO: Regional Organ and Tissue
Transplant Organization
SOTTO: State Organ and Tissue
Transplant Organization
T: Transplant Centre
R: Retrieval Centre
B: Biomaterial Centre (Tissue Bank)

10. NOTTO
NOTTO and Activities being undertaken is as under.
1) Website
2) Helpline/ Call centre
3) Registration of Hospitals in NOTTO registry
4) National Regidtry
5) Pledging for donation
6) Allocation Policy
7) SOPs
8) Operational guidelines
9) Registration of Tissue banks
10) Apex Technical Committees
11) Coordination with other commitees
12) Capacity Building
13) Awareness
14) Covid Specific Guidelines

11. Authority for removal of human organs
Any donor (> 18 years of age) may authorize the removal before his
death of any organ of his body for therapeutic purposes.
If any donor had in writing (in presence of 2 or more witnesses)
authorized the removal of any organ after his death for therapeutic
purposes, the person lawfully in possession of dead body should allow
the doctor all reasonable facilities for removal.

12. When no such authority is there, person lawfully in possession of dead
body can authorize the removal of any organ of the deceased person.
When human organ is to be removed, the medical practitioner should
satisfy himself, that life is extinct in such body or where it is a case of
brainstem death

13. The death has been certified by:
i. The doctor in-charge of hospital in which the brainstem death has
occurred.
ii. An independent doctor, being a specialist nominated by the above in-
charge from the panel of names approved byAppropriateAuthority.
iii. Aneurologist or a neurosurgeon, nominated by the in-charge from the
panel.
iv. The doctor treating the person whose brainstem death has occurred.

14. Under any circumstances, brainstem death tests should not be performed
by transplant surgeons or any doctor in the transplant team or a member
of the Authorization Committee.

15. Removal of human organs cannot be authorized wherein
An inquest may be required to be held in relation to such body.
Aperson who has been entrusted the body solely for the purpose of
cremation.

16. Authority for removal of human organs in case of unclaimed bodies
in hospital or prison
If not claimed by any near-relatives within 48 hours from time of
death, the authority lies with the management of hospital or prison or
by employee of the hospital or prison authorized by management

17. Postmortem or Pathological examination
Person competent under this Act can give authorization, if such organ
will not be required for the purpose for which the body has been sent.

18. Restriction on removal and transplantation of human organs
Human organ should not be removed from the body of donor before his
death and transplanted into recipient, unless the donor is a near-relative
(spouse, son, daughter, father, mother, brother or sister).
When donor authorizes the removal of his organs after his death, these
organs may be transplanted into the body of any recipient.
If any donor authorizes the removal of his organs before his death to such
recipient not being near relative by reason of affection or attachment
towards the recipient, the organs should not be removed and transplanted
without prior approval ofAuthorization Committee.

19. Regulation of hospitals conducting the removal, storage or transplantation of
human organs
Hospital not registered under this Act should not be engaged in transplantation
activities.
Medical practitioner should not conduct transplantation at any unregistered place
under thisAct.
The eyes and the ears may be removed at any place from dead body of any donor
for therapeutic purposes by a doctor.
The doctor is also prohibited from removal or transplantation of human organs for
any purpose other than therapeutic purposes.

20. Punishment for commercial dealings in human organs
Punishable with imprisonment for a term from 2-7 years and fine of `
10,000–20,000.

21. Duties of the Medical Practitioner Regarding Organ
Transplantation
In case of live donation, the doctor should satisfy himself before
removing an organ from the donor that:
a. Donor has given his authorization.
b. Donor is in proper state of health and fit to donate the organ.
c.Donor is a near-relative of the recipient and sign a certificate after
carrying out following tests on donor and recipient

22. i.Tests for the antigenic products of HLA-A, HLAB and HLA-DR using
conventional serological techniques.
ii.Tests to establish HLA-DR and HLA-DQ gene restriction fragment length
polymorphisms.
iii.When the above tests do not establish genetic relationship, tests to
establish DNApolymorphisms using at least two multilocus genes probe.
iv.When (iii) do not establish genetic relationship, further tests to establish
DNApolymorphisms using at least five single locus polymorphism probes.
In case recipient is a spouse of donor, record the statements of both and sign a
certificate.

23. In case of cadaveric donation, the doctor should satisfy himself that:
i. Donor has authorized before his death, the removal of his organ for
therapeutic purpose after his death, in presence of two or more
witnesses, at least one of whom is a near-relative.
ii. Person lawfully in possession of dead body has signed a certificate
as specified under theAct.

24. iii.Adoctor, before removing organ from a brainstem dead person,
should satisfy that:
Certificate regarding the brainstem dead from the Board of medical
experts is present.
In case of a person < 18 years, a certificate has been signed by either
of the parents of such person.