HUMAN ORGANS TRANSPLANTATION ACT.

1994
WHO: Includes organs and tissues, but does not relate to human reproductive tissues namely
ova, sperm, ovaries, testicles or embryos, nor it is intended to deal with blood or blood
constituents for transfusion purpose.

Transplantation of Human Organ Act: Any part of a human body consisting of a structured
arrangement of tissues which, if wholly removed, cannot be replicated by the body.

THO bill was passed by parliament of India in June1994 and the president India gave his assent
in July 1994.

The act came into force in year 1995, Feb 4th Provides for

1. Provision for removal , storage ,transplantation of organs for therapeutic purposes

2. For prevention of commercial dealings in human organs and for the matters connected
there with.
3. Aims to stop live unrelated transplants
4. In case of live related transplant - donor and recipient are genetically related with an
exception if the transplant is done with prior approval of authorization committee on the
application made by donor and recipient.
5. Accepts brain death criterion

Donation of organs are of three type

1. Homologous donation
2. Heterologous donation
3. Cadaveric donation.

Homologous donation relocation of tissue from one part of the body to another in the same
patient.eg skin ,bone grafting. This has no legal implications.

Heterologous donation includes transfusion of blood and blood marrow ,because of there
regenerative capacity, pose no threat to the donor, live heterologous donation can be extend to
paired organ such as kidney.

Cadaveric Donation - this is only means to obtain unpaired organs. this is the area which
requires accurate diagnosis of brain stem death, because organ taken from beating donors have
more chance of successful grafting.

No human organs is to be removed from the body of a person in event of his brain stem death
unless such death is certified by a board of medical experts consisting of the following,

A. RMP in charge of hospital in brain stem death has occurred.

 B. A treating RMP being a specialist treating the patient whose brain death has
occurred.
C. Neurologist / neurosurgeon nominated from the panel of names approved by a
appropriate authority.
D. An independent medical specialist nominated from panel of names, approved by
the appropriate authority.

THE DIAGNOSIS OF BRAINSTEM DEATH INVOLVES THREE STEPS.

1. The patient is comatose and unable to breathe spontaneously and therefore

unconscious and on ventilator.
2. Exclusion of the cause of coma as due to drugs, hypothermia, or profound
metabolic disturbances which may reversibly impair brainstem function.
3. Establishing that the patient fails to breathe, even when after taken off the respirator
after certain preliminary changes made in the blood gas concentration.

TESTING THE BRAINSTEM REFLEXES.

A. Pupillary response to light.

B. Corneal reflex –blinking.

C. Vestibulo ocular reflexes-dolls eye movement.

D. Grimace-painfull stimulus over face.

E. Gag or cough reflex in response to intubation.

The act defines human organ as any part of human body consisting of a structured arrangement
of tissue which if only removed cannot be replicated by the body.

As per the act organs that can be donated are

1. Kidneys

2. Heart

3. Lungs

4. Liver

5. Pancreas

6. Eyes { cornea}
 7. Ear drums

8. Ear bones

The only organ that can be donated during life is kidney.

THE organs can be removed from the dead body of donor at any place.

Removal can be done on his authorization or that of the person lawfully in possession of the
body.

RETRIEVAL PERIOD OF DIFFERENT ORGANS

 Liver within 15 min.

 Kidneys within 45 min.

 Heart within 1 hr.

 Cornea within 6 hr.

 Skin within 24 hr.

 Bone marrow within 48 hr.

 Blood vessels within 72 hr.

POTENTIAL DONATION

Are of three types

1. Donation of tissues readily replaceable e.g. blood these do not cause any serious problem.

2. Donation of organs that are not essential to the life of donor.

3. Donation of one of the paired organs, the organ being capable of maintaining life as long
as it is healthy.eg kidney

Any person between 1 year and 60 years can become a potential donor. However to
donate a kidney during life, the donor should be aged more than 18 years.
PROCEDURE FOR DONATION IN MEDICOLEGAL CASES

1. After the authority for removal of organs and/or tissues, as also the consent to donate
organs from a brain-stem dead donor are obtained, the Registered Medical Practitioner of
the hospital shall make a request to the SHO of the area either directly or through the
Police Post located in the hospital to agree for retrieval of organs from the donor. It has to
be ensured that, by retrieving organs, the determination of the cause of death is not
jeopardized.

2. Only in cases where the definite cause of death is established clinically by the RMP, the
post mortem may be waived off by the competent officer on the request of the RMP and
Investigating Officer of the case.

3. The Registered Medical Practitioner who is designated to do the post mortem can do the
post-mortem in a case of organ retrieval also.

4. Doctor designated to perform Post-Mortem shall be present at the time of retrieval of

organs/tissues by the retrieval team. The Post mortem report in respect of the
organs/tissues being retrieved shall be prepared at the time of retrieval. Rest of the post
mortem procedure shall take place at the designated place for post-mortem.

5. For the purpose of organ(s)/tissue(s) retrieval, request for post mortem beyond specified
timings, can be made by the Registered Medical Practitioner and the investigating officer
of the case.

- REMOVAL AND PRESERVATION OF ORGANS AND/OR TISSUES

- APPLICATION FOR LIVE DONOR TRANSPLANTATION
- COMPOSITION OF AUTHORISATION COMMITTEES AND APPROPRIATE
AUTHORITY
- REGISTRATION OF HOSPITAL/TISSUE BANK
- RENEWAL OF REGISTRATION
The Transplantation of Human Organs (Amendment) Bill, 2009

Amendment Bill offers regulation of the transplantation of human tissue along with organ
transplant.

HIGHLIGHTS:

1. The bill made amendments in the Transplantation of Human Organs Act, 1994.
2. Along with human organs, the Bill also regularized the transplantation of tissues of the
human body.
3. The act permitted donations from living persons who are near relatives. This act also
added grandparents and grandchildren to the list of “near relative”.
4. The doctor had to inform the patient or his relatives about the possibility of organ
donation and made sure that they given their consent to it.
5. If the organ of the donor and the recipient does not match medically, the bill gave a
permission to swap organs with another pair of such a person.
6. The bill made an increase in the penalty for illegal removal of human organs and for
receiving or making payment for a human organ.

The Transplantation of Human Organs (Amendment) Bill, 2013

- Verification Committee - verification of the details that are offered by the donor and
recipient

1. Live donation – Where organ transplant takes place between the patient and his close
friend or a family member
2. Cadaveric donation- Where a person pledges his organs for harvesting and donated after
his death.

 NOC from government for organ transplant from other state.

 Complete health check up.

CADAVER DONATION means that a person takes a pledge to donate his organs after death.
Here the organs of a person are harvested after the person is declared brain dead. In case of
cadaver donation keep the following in mind:

 NGO registration
 Family information
 After donation return of the body
 Organ testing
 Diseases like kidney disease, liver failure or heart conditions etc
 One can donate his skin, eyes, liver, lungs, kidneys, and sometimes intestines.
FOR RECIPIENTS:

In case you are on the receiving side, you should be aware of the following:

 Register yourself with the Zonal Transplant Coordination Center (ZTCC) for cadaveric
donations, as per your need and get an NOC.
 You can take the assistance of your physician who can also guide you through the
process of registering.
 Every available organ has to go through a cross match test. In case the result is negative,
the doctor does not go for the transplant.

PUNISHMENT: Erasing medical practitioners from the registers of state medical council for 2
years for the first offence and permanently for subsequent offences or imprisonment up to 5
years and fine of Rs.10, 000/- based on the nature and degree of the offence.

Section 18: Punishment for removal of human organ without authority

a. In Section 18 sub-section (i), the term five years shall be substituted by the term
ten years and the term ten thousand rupees shall be substituted by term five lakh
rupees.
b. In sub-section (ii), the term two years shall be substituted by the term three years.

Section 19: Punishment for commercial dealings in human organs

c. Section 19 – The term two years shall be substituted by the term five years and
the term seven years shall be substituted by the term ten years and the term ten
thousand rupees shall be substituted by five lakh rupees and the amount twenty
thousand rupees shall be substituted by twenty lakh rupees.
d. The proviso to Section 19 shall be deleted.

Section 20: Punishment for contravention of any other provision of this Act
e. Section 20 – the term three years shall be substituted by the term five years.

An offence under this act is cognizable only when the complaint has been made by either
the appropriate authority or a person who has given notice to such appropriate authority
about the alleged offence and his intention to make complaint to the court.