In exercise of the powers conferred by
sub-section (1) if section 24 of the
Transplantation of Human Organs Act, 1994
(42 of 1994), the Central Government hereby
makes the following rules, namely:
Short title and commencement
Definitions
Authority for removal of human organ
Duties of the Medical Practitioner
Preservation of organs
Composition of Authorisation
Committees
Registration of hospital
Renewal of registration
Conditions for grant of certificate
of registration
Appeal
Short title and commencement
a
These rules may be called the
Transplantation of Human Organs
Rules, 1995.
b
They shall come into force on the
date1 of their publication in the
Official Gazette.
Definitions
a
"Act" means the Transplantation of
Human Organs Act, 1994 (42 of 1994);
b
"Form" means a form annexed to these
Rules;
c
"Section" means a section of the
Act;
d
˛["National Accreditation Board for
Laboratories" (NABL) means a Board
set up by the Quality Council of
India (set up by the Government of
India) for undertaking assessment
and accreditation of testing and
calibration of laboratories in
accordance with the international
standard ISO/IEC/17025 and ISO
15189;
e
The Registered Medical Practitioner,
as defined in clause (n) of section
2 of Transplantation of Human Organs
Act, 1994 includes an allopathic
doctor with MBBS or equivalent
degree under the Medical Council of
India Act.]
f
Words and expressions used and not
defined in these Rules, but defined
in the Act, shall have the same
meanings respectively assigned to
them in the Act.
Authority for removal of human organ
Any donor may authorise the removal, before
his death, of any human organ of his body
for therapeutic purposes in the manner and
so such conditions as specified in 4[Forms
1(A), 1(B) and 1(C)].
Duties of the Medical Practitioner
1
A registered medical practitioner
shall, before removing a human organ
from the body of a donor before his
death, satisfy himself
a
That the donor has given his
authorization in Form 1(A) or 1(B)
or 1(C).
b
That the donor is in proper state of
health and is fit to donate the
organ, and the registered medical
practitioner shall sign a
certificate as specified in Form 2.
c
That the donor is a near relative of
the recipient as certified in Form
3, who has signed Form 1(A) or 1(B)
as applicable to the donor and that
the donor has submitted an
application in Form 10 jointly with
the recipient and that the proposed
donation has been approved by the
concerned competent authority and
that the necessary documents as
prescribed and medical tests, if
required, to determine the factum of
near relationship, have been
examined to the satisfaction of the
Registered Medical Practitioner i.e.
Incharge of transplant center.
d
That in case the recipient is spouse
of the donor, the donor has given a
statement to the effect that they
are so related by signing a
certificate in Form 1(B) and has
submitted an application in Form 10
jointly with the recipient and that
the proposed donation has been
approved by the concerned competent
authority under provision of
sub-rule (2) of rule 4A.
e
In case of a donor who is other than
a near relative and has signed Form
1(C) and submitted an application in
Form 10 jointly with the recipient,
the permission from the
Authorisation Committee for the said
donation has been obtained.
2
A registered medical practitioner
shall, before removing a human organ
form the body of a person after his
death satisfy himself- (a) that the
donor had, in the presence of two or
more witnesses (at least one of whom
is a near relative of such person),
unequivocally authorized as
specified in Form 5 before his
death, the removal of the human
organ of his body, after his death,
for therapeutic purposes and there
is no reason to believe that the
donor had subsequently revoked the
authority aforesaid; 1[(b) that then
person lawfully in possession of the
dead body has signed a certificate
as specified in Form 6.]
3
A registered medical practitioner
shall, before removing a human organ
from the body of a person in the
event of his brain-stem death,
satisfy himself
a
That a certificate as specified in
Form 8 has been signed by all the
members of the Board of Medical
Experts referred to in sub-section
(6) of section 3 of the Act;
b
That in the case of brain-stem death
of a person of less than eighteen
years of age, a certificate
specified in Form 8 has been signed
by all the members of the Board of
Medical Experts referred to in
sub-section (6) of section 3 of the
Act and an authority as specified in
Form 9 has been signed by either of
the parents of such person.
Short title and commencement
1
The medical practitioner who will be
part of the organ transplantation
team for carrying out
transplantation operation shall not
be a member of the Authorisation
committee constituted under the
provision of clauses (a) and (b) of
sub-section (4) of section9 of the
Act.
2
Where the proposed transplantation
is between a married couple, the
Registered Medical Practitioner i.e.
Incharge of transplant center must
evaluate the factum and duration of
marriage and ensure that documents
such as marriage certificate,
marriage photograph etc.
Are kept for records along with the
information on the number of age of
children and family photograph
depicting the entire immediately
family, birth certificate of
children containing particulars of
parents.
3
When the proposed donor or recipient
or both are not Indian
Nationals/citizens whether ‘near
relatives’ or otherwise,
Authorisation Committees shall
consider all such requests.
4
When the proposed donor and the
recipient are not “near relatives’,
as defined under clause (i) of
section 2 of the Act, the
Authorisation Committee shall
evaluate that,-
i
There is no commercial transaction
between the recipient and the donor
and that no payment or money or
moneys worth as referred to the Act,
has been made to the donor or
promised to be made to the donor or
any other person;
ii
The following shall specifically be
assessed by the Authorisation
Committee:-
a
An explanation of the link between
them and the circumstances which led
to the offer being made;
b
Reasons why the donor wished to
donate;
c
Documentary evidence of the link,
e.g. proof that the have lived
together, etc;
d
Old photographs showing the donor
and recipient together;
iii
That there is no middleman or tout
involved;
iv
That financial status of the donor
and the recipient is probed by
asking them to give appropriate
evidence of their vocation and
income for the previous three
financial years. Any gross disparity
between the status of the two must
be evaluated in the backdrop of the
objective of preventing commercial
dealing;
v
That the donor is not a drug addict
or known person with criminal
record;
vi
That the next of the kin of the
proposed unrelated donor is
interviewed regarding awareness
about his or her intention to donate
an organ, the authenticity of the
link between the donor and the
recipient and the reasons for
donation. Any strong views or
disagreement or objection such kin
shall also be recorded and taken
note of.
vii
Where the proposed transplant is
between individuals who are not
“near relatives”. The authorization
committee shall evaluate:-
i
That there is no commercial
transaction between the recipient
and the donor. That no payment of
money or moneys worth as referred to
in the sections of the Act, has been
made to the donor or promised to be
made to the donor or any other
person. In this connection, the
Authorisation Committee shall take
into consideration:-
a
An explanation of the link between
them and the circumstances which led
to the offer being made;
b
Documentary evidence of the link
e.g. proof that they have lived
together etc;
c
Reasons why the donor wihses to
donate; and
d
Old photographs showing the donor
and the recipient together.
ii
That there is no middleman/tout
involved;
iii
That financial status of the donor
and the recipient is probed by
asking them to give appropriate
evidence of their vocation and
income for the previous three
financial years. Any gross disparity
between the status of the two, must
be evaluated in the backdrop of the
objective of preventing commercial
dealing;
iv
That the donor is not a drug addict
or a known person with criminal
record; that the next of kin of the
proposed unrelated donor is
interviewed regarding awareness
about his\her intention to donate an
organ, the authenticity of the link
between the donor and the recipient
and the reasons for donation. Any
strong view of disagreement or
objection of such kin may also be
recorded and taken note of; and
viii
When the proposed donor or the
recipient or both are foreigners:- A
senior Embassy official of the
country of origin has to certify the
relationship between the donor and
the recipient. Authorisation
Committee shall examine the cases of
Indian donors consenting to donate
organs to a foreign national (who is
a near relative), including a
foreign national of India origin,
with greater caution. Such cases
should be considered rarely on case
to case basis.
ix
In the course, of determining
eligibility of the applicant to
donate, the applicant should be
personally interview by the
Authorisation Committee and minutes
of the interview should be recorded.
Such interviews with the donors
should be video graphed.
x
In case where the donor is a woman
greater precautions ought to be
taken. Her identity and independent
consent should be confirmed by a
person other than the recipient. Any
document with regard to the proof of
the residence or domicile and
particulars of parentage should be
relatable to the photo identity of
the applicant in order to ensure
that the documents pertain to the
same person, who is the proposed
donor and in the event of any
inadequate or doubtful information
to this effect, the Authorisation
committee may in its discretion seek
such other information or evidence
as may be expedient; and desirable
in the peculiar facts of the case.
xi
The Authorisation Committee should
state in writing its reason for
rejecting / approving the
application of the proposed donor
and all approvals should be subject
to the following conditions:-
a
That the approved proposed donor
would be subjected to all such
medical test as required at the
relevant stages to determine his
biological capacity and
compatibility to donate the organ in
question.
b
Futhter that the psychiatrist
clearance would also be mandatory to
certify his mental condition,
awareness, absence of any overt or
latent psychiatric disease and
ability to give free consent.
c
All prescribed forms have been and
would be filled up by all relevant
persons involved in the process of
transplantation.
d
All interviews to be video recorded.
xii
The authorization committee shall
expedite its decision making process
and use its discretion judiciously
and pragmatically in all such cases
where, the patient requires
immediate transplantation.
xiii
Every authorized transplantation
center must have its own website.
The Authorization Committee is
required to take final decision with
in 24hours of holding the meeting
for grant of permission of rejection
for transplant. The decision of the
Authorisation committee should be
displayed on the notice board of the
hospital or institution immediately
and should reflect on the website of
the hospital or institution within
24 hours of taking the decision.
Apart from this, the website of the
hospital or institution must update
its website regularly in respect of
the total number of the
transplantations done in that
hospital or institution along with
the details of each transplantation.
The same data should be accessible
for compilation, analysis and
further use by respective State
Governments and Central Government.
Registration of hospital
1
An application for registration
shall be made to the Appropriate
Authority as specified in Form 11.
The application shall be accompanied
by a fee or rupees one thousand
payable to the Appropriate Authority
by means of a bank draft or postal
order.
2
The Appropriate Authority shall,
after holding an inquiry and after
satisfying itself that the applicant
has complied with all the
requirements, grant a certificate of
registration as specified in Form 12
and shall be valid for a period of
five years form the date of its
issue and shall be renewable.
3
Before a hospital is registered
under the provisions of this rule,
it shall be mandatory for the
hospital to nominate a transplant
co-ordinator.
Renewal of registration
1
An application for the renewal of a
certificate of registration shall be
made to the Appropriate Authority
within a period of three months
prior to the date of expiry of the
original certificate of registration
and shall be accompanied by a fee of
rupees five hundred payable to the
Appropriate Authority by means of a
bank draft or postal order.
2
A renewal certificate of
registration shall be as specified
in Form 13 and shall be valid for a
period of five years.
3
If, after an inquiry including
inspection of the hospital and
scrutiny of its past performance and
after giving an opportunity to the
applicant, the Appropriate Authority
is satisfied that the application,
since grant of certificate of
registration under sub-rule (2) of
rule 7 has not complied with the
requirements of this Act and the
Rules made there under and
conditions subject to which the
certificate of registration has been
granted, shall, for reasons to be
recorded in writing, refuse to grant
renewal of the certificate of
registration.
Conditions for grant of certificate of
registration
No
hospital shall be granted a certificate of
registration under this Act unless it
fulfills the following requirement of
manpower, equipment, specialized services
and facilities as laid down below:-
A.
General Manpower
Requirement Specialised Services and
Facilities:
1
24 hours availability of medical and
surgical, (senior and junior) staff.
2
24 hours availability of nursing
staff, (general and specialty
trained).
3
24 hours availability of Intensive
Care Units with adequate equipments,
staff and support system, including
specialists in anesthesiology,
intensive care.
4
24 hours availability of laboratory
with multiple discipline testing
facilities including but not limited
to Microbiology, Bio-Chemistry,
pathology and Hematology and
Radiology departments with trained
staff.
5
24 hours availability of Operation
Theatre facilities (OT facilities)
for planned and emergency procedures
with adequate staff, support system
and equipments.
6
24 hours availability of
communication system, with power
backup, including but not limited to
multiple line telephones, public
telephone system, fax, computers and
paper photo-imaging machine.
7
Experts, (other than the experts
required for the relevant
transplantation) of relevant and
associated specialties including but
not limited to and depending upon
the requirements, the experts in
internal medicine, diabetology,
gastroenterology, nephrology,
neurology, paediatrics, gynaecology,
immunology and cardiology etc.
should be available to the
transplantation center.
B.
Equipments:
Equipments as per current and expected
scientific requirements specific to organ or
organs being transplanted. The transplant
center should ensure the availability of the
accessories, spare-parts and
back-up/maintenance/service support system
in relation to all relevant equipments.
C. Experts and their qualifications:
1
Kidney Transplantation M.S. (Gen.)
Surgery or equivalent qualification
with three years post M.S. training
in a recognized center in India or
abroad and having attended to
adequate number of renal
transplantation as an active member
of team.
2
Transplantation of liver and other
abdominal organs M.S. (Gen.) Surgery
or equivalent qualification with
adequate post M.S. training in an
established center with a reasonable
experience of performing liver
transplantation as an active member
of team.
3
Cardiac, Pulmonary, Cardio-Pulmonary
Transplantation M.Ch.
Cardio-thoracic and vascular surgery
or equivalent qualification in India
or abroad with at least 3 years
experience as an active member of
the team performing an adequate
number of open heart operations per
year and well-versed with Coronary
by-pass surgery and Heart-Valve
surgery.
4
Cornea Transplantation M.D./M.S.
ophthalmology or equivalent
qualification with one year post
M.D./M.S. training in a recoginsed
hospital carrying out Corneal
transplant operations.
Appeal
1
Any person aggrieved by an order of
the Authorisation Committee under
sub-section (6) of section9, or by
an order of the Appropriate
Authority under sub-section (2) of
section 15 and section 16 of the
Act, may, within thirty days from
the date of receipt of the order,
prefer an appeal to the Central
Government.
2
Every appeal shall be in writing and
shall be accompanied by a copy of
the order appealed against.
