THE TRANSPLANTATION OF HUMAN

ORGANS (AMENDMENT) ACT, 2011

AMENDMENTS

LIFE Pass it on

 September, 2004 - Review Committee set

up to examine provisions of THO Act and
the Rules.
The Transplantation of Human Organs
(Amendment) Bill, 2011 Drafted by
Ministry of Health.
LIFE Pass it on

THO Act to cover both organs

& tissues
Regulation

of

removal,

storage

and

transplantation of human organs and

tissues for therapeutic purposes
Prevention of commercial dealings of
human organs and tissues
LIFE Pass it on

Definitions
Expansion of the term Near Relative
Near Relative - To include grandparents
and grandchildren, in addition to spouse,
son, daughter, father, mother, brother or
sister (Section 2)

LIFE Pass it on

Definitions
Human Organ Retrieval Centre
- Hospital with adequate ICU facilities, but
not registered under the THO Act
- Hospital registered under the THO Act

LIFE Pass it on

Definitions
Tissue
A group of cells, except blood, performing
a particular function in the human body

LIFE Pass it on

Definitions
Transplant Coordinator
A person appointed by a hospital to
coordinate all matters relating to removal
or

transplantation

of

human

organs/tissues

LIFE Pass it on

Required Request
Mandatory for ICU doctor, in consultation with
transplant coordinator to request relatives of
brain dead patients for organ donation.
Record of all brain dead patients and that of the
next of kin who are approached to be kept.

LIFE Pass it on

Special Provision for Removal of

Corneas
Technician possessing such qualifications and
experience,

as

may

be

prescribed,

may

enucleate an eye.

LIFE Pass it on

Certification of Brain Death

Expansion of certifying panel of experts.
In addition to neurosurgeon / neurologist,
surgeon / physician and an anesthetist/
intensivist nominated from a panel already
approved by the Appropriate Authority.

LIFE Pass it on

Foreign Nationals
Authorisation Committee to prohibit organ
transplantation where recipient is a foreign
national and donor is an Indian national.
Approval of Authorisation Committee required Donor and / or recipient being near relatives are
foreign nationals.

LIFE Pass it on

Minors
No human organs or tissues to be removed from living
minor for transplantation.
Exceptions
Familial donation of regenerative cells (when a
therapeutically comparable adult donor is not available)
Kidney transplants between identical twins (Ensure no
genetic disorder present. No immunosuppression
required for recipient twin).

LIFE Pass it on

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.
Mental illness like dementia, schizophrenia
Mental retardation

LIFE Pass it on

Swap Donations
Two different willing but incompatible near
relative donors (vis--vis their intended related
recipient) permitted to donate their organs.
Authorisation committee will evaluate on a caseto-case basis.

LIFE Pass it on

Transplant Coordinators
Mandatory for hospitals, prior to registration as a
transplant centre, to appoint a Transplant
Coordinator.

LIFE Pass it on

Appropriate Authority
Single member body
Central Government for Union Territories
Director General of Health Services, Government
of India
State Government for States - Secretary (Health)
or the Director of Health Services of the State
Government concerned.

LIFE Pass it on

Powers of the Appropriate Authority

To grant registration to a hospital for the
removal, storage and transplantation of any
human organ.
To suspend or cancel such registration.
To enforce standards for hospitals engaged in
the removal/ storage or transplantation of human
organs.

LIFE Pass it on

Powers of the Appropriate Authority

To investigate any complaint or breach of any
provision of the Act or the Rules.
To inspect hospitals periodically for examination
of the quality of transplantation and follow-up
medical care to the recipients as well as donors.
Power to summon persons, seek production of
documents, issue search warrants.
LIFE Pass it on

Advisory Committee
To assist Appropriate Authority in the discharge
of its functions
Constituted for a period of two years
Representation from an NGO working in the field
of organ or tissue donation
LIFE Pass it on

Authorisation Committees
Hospital level Authorisation Committees
State or District level Authorisation Committees
Central Government to prescribe composition of
Authorisation Committees to ensure uniformity
Actual appointments made by respective State
Governments / Union Territories.

LIFE Pass it on

Hospital Authorisation Committee

Hospital does more than 25 transplants
annually
Medical director/superintendent
Two doctors not part of transplant team
Two members from society
Director/secretary of health services
LIFE Pass it on

National Registry
Central Govt. to development and maintain
national registry of recipients.
Evaluation of scientific and clinical status of
organ transplantation.

LIFE Pass it on

National Organ Retrieval, Banking and

Transplantation Network
Organ Retrieval & Banking Organisation
(ORBO) set up at AIIMS in New Delhi.
Establishment of a nation-wide network, to
include:
All transplant centres
All retrieval organisations
All certified HLA testing labs
In future all trauma centres, all dialysis centres, all
hospitals with ICUs
LIFE Pass it on

National Organ Retrieval, Banking and

Transplantation Network
Maintain

waiting

list

of

patients

awaiting

transplantation.
Different lists for different organs.
Facilitate

matching

of

organs

through

computerized database.

LIFE Pass it on

Review of Penal Provisions

Difficulty in proving that payments have been made
for procuring organs
Whoever prepares or abets in the preparation and or
submission or whoever, submits false documents
including wrong affidavits to establish that the donor is
making the donation of an organ as a near relative or out
of love and affection for the recipient would also be
punishable as a person who has offered or received
payment for the organs.

LIFE Pass it on

Offences & Penalties

Enhancement of Penalties
Removal of human organ without authority
Imprisonment - Up to 10 years
Fine - Up to Rs.20 lakh

Removal of human tissue without authority

Imprisonment - Up to 3 years
Fine - Up to Rs.5 lakh

LIFE Pass it on

Offences & Penalties

Live unrelated organ donation false
documents
Imprisonment 5 to 10 years
Fine Rs.20 lakh to Rs.1 crore

LIFE Pass it on

Offences & Penalties

Supplying tissues for payment
Imprisonment 1-2 years
Fine: Rs. 5-20 lakh

LIFE Pass it on

Offences & Penalties

Penalties for doctors
First offence name struck off from State
Medical Council for three years
Second offence name struck off
permanently

LIFE Pass it on

Registration of NGOs
Registration of Non-Government Organisations
with Appropriate Authority
New section 17-D to be introduced.

LIFE Pass it on

Power to Make Rules

Expand rule-making powers of Central Government
to provide for:
Qualification and experience to be possessed by a
technician to be eligible for enucleating a cornea.
Conditions for an anesthetist/ intensivist and surgeon/
physician for being included on the medical board for
certification of brain death.

LIFE Pass it on

Power to Make Rules

Expand rule-making powers of Central Government
to provide for:
Qualifications and experience required for the position of
transplant coordinator.
The composition of Authorisation Committees.

LIFE Pass it on

Power to Make Rules

Expand rule-making powers of Central Government
to provide for:
Conduct of business by Authorisation Committees.
Narrow exceptions in which transplants from a living
minor are to be allowed.

LIFE Pass it on

Power to Make Rules

Expand rule-making powers of Central Government
to provide for:
Form and manner for maintaining National Registry
Functions to be performed by the National Organs
Retrieval Banking and Transplantation Network.
Registration of NGOs.

LIFE Pass it on