The document summarizes key proposed amendments to the Transplantation of Human Organs Act in India. The amendments aim to expand the scope of the act to cover both organs and tissues, define more terms, strengthen regulations around organ donation and transplantation, enhance penalties for violations, and establish a national registry and network to facilitate organ retrieval and matching.

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THE TRANSPLANTATION OF HUMAN
ORGANS (AMENDMENT) ACT, 2011
AMENDMENTS

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• 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.

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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

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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)

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

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

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Definitions
• Transplant Coordinator
A person appointed by a hospital to
coordinate all matters relating to removal
or transplantation of human organs/tissues

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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.

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Special Provision for Removal of
Corneas
• Technician possessing such qualifications and
experience, as may be prescribed, may
enucleate an eye.

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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.

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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.

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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).

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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

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

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

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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.

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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.

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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.

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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

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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.

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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

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

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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

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National Organ Retrieval, Banking and
Transplantation Network
• Maintain waiting list of patients awaiting
transplantation.
• Different lists for different organs.
• Facilitate matching of organs through a
computerized database.

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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.

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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

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Offences & Penalties
• Live unrelated organ donation – false
documents
– Imprisonment – 5 to 10 years
– Fine – Rs.20 lakh to Rs.1 crore

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Offences & Penalties
• Supplying tissues for payment
– Imprisonment 1-2 years
– Fine: Rs. 5-20 lakh

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

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

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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.

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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.

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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.

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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.