Acts related to human organ donation

Background

Efficient Organ Transplantation Ecosystem, involves

• Reducing the demand for Organ Transplantation: which means prevention and control of the diseases which cause organ failure e.g. Diabetes,  Hypertension, Alcoholic and non-Alcoholic Chronic liver diseases etc.
  • The main program to reduce the demand is NCD program /National Program for prevention and Control of Cancer, Diabetes, Cardiovascular diseases and stroke
  • Dialysis is an acceptable alternative for management of kidney failure cases and also till the transplantation takes place. Pradhan Mantri National
    Dialysis Program is being implemented to make the hemodialysis facilities available at District Hospital level
• To address the supply side of organ transplantation we need to improve the organ donation and transplantation activities in the country.
• 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 only on living donors, because of risk of commercial trading and inherent risk to the health of living donor.
• Deceased Donor organ transplant can be done from “brain stem dead” persons as well as donation after “cardiac death”.
• 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.
• Organ donation rate (Number of persons who donate organs after death in one million population) in India is less than one (0.52 in 2019) as compared to maximum of around 48 in the Spain. 

Organ donation and transplantation is a Government regulated activity in India as per the provisions of the Transplantation of Human Organs and Tissues Act 1994 (as amended in 2011).

The Transplantation of Human Organs Act, 1994

The Transplantation of Human Organs Act, 1994 was enacted by the Parliament during 1994 and came into force on February 4, 1995 in the States of Goa, Himachal Pradesh and Maharashtra and all the Union Territories. Thereafter it was adopted by all States except the States of Jammu & Kashmir and Andhra Pradesh, which have their own legislations to regulate transplantation of Human Organs.

Purpose of the Act

The main purpose of the Act is to regulate the removal, storage and transplantation of human organs for therapeutic purposes and to prevent commercial dealings in human organs.

The Act contains detailed provisions relating to the authority for removal of human organs, preservation of human organs, regulation of hospitals conducting the removal, storage or transplantation of human organs, functions of appropriate authority, registration of hospitals and punishment/penalties for offences relating to aforesaid matters.

Brain Stem death is recognized as a legal death in India under the Transplantation of Human Organs and Tissues Act, since 1994 like many other countries, which has revolutionized the concept of organ donation after death. After natural cardiac death only a few organs/tissues can be donated (like cornea, bone, skin and blood vessels) whereas after brain stem death almost 8-9 organs including vital organs such as kidneys, heart, liver, pancreas, lungs, small intestine and many types of tissues like cornea, skin, heart valves, bones etc can be donated. 

For more information, visit THOA Act - 1994

Transplantation of Human Organs (Amendment) Act, 2011

The Transplantation of Human Organs Act, 1994 was amended in 2011 and the Transplantation of Human Organs (Amendment) Act 2011, has come into force on 10.1.2014 in the States of Goa, Himachal Pradesh, West Bengal, and Union Territories. Other States who have adopted the amendment Act till date are Rajasthan, Sikkim, Jharkhand, Kerala, Odisha, Punjab, Maharashtra, Assam, Chhattisgarh, Haryana, Manipur, Gujarat, Bihar, Uttar Pradesh, Tamil Nadu and Madhya Pradesh. The amended Act is now named Transplantation of Human Organs and Tissues Act (THOTA), 1994. After reorganization of erstwhile State of Jammu and Kashmir, the THOTA 1994 is now also applicable in the Union Territories of Jammu and Kashmir and Ladakh.

Other States namely Andhra Pradesh, Telangana, Karnataka, Uttarakhand, Arunachal Pradesh, Mizoram, Meghalaya, Nagaland and Tripura have not yet adopted the Transplantation of Human Organs (Amendment) Act 2011.

The Government of India enacted the Transplantation of Human Organs (Amendment) Act, 2011 that allows swapping of organs and widens the donor pool by including grandparents and grandchildren in the list. 

Some of the important amendments under this Act to promote organ donation are as follows.

1. Provision of ‘Retrieval Centres’ for retrieval of organs from deceased donors and their registration under the amended Act.
2. Definition of near relative expanded to include grandparents and grandchildren.
3. Swap Donation (Donor Exchange) included. 
4. Brain death certification Board has been simplified and more experts have been permitted for this certification.
5. ‘Mandatory’ inquiry and informing option to donate in case of unfortunate event of brain stem death of ICU patient for the purpose of organ donation.
6. Mandatory ‘Transplant Coordinator’ for coordinating all matters relating to removal or transplantation of human organs.
7. National Human Organs and Tissues Removal and Storage Network at one or more places and regional network.
8. National Registry of Donors and Recipients.
9. Removal of eye has been permitted by a trained technician to facilitate eye donation.
10. To protect vulnerable and poor there is provision of higher penalties has been made for trading in organs (imprisonment upto 10 years and fine upto Rs One crore).
11. Act has made provision of greater caution in case of minors and foreign nationals and prohibition of organ donation from mentally challenged persons

For more information, visit THOA amendment 2011

Transplantation of Human Organs and Tissues Rules (THOT), 2014

In pursuance to the Transplantation of Human Organs (Amendment) Act, 2011, the Transplantation of Human Organs and Tissues Rules have been notified on 27th March, 2014.

The Transplantation of Human Organs and Tissues Rules (THOT), 2014 has many provisions to remove the impediments to organ donation while curbing misuse/misinterpretation of the rules. The following are a few

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 Act.
2. When the proposed donor or recipient or both are not Indian nationals or citizens whether near relatives or otherwise, the Authorisation Committee shall consider all such requests and the transplantation shall not be permitted if the recipient is a foreign national and donor is an Indian national unless they are near relatives.
3. When the proposed donor and the recipient are not near relatives, the Authorisation Committee shall evaluate that there is no commercial transaction between the recipient and the donor and that no payment has been made to the donor or promised to be made to the donor or any other person
4. Cases of swap donation referred to under subsection shall be approved by Authorisation Committee of hospital or district or State in which transplantation is proposed to be done and the donation of organs shall be permissible only from near relatives of the swap recipients.
5. When the recipient is in a critical condition in need of life saving organ transplantation within a week, the donor or recipient may approach hospital in-charge to expedite evaluation by the Authorisation Committee.
6. The quorum of the Authorisation Committee should be minimum four and is not complete without the participation of the Chairman, Secretary (Health) or nominee and Director of Health Services or nominee.
7. Every authorised transplantation centre must have its own website. The Authorisation Committee is required to take final decision within twenty four hours of holding the meeting for grant of permission or rejection for transplant and the decision of the Authorisation Committee should be displayed on the notice board of the hospital and the website within twenty four hours of taking the decision. The website of transplantation centre shall be linked to State/Regional/National Networks through online system for organ procurement, sharing and transplantation.
8. There would be an apex national networking organization at the centre. There would also be regional and State level networking organizations where large of number of transplantation of organ(s) or tissue (s) are performed. The State units would be linked to hospitals, Organ/Tissue matching Labs and Tissue Banks within their area and also to regional and national networking organisations. Such networks shall coordinate procurement, storage, transportation, matching, allocation and transplantation of organs/tissues and shall develop norms and standard operating procedures.
9. A National Registry on Donors and recipients of Human Organ and Tissue accessible on-line through dedicated website having National, Regional and State level specificities will come into force. National/Regional registry shall be compiled based on similar registries at State level. The identity of the people in the database shall not be in public domain.

For more information, visit Transplantation of Human Organs and Tissues Rules, 2014

Related Resources

• NOTTO
• Ministry of Health and Family Welfare