Organ Transplantation in India | Organ Transplant Governing Laws

Laws and Rules Governing Organ Transplantation in India

The primary legislation related to organ donation and transplantation in India, Transplantation of Human Organs Act, was passed in 1994 and is aimed at regulation of removal, storage and transplantation of human organs for therapeutic purposes and for prevention of commercial dealings in human organs.

In India, matters related to health are governed by each state. The Act was initiated at the request of Maharashtra, Himachal Pradesh and Goa (who therefore adopted it by default) and was subsequently adopted by all states except Andhra Pradesh and Jammu & Kashmir. Despite a regulatory framework, cases of commercial dealings in human organs were reported in the media. An amendment to the act was proposed by the states of Goa, Himachal Pradesh and West Bengal in 2009 to address inadequacies in the efficacy, relevance and impact of the Act. The amendment to the Act was passed by the parliament in 2011, and the rules were notified in 2014. The same is adopted by the proposing states and union territories by default and may be adopted by other states by passing a resolution.

The various forms outlined in the rules are as follows:

Form 1: Near-relative consent

Form 2: Spouse consent

Form 3: Other than near-relative donor consent

Form 4: Psychiatrist evaluation of the donor

Form 5: HLA DNA profiling report

Form 7: Self consent for deceased donation

Form 8: Consent for organ donation from family (also applicable for minors)

Form 9: Consent for organ donation from unclaimed bodies

Form 10: Brain death declaration form

Form 11: Joint transplant application by donor/recipient

Form 12: Registration of hospital for organ transplantation

Form 13: Registration of hospital for organ retrieval

Form 16: Grant of registration

Form 17: Renewal of registration

Form 18: Decision by hospital authorization committee

Form 19: Decision by district authorization committee

Form 20: Verification of Domicile for non near-relative

Form 21: Letter from the Embassy

The main provisions of the Act are as follows:

(including the amendments and rules of 2014)

It identifies brain death as a form of death. It outlines the process and criteria for brain death certification (Form 10).
It allows transplantation of human organs and tissues from living donors and cadavers (after cardiac or brain death).
Living donors are classified as either a near relative or a non-related donor.
- A near-relative (spouse, children, grandchildren, siblings, parents and grandparents) needs the permission of the doctor in-charge of the transplant centre to donate his organ.
- A non-related donor needs the permission of an Authorization Committee established by the state to donate his organs.
Swap Transplantation: When a near relative living donor is medically incompatible with the recipient, the pair is permitted to do a swap transplant with another related unmatched donor/recipient pair.

It outlines the regulatory and advisory bodies for monitoring transplantation activity and defines their constitution.
- Appropriate Authority (AA): inspects and grants registration to hospitals for transplantation, enforces required standards for hospitals, conducts regular inspections to examine the quality of transplantations. It may conduct investigations into complaints regarding breach of provisions of the Act, and has the powers of a civil court to summon any person, request documents and issue search warrants.
- Advisory Committee: consisting of experts in the domain who shall advise the appropriate authority.
- Authorization Committee (AC): regulates living donor transplantation by reviewing each case to ensure that the living donor is not exploited for monetary considerations and to prevent commercial dealings in transplantation. Proceedings to be video recorded and decisions notified within 24 hours. Appeals against their decision may be made to the state or central government.

- Medical board (Brain Death Committee): Panel of doctors responsible for brain death certification. In case of non-availability of neurologist or neurosurgeon, any surgeon, physician, anaesthetist or intensivist, nominated by medical administrator in-charge of the hospital may certify brain death.
Authorization for organ donation after brain death
- May be given before death by the person himself/herself
- By the person in legal possession of the body. A doctor shall ask the patient or relative of every person admitted to the ICU whether any prior authorization had been made. If not, the patient or his near relative should be made aware of the option to authorise such a donation.
- Authorization process for organ or tissue donation from unclaimed bodies outlined.

Organ retrieval is permitted from any hospital with an ICU facility once registered with the appropriate authority. Any hospital that has Intensive Care Unit (ICU) facilities along with the manpower, infrastructure and equipment required to diagnose and maintain the brain-stem dead person and to retrieve and transport organs and tissues, including the facility for their temporary storage, can register as a retrieval centre.
Cost of donor management, retrieval, transportation and preservation to be borne by the recipient, institution, government, NGO or society, and not by the donor family.
Procedure for organ donation in medico-legal cases is defined to avoid jeopardizing determination of the cause of death and delay in retrieval of organs.
Manpower and facilities required for registration of a hospital as a transplant centre are outlined.

Infrastructure, equipment requirements and guidelines and standard operating procedures for tissue banks are outlined.
Qualifications of transplant surgeons, cornea and tissue retrieval technicians are defined.
Appointment of transplant coordinators (with defined qualifications) is mandatory in all transplant centres.
Non-governmental organisations, registered societies and trusts working in the field of organ or tissue removal, storage or transplantation will require registration.

The central government has established a National Human Organs and Tissues Removal and Storage Network i.e. NOTTO (National Organ & Tissue Transplant Organisation), ROTTO (Regional Organ & Tissue Transplant Organisation) and SOTTO (State Organ & Tissue Transplant Organisation). Website – www.notto.nic.in. The manner of establishing National or Regional or State Human Organs and Tissues Removal and Storage Networks and their functions are clearly stated.
The central government shall maintain a registry of the donors and recipients of human organs and tissues.
The penalties for the removal of organs without authority and making or receiving payment for supplying human organs or contravening any other provisions of the Act have been made very stringent in order to serve as a deterrent for such activities.

THOA ACT 1994

THOA Rules 1995

THOA Amendment-2011

Amendment Comparison - Old vs New

THOA Rules-2014

Other Research Reports

Body Donation - Anatomy Act

Guidelines for Body Donation in Delhi

Deceased Donor Transplant in India | Organ Donation After Death

The report was commissioned in September 2013 by the Parashar Foundation, an NGO based in Delhi in partnership with the MOHAN Foundation, and the survey was carried out by the research agency, Outline India.

The objective of the report was to understand the deceased organ donation and transplant environment in Delhi – facts, trends, processes, opportunities and challenges; conduct extensive research around historical developments; efforts made and lessons learnt; understand global systems and success stories in the field; come up with recommendations for action; plan future strategy for growth and effectiveness in Delhi/NCR and India.

A team of researchers from Outline India contacted Senior Medical Officers, doctors, transplant coordinators at 24 of the top hospitals/research centres in the Delhi/NCR region to gather information about the latest organ transplantation system in India of which 16 responded (In two cases, 2 interviews were conducted at two branches of the same group of hospitals, amounting to a total of 18 interviews overall, across 16 institutions).

Hospitals included in the scope of the research were Fortis (FMRI & Vasant Kunj), Max Patparganj, Max, Medanta, Gangaram, BLK, AIIMS, RML, Indraprastha Apollo, St Stephens, Primus Super-specialty Hospital, Jaipur Golden, Pushpawati Singhnia Research Institute, Safdarjung Hospital and Army Hospital R&R.

Some of the Doctors interviewed amongst others were Dr. Avnish Seth (Director FORT, FMRI), Dr. Ravi Mohanka (Fomerly Transplant Surgeon, Medanta), Dr. Aman Gupta (Fortis Vasant Kunj), Dr. PB Singh (Director, Institute of Urological Science, Max Patparganj), Dr Vijay Kher (Chairman Nephrology, Medanta The Medicity), Dr. Sangay Singh Negi (Director Hepatobilliary Surgery & Liver Transplantation, BLK), Dr. Sunil Prakash (Director Kidney Transplantation BLK) and Dr. Sudeep Naidu.

Recommendations of the Report:

Government Push for Organ Donation Awareness

It is only through awareness programmes that the number of deceased donations can be increased. Large-scale advertising campaigns should aim to educate people about the benefits of organ donation, clearing all prevalent myths and misconceptions about it. The concept of brain death needs to be adequately dealt with so that the organs of the deceased, which can be retrieved and utilised, do not go to waste.
What is needed is a large scale campaign, which only the government can undertake or fund. Clear messaging by the government will also add credibility to the cause. In fact all messaging in public places and hospitals in the form of standees, video spots etc. have to have the government logo along with that of the hospital in order to increase people’s trust.

National Organ Sharing Network for Fairness

A central organ sharing registry or a recipient registry is an absolute must, so that the donated organs can be shared in a fair and transparent manner. Apart from a few states, there are no sharing protocols in place. This leads to unethical and unhealthy practices. Further, it leads to wastage of organs which is a shame when a family has taken the courageous decision to donate. The sharing of cost between hospitals also has to be clearly defined.
This system, however, will not work in the current scenario with seemingly unhealthy and negative attitudes amongst the various stakeholders. There needs to be a spirit of cooperation, sharing and the willingness to adopt from successful practices in other parts of the country.

Mandatory Brain Death Declaration to Boost Donation

There was a near unanimous response from the medical fraternity that making the declaration of brain death mandatory will increase instances of organ donation. Making brain death declaration mandatory will help facilitate a discussion between the doctor/physicians and the relatives about brain death and organ donations. It would help Transplant Coordinators and personnel from other Departments to intervene and convince the relatives about organ donation.

Empowering Transplant Coordinators

It is imperative to understand and acknowledge the pivotal role that the Transplant coordinator plays in the entire process of organ donation and transplantation. It is only when the hospital is able to establish a personal rapport with the patient and the patient’s relatives, can it create a precondition necessary to establish talk regarding organ donation later on. An increased number of Transplant Coordinators would help in creating awareness and would also help in counselling the relatives to manage the system of organ donation. Higher numbers of Transplant Coordinators are required in a public set-up as the number of patients there are significantly higher.

Upgrading Public Hospitals for Transplant Services

Improve Infrastructure within public hospitals for transplantation. Transplantation as a service should be readily available in all Government hospitals as the majority of patients go there for treatment and many cannot afford treatment at private hospitals. The Government also needs to take the necessary steps to improve the infrastructural set-up at all public hospitals to store/transport organs, train the hospital staff/personnel for organ transplantation procedures and on the subject of brain death, and to increase awareness regarding the same.

Engaging Non-Transplant Hospitals in Organ Retrieval

Non-transplant hospitals need to be involved in organ retrieval. These medical centres (which have ICU’s but are not transplant centres) are crucial because a lot of accident victims are brought here for treatment. They should be geared up for brain death declaration. They need to be given an incentive to be participants in organ retrieval, and a system has to be worked out wherein they are compensated adequately for their active involvement in the Organ Donation programme.

Sensitizing Police and Forensic Experts for Donations

Sensitization of police personnel and the forensic experts has to be taken up on a war footing to make all medico-legal cases smooth. Most brain death cases are accident cases and therefore medico legal cases. They usually are difficult to handle as they do not get cooperation from these quarters.

Organ Donor Pledge on IDs and Licenses

Provide the public with organ donor intent forms and brochures while issuing driving licences, Aadhar cards and college ID cards, so they can choose to express their intent on the cards.

Replicating Successful State Donation Models

Emulate successful practices from other states: States such as Tamil Nadu for instance have recorded an 80% conversion rate when it comes to donating the organs of one kin. The state has a record organ donation which is 15 times the national average. An important step in this direction was the creation of a network of hospitals for sharing organs. The same should be replicated in other cities, like Delhi.

The Maharashtra government made it compulsory for all non-transplant hospitals equipped with an ICU and operation theatre to retrieve organs for harvesting and made it mandatory for them to officially identify brain dead patients. This was a crucial point highlighted in the primary research as well and hence, needs to be implemented in the Delhi/NCR region.