“Organ Donation Laws In India Explained”

Abstract

The legislation called the Transplantation of Human Organ Act (THO) was passed in India in 1994 to streamline organ donation and transplantation activities. Broadly, the act accepted brain death as a form of death and made the sale of organs a punishable offence. With the acceptance of brain death, it became possible to not only undertake kidney transplantations but also start other solid organ transplants like liver, heart, lungs, and pancreas. Despite the THO legislation, organ commerce and kidney scandals are regularly reported in the Indian media. In most instances, the implementation of the law has been flawed and more often than once its provisions have been abused. Parallel to the living related and unrelated donation program, the deceased donation program has slowly evolved in a few states. In approximately one-third of all liver transplants, the organs have come from the deceased donor program as have all the hearts and pancreas transplants. In these states, a few hospitals along with committed NGOs have kept the momentum of the deceased donor program. The MOHAN Foundation (NGO based in Tamil Nadu and Andhra Pradesh) has facilitated 400 of the 1,300 deceased organ transplants performed in the country over the last 14 years. To overcome organ shortage, developed countries are re-looking at the ethics of unrelated programs and there seems to be a move towards making this an acceptable legal alternative. The supply of deceased donors in these countries has peaked and there has been no further increase over the last few years. India is currently having a deceased donation rate of 0.05 to 0.08 per million population. We need to find a solution on how we can utilize the potentially large pool of trauma-related brain deaths for organ donation. This year in the state of Tamil Nadu, the Government has passed seven special orders. These orders are expected to streamline the activity of deceased donors and help increase their numbers. Recently, on July 30, 2008, the Government brought in a few new amendments as a Gazette with the purpose of putting a stop to organ commerce. The ethics of commerce in organ donation and transplant tourism has been widely criticized by international bodies. The legal and ethical principles that we follow universally with organ donation and transplantation are also important for the future as these may be used to resolve our conflicts related to emerging sciences such as cloning, tissue engineering, and stem cells.

Introduction

Kidney transplants in India first started in the 1970s and since that time, India has been a leading country in this field on the Asian sub-continent. The evolutionary history of transplants in the last four decades has witnessed a different facet of transplant emerging in each decade. The first 10 years were spent mastering the surgical techniques and immune-suppression. Its success resulted in a phenomenal rise in the numbers of transplants in the next 10 years and unrelated kidney donation from economically weaker sections started taking place with commerce in organ donation becoming an acceptable integral part of the program. After this was accepted, the ethics of transplants in India has always been on a slippery slope and all kinds of nefarious activities were accepted as normal practice. The general dictum was “when you can buy one why donate?” The next 10 years saw an outcry from the physicians of the western world at the growing numbers of these exploitative transplants being done in India. There were also protests from many sections in India. The pressure on the Government saw the passing of the Transplantation of Human Organ Act (THO) legislation that made unrelated transplants illegal and deceased donation a legal option with the acceptance of brain death.

The Law And Rules Governing Organ Donation And Transplantation In India

The main provisions of the THO act and the newly passed Gazette by the Government of India include the following:

1. For living donation - it defines who can donate without any legal formalities. The relatives who are allowed to donate include mother, father, brothers, sisters, son, daughter, and spouse. Recently, in the new Gazette grandparents have been included in the list of first relatives. The first relatives are required to provide proof of their relationship by genetic testing and/or by legal documents. In the event of there being no first relatives, the recipient and donor are required to seek special permission from the government appointed authorization committee and appear for an interview in front of the committee to prove that the motive of donation is purely out of altruism or affection for the recipient.

2. Brain-death and its declaration - brain death is defined by the following criteria: two certifications are required 6 hours apart from doctors and two of these have to be doctors nominated by the appropriate authority of the government with one of the two being an expert in the field of neurology.

Regulation of transplant activities by forming an Authorization Committee (AC) and Appropriate Authority (AA.) in each State or Union Territory. Each has a defined role as follows:

A. Role of Authorization Committee (AC) - The purpose of this body is to regulate the process of authorization to approve or reject transplants between the recipient and donors other than a first relative. The primary duty of the committee is to ensure that the donor is not being exploited for monetary consideration to donate their organ. The joint application made by the recipient and donor is scrutinized and a personal interview is essential to satisfy to the AC the genuine motive of donation and to ensure that the donor understands the potential risks of the surgery. Information about approval or rejection is sent by mail to the concerned hospitals. The decision to accept or reject a donor is governed by Sub Clause (3), Clause 9 of Chapter II of the THO act.

B. Role of Appropriate Authority (AA): The purpose of this body is to regulate the removal, storage, and transplantation of human organs. A hospital is permitted to perform such activities only after being licensed by the authority. The removal of eyes from a dead body of a donor is not governed by such an authority and can be done at other premises and does not require any licensing procedure. The powers of the AA include inspecting and granting registration to the hospitals for transplant surgery, enforcing the required standards for hospitals, conducting regular inspections of the hospitals to examine the quality of transplantation and follow-up medical care of donors and recipients, suspending or canceling the registrations or erring hospitals, and conducting investigations into complaints for breach of any provisions of the Act. The AA issues a license to a hospital for a period of 5 years at a time and can renew the license after that period. Each organ requires a separate license.

Key Provisions and Regulations For Organ Donation 

Here are a few key authorities and regulations to keep in mind related to organ donation: 

• Appropriate Authority (AA): Grants and renews hospital licences, inspects facilities, and ensures statutory compliance. 

• Authorization Committee (AC): Scrutinises unrelated donor cases, verifies consent authenticity, and rules out commercial intent. 

• Advisory Committee: Advises both state and central governments on policy improvement. 

• NOTTO, ROTTO, SOTTO: Multi-tier national, regional, and state coordination systems that maintain registries, allocate organs, and monitor hospital performance. 

Punishments, Liability, and Medical Ethics 

Penalties 

THOA (now THOT) prescribes stringent punishments for illegal organ donation: 

• Commercial Dealings: Imprisonment up to 10 years and a fine up to ₹20 lakh. 

• Unauthorised Removal or Transplantation: Criminal prosecution, loss of medical licence, and blacklisting of hospitals. 

• Hospitals: Permanent cancellation of licence for repeated offences.

Legal Framework: THOA 1994 & Amendments 

The Transplantation of Human Organs Act (THOA) was established in 1994. It was India's first comprehensive law on organ transplantation. It was designed to regulate human organ removal, storage, and transplantation and prohibit commercial dealings. It also legally recognized brain-stem death for facilitating cadaveric donation.  

This law was initially adopted in a few states, such as Goa, Maharashtra, and Himachal Pradesh, and later extended to most of the country. 

Core Provisions under THOA 1994 

1. Definition of Death: Introduced brain-stem death as legal death. 

2. Regulation of Organ Removal and Transplantation: Procedures for living and deceased donations. 

3. Hospital Authorisation: Only licensed hospitals with appropriate facilities can conduct transplants. 

4. Ban on Organ Trade: Criminalised buying and selling of human organs. 

Transition to the THOT Act, 2011 

In 2011, the Act was amended and renamed as the Transplantation of Human Organs and Tissues Act (THOT). This expansion brought human tissues under the legal framework, strengthened penalties, and introduced new institutional requirements. 

Key additions under THOT 2011: 

• Inclusion of human tissues such as skin, cornea, heart valves, tendons, and bone marrow. 

• Mandatory transplant coordinators in all registered hospitals. 

• Retrieval centres allowed for organ harvesting even if not performing transplants. 

• Stricter penalties for commercial dealings or violations. 

• Recognition of NGOs to promote donation and assist retrieval. 

• Standardised Brain Death Certification formats across states. 

Guidelines for composition of the AC

There shall be one State Level AC. It will provide approval or a no objection certificate to the donor and recipient to establish legal and residential status in a particular state. Additional ACs may be set up at various levels as per the requirements as follows:

• No member from the transplant team of the institution should be a member of the respective AC.

• The AC should be hospital-based in metros and big cities if the number of transplants exceeds 25 in a year at the respective transplantation centers. In small towns, there shall be state or district level committees if transplants are less than 25 in a year in the respective districts.

Composition of a hospital-based AC

• Medical Director or Medical Superintendent of the Hospital

• Two senior medical practitioners from the same hospital who are not part of the transplant team

• Two members of high integrity, social standing, and credibility

• Secretary (Health) or nominee and Director Health Services or nominee

Interpretation Of Law

To a large extent, the interpretation of the THO act by the AC and the registered medical practitioners has been flawed. To a large extent this has been addressed in the current Gazette. However, this Gazette has to be passed by the state governments before it becomes compulsory for the hospitals to follow the ruling.

The provisions available in Sub Clause (3), Clause 9 of Chapter II of the THO act states “If any donor authorizes the removal of any of his human organs before his death under sub-section (1) of Section 3 for transplantation into the body of such recipient, not being a near relative as is specified by the donor, by reason of affection or attachment towards the recipient or for any other special reasons, such human organ shall not be removed and transplanted without the prior approval of the Authorization Committee” has been misused or misinterpreted by one and all over the years, since the act was passed.

Conclusion

The THO act despite having been passed 15 years ago has neither curbed commerce in organs nor helped promotion of the deceased donation program to take care of the organ shortage. The gap between the numbers of organs available and the number of patients joining the waiting list for a kidney transplant is widening globally. The high demand of organs has led to its commodification, more so in countries where there is a large proportion of the population below the poverty line with weak regulatory authorities. The resulting transplant tourism has caused an outcry from many international bodies. In India, the potential for deceased donation is huge due to the high number of fatal road traffic accidents and this pool is yet to be tapped. Few hospitals and committed NGOs in the country have shown that deceased donation as a feasible option. The ethics of kidney donation has important bearings on the society as this would form the basis to resolve many conflicts in emerging regenerative sciences.

Understanding the ethics of organ donation is important if we are to tackle the moral and ethical challenges that are emerging with cutting edge regenerative medicine such as stem cells transplants, cloning, and tissue re-engineering. The ethical principles of organ donation is an acid test that will help us in evolving and resolving many of the future moral issues that we are likely to encounter.

Here are some questions and answers on the topic:

Q1. What is the primary legislation governing organ donation in India?

A1. The main law is the Transplantation of Human Organs and Tissues Act (THOTA), 1994, later amended in 2011. It regulates the removal, storage, and transplantation of human organs and tissues for therapeutic purposes, while preventing commercial dealings in organs.

Q2. Who is legally allowed to donate organs in India?

A2. According to THOTA:

Living Donors: Can donate organs like kidney, part of liver, etc., but only to near relatives (parents, siblings, spouse, children, grandparents, grandchildren). For non-relatives, approval from an Authorization Committee is required.

Deceased Donors: Organs can be donated after brain death, with consent from the family or prior registration by the donor.

Q3. What is the legal status of brain death in Indian organ donation laws?

A3. Brain death is legally recognized under THOTA, 1994.

It is considered equivalent to death for the purpose of organ donation. Certification of brain death must be done by a panel of doctors, including a neurologist/neurosurgeon, in a government-authorized hospital.

Q4. What are the penalties for illegal organ trade under Indian law?

A4. Engaging in commercial trading of organs is a criminal offense under THOTA. The penalties include imprisonment of 5–10 years and a fine ranging from ₹20 lakh to ₹1 crore, depending on the severity of the offense.