Legal and Ethical Aspects of Organ Donation in India

According to a study by an NGO, around 2 lakh people need a kidney transplant, out of which only 7,000 of them get a match and can afford a transplant surgery. Only 3% of the demands are met. Hence, many people seek illegal routes to get organs. 

This brings us to an important point on World Organ Donation Day – what are the legal repercussions of illegal acts of organ trafficking?  

In this article, we will learn about the THOA Act, different types of donations, ethical gaps for organ donation in India, and the recent developments in this space. 

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. 

What are the Types of Organ Donation? 

There are mainly 3 types of organ donation processes that are followed in India:  

Living Donors 

Living donation is generally restricted to near relatives. When the donor is unrelated, the case is examined by an Authorization Committee, with video-recorded interviews to verify the absence of coercion. 

Deceased (Cadaveric) Donors 

A deceased donation requires brain-stem death certification by a panel: 

• Two doctors from the hospital were not involved in the transplant surgery. 
• One neurologist or neurosurgeon. 
• Certification is repeated after an interval, usually six hours, to confirm death. 

Even if an individual pledged their organs during life, family approval remains essential because there is no presumed consent model in India. 

Living Wills 

A Living Will documents a donor’s wish formally. It was recognized by the Supreme Court in the Common Cause judgment of 2018, affirming the right to die with dignity under Article 21 of the Constitution. It can include refusal of treatment or organ donation preferences. 

The document is written, signed before two independent witnesses, and can be registered or kept with a custodian. Yet public awareness about living wills is low due to administrative delays and procedural complexity.  

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. 

These provisions have been enforced in multiple high-profile cases involving middlemen and medical professionals. 

Liability for Practitioners 

Doctors face: 

• Civil liability for negligence in donor screening or post-transplant care. 
• Criminal liability for breaches of procedure or involvement in commercial transactions. 
• Professional sanctions, including suspension by the Medical Council. 

The high compliance culture sometimes leads to defensive practices where hospitals hesitate to take marginal cases, as they are afraid of legal repercussions. 

Ethical Challenges and Gaps 

India faces several ethical challenges as it is a diverse and densely populated developing country. Let’s understand it in detail: 

• Many families sign the consent under emotional pressure or without a complete understanding of brain death. The absence of trained counsellors in smaller hospitals worsens the gap. 
• Allocation is meant to be based on medical urgency and compatibility, but there are several disparities in between. 
• Economic hardship increases vulnerability to trafficking networks. 
• Delays, vague allocation of organs, and scandals create scepticism. In some cases, families withdraw consent mid-process due to trust issues. 
• Under-reporting of brain-stem deaths is common, as a lot of people are not aware of it or reluctant to engage in the legal process. 

Recent Developments 

Several developments have happened across the country for organ donation. Here’s a detailed overview: 

Development 

Details 

Karnataka: The state plans to set up organ transplant and retrieval centres in all 22 government medical colleges, with funding for a model centre. 

Telangana: Jeevandan programme reached 4.88 deceased donors per million population, far above the national average. 

SMS Hospital, Jaipur: The hospital performed 80 kidney transplants in one year, including 19 cadaveric transplants in six months. 

National Data: There were around 18,900 transplants in 2024, ranking third globally, but it is still under 1% population participation.

Conclusion  

India’s organ donation laws have matured into a strong legal framework through THOA and its evolution into the THOT Act, yet the implementation lacks enforcement, infrastructure, and has several ethical gaps. The shortage of donors is a medical challenge, and no one is paying attention to it.  

Hence, on World Organ Donation Day, it is important to talk about it so that we all can act on it and not just think about it. 

Hinduja Hospital, Mahim, follows legally compliant protocols and ethical standards in transplantation, supported by skilled teams and modern facilities. Whether you wish to pledge organs or seek a transplant, they can guide you through every step.