Laws for Organ Donations and Body Donations in India

Organ donation is a remarkable act of giving and plays a critical role in advancing medical research and saving lives. Across the world, millions of people are in desperate need of organ transplants, yet the availability of donated organs falls alarmingly short. In India, the gap between organ demand and supply is particularly stark, with over a million people suffering from end-stage organ failure each year. At the same time, only around 3,500 transplants are performed. This shortage makes it more urgent to raise awareness about the laws and procedures governing organ and body donation.

There are two main types of donations: body donation, popularly called in the native language “Deh Dan,” where individuals donate their entire body after death for medical research and education, and organ donation, where specific organs are harvested either from living donors or those who have passed away. Understanding the laws that govern these acts is essential for potential donors and their families. In India, the Transplantation of Human Organs Act (THOA), the principal Act governing organ donation, was amended in 2011 to streamline the organ donation process, improve regulations, and increase transparency in transplantation practices.

While the process of body or organ donation is not complicated, it does require planning. Institutions such as medical colleges, hospitals, and NGOs provide consent forms outlining the procedures and policies involved. Though signing a consent form for body donation in advance is not mandatory, informing family members of your wishes ensures they are prepared to make your decision. This proactive step helps reduce confusion and respects the donor’s intent.

One poignant reminder of the significance of body and organ donations can be found at the Postgraduate Institute of Medical Education and Research (PGIMER) in Chandigarh, where the anatomy department honors those who have donated their bodies to science. The wall is lined with photographs of selfless individuals, including Ajmer Singh, a former Olympian, and Rama Bhanot, the mother of Neerja Bhanot. This brave flight attendant sacrificed her life to save others during a hijacking in 1986.

This article delves into the legal compliances associated with organ and body donations in India, clarifying eligibility, procedural requirements, and the crucial role played by various regulatory bodies in overseeing the donation process. By understanding these laws, we can better support this lifesaving cause and encourage more people to participate in bridging the organ donation gap.

A. Compliances required for Organ Donation

The primary legislation related to organ donation and transplantation in India, the Transplantation of Human Organs Act (THOA), was passed in 1994. It regulates the removal, storage, and transplantation of human organs for therapeutic purposes and prevents commercial dealings in human organs.  The hospital should ensure:

Eligibility for Organ Donation

• Under the Transplantation of Human Organs Act (THOA), the source of an organ can come from several types of donors. These include near-relative donors, such as a mother, father, son, daughter, brother, sister, or spouse—an expanded definition of “near relative” to include grandchildren and grandparents post-2011 amendment.
• In cases where the donor is not a near relative, the donation can still occur with the approval of an authorisation committee, typically based on affection, attachment, or another specific reason.
• Deceased donors, particularly those who experience brain stem death, such as victims of road traffic accidents, are also eligible.
• The Act permits trained technicians to enucleate corneas.

Brain stem death occurs when the brain stem is no longer functioning, meaning the individual cannot breathe independently but can be maintained through life-support measures to keep the heart and other organs viable for donation. Brain stem death is now legally recognised as a death in India, like many different countries, greatly enhancing the possibilities for organ donation after death. Simplified guidelines were established for the Brain Death Certification Board, allowing anaesthetists or intensivists to serve as board members if a Neurophysician or neurosurgeon is unavailable, provided they are not part of the transplant team. Brain death is defined by two certifications from doctors, including one expert in neurology, that are done six hours apart. In contrast to natural cardiac death, which allows for the donation of only a few tissues and organs, such as the cornea, bone, skin, and blood vessels, brain stem death enables the donation of up to 37 different organs and tissues, including critical organs like the kidneys, heart, liver, and lungs.

Authorization Committee (AC)

• This committee regulates approving or rejecting transplants between donors and recipients who are not first relatives.

Compliance for Hospitals to Undertake Organ Donation

• Any hospital undertaking organ donation must be registered under the Act. Every hospital must have a ‘certificate of registration’ from the appropriate state authority. They must also inform the Human Organ Retrieval Centre in writing about organ transplantation.

• The Act lists qualifications for doctors. The qualifications and experience of doctors vary for different organs according to the law.

• Additionally, the Act mandates the presence of a ‘Transplant Coordinator’ in all registered hospitals and introduces stricter penalties to prevent organ trading, protecting vulnerable populations.

Stricter regulations for Organ Donations

The new amendment imposes stricter regulations on organ donations involving minors, foreign nationals, and mentally challenged individuals, intending to enhance caution in such cases.

Appropriate Authority (AA)

• This authority inspects and registers hospitals for transplantation, enforces standards, and investigates complaints. The Secretary

B. Compliance for Tissue Bank, Retrieval Centers, Swap Donations

A tissue bank that stores tissues (including heart valves, bones, etc.) must also be registered under the Act.

The new amendment also established ‘Retrieval Centers’ for retrieving organs from deceased donors, with mandatory registration for such centres and tissue banks.

It introduced provisions for swap donations and required mandatory inquiries from the attendants of potential donors in ICUs, informing them of the option to donate organs and notifying retrieval centres if they consent.

A National Human Organs and Tissues Removal and Storage Network and a National Registry for Transplants will also be created.

C. Registry of Donors and Recipients

The central government maintains a registry of the donors and the recipients.

D. National & State Organ & Tissue Transplant Organisation

The National Organ & Tissue Transplant Organisation (NOTTO), Regional Organ & Tissue Transplant Organisation (ROTTO), and State Organ & Tissue Transplant Organisation (SOTTO) were set up under the Act. Their function is to act as the apex centre for coordination and networking activities for the procurement and distribution of Organs and Tissues and registry, as well as for setting policies and creating awareness. The National Organ Transplant Programme, with a budget of Rs. 149.5 Crore for the 12th Five-Year Plan, aims to improve access to life-transforming transplantation for needy citizens of our country by promoting deceased organ donation.

The Government of India undertook a significant process to amend and reform the Transplantation of Human Organs Act (THOA) of 1994, leading to the enactment of the Transplantation of Human Organs (Amendment) Act in 2011.  The fundamental changes under this amendment include including tissues and organs under the Act. The Act contains 21 forms dealing with consent, death certification, registration, etc.

E. Compliances for Body Donation

Eligibility

Any Indian citizen who is at least 18 years old and can give legally valid consent can register to donate their body. However, the donor’s physical condition is the primary factor in determining eligibility.

Consent

While signing a consent form is not required, it is recommended. You can get a consent form from a medical institution or NGO.  Discuss your decision with your family and doctors before making a final decision. If the deceased was not registered as a donor, their next of kin can donate their body.

Organ donation is open to everyone, irrespective of age, caste, religion, or community, though individuals over 18 years are typically preferred, subject to other guidelines. Kidney transplants were the first to be performed, and along with organ donation, have contributed significantly to advancements in medical science, offering new hope to patients in need of transplants. However, India faces several challenges in its organ transplantation system like other nations. While the country has seen an increase in its organ donation rate—from a mere 0.05 per million people to 0.8 per million in recent years—these numbers are still relatively low compared to Croatia’s 36.5, Spain’s 35.3, and the USA’s 26 per million. One of India’s biggest challenges is the substantial gap between organ demand and supply, which puts immense pressure on the system. According to the National Organ and Tissue Transplant Organisation (NOTTO), of the 18,378 organ transplants conducted in India in 2023—a record-breaking number 10% were for foreign nationals who travelled to India for treatment.

Additionally, more than 60% of living organ donors were women. Poor infrastructure, particularly in government hospitals, hinders the effectiveness of organ donation and transplantation efforts. A widespread lack of awareness about brain stem death among stakeholders contributes to the low rate of brain stem death certification by hospitals. This lack of certification leads to limited awareness and negative attitudes toward organ donation, resulting in a low deceased organ donation rate. The system also faces challenges due to the absence of organized procedures for organ procurement from deceased donors and difficulties in maintaining standards for transplantation, organ retrieval, and tissue banking. Controlling and preventing organ trafficking remains a persistent issue, as does the high cost of transplantation, especially for uninsured and economically disadvantaged patients. Moreover, regulating the non-governmental sector adds further complexity to organ donation and transplantation management. Strengthening the role of regulatory bodies and ensuring compliance is crucial to making the system more efficient and effective.

References:

1. Organ Receiving & Giving Awareness Network(n.d.) https://www.organindia.org/overviews/donation-program/
2. Annona Dutt (2024, August 4), 2023 saw highest-ever organ transplants in India, 63% of living donors were women: NOTTO report, The Indian Express, https://indianexpress.com/article/india/2023-saw-highest-ever-organ-transplants-in-india-63-of-living-donors-were-women-notto-report-9493500/
3. Organ donation in India: Know the eligibility, registration process, and more (2024, March 8), The Indian Express, https://indianexpress.com/article/india/2023-saw-highest-ever-organ-transplants-in-india-63-of-living-donors-were-women-notto-report-9493500/
4. 2023 saw highest-ever organ transplants in India, 63% of living donors were women: NOTTO report (2024, August 4). The Indian Express, https://indianexpress.com/article/india/2023-saw-highest-ever-organ-transplants-in-india-63-of-living-donors-were-women-notto-report-9493500/

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