This article is written by Shreya Tandon, a law student from Vivekananda Institute of Professional Studies (VIPS), IP University. In this article, the author talks about the working and functioning of the organ donation process and all the legal framework of organ transplantation in India till date.
Table of Contents
“Every year many thousands of people by seeking the help of organ transplantation receive the gift of life by restoring sight and health and it must be cherished by them as bestowed by almighty.”
The procedure of substitution of healthy organs with the affected ones is known as organ transplantation. This is one of the greatest medical advances of all time. On the Asian subcontinent, India has been the leading country in this field, The growth of medical science has turned out to be a remarkable one, by giving a new facet to the process of transplantation.
The working of organ donation
It all starts when someone’s organ begins to fail or deteriorate and the person will require a transplant to survive. A thorough investigation is conducted in a transplant center and if a person is a good candidate for a transplant he/she is pinned to the National Transplant Waiting List. Once the person appears on the list, the clock starts ticking and the wait for an organ begins. It is a system of matching people on the waiting list with donors. Donors are classified on the basis of a blood type, body size, how severe the patient is, distance from the donor, tissue type, and the time on the waiting list. Organs are never matched on the basis of-
- The gender,
- Income, and lastly,
- A person acquiring a special status and position in society.
There is no telling how the wait would take in fact some people don’t receive organs on time because the waiting list is very long and there aren’t any donors available. That’s why on an average 20% on the waiting list die each passing day.
The science of giving life to another person from a deceased person
Most of the organs for the transplant comes from the deceased person. For example, a person coming to the hospital, with a life-threatening brain injury- from a stroke, heart attack, or massive brutal accident is sometimes declared dead by doctors. That’s the time when a person’s body parts can be used for donations and at the time of his/her loss from their respective family they become a hope for another.
One person can give life to as many as eight people through organ donation such as- heart, lungs, kidney, pancreas, intestines, and liver and hence, 50 people or more through organ donations. But now the minutes’ matter and transplant happen to have taken place immediately. The hospital contacts the Organ Procurement Organisation(OPO) which helps to recover the organ recovery process. If the person is already registered as a donor, they will inform the family, and if not then, the family is asked to authorize donation.
The complete medical examination is conducted in which the medical history and social history are taken into consideration and if the person is eligible for an organ donor, the computer begins to search on the national scale. The best-matched patients are contacted by the transplanting team to the patient and this is the call for which every person on the waiting list is being hoped for. Then the transplant takes place.
The law administering organ donation and transplantation in India
Organ donation and transplantation comes under the ambit of the primary legislation, The Transplantation of The Human Organs Act,1944 (THAO). It aimed at maintaining proper regulation for removal, storage, and transplantation of organs for the therapeutic process. It’s the key duty of the legislation to prevent transplant commercialism.
The need for such an act was proposed by the states of- Maharashtra, Goa, and Himachal Pradesh which was later accepted by all the states excluding Andhra Pradesh and Jammu and Kashmir. Nonetheless, there was no fall in the number of human trafficking and commercial dealing with human organs. Therefore, the urge for the amendment was felt in 2009 to address the discrepancies in the act. In 2011, the amendment was passed by the Parliament of India, and rules for the same were jotted down in 2014.
Some crucial features of the 1994 bill
- The authorization Committee consisting of a special group of experts must be structured at the State and Centre level. The committee would be held responsible for maintaining data of available organs and granting permissions for organ transplants.
- The duty of performing the surgery to remove the organs from the deceased’s body will only be assigned to the registered medical person in the authority.
- Approval from the State authorities to be categorized as an approved centre is mandatory for a hospital where the transplant would take place.
- A person cannot be declared brain dead just before the transplant is about to commence without the approval of a qualified neurosurgeon.
- The relative can give consent on the part of the deceased if no family member objects to it.
Amendments which were implemented in 2014 for further improvement
Twenty years of the existing act, neither there was any improvement in the number of organ donors nor it was able to curb out illegal organ transplant and human trafficking for the same purpose. These amendments came with the purpose to ease the whole process and make organ donation a simpler process. Following are the amendments stated-
- As to widen the scope and accessibility, permission to operate transplantation was given to each and every hospital which could provide proper care facility to donors as well as ventilators to retrieve the organs.
- Relaxation was granted in the earlier mandatory provision in confirmation with the appropriate government regarding the mandatory presence of neurosurgeon at the time of declaring a person dead.
- It was made mandatory on the part of physicians and doctors to approach the deceased’s family and make them aware about the whole transplant system and go ahead with the process as it would be beneficial for the society.
- The transportation cost, medical expenses, donor’s maintenance, retrieval of organs, or tissues would be borne by the receipt or his family or the government, and non- government organization.
Evolution of The Organ Transplant Act
Date and year
Authority in power
11th July, 1994
President (Assent approved by the Parliament)
Sections and sub sections
4th February, 1995
Ministry of Health and Family Affair
Notification of rules and introduction of forms
31st July, 2008
Ministry of Health and Family Affair
Notification of rules and modification of forms(1-10)
28th September, 2011
President(Assent approved by the Parliament ministry of law and Justice and company affairs)
Sections and sub sections
27th March, 2014
Ministry of Health and Family Affair
Notifications and Rules
Critical analysis of THAO,1994 through case laws
The Act aims at prohibiting the illegal trading of human organs and lays down the process of retrieving organs from the dead person, related person, an unrelated person. The prima facie intention established by the law for donating organs arises for the near relatives- father, mother, brother, sister, child or a spouse and their relationship shall be proved by either genetic- testing or legal documents. For the cases of an unrelated donor, The Authorization Committee (AC) has been set- up by the government to ensure that the donation of the organ is solely done because of the reason “Affection and Attachment” with the patient and there is no monetary gain which is being provided to the donor under the table. Thus, the aim of the Authorization Committee is to determine whether there exists any commercial object between the donor and patient or not, if there is even the slightest possibility the donation stands prohibited. In the case, Balbir Singh Vs. Authorization Committee and Others the context of ‘Near Relative’ was brought up.
The motive of the Act was to prevent trade of organs from a person’s body. The law prescribes punishment for whoever commits the illegal and brutal crime of commercializing the organs, imprisonment ranging between two to seven years would be given along with the imposition of a fine between Rs 10,000 and Rs 20,000. Yet, this Act has failed to stop the illegal trading of organs despite the 2011 Amendment.
It did not register much success which is evident mainly from the kidney scams reported in the years 2002, 2003 and 2004 through the fortuitous fact of it being the only lucrative human organ accessible illegally from live donors.
Authorities assigned under the act
For the regulation of transplant activities across the whole nation, the government formed an Authorization committee (AC) and Appropriate Authority (AA) in each State or Union territory.
Work of Authorization Committee(AC):
- It approves or rejects the transplants as it deems fit for the donor and receipts match.
- It supervises the donor’s attitude as to know that he is not exploited in return of petty money considerations in exchange of his organs.
- Makes the donor aware of the potential risks he might face after the surgery.
- A meeting between the donor, receipt and AC takes place after the application of transplant has been filed on the patient’s behalf.
- Details regarding the approval and waiver of application is sent via mail to the hospital in authority.
- Whether to accept or reject a donor is governed by Sub Clause (3), Clause 9 of Chapter II of the THO act.
Work of Appropriate Authority(AA):
- It overlooks the work of removal, storage and transplantation of the organs.
- It can be only performed by the hospitals that hold a proper license through the authorities. The license stands valid for 5 years which can be reviewed after its expiration.
- Each organ requires a different license.
- Eyes from the deceased’s body can be removed without prior permission.
- Its main role is to inspect, supervise, and grant registration to the hospitals for transplant surgeries, follow up hospitals so that they do not compromise on the quality of organs and maintain the regular standards.
National Organ and Tissue Transplant Organization (NOTTO):
The National Organ and Tissue Transplant Organization is a National level organization handled by Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India. It is regarded as the highest center for managing all activities and networking for procurement and distribution of organs and tissues and maintaining a registry of organs and tissues donation and transplantation in the country.
At the initial state in 1987, the WHO prohibited the organ transplant saying its irrational, inconsistent and clashes with the basic fundamental values and contravenes with principles of the Universal Declaration of Human Rights Right(UDHR). Its present Guiding Principles on Organ Transplant states, the organs should be donated ‘freely, without exploiting the donor by offering money as a consideration or any other reward for the same purpose’
What hurdles come in the way which makes organ donation difficult in India
The reasons for non-implementation of the laws properly are-
- Lack of awareness between the people of the majority and low results in finding a match as the data is not managed efficiently. As prescribed by the law, each state is authorized to make authorization committees for proper surveillance. Most states lack such authorities and in the states, Tamil Nadu and Kerala the situation is even worse as the data collected is not adequate.
“The process of organ donation cannot be streamlined unless states have appointed authorities and advisory committees, as stated in the amendment. Since many states are yet to have such committees, people never get to know the status of organ availability, resulting in low donation and transplant rates” said Dr Nagral, Doctor at AIIMS.
- One of the statements by the Joint Director of Regional Organ and Tissue Transplant Organisation(ROTTO) was that the physicians hardly make an effort to approach the patients’ family after his demise as to obtain their consent for transplant nor it maintains any record of the application of reluctance filed by any of the deceased’s relatives.
- Organ trafficking has now become a harsh reality in our society. The reason is the lack of implementation of the laws and amendments which are drafted under the Constitution. Neither the hospitals nor the hospitals adhere to the recommendations.
“Regularising organ donation is still at its nascent stages in India because organ donation is not just a medical issue. Several factors such as economics, the role of state governments and the role of hospitals are crucial in improving organ donation in India. Government hospitals are still ill-equipped and understaffed in many areas, hence organ donation is something majorly dependent on private hospitals. This also excludes a number of people from becoming aware of the method of donating organs,” said Dr. Nagral, the AIIMS Doctor.
Organ shortage: A global issue
The huge gap between the demand and supply for organs has widened over the years. This has resulted in many patients travelling to countries that have weak regulatory mechanisms like India, Iran, China, Pakistan, Philippines, Brazil, Turkey, Moldova, Ukraine, Russia, Bulgaria, and Romania for organ transplantation.
Time and again The World Health Organization (WHO) has affirmed that the sale of organs clearly violates the Universal Declaration of Human Rights and its own constitution: “The human body and its parts cannot be the subject of commercial transactions. Accordingly, giving or receiving payment for organs should be prohibited.” It has also directed that no transplantation should not be performed if there is slightest of suspicion that such organs have been advised physicians not to be the subject of commercial transactions.
In India, the concept of pledging for organ donation after death is still a taboo and people refrain from discussing the same citing their religious beliefs and consequently, the deceased donation rate is exceedingly small. Therefore there is a serious need to explore this option in order to increase the rate of organ donation and to curb illegal trade in organs. Along with these other effective modes like swap or donor exchange in living, transplantation should also be encouraged.
The need and requirement for organ donors have been on a rise constantly and the number of organ donors is still extremely scant.
The high demand for organs has led to a steep rise in the illegal trade of organs and the developing countries where the poverty rate is high and the authorities are not so vigilant are the worst affected.
It is a sad reality that even after 15 years of the THO Act it has failed to limit the commercial trade of organs and neither has it been able to encourage organ donation.
The most suitable option in India is to invest in spreading awareness about the deceased donation and making a legal provision that makes the donation mandatory unless a person withdraws from it. Along with stringent legal provisions and effective implementation, the conservative mindset of the society needs to change in order to fill the wide gap between the demand and supply of organs.
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