ORGAN TRAFFICKING IN INDIA: A LEGAL AND ETHICAL ANALYSIS

Abstract:

Organ trafficking remains a critical global challenge, and India stands at a complex crossroads of legal reform and ethical dilemmas in addressing this illicit trade. This research paper offers a comprehensive legal and ethical analysis of organ trafficking in India within an international context. It examines the effectiveness of the Transplantation of Human Organs and Tissues Act, 1994 (THOTA), its subsequent amendments, and its alignment with global frameworks such as the Palermo Protocol, the WHO Guiding Principles, and the Council of Europe Convention against Trafficking in Human Organs. Through case studies and data-driven insights, the paper highlights systemic loopholes, enforcement challenges, and the exploitation of socio-economically vulnerable populations. It also explores the ethical complexities surrounding consent, commodification of human organs, and transplant tourism. The study concludes by advocating for stronger regulatory mechanisms, cross-border cooperation, and public awareness to combat organ trafficking effectively while preserving human rights and medical ethics.

Keywords:
Organ trafficking, India, THOTA, international law, transplant tourism, human rights, ethical dilemmas, Palermo Protocol, WHO guidelines, cross-border cooperation, medical ethics, socio-legal analysis.

INTRODUCTION

The regulation of organ donation and transplantation stands at a crucial crossroads where medical innovation meets legal oversight and ethical accountability. As transplantation offers unparalleled life-saving opportunities, it also opens avenues for exploitation if not carefully regulated. This chapter examines the multifaceted legal frameworks governing organ donation and transplantation, with a primary focus on India’s landmark Transplantation of Human Organs and Tissues Act (THOTA) of 1994 and its subsequent amendments. It discusses how these regulations attempt to balance the life-saving potential of transplantation against the risks of organ trafficking and other malpractices.

Historically, the medical breakthrough of organ transplantation transformed the prognosis of patients suffering from end-stage organ failure. However, as the demand for organ replacement surged worldwide, so too did the instances of unethical practices, fueling an underground market for organs. It is in this context that national legal frameworks like THOTA have emerged. Enacted in 1994, THOTA was a pioneering step in India’s efforts to regulate both living and deceased organ donations. The law was designed not only to facilitate organ transplantation procedures but also to serve as a protective measure against the exploitative tendencies of organ trafficking networks. Despite its innovative approach, the Act has faced challenges in terms of enforcement, leading to periodic amendments aimed at tightening regulatory loopholes and increasing oversight.

Internationally, the need for robust legal frameworks is echoed by instruments such as the Palermo Protocol, which outlines measures for the prevention, suppression, and punishment of trafficking in persons. This protocol not only covers human trafficking broadly but also specifically addresses the removal of organs under exploitative circumstances. By aligning national laws with global anti-trafficking standards, countries can adopt a more cohesive strategy to combat the illegal organ trade. In recent years, international forums have increasingly called for better harmonization of legal standards, urging both developed and developing nations to enhance cross-border cooperation. Such collaborative efforts are essential given that organ trafficking networks often operate transnationally, exploiting differences in legislation and enforcement.

Furthermore, this chapter will delve into the ethical complexities inherent in organ transplantation. Medical practitioners frequently face the challenging task of weighing the imperative to save lives against the risk of inadvertently fueling criminal activity. The ethical debates are compounded by issues surrounding consent, the commodification of human body parts, and the potential for exploitation within vulnerable communities. For instance, while the legal framework may provide clear guidelines on consent, practical implementation often encounters situations were economic hardship or lack of awareness leaves individuals particularly susceptible to coercion. These instances underscore the profound ethical dilemmas and call for a more nuanced interplay between legal regulation and medical practice.

THE TRANSPLANTATION OF HUMAN ORGAN AND TISSUES ACT, 1994

The Transplantation of Human Organs Act, which was passed in 1994, is the primary piece of legislation in India that pertains to organ donation and transplantation. Its purpose was to regulate the removal, storage, and transplantation of human organs for therapeutic purposes, as well as to prevent commercial dealings in human organs. In India, each state is responsible for regulating issues that are associated with health. After being begun at the request of Maharashtra, Himachal Pradesh, and Goa (which therefore adopted it by default), the act was later adopted by all states with the exception of Andhra Pradesh and Jammu & Kashmir.[1] The media reported on instances of commercial dealings involving human organs, despite the fact that there was a regulated system in place. An amendment to the act was proposed by the states of Goa, Himachal Pradesh, and West Bengal in 2009. The purpose of the amendment was to remedy deficiencies in the act’s effectiveness, relevance, and impact. 2011 was the year that the amended act was approved by the parliament, while 2014 was the year that the rules were made public. The same is adopted by the states and union territories that proposed it by default, and it is possible for other states to adopt it by passing a resolution. Several distinctions can be made between the statute of 1995 and the later regulations that were enacted in 2014.[2]

DONORS OF VARIOUS TYPES

1. Donors who are still alive include parents, siblings, and children. Near-related donors are also an option. Grandparents are now put on the list of donors who are considered to be close relatives, according to the criteria released in 2014. There should be documentary evidence of the relationship, such as relevant birth certificates, a relationship certificate from the Tehsildar or the subdivisional magistrate or the Metropolitan Magistrate or the Sarpanch of the Panchayat, or other identity certificates that are comparable, such as an Electors’ Photo Identity Card or an Aadhaar card, as well as documentary evidence of the identity and residence of the proposed donor, such as a ration card, a voters’ identity card, a passport. It is recommended that human leukocyte antigen matching or DNA fingerprinting be performed by a laboratory that is accredited with the National Accreditation Board for Testing and Calibration Laboratories in the event that the link cannot be proved with absolute certainty subsequent to the evaluation of the evidence presented above.[3]
2. With the exception of donors who are close relatives, all donors anticipate that those who are classified as near-related donors fall into this category. In circumstances like this, the Authorisation committee is the only one who may issue permission. This is the most contentious category since there is the potential for a monetary transaction to take place in the event of a donation from a poor person to a wealthy recipient. In this scenario, the wealthy recipient has the ability to force the poor donor to donate his or her organ against his or her will in order to receive some money in exchange. In order to prevent the trafficking of organs, the transplant statute has included a number of measures. An audio recording is made of the donor-recipient interview. If the proposed donor and the recipient are not close relatives, the Authorisation Committee will-
3. determine that there is no commercial transaction between the donor and the recipient;
4. will create an explanation of the connection between the two parties [4]and the circumstances that led to the offer being made; and 
5. will determine whether or not the donor and receiver are related.
6. analysing the reasons why the donor is interested in donating;
7. analysing the documentary evidence of the connection, such as proof that they have lived together, etc.;
8. analysing old images that show the donor and the beneficiary together.
9. determines that there is no intermediary or tout involved in the transaction;
10. assesses the financial position of both the donor and the receiver by looking at appropriate evidence of their occupation and income for the three most recent fiscal years.
11. Any significant imbalance between the recipients’ and donors’ financial situations is examined in the context of the goal of preventing commercial dealing.
12. ensures that the donor is not a drug addict; and
13.  ensures that the near relative or if near relative is not available, any adult person related to donor by blood or marriage is interviewed regarding awareness about his or her intention to donate an organ or tissue, the authenticity of the link between the donor and the recipient, and the reasons for donation, and any strong views or disagreement or objection of such kin is also recorded.
14. When the living donor is not related to the recipient, and if the donor or recipient is from a state that is not the state in which the transplantation is going to take place, it is necessary to verify the donor’s or recipient’s residential status by a Tehsildar or any other authorised officer for the purpose, with a copy of the verification being marked to the appropriate authority of the state in which the donor or recipient resides, as stipulated in Form 20.
15. Foreign donors– Every single one of these situations is handled by the authorisation committee. In the event that international donors donate to their relatives in India, the transplantation procedure is only going to be allowed for donors who are very close to one another. In the event that an Indian living donor wishes to gift to a foreigner who is not a close relative, their donation will not be approved. In the event that a foreigner comes to India for the purpose of receiving a transplant, for instance, if both the donor and the recipient are foreigners, the transplant can be performed in India with the permission of a senior embassy official from the donor’s country of origin. [5]This official will verify the relationship between the donor and the recipient. In the event that a country does not have an embassy in India, the government of that country will issue the certificate of relationship.  For all living donations, the donor is put through all of these medical procedures in order to identify whether or not they are biologically capable of donating the organ and whether or not they are compatible with the recipient. Form 4 requires the qualified medical practitioner to certify that the donor has undergone both a physical and mental evaluation.
16. Donor who has passed away– Another source of organs can be found here. Deceased donation can occur either after the death of the brain (also known as brain stem death) or after the death of the heart. A clinical diagnosis of brain death is the termination of activity of the brain stem, which is the definition of brain death. When the Glasgow Coma Score (GCS) results in a score of 3/15, it is typically declared in patients who are being ventilated. Whether or whether there are reflexes in the brain stem is examined. At the bedside, an apnoea test is performed, during which the principle raises the concentration of carbon dioxide in the blood to sixty millimetres. This provides the respiratory centre in the brain stem with the largest amount of stimulation possible. On the condition that this does not result in any spontaneous respiration, the individual is said to be brain dead. In an adult, the apnoea test ought to be repeated twice, with a six-hour gap between each repetition. There is a longer period of time that passes between two apnoea tests in the paediatric age group. After the patient has been preoxygenated with one hundred percent oxygen at the beginning of the test, the ventilator is then turned off. During the apnoea test, it is important to keep an eye on the haemodynamics, and if there is a drop in blood pressure, the apnoea test should be terminated.

Both Form 8 and Form 9 are required in order to conduct a donation from a donor who has died from brain death. Permission is granted by the committee in accordance with the format provided in Form 10. It is not the responsibility of the donor family to pay for the costs associated with the maintenance of the cadaver (a person who has been declared brain stem dead), the retrieval of organs or tissues, their transportation, and preservation. Instead, the recipient, the institution, the government, or the non-government organisation or society is responsible for paying these costs, as determined by the government of the respective state.

EVOLUTION OF LEGAL FRAMEWORK

There is a need to ensure that human organ trafficking does not occur by taking advantage of the poverty, illiteracy, and ignorance of a significant portion of Indian population. This is one of the principles of public interest. Because transplantation has the potential to save lives, it is essential that it be permitted. There is a considerable correlation between the protection of the public’s health and the practice of transplantation. Prior to the passage of “The Transplantation of Human Organs and Tissues Act, 1994,” there was no complete regulation that regulated the removal of organs from live as well as deceased individuals and the transplantation of such organs. This legislation was passed in 1994. The Eyes (Authority for use for Therapeutic Purposes) Act, 1982 and the Ear Drums and Ear Bones (Authority for Use for Therapeutic Purposes) Act, 1982 were the two laws that were in effect in the Union territory of Delhi. These laws regulate the removal and transplantation of cornea, ear drum, and ear bones. Both of these laws were passed in 1982.

Both the Bombay Corneal Grafting Act of 1957 and the Maharashtra Kidney Transplantation Act of 1982 are pieces of legislation that govern the transplantation of kidneys and corneas, respectively, in the state of Maharashtra. Therefore, there was a requirement for a complete regulation that would prohibit commercial deals in human organs and regulate the removal of organs from living individuals as well as cadavers or other living individuals. [6]

The Report of the L.M. Singhvi Committee

In addition, a report was compiled by a committee consisting of medical and legal professionals, which was led by Dr. L.M. Singhvi. In order to provide clarity on the following issues, the L.M. Singhvi Committee was established. These issues include the following: the concept and definition of brain death; the necessity of separate legislation to recognise brain death and the legal, medical, and social implications of such legislation; the safeguards that must be adopted in order to prevent the misuse of the concept of brain death; and the manner in which the concept of brain death must be applied in order to promote the availability of human organs for transplantation.

Following the submission of the Committee’s findings in June of 1991, the Cabinet gave its approval to the report in October of that same year. In the study, it was suggested that the Human Organ Transplants Act, 1989 of the United Kingdom be modified in order to bring it into conformity with and accommodate the specific circumstances that are present in India. This piece of law should, in addition to acknowledging the existence of brain-stem death, authorise and accredit hospitals that possess the personnel, equipment, and facilities required for the collection and transplantation of human organs. Based on the findings of the investigation, it is recommended that individuals be granted the opportunity to provide written authorisation for the removal of certain organs from their body after death, in the presence of witnesses, prior to their own passing. In addition, it was recommended that donors receive medical care in order to encourage organ donation from living donors. This was done in order to encourage organ donation from living donors. One of the most significant recommendations made by the Committee was that the act of selling organs should be made illegal and a criminal offence.

LEGAL PROVISIONS RELATED TO ORGAN DONATION

THE TRANSPLANTATION OF HUMAN ORGAN’S ACT, 1994

Following the report that was submitted by the L.M. Singhvi Committee, a Bill was draughted, and three states, namely Goa, Maharashtra, and Himachal Pradesh, issued resolutions that were in favour of the legislative proposal. The bill pertaining to the transplantation of human organs was presented to the Rajya Sabha on May 5, 1993, and it was adopted by the House of Representatives without any opposition. The Lok Sabha, on the other hand, made the decision in December 1993 to send the Bill to a Select Committee for additional scrutiny or investigation. Both the inclusion of in-laws as near relatives and the payment of live donors were subject to some minor adjustments that were proposed by the Committee. Due to the fact that these were not supported by the Union Cabinet, the Bill was ultimately approved by the Lok Sabha on June 15, 1994. On July 8, 1994, it was bestowed with the approval of the President. Regulations pertaining to the Act were published in February of 1995.

“An Act to provide for the regulation of the removal, storage, and transplantation of human organs and tissues for therapeutic purposes and for the prevention of commercial dealings in human organs and tissues] and for matters connected therewith or incidental thereto,” the language of the proposed legislation reads.

Regarding the aforementioned matter, the Honourable High Court of Delhi, in its decision dated September 6, 2004, in the case of Balbir Singh v. Authorisation Committee[7], evaluated the recommendations of the aforementioned committee in conjunction with those of the Rajiv Gandhi Foundation. Following wide consultation and thorough consideration of the guiding principles that were draughted by the World Health Organisation, the Administrative Ministry plans to alter the Act that was previously mentioned. This Act tackles the issue of criminal culpability in situations involving the harvesting of organs and the trafficking of humans for use in such activities. All those who are involved in the illegal transplant procedure are regarded to be the perpetrators. This includes individuals who are involved in the trafficking, procuring, brokering, mediating, hospital or nursing personnel, as well as hospitals and medical laboratories and their technicians. It is stated in Section 11 that it is unlawful to remove or transplant human organs for any purpose other than therapeutic ones.[8] Section 19 addresses the commercial dealing in human organs and makes it abundantly clear that those who engage in such activities will be subject to penalties such as imprisonment for a term that must not be less than five years but may reach ten years, as well as a fine that must not be more than one crore[9].

Regulation of Cadaveric Donation

Sections 3 to 8 of the Act govern cadaver donation.[10] According to Section 3 of the Act, an individual may, at any point prior to their death, provide written authorisation in the presence of two or more witnesses for the removal of any organ from their body post-mortem. Form 7 of the Transplantation of Human Organs and Tissues Rules, 2014, delineates the prescribed format for such authorisation. Authorisation can now also be included in a driving licence. If the individual did not provide authorisation prior to death, the person legally in possession of the deceased’s body may permit the removal of any organ, unless there is reason to believe that a close relative of the deceased objects. The Act does not establish presumed consent for organ donation from a deceased individual, as is the case in Spain, but mandates informed consent from the donor or the one legally in possession of the corpse.

According to Section 3(6) of the Act, organ donation from cadaver donors necessitates certification of brain-stem death by a panel of medical professionals, which includes: (i) the registered medical practitioner overseeing the hospital where brain-stem death has been established; (ii) an independent registered medical practitioner from a list sanctioned by the Appropriate Authority; (iii) a neurologist or neurosurgeon; and (iv) the registered medical practitioner responsible for the care of the individual whose brain-stem death has been confirmed.

Regulation of Living Donation

Section 9 of the Act governs living donation[11]. The Act delineates distinct procedures for living donations from near relatives and those from unrelated donors. Section 2(i) defines a “near relative” as a spouse, son, daughter, father, mother, brother, sister, grandfather, grandmother, grandson, or granddaughter.

For living donations from close relatives, an application using Form 1 or 2 (based on whether the donor is a spouse or another close relative) must be submitted alongside Form 11 of the Transplantation of Human Organs and Tissues Rules, 2014, to the appropriate authority, which is the head of the hospital where the transplant will occur or the Hospital Authorisation Committee established by the hospital. The committee conducts interviews with the recipient, donor, and their relatives, and if satisfied, grants consent for transplantation. The entire interview is recorded on video.

Penalty under the Legislation

According to Section 18 of the Act, any anyone engaged in the unauthorised removal of human organs may face imprisonment for a duration of up to 10 years and a fine of up to Rs. 20 lakhs[12]. If a registered medical practitioner is convicted, the Appropriate Authority shall report their name to the relevant State Medical Council for necessary actions, including removal from the Council’s register for three years for the first offence and permanently for subsequent offences.

According to Section 19 of the Act, individuals engaged in the commercial trade of human organs may face imprisonment for a minimum of 5 years, potentially extending to 10 years, and are subject to a fine of no less than Rs. 20 lakhs, which may reach up to Rs. 1 crore[13].

According to Section 20 of the Act, any anyone who violates any other provision of the Act may face imprisonment for a term of up to 5 years or a fine of up to Rs. 20 lakhs[14].

THE AMENDMENTS TO THE TRANSPLANTATION OF HUMAN ORGANS (2011)

The major purpose of the Act is to provide for the control of the removal, storage, and transplantation of human organs for medicinal purposes, as well as to prevent commercial deals in human organs. This is the primary objective of the Act. The Eyes (Authority for Use for Therapeutic Purposes) Act of 1982 and the Ear Drums and Ear Bones (Authority for Use for Therapeutic Purposes) Act of 1989 were both repealed as a result of this Act. The following is a discussion of the most important aspects of the Act:

• The process of obtaining permission to remove human organs

The Act allowed any anyone who was above the age of 18 to voluntarily approve, prior to their death, the removal of any of their organs for therapeutic purposes, which can be defined as the systematic treatment of any disease or the measures to enhance health according to any particular method or modality. It is required that he or she do so in writing in the presence of two or more witnesses, with at least one of the witnesses being a friend or family member. In such a scenario, once the individual has passed away, the person who is legally in possession of the body has the ability to grant a certified medical practitioner all reasonable facilities for the removal of a human organ from the body of the donor for the purposes of therapeutic treatment. On the other hand, he is only required to carry out the same action provided he does not have any grounds for believing that the donor has subsequently revoked the authority. In the event that such authorisation has not been provided, but the deceased person has not voiced any objections, the individual who is in lawful possession of the deceased person’s body has the ability to give permission for the removal of any organ of the deceased person for therapeutic purposes.

• Control of Healthcare Facilities

Every hospital that is involved in the removal, storage, or transplantation of any human organ is required to be registered under the Act in order to perform, associate, or assist in the process. The removal, storage, or transplantation of a human organ should never take place at a location that is not registered, and no medical practitioner or other individual should ever participate in or assist in the performance of any activity related to these procedures. In addition to being done for therapeutic purposes, the removal, storage, or transplanting of human organs should never be done for any other reason. In contrast, a registered medical practitioner has the ability to remove any part of the donor’s eyes or ears, including the ear drums and ear bones, from the deceased body of the donor for the purpose of therapeutic use.

ROLE OF THE ACT IN PREVENTING ORGAN TRAFFICKING- CASE STUDIES

Indian organ transplant frauds, medical malpractices, and trafficking are the subjects of this case study. Evolution of Offences and Penalties from the amendments made from time to time:

Source: Indian Journal of Medical Ethics[15].

Case 1: The Fraud using Donor Cards[16]

The month of February in the year 2020 finds Surya in a precarious circumstance. As a result of her husband’s job loss and her own inability to work owing to an accident, she was experiencing a debt of ₹5 lakh. In order to pay her financial obligations, she considered selling a kidney. Despite the fact that she was aware that it is against the law in India to sell organs, she ended up posting her phone number on a Facebook group out of desperation. A few days later, she got a phone call from a man named Dr. Sandy, who claimed to be from a medical centre in Ghaziabad during the conversation. His offer was an astounding one crore rupees for her kidney, but it was contingent upon her first paying eight thousand rupees for a donor card. Prior to taking any additional actions, Surya was fortunate enough to discover the MOHAN Foundation, which is a charitable organisation that promotes the legalisation of organ donation. She was made aware of the fact that donor cards are actually free, which assisted her in realising that she was on the verge of being taken advantage of.

Case 2: The Jaipur NOC Fraud [17]

A clandestine operation was discovered by the authorities in Jaipur in the latter half of the year 2023. The operation involved the use of fake no-objection certificates (NOCs) for organ transplantation. Since the year 2021, three prestigious private hospitals have been accused of carrying out an astounding 184 transplants based on the allegations that these documents are fraudulent. It was determined that Bangladesh was the country of origin for over half of the total donors and receivers.

The controversy was brought to light when the Anti-Corruption Bureau arrested an assistant administrative officer of one of the hospitals for receiving a bribe of ₹70,000 to issue a fake NOC. This was the moment when the scam was brought to light. Consequently, this resulted in additional arrests, which included hospital coordinators from the other institutions who were implicated. A prompt response was provided by the Rajasthan health authority, which promptly cancelled the transplantation licenses of the three facilities.

THE PREVENTION OF HUMAN TRAFFICKING ACT AND ITS IMPLICATIONS