From Policy to Practice: A SWOT Analysis of India's Organ Transplantation Regulatory Framework

Strengths

The THOA is strengthened by a comprehensive legal framework that mandates detailed scrutiny of transplantation practices. Each transplant undergoes scrutiny at the hospital level, with various modalities proposed to ensure compliance with legal requirements for establishing valid relationships. These include DNA testing, including testing of other relatives when required (for example, typing of an off-spring to establish wife-husband relationship, or grandparents for cousins); interviewing the parties; assessing their body language; inquiry on questions such as the exact date of marriage to rule out any foul-play; conducting emotional and social counseling sessions to prevent coerced donations and doing domicile checks involving foreigners (KII#5, Hospital Transplant Coordinator; KII#1, Researcher & Previously Transplant Coordinator; KII#6 Journalist and a potential donor). In practice, some states, such as Tamil Nadu and Gujarat, have shown how this framework can be harnessed to increase deceased-donor transplant rates by pairing robust public hospital participation with targeted funding initiatives.

The Brain Death Committee and the Appropriate Authority work towards ensuring certification of brain death, monitoring of hospitals, and examining the quality of transplants. Additionally, under THOA, the responsibility for assessing the legitimacy of donor-recipient relationships, particularly for living donations, rests with hospital-based Authorization Committees comprising medical experts, social workers, and government officials. Transplants involving non-near relatives face increased scrutiny from the Authorization Committee to prevent commercial transactions, including thorough documentation reviews of bank transactions and local body representative letters (KII#3, Policy Maker/Regulator & Transplant surgeon). For out-of-state donors, permissions are required from the Authorization Committee of the donor state to strengthen fairness in the process. Many hospitals have internal committees to evaluate all transplants, with non-first-degree donor transplants being examined by the statutory Authorization Committee.

At the national level, the National Organ and Tissue Transplant Organization (NOTTO) is charged with the coordination of organ and tissue procurement and maintaining a national registry of donors and recipients. Five Regional Organ and Tissue Transplant Organizations (ROTTOs) support NOTTO and State Organ and Tissue Transplant Organizations (SOTTOs), established in 22 states and union territories. These organizations facilitate state-level implementation and collaborate with 857 hospitals to enhance organ transplantation infrastructure and manpower. Such a regulatory framework increases credibility and trust in organ donation, particularly with the inclusion of civil society representatives in the Authorization Committee, which strengthens safeguards for vulnerable populations. (KII#7, CEO, NGO).

Weaknesses

The regulatory framework governing organ transplantation, although comprehensive, faces challenges in its implementation, particularly in areas like accountability and enforcement. Health is a subject traditionally managed by state jurisdictions, which means that the Transplantation of Human Organs Act (THOA), along with its amendments and notified rules, needs to be tailored to each state for effective application. This division has led to inconsistencies across the country; while THOA (1994) is enforced universally in all states and union territories, Andhra Pradesh has created its own regulations. Even Telangana was functioning under its own regulation and adopted the THOA as recent as March of this year. The 2011 amendment was implemented in 2014 across all union territories, but was only fully adopted by three states at that time. To date, 13 more states have accepted the amendment, yet several, including Andhra Pradesh, Karnataka, Uttarakhand, Arunachal Pradesh, Mizoram, Meghalaya, Nagaland, and Tripura, have not.

Among the states that have adopted THOA, significant disparities persist in areas such as deceased donation guidelines, organ allocation criteria, and the establishment of SOTTOs. In Delhi, for example, organ allocations are determined alphabetically by hospital names (KII#5, Hospital Transplant Coordinator) while Tamil Nadu employs a rotational system among hospitals to optimize transport time in the same zone. While on paper, such criteria may appear similar, Tamil Nadu’s state-run, publicly run accessible waitlist ensures that organs enter a pool and are allocated transparently;¹⁸ while in Delhi, hospital-wise allocation practices create systemic disparities. Additionally, some hospitals in Kerala were found to prioritize allocations based on the donor hospital, further contributing to inequity amongst patients (KII#3, Policy maker/Regulator & Transplant Surgeon). Apart from the equity-based concerns, geographic disparities tend to fragment the donor pool, encourage inter-state transplant tourism, complicate oversight, and risk inefficient or even wasteful use of scarce organs.^10,19 This problem is further exacerbated as India still lacks a comprehensive, publicly accessible national transplant registry capturing outcomes and waiting list data.²⁰ As a result, inconsistent enforcement across states and poor reporting end up hampering equitable access to transplantation and allowing unethical practices to go unchecked. Such inconsistencies emphasize the urgent need for standardized regulations to ensure transparency and equitable access to transplantation services.

Second, the shortage of qualified transplant coordinators remains another critical issue.²¹ Despite the legal requirement under THOA, many hospitals fail to employ these essential personnel, resulting in inconsistent and ineffective due diligence processes. Paperwork verification often falls to families of donors or recipients, who encounter bureaucratic challenges, especially during cross-state transplants (KII#5, Hospital Transplant Coordinator). This negligence by local authorities leads to delays, particularly when the donor and recipient are from different states or seeking treatment outside their home state. Furthermore, genetic testing for overseas donor-recipient pairs is typically not conducted, relying heavily on embassy letters for relationship verification. However, this practice has proven unreliable, as there have been instances where unrelated (potentially commercial) donor transactions surfaced.^22,23 Transparency in reporting transplant outcomes, such as donor morbidity and mortality details, is another significant concern. A stakeholder pointed out how hospitals share global statistics, which is nothing but a smoke screen rather than sharing their own data (KII#6, Journalist and a potential donor).

The low rates of deceased donation further compound this issue, with only 35 hospitals successfully conducting transplants from deceased donors in the early years following THOA’s implementation.^24,25 Currently, only one-third of states and union territories (including Tamil Nadu, Gujarat, Telangana, Maharashtra, Kerala, Chandigarh, Karnataka, the National Capital Territory of Delhi, and Rajasthan) have a viable organ donation program.^25,26 Inconsistent brain death declarations (KII#7, CEO, NGO) and inadequate counselling to the families of brain-dead individuals hinder consent for organ donation (KII#10, Transplant Coordinator). Cultural and religious beliefs also play a significant role in deterring families from participating in the donation process, with fears about improper treatment of the body or being born without organs in the next life, or preferences of donating to specific groups such as vegetarian patients (KII#1, Researcher, Previously Transplant Coordinator; KII#7, CEO, NGO; KII#10, Transplant Coordinator).

Participants further highlighted financial burdens and inadequate access to subsidized post-transplant care (KII#2, CEO, NGO; KII#6, Journalist and a potential donor). Organ transplantation is largely the preserve of private hospitals. Most public hospitals either lack the technical expertise or are overburdened.^27-29 National schemes, such as the Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB PM-JAY scheme), meant to financially support the economically weak, do not have enough empaneled hospitals that can provide transplant care.

Financial hardship was highlighted by the story of a couple selling their house to get a transplant for the wife. They could not keep up with the post-transplant medical expenses, and ultimately, the patient died. Similarly, low-income families face challenges in maintaining hygiene and avoiding crowded environments, making them more susceptible to infections (KII#7, CEO, NGO; KII#8, Transplant Policy Maker). Care of donors is suboptimal; regular and long-term post-operative follow-up care for organ donors is not mandated under Indian law.

Only a limited number of institutions in a few states, such as Gujarat and Tamil Nadu, provide for subsidized transplants and immunosuppressive drugs. Routine free health-checkups for post-transplant care are not provided, and participants feel that government capacity in specific districts of the state needs to be built further to provide transplantation services (KII#7, CEO, NGO; KII#8, Transplant Policy Maker).

Opportunities

THOA’s existing framework can be strengthened by bringing in regulatory clarity to enhance enforcement and the current low prosecution rate under THOA. First, Form 20 of THOA should be amended to mandate genetic testing for foreign donors, similar to Indian citizens. This could enable better detection and prosecution of cases involving foul play, as a case can be built regarding incorrect declarations while on oath. A transparent registry with donor and recipient details, while respecting privacy, would improve reporting and serve as a crucial tool against commercial transplants.

Second, the complaint mechanism under THOA, which necessitates a 2-month notice for filing, needs simplification. As courts generally do not entertain cases directly related to THOA, it is vital to enhance the role of civil society in monitoring compliance and establishing timely resolution of complaints (KII#4, NGO Founder; KII#8, Transplant Policy Maker). Enforcement reforms can be operationalized by enabling law enforcement authorities such as police officers and courts to take cognizance of credible media reports and public statements in order to begin an investigation,³⁰ facilitating public hearings on issues of organ trafficking, and tracking convictions against erring medical practitioners.³¹ To support victims of organ trafficking, mechanisms for witness protection and compensation are essential to encourage survivor cooperation in evidence collection. Coordination among departments, especially across state and national boundaries, is crucial.³² In this respect, the Trafficking in Persons (Prevention, Care, and Rehabilitation) Bill (2018 and 2021 versions) provides an opportunity to consolidate the framework for trafficking and enable care, protection, and rehabilitation of victims of trafficking for organ removal.

Third, a participant suggested expansion of the term ‘near relatives’ for living donation to include relationships like in-laws and stepfamilies, reflecting societal changes. (KII#5, Hospital Transplant Coordinator). Similarly, the swap transplantation rules can be broadened to include non-near relatives, such as in-laws, and eliminate the need for separate state clearances in swap transplant cases.

Regulators must ensure that the strict implementation of THOA does not result in harassment of transplant professionals, and a more humane and compassionate approach to regulation must be followed in the transplantation landscape. Transparency and public trust should be strengthened, and systemic barriers to donation should be removed. Such values can be implemented by scaling organ-sharing networks across states,³³ by better integration of the authorities (SOTTO and ROTTO with NOTTO), and implementing a uniform organ allocation criterion based on factors such as the patient’s priority, and MELD score (for liver transplants), all of which would contribute in reducing inequities (KII#5, Hospital Transplant Coordinator). Similarly, transplant infrastructure in tier-2 cities can be further strengthened through investments in immunology laboratories, developing drug-level monitoring facilities, and overall awareness initiatives.

Finally, the need to cover the transplantation cost through public schemes was universally emphasized by all stakeholders. Participants pointed out the contradiction between covering the cost of more expensive dialysis and leaving a cost-effective and patient-friendly treatment like transplantation out of the ambit of universal health coverage. This requires proactive government policies, public-private partnerships to strengthen transplant capacity in tertiary care, subsidies or even waived costs for donor and recipient follow-up, and lifelong access to immunosuppression drugs.³⁴

Threats

Poverty and corruption remain significant challenges, fostering an environment conducive to commercial transactions. Anecdotes of patients “paying money for an organ” remained a widely shared experience from the medical community (KII#3, Policy Maker/Regulatory & Transplant Surgeon). While respondents acknowledge a reduction in such practices since the 1990s, certain cities and hospitals remain known hotspots for these activities, driven by a permissive regulatory environment. The knowledge of such practice often spreads through word of mouth and clandestine networks, leading desperate patients to these locations. Some justify the exchange of organs as a means of alleviating debt, asserting that helping someone in need is not ethically problematic due to the “lack of social support systems in India” (KII#3, Policy Maker/Regulator & Transplant Surgeon). “Getting a few lakh Rupees may actually be a ‘good thing’ because at least people are not starving” (KII#6, Journalist and a potential donor). Others argue that “providing lifelong medical treatment or employment in exchange for organ donations should not be classified as monetary gain” (KII#9, Transplant Coordinator).

Such a context of poverty, income inequality, and a privatized healthcare system creates opportunities for middlemen to mediate transactions between financially distressed donors and patients. Clinicians may also be complicit, claiming ignorance about the approvals despite regulatory oversight (KII 8, Transplant Policy Maker; KII#4, NGO Founder).³

Second, persisting gender disparities with women overrepresented as donors but underrepresented as recipients pose another threat to the system (KII#1, Researcher (Previously Transplant Coordinator; KII#2, CEO, NGO).

Cross-border trafficking, particularly along the India-Nepal and India-Bangladesh borders, is another threat^35-37 as open borders with other countries in the face of weak enforcement mechanisms allow trafficking networks to flourish. Surges have also been reported following natural disasters like earthquakes and floods that force loss of livelihood, resulting in large-scale migration. A legislation criminalizing forced organ removal as a form of human trafficking has been under discussion since 2018 and is currently undergoing revisions for reintroduction in the Parliament (The Trafficking of Persons (Prevention, Protection and Rehabilitation Bill, 2021). The law aims to address all forms of trafficking, including providing protection, compensation, and rehabilitation of victims.