INTRODUCTION
The Transplantation of human organ is a life saving surgical procedure. In this procedure the failed or unhealthy organ or tissues is replaced with the healthy one. The one is known as donor, who donate the organ and other one is called as receipt in whose benefits the organ is transplanted. Donor can be either living or deceased person. It is a complex medical process involving the removal of a donor organ and its surgical implantation into a recipient. This therapeutic procedure can be done to treat end-stage organ failure, restore function, and improve quality of life. The Solid organs that can be removed and transplanted from one person to another is kidney, liver, lungs, and pancreas. Even the tissues like Corneas and heart valves can also be transplanted. The Transplantation of Human Organs and Tissues Act recognizes two types of organ donation: Living donation and cadaveric donation. Certain organs can be donated while a person is still alive because the body can continue to function normally. These include one kidney, a part of the liver, and a portion of the pancreas. Under the current legal framework, a living donor must be at least 18 years old and must give free and informed consent for the removal of any organ or tissue during their lifetime. The law places strong emphasis on the donor’s voluntary decision, enduring that no one is forced or pressured into donating1. As per the law only near relative can be do living organ donation to their relative. Near Relative includes mother, father, wife, husband, sister, brother, grandson, granddaughter, grandmother, grandfather, son, daughter. Although donation from non-relative is also granted by the statute but it should be out of love, affection, attachment and for any other reason. There is no such restriction for multiple organ donation. As far as cadaveric organ donation is concern everyone during his life time can give a consent for the removal of his/ her organ after his death. Informed consent system is prevailing in India for cadaveric organ donation. Although percentage of cadaveric donation is very less as compared to living organ donation in India. But even after having an informed consent of the person, the consent of near relative is mandated while removing the organ of the deceased person after his/her brainstem death.
Uterus Transplantation: Uterus transplantation offers real hope to women living with absolute uterine-factor infertility. So far, about 78 women worldwide have received transplanted uterus, and around 40 children have been born through this procedure, according to recent report. However, despite these positive outcomes, serious ethical concerns and the absence of a clear legal framework still remain unsolved. No such proper and specific guidelines is available for uterus removal and transplantation. Women with congenitally missing uteruses make up the majority of beneficiaries, who primarily receive grafts from living donors. However, as the surgery becomes more widely used, it is expected that both donor and recipient selection will increase. It is still not clear how informed consent is taken from women for the removal and transplantation of the uterus. Such complex procedures demand strong safeguards to endure that patients fully understand the risks involved. Continuous protection of patients is essential, which can only be ensured through strict regulatory oversight and transparent reporting of long-term health outcomes.
The First Uterus Transplant in humans was carried out in Saudi Arabia in 2000, But it was not successful because blood clots blocked the blood vessels, leading to loss of the transplanted uterus. Later, in 2011, Turkey reported a successful uterus transplant marking an important step forward in this filed2. On 4 September 2014, the first baby born from a transplanted uterus marked an important breakthrough in medical science3. After this success in Sweden, uterus transplantation became a promising treatment for women suffering from absolute uterine factor infertility, a condition that affects about one in every 500 women. Since then, more than 130 uterus transplant surgeries have been performed worldwide, leading to the birth of over 70 children. The world’s first eight successful births following uterus transplantation took place at Sahlgrenska University Hospital in Sweden4.
INTERNATIONAL PERSPECTIVE ON UTERUS TRANSPLANTATION
Uterine dysfunction accounts for 3 to 5% of all cases of infertility, which effects up to 15% of the reproductive population5. This anomaly typically prompts women to think about adoption or surrogacy. However, surrogacy is severely limited or even forbidden in many nations, including Sweden and Japan. In Some situations, uterine transplantation may be an option, however it is experimental.6 Donating live or deceased organs is not the only option for uterine transplantation. The World Health Organization Guiding Principles states that “in order to avoid the inherent hazards to living donors, organ donations from deceased donors should always be developed to their full potential”.7 However, due to the shortage of suitable organs from deceased donors, transplants often depend on living donors to meet current patient needs. As a result, live organ donation is practiced even though it may involve significant health risks for the donor.The WHO’s “Guiding Principles on Human Cell, Tissue and Organ Transplantation” provide the foundational ethical and regulatory framework for organ and tissue transplantation worldwide.8 These principles emphasize consent, voluntary donation, non-commercialization (i.e. no organ trade), transparency, equitable access, and strong protections for living donors.9 European Union parliament is also not having special documents or guidelines related to Uterus Transplantation. Although recently European Parliamentary Research Service (EPRS) summarizes the legal situation on surrogacy across EU Member States, showing wide variation. There is no uniform EU Legislation specific to Uterus Transplantation. Even Uterus Transplantation is expected to fit under the general organ/ tissue-transplant regime.10 There is a regulatory overlap between transplant law and assisted-reproduction law. Even USA the uterus transplantation is regulated by existing legal framework for the organ donation. No specific legislation is enacted related to Uterus transplantation in USA.
MEDICAL COUNSEL OF INDIA’S GUIDELINES FOR UTERUS TRANSPLANTATION
Because India has a large assisted reproductive technology (ART) industry, it was natural for the country to explore uterus transplants, which are expected to become a routine medical practice in the coming years. The legal dimension of uterus transplantation in India is presently managed indirectly through general organ transplant and medical research laws and guidelines, particularly the Transplantation of Uterus transplantation is still a very new and experimental procedure in India. While this development offers hope to women who are unable to carry a pregnancy, it also raises significant medical and social concerns. In a society where women are often under pressure to have a biologically related child, such research may be rushed or misused without enough protection for women. In India, organ transplant are usually governed by the Transplantation of Human Organs and Tissues Act, 1994 which sets clear rules for donor consent and permits only authorised hospitals to carry out transplant proceedings.
But THOTA is meant for established treatments, not experimental procedures like uterus transplantation. The Indian Council of Medical Research (ICMR) is supposed to guide and regulate all biomedical and health research. Ideally, before the first uterus transplant took place in India, the ICMR should have convened experts, ethicists, women’s rights groups, and doctors to frame clear ethical guidelines. This did not happen. Other bodies have limited roles like The Drugs Controller General of India (DCGI) approves drug trials, not surgical experiments like this. The Health Ministry’s Screening Committee (HMSC) reviews international research projects. Institutional ethics committees can review the research proposal but cannot enforce penalties if guidelines are broken. The problem is that while ICMR’s guidelines apply on paper, the ICMR has no legal power to stop unethical trials or punish violations. If a patient is injured or dies during uterus transplant research, compensation is not guaranteed. The Medical Council of India (now NMC) technically can act against unethical doctors, but such action is extremely rare. This lack of regulation has led to problems before, especially with unproven stem cell “therapies,” where ICMR declared trials unethical but could do nothing to stop them. The same risk exists with uterus transplant—an experimental procedure that involves not only the surgical risk to the recipient, but also a major surgery for the donor, who is often a woman from the same family. Overall, the case of uterus transplantation exposes a major gap in India’s oversight system: We have laws for organ transplants (THOTA) and guidelines for research (ICMR), but no strong authority to regulate high-risk experimental surgeries like uterus transplant. Until such regulation exists, both donors and recipients remain vulnerable, and the ethical concerns around women’s autonomy, family pressure, and medical risk remain unaddressed.
ISSUE WITH THE TRANSPLANTATION OF HUMAN ORGANS AND TISSUES ACT, 1994 AND UTERUS TRANSPLANTATION
Since that historic 2014 birth in Sweden, uterus transplantation programs have been initiated in various countries, including the United States, the United Kingdom, Turkey, India, and more. Researchers and medical teams worldwide are working to refine the procedure and expand the pool of potential donors. In the United States, the first successful uterus transplant was achieved in 2016 at the Cleveland Clinic11. The recipient gave birth to a healthy baby boy in 2017, further solidifying the potential of this procedure. In India, the first successful womb transplant was done at the Galaxy Hospital in Pune. After conducting two successful uterine transplants in May 2017, the third successful uterine transplant was conducted in January 2018 by Dr. Shailesh Puntambekar and his team. All three womb (uterus) transplants at Galaxy Care Hospital were performed using laparoscopic (keyhole) surgery, which caused less pain and helped patients recover faster. The hospital has also started India’s first Uterus Transplant OPD to provide consultation and care for patients who need this treatment. Earlier, the first uterus transplant surgeries in India were carried out at a hospital in Pune in May 2017, where surgeon performed the surgery with the support of a cardiac transplant surgeon12. As the Transplantation of Human Organ and Tissue Act hospital has the approval for therapeutic transplants and certification as transplant Hospital which is one of the mandate of this act. It is one of mandatory requirement of this act is to obtain certification and approval from the appropriate authority13. In totality this transplantation of uterus procedure is not for therapeutic14 purpose. This process in not a lifesaving process.
ISSUES OF CONSENT AND SOCIAL, RELIGIOUS AND ETHICAL ISSUES
The Inform consent system is adopted in India for the human organ donation purpose. As Per Section 3 of Transplantation of Human Organ and tissue Act, 1994 a person can authorize the removal of their organs after death, either by making a written declaration with witnesses or by authorizing it on their driving license. If the person has not given prior authorization, the person in lawful possession of the body can give consent, provided no near relative objects15. As far as living organ donation is concerns the provision of section 9 clearly states that living donations are generally restricted to “near relatives” (spouse, son, daughter, father, mother, brother, sister), and requires approval from an Authorization Committee, especially for unrelated donors or foreign nationals16. The section also addresses the removal of organs from minors and mentally challenged individuals. Uterus transplants raise consent issues regarding vulnerable recipients, pressure on living donors, and cultural views on reproductive organs. Socially, concerns exist about potential pressures influencing decisions and potential reproductive tourism. When ethical concerns neglect to take into account the many social, economic and geographic gaps among women, this risk emerges. The creation of unambiguous, universally applicable rules that address the particular ethical issue of uterus Transplantation from deceased donors in diverse socio-economic circumstances should be a top priority for collaborations between academics and policy making. This is a complex and evolving area that offers an opportunity to shape new knowledge and meaningful policy. Any guidelines developed must place equity, protection of vulnerable groups, and the prevention of exploitation at their core.
UTERUS TRANSPLANT AS AN EXTENSION OF REPRODUCTIVE RIGHTS
Uterus transplantation (UTx) and reproductive rights are closely linked, with the procedure offering a new way to exercise reproductive autonomy but also raising complex ethical, legal, and social issues17. While reproductive technologies use the language of “reproduction as a right,” this can create social pressure, particularly for women, to reproduce and be a mother to be considered “complete”. This pressure might influence a woman’s decision to undergo the risky procedure or for a relative to be a living donor, potentially transforming a right into a perceived duty within patriarchal and pronatalist social contexts.18
Reproductive autonomy is an integral part of Article 21 of the Indian Constitution, which guarantees the right to life and personal liberty.19 The Supreme Court of India has also through various judgments recognized reproductive autonomy as pivotal aspect of personal dignity and individual freedom. This means that every person has the right to make their own reproductive choices without unnecessary interference. In India, women’s reproductive rights are mainly governed by the Medical Termination of Pregnancy Act, 1971. By amending this act, reproductive rights of women are recognized, regardless of their marital status. One of major reason of this shift is India’s Commitment to international human rights obligations especially after ratifying treaties such as the International Covenant on Civil and Political Rights20, which requires countries to align their domestic laws with international human rights standards. Reproductive rights refer to the rights and freedoms of individuals in matters related to reproduction and reproductive health. According to the World Health Organization (WHO), reproductive rights are closely connected to the right to equality, personal autonomy, and freedom of choice. These rights include the ability to make informed decisions about reproductive health, access to accurate information and medical facilities, and the right to achieve the highest possible standard of sexual and reproductive health.
Therefore, reproductive rights form the foundation for the exercise of many other human rights. The inclusion of reproductive rights in the constitutions and laws of different countries reflects a growing recognition of women’s freedom, dignity, and control over their own bodies. India is a signatory to a number of international instruments, namely the International Covenant on Civil and Political Rights, International Covenant on Economic, Social, Cultural Rights, Convention on the Rights of the Child, and Convention on the Elimination of All Forms of Discrimination against Women, whereby the afore-stated principle is taken into account. Moreover, on the basis of Article 51(c) of the Constitution of India, the State is bound by the treaty obligations of the state. Today, the recent decisions rendered by the Supreme Court of India on the principle could be perceived to have rendered a few landmark decisions identifying Women’s Reproductive rights as a part of the inalienable survival rights implicitly guaranteed by the Fundamental Right to Life. Globally, the concept of the principle of the Reproductive rights has developed on the basis of two major components, namely, on the one hand the “right to reproductive health care” and on the other, the “right to reproductive self-determination”
CONCLUSION
The Uterus transplantation in India stands at a critical intersection of medical innovation and evolving legal frameworks. While the procedure offers new reproductive possibilities to women facing absolute uterine factor infertility, its legal dimension remains underdeveloped, particularly regarding consent, donor protection, ethical oversight, and post-transplant reproductive rights. The current reliance on general provisions of the Transplantation of Human Organs and Tissues Act, 1994 (THOTA) leaves significant gaps in areas such as psychological evaluation, commercialization risks, gestational responsibilities, and long-term monitoring of recipients. To strengthen legal safeguards, India must develop specific guidelines for uterus transplantation, including (1) a clear consent protocol addressing fertility expectations and associated risks; (2) strict regulation of altruistic and living donors to prevent coercion; (3) mandatory ethics-committee review and transparent reporting; (4) legal clarity on pregnancy rights and medical liability post-transplant; and (5) a national registry to ensure accountability and data-driven policy refinements. A dedicated legal framework will ensure that the technology progresses in a manner that is ethical, equitable, and respectful of women’s bodily autonomy.
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Footnotes
1. Available at https://www.ncbi.nlm.nih.gov/books/NBK555947/Accessed on 24th July, 2024.
2. Available at https://www.aa.com.tr/en/health/turkey-baby-born-after-uterus-transplant-healthy/1963109 accessed on 24th July, 2025.
3. Ibid
4. Ibid
5. Ibid
6. Taneja Alnkrita, Das Siddhartha, “ Uterine Transplant A Risk to Life or a Chance, Science and Engineering ethics, Vol 25 Page. 635-642, 2018
7. Sixty-Third World Health Assembly, World Health Organization. WHO guiding principles on human cell, tissue and organ transplantation. Cell Tissue Bank. 2010; 11(4):413–419.
8. Available at https://iris.who.int/bitstream/handle/10665/341814/WHO-HTP-EHT-CPR-2010.01-eng.pdf Accessed on 12.12.2023.
9. Ibid
10. Available at https://spiral.imperial.ac.uk/server/api/core/bitstreams/80c240ac-ba51-4c61-adda-20ed875e7be6/content Accessed on 23th June, 2024.
11. Available at https://www.sunrisehospitalcochin.com/blog/uterus-transplantation accessed on 26th July, 2025.
12. Ibid
13. The Transplantation of Human Organ and Tissue Act, 1994 sec.14
14. Ibid sec.2(o)
15. Ibid section 3
16. Ibid section9
17. Donovan Laura O’, Pushing the boundaries: Uterine transplantation and limits of reproductive autonomy”, Vol 32(8) Bioethics 2018 489-498
18. Ibid
19. The Constitution of India, 1949 art. 21
20. Avaiable at https://nhrc.nic.in/international-covenant-on-civil-and-political-rights-%28iccpr%29#:~:text=The%20International%20Covenant%20on%20Civil%20and%20Political,on%20Economic%2C%20Social%20and%20Cultural%20Rights%20(ICESCR) Accesssed on 25th July, 2024.