INTRODUCTION
The law has been challenged by technology for a long time, and few areas are more of a challenge to the law, and more of a nexus of the science, society, state, like the assisted reproduction technologies (ART). Technological innovations in assisted reproduction, have revolutionized the ways of achieving parenthood by separating reproduction from the traditional biological processes. Not only have these innovations altered the ways in which families can be formed, they have also transformed the ways in which the state regulates and understands the meanings of intimacy, kinship, and bodily autonomy.
Assisted Reproductive Technology (ART) refers to medical procedures used to treat infertility by handling eggs, sperm, or embryos outside the body to achieve pregnancy. The various types of ART are IVF (in-vitro fertilization), surrogacy, intracytoplasmic sperm injection, frozen embryo transfer, use of third-party gametes, etc.
The transformed ways of achieving parenthood through ART and the accompanying state regulation in the context of India, have to be understood against the social, cultural, economic backdrop of the legitimate heterosexual adult marital union where biological parenthood is intricately linked to the social identity of the couple, the stability of the marriage, and the expectations of the family. Infertility, in any of its forms, is a major health issue with severe emotional, social, and relational consequences. Over the last three decades, the emergence of fertility clinics and the availability of assisted reproductive technology (ART) procedures, have made India one of the leading countries in the world for reproductive health services.1 This growth has, however, been more or less spontaneous and in the absence of any enforceable statutory regulations earlier was based on consumer and professional self-regulation.
The Assisted Reproductive Technology (Regulation) Act, 2021 is the most comprehensive effort by the state to regulate the sector’s fast growth.2 The Act seeks to enforce ethical norms, prevent the exploitation of individuals, and address the legal concerns regarding the parentage of children born through ART by setting up a licensing, monitoring, and penalizing regime. Specifically, the Act addresses the long-standing concern about the commoditization of reproductive care and the exploitation of donors and patients. The Act introduces a new system of legal regulation.
Like other laws which attempt to tackle intimately personal issues, the ART Act cannot be seen as a mere collection of technical provisions. It reflects certain assumptions about the nature of a family, how technology should be used to aid reproduction, and how much of personal choice the government should control. By instituting access barriers to certain groups, and by operating taxonomy of assisted reproduction as a medical issue of infertility and not a personal choice, the statute advances a reproductive framework of a certain normative standard.3 This brings us to the fundamental question of how much the state can control the approach to parenthood without violating the constitutional guarantees of autonomy, equality, and dignity.
In the Indian context, a body of constitutional jurisprudence has developed the idea that family, reproduction, and bodily autonomy decisions fall within the preserved realm of personal liberty. The privacy protection coupled with the developing equality adjudication of the Court presents an important angle from which the ART Act should be analyzed. These trends indicate that reproductive choice is not simply a matter of policy arbitrariness, but a matter that ought to be nuanced with the constitutional framework of individual autonomy and the right to not be discriminated against.4
This article begins with the assumption that the regulation of reproductive technologies has to strike a balance between reasonable state concerns and individual liberties. While regulation is needed to ensure safety and prevent predatory practices, frameworks that are overly prescriptive can result in the regulation becoming moralistic. The primary case being made is that although the ART Act is likely well-intentioned, it is a protectionist approach that unwittingly constrains reproductive autonomy and reinforces a more traditional view of family5The author has chronicled the history of ART regulation in India and the evolution of the 2021 Act. The author suggests that we should approach reproductive law and privacy law from the perspective of the positive or pro rights of the individual. The law should regulate scientific developments and at the same time uphold constitutional values, individual autonomy and reflect the pluralism of contemporary society.
LEGISLATIVE HISTORY OF THE ASSISTED REPRODUCTIVE TECHNOLOGY (REGULATION) ACT, 2021
To better understand the Assisted Reproductive Technology (Regulation) Act, 2021, it is pertinent to analyze the history of reproductive governance in India. The Act has come into being after several years of policy deliberations influenced by ethical considerations, judicial activism, and the ever-growing fertility business. It embodies the state’s attempt at both controlling a complicated medical sector and engaging with emerging social discourses on family formation, technology, and reproductive autonomy.6
An attempt at regulating assisted reproduction in India for the first time was made by the Indian Council of Medical Research (ICMR). It proposed in 2005 National Guidelines for Accreditation, Supervision and Regulation of ART Clinics which tries to provide a uniform standard for clinical practice. These guidelines were the first to address matters surrounding ethical issues in assisted reproductive technologies like donor screening, informed consent, confidentiality, and record-keeping. The guidelines only provided suggestions and not concrete instruction. This meant that compliance was entirely left up to voluntary consistency which created varying standards among clinics. With the rapid expansion of fertility services, the concerns regarding commercialization and the potential exploitation of women as donors or surrogates grew. This highlighted the need for law to be put into place. 7
The draft Assisted Reproductive Technology (Regulation) Bill of 2008 proposed a comprehensive licensing model, along with national and state regulatory authorities. This draft was the first indication of a move away from self-regulation by the profession to the legal regulation of the industry. Revised drafts from 2010 and 2014 included responses from a diverse range of stakeholders , including clinicians, women’s advocacy groups, and policymakers. These drafts reflect the competing concerns that balanced the law’s encouragement of scientific progress with ethical concerns about commodification and unequal roles in bargaining. In this context, policy discussions started to see ART in conjunction with surrogacy, and the regulatory over lapses with issues of parental rights, consent, and contracts.
In its 228th report8, the Law Commission of India underlined the need for legal clarity on issues of parental rights, consent, assisted reproduction. The Commission also warned about the unregulated commercialization of reproduction, particularly for women in lower economic brackets. By proposing a regulatory framework that sought to balance control and freedom with respect to reproductive rights, the Commission shaped the direction of legislative ‘thinking’ in the subsequent order.9
One of the greatest accomplishments for formal regulation of assisted reproductive technology was the introduction of Assisted Reproductive Technology (Regulation) Bill, 2020 that was tabled in Parliament and then sent to the Department-related Parliamentary Standing Committee on Health and Family Welfare for additional review. The report from the Committee addressed various issues from the standpoint of transparency regarding how clinics operate, donor protection and exploitation, the legal status of children born to parents who utilize ART, and the sociological debates surrounding access and eligibility (including non-normative families) and the dichotomy between the rights of individuals to reproduce freely and the conflict with social norms.10
The passing of the ART Act in 2021, along with the Surrogacy (Regulation) Act, indicated the first instance of legislative coordination on assisted reproduction in India.11 These two Acts represent the state’s attempt to regulate a growing area of biomedicine. However, the law, in addition to clinical standards, takes into consideration social values concerning family and reproduction.
KEY FEATURES OF THE ASSISTED REPRODUCTIVE TECHNOLOGY (REGULATION) ACT, 2021
The Assisted Reproductive Technology (Regulation) Act, 2021 is an important step forward in ensuring access to and regulation of assisted reproductive technologies (ART). This law is significant as it establishes a detailed regulatory framework for the ART sector, which has, until now, been unregulated without any laws governing it.
National and State Assisted Reproductive Technology and Surrogacy Boards
One of the noteworthy aspects of this legislation is the establishment of National Assisted Reproductive Technology and Surrogacy Board along with corresponding State Boards.12 These bodies are given the authority to set baseline standards, provide policy guidance to governments, and ensure adherence to legislation. The creation of a multi-agency regulatory framework is an important departure from relying on self-regulation by the professionals and represents a significant level of formal accountability. Ideally, this type of framework would enhance the consistency of standards and reduce the likelihood of unethical or unsafe practices.
Registration of ART Clinics and Banks
To complement this oversight framework, the legislation mandates the registration of all ART clinics and gamete banks.13 To obtain a license, a facility must meet baseline requirements including, but not limited to, the minimum standards for health facility infrastructure, staffing, and health records. The Act promotes audits and compliance to prevent fraud, and keep the fertility industry accountable.
Informed Consent
Informed consent is one of the Act’s main features. Consent in writing must be obtained from the intended parents and gamete donors before any procedures may be performed.14 The Act mandates what is required to be disclosed, including the risks, benefits, chances of success, and the potential impact of the procedures. This legislation promotes transparency, and protects the individuals from being misled, or not being informed, or being influenced, or the information being inadequate.
Anti-Commercialization
The Act is the first to regulate gamete donation and ART banks. The Act regulates the collection, storage and use of gametes, and the eligibility requirements of donors. This regulation has addressed the concerns of commercialization and exploitation. These measures, along with medical safety, are meant to protect donors’ ethical and medical safety and are aimed at preventing, even more, the legislative intent to prevent the commercialization of reproductive materials, which is a recurring theme in the debates concerning India’s fertility sector.
Parentage
The Act clearly states that the children resulting from assisted reproduction are the biological offspring of the commissioning parents, thus clearly granting them full parental rights and inheritance rights.15 Before the enactment of this Act, there were many uncertainties regarding guardianship, and there was no legislation on this issue. The Act recognizes the parentage and provides the family created through ART with a higher degree of legal certainty.
Offences and Punishments
The Act’s objectives are further clarified in the provisions pertaining to offences and punishments16, which are intended to limit the number of unlicensed clinics, the trafficking of embryos, and the exploitation of donors. These measures are intended to minimize the ethical risks in reproductive care and to demonstrate the level of seriousness that the state expects of ethical compliance.17 The law also requires clinics to maintain specific and extensive records, and to report their data. Although this supports improved oversight and accountability, it also raises the concerns around clinics and their data management and the sensitive nature of reproductive information.
By setting minimum standards for clinic infrastructure and staffing and outlining how procedures should be carried out, it attempts to guarantee that all patients seeking care in fertility clinics receive an adequate level of safety and quality. These elements indicate that the ART Act attempts to do more than just provide a set of regulations; it offers a set of tools to control how reproductive health care is practiced in India. It aims to ensure a safety net for patients and ethically, some control on the operations of the ART clinics, while also providing a detailed blueprint of how ART services should be provided. Articulated in the legislation is a set of regulatory mechanisms that define and govern assisted reproductive services and a recognition of the need to adjust to the established legal order, constitutional and social developments.18
Age Limits Prescribed under the Act
One of the most contentious issues in the assisted reproduction regime in India is the age criteria prescribed for different stakeholders. These sections reflect the effort of the legislature to strike a balance between ethical and medical imperatives. However, these sections have been criticized on the grounds of reproductive autonomy. The ART Act has directly correlated the eligibility for assisted reproductive technologies with certain age criteria. For instance, a woman seeking access to ART services must be between the ages of 21 and 50 years, while a man must be between the ages of 21 and 55 years.19 The age criteria prescribed for eligibility under the Act is based on medical imperatives of reproductive health and the risks associated with older reproductive age. The prescription of an upper age limit for eligibility is based on the medical consideration of ensuring that these procedures occur in a relatively safer biological window, as well as taking into account the concerns regarding the welfare of the child in the long run.
The Act understands the importance of the health and genetic viability of potential donors, and outlines age requirements for gamete donors. For instance, potential egg donors must be women of a certain age within the reproductive capacity, while potential sperm donors must be within a certain age range deemed medically appropriate. These provisions demonstrate the regulations aimed at balancing the health and safety of the practice and the ethical concerns surrounding the process. The Surrogacy (Regulation) Act, 2021 takes a strict approach, especially when it comes to surrogacy mothers. It provides that a surrogate must be a married woman between 25 and 35 years of age and may act as a surrogate only once in her lifetime.20 This shows there is legislation that is trying to focus on health and exploitation. While the age range is based on lower obstetric risks, critics argue it is reductive. In addition the Surrogacy Act sets age criteria for intending couples also. The intending woman must be 23 years and not older than 50 years of age, and the intending man must be aged 26 years and not older than 55 years.21 The Act also allows a woman who is a widow or divorcee between the age of 35 to 45 years to avail the surrogacy.22 These thresholds suggest there is an attempt to maintain coherence across the regulatory framework governing assisted reproduction.
Limiting age for intending couples is a policy that serves various purposes. Firstly, it shows there is a need for precaution which works on the principles of risk management as it is known that fertility treatment, pregnancy and child birth come with different risk and dangers which could be worse depending on the age of the intended parents. This is also important when it comes to the welfare of the child when birth is done through assisted reproduction as it is of concern to how the parents will provide long term care to the child. However there are some normative and constitutional issues raised by these provisions. Critics argue that firm upper age limits may unduly curtail the right to reproduce. This is particularly true in a social setting where people are encouraged to delay becoming parents for educational, professional, or personal reasons. Constitutionally, these restrictions are considered to be overstepping role of the state’s right to control people’s private lives.
The age limits outlined in the two statutes are a reflection of the dominant norm in India with regard to the governance of reproduction. Rather than giving the determination of eligibility to the discretion of a medical practitioner, the legislature has opted to include specific criteria within the statutes. This model highlights the ongoing balancing act between social control and personal freedom that is characteristic of the regulation of reproduction and the law. The age limits in the Surrogacy and ART Acts illustrates the complex intersection of social, ethical and medical issues in the control of assisted reproduction. Although these provisions are aimed at protecting the health and preventing the exploitation of women, their continued validity will depend on how they are enforced against the background of an evolving jurisprudence on with regard to the right to privacy, dignity, and reproductive choice.
CONSTITUTIONAL ANALYSIS OF THE ACT AND THE JUDICIAL TREND REGARDING POSTHUMOUS REPRODUCTION
Article 21 of the Constitution of India and Reproductive Autonomy
The Constitution of India has progressively included measures to protect the personal rights and liberties of individuals, such that individuals have power over their own lives. As per the judgement of the Supreme Court in Justice K.S. Puttaswamy (Retd.) v. Union of India23, the Supreme Court has determined that an individual’s right to privacy also includes the right to choose for oneself how to live one’s life as a family, to reproduce, and to have control over one’s body.
Furthermore, in the case of Suchita Srivastava v. Chandigarh Administration24, the Hon’ble Supreme Court recognized that freedom to make reproductive choices as to whether and how t bear children is an intrinsic part of personal liberty. The Supreme Court has, again, reiterated this belief in Devika Biswas v. Union of India25, and stated that reproductive health policies should honour the dignity and autonomy of individuals; there should not be any paternalistic intervention by the State.
In the light of the above, the eligibility requirements of the ART Act, particularly those related to marital status, raise the question of whether the regulations have an impact on reproductive autonomy in violation of the Constitution.
Equality and Article 14
The essence of Article 14, therefore, is that laws must classify and categorize in a way that makes reasonable sense and must do so in a way that relates to the purpose of the legislation. In Navtej Singh Johar v. Union of India,26 the Supreme Court directed to think beyond social stereotypes and accept a range of identities and relationships. In National Legal Services Authority v. Union of India27, the Supreme Court held that transgender persons are equal to all other persons and deserve to be accepted, recognized, and valued.
The decision in Anuj Garg v. Hotel Association of India28 indicates that laws that are based on gender stereotypes or patronizing ideas are open to challenge under the Constitution. From this perspective, one could ask whether the discrimination in the ART Act as to the necessity of heterosexual marital families is justified or merely perpetuates stereotypes. Morever, the Act also excludes single men and LGBTQ+ community people, which is violative of their right to equality.
Decisional Freedom and Article 19
The courts view the right to marry and to form a family as part of “Decisional Autonomy,” which is afforded constitutional protection. As held by the Supreme Court in Shafin Jahan v. Asokan K.M.29, making personal decisions regarding one’s relationships is an essential aspect of one’s liberty. Also, as held by the Supreme Court in Joseph Shine v. Union of India30, the State’s “moral judgement” cannot interfere with private or intimate relationships and thus should respect private choice.
Posthumous Reproduction and the Judicial Response
The case of posthumous reproduction in India appears to be at a crossroads, where developments in technology meet ethics, legislation, and the grundnorm of the country, i.e. the Constitution of India. While the ART Act does deal with the use and storage of reproductive materials, it does so on the assumption that the commissioning party is alive. On the other hand, the Surrogacy Act assumes living intending couple and does not leave for a lot of room for interpretation in cases where one of the persons whose gametes used in reproduction has died.
Neglecting to include a broad and cohesive rights and law paves the way to having inconsistent regulation of posthumous reproduction, usually developed based on individual freedom and the right of individuals to make their own decisions (as per Article 21) in the Indian Constitution. While this protects individual choices, it does so in a fragmented and inconsistent way, leaving the most affected stakeholders, such as the medical profession, the family, and the child, in a gray area.
The Indian courts appear to place the most importance on the consent of the deceased in relation to posthumous reproduction and whether it would be considered legal. In a recent case, the Delhi High Court allowed for posthumous reproduction if there is express consent from the donor of the gametes used in reproduction.31 This follows the approach taken in relation to reproductive rights, as indicated in Suchita Srivastava, but in the absence of legislation in this area, the burden of proof in relation to consent remains a significant concern.
One emerging trend in the law is that of the treatment of reproductive material as part of the deceased’s estate. In a 2024 Delhi High Court ruling, the court allowed the deceased’s semen to be released to his parents. The judges in this case treated the semen as part of the deceased’s assets, and it was therefore something that his legal heirs could claim.32 Although this was a practical solution to the problem in this particular case, it is also somewhat worrying in that it does not deal with the moral or ethical implications of the decision.
One of the most important questions that have been left unanswered by the law is that of the treatment of children born after the death of their parent. The law on succession assumes that the heir to an estate is conceived while the deceased was alive, but it does not say what happens to the rights of the heir conceived after the death of the deceased. The law has avoided dealing with this question in most cases by focusing on who is entitled to the deceased’s reproductive material instead of dealing with the implications of posthumous reproduction. Apart from the law, there are also serious questions about the implications of posthumous reproduction on the child and the motives of the relatives in wanting to have children through the deceased’s reproductive material. However, it would be too restrictive to reproduction rights to prohibit it altogether in the case of someone who had expressed a genuine desire to have children but was suffering from a fatal illness.
CONCLUSION
The Act for the first time, provides regulatory frameworks to a rapidly evolving area of practice of ART. With this, the Act tries to address a growing concern regarding the exploitation and malpractice, and the ambiguous parental identities of the children born via assisted reproduction. The Act, therefore, is an attempt to fill the regulatory void concerning the newly emerging area of assisted reproduction and recognizes the area’s increasing significance to modern healthcare and the formation of families.
The law, in a protectionist fashion, reduces a person’s options by restricting access to certain family structures and defining an individual’s situation through eligibility criteria. The law, particularly constitutional law and the developing jurisprudence relating to privacy, dignity, and equality, positions the law on the ‘intrusive’ involvement of the state on what is deeply personal and fundamental to the individual’s decision-making. While the ART Act is a requisite regulatory intervention, it is also a site of constitutional challenges. This approach isolates reproductive technologies from their potentially or actually diverse and multiple uses in family formation. The law needs to keep up with the expanding social understanding of kinship.
There are several potential proposals related to this situation. One option could be to change the criteria regarding applying for ART. These criteria could be modified so that individuals or families are not restricted based on their marital status or the existing socio-cultural practices. Balancing the ethical considerations surrounding assisted reproduction with providing affordable and accessible services remains a challenge. In the absence of additional policy measures such as health insurance coverage, selective subsidization, or a greater number of fertility services in the public sector, assisted reproduction will remain a dream for the economically disadvantaged. As a result, inequities in reproductive healthcare will continue to be deepened. There must be greater emphasis on privacy and data protection within the regulatory framework. The law must ensure that there are confidentiality protections.
It would be prudent to create mechanisms in the law that allow for a review at defined intervals. Laws that do not adapt to the changes in science and the accompanying ethical issues will quickly become irrelevant. The ART Act will only be successful if the regulations are precise, and the provisions are adaptable to the core values of the Constitution. The types of changes ART Act demand will balance the need for protective measures in support of reproductive autonomy, and the need to protect rights. Such a balance will be essential to guarantee that, reproductive technologies will not be a hindrance to, but will rather assist, reproductive choices. In this sense, the Act is not a closure, but rather a starting point of the conversation on the law’s ability to ethically and constitutionally regulate reproductive rights in India.
*****
Footnotes
1. Gupta, J. A. Reproductive biomedicine in India: Regulation and policy gaps. Reproductive Biomedicine Online, 24(6), 660–666 (2012).
2. The Assisted Reproductive Technology (Regulation) Act, 2021, No. 42 of 2021 (India).
3. Macklin, R. Ethical challenges in assisted reproduction. Cambridge Quarterly of Healthcare Ethics, 28(1), 5–16 (2019).
4. Bhatia, G. The Transformative Constitution. HarperCollins India. (2019).
5. Dorothy Roberts, Killing the Black Body: Race, Reproduction, and the Meaning of Liberty (Vintage Books 2015).
6. Qadeer, I. The ART of regulation: Assisted reproductive technologies in India. Social Scientist, 38(9–10), 49–64 (2010).
7. Gupta, J. A. Reproductive biomedicine in India. Reproductive Biomedicine Online, 24(6), 660–666 (2012).
8. Law Commission of India, “228th Report on Need for Legislation to Regulate Assisted Reproductive Technology Clinics and Rights of Parties” (2009). Available at https://lawcommissionofindia.nic.in/cat_new/
9. Saxena, P. Surrogacy and legal parentage in India. 9, 85–102 (2018).
10. Department-related Parliamentary Standing Committee on Health and Family Welfare, 129th Report on the ART (Regulation) Bill, 2020 (2021). https://prsindia.org/files/bills_acts/bills_parliament/2020/SCR%20The% 20Assisted%20Reproductive%20Technology%20(Regulation)%20Bill,%202020.pdf
11. The Surrogacy (Regulation) Act, 2021, No. 47 of 2021 (India).
12. Assisted Reproductive Technology (Regulation) Act, 2021, §§ 6-8.
13. Assisted Reproductive Technology (Regulation) Act, 2021, § 15.
14. Assisted Reproductive Technology (Regulation) Act, 2021, § 22.
15. Assisted Reproductive Technology (Regulation) Act, 2021, § 31.
16. Assisted Reproductive Technology (Regulation) Act, 2021, § 32-37.
17. Sarojini, N. B., &Marwah, V. Regulating ART in India. Indian Journal of Medical Ethics, 7(1), 12–18. (2022).
18. Devyani Jain, Regulating Fertility Services in India, 5 Indian L. Rev. 215 (2021).
19. The Assisted Reproductive Technology (Regulation) Act, 2021, § 21(g).
20. The Surrogacy (Regulation) Act, 2021. §. 4(iii)(b).
21. The Surrogacy (Regulation) Act, 2021. §. 4(iii)(c)
22. The Surrogacy (Regulation) Act, 2021. §. 2(1)(s).
23. (2017) 10 S.C.C. 1.
24. (2009) 9 S.C.C. 1.
25. (2016) 10 S.C.C. 726.
26. (2018) 10 S.C.C. 1.
27. A.I.R. 2014 S.C. 1863.
28. (2008) 3 S.C.C. 1.
29. (2018) 16 S.C.C. 368.
30. (2019) 3 S.C.C. 39.
31. Ishita Mishra, No Prohibition under Indian Law on Posthumous Reproduction, Says Delhi HC, The Hindu, Oct. 5, 2024, https://www.thehindu.com/news/cities/Delhi/no-prohibition-under-indian-law-on-posthumous-reproduction-says-delhi-hc/article68721837.ece.
32. Gurvinder Singh v. Govt. of NCT of Delhi, 2024 S.C.C. Online Del. 6902. https://www.scconline.com/blog/post/2024/10/08/delhi-hc-directs-ganga-ram-hospital-hand-over-semen-sample-deceased-son-parents-posthumous-reproduction/