Assisted Reproductive Technology (Regulation) Act 2021: Critique and Contestations

Abstract

The article critically examines the Assisted Reproductive Technology (Regulation) Act 2021, its development process spanning 15 years, and its potential shortcomings in addressing the needs of India’s 27 million infertile couples. By scrutinizing the recommendations presented in the Parliamentary Standing Committee on Health and Family Welfare’s 129th report, the critique argues that the Act may not effectively cater to the diverse reproductive rights of the population. The article claims that most of its suggestions are in opposition to redefining families and accepting inclusive family structures other than heterosexual marriages. The study posits that the Act, with its inherent limitations, perpetuates the reinforcement of patriarchal family structures that medical science intends to disrupt. In order to foster inclusivity and comprehensibility, the article advocates for necessary amendments that align with the interest of the general populace.

Introduction

In contemporary India, infertility has emerged as a significant public health concern. According to the World Health Organization, India has a primary infertility prevalence of between 3.9 and 16.8% (Mittal and Sharma 2017). Fortune Business Insights anticipates the ART sector will hit $45 billion by 2026. India is ranked third among Asian nations in its ART market (Kaunain 2021). In vitro fertilization (IVF) has the potential to account for around 4% of the world’s population by the end of this century, or 400 million babies (Banker 2019). This necessitates the creation of nation-specific standards for assisted reproduction due to the wide range of management methods and lack of standard operating procedures. There has been a surge in assisted reproductive technology (ART) use since Louis Brown, the first IVF baby, was born in 1978, enabling infertile couples to have their biological progeny. In 1981, Dr Subhash Mukhopadhyay’s successful efforts resulted in the birth of Durga, the first IVF child in Kolkata, India; however, the government refused to acknowledge this claim for moral and ethical reasons (Jaggi and Chaudhary 2022). On the contrary, in 1986, Dr T. C. Anand Kumar and Dr Indira Hinduja claimed India’s first IVF baby named Harsha and was backed by the Indian Council of Medical Research (ICMR) (Jamwal and Yadav 2022). Since then, there has been a proliferation of assisted reproduction facilities around the nation. The public health sector, however, lacks fertility services and is ill-equipped to handle them. As a result, most ART clinics are in the private sector and are therefore commercialized. Because there is no framework in place to ensure compliance, the industry is largely unregulated despite the existence of ICMR standards. In an effort to address this issue, the Indian Council of Medical Research (ICMR) drafted an assisted reproductive technology (ART) statute for assessment in 2014. To ensure that ART benefits patients and healthcare professionals equally, it is crucial that appropriate measures are implemented. Prabha Kotiswaran noted discrepancies between the Surrogacy (Regulation) Bill of 2018 and the Assisted Reproduction Technology (ART) Bills in a recent review of the murky and ambiguous landscape of commercial surrogacy in India (Banerjee and Kotiswaran 2021a). Since the ART legislation already had provisions for surrogacy agreements, many feminists think the Surrogacy Bill is unnecessary and should be repealed. Kotiswaran draws attention to various gaps in the Surrogacy Bill’s definitions of ART procedures, frequently failing to distinguish between gestational surrogacy using anonymous sperm/ova donors and that which does not. In addition, the Supreme Court heard arguments in Jayashree Wad v. Union of India (WP [C] No. 95/2015), a public interest litigation (PIL) that sought to criminalize transnational commercial surrogacy (Banerjee and Kotiswaran 2021b). In 2016, the government barred international commissioning parents’ access to surrogacy in India due to rising concerns about the mistreatment of women as surrogates. It announced a distinct surrogacy law, separating it from the broader ARTs category. Nonetheless, parliamentary authorities, most notably a Rajya Sabha select committee that examined the Surrogacy (Regulation) Bill, 2019, have suggested that surrogacy and ARTs be regulated concurrently, stressing the necessity for an ART Bill (hence, SRB, 2019) (Chandran 2022a, b). Finally in September 2020, the Lok Sabha was presented with the Assisted Reproductive Technology (Regulation) Act, 2021. The Parliamentary Standing Committee (PSC) on Health and Family Welfare, which oversees the department, received the ART Bill, 2020, and on 17 March 2021, it delivered its 129^th report on the matter. The ART Bill, 2020, was tabled in the Lok Sabha on 14 September by Union Health Minister Harsh Vardhan (Kotiswaran 2020). Its objectives were to monitor ART banks and clinics, permit ethical and moral ART practice, and safeguard young girls and women from exploitation. A supplement to that measure was presented in the form of the Surrogacy (Regulation) Bill, 2019 (SRB), which has now become an act. However, the 15-year-old ART Act is still insufficient and does not take into account the needs of the 27 million infertile Indian couples (Sharma 2018). This acted as an impetus for our present investigation, which assessed whether the new act aligns with the requirements and norms of contemporary Indian society concerning its suitability and practicality. By analyzing medical, bioethical, and sociological literature, this study has employed an interdisciplinary research method encompassing socioeconomic and legal aspects. The objective of this article is to perform a layered examination specifically focusing on all aspects of artificial reproductive technology. In order to make the Act more inclusive and lucid, the article aims to call attention to the need for amendments that are both pertinent and in the best interests of the general public. Moreover, the Indian Government’s flagship program, Digital India, has markedly heightened the news media’s onus in shaping and fostering public consciousness while imparting up-to-date information. In light of this, the article has employed the methodology of content analysis and turned to netnographic research, commencing with a naturalistic perspective to facilitate a strategic analysis of news content concerning ART (Kashyap and Tripathi 2022; Tripathi 2023). The initial section of the article establishes the historical backdrop of the ART Act and underscores the significance of engaging further in a comprehensive discussion. Subsequently, the article delves into a detailed examination of the provisions within the Act, exposing the critical concerns it fails to address and the shortcomings in its inclusivity quotient. The next segment investigates the potential impact of the Act on different stakeholders, particularly highlighting the uncertainties surrounding gamete donors, as well as the contentious issue of punitive penalties that have drawn criticism from various parties. Finally, the article concludes with its major findings and gets into a space where it pins down on points that will lead to a more socially engaging policy on ART.

What is in the Assisted Reproductive Technology (Regulation) Act 2021?

Even a low estimate puts the number of ART clinics nationwide at around 40 thousand (Jaggi and Chaudhary 2022). This resulted in a variety of legal, moral, and social problems that called for uniform protocol (The Hindu 2020). In its 228^th report, the Law Commission recommended implementing legislation in 2009 to make it easier to utilize ART appropriately and to render surrogacy legal. In an effort to fill the legislative gap, the Indian Council of Medical Research (ICMR) established the National Rules for Accreditation, Supervision, and Regulation of ART institutions in India in 2005. The first surrogacy conduct regulations in the nation were established under these regulations. This comprises in vitro conception, gestational surrogacy, and gamete donation (of sperm or eggs) (Mishra and Dutta 2022). However, these treatments may only be carried out in ART clinics approved and registered with India’s National Registry of Banks and Clinics. The Central Government must establish the National Registry in accordance with Sect. 9 of the Act, and it must go into force on the date stated in a public notification (Ministry of Law and Justice 2021). As mentioned in Sect. 13, ART banks must first obtain permission from Indian clinics in order to store and provide gametes to such facilities. Additionally, these hospitals and banks will not be registered until they meet specific requirements (specialized manpower, physical infrastructure, and diagnostic facilities). Section 16(6) states that the registration is valid for 5 years and that it may be renewed for an additional 5 years (Sect. 17), subject to cancellation and suspension if the conditions of the Act are not violated (Mittal and Sharma 2017). If all compliances are accomplished, the Registration Authority will issue registration in accordance with Sect. 16 of the Act within a 30-day window. Among other things, it forbids such clinics from offering to reveal the gender of the baby. The Bill calls for the creation of the National Registry, which would serve as a lone database harboring information on all ART clinics and banks nationwide. The state government will designate registration officials to streamline the registration procedure. According to Sect. 22 of the Act, both the couple and the donor must provide their written informed permission in order to register with the clinics and avail of their services. Additionally, that party will have to offer insurance protection in support of the oocyte donor (for any harm, demise, or loss incurred by the donor) (Saraswat and Mondal 2022). Male donors must be between the ages of 21 and 55 for the treatment, while female donors must range in age from the ages of 23 and 35. Additionally, it stipulates that the female donor must be in a stable marriage with a young kid of her own (age of at least 3 years) (Ministry of Law and Justice 2021). The lady may only give one oocyte once, and a maximum of seven can be removed. These codes and standards have been described in detail in accordance with Sect. 27 of the Act. The Act’s subsection that states the rights of a child conceived through an ART technique is arguably its most crucial component. This newborn shall be considered the biological child of the commissioning spouse and shall be accorded all the rights and privileges normally accorded to a biological child, as specified in Sect. 31. No parental authority will be granted to the donor over the baby. The Surrogacy (Regulation) Act, 2021, creates federal and state agencies that would also serve as the authority in charge of overseeing ART services (Malhotra et al. 2013). Furthermore, harsh penalties are enforced if the law’s regulations are breached. For repeated violations, the criminal may receive a sentence ranging from 8 to 12 years in prison and a fine between 15,000 USD approx. (Kashyap and Tripathi 2022). Those found guilty of a violation for the first time may be required to pay a fine of 8–12,000 USD. A 5- to 10-year jail term, a penalty of 8–12,000 USD, or both might be imposed on owners of clinics or banks who provide or promote sex-selective ART. Despite being a substantial and decisive step toward minimizing the danger posed by unlicensed and illegal ART facilities and protecting donors and women receiving ART from the health risks associated with unsafe and illegal treatments, the Act falls short of adequately addressing a number of crucial issues. For instance, it is essential to note that the Act under consideration excludes various categories of individuals from accessing assisted reproductive technology (ART) services. This includes unmarried men, divorced men, widowed men, unmarried cohabiting heterosexual couples, trans persons, and married and cohabiting homosexual couples. This exclusion is particularly noteworthy as it aligns with the provisions of the Surrogacy Act, which also bars the aforementioned individuals from pursuing surrogacy as a reproductive option. Consequently, the Act’s application is restricted, significantly curtailing the reproductive choices of those excluded from its purview. Moreover, the Act lacks regulation of service prices, a matter that could potentially be addressed through the implementation of straightforward directives. Presently, infertility treatment expenses are not covered by any medical insurance in India, and the costs of such treatments vary across urban and rural areas, depending on the specific type and phase of treatment sought. Even if the aforementioned recommendations were adopted, it is important to acknowledge that the ART Act of 2021 would still result in an inequitable redistribution of reproductive services. Given the aforementioned concerns, the ART Bill has the potential to be a timely and proactive measure in addressing these issues, as it can promote reproductive autonomy and safeguard the rights of service users through the establishment of clear standards and protocols for treatment and care.

The ART (Regulation) Act 2021: a Departure from Inclusive Family Forms

One of the most significant human pursuits is the desire to start a family and have kids. However, family and kinship systems in India have traditionally been governed by the demand for blood relations within a patriarchal realm. As a result, stigmatization of infertility and childlessness stems from one’s failure to generate one’s biological children (Widge 2000). In these circumstances, ARTs are crucial in facilitating the formation of families in circumstances when doing so is socially or medically difficult. Nonetheless, the ART Act 2021 does not recognize the significance of this technology. The act forbids the use of ARTs by nonmarital and same-sex couples. The PSC report endorses these legislative changes and cites progressive laws from France, Switzerland, and Ireland that permits lesbian couples and single women to get ARTs. It exemplifies the ingrained gender inequality in our culture. It limits surrogacy to partners legally wed under Indian law, barring same-sex and non-binary couples from having children. Acts like these are egregious insults to the LGBTQ + community and childless single fathers.

Validation of same-sex relationships in India is as recent as 2018 when a bench of five judges of the Supreme Court of India decriminalized homosexuality. In their judgment, they modified certain aspects of Sect. 377 of the Indian Penal Code (IPC), thereby granting LGBTQ + individuals the freedom to engage in consensual sexual activities without the threat of being imprisoned. Data regarding the precise count of gender and sexual minorities in India is still not available publicly, but a rough estimate from 2018 suggested that approximately 104 million individuals in India, constituting 8% of the total population, identify as part of the LGBTQIA + community (Gopinath 2022). Around 15% comprises lesbian, homosexual, bisexual, transgender, and queer (LGBTQ +) people, whereas 20% of surrogacy recipients are single parents. Despite this substantial demographic, the noticeable disparities in health outcomes among LGBTQIA + citizens reveal significant marginalization. Some gay and lesbian couples are unable to comply with Sect. 2(h) of the Act since same-sex marriages are still illegal in India. Additionally, the regulation is extremely explicit that only heterosexual married couples are permitted to employ surrogates and undertake ART procedures as it does not align with the “Indian ethos” (Fotedar 2019). In the parliamentary debate, the bill was criticized for excluding live-in couples, single men, and the LGBTQ + community from the Assisted Reproductive Technology (Regulation) Act 2021 provisions. They condemned the legislation as being “discriminatory” and “patriarchal.” Congress member Karti P Chidambaram, who initiated the debate on the Bill, remarked, “This law is not in line with Hindu principles, but rather resembles a law from the Victorian era” (Sharma 2021). Supriya Sule, representing the Nationalist Congress Party (NCP) from Baramati, Maharashtra, expressed her intention to inquire about the synergy between the Surrogacy Bill and the ART Bill to the Health Minister. In her statement, Sule emphasized the importance of considering couples desiring to have children and a diverse group of individuals in the country who aspire to become parents, including the LGBTQ + community and single fathers. She highlighted the current restrictions faced by single men due to the 2017 adoption rule, which prevents them from adopting girls. Consequently, this limitation also hampers their ability to benefit from the ART Bill (Press Trust of India 2021).

Even the Select Committee’s 102nd Report on the Surrogacy Regulation Bill (SRB) restricts access to surrogacy to married couples and has an impact on PSC. The PSC defends its biased stance by arguing, “[g]iven Indian family structure and social milieu and norms, it will not be very easy to accept a child whose parents are together but not legally married” (para 4.2.15) (Parliamentary Standing Committee on Health and Family Welfare 2017). This is due to concerns regarding potential parentage/parenting issues in the event that same-sex and live-in couples decide to part ways. This seems to be a very biased, stereotypically patriarchal view where marriage is sacred, stable, and permanent, whereas all other kinds of coupledom are temporary and in the process of “separation-in-waiting” (Parliamentary Standing Committee on Health and Family Welfare 2017). Additionally, it does not have anything particularly Indian, about this concept of “family structure and social milieu” (Banerjee and Kotiswaran 2021a, b). Even though it is believed that a variety of intimate relationships were common in the ancient world, including various kinds of marriage, such as gandharva vivaha (mentioned in the Vedas, this type of marriage was purely based on love, passion, mutual consent, and freedom of choice), which, much like modern-day live-in couples, involves partners presenting themselves together without any kind of ritualistic ceremony (Bhatnagar n.d; Bhattacharya 2019). Also in light of the Medical Termination of Pregnancy Act of 1971, it prohibits women from having an abortion. It penalizes them for becoming pregnant as a result of sexual relations by obligating them to give birth. In contrast, widows or single women are not allowed to avail themselves of surrogacy services, even if they desire to have children but are unable to bear them (Manjunath 2018). The 2021 Act defines a couple as an “Indian man and woman” married and above the ages of 21 and 18, respectively. These restrictions exclude individuals in live-in relationships who may wish to access surrogacy services. Aligning the definition of a couple with the stipulation in Sect. 2(h) of the Act reinforces the institution of marriage (Sasha 2020). Moreover, the Act excludes couples who may be medically unfit or dealing with chronic diseases that could increase the risks for the unborn child. The Act remains vague regarding which conditions or diseases are permissible for surrogacy, leaving the discretion with the National Assisted Reproductive Technology and Surrogacy Board to make determinations on this matter. Contrary to expectations, the PSC cites Puttaswamy v. Union of India [(2017) Writ Petition Civ 494/12, (SC)], in which the Supreme Court acknowledged women’s right to reproductive autonomy. And it does not base eligibility for ARTs on a woman’s marital status; rather, it sets the minimum age for access at 21. In this way, ARTs are accessible to women who are single, unmarried, divorced, or separated. However, their rights become irrelevant when those very women get into relationships (i.e., as same-sex or live-in couples). Therefore, the study selectively employs pro-women constitutional language, as though women’s reproductive rights might be modified based on their marital status. In a nation where advocating for the rights of single parents and live-in couples with children remains an uphill battle, the issue of discrimination against LGBTQ + parents is conspicuously absent from public discussions. The legal and societal recognition of parenthood rights for individuals in the LGBTQ + community is nonexistent. Despite previous Supreme Court judgments that have interpreted Article 21 of the Constitution, pertaining to the right to life and personal liberty, as encompassing the right to motherhood and reproductive autonomy, these interpretations do not seem to extend equally to same-sex couples, transgender individuals, and the broader LGBTQ + community. Even the United Nations’ Universal Declaration of Human Rights, as articulated in Article 16, establishes that “men and women of full age… have the right to marry and to have family” (Mehta 2021). However, this phrasing in a document over 72 years old remains exclusionary. Regrettably, in India, even in 2023, the opportunity to start a family is exclusively available to heterosexual cisgender men and women. The majority of family laws in India, encompassing adoption, surrogacy, succession, guardianship, and similar matters, are interconnected with the institution of marriage. Unfortunately, as the LGBTQ + community has been excluded from the right to marry, their access to these laws is significantly restricted. As per the Adoption Regulations of India in 2017, outlined on the official website of the Central Adoption Resource Authority (CARA), couples who have been married for a minimum of 2 years, along with single women, are eligible to adopt children of any gender. However, single men are only permitted to adopt male children. Surprisingly, there is a complete absence of mention regarding couples in live-in relationships, same-sex couples, and transgender individuals, almost as if their existence is disregarded (Mehta 2021).

The Supreme Court invalidated Sect. 377 of the Indian Penal Code, 1860 in Navtej Singh Johar and Ors v. Union of India, which paved the way for homosexuality to be accepted as a legal lifestyle in India (Babbar and Sivakami 2022). Since gay relationships are legal in India, it is logical to assume that any homosexual couple that resides together should be regarded as a live-in couple. In S.PS. Balasubramanyam v. Suruttayan, the Supreme Court decided that children who reside with their parents are treated the same as their biological siblings. The Act also breaches a number of prior statutes. In accordance with adoption legislation, for instance, divorced and unmarried individuals may adopt. Sections 7 and 8 of the Hindu Adoptions and Maintenance Act of 1956 and Sect. 57 of the Juvenile Justice (Care and Protection of Children) Act of 2015 authorize single and divorced adults to adopt children (Saraswat and Mondal 2022). The reasoning for aforementioned regulations presents a persuasive argument for allowing unmarried and separated individuals of any gender to utilize the services offered by ART clinics and banks.

Intent-based parenting and individual planning have replaced the traditional notion of a family, placing a greater focus on an individual’s autonomy (Chandran 2022b). The Supreme Court in Puttaswamy, emphasized reproductive autonomy, which entails exercising free will in decisions about conception, as a critical component of privacy rights (Saini 2022). Equal protection under the law is also guaranteed under Article 14 of the Constitution, which prohibits arbitrary legislation without a reasonable, credible, and legal basis for discriminatory action. This implies that the state cannot ban surrogacy for a specific group without presenting them with a rationale (in any form it has authorized). When restricting a fundamental right, “the greater good” of society must always come first. The well-being of the intended child should also be considered in the surrogacy agreement, in addition to the engaged couples. The emotional and psychological health of the intended kid is more important than any formal claim of paternity. In the Mausami Moitra Ganguli v. Jayanti Ganguli case, the Supreme Court defined “child welfare” as encompassing a stable and safe environment, affection, and an atmosphere that promotes the child’s healthy development. Numerous rulings on the subject by Indian and foreign courts have led to this viewpoint. Regardless of how the parent–child relationship may seem, atmosphere and temperament will ultimately define these situations. There is no testimony that a committed gay couple could not parent their kids as effectively as heterosexual couples. According to a recent study conducted by the University of Oxford researchers, children raised by LGBTQ + couples exhibit better academic performance compared to their counterparts raised by heterosexual couples. The study, conducted in the Netherlands, the first country to legalize same-sex marriage, analyzed data from 2971 children with same-sex parents (comprising 2786 lesbian couples and 185 gay male couples). Additionally, the study encompassed data from over a million children with different-sex parents, tracking their educational progress from birth through primary and secondary education. The Delhi Commission for Protection of Child Rights (DCPCR) has lent its support to the adoption of children by same-sex couples through an intervention application (Bakshi 2023). The commission asserts that no evidence or empirical data is indicating that same-sex couples are unsuitable as parents or that the psychosocial development of children raised by same-sex couples is compromised in comparison to those raised by heterosexual parents. The DCPCR emphasizes the importance of creating public awareness, both at the national and state levels, that same-sex family units are as fine as the children belonging to such families are in no way incomplete. The commission urges the Union and state governments to take proactive measures to foster understanding and acceptance of same-sex families (Ermac 2020). In light of this, the Act’s ban for a couple or a person from having a child via surrogacy remains until the time their sexual orientation does not influence the best interest of the child. Even after death, the need to restrict procreation to the marital state persists. Consequently, the study illustrates:

that posthumous reproduction should be permitted, even in the absence of the deceased’s prior consent unless the deceased person has previously objected to it or there are strong indications that the person would not have agreed to the collection of gametes, posthumously (PSC para 4.17.12)

It is incongruous that the ART Bill and PSC report exclude the desire to produce offspring of single males and live-in or same-sex couples while presuming that a deceased person had provided permission for the harvesting of his gametes for use by his spouse. Consequently, the cultural occurrence of childlessness is viewed as a “problem” that ARTs should selectively address. The use of technology to rethink families or come up with other arrangements is prohibited. Instead, it is seen as nothing more than a tool for reproducing in a way that the patriarchy permits (Chandran 2022a, b). Notably, the PSC report promotes access to ARTs for persons with HIV, intersex people who are infertile, couples who do not want to pass on genetic diseases to their kids, and anybody else with a medical condition and equivalent transmission concerns. However, as suggested by the PSC report, the ART Bill, 2020, cannot include such important eligibility restrictions for obtaining ARTs that are not directly related to infertility. It must be explicitly stated in the law itself. It is important to note that the ART Act, 2021, restricts surrogacy eligibility to “infertility” alone, but the SRA 2021 increases eligibility to include “medically necessary conditions.” In contrast to Article 14, which guarantees equality to all, this results in various requirements for commissioning couples, which are then implemented differently (Kashyap and Tripathi 2022).

Discrepancies over Gamete Donors

The PSC report overlooks a significant aspect by not adequately considering the rights of donors, specifically those who donate eggs. This oversight is notable given the essentiality of hormonal treatment and the egg extraction procedure’s invasive and potentially life-threatening nature. The PSC report suggests providing insurance coverage to the donor for 12 months and social security insurance. However, these insurance plans’ specific details and criteria are not clearly outlined. Additionally, the report proposes granting maternity benefits to an egg donor in the unfortunate event of a miscarriage. The inclusion of maternity benefits for egg donors in cases of miscarriage raises confusion, as a gamete donor is not involved in carrying a pregnancy, and therefore, the concept of miscarriage is not applicable. Notwithstanding the aforementioned recommendations, there is a notable absence of provisions for compensating donors or reimbursing them for expenses incurred, including salary loss, time, and effort. The labor involved in producing and providing biomaterial for the benefit of third parties remains unrecognized. Compensation is only available in the event of an adverse medical incident, such as a miscarriage, in line with the altruistic nature of the ART Bill 2020. However, as argued elsewhere (Banerjee and Kotiswaran 2021a, b), the Supreme Court recognizes reproductive labor as labor, thereby rendering the absence of compensation for such labor a violation of Article 23 of the Constitution, which prohibits forced labor defined as labor remunerated below the minimum wage.

Despite the altruistic orientation of the ART Act 2021, concerns raised by stakeholders include the potential shortage of gametes. The PSC supports the provisions of the ART Act 2021, suggesting that a single source of sperm or oocytes should be supplied to a single commissioning couple to avoid issues of parentage. However, the PSC appears to have overlooked Sect. 31(2) of the ART Bill 2020, which already stipulates that donors cannot assert parental rights in the future. Similarly, regarding the anticipated scarcity of egg donors, the PSC dismisses the argument that the lack of compensation for egg donation would lead to donor shortages. Instead, it recommends expanding the eligibility criteria for egg donation by removing marital status as a criterion, with the expectation that this would offset any scarcity (para 4.20.14). While the dissociation of marital and donor status is a positive step, it is unlikely to significantly increase the number of women willing to endure significant inconvenience to donate their eggs.

Furthermore, the PSC report optimistically states that commissioning parents will likely be able to independently procure gametes, possibly “in coordination with” ART clinics and banks (para 4.20.16). While allowing commissioning couples to access gametes through relatives and friends is a welcome move, the practicality of acquiring gametes in this manner is easier said than done, and the potential for a shortage of gametes is a genuine concern. Previous versions of the ART Bill did not permit the gifting or donation of gametes, and the market served as the sole intermediary.

A Regulatory Framework for ART

The SRA, 2021, and ART Act, 2021, call for the establishment of a number of organizations to oversee ARTs and surrogacy; however, it is not obvious from the laws’ text how these organizations would be related. The new organizations into which the PSC correctly suggests their merging are the National and State ART and Surrogacy Boards, the National ART and Surrogacy Registry, and the Appropriate ART and Surrogacy Registration Authority, or AASRA. This demonstrates that the PSC is aware that the two measures must be brought into conformity with one another. The PSC observes that the roles of ART banks and ART clinics are ambiguous in terms of their distinct and overlapped responsibilities. The Department of Health Research noted in its response to the PSC that it wished to keep the ART bank and clinic apart, but it was not obvious if the bank had the personnel necessary to screen and collect gametes, especially oocytes. The privatized ART sector is robust because of this centralization of responsibilities; the ART Act 2021 would suffer severely if it overlooked this element. Both acts still lack synchronization on key definitions (Banerjee and Kotiswaran 2021a). For instance, the SRA, 2021, does not mention ART—be it banks or clinics—it finds mention in the ART Act 2021. Similar to that, a few terms were mentioned in the SRB for 2019 but not in the ART Bill (e.g., fertilization, implantation, fetus, sex selection). The two acts also use different definitions of infertility. It is critical that the terminology used in the two pieces of legislation be explicit and consistent given the convergence of ART and surrogacy practices.

Unfortunately, there is no mention of this in the PSC report. Last but not least, the ART Act 2021 has been under fire from several stakeholders for its punitive penalties, including extended jail sentences that are excessively harsh in comparison to the offense committed. The PSC generally concurs with this criticism. Regarding the conduct meant to be prohibited, it distinguishes between various penalties under the Pre-Conception and Pre-Natal Diagnostic Techniques (PCPNDT) Act and the ART Bill, 2020. It aligns with the PCPNDT Act and suggests a tiered penalty for promoting sex-selective ART, reducing the sentence from 5–10 years to 3–5 years (with a maximum sentence of 3 years (PCNPDT Act 1994). However, the case for a 3-year minimum obligatory sentence is unpersuasive (Chandrashekar and Amoolya 2020). In addition, the PSC advises that the penalty for abusing and manipulating stakeholders as well as commercializing ART components be reduced from 8–12 years in prison to 5–10 years in prison. This harmonizes the 10-year maximum sentences under the SRA of 2021 with the ART Act of 2021. However, the PSC advocates for keeping a 5-year minimum obligatory term. Because the underlying infraction may trigger the requirements of both statutes, implementing both sections would necessitate equitable prosecution tactics. For instance, importing human embryos or human gametes might result in legal action under Sect. 35(f) of the SRB from 2019 and Sect. 33(1) of the ART Bill from 2020. Under the SRA of 2021, this individual may face a term of up to 10 years, while the ART Act of 2021 would impose an obligatory minimum of 5 years. Furthermore, the offenses are not bailable under the SRA of 2021 but are cognizable and bailable under the ART Act of 2021. Under the SRA of 2021, the doctor would not be eligible for release in the aforementioned scenario, but, under the ART Act of 2021, bail might be granted for similar criminal behavior. Differentiating between defendants who have violated the same laws under both measures will be considered arbitrary, presidential action and will therefore be considered unlawful. In conclusion, the PSC report provided a number of wise recommendations. However, the PSC has refrained from taking action on crucial matters with constitutional implications, such as accessibility to ARTs and payment for egg donors. As a result, paternalistic conservatism, which is substantiated by the PSC report, is at the core of the character that the legislation of reproductive technology is taking. It expresses itself only in favor of the heteronormative family structure.

Unveiling Disparities: Addressing Inequities in ART Service Accessibility

Given that the ART industry is far larger than the surrogacy sector, it is evident that the ART Act, 2021, is being driven by the SRA’s 2021 constrained reasoning, although the reverse should be true. Since only gestational surrogacy is allowed and the surrogate mother cannot contribute her gametes, surrogacy inevitably involves the use of ARTs. However, while utilizing ARTs, it may not always be essential to utilize a surrogate (for instance, a couple could utilize their own gametes for IVF while employing the mother who is already carrying the baby). Even the most successful surrogacy programs have still produced a small number of children, compared to India’s current 27 million infertile couples and the projected two lakh IVF procedures performed there each year (Sharma 2018; Murdia 2020). In addition, although couples in need of fertility treatment come from all socioeconomic backgrounds, couples contracting surrogacy often have the financial means to pay for a surrogate’s services.

For these reasons, the more prevalent use of ARTs cannot be modeled after a (defective) legislative framework designed to outlaw exploitational international commercial surrogacy. The anticipated distributive consequences of the ART Act, 2021, must also be examined. Sadly, the PSC report mentions that there are just six IVF centers in the public sector. It again contends that they should be included into the rules and regulations rather than being mandated by the actual wording of the law and supports cost regulation and increased access to ARTs in public institutions for the “poor masses.” One must note that infertility is not limited to metropolitan areas and large cities but also affects people in smaller cities and rural regions. As the government strives to raise awareness nationwide, tackling the challenge of providing quality fertility treatment in areas beyond major cities is crucial. The objective is to ensure equal access to advanced technology, internationally recognized standards of fertility care, and state-of-the-art equipment, even in the most remote parts of the country. Less than 1% of affected individuals seek medical evaluation for their condition due to a lack of awareness, access, and affordability. Reproductive health services, specifically infertility care, are also a crucial need in village health centers in India. According to research by the International Institute of Population Sciences, 40% of respondents emphasized the need for affordable treatment facilities for couples experiencing infertility, while 57% mentioned the importance of affordable diagnostic facilities. Approximately three-fourths of respondents expressed their need for infertility care and advice within the village, with 22% inquiring about the presence of female doctors at village health centers and 55% requesting proper information on infertility and treatment. Additional services required in rural areas include counseling for infertile couples, accessible transportation, male reproductive health specialists, low-cost or discounted medications, support from healthcare workers, and financial assistance for treatment (Patra and Unisa 2022). The research reveals a contrasting situation in fertility care within the study villages, with a small proportion of women achieving successful treatment and satisfaction. There are two issues that women have expressed for discontinuing their infertility treatment: one, that the available resources are scanty, and two, if they are accessible, they are outrageously priced. A significant number of respondents expressed the need for free-of-cost treatment. Therefore, establishing a dedicated department in rural health centers with advanced diagnostic facilities and trained male and female health professionals is necessary to address sexual and reproductive health issues and provide affordable and high-quality fertility treatment. Decreasing waiting times in community health centers, offering personalized services, and providing medical counseling can alleviate couples’ challenges in their pursuit of conception. Currently, no medical insurance in India covers the expenses associated with infertility treatment, and the cost of treatment varies across urban and rural areas depending on the type and phase of the treatment sought (Women’s Health Council 2009). Even if these recommendations were adopted, the ART Act, 2021, will still lead to inequitable redistribution. The ART Act, 2021, in contrast to surrogacy, permits foreign commissioning couples to receive ART treatments, allowing the government to benefit from international reproductive tourism.

As overseas commissioning couples may have the financial wherewithal to pay the high tariffs imposed by private clinics, this certainly boosts demand for ART procedures and raises pricing. The industry is making an effort to rely on the generosity of gamete donors, but doing so will result in a shortage of gametes and an issue with the gamete supply. As a result, gametes will cost more, which is likely to encourage the development of a gametes black market. The prospect of the ART Act’s implementation in 2021 means that women who donate their eggs will only slightly profit from these price increases. The extraction of their eggs is likely to be done clandestinely in clinics under authorities’ radar, putting their health at greater risk. The Sama Resource Group for Women and Health in Delhi recommended that clinics perform routine inspections; however, the PSC has not yet issued such a recommendation.

The economics of the ART market change when foreigners are allowed to access medical tourism and ART. Without pricing restrictions, ART clinics and banks would continue to expand unfettered, making it impossible for millions of people from non-elite socioeconomic categories who wish to start families to afford ARTs. As the clandestine marketplaces for egg donors and surrogacy flourish, women who provide reproductive resources and labor will continue to be undervalued, unpaid, and unprotected. There is no mention whatsoever in the ART Bill, 2020, of a child born via ARTs knowing their paternity, which was included in earlier versions of the ART Bill and is essential to their best interests. The PSC erroneously believes that the bill grants access to these rights. In practice, the ART Act, which stimulates medical travel (and the PSC report supporting the structure of the act), would lead to a scarcity of gametes and perhaps the rise of the illegal market. The purpose of the measure, which is to promote altruism, will ultimately be detrimental to women, but it may continue to help everyone else in the system because of rich and middle-class heterosexual married commissioning couples who are Indian and foreign. Therefore, millions of infertile or childless couples and individuals will have to live with hollow promises from the thriving ART industry.

Conclusion

In conclusion, this article argues for the recognition that sexual orientation, gender, and marital status should not serve as grounds for denying individuals their fundamental human rights. These factors bear no relevance to the well-being and upbringing of a child. The legislature has displayed a regressive, legally unsound, unscientific mindset by implementing exclusionary policies. In response, the Supreme Court of India has consistently strived to dismantle moralistic restrictions on personal liberty through a series of judgments. The current framework of the Act is entirely unacceptable and thus necessitates an amendment. The author suggests making the Act gender-neutral by replacing the terms “infertile couple” and “women” in Sect. 2(1)(e) and Sect. 2(1)(u) respectively with “couple or individual.” This modification would enable the inclusion of single parents, live-in couples, and same-sex couples, thereby advancing the goal of child welfare. Given that India serves as a prominent hub for assisted reproductive technology practices, the Act represents a step in the right direction. However, it is imperative to establish a dynamic oversight mechanism to ensure that the law adapts to rapidly evolving technology, changing societal norms, and moral considerations. This legislation must be closely monitored over time to evaluate its impact, strengths, and weaknesses. Undoubtedly, this landmark legislation sets the stage for shaping and reflecting the future trajectory in the field of assisted reproductive technology.

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The authors declare no competing interests.