1. Abstract
India has emerged as a significant hub for assisted reproductive technologies (ART), including in vitro fertilization (IVF), surrogacy, and egg donation, driven by advanced medical facilities and historically lenient regulations. However, concerns over ethical issues, exploitation, and unregulated practices prompted the Indian government to introduce stringent laws to regulate these procedures. The Surrogacy (Regulation) Act, 2021, and the Assisted Reproductive Technology (Regulation) Act, 2021, aim to protect the rights of surrogate mothers, intended parents, and children born through ART while curbing commercial practices. This blog provides an in-depth analysis of the current legal framework governing surrogacy, IVF, and egg donation in India, highlighting eligibility criteria, restrictions, recent amendments, and their implications for stakeholders. It also examines the ethical and social challenges that persist despite these regulations, offering insights into the evolving landscape of reproductive medicine in India.
2. Introduction
Assisted reproductive technologies (ART), encompassing in vitro fertilization (IVF), surrogacy, and gamete donation, have transformed the journey to parenthood for millions of infertile couples and individuals worldwide. In India, these technologies gained prominence due to the country’s advanced medical infrastructure, skilled professionals, and relatively low costs, making it a global destination for reproductive tourism. By 2012, the surrogacy industry alone was estimated to be worth over $400 million annually, with thousands of fertility clinics operating across the nation. However, the rapid growth of this industry led to ethical concerns, including the exploitation of surrogate mothers, commodification of children, and unregulated practices. To address these issues, India introduced the Surrogacy (Regulation) Act, 2021, and the Assisted Reproductive Technology (Regulation) Act, 2021, which came into effect in January 2022. These laws aim to regulate ART practices, ban commercial surrogacy, and ensure ethical standards. This blog explores the key provisions of these laws, their impact on surrogacy, IVF, and egg donation, and the challenges that remain.
3. The Legal Framework: Surrogacy (Regulation) Act, 2021
The Surrogacy (Regulation) Act, 2021, defines surrogacy as a practice where a woman gives birth to a child for an intending couple or individual with the intention of handing over the child after birth. The Act categorically bans commercial surrogacy, which involves financial compensation beyond reasonable medical expenses and insurance coverage, and permits only altruistic surrogacy. Altruistic surrogacy requires the surrogate to act without monetary compensation, except for medical costs and insurance for three years. The primary objectives are to prevent exploitation of women, particularly those from economically disadvantaged backgrounds, and to ensure ethical practices.
4. Eligibility Criteria for Surrogacy
· Eligibility of Intended Parents:
Under current surrogacy laws, only Indian couples who are legally married can pursue surrogacy — with specific age brackets: the woman must be between 23 and 50, and the man between 26 and 55. They must also not have any surviving biological or adopted children from a previous relationship. Interestingly, the law also includes a provision for single women, such as widows or divorcees, aged 35 to 45. However, they’re only allowed to use their own eggs, paired with donor sperm. Unmarried women and single men, on the other hand, are still left out — although this is being challenged in the Supreme Court and may change soon.
· Criteria for Surrogate Mothers:
A woman offering to become a surrogate must be married and fall within the 25–35 age group. She must also have at least one child of her own. Initially, the law required her to be a close relative of the intended parents, though this rule has been softened over time. Importantly, surrogacy can only be done once by any individual. In addition, a surrogate must provide valid certificates proving her medical and psychological fitness before the process can proceed.
· Genetic Contribution Rule:
To maintain a biological link, the law mandates that at least one gamete (sperm or egg) must come from the intended parents — meaning full embryo donations aren't allowed. However, a significant update came in 2024: if one partner is medically unable to contribute their gametes, they may now use a donor, provided the condition is confirmed by the District Medical Board.
5. Regulatory Mechanisms
To keep surrogacy practices in check and ensure they’re carried out responsibly, the law provides for the establishment of both National and State Surrogacy Boards. These bodies are tasked with supervising how surrogacy is implemented across the country. Clinics offering surrogacy services are required to register with the relevant authority, and operating without approval isn't taken lightly penalties for unauthorized clinics can range from hefty fines of ₹5 to ₹10 lakh, and even imprisonment for a period between 5 and 10 years.
In addition, a centralized National Registry has been set up to keep track of vital information including details about surrogacy clinics, surrogate mothers, and intending parents. This system helps maintain transparency and prevents the misuse or exploitation that might otherwise go unnoticed.
5.1 The Assisted Reproductive Technology (Regulation) Act, 2021
The ART Act goes a step further by regulating all medical procedures that involve handling human gametes (sperm or eggs) outside the body. This includes popular reproductive techniques like IVF, donor insemination, and gestational surrogacy. The goal is to bring consistency and ethical oversight to these practices.
By setting clear standards for how ART clinics and gamete banks should function, the Act aims to minimize malpractice and protect everyone involved — from hopeful parents and donors to the children born through these advanced methods. It's about ensuring that science serves society without compromising dignity, safety, or fairness.
6. Key Provisions
· Clinic and Bank Registration:
All ART clinics and gamete banks must register with the National Registry of Banks and Clinics of India. Registration lasts for five years and can be renewed once for another five. Only registered centers are legally allowed to carry out ART procedures.
· Gamete Donation:
Egg donors must be married women aged 23 to 35, with at least one child over three years old. A woman can donate eggs only once, with a limit of seven eggs retrieved. Sperm donors may donate to only one couple to avoid multiple-use cases.
· Informed Consent and Insurance:
Both the donors and the intended parents must give written, informed consent. Clinics are also required to provide insurance to egg donors to cover any risks like loss, damage, or death.
· Prohibited Practices:
Sex-selective ART is strictly banned, with violations leading to 5–10 years of imprisonment and fines ranging from ₹10 to ₹25 lakh. Selling gametes, zygotes, or embryos is also illegal, and only medical expenses and insurance are allowed as compensation.
· Relaxation of Donor Gamete Rules
In February 2024, the Surrogacy (Regulation) Amendment Rules brought a significant shift by easing earlier restrictions on donor gametes. Previously, a March 2023 amendment had required both gametes to come from the intending couple, barring the use of donor eggs or sperm. This posed a major hurdle for couples with medical infertility. Following petitions by affected individuals and Supreme Court intervention, the law was amended to allow the use of donor gametes—provided at least one gamete is from the intending couple and a District Medical Board certifies the medical need. This revision has been welcomed by many, especially those facing conditions like low ovarian reserve or repeated IVF failure.
7. Egg Donation: Legal and Ethical Framework
Egg donation is a vital part of ART, offering a path to parenthood for women who cannot conceive due to infertility or genetic risks. The ART Act outlines strict criteria to ensure safety and ethical compliance:
· Eligibility: Egg donors must be married women aged 23 to 35, with at least one child. They must undergo comprehensive medical and psychological evaluations to ensure they are fit for donation.
· Donation Limits: A donor can donate only once in her lifetime, and no more than seven eggs may be retrieved to reduce physical risk.
· Legal Standing: The child born through egg donation is legally recognized as the biological child of the intending couple. The Bombay High Court clarified in 2024 that donors do not acquire parental rights, reinforcing their role as genetic contributors only.
· Consent and Anonymity: Informed consent is mandatory, and donors may remain anonymous or be known to the couple (e.g., a relative). Clinics must provide full disclosure of medical risks and procedures.
Despite the clarity of these provisions, enforcement has been patchy. Posts on X and other social media platforms allege that some clinics continue to operate commercial egg donation networks, pointing to an unregulated black market that exploits vulnerable women. These concerns underscore the need for stronger oversight.
8. Key Ethical and Social Concerns
While India’s legal framework has sought to curb unethical practices, several systemic challenges persist:
Ban on Commercial Surrogacy: The prohibition of paid surrogacy has shifted the model to altruism, which depends on relatives volunteering. In an era of nuclear families, this is often impractical. Critics worry that this could drive the practice underground, where surrogates are exposed to exploitation without legal protection.
Limited Access: Current laws exclude unmarried women, single men, and LGBTQ+ individuals from surrogacy. This has led to legal challenges, with courts reviewing the constitutionality of such restrictions. Advocates argue for a rights-based approach that embraces diversity in family structures.
High Costs and Rural Exclusion: Regulatory requirements, including clinic registration and compliance costs, have made ART services more expensive. Smaller clinics, especially in rural areas, struggle to meet these demands, limiting access to fresh egg donations and specialized procedures for low-income populations.
Donor Exploitation: While compensation is legally limited to medical expenses and insurance, under-the-table payments continue to occur. The tragic case of 17-year-old Sushma Pandey, who died following egg donation in 2010, is a stark reminder of the dangers posed by poor enforcement and commercial motives.
9. Impact on Stakeholders
Intended Parents: The 2024 amendment offers much-needed relief for couples facing medical infertility, but the requirement that one gamete come from the couple still excludes those unable to contribute either.
Surrogate Mothers: The altruistic model helps reduce financial coercion but has made participation more difficult, especially when emotional ties or family expectations complicate the arrangement. The previous requirement for surrogates to be close relatives has been relaxed but still impacts availability.
Children: The legal recognition of children born through ART as the biological offspring of the intending couple offers clarity and protection. However, concerns remain about long-term health impacts, such as immune system influences from the surrogate.
Clinics and ART Banks: The strict compliance structure aims to ensure ethical practices but has overwhelmed smaller clinics. Of an estimated 40,000 ART clinics in India, only around 1,850 are officially registered with the Indian Council of Medical Research (ICMR), pointing to a large regulatory gap.
10. Way Forward
India’s legal reforms in the field of assisted reproduction reflect a growing emphasis on ethical oversight. But to translate regulation into meaningful impact, several key steps must be taken:
Enforce Compliance: Stronger monitoring by National and State Boards is essential to prevent underground practices and ensure adherence to donation and consent rules.
Expand Legal Access: Updating eligibility criteria to include unmarried and LGBTQ+ individuals would make the system more inclusive and rights-focused, in line with global standards.
Educate Stakeholders: Awareness programs for donors, surrogates, and intending parents can help dispel myths and promote informed decision-making.
Support Smaller Clinics: Simplifying procedures and offering regulatory guidance to rural clinics would improve service access without undermining ethical safeguards.
11. Conclusion
The Surrogacy (Regulation) Act, 2021, and the ART Act, 2021, mark a milestone in India’s effort to regulate reproductive technology and protect all parties involved — from donors and surrogates to the children born through these methods. By prohibiting commercial surrogacy and enforcing ethical standards for gamete donation and IVF, these laws seek to strike a balance between compassion and caution. The 2024 amendment allowing donor gametes is a progressive step, but challenges remain around enforcement, inclusivity, and affordability. As courts, policymakers, and civil society continue to engage with these issues, India's reproductive laws must evolve to reflect fairness, dignity, and scientific advancement.