Introduction
Imagine walking into a fertility clinic and choosing every detail of your future baby, including eye colour, height, intelligence, athletic ability, and even resistance to genetic diseases. Advancements in reproductive technology are pushing the boundaries of what is possible. In the United States, the demand for sperm and egg selection is soaring, with individuals spending thousands of dollars to “curate” their ideal baby. However, it is important to note that experts in the United States currently do not support the practice of creating designer babies through gene editing.
The advent of CRISPR-Cas9 technology is considered a promising development for eliminating certain genetic diseases. However, experts still do not recommend its use on human embryos, as its safety or effectiveness is yet to be established. Despite this, private entities may still undertake such procedures in the absence of explicit legal prohibitions.
This trend of individuals selecting specific genetic traits has been rising, for not just health reasons but also aesthetic and personal preferences. Technologies like gene-editing tools raise ethical and legal questions about how far science should go in shaping human life. One of the most significant concerns associated with genetic modification is the possibility of eugenics, where individuals or societies might seek to create “designer babies” with preferred traits. In this blog post, we shed light on the regulatory framework governing assisted reproductive procedures in India.
India’s Regulatory Landscape
India’s fertility market is booming and is expected to surpass $3721 billion by 2030[1] due to rising infertility rates attributable to lifestyle diseases, delayed parenthood, and genetic disorders. Assisted Reproductive Technology (“ART”) (meaning “all techniques that attempt to obtain a pregnancy by handling the sperm or the oocyte outside the human body and transferring the gamete or the embryo into the reproductive system of a woman”) has given millions of couples the chance to conceive. However, unlike in some western nations where genetic selection is gaining traction, the legal framework in India prohibits the sale or manipulation of human gametes, zygotes, or embryos and takes a strict stance against genetic modification, and embryo selection. While the country’s fertility industry is booming, the creation of designer babies remains prohibited.
Prohibition on the Sale and Transfer of Gametes & Embryos
The Assisted Reproductive Technology (Regulation) Act, 2021 (“ART Act”) was introduced in India to regulate fertility treatments, protect patient rights, and ensure ethical practices in assisted reproduction. The direct or indirect sale, transfer, or use of gametes (meaning “sperm and oocyte”), zygotes (meaning “the fertilised oocyte prior to the first cell division”), and embryos (meaning “developing or developed organism after fertilisation till the end of fifty-six days from the day of fertilisation”) to any party within or outside India is prohibited, except in cases where individuals are using/transferring their own gametes or embryos with approval from the National Board.[2] Instances of transfer may occur if the location of the ART bank or ART clinic storing the gametes differs from the physical location of the intending couple, or if the donor providing the gametes is situated elsewhere. Additionally, such instances may also occur if the intending couple has frozen the embryos and stored it in a particular location but wishes to continue treatment at a clinic somewhere else.
The restriction also extends to the donation of gametes or embryos by eligible donors. It also prohibits the payment of any consideration/fee to the donor in exchange for the gametes or embryos, as such quid pro quo may amount to sale.
The ART Act restricts the commercialisation of human gametes and embryos, which makes selecting embryos for genetic traits legally unfeasible in India. Unlike in some foreign jurisdictions where prospective parents may screen embryos for desirable characteristics, the regulatory framework in India does not permit embryos to be transferred, exchanged, or modified beyond medical necessity as prescribed. While preimplantation genetic testing (a technique used to identify genetic defects in embryos created through in vitro fertilisation before pregnancy) (“PGT”) is permissible in India for detecting genetic disorders, editing an embryo’s genes for non-medical reasons is strictly prohibited.[3] In terms of noncompliance, any person who engages in the sale or trade of human embryos or gametes may be punished with fines.
Gene Editing & Eugenics: The Ethical Dilemma
Gene editing raises profound ethical questions, particularly when used for non-therapeutic purposes. Altering an embryo’s DNA for traits such as intelligence, physical appearance, or athletic ability interferes with the natural course of human development and raises concerns about playing the role of nature. Additionally, such modifications, if heritable, could have unintended consequences for future generations, making ethical oversight crucial. While CRISPR and other gene-editing technologies hold immense potential for preventing genetic disorders, they are still relatively new, with limited long-term studies on their safety and efficacy. Unintended mutations, off-target effects, or unforeseen health complications could emerge over time, potentially causing irreversible harm. Given these risks, India’s ART laws adopt a precautionary approach, permitting genetic interventions only when essential for preventing hereditary diseases (refer to our CRISPR blog post series accessible at CRISPR, The New Gold Standard? Understanding The Rise Of Genetic Engineering In India ).
This could exacerbate existing social inequalities, with wealthier individuals having access to genetic enhancements that provide advantages in intelligence, physical abilities, or appearance, thereby deepening societal divisions. To prevent such ethical dilemmas, India strictly limits ART and gene-editing interventions to medical necessities rather than allow these for personal or societal preferences. India’s ART regulations emphasise that reproductive technologies should be used as a medical solution rather than a tool for human enhancement. This distinction is critical in ensuring that ART remains focused on assisting couples facing infertility and preventing hereditary diseases rather than enabling genetic selection for non-essential traits.
While India recognises the advancements in reproductive and genetic medicine, it prioritises ethical responsibility. Unlike some countries that may have allowed commercial interests to drive the expansion of ART services beyond medical needs, India has placed ethical safeguards to maintain ART’s primary purpose. The ART framework ensures that scientific progress does not outpace regulatory safeguards, preventing unintended social and biological consequences. By focusing on medical necessity and patient welfare, India’s regulatory approach reflects a commitment to ethical and responsible use of reproductive technology.
Final Thoughts: A Distant Dream for India?
The ART Act represents a significant step towards ensuring transparency, ethical practices, and patient safety in fertility treatments. The restriction on the trade and sale of human gametes and embryos in India is a key safeguard to prevent exploitation and maintain ethical standards. For now, curating the ideal baby remains a chimera in India due to legal restrictions.
However, as science and technology evolve and global perspectives shift, the debate over how much control we should have over human genetics will continue. While science may be moving forward in other parts of the world, India’s laws prioritise ethical safeguards over technological ambition, ensuring that ART remains a medical solution, not a tool for human enhancement. On the one hand, the advancements in genetic screening and embryo selection continue to blur the lines between medical necessity and genetic enhancement, but on the other hand, the concerns about socio-economic disparities, eugenics, and the commodification of human life complicate the debate. As the field of assisted reproduction continues to evolve, holistic legal and ethical discussions will be crucial in shaping future policies and ensuring equitable access to such advanced technologies.
For further information, please contact:
Biplab Lenin, Partner, Cyril Amarchand Mangaldas
biplab.lenin@cyrilshroff.com
[1] The rising tide of IVF services in India: Factors driving growth and potential challenges – CNBC TV18
[2] Section 29 of the ART Act
[3] Section 33 of the ART Act
