E-Paper
India’s push to regulate IVF and protect patients
This article is authored by Dr Satish Kumar Adiga, Kasturba Medical College, Manipal and member, National ART and Surrogacy Board, Government of India.
July 25, the world marks IVF Day, a proud moment to celebrate the scientific breakthrough that has transformed millions of lives across the globe. For countless couples struggling with infertility, IVF is a hope, possibility, and the promise of parenthood. Yet, behind this promise lies a complex landscape, medical, emotional, social, and increasingly, commercial.
In India, where the demand for IVF has grown rapidly over the past decade, this field of medicine has been facing multiple challenges. Reports of unregulated clinics, misleading success claims, exploitation of donors, mismatch of embryos, and unregulated treatment cost have raised critical concerns. For vulnerable couples struggling to find a hope to their problems, this can turn into distress.
Recognising these realities, the Government of India has, in recent years, taken decisive and long-awaited steps to bring order, accountability, and ethics into the Assisted Reproductive Technology (ART) ecosystem. The enactment of the Assisted Reproductive Technology (Regulation) Act, 2021 and the Surrogacy (Regulation) Act, 2021 marks a turning point in the governance of infertility treatment in the country.
During the last two decades, India’s IVF sector expanded rapidly in a largely unregulated environment. While this enabled innovation and accessibility, it also allowed uneven standards of care and, in some cases, unethical practices. The new legislation shifts the paradigm from uncontrolled expansion to structured, ethical regulation. This change happens because we realise IVF is more than just a medical treatment. It involves creation of a human life in the lab, a safe outcome, and dealing with deep emotions experienced by the couples throughout the journey of childlessness.
The new legal framework establishes a multi-tiered system of governance through National and State ART and Surrogacy Boards. These bodies are tasked with policy guidance, enforcement, and continuous monitoring of clinics and practices.
Further, a significant step by the government was the creation of a National Registry of ART Clinics and Banks, which mandates compulsory registration, to generate patient database, on a regular basis. Due to this, this registry is not only administrative, but also a powerful instrument for transparency and accountability. Clinics are now required to report procedures, outcomes, and complications, allowing for data-driven regulation and informed patient choice.
Mandatory registration has effectively drawn a clear line between legitimate and illegal practice. Clinics must adhere to specified standards of infrastructure, personnel qualification, and laboratory protocols. This eliminates the informal and often unsafe settings that previously operated on the margins of the system. For patients, this provides a basic but critical assurance: That the clinic they approach meets nationally prescribed standards of care.
Perhaps the most important shift brought about by the legislation is the centrality of ethics. IVF treatment is emotionally charged, and patients are often willing to take significant financial and personal risks. The law now mandates informed consent at every stage, ensuring that patients are fully aware of their chance of success, potential risks and complications, alternative options and financial implications from the treatment.
This move directly addresses one of the long-standing gaps in IVF practice, information asymmetry between providers and patients. Confidentiality, too, has been strengthened. Patient identities and donor information are protected under strict provisions, preserving dignity and privacy.
The law has introduced clear eligibility criteria for sperm and egg donors, including age limits, medical screening, and restrictions on how many times they can donate. Importantly, it prohibits commercial exploitation of the donors and protect them from health risks arising from donation. These safeguards are particularly significant in the Indian context, where economically vulnerable individuals have historically been at risk of exploitation in reproductive services.
In India, the average cost of undergoing one treatment cycle ranges from ₹150,000 to 4,50,000. Due to low success rate, couples may have to undergo more than one attempts. Hence, financial opacity has been a major concern in IVF treatment, often leading to distress and mistrust. The regulatory framework now mandates clinics to provide clear, itemised cost structures and discourages exaggerated or misleading success rate claims.
By standardising disclosures, the law empowers couples to make informed decisions and reduces the likelihood of financial exploitation.
The legislation takes a firm stance against unethical and illegal practices, including:
- Sex selection
- Sale of embryos or gametes
- Using sperm, egg and embryos of other patients
- Unregistered surrogacy arrangements
- Misleading advertisements
Violations attract stringent penalties, including fines and imprisonment. This sends a clear signal: reproductive medicine cannot operate outside the bounds of ethics and law.
Infertility is not only a medical issue, it carries deep psychological and social implications, particularly in India where parenthood is closely tied to identity and societal expectations. The new framework encourages the integration of counselling services, recognising the emotional dimension of IVF treatment. This is an important step toward humane and patient-centred care.
While the legislative framework is robust, its success will ultimately depend on effective implementation. Continued efforts are needed to:
- Increase awareness among patients about their rights
- Ensure rigorous inspection and accreditation of clinics
- Train professionals in ethical and regulatory compliance
- Strengthen grievance redressal systems
India’s approach to regulating IVF reflects a thoughtful balance, encouraging scientific advancement while protecting human dignity. The shift from unregulated growth to accountable practice is both timely and necessary.
On this World IVF Day, it is worth acknowledging that technology alone does not build trust systems do. By embedding ethics, transparency, and accountability into the framework of IVF services, India is taking important strides toward ensuring that the journey to parenthood remains safe and respectful.
For couples seeking IVF, hope must not come at the cost of vulnerability. With sustained vigilance and collective responsibility, our country can ensure that IVF remains a field defined not just by success rates, but by integrity and trust.
(The views expressed are personal)
This article is authored by Dr Satish Kumar Adiga, Kasturba Medical College, Manipal and member, National ART and Surrogacy Board, Government of India.
