New Delhi: India plans to tighten the regulatory framework for assisted reproduction (ART) and surrogacy clinics through strict inspections and license renewal protocols, according to two government officials and a document reviewed by Mint.
A plan being prepared at the Ministry of Health and Family Welfare stipulates that private clinics must pay a non-refundable renewal fee of ₹100,000 every three years. Funds raised will be used by state governments to enforce regulatory provisions, conduct inspections and monitor compliance.
These clinics must also apply for renewal 60 days before the license expires. If you don’t, he will be punished ₹200,000. However, government institutions are exempt from these fees. India has about 2,500 infertility clinics, most of them private.
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There is currently no renewal fee other than the initial registration fee ₹200,000.
The draft notification, titled Surrogacy Amendment (Regulation) Rules, 2025, specifically focuses on financial strengthening of state-level regulatory bodies. Under the proposed framework, the license will be renewed for another three years only after authorities verify full compliance through new inspections. The draft, reviewed by Mint, has not yet been made public.
“The state agency is required to conduct a new inspection of the clinic to ensure that the facility continues to meet all medical and ethical standards. The license will be renewed for another three years only after authorities verify full compliance and compliance with ethical practice,” said the first of two officials cited earlier, both of whom spoke on condition of anonymity.
Treatment of infertility
Assisted reproductive technology refers to a variety of infertility treatments in which eggs and sperm are manipulated to achieve pregnancy. In vitro fertilization (IVF) is one of the most common types of ART, in which eggs are fertilized in the laboratory to create embryos, which are then transferred to the uterus.
According to a research report by consulting firm IMARC Group, India’s IVF market size reached $864.6 million in 2024 and is expected to grow to $3.4 billion by 2033.
While commercial surrogacy has been banned in India through the Surrogacy (Regulation) Act, 2021, the demand for altruistic (non-financial) surrogacy remains strong. In surrogacy, a woman carries and gives birth to a child for someone else. Under existing rules, clinics must report every single case (pregnancy, embryo transfer, IVF procedure, altruistic surrogacy, etc.) to the government.
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Queries sent to the Union Health Ministry remained unanswered till press time.
Compliance is paramount at fertility centers, broadly categorized into compliance and patient safety.
“Regulatory compliance means obtaining essential licenses and certifications, including fire NOC, pollution control board license, pre-conception and prenatal diagnostic techniques (PCPNDT) license, ART regulations, biomedical waste management and hospital license,” said Shobhit Agarwal, chief executive officer (CEO), Nova IVF Fertility.
He also said that to prioritize patient safety, fertility centers must obtain informed consent, maintain the confidentiality of patient records and ensure secure data storage, thereby maintaining the highest standards of care and confidentiality.
Demand strict regulations
Doctors said the IVF industry is large and needs robust regulations.
Dr. Archana Dhawan Bajaj, a gynecologist and IVF expert at Nurture Clinic in Delhi, said the ART sector in India was largely unregulated until the 2021 law was introduced. The Surrogacy (Regulation) Act, 2021 banned commercial surrogacy, requiring, among other things, that the intended parents be Indian married couples, they must demonstrate a medical need for surrogacy, and surrogate mothers must be a close relative and a married woman with a child of her own.
Dr. Bajaj emphasized that strict rules can minimize malpractice. “Legislation builds accountability, standardizes work patterns and ensures uniformity and integrity,” she said.
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She said it ₹100,000 every three years is a reasonable amount for any reputed IVF center. “Strict regulations and audits ensure that public health and safety are taken seriously, while helping to maintain proper data and records. While commercial surrogacy is banned in India, altruistic need-based surrogacy remains permitted under strict conditions,” Dr Bajaj added.
The tightening of norms comes against the backdrop of rising infertility in India. According to the World Health Organization, at least one in six Indian couples face infertility, increasing the demand for IVF treatment. A study by the Indian Council of Medical Research, published in January 2025, also found that 85% of couples undergoing IVF face high health expenses.
Average out-of-pocket expenses (OOPE) for IVF treatment are substantial, recorded at ₹110,000 in public hospitals and rising to ₹237,000 in private facilities.
Patient safety is a priority
The proposed rules prioritize patient safety and prevent surrogate exploitation by enforcing high ethical standards through regular review. “Strict deadlines are followed and clinics must apply for renewal through the national registry portal at least 60 days before their registration expires to maintain compliance,” said the second official.
Dr. Kshitiz Murdia, Managing Director and Permanent Director of Indira IVF Hospital Ltd, said the proposed draft rules for renewal of registrations of ART and surrogacy clinics is a positive step towards stronger oversight in India’s fertility sector amid India’s growing infertility problems – underscoring the growing importance of regulated fertility care.
He said those 2021 updates to the law require clinics to apply online 60 days before a license expires, pay tiered fees and undergo state inspections funded by those collections to ensure safety and ethics.
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“This move will strengthen patient protections by mandating regular audits, addressing loopholes in existing 2022 rules where renewals are already in place but lack dedicated enforcement resources. Such measures build confidence in complex procedures like IVF by ensuring clinics undergo regular, funded inspections that verify equipment standards, ethical practices (eg, no unauthorized handling of embryos) and patient safety protocols,” said Dr. Murdia.
However, Nova IVF Fertility’s Agarwalof suggested that the increase in renewal costs could become a challenge for smaller IVF clinics operating in underserved areas and ultimately be passed on to their patients.
He said the Assisted Reproductive Technology (Regulation) Bill, 2021 has brought much-needed standardization and regulation to the fertility sector.
“However, we believe that more than focusing on the recovery aspects, there are much more pressing and unresolved issues of the already passed ART law that need to be addressed, such as the national donor registry that the industry is pushing for and even stricter regulation for the acceptance of donors by ART Banks. If these challenges are also considered, it can really bring much needed transparency in the ARTgareco system,” Agareco said.
