(MENAFN- Live Mint) New Delhi: India is planning to tighten the regulatory framework for assisted reproductive technology (ART) and surrogacy clinics through rigorous inspections and licence renewal protocols, according to two government officials and a document reviewed by Mint.

The plan in the works at the ministry of health and family welfare will make it mandatory for private clinics to pay a non-refundable renewal fee of ₹100,000 every three years. The funds collected will be utilized by the state governments to enforce the regulatory provisions, conduct inspections, and monitor compliance.

Also, these clinics must apply for renewal 60 days before their license expires. Failure to do so will attract a penalty of ₹200,000. However, government institutes are exempt from these fees. India has about 2,500 fertility clinics, most of them private.

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Currently, there is no renewal fee, except the initial registration charge of ₹200,000.

A draft notification, titled the Surrogacy (Regulation) Amendment Rules, 2025, specifically aims to financially empower the state-level regulatory bodies. Under the proposed framework, the licence will be renewed for another three years only after the authorities verify full compliance through fresh inspections. The draft, reviewed by Mint, hasn't been released publicly yet.

“The state authority is required to conduct a fresh inspection of the clinic to satisfy itself that the facility continues to meet all medical and ethical standards. The licence will be renewed for another three years only after the authorities verify full compliance and following ethical practice,” the first of the two officials cited earlier said, both of whom spoke on the condition of anonymity.

Infertility treatments

Assisted reproductive technology refers to various infertility treatments under which the eggs and sperms are manipulated to achieve pregnancy. In vitro fertilization (IVF) is one of the most common types of ART, in which eggs are fertilized in a laboratory to create embryos that are then transferred into the uterus.

As per a research report by the IMARC Group, a consulting firm, India's IVF market size reached $864.6 million in 2024, and is expected to swell to $3.4 billion by 2033.

While commercial surrogacy was banned in India through Surrogacy (Regulation) Act, 2021, the demand for altruistic surrogacy (without financial involvement) remains robust. Under surrogacy, a woman carries and gives birth to a baby for someone else. Under existing rules, clinics must report each and every 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 in fertility centres, broadly categorized into regulatory compliance and patient safety.

“Regulatory compliance entails obtaining essential licenses and certifications, including fire NOC, pollution control board license, pre-conception and pre-natal diagnostic techniques (PCPNDT) licence, ART regulations, biomedical waste management, and hospital licence,” Shobhit Agarwal, chief executive officer (CEO), Nova IVF Fertility, said.

He also said that to prioritise patient safety, fertility centres must obtain informed consent, maintain confidentiality of patient records, and ensure secure data storage, thereby upholding the highest standards of care and confidentiality.

Call for robust regulations

Doctors said that IVF industry is big and needs robust regulations.

Dr. Archana Dhawan Bajaj, a gynaecologist and IVF expert at Nurture Clinic in Delhi, said that the ART sector in India was largely unregulated until the 2021 law was introduced. The Surrogacy (Regulation) Act, 2021 has banned commercial surrogacy, requires that intended parents must 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, among other norms.

Dr. Bajaj emphasized that strict rules can minimise unscrupulous activities. "Legislation builds accountability, standardizes work patterns, and ensures uniformity and integrity," she said.

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She said that ₹100,000 every three years is a reasonable amount for any reputable IVF centre. "Strict regulations and audits ensure that public health and safety are taken seriously, while also helping to maintain proper data and records. While commercial surrogacy is banned in India, need-based altruistic surrogacy remains permitted under stringent 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 experiences infertility, fuelling demand for IVF treatments. An Indian Council of Medical Research study, released in January 2025, also found that 85% of couples undergoing IVF face a large health expenditure.

The average out-of-pocket expenditure (OOPE) for IVF treatment is substantial, recorded at ₹110,000 in public hospitals and rising to ₹237,000 in private facilities.

Patient safety priority

The proposed rules prioritize patient safety and prevent surrogate exploitation by enforcing high ethical standards through regular scrutiny. "The strict timelines are being enforced and clinics must apply for renewal via the National Registry Portal at least 60 days before their registration expires to maintain compliance," the second official said.

Dr. Kshitiz Murdia, CEO and whole-time director, Indira IVF Hospital Ltd, said the proposed draft rules for renewing ART and surrogacy clinic registrations represent a positive step toward stronger oversight in India's fertility sector amid India's growing infertility challenges-highlighting the rising importance of regulated fertility care.

He said that these updates to the 2021 law require clinics to apply online 60 days before licence expiry, pay tiered fees, and undergo state inspections funded by these collections to ensure safety and ethics.

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“This move will enhance patient protection by mandating periodic audits, addressing gaps in the existing 2022 rules where renewals already occur but lack dedicated enforcement resources. Such measures build trust in complex procedures like IVF by ensuring clinics undergo regular, funded inspections that verify equipment standards, ethical practices (e.g., no unapproved embryo manipulation), and patient safety protocols,” Dr. Murdia said.

However, Agarwalof Nova IVF Fertility suggested that the increase in cost of renewal might become a challenge for the smaller IVF clinics functioning in the underserved areas and eventually will get passed on to their patients.

He said that the Assisted Reproductive Technology (Regulation) Act, 2021 has brought in the much-needed standardisation and regulation to the fertility sector.

“But we believe more than focussing on aspects of renewal, there are far more pressing and pending issues of already passed ART Act, that need to be addressed, such as a national registry for donors that the industry has been pushing for, and even a stricter regulation for onboarding donors by the ART Banks. If these challenges are also considered, it can really bring in the much-needed transparency in ART ecosystem,” Agarwal said

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