The Indian government is set to introduce a stringent regulatory regime for assisted reproductive technology (ART) and surrogacy clinics, mandating hefty renewal fees and rigorous inspections to ensure compliance with medical and ethical standards. This move aims to bring greater accountability to India's rapidly expanding fertility treatment sector, which comprises an estimated 2,500 clinics, most privately run.
New Financial and Compliance Framework
According to a draft notification and government officials, the Ministry of Health and Family Welfare is finalizing plans that will require private ART clinics to pay a non-refundable renewal fee of ₹100,000 every three years. This marks a significant shift from the current system, where clinics only pay an initial registration charge of ₹200,000 with no renewal fee.
The collected funds will be utilized by state governments to enforce regulations, conduct thorough inspections, and monitor clinic compliance. Under the proposed Surrogacy (Regulation) Amendment Rules, 2025, clinics must apply for licence renewal at least 60 days before expiry. Failure to meet this deadline will attract a steep penalty of ₹200,000. Government institutes, however, are exempt from these fees.
"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," explained a government official familiar with the matter.
Driving Factors: A Booming Market and Patient Safety
This regulatory tightening comes against the backdrop of a surging infertility treatment market and rising patient safety concerns. As per a report by IMARC Group, India's IVF market size reached $864.6 million in 2024 and is projected to grow to a staggering $3.4 billion by 2033. The World Health Organization notes that at least one in six Indian couples experiences infertility, fueling this demand.
Doctors and industry leaders have largely welcomed the move for bringing much-needed structure. Dr. Archana Dhawan Bajaj, a gynaecologist and IVF expert at Nurture Clinic in Delhi, stated that the ART sector was largely unregulated until the 2021 law. She emphasized that strict rules minimize unscrupulous activities and build accountability. "₹100,000 every three years is a reasonable amount for any reputable IVF centre," she added.
Dr. Kshitiz Murdia of Indira IVF highlighted that the rules represent a positive step toward stronger oversight. "This move will enhance patient protection by mandating periodic audits... ensuring clinics undergo regular, funded inspections that verify equipment standards, ethical practices, and patient safety protocols," he said.
Potential Challenges and Industry Calls
While the intent is to standardize care, some industry voices point to potential hurdles. Shobhit Agarwal, CEO of Nova IVF Fertility, suggested that the increased renewal cost might challenge smaller clinics in underserved areas, potentially leading to higher costs for patients.
Agarwal also urged authorities to address other pending issues under the ART Act, 2021. "More than focussing on aspects of renewal, there are far more pressing... issues, such as a national registry for donors that the industry has been pushing for, and even stricter regulation for onboarding donors by the ART Banks," he noted. Addressing these, he argued, could bring greater transparency to the ecosystem.
The proposed framework also strictly enforces the ban on commercial surrogacy enacted in 2021, allowing only altruistic surrogacy under stringent conditions for eligible Indian married couples. The rules prioritize preventing surrogate exploitation and ensuring high ethical standards through regular scrutiny. With substantial out-of-pocket expenses for IVF treatments—averaging ₹237,000 in private facilities—the government's push for robust regulation seeks to build greater trust and safety in this critical healthcare domain.
