IVF, surrogacy clinics must renew licenses under new rules | Today’s news
The center has ordered fertility and sperm clinics to renew their registration certificates or licenses every five years and surrogacy clinics every three years by paying a non-refundable fee that can be doubled if payment is not made within the stipulated time.
The policy change, doctors say, introduces a standardized license renewal process for assisted reproduction facilities and surrogacy clinics, which are mushrooming across the country.
“This will ensure that people upgrade their facilities and services when it comes time to recover. They will step up their services, keep better records and improve the quality of their work. Currently, inspections and approvals have only been completed for about 20 to 25% of clinics nationwide,” said Dr. Archana Dhawan Bajaj, gynecologist and IVF expert at Nurture Clinic in New Delhi.
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All such facilities will now have to apply online for renewal through the National ART and Surrogacy Registry portal at least 60 days before their certificates expire. Sperm banks and Tier 1 IVF clinics must pay a non-refundable renewal fee of ₹25,000 while Tier 2 IVF clinics will be charged ₹1 lakh. A double fee is payable for late applications – ₹50,000 for sperm banks and Tier 1 clinics a ₹2 lakh for Tier 2 clinics.
Exceptions are establishments in state institutions.
Detailed framework
After the application is submitted, the authorities have 60 days to complete the review. According to the notification, the certificate will be renewed if, based on the inspection, it is found that the applicant has fulfilled the requirements of the Act and the rules contained therein. Applications found to be insufficient may be rejected, but only after the applicant has been given an opportunity to be heard.
Once approved, the renewed registration will remain valid for five years and the certificate must be displayed in a visible place at the clinic or bank premises. If the rejected application is later resubmitted in accordance with the rules, no additional renewal fee will be charged.
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The notification also states that all renewal fees collected will be deposited in a bank account maintained by the relevant authority and used to implement the provisions of the Act.
Mint’s questions emailed Tuesday to a Health Department spokesman went unanswered.
An expanding market
Industry estimates value the country’s reproductive health market at around $900 million by 2024, with a network of more than 5,000 fertility clinics, and predict it will nearly double to $1.874 billion by 2029.
According to the World Health Organization, nearly 15% of couples in India face infertility. Although commercial surrogacy is banned, demand for altruistic surrogacy, where no financial consideration is involved, remains strong.
Mint reported on December 4 that the government plans to tighten the regulatory framework for ART clinics and surrogacy.
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“The license renewal framework for IVF clinics and sperm banks is a positive step towards improving quality, accountability and patient safety in assisted reproductive care in the country,” said Hrishikesh Pai, consultant gynecologist and IVF specialist, Lilavati Hospital, Mumbai and Fortis Hospital, Delhi and Chandigarh.
“Standardized regulations can help ensure that fertility services are provided only by centers that meet defined clinical and ethical standards. However, its implementation must be practical, especially for smaller clinics, so that compliance is not a barrier to access.”
