In a move aimed at strengthening oversight of fertility and surrogacy services, the Union Health Ministry has introduced a formal renewal mechanism for the registration of Assisted Reproductive Technology (ART) clinics, ART banks and surrogacy clinics that have mushroomed across the country.
The new provisions, notified by the Department of Health Research under the Ministry, make periodic regulatory review mandatory for all registered establishments. The notification follows an earlier draft amendment issued by the DHR seeking public comments on the proposal.
Under the revised new framework, ART clinics and ART banks will have to renew their registration every five years, while surrogacy clinics will be required to seek renewal every three years.
The decision comes amid growing demand for fertility treatment services and tighter regulation of the reproductive medicine sector following the implementation of the Assisted Reproductive Technology (Regulation) Act, 2021, and the Surrogacy (Regulation) Act, 2021.
All registered ART clinics, ART banks and surrogacy clinics must apply for renewal through the National Registry portal at least 60 days before the expiry of their existing registration certificates.
"The objective is to ensure continuous compliance with prescribed standards and facilitate periodic assessment of infrastructure, staffing, record-keeping and ethical practices," a senior Health Ministry official said.
For ART facilities, the renewal fee has been fixed at Rs25,000 for Level-1 clinics and ART banks, while Level-2 ART clinics will have to pay Rs1 lakh.
Failure to apply within the stipulated period will attract a penalty in the form of higher renewal fees. Delayed applications will require payment of Rs50,000 for Level-1 clinics and ART banks and Rs2 lakh for Level-2 ART clinics.
Similarly, surrogacy clinics will have to pay a non-refundable renewal fee of Rs1 lakh. The fee will double if the application is submitted after the prescribed deadline.
Government-run institutions have been exempted from payment of renewal fees under both regulatory frameworks.
The fees collected will be utilised by the appropriate authorities for activities related to implementation of the ART and Surrogacy Acts and the rules framed under them, the official said.
The notification also prescribes a time-bound process for scrutiny of applications, he added.
The appropriate authority will be required to inspect the clinic and decide on the renewal application within 60 days of submission.
Importantly, no application can be rejected without providing the applicant an opportunity to be heard.
The Ministry has also incorporated safeguards for clinics whose applications are rejected. If deficiencies are rectified and the application is resubmitted, no additional fee will be charged for reconsideration.
All decisions on approval or rejection will be communicated to the concerned state board, strengthening coordination between central and state-level regulatory authorities, as per the official.
The introduction of periodic renewals marks an important shift in the regulation of India's fertility sector. Until now, registration largely focused on initial approval, with limited provisions for periodic reassessment.
The ART and Surrogacy Acts were enacted to address concerns relating to unregulated fertility services, varying standards of care, exploitation of surrogate mothers and the absence of uniform oversight mechanisms.
Since the laws came into force, fertility clinics have been required to comply with detailed standards relating to infrastructure, staffing, counselling services, gamete donation, record maintenance and patient safety.
However, experts have often pointed out that one-time registration alone cannot guarantee continued adherence to these standards.
The newly notified renewal mechanism seeks to bridge that gap by linking continued operation to regular regulatory evaluation, the official said.
India has emerged as one of the largest markets for assisted reproductive technologies, driven by delayed parenthood, lifestyle factors and rising infertility rates.
Government officials believe that periodic inspections and renewals will help ensure that clinics continue to meet prescribed standards and adhere to ethical and legal requirements laid down under the two Acts.
"The exercise is not merely administrative. It is intended to make reproductive healthcare services more transparent, accountable and aligned with the standards envisaged under the country's fertility and surrogacy laws," the official said.
