Draft Rules for Renewal of ART and Surrogacy Clinic Registrations

The Ministry of Health and Family Welfare’s Department of Health Research (ART & Surrogacy Division) has issued a notice to the general public on the Draft Rules for the Renewal of Registration of Assisted Reproductive Technology (ART) clinics, ART banks, and surrogacy clinics.

The proposed rules, framed under Section 17 of the Assisted Reproductive Technology (Regulation) Act, 2021 and Section 12(3) of the Surrogacy (Regulation) Act, 2021, outline procedures and requirements for the continued operation of such facilities. According to the department, the initiative aims to promote transparency, accountability, and inclusive participation in shaping the regulatory framework.

The draft rules are available for public viewing on the Department of Health Research website.

Key Amendments Proposed

1. New Rule 8A – ART (Regulation) Rules, 2022

This addition specifies the conditions, forms, and fees for renewal applications:

Application timeline: At least 60 days before registration expiry, through the National Registry Portal.

Fee structure:

• ₹25,000 for Level I ART Clinics
• ₹1,00,000 for Level II ART Clinics
• ₹25,000 for ART Banks

No fees for government-run institutes. Fees are non-refundable, but no additional fee is required on resubmission after rejection.

1. Applications must be submitted both online and as a signed PDF to the Appropriate Authority.
2. Renewal decisions must be made within 60 days, following inspection and compliance checks.
3. Renewed certificates are valid for 5 years and must be prominently displayed.
4. Old certificates must be surrendered upon renewal or rejection.

2. New Rule 11A – Surrogacy (Regulation) Rules, 2022

This rule mirrors the ART renewal process but applies to surrogacy clinics:

Application timeline: At least 60 days before registration expiry, via the National Registry Portal.

Fee structure:

• ₹1,00,000 for Surrogacy Clinics

No fees for government-run institutes. Fees are non-refundable, but no additional fee for resubmission after rejection.

1. Both online submission and signed PDF copies are required.
2. Renewal or rejection decisions to be made within 60 days after inspection.
3. Renewed certificates are valid for 3 years and must be displayed at the clinic.
4. Previous certificates must be surrendered upon issuance of a new one or after rejection.