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Core Purpose

This notification introduces the Assisted Reproductive Technology (Regulation) Amendment Rules, 2026, to further amend the Assisted Reproductive Technology (Regulation) Rules, 2022.

Detailed Summary

The Ministry of Health and Family Welfare (Department of Health Research), on June 17, 2026, issued G.S.R. 491(E) to introduce the Assisted Reproductive Technology (Regulation) Amendment Rules, 2026, which further amend the Assisted Reproductive Technology (Regulation) Rules, 2022. Exercising powers under section 42 of the Assisted Reproductive Technology (Regulation) Act, 2021 (42 of 2021), the Central Government inserted new rules 7A and 8A. Rule 7A mandates that registration fees for assisted reproductive technology clinics or banks be deposited in a bank account opened in the name of the appropriate authority for utilization in implementing the Act and rules. Rule 8A specifies conditions, forms, and fees for renewal of registration certificates under section 17. Applications for renewal must be made through the National Registry portal 60 days before expiry, using Form 1 for clinics and Form 2 for banks. Non-refundable renewal fees are ₹25,000 for Level 1 ART clinics and ART banks, and ₹1,00,000 for Level 2 ART clinics. Late applications incur higher fees: ₹50,000 for Level 1 ART clinics and ART banks, and ₹2,00,000 for Level 2 ART clinics. Government-run institutes are exempt from renewal fees. The appropriate authority, within 60 days of receiving the application and fee, shall renew the certificate in Form 3 after inspection or reject it with reasons and an opportunity to be heard. Renewed certificates are valid for a further five years from the date of expiry of the previous certificate. The notification also notes previous amendments to the 2022 Rules, including G.S.R. 419(E) dated June 7, 2022, G.S.R. 771(E) dated October 10, 2022, G.S.R. 126(E) dated February 24, 2023, and G.S.R. 493(E) dated July 11, 2023.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-18062026-273565 EXTRAORDINARY PART II-Section 3-Sub-section (i) PUBLISHED BY AUTHORITY No. 440] NEW DELHI, WEDNESDAY, JUNE 17, 2026/JYAISTHA 27, 1948 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health Research) NOTIFICATION New Delhi, the 17th June, 2026 G.S.R.491(E).—In exercise of the powers conferred by section 42 of the Assisted Reproductive Technology (Regulation) Act, 2021 (42 of 2021), the Central Government hereby makes the following rules further to amend the Assisted Reproductive Technology (Regulation) Rules, 2022, namely:- 1. (1) These rules may be called the Assisted Reproductive Technology (Regulation) Amendment Rules, 2026. (2) They shall come into force on the date of their publication in the Official Gazette. 2. In the Assisted Reproductive Technology (Regulation) Rules, 2022,- (a) after rule 7, the following rule shall be inserted, namely:- "7A. Mode of payment of registration fee and its utilisation.-The fee for registration of assisted reproductive technology clinic or bank shall be deposited in a bank account opened in the name of the official designation of the appropriate authority concerned and shall be utilised by the appropriate authority in connection with the activities connected with implementation of the provisions of the Act and rules made thereunder."; (b) after rule 8, the following rule shall be inserted, namely:- "8A. The conditions, form and fee for application of renewal of certificate of registration of clinic or bank under section 17.-(1) An application for renewal of a certificate of registration shall be made by the assisted reproductive technology clinics in Form 1 and by the Assisted reproductive technology banks in Form-2 to the appropriate authority through the National Registry portal, sixty days before the date of expiry of such certificate of registration. (2) Every application for renewal of registration under sub-rule (1) shall be accompanied with a non- refundable fee of - (i) twenty-five thousand rupees for Level 1 assisted reproductive technology clinic; (ii) one lakh rupees for Level 2 assisted reproductive technology clinic; (iii) twenty-five thousand rupees for assisted reproductive technology bank. (3) Where an application for renewal of registration of any assisted reproductive technology clinic or assisted reproductive technology bank is not received within a period of sixty days before the date of expiry of its certificate of registration, the following application fees as applicable in case of initial registration shall be required to be paid namely:- (i) fifty thousand rupees for Level 1 assisted reproductive technology clinic; (ii) two lakh rupees for Level 2 assisted reproductive technology clinic; and (iii) fifty thousand rupees for assisted reproductive technology bank: Provided that establishments in the Government-run institutes need not pay any fee for the renewal of certificate of registration. (4) After submission of the online application for renewal of certificate of registration on the National Registry portal, a PDF printout of the filled-in application form, duly signed by the authorised signatory on behalf of the clinic or bank, shall be submitted to the appropriate authority of the respective State Government or Union territory Administration and the application for renewal shall be considered only from the date the prescribed fee, along with the PDF copy of the application, is received by the appropriate authority. (5) The fee for renewal of certificate of registration shall be deposited in a bank account opened in the name of the official designation of the appropriate authority concerned and shall be utilised by the appropriate authority in connection with the activities connected with implementation of the provisions of the Act and rules made thereunder. (6) On receipt of the application for renewal of certificate of registration, the appropriate authority shall, within a period of sixty days,- (a) after inspection and satisfying itself that the applicant has complied with all the requirements prescribed under the Act and rules made thereunder, renew the certificate of registration of the clinic or bank as specified in Form 3, subject to the provisions of the Act and the rules and regulations made thereunder; or (b) reject such application for reasons to be recorded in writing, if that application does not conform to the provisions of the Act or the rules or regulations made thereunder: Provided that no application for renewal of registration shall be rejected without giving an opportunity of being heard to the applicant. (7) If an application for renewal of registration of any assisted reproductive technology clinic or bank is rejected by the appropriate authority, no fee shall be required to be paid on re-submission of the renewal application by the applicant for the same clinic or bank, if it complies with the provisions of the Act, or the rules or regulations made thereunder, as the case may be. (8) The intimation with regard to renewal of certificate of registration or rejection of application for such renewal shall be made to the State Board. (9) The renewed certificate of registration shall be displayed by the assisted reproductive technology clinic or bank at a conspicuous place at its place of business. (10) The renewal of certificate of registration shall be valid for a further period of five years from the date of expiry of the certificate of registration earlier granted.". [F. No. U.11019/14/2022-HR] RICHA KHODA, Jt. Secy. Note: The Assisted Reproductive Technology (Regulation) Rules, 2022 were published in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i) vide notification number G.S.R. 419(E), dated the 7th June, 2022 and subsequently amended vide notification numbers G.S.R. 771(E), dated the 10th October, 2022, G.S.R. 126(E), dated the 24th February, 2023 and G.S.R. 493 (E), dated the 11th July, 2023. Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.

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