The gazette notification introduces the Assisted Reproductive Technology (Regulation) Amendment Rules, 2023, which amends the Assisted Reproductive Technology (Regulation) Rules, 2022.
The amendment modifies the qualifications and experience required for Andrologists performing surgical sperm retrieval procedures.
Key Changes
The amendment revises the eligibility criteria for Andrologists by modifying sub-section (c) (ii) of Para A in Part 1 of Schedule 1 of the Assisted Reproductive Technology (Regulation) Rules, 2022.
The revised rule states that an Andrologist must have an MCh/DNB in urology or MS General Surgery or FNB/MCh/DM in reproductive medicine with a minimum of 2 years of experience and hands-on experience of a minimum of 15 surgical sperm retrieval procedures (PESA / TESA / TESE / MESA / MICROTESE).
Impact Analysis
Healthcare Providers (ART Clinics)
There could be a need for additional training or hiring of qualified Andrologists to meet the amended requirements.
Andrologists
Andrologists must have a minimum of 2 years experience and having hands-on experience of minimum 15 surgical sperm retrieval.
Patients
The amendment aims to improve the quality and safety of ART procedures by ensuring that qualified professionals perform them.
Regulatory Bodies
Monitoring and auditing of ART clinics may be necessary to verify compliance with the amended rules.
Suggested Action Items
Regulatory bodies should update their guidelines and monitoring procedures to reflect the changes introduced by the amendment rules.
Key Entities Referenced
Central Government: The entity that has the power to make rules to amend the Assisted Reproductive Technology (Regulation) Rules, 2022, as per Section 42 of the Assisted Reproductive Technology (Regulation) Act, 2021.
Ministry of Health and Family Welfare (Department of Health Research): The ministry responsible for issuing the notification and implementing the rules related to Assisted Reproductive Technology.
Assisted Reproductive Technology (Regulation) Act, 2021 (42 of 2021): The principal legislation that empowers the Central Government to regulate Assisted Reproductive Technology.
Assisted Reproductive Technology (Regulation) Rules, 2022: The rules that are being amended by this notification. These rules were initially published on June 7, 2022, and subsequently amended on October 10, 2022, and February 24, 2023.
Andrologist: A specialist who must have specific qualifications (MCh/DNB in urology or MS General Surgery or FNB/MCh/DM in reproductive medicine) and experience (minimum 2 years and hands-on experience of minimum 15 surgical sperm retrieval procedures) to perform surgical sperm retrieval.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-11072023-247228
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CG-DL-E-11072023-247228
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असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 394] नई दिल्ली, मगं लवार, िुलाई 11, 2023/आर्ाढ़ 20, 1945
No. 394] NEW DELHI, TUESDAY, JULY 11, 2023/ASHADHA 20, 1945
स्ट्वास्ट््य एव ंपररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य अनसु धं ान जवभाग)
अजधसचू ना
नई दिल्ली, 11 िलु ाई, 2023
सा.का.जन. 493(अ).—सहायता प्राप्त िननीय प्रोद्योजगकी (जवजनयमन) अजधजनयम, 2021 (2021 का 42) की
धारा 42 द्वारा प्रित्त िजि का प्रयोग करते हुए, केंद्रीय सरकार सहायता प्राप्त िननीय प्रोद्योजगकी (जवजनयमन) जनयम
2022 में और संिोधन करन े के जलए जनम्नजलजखत जनयम बनाती है-
1. (1) इन जनयमों को सहायता प्राप्त िननीय प्रोद्योजगकी (जवजनयमन) संिोधन जनयम 2023 कहा िाएगा।
(2) य ेरािपत्र में इनके प्रकािन की तारीख स ेप्रवृत्त होंगे।
2. सहायता प्राप्त िननीय प्रोद्योजगकी (जवजनयमन) जनयम, 2022 म,ें अनुसूची 1 के भाग 1 म ें पैरा क की
उप-धारा (ग) (ii) को जनम्नानुसार प्रजतस्ट्थाजपत दकया िाएगा: –
“एंड्रोलॉजिस्ट्ट यरू ोलॉिी म ें एमसीएच/डीएनबी या एमएस िनरल सिजरी या प्रिनन जचदकत्सा में
एफएनबी/एमसीएच/डीएम के साथ न्यूनतम 2 वर् ज काअनभु व और न्यनू तम 15 सर्िजकल िुक्राणु पुनप्राजजप्त (अथातज ्
पीईएसए /टीईएसए/टीईएसई/एमईएसए/माइक्रोटेसी प्रदक्रयाएं) का व्यावहाररक अनुभवी होगा।“
[फा. सं. य.ू 11019/14/2022 एचआर]
अनु नागर, संयुि सजचव
4425 GI/2023 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
रटप्पणः सहायता प्राप्त िननीय प्रोद्योजगकी (जवजनयमन) जनयम, 2022 को भारत के रािपत्र, असाधारण,
भाग II, खंड 3, उपखडं (i) में दिनांक 07 िून 2022 की अजधसूचना संख्या सा.का.जन. 419 (अ)
द्वारा प्रकाजित दकया गया था और बाि म ें दिनांक 10 अक्टूबर 2022 की अजधसूचना संख्या
सा.का.जन. 771(अ), और दिनांक 24 फरवरी 2023 की अजधसूचना संख्या सा.का.जन. 179 (अ) द्वारा
संिोजधत दकया गया था।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health Research)
NOTIFICATION
New Delhi, the 11th July, 2023
G.S.R. 493(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,
2023.
(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, sub-section (c) (ii) of Para A in
Part 1 of Schedule 1 shall be substituted as under:—
“The Andrologist shall be MCh/DNB in urology or MS General Surgery or FNB/MCh/DM in reproductive
medicine with minimum 2 years experience and having hands-on experience of minimum 15 surgical sperm retrieval
(namely PESA / TESA / TESE / MESA / MICROTESE procedures).”
[F. No. U.11019/14/2022-HR]
ANU NAGAR, Jt. Secy.
Note: The Assisted Reproductive Technology (Regulation) Rules, 2022 was published in the Gazette of
India, Extraordinary, Part II, Section 3, Subsection (i) vide notification number G.S.R.419 (E), dated
the 7th June, 2022 and subsequently amended vide notification number G.S.R.771 (E), dated the 10th
October, 2022 and vide G.S.R.126 (E), dated the 24th February, 2023.
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and Published by the Controller of Publications, Delhi-110054.