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Date: 05-Apr-2023 Category: Extra Ordinary State: Union Government Country: India

Assisted Reproductive Technology Regulations, 2023

Issued by Ministry of Health and Family Welfare · Department of Health Research

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Executive Summary & Key Takeaways

Key Changes

  • Clinics must ensure controlled ovarian stimulation to prevent ovarian hyperstimulation in women.
  • Gynaecologists should transfer 1-2 embryos into the uterus of a woman during a treatment cycle, based on the patient's medical condition.
  • In exceptional circumstances such as advanced maternal age, recurrent miscarriages, or recurrent implantation failure, up to three embryos may be transferred.
  • Gynaecologists are prohibited from transferring more than three embryos in any case.
  • The notification introduces the Assisted Reproductive Technology Regulations, 2023, which come into force from the date of their publication in the Official Gazette (April 5, 2023).
  • Clinics must obtain consent from the oocyte donor before retrieving oocytes.
  • Clinics should aim to retrieve no more than seven oocytes during one cycle from a donor, while retrieving all formed follicles.

What it means

  • The gazette notification issued by the Ministry of Health and Family Welfare, Department of Health Research, pertains to the Assisted Reproductive Technology (ART) Regulations, 2023. These regulations are framed by the National Assisted Reproductive Technology and Surrogacy Board (National Board) in exercise of the powers conferred by section 43 of the Assisted Reproductive Technology (Regulation) Act, 2021.
  • The regulations specify the manner of retrieving oocytes from donors and the manner of placing embryos in the uterus of a woman during ART procedures.

Impact Analysis

ART Clinics

  • Action Item: Review and update clinic protocols to comply with the new regulations. Train staff on the updated procedures and documentation requirements.

Gynaecologists

  • Action Item: Educate gynaecologists about the new regulations and ensure they understand the criteria for transferring more than two embryos. Update patient consent forms to reflect the new guidelines.

Oocyte Donors

  • Action Item: Update donor consent forms to comply with the new regulations. Review and adjust donor compensation policies as needed.

Patients undergoing ART

  • Action Item: Communicate the changes in ART protocols to patients and explain the rationale behind them. Provide counseling to patients regarding the implications of the new regulations on their treatment options.

Key Entities Referenced

National Assisted Reproductive Technology and Surrogacy Board (National Board): The body responsible for making the regulations pertaining to Assisted Reproductive Technology and Surrogacy in India. Assisted Reproductive Technology (Regulation) Act, 2021 (42 of 2021): The Act that empowers the National Board to make regulations related to ART. Assisted Reproductive Technology Regulations, 2023: The regulations introduced by this gazette notification, specifying the manner of retrieving oocytes and placing embryos during ART procedures.
Official Source Record View Original Source →
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 xxxGIDHxxx सी.जी.-डी.एxxलxG.-IअDE.-x0xx5 042023-244935 CG-DL-E-05042023-244935 असाधारण EXTRAORDINARY भाग II—खण् ड 3—उप-खण्ड (i) PART II—Section 3—Sub-section (i) प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 208] नई दिल्ली, बुधवार, अप्रलै 5, 2023/चत्रै 15, 1945 No. 208] NEW DELHI, WEDNESDAY, APRIL 5, 2023/CHAITRA 15, 1945 स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय (स्ट्वास्ट््य अनसु धं ान जवभाग) (राष्ट्रीय सहायताप्राप्त िननीय प्रौद्योजगकी और सरोगसे ी बोडड) अजधसचू ना नई दिल्ली, 5 अप्रैल 2023 सा.का.जन. 269(अ).—सहायताप्राप्त िननीय प्रौद्योजगकी (जवजनयमन) अजधजनयम 2021 (2021 का 42) की धारा 43 द्वारा प्रित्त िजियों का प्रयोग करत े हुए, राष्ट्रीय सहायताप्राप्त िननीय प्रौद्योजगकी और सरोगेसी बोडड (राष्ट्रीय बोडड) इसके द्वारा जनम्नजलजखत जवजनयम बनाता ह,ै अर्ाडत:्- 1. सजं िप्त िीर्कड और प्रारंभ– (1) इन जवजनयमों को सहायताप्राप्त िननीय प्रौद्योजगकी जवजनयम 2023 कहा िाएगा। (2) ये रािपत्र म ें इनके प्रकािन की तारीख स ेप्रवृत्त होंगे। 2. धारा 24 के खडं (क) के अधीन अडं ाणओंु को प्राप्त करन े का तरीका - (1) क्लीजनक िाता से सहमजत प्राप्त करने के बाि अंडाण ु िाताओं से अंडाणओंु को प्राप्त करेंगे। (2) िाता से अंडाणओंु को प्राप्त करने के जलए, क्लीजनक प्रयास करेंगे दक एक चक्र के िौरान सात अडं ाणुओं से अजधक प्राप्त न हों: बिते दक क्लीजनक सभी गरित रोमों को प्राप्त करेंगे। (3) जक्लजनक जडम्बग्रंजर् हाइपरजस्ट्िम्यूलेिन को रोकन े के जलए मजहला की जनयंजत्रत जडम्बग्रंजर् उत्तेिना सुजनजित करेंगे। 2268 GI/2023 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] 3. धारा 24 के खडं (ख) के अधीन दकसी मजहला के गभािड य म ें भ्रणू रखन े का तरीका- (1) स्त्री रोग जविेर्ज्ञ, रोगी की जचदकत्सीय जस्ट्र्जत के आधार पर उपचार चक्र के िौरान दकसी मजहला के गभाडिय में 1-2 भ्रूण स्ट्र्ानांतररत करेगा बिते दक केवल असाधारण पररजस्ट्र्जतयों िैसे उन्नत मातृ आयु, आवती गभडपात और आवतडक आरोपण जवफलता और ऐसी अन्य पररजस्ट्र्जतयों म ेंतीन भ्रूण स्ट्र्ानांतररत दकए िा सकत े ह।ैं (2) उप-जवजनयमन (1) के प्रयोिनों के जलए, स्त्री रोग जविेर्ज्ञ तीन स ेअजधक भ्रूणों को स्ट्र्ानातं ररत नहीं करेगा। [फा. संख्या.यू.11019/29/2022-एचआर(भाग-I)] गीता नारायण, संयक्ु त सजचव MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health Research) (NATIONAL ASSISTED REPRODUCTIVE TECHNOLOGY AND SURROGACY BOARD) NOTIFICATION New Delhi, the 5th April, 2023 G.S.R. 269(E).—In exercise of the powers conferred by section 43 of the Assisted Reproductive Technology (Regulation) Act, 2021 (42 of 2021), the National Assisted Reproductive Technology and Surrogacy Board (National Board) hereby makes the following regulations, namely:- 1. Short title and commencement. – (1) These regulations may be called the Assisted Reproductive Technology Regulations, 2023. (2) They shall come into force from the date of their publication in the Official Gazette. 2. The manner of retrieving the oocytes under clause (a) of section 24.- (1) The clinics shall retrieve oocytes from the donor after obtaining consent from the donor. (2) For retrieving oocytes from the donor, clinics shall make efforts to retrieve not more than seven oocytes during one cycle: Provided that the clinics shall retrieve all formed follicles. (3) The clinics shall ensure the controlled ovarian stimulation of woman in order to prevent ovarian hyperstimulation. 3. The manner of placing the embryos in the uterus of a woman under clause (b) of section 24.- (1) The gynaecologist shall transfer 1-2 embryos in the uterus of a woman during a treatment cycle depending upon the medical condition of the patient provided that only in exceptional circumstances such as advanced maternal age, recurrent miscarriages and recurrent implantation failure and such other circumstances three embryos may be transferred. (2) For the purposes of sub-regulation (1), the gynaecologist shall not transfer more than three embryos. [F. No. U.11019/29/2022-HR(Part-I)] GEETA NARAYAN, Jt. Secy. 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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