Assisted Reproductive Technology (Regulation) Amendment Rules, 2023

The Ministry of Health and Family Welfare (MoHFW) has notified the Assisted Reproductive Technology (Regulation) Amendment Rules, 2023. This amendment has come into effect from 11th July, 2023.

It may be recalled that the Assisted Reproductive Technology (Regulation) Act, 2021 was notified on 18th December, 2021. The Act covers the regulation and supervision of the assisted reproductive technology clinics and the assisted reproductive technology banks, prevention of misuse, safe and ethical practice of assisted reproductive technology services for addressing the issues of reproductive health where assisted reproductive technology is required for becoming a parent or for freezing gametes, embryos, embryonic tissues for further use due to infertility, disease or social or medical concerns and for regulation and supervision of research and development and for matters connected therewith or incidental thereto.

Subsequently, it may also be recalled that the Assisted Reproductive Technology (Regulation) Rules, 2022 were published to regulate the functioning of Assisted Reproductive Technology (ART) clinics and banks.

Now therefore, by the present amendment, the MoHFW has revised the qualifications of the andrologist in ART Level 2 clinics. The amendment now also permits an andrologist to qualify under the Rules if they possess an MS General Surgery or FNB/MCh/DM in reproductive medicine. Prior to this amendment, only a person possessing a Mch or DNB in Urology with special training in Diagnosing and Treating Male infertility was classified as an andrologist for the purposes of ART.

Hence, as per the present amendment, an andrologist shall possess the following qualifications:

  • MCh/DNB in urology or
  • MS General Surgery or
  • FNB/MCh/DM in reproductive medicine
  • must have a minimum 2 years experience
  • shall also have hands-on experience of minimum 15 surgical sperm retrieval (namely PESA / TESA / TESE / MESA / MICROTESE procedures)

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