New Delhi : The Union Health Ministry has notified the Surrogacy (Regulation) Rules, 2022, with provisions on requirement of staff and their qualifications at a registered surrogacy clinic, and the application and other procedures at the surrogacy clinic, under the recently enacted Surrogacy (Regulation) Act, 2021.
The rule emphasises the provisions in the Act, that the surrogacy clinic shall have at least one gynaecologist, one anesthetist, one embryologist and one counsellor and the clinic may employ additional staff by the Assisted Reproductive Technology (ART) Level 2 clinics, normally director, andrologist and shall appoint such staff as may be necessary to assist the clinic into day-to-day work.
The Rule elaborates the qualification of the staff in these clinics. A gynaecologist shall be a medical postgraduate in gynaecology and obstetrics and should have a record of performing 50 ovum pick up procedures and at least three years of working experience in an ART clinic under supervision of a trained ART specialist. A medical post-graduate in gynaecology and obstetrics with super specialist doctorate of medicine/fellowship in reproductive medicine with experience not less than three years in an ART clinic shall also be eligible for the post.
An embryologist should be a post graduate in clinical embryology from a recognised university or institute with additional three years of human ART laboratory experience in handling human gamers and embryos; or a PhD holder with PhD project related to clinical embryology/ART from a recognised university with an additional one year of experience in human ART laboratory. Medical graduates or veterinary graduates with post graduate degree in clinical embryology from a recognised university with two years of ART laboratory experience or post graduate in life sciences/biotechnology with at least one year of on-site, full time clinical embryology certified training and four years experience in handling human gamers and embryos in a registered ART level 2 clinics are also allowed to be an embryologist in a surrogacy clinic.
As a one-time measure, all embryologists working in ART or In Vitro Fertilisation (IVF) clinics before the commencement of the Act, with certain qualifications and experience may be allowed to continue as embryologists. However, after the commencement of the Act, all clinics will hire embryologists only with any of the four qualifications and experienced criteria mentioned in the Rules.
According to the Rule, the number of attempts of any surrogacy procedure on the surrogate mother shall not be more than three times and the consent of a surrogate mother shall be submitted in Form 2, notified in the rule. The gynaecologist shall transfer one embryo in the uterus of a surrogate mother during a treatment cycle, provided that only in special circumstances up to three embryos may be transferred.
The surrogate mother may be allowed for abortion during the process of surrogacy in accordance with the he Medical Termination of Pregnancy Act, 1971.
The application for registration for a surrogacy clinic shall be accompanied by an application fee of rupees two lakh for surrogacy clinic and the application fee once paid shall not be refunded. However, if an application for registration of any surrogacy clinic is rejected by the appropriate authority, no fee shall be required to be paid on re-submission of the application by the applicant for the same clinic. Government run institutes need not pay for applications.
It also describes the minimum requirement of equipment for surrogacy clinics, in the Schedule I Part 2 of the Rule.
Centre has earlier this year notified the National Assisted Reproductive Technology and Surrogacy Board headed by the Minister of Health and Family Welfare as the chairperson to regulate ART clinics and banks.
The ART (Regulation) Act was notified by the government on December 21, and the Surrogacy (Regulation) Act was notified on December 25, 2021.
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