Rules for clinics and ART banks notified by Union Department of Health, Health News, ET HealthWorld

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New Delhi: The Union Health Ministry has notified the Assisted Reproductive Technology (ART) rules in the country, which includes registration process, staffing requirements, minimum equipment required and the licensing format. The notification followed the ART (regulation) Act late last year.

According to the Assisted Human Reproduction Rules (Regulation) 2022, notified by the Ministry, in accordance with earlier documents issued by the Ministry of Health Research, ART clinics and banks are classified into two levels, ART clinics of level 1 only dealing with intrauterine insemination (IUI) procedure as part of the treatment and level 2 clinics will have the procedures or techniques that attempt to achieve pregnancy. Level 2 clinics can perform surgical gamete retrieval; manipulation of the oocyte outside the human body; use spermatozoa for the fertilization of oocytes; transfer of the embryo into a woman’s reproductive system, provided that these clinics can also undertake research.

ART banks will be responsible for sperm donor screening, collection and registration and sperm cryopreservation; performing egg donor screening and registration; operate as sperm banks or egg banks or both; and maintain the records or data of all donors and shall regularly update the National Registry as provided for in the sections of the Act.

An application for registration must be made by ART clinics or any healthcare facility that performs procedures related to assisted reproductive technology, as defined in law, to the appropriate authority in Form-1 and by banks ART in Form- 2. Each registration application must be accompanied by a fee of Rs, 50,000 for Level ART Clinic, Rs. 2 lakh for Level 2 ART Clinic and Rs. 50,000 for ART Bank

The format for licensing clinics or banks should be the same as the certificate of registration issued under the rule.

Each clinic and bank must maintain a grievance cell in relation to matters relating to those clinics and banks and the manner of filing a complaint with this grievance cell must be specified in Form 5.

The couple or the intended woman must take out general health insurance cover in favor of the egg donor for a period of 12 months with an insurance company or an agent recognized by the Authority of Insurance Regulation and Development (IRDAI) established in accordance with the provisions of the Insurance Regulation Act. and Development Authority Act, 1999 for an amount sufficient to cover all expenses for all complications resulting from egg retrieval.

The ART clinic must ensure that any unused gametes or embryos are kept by the assisted reproduction clinic for use on the same recipient and must not be used for another couple or, as the case may be, a woman ; allow the cryopreservation of oocytes, spermatozoa for onco-fertile patients undergoing treatment and for other similar conditions, for a period of more than ten years with the authorization of the National Council; ensure controlled ovarian stimulation of the woman in order to prevent ovarian hyperstimulation; ensure that preimplantation genetic testing is used to screen human embryos for known pre-existing hereditary or genetic diseases and when medically indicated; and to ensure that no preimplantation genetic testing is carried out for sex selection for non-medical reasons or the selection of particular traits due to the personal preferences of the intended parents or to alter or with the intention of altering the genetic makeup of an embryo. He must also keep an up-to-date list of consent forms from the various parties involved.

ART banks must maintain a record of the use of donor gametes as specified in the forms and the consent form for the sperm donor as specified in the rule.

Research on human gametes or embryos in India must be carried out after obtaining the consent of the requesting couple for the transfer of such gametes or embryos to a research institute identified and notified by the national council as specified in Forms 9 and 10. Subject to revision of the guidelines, such research will be permitted in accordance with Indian Council of Medical Research guidelines or stem cell research guidelines or biomedical ethics guidelines.

Surprise inspections will be carried out by the competent council or authority, and each ART clinic or bank will allow inspection of its premises, equipment and records by the national council, national registry, state council or the competent authority or any agent authorized in this capacity.

The Center earlier this year notified the National Assisted Reproductive Technology and Surrogacy Board (NARTSB) led by the Ministry of Health and Family Welfare (MoHFW) as chairman to regulate ART clinics and banks.

Under the act, the NARTSB has the power to advise the central government on policy matters relating to ART, to review and monitor the implementation of the law, rules and regulations, to establish a code of conduct to be observed by people working in clinics and banks, to see the minimum standards of physical infrastructure, laboratory and diagnostic equipment and expert manpower to be employed by clinics and banks . The Council shall also oversee the performance of the various bodies constituted under the Act and oversee the operation of the National Registry and liaison with State Councils and pass orders in accordance with provisions made under the Act.

The ART Act (Regulation) was notified by the Government on December 21 and the Surrogacy Act (Regulation) was notified on December 25, 2021

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