New Delhi : The Union health ministry has notified the rules for Assisted Reproductive Technology (ART) in the country which includes the registration process, staff requirement, minimum equipment required and the license granting format. The notification was a follow up of the ART (Regulation) Act late last year.
According to the Assisted Reproductive Technology (Regulation) Rules, 2022, notified by the ministry, as per the earlier documents released by the Department of Health Research, the ART clinics and banks are classified as two levels, with the Level 1 ART clinics only handling intrauterine insemination (IUI) procedure as part of treatment and Level 2 clinics will have the procedures, or techniques, that attempt to obtain a pregnancy. The Level 2 clinics can carry out surgical retrieval of gametes; handling the oocyte outside the human body; use sperms for fertilization of oocytes; transfer of the embryo into the reproductive system of a woman, provided that such clinics may also undertake research.
ART banks shall be responsible for screening, collection and registration of the semen donor and cryopreservation of sperms; perform screening and registration of oocyte donor; operate as semen banks or oocyte banks or both; and maintain the records or data of all the donors and shall regularly update the National Registry as provided in sections of the Act.
An application for registration shall be made by the ART clinics or any such health facility which are carrying out procedures related to the assisted reproductive technology, as defined in the Act, to the appropriate authority in Form-1 and by the ART banks in Form-2. Every application for registration shall be accompanied with 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 granting of licenses to clinics or banks shall be the same as that of certificate of registration granted under the Rule.
Every clinic and every bank shall maintain a grievance cell in respect of matters relating to such clinics and banks and the manner of making a complaint before such grievance cell be as specified in Form 5.
The intending couple or woman need to purchase a general health insurance coverage in favor of oocyte donor for a period of 12 months from an insurance company or an agent recognized by the Insurance Regulatory and Development Authority (IRDAI) established under the provisions of the Insurance Regulatory and Development Authority Act, 1999 for an amount which is sufficient enough to cover all expenses for all complications arising due to oocyte retrieval.
The ART clinic shall ensure that all unused gametes or embryos shall be preserved by the assisted reproductive technology clinic for use on the same recipient and shall not be used for any other couple, or as the case may be, woman; allow cryopreservation of oocytes, sperms for onco-fertility patients undergoing treatment and for other such conditions, for duration longer than ten years with the permission from the National Board; ensure the controlled ovarian stimulation of woman in order to prevent ovarian hyperstimulation; ensure that pre-implantation genetic testing shall be used to screen the human embryos for known pre existing heritable or genetic diseases and when medically indicated; and ensure that no pre-implantation genetic testing shall be done for sex selection for non-medical reasons or selection of particular traits due to personal preferences of the prospective parents or to alter or with a view to alter the genetic constitution of an embryo. It shall also maintain a list of consent forms, from various parties involved.
The ART banks shall maintain record of use of donor gametes as specified in the forms and consent form for the donor of sperm as specified in the Rule.
The research on human gamete or embryo within India shall be performed after obtaining consent of the commissioning couple for transfer of such gamete or embryo to identified empaneled research institute and notified by the national board as specified in Forms 9 and 10. Subject to revision of the guidelines, such research shall be permitted as per the Indian Council of Medical Research guidelines or Stem Cell research guidelines or the Bio-medical ethics guidelines.
Surprise inspections will be carried out by the board or appropriate authority, and every ART clinic or bank shall allow inspection of their place, equipment and records by the National Board, National Registry, State Board or appropriate authority or any officer authorized on this behalf.
Centre has earlier this year notified National Assisted Reproductive Technology and Surrogacy Board (NARTSB) headed by the Ministry of Health and Family Welfare (MoHFW) as the Chairperson to regulate ART clinics and banks.
Under the Act, the NARTSB has powers to advise the Central Government on policy matters relating to the ART, to review and monitor the implementation of the Act, Rules and regulations, to lay down code of conduct to be observed by persons working at clinics and banks, to see the minimum standards of physical infrastructure, laboratory and diagnostic equipment and expert manpower to be employed by the clinics and banks. The Board also has to oversee the performance of various bodies constituted under the Act and supervise the functioning of the National Registry and liaison with the State Boards and pass orders as per the provisions made under the Act.
The ART (Regulation) Act was notified by the government on December 21, and the Surrogacy (Regulation) Act was notified on December 25, 2021