MoHFW notifies Assisted Reproductive Technology (Regulation) Rules, 2022

The Central Government has notified the Assisted Reproductive Technology (Regulation) Rules, 2022 in order to regulate the functioning of Assisted Reproductive Technology (ART) clinics and banks.

Key points:

• Assisted Reproductive Technology (ART) clinics and banks: These shall be two levels of clinics:–
  

1. 1. Level 1 ART Clinics, where only intrauterine insemination (IUI) procedure is carried out as part of treatment;
   2. Level 2 ART clinics, where the procedures, or techniques, that attempt to obtain a pregnancy shall be carried out by 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; or by carryout storage of gametes or embryos or perform any kind of procedure or technique involving gametes or embryos.

• ART banks shall be responsible for screening, collection and registration of the semen donor and cryopreservation of sperms; performing screening and registration of oocyte donor; operating as semen banks or oocyte banks or both; and maintaining  the records or data of all the donors and shall regularly update the National Registry.
• Registration: 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 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: –

1. 1. Rupees 50,000 for Level 1 ART clinic;
   2. Rupees 2,00,000 for Level 2 ART clinic;
   3. Rupees 50,000 for ART bank

• Other Duties of ART Clinic: The ART clinic shall-
  

1. 1. 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;
   2. 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;
   3. ensure the controlled ovarian stimulation of woman in order to prevent ovarian hyperstimulation;
   4. 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;
   5. 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;
   6. maintain consent form to be signed by the couple or woman as specified in Form-6; Intrauterine Insemination with husband’s semen or sperm as specified in Form-7; Intrauterine Insemination with donor semen as specified in Form-8; freezing of embryos as specified in Form-9; freezing gametes as specified in Form-10; freezing of gametes sperm or oocytes and parental consent as specified in Form-11; oocyte retrieval as specified in Form–12; oocyte donor as specified in Form–13.