The Assisted Reproductive Technology (Regulation) Rules, 2022.

The Ministry of Health and Family Welfare on 7th June 2022, has published the Assisted Reproductive Technology (Regulation) Rules, 2022 to regulate the functioning of Assisted Reproductive Technology (ART) clinics and banks.

As per this rule, there shall be two levels of clinics, namely,  Level 1 ART Clinics, where only intrauterine insemination (IUI) procedure is carried out as part of treatment and Level 2 ART clinics, where the procedures, or as the case may be, techniques, that attempt to obtain a pregnancy shall be carried out.

The Assisted Reproductive Technology (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;
  • Maintain the records or data of all the donors and shall regularly update the National Registry.

An application for registration shall be made by the ART clinics or any such health facility which are carrying out procedures related to assisted reproductive technology, to the appropriate authority in Form-1 and by the ART banks in Form-2.

The appropriate authority shall, after making such enquiry and after satisfying itself that the applicant has complied with all the requirements, shall grant a certificate of registration in Form 3 to the applicant. One copy of the certificate of registration shall be displayed by the registered ART clinic or ART bank at a conspicuous place at its place of business.

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 compliant before such grievance cell be as specified in Form 5.

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 and it shall 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.

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