{"id":268178,"date":"2022-06-09T16:00:35","date_gmt":"2022-06-09T10:30:35","guid":{"rendered":"https:\/\/www.scconline.com\/blog\/?p=268178"},"modified":"2022-06-09T14:35:33","modified_gmt":"2022-06-09T09:05:33","slug":"mohfw-notifies-assisted-reproductive-technology-regulation-rules-2022","status":"publish","type":"post","link":"https:\/\/www.scconline.com\/blog\/post\/2022\/06\/09\/mohfw-notifies-assisted-reproductive-technology-regulation-rules-2022\/","title":{"rendered":"MoHFW notifies Assisted Reproductive Technology (Regulation) Rules, 2022"},"content":{"rendered":"<p style=\"text-align: justify;\"><span class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">The Central Government has notified the Assisted Reproductive Technology (Regulation) Rules, 2022 in order to regulate the functioning of <\/span><\/span><span id=\"page50R_mcid27\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">Assisted Reproductive Technology (ART)<\/span><\/span><span id=\"page50R_mcid28\" class=\"markedContent\"><\/span><span id=\"page50R_mcid29\" class=\"markedContent\"> <span dir=\"ltr\" role=\"presentation\">c<\/span><\/span><span id=\"page50R_mcid30\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">linics and banks.<\/span><\/span><\/p>\n<p>&nbsp;<\/p>\n<h4 style=\"text-align: justify;\">Key points:<\/h4>\n<ul style=\"text-align: justify;\">\n<li><strong><span id=\"page50R_mcid27\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">Assisted Reproductive Technology (ART)<\/span><\/span><span id=\"page50R_mcid28\" class=\"markedContent\"><\/span><span id=\"page50R_mcid29\" class=\"markedContent\"> <span dir=\"ltr\" role=\"presentation\">c<\/span><\/span><\/strong><span id=\"page50R_mcid30\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\"><strong>linics and banks<\/strong>:<\/span><\/span><span id=\"page50R_mcid32\" class=\"markedContent\"><\/span><span id=\"page50R_mcid33\" class=\"markedContent\"> <span dir=\"ltr\" role=\"presentation\">These shall be two levels of clinics<\/span><\/span><span id=\"page50R_mcid34\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">:<\/span><\/span><span id=\"page50R_mcid35\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">&#8211;<\/span><\/span><span id=\"page50R_mcid36\" class=\"markedContent\"><\/span><span id=\"page50R_mcid37\" class=\"markedContent\"><\/span><span id=\"page50R_mcid38\" class=\"markedContent\"><\/span><br role=\"presentation\" \/><span id=\"page50R_mcid38\" class=\"markedContent\"><\/span><\/li>\n<\/ul>\n<ol style=\"text-align: justify;\">\n<li style=\"list-style-type: none;\">\n<ol>\n<li><span id=\"page50R_mcid38\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\"><strong>Level 1 ART Clinics<\/strong>, where only intrauterine insemination (IUI) procedure is carried out as part of <\/span><span dir=\"ltr\" role=\"presentation\">treatment;<\/span><\/span><span id=\"page50R_mcid39\" class=\"markedContent\"><\/span><\/li>\n<li><span id=\"page50R_mcid39\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\"><strong>Level 2 ART clinics<\/strong>, where the procedures, or techniques, that attempt to obtain <\/span><span dir=\"ltr\" role=\"presentation\">a pregnancy shall be carried out by <\/span><\/span><span id=\"page50R_mcid43\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">surgical retrieval of gametes;<\/span><\/span><span id=\"page50R_mcid44\" class=\"markedContent\"><\/span><span id=\"page50R_mcid45\" class=\"markedContent\"><\/span> <span id=\"page50R_mcid48\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">handling the oocyte outside the human body;<\/span><\/span><span id=\"page50R_mcid49\" class=\"markedContent\"><\/span><span id=\"page50R_mcid50\" class=\"markedContent\"><\/span> <span id=\"page50R_mcid53\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">use sperms for fertilization of oocytes;<\/span><\/span><span id=\"page50R_mcid54\" class=\"markedContent\"><\/span><span id=\"page50R_mcid55\" class=\"markedContent\"><\/span> <span id=\"page50R_mcid58\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">transfer of the embryo into the reproductive system of a woman;<\/span><\/span><span id=\"page50R_mcid59\" class=\"markedContent\"><\/span><span id=\"page50R_mcid60\" class=\"markedContent\"><\/span> or by <span id=\"page50R_mcid63\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">carryout storage of gametes or embryos or<\/span><\/span><span id=\"page50R_mcid64\" class=\"markedContent\"> <span dir=\"ltr\" role=\"presentation\">perform any kind of procedure or technique <\/span><\/span><span id=\"page50R_mcid65\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">involving gametes or embryos.<\/span><\/span><span id=\"page50R_mcid66\" class=\"markedContent\"><\/span><span id=\"page50R_mcid67\" class=\"markedContent\"><\/span><span id=\"page50R_mcid68\" class=\"markedContent\"><\/span><span id=\"page50R_mcid70\" class=\"markedContent\"><\/span><\/li>\n<\/ol>\n<\/li>\n<\/ol>\n<ul style=\"text-align: justify;\">\n<li><span id=\"page50R_mcid70\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\"><strong>ART banks<\/strong> shall <\/span><\/span><span id=\"page50R_mcid71\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">be<\/span> <span dir=\"ltr\" role=\"presentation\">responsible<\/span> <span dir=\"ltr\" role=\"presentation\">for<\/span> <span dir=\"ltr\" role=\"presentation\">screening,<\/span> <span dir=\"ltr\" role=\"presentation\">collection<\/span> <span dir=\"ltr\" role=\"presentation\">and<\/span> <span dir=\"ltr\" role=\"presentation\">registration<\/span> <span dir=\"ltr\" role=\"presentation\">of<\/span> <span dir=\"ltr\" role=\"presentation\">the<\/span> <span dir=\"ltr\" role=\"presentation\">semen<\/span> <span dir=\"ltr\" role=\"presentation\">donor<\/span> <span dir=\"ltr\" role=\"presentation\">and <\/span><span dir=\"ltr\" role=\"presentation\">cryopreservation of sperms;<\/span><\/span><span id=\"page50R_mcid72\" class=\"markedContent\"> <span dir=\"ltr\" role=\"presentation\">performing screening and registration of oocyte donor;<\/span><\/span><span id=\"page50R_mcid73\" class=\"markedContent\"> <span dir=\"ltr\" role=\"presentation\">operating as semen banks or oocyte banks or both;<\/span><\/span><span id=\"page50R_mcid74\" class=\"markedContent\"> and <span dir=\"ltr\" role=\"presentation\">maintaining\u00a0 the records or data of all the donors and shall regularly update the National <\/span><span dir=\"ltr\" role=\"presentation\">Registry.<\/span><\/span><\/li>\n<li><span id=\"page50R_mcid78\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\"><strong>Registration<\/strong>: An application for registration shall be made by the ART clinics or any such health <\/span><span dir=\"ltr\" role=\"presentation\">facility which are carrying out procedures related to the assisted reproductive technology <\/span><span dir=\"ltr\" role=\"presentation\">to the appropriate authority in Form-1 and by the ART banks in Form-2.<\/span> <span dir=\"ltr\" role=\"presentation\">Every application for <\/span><span dir=\"ltr\" role=\"presentation\">registration shall be accompanied with a fee of: &#8211;<\/span><\/span><\/li>\n<\/ul>\n<ol style=\"text-align: justify;\">\n<li style=\"list-style-type: none;\">\n<ol>\n<li style=\"text-align: justify;\"><span id=\"page55R_mcid0\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">Rupees<\/span> <span dir=\"ltr\" role=\"presentation\">50,000<\/span> <span dir=\"ltr\" role=\"presentation\">for Level 1 ART clinic;<\/span><\/span><span id=\"page55R_mcid1\" class=\"markedContent\"><\/span><\/li>\n<li style=\"text-align: justify;\"><span id=\"page55R_mcid1\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">Rupees<\/span> <span dir=\"ltr\" role=\"presentation\">2,00,000<\/span> <span dir=\"ltr\" role=\"presentation\">for Level 2 ART clinic;<\/span><\/span><span id=\"page55R_mcid2\" class=\"markedContent\"><\/span><\/li>\n<li style=\"text-align: justify;\"><span id=\"page55R_mcid2\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">Rupees<\/span> <span dir=\"ltr\" role=\"presentation\">50,000<\/span> <span dir=\"ltr\" role=\"presentation\">for ART bank<\/span><\/span><\/li>\n<\/ol>\n<\/li>\n<\/ol>\n<ul style=\"text-align: justify;\">\n<li><span id=\"page55R_mcid15\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\"><strong>Other Duties of ART Clinic<\/strong>: The ART clinic shall-<\/span><\/span><span id=\"page55R_mcid16\" class=\"markedContent\"><br role=\"presentation\" \/><\/span><\/li>\n<\/ul>\n<ol style=\"text-align: justify;\">\n<li style=\"list-style-type: none;\">\n<ol>\n<li><span id=\"page55R_mcid16\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">ensure that all<\/span> <span dir=\"ltr\" role=\"presentation\">unused gametes or embryos shall be preserved by the assisted reproductive <\/span><span dir=\"ltr\" role=\"presentation\">technology clinic for use on the same recipient and shall not be used for any other couple<\/span><span dir=\"ltr\" role=\"presentation\">;<\/span><\/span><span id=\"page55R_mcid17\" class=\"markedContent\"><\/span><\/li>\n<li><span id=\"page55R_mcid17\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">allow cryopreservation of oocytes, sperms for onco-fertility patients undergoing treatment and for <\/span><span dir=\"ltr\" role=\"presentation\">other such conditions, for duration longer than ten years with the permission from the National <\/span><span dir=\"ltr\" role=\"presentation\">Board;<\/span><\/span><span id=\"page55R_mcid18\" class=\"markedContent\"><\/span><\/li>\n<li><span id=\"page55R_mcid18\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">ensure the controlled ovarian stimulation of woman in order to prevent ovarian hyperstimulation;<\/span><\/span><span id=\"page55R_mcid19\" class=\"markedContent\"><\/span><\/li>\n<li><span id=\"page55R_mcid19\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">ensure that pre-implantation genetic testing shall be used to screen the human embryos for known <\/span><span dir=\"ltr\" role=\"presentation\">pre-existing heritable or genetic diseases and when medically indicated;<\/span><\/span><span id=\"page55R_mcid20\" class=\"markedContent\"><\/span><\/li>\n<li><span id=\"page55R_mcid20\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">ensure that no pre-implantation genetic testing shall be done for sex selection for non-medical <\/span><span dir=\"ltr\" role=\"presentation\">reasons or selection of particular traits due to personal preferences of the prospective parents or to <\/span><span dir=\"ltr\" role=\"presentation\">alter or with a view to alter the genetic constitution of an embryo;<\/span><\/span><span id=\"page55R_mcid21\" class=\"markedContent\"><\/span><\/li>\n<li><span id=\"page55R_mcid21\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">maintain <\/span><\/span><span id=\"page55R_mcid22\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">consent form to be signed by the couple or woman as specified in Form-6; <\/span><\/span><span id=\"page55R_mcid23\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">Intrauterine<\/span> <span dir=\"ltr\" role=\"presentation\">Insemination with husband\u2019s semen or sperm as specified in Form<\/span><span dir=\"ltr\" role=\"presentation\">-7;<\/span><\/span><span id=\"page55R_mcid24\" class=\"markedContent\"> <span dir=\"ltr\" role=\"presentation\">Intrauterine Insemination with donor semen as specified in Form-8; <\/span><\/span><span id=\"page57R_mcid0\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">freezing of embryos as specified in Form-9; <\/span><\/span><span id=\"page57R_mcid1\" class=\"markedContent\"><\/span><span id=\"page57R_mcid1\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">freezing gametes as specified in Form-10; <\/span><\/span><span id=\"page57R_mcid2\" class=\"markedContent\"><\/span><span id=\"page57R_mcid2\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">freezing of gametes sperm or oocytes and parental consent as specified in Form-<\/span><\/span><span id=\"page57R_mcid2\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">11; <\/span><\/span><span id=\"page57R_mcid3\" class=\"markedContent\"><\/span><span id=\"page57R_mcid4\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">oocyte retrieval as specified in Form<\/span><\/span><span id=\"page57R_mcid5\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">&#8211;<\/span><\/span><span id=\"page57R_mcid6\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">12; <\/span><\/span><span id=\"page57R_mcid7\" class=\"markedContent\"><\/span><span id=\"page57R_mcid8\" class=\"markedContent\"><\/span><span id=\"page57R_mcid9\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">oocyte donor as specified in Form<\/span><\/span><span id=\"page57R_mcid10\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">&#8211;<\/span><\/span><span id=\"page57R_mcid11\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">13.<\/span><\/span><span id=\"page57R_mcid12\" class=\"markedContent\"><\/span><span id=\"page57R_mcid13\" class=\"markedContent\"><\/span><br role=\"presentation\" \/><span id=\"page57R_mcid13\" class=\"markedContent\"><\/span><\/li>\n<\/ol>\n<\/li>\n<\/ol>\n<p style=\"padding-left: 40px; text-align: justify;\"><span id=\"page57R_mcid13\" class=\"markedContent\"><\/span><span id=\"page57R_mcid15\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\"><br \/>\n<\/span><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Central Government has notified the Assisted Reproductive Technology (Regulation) Rules, 2022 in order to regulate the functioning of Assisted Reproductive Technology <\/p>\n","protected":false},"author":8808,"featured_media":266806,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[4,15],"tags":[49665,43470,9631,49666,37264],"class_list":["post-268178","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-legislationupdates","category-rules_regulations","tag-art-clinic","tag-assisted-reproductive-technology","tag-banks","tag-embryos","tag-ministry-of-health-and-family-welfare"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.4 (Yoast SEO v27.4) - 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