{"id":286887,"date":"2023-03-14T14:00:45","date_gmt":"2023-03-14T08:30:45","guid":{"rendered":"https:\/\/www.scconline.com\/blog\/?p=286887"},"modified":"2023-03-14T13:07:08","modified_gmt":"2023-03-14T07:37:08","slug":"ministry-of-health-and-family-welfare-notified-new-drugs-and-clinical-trials-amendment-rules-legal-research-legal-update-legal-news","status":"publish","type":"post","link":"https:\/\/www.scconline.com\/blog\/post\/2023\/03\/14\/ministry-of-health-and-family-welfare-notified-new-drugs-and-clinical-trials-amendment-rules-legal-research-legal-update-legal-news\/","title":{"rendered":"MOHFW revises Development Methodology vide New Drugs and Clinical Trials (Amendment) Rules, 2023"},"content":{"rendered":"<p><script type=\"text\/javascript\">\n\tdocument.title = 'MOHFW revises Development Methodology vide NDCT Rules 2023 | SCC Blog'\n\tdocument.querySelector('meta[name=\"description\"]').setAttribute(\"content\", \"Ministry of Health and Family Welfare revises Development Methodology to assess new drugs vide New Drugs and Clinical Trials (Amendment) Rules, 2023.\");\n<\/script><\/p>\n<div style=\"text-align: justify; line-height: 150%;\">\n<p style=\"margin-bottom: 3%;\">On 13-3-2023, the Ministry of Health and Family Welfare notified the New Drugs and Clinical Trials (Amendment) Rules, 2023 to amend the New Drugs and Clinical Trials Rules, 2019. The provisions came into force on 13-3-2023.<\/p>\n<p style=\"\">First Schedule, Para 3 (1) (b) relating to <span style=\"font-weight: bold;\">Development Methodology<\/span> has been revised:<\/p>\n<table style=\"border-bottom-width: 0.5pt; border-bottom-style: solid; border-left-width: 0.5pt; border-left-style: solid; border-right-width: 0.5pt; border-right-style: solid; border-collapse: collapse; border-top-width: 0.5pt; border-top-style: solid; margin-left: 0.09mm; margin-right: auto; table-layout: fixed; width: 153.73mm; margin-bottom: 3%; margin-left: auto; margin-left: right;\">\n<colgroup>\n<col width=\"271\">\n<col width=\"310\">\n<\/colgroup>\n<tbody>\n<tr>\n<td valign=\"top\" colspan=\"1\" rowspan=\"\" style=\"border-bottom-width: 0.5pt; border-bottom-style: solid; border-left-width: 0.5pt; border-left-style: solid; border-right-width: 0.5pt; border-right-style: solid; border-top-width: 0.5pt; border-top-style: solid; padding-bottom: 0.0mm; padding-left: 1.91mm; padding-right: 1.91mm; padding-top: 0.0mm; vertical-align: top; width: 71.71mm;\">\n<p style=\"line-height: normal; text-align: center; font-weight: bold; font-family: Times New Roman; font-size: 12.0pt;\">Previous<\/p>\n<\/td>\n<td valign=\"top\" colspan=\"1\" rowspan=\"\" style=\"border-bottom-width: 0.5pt; border-bottom-style: solid; border-left-width: 0.5pt; border-left-style: solid; border-right-width: 0.5pt; border-right-style: solid; border-top-width: 0.5pt; border-top-style: solid; padding-bottom: 0.0mm; padding-left: 1.91mm; padding-right: 1.91mm; padding-top: 0.0mm; vertical-align: top; width: 82.03mm;\">\n<p style=\"line-height: normal; text-align: center; font-weight: bold; font-family: Times New Roman; font-size: 12.0pt;\">Now<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td valign=\"top\" colspan=\"1\" rowspan=\"\" style=\"border-bottom-width: 0.5pt; border-bottom-style: solid; border-left-width: 0.5pt; border-left-style: solid; border-right-width: 0.5pt; border-right-style: solid; border-top-width: 0.5pt; border-top-style: solid; padding-bottom: 0.0mm; padding-left: 1.91mm; padding-right: 1.91mm; padding-top: 0.0mm; vertical-align: top; width: 71.71mm;\">\n<p style=\"line-height: normal; font-family: Times New Roman; font-size: 12.0pt;\">The <span style=\"font-weight: bold;\">detailed requirements<\/span> of non-clinical studies have been specified in the Second Schedule.<\/p>\n<\/td>\n<td valign=\"top\" colspan=\"1\" rowspan=\"\" style=\"border-bottom-width: 0.5pt; border-bottom-style: solid; border-left-width: 0.5pt; border-left-style: solid; border-right-width: 0.5pt; border-right-style: solid; border-top-width: 0.5pt; border-top-style: solid; padding-bottom: 0.0mm; padding-left: 1.91mm; padding-right: 1.91mm; padding-top: 0.0mm; vertical-align: top; width: 82.03mm;\">\n<p style=\"line-height: normal; font-family: Times New Roman; font-size: 12.0pt;\">The <span style=\"font-weight: bold;\">general requirements<\/span> of non- clinical studies are specified in the Second Schedule.<\/p>\n<p style=\"line-height: normal; font-family: Times New Roman; font-size: 12.0pt;\">The following testing methods to assess the safety and efficacy of a new drug or investigational new drug now includes the following:<\/p>\n<ol>\n<li>\n<p style=\"line-height: normal; margin-left: 0.0mm; font-family: Times New Roman; font-size: 12.0pt;\">Cell- based assay<\/p>\n<\/li>\n<li>\n<p style=\"line-height: normal; margin-left: 0.0mm; font-family: Times New Roman; font-size: 12.0pt;\">Organ chips and micro physiological systems<\/p>\n<\/li>\n<li>\n<p style=\"line-height: normal; margin-left: 0.0mm; font-family: Times New Roman; font-size: 12.0pt;\">Sophisticated computer modeling<\/p>\n<\/li>\n<li>\n<p style=\"line-height: normal; margin-left: 0.0mm; font-family: Times New Roman; font-size: 12.0pt;\">Other human biology-based test methods<\/p>\n<\/li>\n<li>\n<p style=\"line-height: normal; margin-left: 0.0mm; font-family: Times New Roman; font-size: 12.0pt;\">Animal Studies<\/p>\n<\/li>\n<\/ol>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>On 13-3-2023, the Ministry of Health and Family Welfare notified the New Drugs and Clinical Trials (Amendment) Rules, 2023 to amend the <\/p>\n","protected":false},"author":67515,"featured_media":286869,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[4,15],"tags":[32367,55949,55950,55948],"class_list":["post-286887","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-legislationupdates","category-rules_regulations","tag-clinical-trials","tag-development-methodology","tag-ndctrules","tag-new-drugs"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.4 (Yoast SEO v26.4) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>MOHFW revises Development 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The provisions came into\u2026","rel":"","context":"In &quot;Legal RoundUp&quot;","block_context":{"text":"Legal RoundUp","link":"https:\/\/www.scconline.com\/blog\/post\/category\/columns-for-roundup\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/04\/tmp_a43267b2-94d9-4609-afc3-6fd7e69d455b.png?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/04\/tmp_a43267b2-94d9-4609-afc3-6fd7e69d455b.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/04\/tmp_a43267b2-94d9-4609-afc3-6fd7e69d455b.png?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/04\/tmp_a43267b2-94d9-4609-afc3-6fd7e69d455b.png?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":253692,"url":"https:\/\/www.scconline.com\/blog\/post\/2021\/09\/04\/new-drugs-and-clinical-trials-amendment-rules-2021\/","url_meta":{"origin":286887,"position":1},"title":"New Drugs and Clinical Trials (Amendment) Rules, 2021","author":"Prachi Bhardwaj","date":"September 4, 2021","format":false,"excerpt":"The Ministry of Health and Family Welfare has notified the New Drugs and Clinical Trials (Amendment) Rules, 2021 vide notification dated August 31, 2021. 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Revised definition under Rule 2(1)(g)\u2026","rel":"","context":"In &quot;Legislation Updates&quot;","block_context":{"text":"Legislation Updates","link":"https:\/\/www.scconline.com\/blog\/post\/category\/legislationupdates\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/09\/MicrosoftTeams-image-10.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/09\/MicrosoftTeams-image-10.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/09\/MicrosoftTeams-image-10.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/09\/MicrosoftTeams-image-10.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/09\/MicrosoftTeams-image-10.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":286987,"url":"https:\/\/www.scconline.com\/blog\/post\/2023\/03\/15\/ministry-of-health-and-family-welfare-notified-surrogacy-regulation-amendment-rules-legal-research-legal-update-legal-news\/","url_meta":{"origin":286887,"position":2},"title":"Methods of Treatment revised vide Surrogacy (Regulation) Amendment Rules, 2023","author":"Kriti","date":"March 15, 2023","format":false,"excerpt":"On 14-3-2023, the Ministry of Health and Family Welfare notified the Surrogacy (Regulation) Amendment Rules, 2023 to amend the Surrogacy (Regulation) Rules, 2022. The provisions came into force on 14-3-2023. Form 2, Rule 7, Para 1 (d) relating to Methods of Treatment has been revised: Previous Now The fertilization of\u2026","rel":"","context":"In &quot;Legislation Updates&quot;","block_context":{"text":"Legislation Updates","link":"https:\/\/www.scconline.com\/blog\/post\/category\/legislationupdates\/"},"img":{"alt_text":"Ministry of Health and Family Welfare","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/03\/MicrosoftTeams-image-724.png?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/03\/MicrosoftTeams-image-724.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/03\/MicrosoftTeams-image-724.png?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/03\/MicrosoftTeams-image-724.png?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":267132,"url":"https:\/\/www.scconline.com\/blog\/post\/2022\/05\/19\/inclusion-of-acitretin-in-schedule-h-of-the-drugs-rules-1945-vide-drugs-fourth-amendment-rules-2022\/","url_meta":{"origin":286887,"position":3},"title":"Inclusion of Acitretin in schedule H of the Drugs Rules, 1945 vide Drugs (Fourth Amendment) Rules, 2022","author":"Bhumika Indulia","date":"May 19, 2022","format":false,"excerpt":"On May 18, 2022, the Ministry of Health and Family Welfare (MoHFW) has issued the Drugs (Fourth Amendment) Rules, 2022 to further amend the Drugs Rules, 1945. This will come into force into November 1, 2022. \u00a0 The amendment inserts \"552. Acitretin\u201d in Schedule H which specify \u201cPrescription Drugs\u201d.","rel":"","context":"In &quot;Legislation Updates&quot;","block_context":{"text":"Legislation Updates","link":"https:\/\/www.scconline.com\/blog\/post\/category\/legislationupdates\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/09\/MicrosoftTeams-image-10.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/09\/MicrosoftTeams-image-10.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/09\/MicrosoftTeams-image-10.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/09\/MicrosoftTeams-image-10.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/09\/MicrosoftTeams-image-10.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":116811,"url":"https:\/\/www.scconline.com\/blog\/post\/2017\/03\/29\/drugs-and-cosmetics-5th-amendment-rules-2017-notified\/","url_meta":{"origin":286887,"position":4},"title":"Drugs and Cosmetics (5th Amendment) Rules, 2017, notified","author":"Saba","date":"March 29, 2017","format":false,"excerpt":"G.S.R. 250(E).\u2014Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules,\u00a01945 was published as required by Section 12 and Section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) vide notification of the Government of India in the Ministry of Health and Family Welfare\u2026","rel":"","context":"In &quot;Foreign Legislation&quot;","block_context":{"text":"Foreign Legislation","link":"https:\/\/www.scconline.com\/blog\/post\/category\/legislationupdates\/foreign\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/12\/DSC_4762-e1474523869607.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/12\/DSC_4762-e1474523869607.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/12\/DSC_4762-e1474523869607.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/12\/DSC_4762-e1474523869607.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/12\/DSC_4762-e1474523869607.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":277743,"url":"https:\/\/www.scconline.com\/blog\/post\/2022\/11\/19\/mandatory-qr-code-for-300-drugs-vide-drugs-eighth-amendment-rules-2022\/","url_meta":{"origin":286887,"position":5},"title":"Mandatory QR Code for 300 drugs vide Drugs (Eighth Amendment) Rules, 2022","author":"Bhumika Indulia","date":"November 19, 2022","format":false,"excerpt":"\u00a0 \u00a0 On 17-11-2022, the Ministry of Health and Family Welfare has published the Drugs (Eighth Amendment) Rules, 2022 to further amend the Drugs Rules, 1945. The amendment inserts a clause in Rule 96 providing the manufacturers of drug formulation products must print or affix Bar Code or Quick Response\u2026","rel":"","context":"In &quot;Legislation Updates&quot;","block_context":{"text":"Legislation Updates","link":"https:\/\/www.scconline.com\/blog\/post\/category\/legislationupdates\/"},"img":{"alt_text":"Ministry of Health and Family Welfare","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/10\/Ministry-of-Health-and-Family-Welfare-1.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/10\/Ministry-of-Health-and-Family-Welfare-1.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/10\/Ministry-of-Health-and-Family-Welfare-1.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/10\/Ministry-of-Health-and-Family-Welfare-1.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/10\/Ministry-of-Health-and-Family-Welfare-1.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]}],"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/posts\/286887","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/users\/67515"}],"replies":[{"embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/comments?post=286887"}],"version-history":[{"count":0,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/posts\/286887\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/media\/286869"}],"wp:attachment":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/media?parent=286887"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/categories?post=286887"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/tags?post=286887"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}