{"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 v27.4 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>MOHFW revises 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