{"id":347612,"date":"2025-10-08T17:05:07","date_gmt":"2025-10-08T11:35:07","guid":{"rendered":"https:\/\/forumias.com\/blog\/?p=347612"},"modified":"2025-10-08T17:05:07","modified_gmt":"2025-10-08T11:35:07","slug":"schedule-m-norms","status":"publish","type":"post","link":"https:\/\/forumias.com\/blog\/schedule-m-norms\/","title":{"rendered":"Schedule M Norms"},"content":{"rendered":"<p><strong>News<\/strong><strong>: <\/strong>18 States use the Online National Drugs Licensing System (ONDLS), but none has fully met the Corrective and Preventive Action (CAPA) requirements under the revised Schedule M norms.<\/p>\n<h2>About Schedule M Norms<\/h2>\n<figure id=\"attachment_347622\" aria-describedby=\"caption-attachment-347622\" style=\"width: 358px\" class=\"wp-caption aligncenter\"><img data-recalc-dims=\"1\" loading=\"lazy\" decoding=\"async\" class=\" wp-image-347622\" src=\"https:\/\/i0.wp.com\/forumias.com\/blog\/wp-content\/uploads\/2025\/10\/Source-Apollo-Hospitals.jpg?resize=358%2C211&#038;ssl=1\" alt=\"\" width=\"358\" height=\"211\" srcset=\"https:\/\/i0.wp.com\/forumias.com\/blog\/wp-content\/uploads\/2025\/10\/Source-Apollo-Hospitals.jpg?resize=300%2C177&amp;ssl=1 300w, https:\/\/i0.wp.com\/forumias.com\/blog\/wp-content\/uploads\/2025\/10\/Source-Apollo-Hospitals.jpg?resize=1024%2C605&amp;ssl=1 1024w, https:\/\/i0.wp.com\/forumias.com\/blog\/wp-content\/uploads\/2025\/10\/Source-Apollo-Hospitals.jpg?resize=768%2C453&amp;ssl=1 768w, https:\/\/i0.wp.com\/forumias.com\/blog\/wp-content\/uploads\/2025\/10\/Source-Apollo-Hospitals.jpg?w=1304&amp;ssl=1 1304w\" sizes=\"auto, (max-width: 358px) 100vw, 358px\" \/><figcaption id=\"caption-attachment-347622\" class=\"wp-caption-text\">Source &#8211; Apollo Hospitals<\/figcaption><\/figure>\n<ul>\n<li>Schedule M prescribes<strong> Good Manufacturing Practices (GMPs) <\/strong>to ensure medicines are<strong> safe, effective, <\/strong>and of<strong> consistent quality.<\/strong><\/li>\n<li><strong>Legality<\/strong>: It is a key part of the <strong>Drugs and Cosmetics Act, 1940 (and Rules, 1945).<\/strong><\/li>\n<li><strong>Origin: <\/strong>It was first established in 2001.<\/li>\n<li><strong>Recent revision (2023\u20132024): <\/strong>The revised Schedule M <strong>updates India<\/strong><strong>\u2019<\/strong><strong>s Good Manufacturing Practices (GMP)<\/strong> for pharmaceutical products and mandates stronger, system-based quality controls.<\/li>\n<li><strong>Compliance deadline:<\/strong> Manufacturers must achieve full compliance with these revisions by <strong>December 31, 2025<\/strong>.<\/li>\n<li><strong>Scope:<\/strong>\u00a0Applies to<strong> all pharmaceutical manufacturing<\/strong> units in India for <strong>both<\/strong> domestic and export markets.<\/li>\n<li><strong>Key features of revised Schedule <\/strong>\n<ul>\n<li>It mandates stronger <strong>quality systems<\/strong>, including a <strong>Pharmaceutical Quality System (PQS)<\/strong>, <strong>Quality Risk Management (QRM)<\/strong>, and <strong>Product Quality Review (PQR)<\/strong> to ensure consistent product quality.<\/li>\n<li>It requires <strong>qualification and validation of equipment<\/strong> so that manufacturing processes remain reliable and controlled.<\/li>\n<li>It asks manufacturers to set up <strong>computerised storage systems for all drug products<\/strong> to improve control, traceability, and record-keeping.<\/li>\n<li>It introduces <strong>regulatory tools<\/strong> such as the <strong>Online National Drugs Licensing System (ONDLS)<\/strong> for licensing and <strong>Corrective and Preventive Action (CAPA)<\/strong> for continual improvement and issue prevention.<\/li>\n<li>It aligns India\u2019s Good Manufacturing Practices with <strong>international GMP guidelines<\/strong>, bringing them closer to <strong>WHO-GMP<\/strong> and <strong>PIC\/S (Pharmaceutical Inspection Co-operation Scheme)<\/strong> guidelines<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>News: 18 States use the Online National Drugs Licensing System (ONDLS), but none has fully met the Corrective and Preventive Action (CAPA) requirements under the revised Schedule M norms. About Schedule M Norms Schedule M prescribes Good Manufacturing Practices (GMPs) to ensure medicines are safe, effective, and of consistent quality. Legality: It is a key&hellip; <a class=\"more-link\" href=\"https:\/\/forumias.com\/blog\/schedule-m-norms\/\">Continue reading <span class=\"screen-reader-text\">Schedule M Norms<\/span><\/a><\/p>\n","protected":false},"author":10393,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"footnotes":""},"categories":[1566,3127,1760,12039],"tags":[11872],"class_list":["post-347612","post","type-post","status-publish","format-standard","hentry","category-daily-factly-articles","category-economy","category-polity-and-nation","category-knolls","tag-9pm-daily-factly","entry"],"jetpack_featured_media_url":"","views":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts\/347612","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/users\/10393"}],"replies":[{"embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/comments?post=347612"}],"version-history":[{"count":0,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts\/347612\/revisions"}],"wp:attachment":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/media?parent=347612"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/categories?post=347612"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/tags?post=347612"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}