{"id":66672,"date":"2025-10-06T10:44:43","date_gmt":"2025-10-06T05:14:43","guid":{"rendered":"https:\/\/vajiramandravi.com\/current-affairs\/?p=66672"},"modified":"2025-10-06T11:45:56","modified_gmt":"2025-10-06T06:15:56","slug":"ensuring-drug-safety-in-india-union-health-ministry-push-for-revised-schedule-m-norms","status":"publish","type":"post","link":"https:\/\/vajiramandravi.com\/current-affairs\/ensuring-drug-safety-in-india-union-health-ministry-push-for-revised-schedule-m-norms\/","title":{"rendered":"Ensuring Drug Safety in India &#8211; Union Health Ministry Push for Revised Schedule M Norms"},"content":{"rendered":"<h2 style=\"text-align: justify;\"><b>Ensuring Drug Safety in India Latest News<\/b><\/h2>\n<ul style=\"text-align: justify;\">\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The Union Health Ministry has <\/span><b>intensified regulatory measures<\/b><span style=\"font-weight: 400;\"> following <\/span><b>reports of adulterated cough syrup leading to child deaths <\/b><span style=\"font-weight: 400;\">in Rajasthan and Madhya Pradesh.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The move underscores India\u2019s efforts to strengthen pharmaceutical quality standards under the <\/span><b>revised Schedule M norms<\/b><span style=\"font-weight: 400;\"> of the Drugs and Cosmetics Act, 1940.<\/span><\/li>\n<\/ul>\n<h2 style=\"text-align: justify;\"><b>Key Developments<\/b><\/h2>\n<ul style=\"text-align: justify;\">\n<li aria-level=\"1\"><b>Trigger event:\u00a0<\/b><\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><b>Over 10 children died<\/b><span style=\"font-weight: 400;\"> in Rajasthan and Madhya Pradesh<\/span><b> after consuming cough syrups<\/b><span style=\"font-weight: 400;\">.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Investigations <\/span><b>ruled out infectious diseases<\/b><span style=\"font-weight: 400;\">, and out of 10 samples tested, one\u2014<\/span><b>Coldrif cough syrup<\/b><span style=\"font-weight: 400;\">\u2014was found with d<\/span><b>iethylene glycol (DEG) <\/b><span style=\"font-weight: 400;\">beyond permissible limits.<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul style=\"text-align: justify;\">\n<li aria-level=\"1\"><b>Regulatory action taken:<\/b><\/li>\n<\/ul>\n<ul style=\"text-align: justify;\">\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><b>Tamil Nadu<\/b><span style=\"font-weight: 400;\"> Drugs Control Department ordered an immediate stop to production of Coldrif.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Inspection by the Central Drugs Standard Control Organisation (<\/span><b>CDSCO<\/b><span style=\"font-weight: 400;\">) recommended <\/span><b>cancellation of the manufacturing license<\/b><span style=\"font-weight: 400;\">.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><b>Criminal proceedings<\/b><span style=\"font-weight: 400;\"> initiated against the concerned unit in Kancheepuram.<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h2 style=\"text-align: justify;\"><b>Revised Schedule M Norms<\/b><\/h2>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>About Schedule M: <\/b><span style=\"font-weight: 400;\">Schedule M defines the <\/span><b>minimum standards for Good Manufacturing Practices (GMP) <\/b><span style=\"font-weight: 400;\">for pharmaceutical products in India under the <\/span><b>Drugs and Cosmetics Act,<\/b> <b>1940<\/b><span style=\"font-weight: 400;\">, and Rules, 1945, <\/span><b>aligning with international standards<\/b><span style=\"font-weight: 400;\">.<\/span><\/li>\n<\/ul>\n<ul style=\"text-align: justify;\">\n<li aria-level=\"1\"><b>Revised norms:<\/b><\/li>\n<\/ul>\n<ul style=\"text-align: justify;\">\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Notified in (Jan) 2024, the revised norms introduce a comprehensive Pharmaceutical Quality System (<\/span><b>PQS<\/b><span style=\"font-weight: 400;\">), Quality Risk Management (<\/span><b>QRM<\/b><span style=\"font-weight: 400;\">), and Product Quality Review (<\/span><b>PQR<\/b><span style=\"font-weight: 400;\">).<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Key updates also cover <\/span><b>mandatory computerised storage systems, equipment and process validation<\/b><span style=\"font-weight: 400;\">, more specific rules for hazardous drug products, etc.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">It aims to <\/span><b>improve product quality, safety, and international harmonisation<\/b><span style=\"font-weight: 400;\">, with phased implementation timelines based on manufacturer turnover.\u00a0\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Implementation deadline<\/b><span style=\"font-weight: 400;\">: December 31, 2025.<\/span><\/li>\n<\/ul>\n<h2 style=\"text-align: justify;\"><b>Government\u2019s Directives<\/b><\/h2>\n<ul style=\"text-align: justify;\">\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Strict compliance<\/b><span style=\"font-weight: 400;\">: Licenses of non-compliant drug manufacturers will be cancelled.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Enhanced surveillance<\/b><span style=\"font-weight: 400;\">: All States\/UTs to ensure timely reporting of adverse drug reactions and deaths.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Integrated monitoring<\/b><span style=\"font-weight: 400;\">: Use of the Integrated Disease Surveillance Programme (IDSP) and Integrated Health Information Platform (IHIP) for community-level reporting.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Rational use of cough syrups:<\/b><span style=\"font-weight: 400;\"> Awareness promoted among doctors and parents, especially for children, since most coughs are self-limiting.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Inter-state coordination<\/b><span style=\"font-weight: 400;\">: Strengthened cooperation for early detection and joint action.<\/span><\/li>\n<\/ul>\n<h2 style=\"text-align: justify;\"><b>Way Forward<\/b><\/h2>\n<ul style=\"text-align: justify;\">\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Strengthening drug regulation<\/b><span style=\"font-weight: 400;\">: Ensure uniform enforcement of Schedule M norms across States.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Capacity building<\/b><span style=\"font-weight: 400;\">: Training drug inspectors, upgrading labs, and digital monitoring systems.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Industry compliance<\/b><span style=\"font-weight: 400;\">: Support pharmaceutical units in infrastructure upgrade for GMP compliance.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Public awareness<\/b><span style=\"font-weight: 400;\">: Promote safe drug usage and discourage irrational consumption of cough syrups.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>International image<\/b><span style=\"font-weight: 400;\">: Restoring trust in Indian pharma exports by aligning with WHO standards.<\/span><\/li>\n<\/ul>\n<h2 style=\"text-align: justify;\"><b>Conclusion<\/b><\/h2>\n<ul style=\"text-align: justify;\">\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The Coldrif incident highlights <\/span><b>recurring lapses<\/b><span style=\"font-weight: 400;\"> in drug quality monitoring in India.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The Union Health Ministry\u2019s push for <\/span><b>strict compliance<\/b><span style=\"font-weight: 400;\"> under revised Schedule M is a <\/span><b>crucial step to safeguard public health<\/b><span style=\"font-weight: 400;\">, particularly children.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>A coordinated approach<\/b><span style=\"font-weight: 400;\"> will be essential to prevent future tragedies and strengthen India\u2019s pharmaceutical reputation globally.<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify;\"><b>Source: <\/b><a href=\"https:\/\/www.thehindu.com\/news\/national\/cough-syrup-contamination-health-ministry-directs-strict-compliance-with-revised-schedule-m-norms\/article70128414.ece\" target=\"_blank\" rel=\"nofollow noopener\"><b>TH<\/b><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Union Health Ministry has pushed for implementing the revised Schedule M norms of the Drugs and Cosmetics Act, 1940.<\/p>\n","protected":false},"author":19,"featured_media":66717,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[18],"tags":[3082,60,22,59],"class_list":{"0":"post-66672","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-upsc-mains-current-affairs","8":"tag-ensuring-drug-safety-in-india","9":"tag-mains-articles","10":"tag-upsc-current-affairs","11":"tag-upsc-mains-current-affairs","12":"no-featured-image-padding"},"acf":[],"_links":{"self":[{"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/posts\/66672","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/users\/19"}],"replies":[{"embeddable":true,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/comments?post=66672"}],"version-history":[{"count":0,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/posts\/66672\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/media\/66717"}],"wp:attachment":[{"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/media?parent=66672"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/categories?post=66672"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/tags?post=66672"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}