{"id":27497,"date":"2018-10-23T14:26:28","date_gmt":"2018-10-23T08:56:28","guid":{"rendered":"https:\/\/blog.forumias.com\/?p=27497"},"modified":"2018-10-23T14:26:28","modified_gmt":"2018-10-23T08:56:28","slug":"health-ministry-bans-328-fixed-dose-combination-drugs","status":"publish","type":"post","link":"https:\/\/forumias.com\/blog\/health-ministry-bans-328-fixed-dose-combination-drugs\/","title":{"rendered":"Health Ministry bans 328 fixed dose combination drugs"},"content":{"rendered":"<p><a href=\"https:\/\/www.thehindubusinessline.com\/economy\/health-ministry-bans-328-fixed-dose-drug-combination-drugs\/article24933600.ece\"><strong>Health Ministry bans 328 fixed dose combination drugs<\/strong><\/a><\/p>\n<p><strong>News: <\/strong><\/p>\n<ol>\n<li>The Ministry of Health and Family Welfare (MoHFW) has prohibited the manufacture, sale or distribution of 328 fixed dose combinations (FDCs) for human use with immediate effect.<\/li>\n<\/ol>\n<p>FDCs : A drug which contains two or more active ingredients in a fixed dosage ratio.<\/p>\n<p>The FDC formulation may have up to 5 or even more ingredients with or without rationality of their presence and in the quantity.<\/p>\n<p>Important Facts:<\/p>\n<ol start=\"2\">\n<li>The prohibition is done under the Section 26 A of the Drugs and Cosmetics Act, 1940 .<\/li>\n<li>The ban on FDCs will \u00a0include painkillers, anti-diabetic, respiratory and gastrointestinal medicines, covering 6,000 brands.<\/li>\n<li>The ban notifications do not include 15 FDCs that were manufactured since before 1988.<\/li>\n<li>The MoHFW earlier in 2016, had banned 349 FDCs but Supreme Court(SC) stayed it after drug manufacturers petitioned .<\/li>\n<li>SC also directed to form an expert panel by the DTAB to review the matter.<\/li>\n<li>Findings of the Expert Panel formed under Chairmanship of NilimaKshirsagar:<\/li>\n<\/ol>\n<ul>\n<li>These FDCs were \u201cirrational\u201d and have \u00a0lack of therapeutic justification.<\/li>\n<\/ul>\n<ul>\n<li>Many FDCs were formulated without due diligence, with dosing mismatches that could result in toxicity.<\/li>\n<li>FDCs may raise safety issues for human beings.<\/li>\n<\/ul>\n<ol start=\"8\">\n<li>Central Government considered the recommendations of the Expert Committee and concluded that it was expedient in public interest to prohibit these 328 FDCs.<\/li>\n<li>General issues with FDCs:<\/li>\n<\/ol>\n<ul>\n<li>Pharmacodynamic mismatch between two FDC components i.e., having opposite effects leading to reduced efficacy or enhanced toxicity,<\/li>\n<li>Pharmacokinetic mismatch between components with peak efficacy at different times.<\/li>\n<li>Chemical non-compatibility leading to decreased shelf life.<\/li>\n<\/ul>\n<ol start=\"10\">\n<li>Impact of the FDCs ban:<\/li>\n<\/ol>\n<ul>\n<li>Ban will shave off over Rs1,500 crore from India&#8217;s Rs1.18-lakh crore pharmaceutical industry.<\/li>\n<li>It would also \u00a0impact medicine brands across several therapy areas.<\/li>\n<li>However the impact of this ban is expected to be limited as most of these brands are &#8220;very small&#8221; and \u00a0ban may have a &#8220;marginal&#8221; impact.<\/li>\n<li>\u00a0Moreover the drug makers with FDCs banned between 2016 and 2017 have either changed the compositions of their combinations or discontinued production of some brands that fell into the &#8216;banned&#8217; category.<\/li>\n<li>Companies can \u00a0launch variants to FDCs that would be compliant with regulations.<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Health Ministry bans 328 fixed dose combination drugs News: The Ministry of Health and Family Welfare (MoHFW) has prohibited the manufacture, sale or distribution of 328 fixed dose combinations (FDCs) for human use with immediate effect. FDCs : A drug which contains two or more active ingredients in a fixed dosage ratio. The FDC formulation&hellip; <a class=\"more-link\" href=\"https:\/\/forumias.com\/blog\/health-ministry-bans-328-fixed-dose-combination-drugs\/\">Continue reading <span class=\"screen-reader-text\">Health Ministry bans 328 fixed dose combination drugs<\/span><\/a><\/p>\n","protected":false},"author":61,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"footnotes":""},"categories":[555],"tags":[],"class_list":["post-27497","post","type-post","status-publish","format-standard","hentry","category-test-1","entry"],"jetpack_featured_media_url":"","views":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts\/27497","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\/61"}],"replies":[{"embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/comments?post=27497"}],"version-history":[{"count":0,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts\/27497\/revisions"}],"wp:attachment":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/media?parent=27497"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/categories?post=27497"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/tags?post=27497"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}