{"id":38551,"date":"2018-12-11T17:59:13","date_gmt":"2018-12-11T12:29:13","guid":{"rendered":"https:\/\/blog.forumias.com\/?p=38551"},"modified":"2018-12-11T17:59:13","modified_gmt":"2018-12-11T12:29:13","slug":"many-combination-drugs-not-approved-by-regulator","status":"publish","type":"post","link":"https:\/\/forumias.com\/blog\/many-combination-drugs-not-approved-by-regulator\/","title":{"rendered":"\u2018Many combination drugs not approved by regulator\u2019"},"content":{"rendered":"<p><a href=\"https:\/\/www.thehindu.com\/news\/national\/many-combination-drugs-not-approved-by-regulator\/article25712141.ece\"><strong>\u2018Many combination drugs not approved by regulator\u2019<\/strong><\/a><\/p>\n<p><strong><u>News:<\/u><\/strong><\/p>\n<p>According to the study published in Tropical Medicine &amp; International Health, many Fixed Dose Combinations (FDCs) do not have approval from the Central Drugs Standard Control Organization (CDSCO).<\/p>\n<p><strong><u>Important Facts:<\/u><\/strong><\/p>\n<p><strong><em>Highlights of the Report:<\/em><\/strong><\/p>\n<ol>\n<li>Out of 110 anti-TB FDCs available in India, only 32, (&lt;30%), had approval. In the case of malaria FDCs, only eight out of 20 (40%), were approved by CDSCO.<\/li>\n<li>According to the author, a least transparent regulatory framework and ambiguity over licensing powers have contributed to the problem<\/li>\n<\/ol>\n<p>Note: An FDC or combination product is a formulation with more than one active pharmaceutical ingredient (API) in a fixed ratio of doses formulated into a single dosage form.<\/p>\n<p><strong><em>Concerns:<\/em><\/strong><\/p>\n<p>These unapproved FDCs, including those dispensed for diseases like TB and malaria, raises safety and efficacy concerns. In the absence of a robust pharmacovigilance mechanism in India, there is no track on the adverse effects of these FDCs<\/p>\n<p><strong><em>About CDSCO<\/em><\/strong><\/p>\n<ol>\n<li>It\u00a0is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act<\/li>\n<li>CDSCO is controlled and governed by Directorate General of Health Services which comes under Ministry of Health and Family Welfare, Government of India<\/li>\n<li><strong>Functions:<\/strong><\/li>\n<\/ol>\n<ul>\n<li>Laying down standards of drugs, cosmetics, diagnostics and devices.<\/li>\n<li>To regulate market authorization of new drugs.<\/li>\n<li>To regulate clinical research in India.<\/li>\n<li>To approve licenses to manufacture certain categories of drugs as Central Licence\u00a0approving Authority e.g. for Blood Banks<\/li>\n<li>To regulate the standards of imported drugs.<\/li>\n<li>Work relating to the Drugs Technical Advisory Board (DTAB) and Drugs Consultative\u00a0Committee (DCC).<\/li>\n<li>Testing of drugs by Central Drugs Labs<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>\u2018Many combination drugs not approved by regulator\u2019 News: According to the study published in Tropical Medicine &amp; International Health, many Fixed Dose Combinations (FDCs) do not have approval from the Central Drugs Standard Control Organization (CDSCO). Important Facts: Highlights of the Report: Out of 110 anti-TB FDCs available in India, only 32, (&lt;30%), had approval.&hellip; <a class=\"more-link\" href=\"https:\/\/forumias.com\/blog\/many-combination-drugs-not-approved-by-regulator\/\">Continue reading <span class=\"screen-reader-text\">\u2018Many combination drugs not approved by regulator\u2019<\/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-38551","post","type-post","status-publish","format-standard","hentry","category-test-1","entry"],"jetpack_featured_media_url":"","views":{"total":0,"cached_at":"","cached_date":1704844662},"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts\/38551","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=38551"}],"version-history":[{"count":0,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts\/38551\/revisions"}],"wp:attachment":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/media?parent=38551"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/categories?post=38551"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/tags?post=38551"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}