{"id":639,"date":"2015-05-16T06:46:02","date_gmt":"2015-05-16T06:46:02","guid":{"rendered":"http:\/\/www.dailyrounds.org\/blog\/?p=639"},"modified":"2015-05-16T06:46:02","modified_gmt":"2015-05-16T06:46:02","slug":"forget-about-irrational-ones-several-fixed-drug-combinations-in-indian-market-arent-even-approved-by-cdsco","status":"publish","type":"post","link":"https:\/\/www.dailyrounds.org\/blog\/forget-about-irrational-ones-several-fixed-drug-combinations-in-indian-market-arent-even-approved-by-cdsco\/","title":{"rendered":"Forget about irrational ones!!! Several fixed drug combinations in Indian market aren&#8217;t even approved by CDSCO"},"content":{"rendered":"<p>British researchers have found that many fixed-dose drug combinations (FDCs) in India lack central regulatory approval despite concerns over the safety and efficacy of such combinations. A study led by Queen Mary University of London, revealed that these FDCs are being sold in substantial numbers in India.<\/p>\n<p>In 2012, the Parliamentary Standing Committee on Health &amp; Family Welfare reported that a very large number of FDCs had been licensed by state drug authorities without approval by the Central Drugs Standard Control Organisation (CDSCO).<\/p>\n<p>Patricia McGettigan who led the study at Queen Mary University of London, is of the opinion,<\/p>\n<p><em><strong>&#8220;India needs to ban the sale and manufacturing of fixed-dose drug combinations not approved by the CDSCO &#8212; beginning with those which include drugs banned or unapproved internationally and, therefore, most likely to be harmful.&#8221;<\/strong><\/em><\/p>\n<h2 style=\"text-align: center;\">Factsheet<\/h2>\n<ul>\n<li><strong>Among 175 FDC formulations marketed in India between 2011 and 2012, the researchers found CDSCO approval for only 60 (34 percent).<\/strong><\/li>\n<li><strong>While almost all Metformin FDC sales were from CDSCO-approved formulations, products with no record of CDSCO approval accounted for<\/strong>\n<ul>\n<li><strong>Over two-thirds of anti-depressant\/benzodiazepine FDC sales (69%),<\/strong><\/li>\n<li><strong>Almost half of anti-psychotic FDC sales (43%)<\/strong><\/li>\n<li><strong>More than a quarter of NSAID FDC sales (28%)<\/strong><\/li>\n<\/ul>\n<\/li>\n<li><strong>Multiple formulations included drugs which are restricted, banned or were never approved in other countries because of associations with serious adverse events including death.<\/strong><\/li>\n<\/ul>\n<p>The authors believe, &#8220;The well-being of patients is paramount. People taking these FDCs need to be reviewed and carefully switched to safe and appropriate alternatives.&#8221;<\/p>\n<p>Allyson Pollock, professor, global health expert and study co-author, says,<\/p>\n<p><em><strong>&#8220;Our research wholly supports the need for a complete overhaul of the new Drugs Bill and we urge the government of India to make this a priority.&#8221;<\/strong><\/em><\/p>\n<p><a href=\"https:\/\/www.google.co.in\/url?sa=t&amp;rct=j&amp;q=&amp;esrc=s&amp;source=web&amp;cd=1&amp;cad=rja&amp;uact=8&amp;ved=0CCEQFjAA&amp;url=http%3A%2F%2Fjournals.plos.org%2Fplosmedicine%2Farticle%3Fid%3D10.1371%2Fjournal.pmed.1001826&amp;ei=oOZWVa3pAcjX8gXT1ICgAg&amp;usg=AFQjCNEicyaxTvKYNxbtYrqzGYie6glRYg&amp;sig2=zdq3851jsDic29PUIQOQ_Q&amp;bvm=bv.93564037,d.dGc\">Source:<\/a> McGettigan P, Roderick P, Mahajan R, Kadam A, Pollock AM. Use of Fixed Dose Combination (FDC) Drugs in India: Central Regulatory Approval and Sales of FDCs Containing Non-Steroidal Anti-Inflammatory Drug(NSAIDs), Metformin, or Psychotropic Drugs. PLoS Med. 2015 May 12;12(5):e1001826<\/p>\n","protected":false},"excerpt":{"rendered":"<p>British researchers have found that many fixed-dose drug combinations (FDCs) in India lack central regulatory approval despite concerns over the safety and efficacy of such combinations. A study led by Queen Mary University of London, revealed that these FDCs are being sold in substantial numbers in India. In 2012, the Parliamentary Standing Committee on Health [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":640,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_exactmetrics_skip_tracking":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_post_was_ever_published":false},"categories":[12,15],"tags":[],"class_list":["post-639","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-regulatory"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Forget about irrational ones!!! 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