{"id":35587,"date":"2013-04-21T20:00:08","date_gmt":"2013-04-22T00:00:08","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=35587"},"modified":"2013-04-22T00:48:39","modified_gmt":"2013-04-22T04:48:39","slug":"35587","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2013\/04\/21\/35587\/","title":{"rendered":"CROs exposed in India&#8230;"},"content":{"rendered":"<div align=\"center\"><img loading=\"lazy\" decoding=\"async\" border=\"0\" width=\"300\" vspace=\"7\" height=\"175\" src=\"http:\/\/1boringoldman.com\/images\/acro-1.gif\" \/>&nbsp;<\/div>\n<div align=\"justify\">This has been a rotten story. When I first encountered the Clinical Research Industry, I thought it sounded shady, primarily because of its big push for &quot;Globalization.&quot; It smelled like exploitation: <\/div>\n<ul>\n<li> \t\t\t\t\t\t<a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2011\/03\/05\/the-clinical-research-industry-time-to-market-and-beyond\/\"><img loading=\"lazy\" decoding=\"async\" border=\"0\" align=\"right\" width=\"215\" hspace=\"4\" height=\"140\" src=\"http:\/\/1boringoldman.com\/images\/acro-2.gif\" \/>the clinical research industry:<br \/> time-to-market and beyond&hellip;<\/a><\/li>\n<li><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2011\/03\/06\/the-clinical-research-industry-the-cro-running-in-the-background\/\">the clinical research industry:<br \/> the cro running in the background&hellip;<\/a><\/li>\n<li> \t\t\t\t\t\t<a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2011\/03\/08\/the-clinical-research-industry-cross-purposes\/\">the clinical research industry:<br \/> cross purposes&hellip;<\/a><\/li>\n<li> \t\t\t\t\t\t<a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2011\/03\/11\/the-clinical-research-industry-something-to-change\/\">the clinical research industry:<br \/> an invisible empire&hellip;<\/a><\/li>\n<li><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2011\/03\/12\/the-clinical-reasearch-industry-the-atypical-decade\/\">the clinical research industry:<br \/> the &lsquo;atypical&rsquo; decade&hellip;<\/a> <\/li>\n<\/ul>\n<div align=\"justify\">And that seems to have been the case, particularly in India. Well, the Indian <strong><font color=\"#200020\">Supreme Court<\/font><\/strong> clamped down on the <strong><font color=\"#200020\">Health Ministry<\/font><\/strong>, to their credit:<\/div>\n<ul>\n<li><a target=\"_self\" href=\"http:\/\/1boringoldman.com\/index.php\/2013\/02\/03\/on-a-war-footing\/\">slumdog trials: on a war footing&hellip; <\/a><\/li>\n<li><a href=\"http:\/\/1boringoldman.com\/index.php\/2013\/03\/12\/the-light-of-day\/\">the light of day&hellip; <\/a><\/li>\n<\/ul>\n<div>And they&#8217;ve succeeded in doing something about it:<\/p>\n<div>\n<blockquote>\n<div align=\"center\"><a href=\"http:\/\/newindianexpress.com\/nation\/Clinical-trials-of-drugs-in-India-plummet\/2013\/04\/21\/article1554980.ece\" target=\"_blank\">Clinical trials of drugs in India plummet<\/a><br \/>       <strong><font color=\"#200020\">The New India Express<\/font><\/strong><br \/>        By PTI<br \/>       21st April 2013<\/div>\n<div align=\"justify\"><sup><strong>       <\/p>\n<p>Clinical trials of drugs in India have seen a drastic fall this year  after toughened norms were introduced following Supreme Court  directives. Not only have the number of trial approvals in the  country reduced, there has also been a significant reduction in the  number of sponsoring pharma firms applying for such approvals.<\/p>\n<p>Official  Health Ministry data shows that until January 31 this year, only six  trials had been approved. Even these pertained to older applications  where the Drug Controller General of India had asked the applying firms  to make some amendments. Sources say until April, only around 12  approvals have been granted by the DCGI for trials of drugs in India.  Pending applications for trials as of today are just 70. This is  in sharp contrast to the past when the number of Global Clinical Trials[ GCTs] approved for conduct in India was in hundreds. Though in 2008 the DCGI had granted just 65 approvals for trials, the number in 2009 rose sharply to 391. The trend continued with a whopping 500 GCTs being allowed in 2010 and 325 in 2011 followed by 262 approvals in 2012.<\/p>\n<div>Admitting  that there has been a drastic fall in fresh applications for conduct of  global clinical trials of drugs in the country, DCGI GN Singh told PTI,  &quot;The safety and well being of Indian subjects participating in clinical  trials is the foremost in our minds. &quot;This is why the Government  has tightened the norms <font color=\"#990000\">putting the onus of safety of participants on  firms conducting the trials<\/font>. It is for the first time that such norms  have been put in place.&quot; <font color=\"#990000\">As many as 2,262 people died in these  trials during the past five years<\/font>, leading to a public outcry and  Supreme Court intervention for stricter norms for holding drug trials.  The apex court had rapped the Health Ministry for allowing Indians to be  used as &quot;guinea pigs&quot; in the conduct of drug trials.<\/div>\n<p> <\/strong><\/sup><\/div>\n<div align=\"right\"><sup><strong>hat tip to Pharmagossip&hellip;  <img decoding=\"async\" border=\"0\" align=\"middle\" height=\"35\" src=\"http:\/\/1boringoldman.com\/images\/hat-tip.gif\" \/><\/strong><\/sup><\/div>\n<\/blockquote><\/div>\n<div>So as to the question, &quot;Were they exploiting trial participants?&quot; The answer is obviously &quot;Yes.&quot; Otherwise the CROs wouldn&#8217;t have pulled out when some reasonable safeguards were introduced. The <a href=\"http:\/\/www.acrohealth.org\/\" target=\"_blank\">ACRO<\/a> web site continues to lobby for &quot;globalization&quot;&#8230;  <\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>&nbsp; This has been a rotten story. When I first encountered the Clinical Research Industry, I thought it sounded shady, primarily because of its big push for &quot;Globalization.&quot; It smelled like exploitation: the clinical research industry: time-to-market and beyond&hellip; the clinical research industry: the cro running in the background&hellip; the clinical research industry: cross purposes&hellip; [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-35587","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/35587","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/comments?post=35587"}],"version-history":[{"count":19,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/35587\/revisions"}],"predecessor-version":[{"id":35606,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/35587\/revisions\/35606"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=35587"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=35587"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=35587"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}