Deprecated (16384): The ArrayAccess methods will be removed in 4.0.0.Use getParam(), getData() and getQuery() instead. - /home/brlfuser/public_html/src/Controller/ArtileDetailController.php, line: 150
 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php. [CORE/src/Core/functions.php, line 311]
Code Context


        trigger_error($message, E_USER_DEPRECATED);

    }
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 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php.'
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Cake\Http\ServerRequest::offsetGet() - CORE/src/Http/ServerRequest.php, line 2421
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Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51
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Deprecated (16384): The ArrayAccess methods will be removed in 4.0.0.Use getParam(), getData() and getQuery() instead. - /home/brlfuser/public_html/src/Controller/ArtileDetailController.php, line: 151
 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php. [CORE/src/Core/functions.php, line 311]
Code Context


        trigger_error($message, E_USER_DEPRECATED);

    }
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 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php.'
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deprecationWarning - CORE/src/Core/functions.php, line 311
Cake\Http\ServerRequest::offsetGet() - CORE/src/Http/ServerRequest.php, line 2421
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Cake\Controller\Controller::invokeAction() - CORE/src/Controller/Controller.php, line 610
Cake\Http\ActionDispatcher::_invoke() - CORE/src/Http/ActionDispatcher.php, line 120
Cake\Http\ActionDispatcher::dispatch() - CORE/src/Http/ActionDispatcher.php, line 94
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Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
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Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Error\Middleware\ErrorHandlerMiddleware::__invoke() - CORE/src/Error/Middleware/ErrorHandlerMiddleware.php, line 96
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51
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Warning (512): Unable to emit headers. Headers sent in file=/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Debugger.php line=853 [CORE/src/Http/ResponseEmitter.php, line 48]
Code Context
            if (Configure::read('debug')) {

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        LATEST NEWS UPDATES | Health ministry underplays parliamentary panel report-Vidya Krishnan    </title>
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A key finding in the report was that several multinational firms had launched drugs without conducting mandatory clinical trials or seeking expert medical opinion

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A key finding in the report was that several multinational firms had launched drugs without conducting mandatory clinical trials or seeking expert medical opinion

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                            <br /><div align="justify"><em>A key finding in the report was that several multinational firms had launched drugs without conducting mandatory clinical trials or seeking expert medical opinion<br /></em><br />The health ministry has denied the presence of any systemic rot in the drug approval process and pharmaceutical firms have refuted charges of collusion after a report by a parliamentary panel pointed to regulatory lapses in clinical trials.<br /><br />The panel, which looked into the functioning of Central Drugs Standard Control Organization (CDSCO), said the regulator has been approving, on average, one new drug a month without conducting mandatory clinical trials or seeking expert medical opinion. It asked the health ministry to withdraw the discretionary power given to the organization to grant approvals to drug firms.<br /><br />Health secretary P.K. Pradhan said in an interview that the report had pointed out deficiencies, &ldquo;which does not indicate that the entire system was rotten&rdquo;. Health minister Ghulam Nabi Azad has constituted a panel to look into the suggestions made in the report, he said. The health ministry is due to submit a so-called action taken report in two months. &ldquo;In specific instances, where doctors and drug companies are mentioned, our committee will look at the circumstances under which the approvals were given and take remedial action,&rdquo; Pradhan said. &ldquo;We will be streamlining CDSCO and make the procedures more transparent.&rdquo;<br /><br />A key finding in the report was that several multinational firms had launched drugs without conducting mandatory clinical trials or seeking expert medical opinion. Novartis Pharmaceuticals, Eli Lilly and Co., Cipla Pharmaceuticals, GlaxoSmithKline (GSK), Sanofi Aventis, Theon Pharmaceuticals, UCB Biosciences and Panacea Biotech have been named in the report.<br /><br />&ldquo;If the drug is already approved/marketed in other countries, phase-III data should generally be obtained on at least 100 patients distributed over three-four centres, primarily to confirm the efficacy and safety of the drug in Indian patients when used as recommended in the product monograph for the claims made,&rdquo; according to the Indian Drugs and Cosmetics Act.<br /><br />While Cipla said it was not mandatory to conduct clinical trials in India before launching a new drug, Novartis said it followed standard international procedures. The panel said Cipla colluded with CDSCO officials to launch pirfenidone and colistimethate drugs without conducting clinical trials.<br /><br />&ldquo;We have followed the procedure as laid down under the Drugs and Cosmetics Act for grant of such licenses and there has been no violation. It is not mandatory to carry out phase-III trials in India for each and every new drug,&rdquo; a Cipla spokesperson said. &ldquo;Both the drugs in question are marketed in a number of countries internationally and have been proven to be life-saving. We deny there has been any collusion with DCGI.&rdquo;<br /><br />GSK said it was granted a local clinical trial waiver because the drug concerned for pulmonary artery hypertension called ambrisetan treated a rare disease &ldquo;which is life threatening and debilitating&rdquo;.<br /><br />Although a collusion between drug makers, doctors and CDSCO officials may have been pointed out, no action is expected against pharma firms, said an expert. &ldquo;The firms will walk away from this scot-free because there might be enough evidence of collusion, but collusion, as unethical as it might be, is not illegal,&rdquo; said C.M. Gulati, editor of the Monthly Index of Medical Specialities. &ldquo;The guilt of doctors, who signed letters written by drug firms and forwarded them as expert medical opinion on the subject, is established beyond doubt, and we will have to see what action is taken against them.&rdquo;</div>                                                           
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    <br><a href="http://www.livemint.com/2012/05/10233819/Health-ministry-underplays-par.html" class="re" target="_blank">Live Mint, 10 May, 2012, http://www.livemint.com/2012/05/10233819/Health-ministry-underplays-par.html</a><div class="clear"></div>
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A key finding in the report was that several multinational firms had launched drugs without conducting mandatory clinical trials or seeking expert medical opinion

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    <h1 class="cat-box-title">Health ministry underplays parliamentary panel report-Vidya Krishnan</h1>
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		 Published on</span><span class="text-date"> May 11, 2012</span>
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                            <br /><div align="justify"><em>A key finding in the report was that several multinational firms had launched drugs without conducting mandatory clinical trials or seeking expert medical opinion<br /></em><br />The health ministry has denied the presence of any systemic rot in the drug approval process and pharmaceutical firms have refuted charges of collusion after a report by a parliamentary panel pointed to regulatory lapses in clinical trials.<br /><br />The panel, which looked into the functioning of Central Drugs Standard Control Organization (CDSCO), said the regulator has been approving, on average, one new drug a month without conducting mandatory clinical trials or seeking expert medical opinion. It asked the health ministry to withdraw the discretionary power given to the organization to grant approvals to drug firms.<br /><br />Health secretary P.K. Pradhan said in an interview that the report had pointed out deficiencies, &ldquo;which does not indicate that the entire system was rotten&rdquo;. Health minister Ghulam Nabi Azad has constituted a panel to look into the suggestions made in the report, he said. The health ministry is due to submit a so-called action taken report in two months. &ldquo;In specific instances, where doctors and drug companies are mentioned, our committee will look at the circumstances under which the approvals were given and take remedial action,&rdquo; Pradhan said. &ldquo;We will be streamlining CDSCO and make the procedures more transparent.&rdquo;<br /><br />A key finding in the report was that several multinational firms had launched drugs without conducting mandatory clinical trials or seeking expert medical opinion. Novartis Pharmaceuticals, Eli Lilly and Co., Cipla Pharmaceuticals, GlaxoSmithKline (GSK), Sanofi Aventis, Theon Pharmaceuticals, UCB Biosciences and Panacea Biotech have been named in the report.<br /><br />&ldquo;If the drug is already approved/marketed in other countries, phase-III data should generally be obtained on at least 100 patients distributed over three-four centres, primarily to confirm the efficacy and safety of the drug in Indian patients when used as recommended in the product monograph for the claims made,&rdquo; according to the Indian Drugs and Cosmetics Act.<br /><br />While Cipla said it was not mandatory to conduct clinical trials in India before launching a new drug, Novartis said it followed standard international procedures. The panel said Cipla colluded with CDSCO officials to launch pirfenidone and colistimethate drugs without conducting clinical trials.<br /><br />&ldquo;We have followed the procedure as laid down under the Drugs and Cosmetics Act for grant of such licenses and there has been no violation. It is not mandatory to carry out phase-III trials in India for each and every new drug,&rdquo; a Cipla spokesperson said. &ldquo;Both the drugs in question are marketed in a number of countries internationally and have been proven to be life-saving. We deny there has been any collusion with DCGI.&rdquo;<br /><br />GSK said it was granted a local clinical trial waiver because the drug concerned for pulmonary artery hypertension called ambrisetan treated a rare disease &ldquo;which is life threatening and debilitating&rdquo;.<br /><br />Although a collusion between drug makers, doctors and CDSCO officials may have been pointed out, no action is expected against pharma firms, said an expert. &ldquo;The firms will walk away from this scot-free because there might be enough evidence of collusion, but collusion, as unethical as it might be, is not illegal,&rdquo; said C.M. Gulati, editor of the Monthly Index of Medical Specialities. &ldquo;The guilt of doctors, who signed letters written by drug firms and forwarded them as expert medical opinion on the subject, is established beyond doubt, and we will have to see what action is taken against them.&rdquo;</div>                                                           
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    <br><a href="http://www.livemint.com/2012/05/10233819/Health-ministry-underplays-par.html" class="re" target="_blank">Live Mint, 10 May, 2012, http://www.livemint.com/2012/05/10233819/Health-ministry-underplays-par.html</a><div class="clear"></div>
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A key finding in the report was that several multinational firms had launched drugs without conducting mandatory clinical trials or seeking expert medical opinion

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A key finding in the report was that several multinational firms had launched drugs without conducting mandatory clinical trials or seeking expert medical opinion

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    <h1 class="cat-box-title">Health ministry underplays parliamentary panel report-Vidya Krishnan</h1>
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		 Published on</span><span class="text-date"> May 11, 2012</span>
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                            <br /><div align="justify"><em>A key finding in the report was that several multinational firms had launched drugs without conducting mandatory clinical trials or seeking expert medical opinion<br /></em><br />The health ministry has denied the presence of any systemic rot in the drug approval process and pharmaceutical firms have refuted charges of collusion after a report by a parliamentary panel pointed to regulatory lapses in clinical trials.<br /><br />The panel, which looked into the functioning of Central Drugs Standard Control Organization (CDSCO), said the regulator has been approving, on average, one new drug a month without conducting mandatory clinical trials or seeking expert medical opinion. It asked the health ministry to withdraw the discretionary power given to the organization to grant approvals to drug firms.<br /><br />Health secretary P.K. Pradhan said in an interview that the report had pointed out deficiencies, &ldquo;which does not indicate that the entire system was rotten&rdquo;. Health minister Ghulam Nabi Azad has constituted a panel to look into the suggestions made in the report, he said. The health ministry is due to submit a so-called action taken report in two months. &ldquo;In specific instances, where doctors and drug companies are mentioned, our committee will look at the circumstances under which the approvals were given and take remedial action,&rdquo; Pradhan said. &ldquo;We will be streamlining CDSCO and make the procedures more transparent.&rdquo;<br /><br />A key finding in the report was that several multinational firms had launched drugs without conducting mandatory clinical trials or seeking expert medical opinion. Novartis Pharmaceuticals, Eli Lilly and Co., Cipla Pharmaceuticals, GlaxoSmithKline (GSK), Sanofi Aventis, Theon Pharmaceuticals, UCB Biosciences and Panacea Biotech have been named in the report.<br /><br />&ldquo;If the drug is already approved/marketed in other countries, phase-III data should generally be obtained on at least 100 patients distributed over three-four centres, primarily to confirm the efficacy and safety of the drug in Indian patients when used as recommended in the product monograph for the claims made,&rdquo; according to the Indian Drugs and Cosmetics Act.<br /><br />While Cipla said it was not mandatory to conduct clinical trials in India before launching a new drug, Novartis said it followed standard international procedures. The panel said Cipla colluded with CDSCO officials to launch pirfenidone and colistimethate drugs without conducting clinical trials.<br /><br />&ldquo;We have followed the procedure as laid down under the Drugs and Cosmetics Act for grant of such licenses and there has been no violation. It is not mandatory to carry out phase-III trials in India for each and every new drug,&rdquo; a Cipla spokesperson said. &ldquo;Both the drugs in question are marketed in a number of countries internationally and have been proven to be life-saving. We deny there has been any collusion with DCGI.&rdquo;<br /><br />GSK said it was granted a local clinical trial waiver because the drug concerned for pulmonary artery hypertension called ambrisetan treated a rare disease &ldquo;which is life threatening and debilitating&rdquo;.<br /><br />Although a collusion between drug makers, doctors and CDSCO officials may have been pointed out, no action is expected against pharma firms, said an expert. &ldquo;The firms will walk away from this scot-free because there might be enough evidence of collusion, but collusion, as unethical as it might be, is not illegal,&rdquo; said C.M. Gulati, editor of the Monthly Index of Medical Specialities. &ldquo;The guilt of doctors, who signed letters written by drug firms and forwarded them as expert medical opinion on the subject, is established beyond doubt, and we will have to see what action is taken against them.&rdquo;</div>                                                           
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    <br><a href="http://www.livemint.com/2012/05/10233819/Health-ministry-underplays-par.html" class="re" target="_blank">Live Mint, 10 May, 2012, http://www.livemint.com/2012/05/10233819/Health-ministry-underplays-par.html</a><div class="clear"></div>
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Home हिन्दी

Health ministry underplays parliamentary panel report-Vidya Krishnan

Published on May 11, 2012   Modified on May 11, 2012

A key finding in the report was that several multinational firms had launched drugs without conducting mandatory clinical trials or seeking expert medical opinion The health ministry has denied the presence of any systemic rot in the drug approval process and pharmaceutical firms have refuted charges of collusion after a report by a parliamentary panel pointed to regulatory lapses in clinical trials. The panel, which looked into the functioning of Central Drugs Standard Control Organization (CDSCO), said the regulator has been approving, on average, one new drug a month without conducting mandatory clinical trials or seeking expert medical opinion. It asked the health ministry to withdraw the discretionary power given to the organization to grant approvals to drug firms. Health secretary P.K. Pradhan said in an interview that the report had pointed out deficiencies, “which does not indicate that the entire system was rotten”. Health minister Ghulam Nabi Azad has constituted a panel to look into the suggestions made in the report, he said. The health ministry is due to submit a so-called action taken report in two months. “In specific instances, where doctors and drug companies are mentioned, our committee will look at the circumstances under which the approvals were given and take remedial action,” Pradhan said. “We will be streamlining CDSCO and make the procedures more transparent.” A key finding in the report was that several multinational firms had launched drugs without conducting mandatory clinical trials or seeking expert medical opinion. Novartis Pharmaceuticals, Eli Lilly and Co., Cipla Pharmaceuticals, GlaxoSmithKline (GSK), Sanofi Aventis, Theon Pharmaceuticals, UCB Biosciences and Panacea Biotech have been named in the report. “If the drug is already approved/marketed in other countries, phase-III data should generally be obtained on at least 100 patients distributed over three-four centres, primarily to confirm the efficacy and safety of the drug in Indian patients when used as recommended in the product monograph for the claims made,” according to the Indian Drugs and Cosmetics Act. While Cipla said it was not mandatory to conduct clinical trials in India before launching a new drug, Novartis said it followed standard international procedures. The panel said Cipla colluded with CDSCO officials to launch pirfenidone and colistimethate drugs without conducting clinical trials. “We have followed the procedure as laid down under the Drugs and Cosmetics Act for grant of such licenses and there has been no violation. It is not mandatory to carry out phase-III trials in India for each and every new drug,” a Cipla spokesperson said. “Both the drugs in question are marketed in a number of countries internationally and have been proven to be life-saving. We deny there has been any collusion with DCGI.” GSK said it was granted a local clinical trial waiver because the drug concerned for pulmonary artery hypertension called ambrisetan treated a rare disease “which is life threatening and debilitating”. Although a collusion between drug makers, doctors and CDSCO officials may have been pointed out, no action is expected against pharma firms, said an expert. “The firms will walk away from this scot-free because there might be enough evidence of collusion, but collusion, as unethical as it might be, is not illegal,” said C.M. Gulati, editor of the Monthly Index of Medical Specialities. “The guilt of doctors, who signed letters written by drug firms and forwarded them as expert medical opinion on the subject, is established beyond doubt, and we will have to see what action is taken against them.”

Live Mint, 10 May, 2012, http://www.livemint.com/2012/05/10233819/Health-ministry-underplays-par.html

Tagged with: medicines Health

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