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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deprecationWarning - CORE/src/Core/functions.php, line 311
Cake\Http\ServerRequest::offsetGet() - CORE/src/Http/ServerRequest.php, line 2421
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Cake\Http\ActionDispatcher::_invoke() - CORE/src/Http/ActionDispatcher.php, line 120
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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
Cake\Http\Server::run() - CORE/src/Http/Server.php, line 98

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
App\Controller\ArtileDetailController::index() - APP/Controller/ArtileDetailController.php, line 151
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
Cake\Http\BaseApplication::__invoke() - CORE/src/Http/BaseApplication.php, line 235
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\RoutingMiddleware::__invoke() - CORE/src/Routing/Middleware/RoutingMiddleware.php, line 162
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\AssetMiddleware::__invoke() - CORE/src/Routing/Middleware/AssetMiddleware.php, line 97
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
Cake\Http\Server::run() - CORE/src/Http/Server.php, line 98

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')) {

                trigger_error($message, E_USER_WARNING);

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                            <br /><div align="justify">Confusion sparked by the setting up of a new committee for drug approvals has led to a slide in the number of new medicines getting cleared even as millions of Indians struggle with diabetes and heart failures remain a major killer.<br /><br />The Drug Controller General of India (DCGI) has shed its role as the sole approver of new drugs in the country after a new committee, set up by the health ministry, has taken over crucial approvals.<br /><br />The New Drug Advisory Committee (NDAC), in turn, oversees the work of 12 committees whose responsibility is to review the files submitted by the industry and give approvals within six weeks. The NDAC has a final say in giving an approval to the drug or rejecting it.<br /><br />Data from the DCGI shows that the number of new drug approvals dropped to 98 in 2011 from about 224 in 2010. So far this year, the NDAC has approved nine drugs.<br /><br />&quot;DCGI has become a defunct body as it has no powers in decision-making,&quot; said one industry official, who did not wish to be quoted due to sensitivity of the matter. Dara Patel, chairman, Indian Drugs Manufacturers Association, says that there should have been more industry representation.<br /><br />GN Singh, head, DCGI, did not respond to an e-mail query and phone calls of ET. His office said he is not authorised to speak in the matter.<br /><br />All this is happening at a time when lifestyle and infectious diseases are affecting a large number of Indians every year. The 5th edition of the Diabetes Atlas shows that about 61.3 million Indians suffer from diabetes while the World Health Organisation estimates that cardiovascular diseases will be the largest cause of death and disability in India by 2020.<br /><br />Companies say NDAC has made the regulatory process tedious and long. Companies also allege the NDAC has not been sticking to its deadline of giving decision within six weeks and when the committees meet, the approval is outright rejected without giving the firms a chance of re-examination.<br /><br />The DCGI came under severe criticism last year for issuing licences to companies who were carrying out unethical clinical trials. The matter reached Parliament where questions were raised about the health ministry's role in protecting trial patients. The incidents rattled the health ministry to which DCGI reports.<br /><br />The drug controller after these allegations in 2010 decided not to take any responsibility of issuing licences.<br /><br />Post this incident, the health ministry decided to create NDAC that would oversee the matters of drug approvals. Drug companies say DCGI has washed its hands off from drug approvals due to this quasi-regulatory body.<br /><br />Earlier, for a drug to get approval, companies would directly approach the drug controller's office, who would then consult experts before giving its decision.</div>                                                           
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    <h1 class="cat-box-title">Drug approvals fall on account of tardy &amp; tedious process by NDAC-Divya Rajagopal</h1>
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                            <br /><div align="justify">Confusion sparked by the setting up of a new committee for drug approvals has led to a slide in the number of new medicines getting cleared even as millions of Indians struggle with diabetes and heart failures remain a major killer.<br /><br />The Drug Controller General of India (DCGI) has shed its role as the sole approver of new drugs in the country after a new committee, set up by the health ministry, has taken over crucial approvals.<br /><br />The New Drug Advisory Committee (NDAC), in turn, oversees the work of 12 committees whose responsibility is to review the files submitted by the industry and give approvals within six weeks. The NDAC has a final say in giving an approval to the drug or rejecting it.<br /><br />Data from the DCGI shows that the number of new drug approvals dropped to 98 in 2011 from about 224 in 2010. So far this year, the NDAC has approved nine drugs.<br /><br />&quot;DCGI has become a defunct body as it has no powers in decision-making,&quot; said one industry official, who did not wish to be quoted due to sensitivity of the matter. Dara Patel, chairman, Indian Drugs Manufacturers Association, says that there should have been more industry representation.<br /><br />GN Singh, head, DCGI, did not respond to an e-mail query and phone calls of ET. His office said he is not authorised to speak in the matter.<br /><br />All this is happening at a time when lifestyle and infectious diseases are affecting a large number of Indians every year. The 5th edition of the Diabetes Atlas shows that about 61.3 million Indians suffer from diabetes while the World Health Organisation estimates that cardiovascular diseases will be the largest cause of death and disability in India by 2020.<br /><br />Companies say NDAC has made the regulatory process tedious and long. Companies also allege the NDAC has not been sticking to its deadline of giving decision within six weeks and when the committees meet, the approval is outright rejected without giving the firms a chance of re-examination.<br /><br />The DCGI came under severe criticism last year for issuing licences to companies who were carrying out unethical clinical trials. The matter reached Parliament where questions were raised about the health ministry's role in protecting trial patients. The incidents rattled the health ministry to which DCGI reports.<br /><br />The drug controller after these allegations in 2010 decided not to take any responsibility of issuing licences.<br /><br />Post this incident, the health ministry decided to create NDAC that would oversee the matters of drug approvals. Drug companies say DCGI has washed its hands off from drug approvals due to this quasi-regulatory body.<br /><br />Earlier, for a drug to get approval, companies would directly approach the drug controller's office, who would then consult experts before giving its decision.</div>                                                           
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    <br><a href="http://economictimes.indiatimes.com/news/news-by-industry/healthcare/biotech/pharmaceuticals/drug-approvals-fall-on-account-of-tardy-tedious-process-by-ndac/article" class="re" target="_blank">The Economic Times, 20 April, 2012, http://economictimes.indiatimes.com/news/news-by-industry/healthcare/biotech/pharmaceuticals/drug-approvals-fall-on-account-of-tardy-tedious-process-by-ndac/article</a><div class="clear"></div>
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    <h1 class="cat-box-title">Drug approvals fall on account of tardy &amp; tedious process by NDAC-Divya Rajagopal</h1>
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                            <br /><div align="justify">Confusion sparked by the setting up of a new committee for drug approvals has led to a slide in the number of new medicines getting cleared even as millions of Indians struggle with diabetes and heart failures remain a major killer.<br /><br />The Drug Controller General of India (DCGI) has shed its role as the sole approver of new drugs in the country after a new committee, set up by the health ministry, has taken over crucial approvals.<br /><br />The New Drug Advisory Committee (NDAC), in turn, oversees the work of 12 committees whose responsibility is to review the files submitted by the industry and give approvals within six weeks. The NDAC has a final say in giving an approval to the drug or rejecting it.<br /><br />Data from the DCGI shows that the number of new drug approvals dropped to 98 in 2011 from about 224 in 2010. So far this year, the NDAC has approved nine drugs.<br /><br />&quot;DCGI has become a defunct body as it has no powers in decision-making,&quot; said one industry official, who did not wish to be quoted due to sensitivity of the matter. Dara Patel, chairman, Indian Drugs Manufacturers Association, says that there should have been more industry representation.<br /><br />GN Singh, head, DCGI, did not respond to an e-mail query and phone calls of ET. His office said he is not authorised to speak in the matter.<br /><br />All this is happening at a time when lifestyle and infectious diseases are affecting a large number of Indians every year. The 5th edition of the Diabetes Atlas shows that about 61.3 million Indians suffer from diabetes while the World Health Organisation estimates that cardiovascular diseases will be the largest cause of death and disability in India by 2020.<br /><br />Companies say NDAC has made the regulatory process tedious and long. Companies also allege the NDAC has not been sticking to its deadline of giving decision within six weeks and when the committees meet, the approval is outright rejected without giving the firms a chance of re-examination.<br /><br />The DCGI came under severe criticism last year for issuing licences to companies who were carrying out unethical clinical trials. The matter reached Parliament where questions were raised about the health ministry's role in protecting trial patients. The incidents rattled the health ministry to which DCGI reports.<br /><br />The drug controller after these allegations in 2010 decided not to take any responsibility of issuing licences.<br /><br />Post this incident, the health ministry decided to create NDAC that would oversee the matters of drug approvals. Drug companies say DCGI has washed its hands off from drug approvals due to this quasi-regulatory body.<br /><br />Earlier, for a drug to get approval, companies would directly approach the drug controller's office, who would then consult experts before giving its decision.</div>                                                           
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    <br><a href="http://economictimes.indiatimes.com/news/news-by-industry/healthcare/biotech/pharmaceuticals/drug-approvals-fall-on-account-of-tardy-tedious-process-by-ndac/article" class="re" target="_blank">The Economic Times, 20 April, 2012, http://economictimes.indiatimes.com/news/news-by-industry/healthcare/biotech/pharmaceuticals/drug-approvals-fall-on-account-of-tardy-tedious-process-by-ndac/article</a><div class="clear"></div>
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Drug approvals fall on account of tardy & tedious process by NDAC-Divya Rajagopal

Published on Apr 20, 2012   Modified on Apr 20, 2012

Confusion sparked by the setting up of a new committee for drug approvals has led to a slide in the number of new medicines getting cleared even as millions of Indians struggle with diabetes and heart failures remain a major killer. The Drug Controller General of India (DCGI) has shed its role as the sole approver of new drugs in the country after a new committee, set up by the health ministry, has taken over crucial approvals. The New Drug Advisory Committee (NDAC), in turn, oversees the work of 12 committees whose responsibility is to review the files submitted by the industry and give approvals within six weeks. The NDAC has a final say in giving an approval to the drug or rejecting it. Data from the DCGI shows that the number of new drug approvals dropped to 98 in 2011 from about 224 in 2010. So far this year, the NDAC has approved nine drugs. "DCGI has become a defunct body as it has no powers in decision-making," said one industry official, who did not wish to be quoted due to sensitivity of the matter. Dara Patel, chairman, Indian Drugs Manufacturers Association, says that there should have been more industry representation. GN Singh, head, DCGI, did not respond to an e-mail query and phone calls of ET. His office said he is not authorised to speak in the matter. All this is happening at a time when lifestyle and infectious diseases are affecting a large number of Indians every year. The 5th edition of the Diabetes Atlas shows that about 61.3 million Indians suffer from diabetes while the World Health Organisation estimates that cardiovascular diseases will be the largest cause of death and disability in India by 2020. Companies say NDAC has made the regulatory process tedious and long. Companies also allege the NDAC has not been sticking to its deadline of giving decision within six weeks and when the committees meet, the approval is outright rejected without giving the firms a chance of re-examination. The DCGI came under severe criticism last year for issuing licences to companies who were carrying out unethical clinical trials. The matter reached Parliament where questions were raised about the health ministry's role in protecting trial patients. The incidents rattled the health ministry to which DCGI reports. The drug controller after these allegations in 2010 decided not to take any responsibility of issuing licences. Post this incident, the health ministry decided to create NDAC that would oversee the matters of drug approvals. Drug companies say DCGI has washed its hands off from drug approvals due to this quasi-regulatory body. Earlier, for a drug to get approval, companies would directly approach the drug controller's office, who would then consult experts before giving its decision.

The Economic Times, 20 April, 2012, http://economictimes.indiatimes.com/news/news-by-industry/healthcare/biotech/pharmaceuticals/drug-approvals-fall-on-account-of-tardy-tedious-process-by-ndac/article

Tagged with: medicines Health

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