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
App\Controller\ArtileDetailController::index() - APP/Controller/ArtileDetailController.php, line 150
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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
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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
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')) {

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        LATEST NEWS UPDATES | Government eases norms to test, launch drugs -Sushmi Dey    </title>
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-The Times of India

NEW DELHI: In an attempt to ease norms for testing and introduction of new medicines in the country, the government has taken steps to fast-track approvals for clinical trials as well as launch of drugs already approved..."/>
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NEW DELHI: In an attempt to ease norms for testing and introduction of new medicines in the country, the government has taken steps to fast-track approvals for clinical trials as well as launch of drugs already approved..." />
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                            <div align="justify">-The Times of India<br /><br /><em>NEW DELHI: </em>In an attempt to ease norms for testing and introduction of new medicines in the country, the government has taken steps to fast-track approvals for clinical trials as well as launch of drugs already approved in other countries.<br /><br />Pharmaceutical companies planning to launch new drugs already approved outside India after conducting pre-clinical or toxicological studies on animals will not be required to repeat such studies in India for importing or manufacturing them here unless some specific concerns are raised, the Drugs Controller General of India, under the health ministry, said in a latest circular issued this week.<br /><br />The drug regulator has also given more freedom and responsibility to the Ethics Committee-- that monitors clinical trials for new medicines. As per the new norms, the Ethics Committee is expected to cut timelines for launch of new medicines, including biologics.<br /><br />Ethics Committee has also been allowed to add trial sites and investigators without the need to obtain a no objection certificate from the DCGI. However, companies will have to inform any changes to the DCGI.<br /><br />The move comes in the wake of concerns raised by the industry which complained of repeat tests and data submissions to different authorities. Of late, the regulator has also been cautious on approving new drug trials after the Supreme Court's directive asking the government to ensure patient safety while approving clinical trials. The recommendations to ease the norms for additional tests were made by the Investigational New Drug Committee and Drug Technical Advisory Board.<br /><br />Though, the latest order by the DCGI gives more power and independence to the ethics committee, but still the final authority of approval of the application will however be with the DCGI.<br /><br />Apart from commercial testing and research, norms have also been eased for academic research. Making it easier to conduct clinical trials for academic and research purposes that are non-regulatory in nature, the DCGI has said its permission will not be needed provided that the trials are approved by the ethics committee. However, the regulator can raise objections if there are any concerns highlighted. <br /></div>                                                           
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    <br><a href="http://timesofindia.indiatimes.com/india/Government-eases-norms-to-test-launch-drugs/articleshow/49762844.cms" class="re" target="_blank">The Times of India, 13 November, 2015, http://timesofindia.indiatimes.com/india/Government-eases-norms-to-test-launch-drugs/articleshow/49762844.cms</a><div class="clear"></div>
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    <h1 class="cat-box-title">Government eases norms to test, launch drugs -Sushmi Dey</h1>
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                            <div align="justify">-The Times of India<br /><br /><em>NEW DELHI: </em>In an attempt to ease norms for testing and introduction of new medicines in the country, the government has taken steps to fast-track approvals for clinical trials as well as launch of drugs already approved in other countries.<br /><br />Pharmaceutical companies planning to launch new drugs already approved outside India after conducting pre-clinical or toxicological studies on animals will not be required to repeat such studies in India for importing or manufacturing them here unless some specific concerns are raised, the Drugs Controller General of India, under the health ministry, said in a latest circular issued this week.<br /><br />The drug regulator has also given more freedom and responsibility to the Ethics Committee-- that monitors clinical trials for new medicines. As per the new norms, the Ethics Committee is expected to cut timelines for launch of new medicines, including biologics.<br /><br />Ethics Committee has also been allowed to add trial sites and investigators without the need to obtain a no objection certificate from the DCGI. However, companies will have to inform any changes to the DCGI.<br /><br />The move comes in the wake of concerns raised by the industry which complained of repeat tests and data submissions to different authorities. Of late, the regulator has also been cautious on approving new drug trials after the Supreme Court's directive asking the government to ensure patient safety while approving clinical trials. The recommendations to ease the norms for additional tests were made by the Investigational New Drug Committee and Drug Technical Advisory Board.<br /><br />Though, the latest order by the DCGI gives more power and independence to the ethics committee, but still the final authority of approval of the application will however be with the DCGI.<br /><br />Apart from commercial testing and research, norms have also been eased for academic research. Making it easier to conduct clinical trials for academic and research purposes that are non-regulatory in nature, the DCGI has said its permission will not be needed provided that the trials are approved by the ethics committee. However, the regulator can raise objections if there are any concerns highlighted. <br /></div>                                                           
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    <br><a href="http://timesofindia.indiatimes.com/india/Government-eases-norms-to-test-launch-drugs/articleshow/49762844.cms" class="re" target="_blank">The Times of India, 13 November, 2015, http://timesofindia.indiatimes.com/india/Government-eases-norms-to-test-launch-drugs/articleshow/49762844.cms</a><div class="clear"></div>
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    <h1 class="cat-box-title">Government eases norms to test, launch drugs -Sushmi Dey</h1>
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                            <div align="justify">-The Times of India<br /><br /><em>NEW DELHI: </em>In an attempt to ease norms for testing and introduction of new medicines in the country, the government has taken steps to fast-track approvals for clinical trials as well as launch of drugs already approved in other countries.<br /><br />Pharmaceutical companies planning to launch new drugs already approved outside India after conducting pre-clinical or toxicological studies on animals will not be required to repeat such studies in India for importing or manufacturing them here unless some specific concerns are raised, the Drugs Controller General of India, under the health ministry, said in a latest circular issued this week.<br /><br />The drug regulator has also given more freedom and responsibility to the Ethics Committee-- that monitors clinical trials for new medicines. As per the new norms, the Ethics Committee is expected to cut timelines for launch of new medicines, including biologics.<br /><br />Ethics Committee has also been allowed to add trial sites and investigators without the need to obtain a no objection certificate from the DCGI. However, companies will have to inform any changes to the DCGI.<br /><br />The move comes in the wake of concerns raised by the industry which complained of repeat tests and data submissions to different authorities. Of late, the regulator has also been cautious on approving new drug trials after the Supreme Court's directive asking the government to ensure patient safety while approving clinical trials. The recommendations to ease the norms for additional tests were made by the Investigational New Drug Committee and Drug Technical Advisory Board.<br /><br />Though, the latest order by the DCGI gives more power and independence to the ethics committee, but still the final authority of approval of the application will however be with the DCGI.<br /><br />Apart from commercial testing and research, norms have also been eased for academic research. Making it easier to conduct clinical trials for academic and research purposes that are non-regulatory in nature, the DCGI has said its permission will not be needed provided that the trials are approved by the ethics committee. However, the regulator can raise objections if there are any concerns highlighted. <br /></div>                                                           
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    <br><a href="http://timesofindia.indiatimes.com/india/Government-eases-norms-to-test-launch-drugs/articleshow/49762844.cms" class="re" target="_blank">The Times of India, 13 November, 2015, http://timesofindia.indiatimes.com/india/Government-eases-norms-to-test-launch-drugs/articleshow/49762844.cms</a><div class="clear"></div>
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Home हिन्दी

Government eases norms to test, launch drugs -Sushmi Dey

Published on Nov 13, 2015   Modified on Nov 13, 2015

-The Times of India NEW DELHI: In an attempt to ease norms for testing and introduction of new medicines in the country, the government has taken steps to fast-track approvals for clinical trials as well as launch of drugs already approved in other countries. Pharmaceutical companies planning to launch new drugs already approved outside India after conducting pre-clinical or toxicological studies on animals will not be required to repeat such studies in India for importing or manufacturing them here unless some specific concerns are raised, the Drugs Controller General of India, under the health ministry, said in a latest circular issued this week. The drug regulator has also given more freedom and responsibility to the Ethics Committee-- that monitors clinical trials for new medicines. As per the new norms, the Ethics Committee is expected to cut timelines for launch of new medicines, including biologics. Ethics Committee has also been allowed to add trial sites and investigators without the need to obtain a no objection certificate from the DCGI. However, companies will have to inform any changes to the DCGI. The move comes in the wake of concerns raised by the industry which complained of repeat tests and data submissions to different authorities. Of late, the regulator has also been cautious on approving new drug trials after the Supreme Court's directive asking the government to ensure patient safety while approving clinical trials. The recommendations to ease the norms for additional tests were made by the Investigational New Drug Committee and Drug Technical Advisory Board. Though, the latest order by the DCGI gives more power and independence to the ethics committee, but still the final authority of approval of the application will however be with the DCGI. Apart from commercial testing and research, norms have also been eased for academic research. Making it easier to conduct clinical trials for academic and research purposes that are non-regulatory in nature, the DCGI has said its permission will not be needed provided that the trials are approved by the ethics committee. However, the regulator can raise objections if there are any concerns highlighted.

The Times of India, 13 November, 2015, http://timesofindia.indiatimes.com/india/Government-eases-norms-to-test-launch-drugs/articleshow/49762844.cms

Tagged with: Clinical Trials medicines

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