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: 73 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);
}
$message = '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: 73 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php.' $stackFrame = (int) 1 $trace = [ (int) 0 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/ServerRequest.php', 'line' => (int) 2421, 'function' => 'deprecationWarning', 'args' => [ (int) 0 => 'The ArrayAccess methods will be removed in 4.0.0.Use getParam(), getData() and getQuery() instead.' ] ], (int) 1 => [ 'file' => '/home/brlfuser/public_html/src/Controller/ArtileDetailController.php', 'line' => (int) 73, 'function' => 'offsetGet', 'class' => 'Cake\Http\ServerRequest', 'object' => object(Cake\Http\ServerRequest) {}, 'type' => '->', 'args' => [ (int) 0 => 'catslug' ] ], (int) 2 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Controller/Controller.php', 'line' => (int) 610, 'function' => 'printArticle', 'class' => 'App\Controller\ArtileDetailController', 'object' => object(App\Controller\ArtileDetailController) {}, 'type' => '->', 'args' => [] ], (int) 3 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/ActionDispatcher.php', 'line' => (int) 120, 'function' => 'invokeAction', 'class' => 'Cake\Controller\Controller', 'object' => object(App\Controller\ArtileDetailController) {}, 'type' => '->', 'args' => [] ], (int) 4 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/ActionDispatcher.php', 'line' => (int) 94, 'function' => '_invoke', 'class' => 'Cake\Http\ActionDispatcher', 'object' => object(Cake\Http\ActionDispatcher) {}, 'type' => '->', 'args' => [ (int) 0 => object(App\Controller\ArtileDetailController) {} ] ], (int) 5 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/BaseApplication.php', 'line' => (int) 235, 'function' => 'dispatch', 'class' => 'Cake\Http\ActionDispatcher', 'object' => object(Cake\Http\ActionDispatcher) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {} ] ], (int) 6 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Runner.php', 'line' => (int) 65, 'function' => '__invoke', 'class' => 'Cake\Http\BaseApplication', 'object' => object(App\Application) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {}, (int) 2 => object(Cake\Http\Runner) {} ] ], (int) 7 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Routing/Middleware/RoutingMiddleware.php', 'line' => (int) 162, 'function' => '__invoke', 'class' => 'Cake\Http\Runner', 'object' => object(Cake\Http\Runner) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {} ] ], (int) 8 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Runner.php', 'line' => (int) 65, 'function' => '__invoke', 'class' => 'Cake\Routing\Middleware\RoutingMiddleware', 'object' => object(Cake\Routing\Middleware\RoutingMiddleware) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {}, (int) 2 => object(Cake\Http\Runner) {} ] ], (int) 9 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Routing/Middleware/AssetMiddleware.php', 'line' => (int) 88, 'function' => '__invoke', 'class' => 'Cake\Http\Runner', 'object' => object(Cake\Http\Runner) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {} ] ], (int) 10 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Runner.php', 'line' => (int) 65, 'function' => '__invoke', 'class' => 'Cake\Routing\Middleware\AssetMiddleware', 'object' => object(Cake\Routing\Middleware\AssetMiddleware) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {}, (int) 2 => object(Cake\Http\Runner) {} ] ], (int) 11 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Middleware/ErrorHandlerMiddleware.php', 'line' => (int) 96, 'function' => '__invoke', 'class' => 'Cake\Http\Runner', 'object' => object(Cake\Http\Runner) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {} ] ], (int) 12 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Runner.php', 'line' => (int) 65, 'function' => '__invoke', 'class' => 'Cake\Error\Middleware\ErrorHandlerMiddleware', 'object' => object(Cake\Error\Middleware\ErrorHandlerMiddleware) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {}, (int) 2 => object(Cake\Http\Runner) {} ] ], (int) 13 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Runner.php', 'line' => (int) 51, 'function' => '__invoke', 'class' => 'Cake\Http\Runner', 'object' => object(Cake\Http\Runner) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {} ] ], (int) 14 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Server.php', 'line' => (int) 98, 'function' => 'run', 'class' => 'Cake\Http\Runner', 'object' => object(Cake\Http\Runner) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\MiddlewareQueue) {}, (int) 1 => object(Cake\Http\ServerRequest) {}, (int) 2 => object(Cake\Http\Response) {} ] ], (int) 15 => [ 'file' => '/home/brlfuser/public_html/webroot/index.php', 'line' => (int) 39, 'function' => 'run', 'class' => 'Cake\Http\Server', 'object' => object(Cake\Http\Server) {}, 'type' => '->', 'args' => [] ] ] $frame = [ 'file' => '/home/brlfuser/public_html/src/Controller/ArtileDetailController.php', 'line' => (int) 73, 'function' => 'offsetGet', 'class' => 'Cake\Http\ServerRequest', 'object' => object(Cake\Http\ServerRequest) { trustProxy => false [protected] params => [ [maximum depth reached] ] [protected] data => [[maximum depth reached]] [protected] query => [[maximum depth reached]] [protected] cookies => [ [maximum depth reached] ] [protected] _environment => [ [maximum depth reached] ] [protected] url => 'latest-news-updates/supreme-court-blocks-157-clinical-trials-says-must-follow-new-regime-utkarsh-anand-23087/print' [protected] base => '' [protected] webroot => '/' [protected] here => '/latest-news-updates/supreme-court-blocks-157-clinical-trials-says-must-follow-new-regime-utkarsh-anand-23087/print' [protected] trustedProxies => [[maximum depth reached]] [protected] _input => null [protected] _detectors => [ [maximum depth reached] ] [protected] _detectorCache => [ [maximum depth reached] ] [protected] stream => object(Zend\Diactoros\PhpInputStream) {} [protected] uri => object(Zend\Diactoros\Uri) {} [protected] session => object(Cake\Http\Session) {} [protected] attributes => [[maximum depth reached]] [protected] emulatedAttributes => [ [maximum depth reached] ] [protected] uploadedFiles => [[maximum depth reached]] [protected] protocol => null [protected] requestTarget => null [private] deprecatedProperties => [ [maximum depth reached] ] }, 'type' => '->', 'args' => [ (int) 0 => 'catslug' ] ]deprecationWarning - CORE/src/Core/functions.php, line 311 Cake\Http\ServerRequest::offsetGet() - CORE/src/Http/ServerRequest.php, line 2421 App\Controller\ArtileDetailController::printArticle() - APP/Controller/ArtileDetailController.php, line 73 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 88 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: 74 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);
}
$message = '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: 74 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php.' $stackFrame = (int) 1 $trace = [ (int) 0 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/ServerRequest.php', 'line' => (int) 2421, 'function' => 'deprecationWarning', 'args' => [ (int) 0 => 'The ArrayAccess methods will be removed in 4.0.0.Use getParam(), getData() and getQuery() instead.' ] ], (int) 1 => [ 'file' => '/home/brlfuser/public_html/src/Controller/ArtileDetailController.php', 'line' => (int) 74, 'function' => 'offsetGet', 'class' => 'Cake\Http\ServerRequest', 'object' => object(Cake\Http\ServerRequest) {}, 'type' => '->', 'args' => [ (int) 0 => 'artileslug' ] ], (int) 2 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Controller/Controller.php', 'line' => (int) 610, 'function' => 'printArticle', 'class' => 'App\Controller\ArtileDetailController', 'object' => object(App\Controller\ArtileDetailController) {}, 'type' => '->', 'args' => [] ], (int) 3 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/ActionDispatcher.php', 'line' => (int) 120, 'function' => 'invokeAction', 'class' => 'Cake\Controller\Controller', 'object' => object(App\Controller\ArtileDetailController) {}, 'type' => '->', 'args' => [] ], (int) 4 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/ActionDispatcher.php', 'line' => (int) 94, 'function' => '_invoke', 'class' => 'Cake\Http\ActionDispatcher', 'object' => object(Cake\Http\ActionDispatcher) {}, 'type' => '->', 'args' => [ (int) 0 => object(App\Controller\ArtileDetailController) {} ] ], (int) 5 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/BaseApplication.php', 'line' => (int) 235, 'function' => 'dispatch', 'class' => 'Cake\Http\ActionDispatcher', 'object' => object(Cake\Http\ActionDispatcher) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {} ] ], (int) 6 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Runner.php', 'line' => (int) 65, 'function' => '__invoke', 'class' => 'Cake\Http\BaseApplication', 'object' => object(App\Application) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {}, (int) 2 => object(Cake\Http\Runner) {} ] ], (int) 7 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Routing/Middleware/RoutingMiddleware.php', 'line' => (int) 162, 'function' => '__invoke', 'class' => 'Cake\Http\Runner', 'object' => object(Cake\Http\Runner) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {} ] ], (int) 8 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Runner.php', 'line' => (int) 65, 'function' => '__invoke', 'class' => 'Cake\Routing\Middleware\RoutingMiddleware', 'object' => object(Cake\Routing\Middleware\RoutingMiddleware) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {}, (int) 2 => object(Cake\Http\Runner) {} ] ], (int) 9 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Routing/Middleware/AssetMiddleware.php', 'line' => (int) 88, 'function' => '__invoke', 'class' => 'Cake\Http\Runner', 'object' => object(Cake\Http\Runner) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {} ] ], (int) 10 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Runner.php', 'line' => (int) 65, 'function' => '__invoke', 'class' => 'Cake\Routing\Middleware\AssetMiddleware', 'object' => object(Cake\Routing\Middleware\AssetMiddleware) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {}, (int) 2 => object(Cake\Http\Runner) {} ] ], (int) 11 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Middleware/ErrorHandlerMiddleware.php', 'line' => (int) 96, 'function' => '__invoke', 'class' => 'Cake\Http\Runner', 'object' => object(Cake\Http\Runner) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {} ] ], (int) 12 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Runner.php', 'line' => (int) 65, 'function' => '__invoke', 'class' => 'Cake\Error\Middleware\ErrorHandlerMiddleware', 'object' => object(Cake\Error\Middleware\ErrorHandlerMiddleware) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {}, (int) 2 => object(Cake\Http\Runner) {} ] ], (int) 13 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Runner.php', 'line' => (int) 51, 'function' => '__invoke', 'class' => 'Cake\Http\Runner', 'object' => object(Cake\Http\Runner) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {} ] ], (int) 14 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Server.php', 'line' => (int) 98, 'function' => 'run', 'class' => 'Cake\Http\Runner', 'object' => object(Cake\Http\Runner) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\MiddlewareQueue) {}, (int) 1 => object(Cake\Http\ServerRequest) {}, (int) 2 => object(Cake\Http\Response) {} ] ], (int) 15 => [ 'file' => '/home/brlfuser/public_html/webroot/index.php', 'line' => (int) 39, 'function' => 'run', 'class' => 'Cake\Http\Server', 'object' => object(Cake\Http\Server) {}, 'type' => '->', 'args' => [] ] ] $frame = [ 'file' => '/home/brlfuser/public_html/src/Controller/ArtileDetailController.php', 'line' => (int) 74, 'function' => 'offsetGet', 'class' => 'Cake\Http\ServerRequest', 'object' => object(Cake\Http\ServerRequest) { trustProxy => false [protected] params => [ [maximum depth reached] ] [protected] data => [[maximum depth reached]] [protected] query => [[maximum depth reached]] [protected] cookies => [ [maximum depth reached] ] [protected] _environment => [ [maximum depth reached] ] [protected] url => 'latest-news-updates/supreme-court-blocks-157-clinical-trials-says-must-follow-new-regime-utkarsh-anand-23087/print' [protected] base => '' [protected] webroot => '/' [protected] here => '/latest-news-updates/supreme-court-blocks-157-clinical-trials-says-must-follow-new-regime-utkarsh-anand-23087/print' [protected] trustedProxies => [[maximum depth reached]] [protected] _input => null [protected] _detectors => [ [maximum depth reached] ] [protected] _detectorCache => [ [maximum depth reached] ] [protected] stream => object(Zend\Diactoros\PhpInputStream) {} [protected] uri => object(Zend\Diactoros\Uri) {} [protected] session => object(Cake\Http\Session) {} [protected] attributes => [[maximum depth reached]] [protected] emulatedAttributes => [ [maximum depth reached] ] [protected] uploadedFiles => [[maximum depth reached]] [protected] protocol => null [protected] requestTarget => null [private] deprecatedProperties => [ [maximum depth reached] ] }, 'type' => '->', 'args' => [ (int) 0 => 'artileslug' ] ]deprecationWarning - CORE/src/Core/functions.php, line 311 Cake\Http\ServerRequest::offsetGet() - CORE/src/Http/ServerRequest.php, line 2421 App\Controller\ArtileDetailController::printArticle() - APP/Controller/ArtileDetailController.php, line 74 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 88 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 Contextif (Configure::read('debug')) {
trigger_error($message, E_USER_WARNING);
} else {
$response = object(Cake\Http\Response) { 'status' => (int) 200, 'contentType' => 'text/html', 'headers' => [ 'Content-Type' => [ [maximum depth reached] ] ], 'file' => null, 'fileRange' => [], 'cookies' => object(Cake\Http\Cookie\CookieCollection) {}, 'cacheDirectives' => [], 'body' => '<!DOCTYPE html PUBLIC "-//W3C//DTD XHTML 1.0 Transitional//EN" "http://www.w3.org/TR/xhtml1/DTD/xhtml1-transitional.dtd"> <html xmlns="http://www.w3.org/1999/xhtml"> <head> <link rel="canonical" href="https://im4change.in/<pre class="cake-error"><a href="javascript:void(0);" onclick="document.getElementById('cakeErr67f33bdfdb67b-trace').style.display = (document.getElementById('cakeErr67f33bdfdb67b-trace').style.display == 'none' ? '' : 'none');"><b>Notice</b> (8)</a>: Undefined variable: urlPrefix [<b>APP/Template/Layout/printlayout.ctp</b>, line <b>8</b>]<div id="cakeErr67f33bdfdb67b-trace" class="cake-stack-trace" style="display: none;"><a href="javascript:void(0);" onclick="document.getElementById('cakeErr67f33bdfdb67b-code').style.display = (document.getElementById('cakeErr67f33bdfdb67b-code').style.display == 'none' ? '' : 'none')">Code</a> <a href="javascript:void(0);" onclick="document.getElementById('cakeErr67f33bdfdb67b-context').style.display = (document.getElementById('cakeErr67f33bdfdb67b-context').style.display == 'none' ? '' : 'none')">Context</a><pre id="cakeErr67f33bdfdb67b-code" class="cake-code-dump" style="display: none;"><code><span style="color: #000000"><span style="color: #0000BB"></span><span style="color: #007700"><</span><span style="color: #0000BB">head</span><span style="color: #007700">> </span></span></code> <span class="code-highlight"><code><span style="color: #000000"> <link rel="canonical" href="<span style="color: #0000BB"><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">Configure</span><span style="color: #007700">::</span><span style="color: #0000BB">read</span><span style="color: #007700">(</span><span style="color: #DD0000">'SITE_URL'</span><span style="color: #007700">); </span><span style="color: #0000BB">?><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">$urlPrefix</span><span style="color: #007700">;</span><span style="color: #0000BB">?><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">$article_current</span><span style="color: #007700">-></span><span style="color: #0000BB">category</span><span style="color: #007700">-></span><span style="color: #0000BB">slug</span><span style="color: #007700">; </span><span style="color: #0000BB">?></span>/<span style="color: #0000BB"><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">$article_current</span><span style="color: #007700">-></span><span style="color: #0000BB">seo_url</span><span style="color: #007700">; </span><span style="color: #0000BB">?></span>.html"/> </span></code></span> <code><span style="color: #000000"><span style="color: #0000BB"> </span><span style="color: #007700"><</span><span style="color: #0000BB">meta http</span><span style="color: #007700">-</span><span style="color: #0000BB">equiv</span><span style="color: #007700">=</span><span style="color: #DD0000">"Content-Type" </span><span style="color: #0000BB">content</span><span style="color: #007700">=</span><span style="color: #DD0000">"text/html; charset=utf-8"</span><span style="color: #007700">/> </span></span></code></pre><pre id="cakeErr67f33bdfdb67b-context" class="cake-context" style="display: none;">$viewFile = '/home/brlfuser/public_html/src/Template/Layout/printlayout.ctp' $dataForView = [ 'article_current' => object(App\Model\Entity\Article) { 'id' => (int) 22929, 'title' => 'Supreme Court blocks 157 clinical trials, says must follow new regime -Utkarsh Anand', 'subheading' => '', 'description' => '<div align="justify"> -The Indian Express </div> <p align="justify"> <br /> The fate of 157 government-approved global clinical trials seemed uncertain on Monday as the Supreme Court ordered the Centre to wait for its nod while the authorities re-examined the cases under the new regulatory regime. </p> <p align="justify"> Making it clear that clinical trials being conducted in India must be done for the benefit of the people here, a bench of Justices R M Lodha and S K Singh directed the government to put the trials through the new stringent three-tier test. </p> <p align="justify"> The Indian Express had reported that of the 162 approvals granted by the Drug Controller General of India until August 31 this year, 157 trials were cleared in 2012, after a nod from just the New Drug Advisory Committees (NDACs). They escaped the new regulatory regime - a three-tier test involving the NDACs, technical committee and apex committee - which was put in place following the SC's order in January. </p> <p align="justify"> Between January 1and August 31 this year, only five trials were cleared under the new three-tier test. </p> <p align="justify"> After Additional Solicitor General Sidharth Luthra admitted that 157 trials were not evaluated by the technical and apex committees, the bench asked him to get it done, and submit the reports to the court by December 16. </p> <p align="justify"> &quot;The committees shall keep in view all the relevant aspects of clinical trials and efficacy data, particularly in terms of assessment of risk vs benefits to patients, innovation vis-a-vis existing therapeutic options, and medical needs of the country,&quot; it said. </p> <p align="justify"> The bench said it would not pass any order on carrying out these 157 trials until it was satisfied that the safety of the subjects was not being jeopardised, and that the trials would benefit India. </p> <p align="justify"> On the remaining five trials, the bench said they could be proceeded with, but only after &quot;proper framework is in place concerning audio-video recording for informed consent of the subjects and presentation of requisite documents while simultaneously adhering to the principle of confidentiality&quot;. </p> <p align="justify"> The court said the contention that investigators, who inquire into cases of adverse events during and after trials, were hired by the pharmaceutical companies and were paid by them, was an &quot;area of concern&quot;. </p> <p align="justify"> &quot;If investigators are paid by the companies, there is likelihood that serious adverse events will not be duly reported. Let there be a panel of independent investigators who can be paid by the government and the list of such persons can be updated periodically,&quot; it said. </p>', 'credit_writer' => 'The Indian Express, 22 October, 2013, http://www.indianexpress.com/news/supreme-court-blocks-157-clinical-trials-says-must-follow-new-regime/1185664/0', 'article_img' => '', 'article_img_thumb' => '', 'status' => (int) 1, 'show_on_home' => (int) 1, 'lang' => 'EN', 'category_id' => (int) 16, 'tag_keyword' => '', 'seo_url' => 'supreme-court-blocks-157-clinical-trials-says-must-follow-new-regime-utkarsh-anand-23087', 'meta_title' => null, 'meta_keywords' => null, 'meta_description' => null, 'noindex' => (int) 0, 'publish_date' => object(Cake\I18n\FrozenDate) {}, 'most_visit_section_id' => null, 'article_big_img' => null, 'liveid' => (int) 23087, 'created' => object(Cake\I18n\FrozenTime) {}, 'modified' => object(Cake\I18n\FrozenTime) {}, 'edate' => '', 'tags' => [ [maximum depth reached] ], 'category' => object(App\Model\Entity\Category) {}, '[new]' => false, '[accessible]' => [ [maximum depth reached] ], '[dirty]' => [[maximum depth reached]], '[original]' => [[maximum depth reached]], '[virtual]' => [[maximum depth reached]], '[hasErrors]' => false, '[errors]' => [[maximum depth reached]], '[invalid]' => [[maximum depth reached]], '[repository]' => 'Articles' }, 'articleid' => (int) 22929, 'metaTitle' => 'LATEST NEWS UPDATES | Supreme Court blocks 157 clinical trials, says must follow new regime -Utkarsh Anand', 'metaKeywords' => 'Clinical Trials,Health,Law and Justice,medicines', 'metaDesc' => ' -The Indian Express The fate of 157 government-approved global clinical trials seemed uncertain on Monday as the Supreme Court ordered the Centre to wait for its nod while the authorities re-examined the cases under the new regulatory regime. Making it clear that...', 'disp' => '<div align="justify">-The Indian Express</div><p align="justify"><br />The fate of 157 government-approved global clinical trials seemed uncertain on Monday as the Supreme Court ordered the Centre to wait for its nod while the authorities re-examined the cases under the new regulatory regime.</p><p align="justify">Making it clear that clinical trials being conducted in India must be done for the benefit of the people here, a bench of Justices R M Lodha and S K Singh directed the government to put the trials through the new stringent three-tier test.</p><p align="justify">The Indian Express had reported that of the 162 approvals granted by the Drug Controller General of India until August 31 this year, 157 trials were cleared in 2012, after a nod from just the New Drug Advisory Committees (NDACs). They escaped the new regulatory regime - a three-tier test involving the NDACs, technical committee and apex committee - which was put in place following the SC's order in January.</p><p align="justify">Between January 1and August 31 this year, only five trials were cleared under the new three-tier test.</p><p align="justify">After Additional Solicitor General Sidharth Luthra admitted that 157 trials were not evaluated by the technical and apex committees, the bench asked him to get it done, and submit the reports to the court by December 16.</p><p align="justify">&quot;The committees shall keep in view all the relevant aspects of clinical trials and efficacy data, particularly in terms of assessment of risk vs benefits to patients, innovation vis-a-vis existing therapeutic options, and medical needs of the country,&quot; it said.</p><p align="justify">The bench said it would not pass any order on carrying out these 157 trials until it was satisfied that the safety of the subjects was not being jeopardised, and that the trials would benefit India.</p><p align="justify">On the remaining five trials, the bench said they could be proceeded with, but only after &quot;proper framework is in place concerning audio-video recording for informed consent of the subjects and presentation of requisite documents while simultaneously adhering to the principle of confidentiality&quot;.</p><p align="justify">The court said the contention that investigators, who inquire into cases of adverse events during and after trials, were hired by the pharmaceutical companies and were paid by them, was an &quot;area of concern&quot;.</p><p align="justify">&quot;If investigators are paid by the companies, there is likelihood that serious adverse events will not be duly reported. 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Let there be a panel of independent investigators who can be paid by the government and the list of such persons can be updated periodically,&quot; it said. </p>', 'credit_writer' => 'The Indian Express, 22 October, 2013, http://www.indianexpress.com/news/supreme-court-blocks-157-clinical-trials-says-must-follow-new-regime/1185664/0', 'article_img' => '', 'article_img_thumb' => '', 'status' => (int) 1, 'show_on_home' => (int) 1, 'lang' => 'EN', 'category_id' => (int) 16, 'tag_keyword' => '', 'seo_url' => 'supreme-court-blocks-157-clinical-trials-says-must-follow-new-regime-utkarsh-anand-23087', 'meta_title' => null, 'meta_keywords' => null, 'meta_description' => null, 'noindex' => (int) 0, 'publish_date' => object(Cake\I18n\FrozenDate) {}, 'most_visit_section_id' => null, 'article_big_img' => null, 'liveid' => (int) 23087, 'created' => object(Cake\I18n\FrozenTime) {}, 'modified' => object(Cake\I18n\FrozenTime) {}, 'edate' => '', 'tags' => [ (int) 0 => object(Cake\ORM\Entity) {}, (int) 1 => object(Cake\ORM\Entity) {}, (int) 2 => object(Cake\ORM\Entity) {}, (int) 3 => object(Cake\ORM\Entity) {} ], 'category' => object(App\Model\Entity\Category) {}, '[new]' => false, '[accessible]' => [ '*' => true, 'id' => false ], '[dirty]' => [], '[original]' => [], '[virtual]' => [], '[hasErrors]' => false, '[errors]' => [], '[invalid]' => [], '[repository]' => 'Articles' } $articleid = (int) 22929 $metaTitle = 'LATEST NEWS UPDATES | Supreme Court blocks 157 clinical trials, says must follow new regime -Utkarsh Anand' $metaKeywords = 'Clinical Trials,Health,Law and Justice,medicines' $metaDesc = ' -The Indian Express The fate of 157 government-approved global clinical trials seemed uncertain on Monday as the Supreme Court ordered the Centre to wait for its nod while the authorities re-examined the cases under the new regulatory regime. Making it clear that...' $disp = '<div align="justify">-The Indian Express</div><p align="justify"><br />The fate of 157 government-approved global clinical trials seemed uncertain on Monday as the Supreme Court ordered the Centre to wait for its nod while the authorities re-examined the cases under the new regulatory regime.</p><p align="justify">Making it clear that clinical trials being conducted in India must be done for the benefit of the people here, a bench of Justices R M Lodha and S K Singh directed the government to put the trials through the new stringent three-tier test.</p><p align="justify">The Indian Express had reported that of the 162 approvals granted by the Drug Controller General of India until August 31 this year, 157 trials were cleared in 2012, after a nod from just the New Drug Advisory Committees (NDACs). They escaped the new regulatory regime - a three-tier test involving the NDACs, technical committee and apex committee - which was put in place following the SC's order in January.</p><p align="justify">Between January 1and August 31 this year, only five trials were cleared under the new three-tier test.</p><p align="justify">After Additional Solicitor General Sidharth Luthra admitted that 157 trials were not evaluated by the technical and apex committees, the bench asked him to get it done, and submit the reports to the court by December 16.</p><p align="justify">&quot;The committees shall keep in view all the relevant aspects of clinical trials and efficacy data, particularly in terms of assessment of risk vs benefits to patients, innovation vis-a-vis existing therapeutic options, and medical needs of the country,&quot; it said.</p><p align="justify">The bench said it would not pass any order on carrying out these 157 trials until it was satisfied that the safety of the subjects was not being jeopardised, and that the trials would benefit India.</p><p align="justify">On the remaining five trials, the bench said they could be proceeded with, but only after &quot;proper framework is in place concerning audio-video recording for informed consent of the subjects and presentation of requisite documents while simultaneously adhering to the principle of confidentiality&quot;.</p><p align="justify">The court said the contention that investigators, who inquire into cases of adverse events during and after trials, were hired by the pharmaceutical companies and were paid by them, was an &quot;area of concern&quot;.</p><p align="justify">&quot;If investigators are paid by the companies, there is likelihood that serious adverse events will not be duly reported. Let there be a panel of independent investigators who can be paid by the government and the list of such persons can be updated periodically,&quot; it said. </p>' $lang = 'English' $SITE_URL = 'https://im4change.in/' $site_title = 'im4change' $adminprix = 'admin'</pre><pre class="stack-trace">include - APP/Template/Layout/printlayout.ctp, line 8 Cake\View\View::_evaluate() - CORE/src/View/View.php, line 1413 Cake\View\View::_render() - CORE/src/View/View.php, line 1374 Cake\View\View::renderLayout() - CORE/src/View/View.php, line 927 Cake\View\View::render() - CORE/src/View/View.php, line 885 Cake\Controller\Controller::render() - CORE/src/Controller/Controller.php, line 791 Cake\Http\ActionDispatcher::_invoke() - CORE/src/Http/ActionDispatcher.php, line 126 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 88 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</pre></div></pre>latest-news-updates/supreme-court-blocks-157-clinical-trials-says-must-follow-new-regime-utkarsh-anand-23087.html"/> <meta http-equiv="Content-Type" content="text/html; charset=utf-8"/> <link href="https://im4change.in/css/control.css" rel="stylesheet" type="text/css" media="all"/> <title>LATEST NEWS UPDATES | Supreme Court blocks 157 clinical trials, says must follow new regime -Utkarsh Anand | Im4change.org</title> <meta name="description" content=" -The Indian Express The fate of 157 government-approved global clinical trials seemed uncertain on Monday as the Supreme Court ordered the Centre to wait for its nod while the authorities re-examined the cases under the new regulatory regime. Making it clear that..."/> <script src="https://im4change.in/js/jquery-1.10.2.js"></script> <script type="text/javascript" src="https://im4change.in/js/jquery-migrate.min.js"></script> <script language="javascript" type="text/javascript"> $(document).ready(function () { var img = $("img")[0]; // Get my img elem var pic_real_width, pic_real_height; $("<img/>") // Make in memory copy of image to avoid css issues .attr("src", $(img).attr("src")) .load(function () { pic_real_width = this.width; // Note: $(this).width() will not pic_real_height = this.height; // work for in memory images. }); }); </script> <style type="text/css"> @media screen { div.divFooter { display: block; } } @media print { .printbutton { display: none !important; } } </style> </head> <body> <table cellpadding="0" cellspacing="0" border="0" width="98%" align="center"> <tr> <td class="top_bg"> <div class="divFooter"> <img src="https://im4change.in/images/logo1.jpg" height="59" border="0" alt="Resource centre on India's rural distress" style="padding-top:14px;"/> </div> </td> </tr> <tr> <td id="topspace"> </td> </tr> <tr id="topspace"> <td> </td> </tr> <tr> <td height="50" style="border-bottom:1px solid #000; padding-top:10px;" class="printbutton"> <form><input type="button" value=" Print this page " onclick="window.print();return false;"/></form> </td> </tr> <tr> <td width="100%"> <h1 class="news_headlines" style="font-style:normal"> <strong>Supreme Court blocks 157 clinical trials, says must follow new regime -Utkarsh Anand</strong></h1> </td> </tr> <tr> <td width="100%" style="font-family:Arial, 'Segoe Script', 'Segoe UI', sans-serif, serif"><font size="3"> <div align="justify">-The Indian Express</div><p align="justify"><br />The fate of 157 government-approved global clinical trials seemed uncertain on Monday as the Supreme Court ordered the Centre to wait for its nod while the authorities re-examined the cases under the new regulatory regime.</p><p align="justify">Making it clear that clinical trials being conducted in India must be done for the benefit of the people here, a bench of Justices R M Lodha and S K Singh directed the government to put the trials through the new stringent three-tier test.</p><p align="justify">The Indian Express had reported that of the 162 approvals granted by the Drug Controller General of India until August 31 this year, 157 trials were cleared in 2012, after a nod from just the New Drug Advisory Committees (NDACs). They escaped the new regulatory regime - a three-tier test involving the NDACs, technical committee and apex committee - which was put in place following the SC's order in January.</p><p align="justify">Between January 1and August 31 this year, only five trials were cleared under the new three-tier test.</p><p align="justify">After Additional Solicitor General Sidharth Luthra admitted that 157 trials were not evaluated by the technical and apex committees, the bench asked him to get it done, and submit the reports to the court by December 16.</p><p align="justify">"The committees shall keep in view all the relevant aspects of clinical trials and efficacy data, particularly in terms of assessment of risk vs benefits to patients, innovation vis-a-vis existing therapeutic options, and medical needs of the country," it said.</p><p align="justify">The bench said it would not pass any order on carrying out these 157 trials until it was satisfied that the safety of the subjects was not being jeopardised, and that the trials would benefit India.</p><p align="justify">On the remaining five trials, the bench said they could be proceeded with, but only after "proper framework is in place concerning audio-video recording for informed consent of the subjects and presentation of requisite documents while simultaneously adhering to the principle of confidentiality".</p><p align="justify">The court said the contention that investigators, who inquire into cases of adverse events during and after trials, were hired by the pharmaceutical companies and were paid by them, was an "area of concern".</p><p align="justify">"If investigators are paid by the companies, there is likelihood that serious adverse events will not be duly reported. Let there be a panel of independent investigators who can be paid by the government and the list of such persons can be updated periodically," it said. </p> </font> </td> </tr> <tr> <td> </td> </tr> <tr> <td height="50" style="border-top:1px solid #000; border-bottom:1px solid #000;padding-top:10px;"> <form><input type="button" value=" Print this page " onclick="window.print();return false;"/></form> </td> </tr> </table></body> </html>' } $maxBufferLength = (int) 8192 $file = '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Debugger.php' $line = (int) 853 $message = 'Unable to emit headers. Headers sent in file=/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Debugger.php line=853'Cake\Http\ResponseEmitter::emit() - CORE/src/Http/ResponseEmitter.php, line 48 Cake\Http\Server::emit() - CORE/src/Http/Server.php, line 141 [main] - ROOT/webroot/index.php, line 39
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'' : 'none')">Context</a><pre id="cakeErr67f33bdfdb67b-code" class="cake-code-dump" style="display: none;"><code><span style="color: #000000"><span style="color: #0000BB"></span><span style="color: #007700"><</span><span style="color: #0000BB">head</span><span style="color: #007700">> </span></span></code> <span class="code-highlight"><code><span style="color: #000000"> <link rel="canonical" href="<span style="color: #0000BB"><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">Configure</span><span style="color: #007700">::</span><span style="color: #0000BB">read</span><span style="color: #007700">(</span><span style="color: #DD0000">'SITE_URL'</span><span style="color: #007700">); </span><span style="color: #0000BB">?><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">$urlPrefix</span><span style="color: #007700">;</span><span style="color: #0000BB">?><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">$article_current</span><span style="color: #007700">-></span><span style="color: #0000BB">category</span><span style="color: #007700">-></span><span style="color: #0000BB">slug</span><span style="color: #007700">; </span><span style="color: #0000BB">?></span>/<span style="color: #0000BB"><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">$article_current</span><span style="color: #007700">-></span><span style="color: #0000BB">seo_url</span><span style="color: #007700">; </span><span style="color: #0000BB">?></span>.html"/> </span></code></span> <code><span style="color: #000000"><span style="color: #0000BB"> </span><span style="color: #007700"><</span><span style="color: #0000BB">meta http</span><span style="color: #007700">-</span><span style="color: #0000BB">equiv</span><span style="color: #007700">=</span><span style="color: #DD0000">"Content-Type" </span><span style="color: #0000BB">content</span><span style="color: #007700">=</span><span style="color: #DD0000">"text/html; charset=utf-8"</span><span style="color: #007700">/> </span></span></code></pre><pre id="cakeErr67f33bdfdb67b-context" class="cake-context" style="display: none;">$viewFile = '/home/brlfuser/public_html/src/Template/Layout/printlayout.ctp' $dataForView = [ 'article_current' => object(App\Model\Entity\Article) { 'id' => (int) 22929, 'title' => 'Supreme Court blocks 157 clinical trials, says must follow new regime -Utkarsh Anand', 'subheading' => '', 'description' => '<div align="justify"> -The Indian Express </div> <p align="justify"> <br /> The fate of 157 government-approved global clinical trials seemed uncertain on Monday as the Supreme Court ordered the Centre to wait for its nod while the authorities re-examined the cases under the new regulatory regime. </p> <p align="justify"> Making it clear that clinical trials being conducted in India must be done for the benefit of the people here, a bench of Justices R M Lodha and S K Singh directed the government to put the trials through the new stringent three-tier test. </p> <p align="justify"> The Indian Express had reported that of the 162 approvals granted by the Drug Controller General of India until August 31 this year, 157 trials were cleared in 2012, after a nod from just the New Drug Advisory Committees (NDACs). 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Making it clear that..."/> <script src="https://im4change.in/js/jquery-1.10.2.js"></script> <script type="text/javascript" src="https://im4change.in/js/jquery-migrate.min.js"></script> <script language="javascript" type="text/javascript"> $(document).ready(function () { var img = $("img")[0]; // Get my img elem var pic_real_width, pic_real_height; $("<img/>") // Make in memory copy of image to avoid css issues .attr("src", $(img).attr("src")) .load(function () { pic_real_width = this.width; // Note: $(this).width() will not pic_real_height = this.height; // work for in memory images. }); }); </script> <style type="text/css"> @media screen { div.divFooter { display: block; } } @media print { .printbutton { display: none !important; } } </style> </head> <body> <table cellpadding="0" cellspacing="0" border="0" width="98%" align="center"> <tr> <td class="top_bg"> <div class="divFooter"> <img src="https://im4change.in/images/logo1.jpg" height="59" border="0" alt="Resource centre on India's rural distress" style="padding-top:14px;"/> </div> </td> </tr> <tr> <td id="topspace"> </td> </tr> <tr id="topspace"> <td> </td> </tr> <tr> <td height="50" style="border-bottom:1px solid #000; padding-top:10px;" class="printbutton"> <form><input type="button" value=" Print this page " onclick="window.print();return false;"/></form> </td> </tr> <tr> <td width="100%"> <h1 class="news_headlines" style="font-style:normal"> <strong>Supreme Court blocks 157 clinical trials, says must follow new regime -Utkarsh Anand</strong></h1> </td> </tr> <tr> <td width="100%" style="font-family:Arial, 'Segoe Script', 'Segoe UI', sans-serif, serif"><font size="3"> <div align="justify">-The Indian Express</div><p align="justify"><br />The fate of 157 government-approved global clinical trials seemed uncertain on Monday as the Supreme Court ordered the Centre to wait for its nod while the authorities re-examined the cases under the new regulatory regime.</p><p align="justify">Making it clear that clinical trials being conducted in India must be done for the benefit of the people here, a bench of Justices R M Lodha and S K Singh directed the government to put the trials through the new stringent three-tier test.</p><p align="justify">The Indian Express had reported that of the 162 approvals granted by the Drug Controller General of India until August 31 this year, 157 trials were cleared in 2012, after a nod from just the New Drug Advisory Committees (NDACs). They escaped the new regulatory regime - a three-tier test involving the NDACs, technical committee and apex committee - which was put in place following the SC's order in January.</p><p align="justify">Between January 1and August 31 this year, only five trials were cleared under the new three-tier test.</p><p align="justify">After Additional Solicitor General Sidharth Luthra admitted that 157 trials were not evaluated by the technical and apex committees, the bench asked him to get it done, and submit the reports to the court by December 16.</p><p align="justify">"The committees shall keep in view all the relevant aspects of clinical trials and efficacy data, particularly in terms of assessment of risk vs benefits to patients, innovation vis-a-vis existing therapeutic options, and medical needs of the country," it said.</p><p align="justify">The bench said it would not pass any order on carrying out these 157 trials until it was satisfied that the safety of the subjects was not being jeopardised, and that the trials would benefit India.</p><p align="justify">On the remaining five trials, the bench said they could be proceeded with, but only after "proper framework is in place concerning audio-video recording for informed consent of the subjects and presentation of requisite documents while simultaneously adhering to the principle of confidentiality".</p><p align="justify">The court said the contention that investigators, who inquire into cases of adverse events during and after trials, were hired by the pharmaceutical companies and were paid by them, was an "area of concern".</p><p align="justify">"If investigators are paid by the companies, there is likelihood that serious adverse events will not be duly reported. Let there be a panel of independent investigators who can be paid by the government and the list of such persons can be updated periodically," it said. </p> </font> </td> </tr> <tr> <td> </td> </tr> <tr> <td height="50" style="border-top:1px solid #000; border-bottom:1px solid #000;padding-top:10px;"> <form><input type="button" value=" Print this page " onclick="window.print();return false;"/></form> </td> </tr> </table></body> </html>' } $reasonPhrase = 'OK'header - [internal], line ?? Cake\Http\ResponseEmitter::emitStatusLine() - CORE/src/Http/ResponseEmitter.php, line 148 Cake\Http\ResponseEmitter::emit() - CORE/src/Http/ResponseEmitter.php, line 54 Cake\Http\Server::emit() - CORE/src/Http/Server.php, line 141 [main] - ROOT/webroot/index.php, line 39
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They escaped the new regulatory regime - a three-tier test involving the NDACs, technical committee and apex committee - which was put in place following the SC's order in January.</p><p align="justify">Between January 1and August 31 this year, only five trials were cleared under the new three-tier test.</p><p align="justify">After Additional Solicitor General Sidharth Luthra admitted that 157 trials were not evaluated by the technical and apex committees, the bench asked him to get it done, and submit the reports to the court by December 16.</p><p align="justify">"The committees shall keep in view all the relevant aspects of clinical trials and efficacy data, particularly in terms of assessment of risk vs benefits to patients, innovation vis-a-vis existing therapeutic options, and medical needs of the country," it said.</p><p align="justify">The bench said it would not pass any order on carrying out these 157 trials until it was satisfied that the safety of the subjects was not being jeopardised, and that the trials would benefit India.</p><p align="justify">On the remaining five trials, the bench said they could be proceeded with, but only after "proper framework is in place concerning audio-video recording for informed consent of the subjects and presentation of requisite documents while simultaneously adhering to the principle of confidentiality".</p><p align="justify">The court said the contention that investigators, who inquire into cases of adverse events during and after trials, were hired by the pharmaceutical companies and were paid by them, was an "area of concern".</p><p align="justify">"If investigators are paid by the companies, there is likelihood that serious adverse events will not be duly reported. Let there be a panel of independent investigators who can be paid by the government and the list of such persons can be updated periodically," it said. </p> </font> </td> </tr> <tr> <td> </td> </tr> <tr> <td height="50" style="border-top:1px solid #000; border-bottom:1px solid #000;padding-top:10px;"> <form><input type="button" value=" Print this page " onclick="window.print();return false;"/></form> </td> </tr> </table></body> </html>' } $cookies = [] $values = [ (int) 0 => 'text/html; charset=UTF-8' ] $name = 'Content-Type' $first = true $value = 'text/html; charset=UTF-8'header - [internal], line ?? Cake\Http\ResponseEmitter::emitHeaders() - CORE/src/Http/ResponseEmitter.php, line 181 Cake\Http\ResponseEmitter::emit() - CORE/src/Http/ResponseEmitter.php, line 55 Cake\Http\Server::emit() - CORE/src/Http/Server.php, line 141 [main] - ROOT/webroot/index.php, line 39
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Supreme Court blocks 157 clinical trials, says must follow new regime -Utkarsh Anand |
-The Indian Express
Making it clear that clinical trials being conducted in India must be done for the benefit of the people here, a bench of Justices R M Lodha and S K Singh directed the government to put the trials through the new stringent three-tier test. The Indian Express had reported that of the 162 approvals granted by the Drug Controller General of India until August 31 this year, 157 trials were cleared in 2012, after a nod from just the New Drug Advisory Committees (NDACs). They escaped the new regulatory regime - a three-tier test involving the NDACs, technical committee and apex committee - which was put in place following the SC's order in January. Between January 1and August 31 this year, only five trials were cleared under the new three-tier test. After Additional Solicitor General Sidharth Luthra admitted that 157 trials were not evaluated by the technical and apex committees, the bench asked him to get it done, and submit the reports to the court by December 16. "The committees shall keep in view all the relevant aspects of clinical trials and efficacy data, particularly in terms of assessment of risk vs benefits to patients, innovation vis-a-vis existing therapeutic options, and medical needs of the country," it said. The bench said it would not pass any order on carrying out these 157 trials until it was satisfied that the safety of the subjects was not being jeopardised, and that the trials would benefit India. On the remaining five trials, the bench said they could be proceeded with, but only after "proper framework is in place concerning audio-video recording for informed consent of the subjects and presentation of requisite documents while simultaneously adhering to the principle of confidentiality". The court said the contention that investigators, who inquire into cases of adverse events during and after trials, were hired by the pharmaceutical companies and were paid by them, was an "area of concern". "If investigators are paid by the companies, there is likelihood that serious adverse events will not be duly reported. Let there be a panel of independent investigators who can be paid by the government and the list of such persons can be updated periodically," it said. |