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/hit-by-red-tape-clinical-trial-companies-eye-south-east-asia-for-expansion-divya-rajagopal-15652/print' [protected] base => '' [protected] webroot => '/' [protected] here => '/latest-news-updates/hit-by-red-tape-clinical-trial-companies-eye-south-east-asia-for-expansion-divya-rajagopal-15652/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/hit-by-red-tape-clinical-trial-companies-eye-south-east-asia-for-expansion-divya-rajagopal-15652/print' [protected] base => '' [protected] webroot => '/' [protected] here => '/latest-news-updates/hit-by-red-tape-clinical-trial-companies-eye-south-east-asia-for-expansion-divya-rajagopal-15652/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('cakeErr6824456cea179-trace').style.display = (document.getElementById('cakeErr6824456cea179-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="cakeErr6824456cea179-trace" class="cake-stack-trace" style="display: none;"><a href="javascript:void(0);" onclick="document.getElementById('cakeErr6824456cea179-code').style.display = (document.getElementById('cakeErr6824456cea179-code').style.display == 'none' ? '' : 'none')">Code</a> <a href="javascript:void(0);" onclick="document.getElementById('cakeErr6824456cea179-context').style.display = (document.getElementById('cakeErr6824456cea179-context').style.display == 'none' ? '' : 'none')">Context</a><pre id="cakeErr6824456cea179-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="cakeErr6824456cea179-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) 15525, 'title' => 'Hit by red tape, clinical trial companies eye South-East Asia for expansion-Divya Rajagopal', 'subheading' => '', 'description' => '<div style="text-align: justify"> -The Economic Times </div> <div style="text-align: justify"> &nbsp; </div> <div style="text-align: justify"> Pushed to the wall by an overly cautious drug regulator and an alarmist Indian government, clinical trial companies are looking at South East Asian countries to expand their business and escape the red tape of Indian authorities.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Clinical research companies (CROs), that were aspiring to become billion- dollar companies by 2010, had to rework their plans after a Parliamentary Standing Committee report questioned the allegedly unfair and unethical trials conducted on Indian patients .&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> In the past one year, approvals for trials have dropped significantly after companies realised that it would be difficult to operate in India. But eager governments in other South Asian countries are opening their doors to these companies and inviting them to set up shop.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> CRO officials say that countries such as Cambodia, Vietnam, Bangkok and Thailand are much more conducive for doing clinical trials.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> &quot;South East Asia is a big hub, there is adequate patient population , the disease profile is similar to India and the governments are responsive towards pharma companies ,&quot; said RK Shanghavi, a pharma consultant based in Mumbai .&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Cost is another big factor. In India, doctors charge anywhere between Rs 10,000 and Rs 2 lakh per patient for conducting a clinical trial, while in Cambodia it is Rs 10,000 per doctor, says Shanghavi.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Last month, Ahmedabad-based Lambda Research Labs opened its first centre in Thailand after a request by the Thai government. It has tied up with Government Pharmaceutical Organisation, a state-run pharma company, to set up a clinical trial unit and train its workforce.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> &quot;Indian drug makers want to launch their products in a country like Bangkok, and hence their government wants the trial to be conducted in their own country,&quot; said Kiran Marthak of Lambda.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> In India, the Drugs Controller General of India (DGCI) has become defunct after the health ministry decided to set up the New Drug Advisory Committee (NDAC) with the responsibility for giving approvals for drug trials.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> But CROs say the new body has virtually stopped giving approvals. In 2011, only 98 drugs were approved compared with 224 in 2010.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> So far in 2012, the number of approvals is nine. The government started delaying approvals after a series of reports erupted on botched up drug trails by CRO's , which raised ethical concerns. Organisations came under probe for allegedly carrying out drug trails without the appropriate consent of patients.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Some organisations faced a ban and the drug controller was also severely criticised for issuing licenses to such organisations . The matter reached Parliament where questions were raised about the health ministry's role in protecting trial patients. These incidents rattled the health ministry.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> The drug controller went into a damage control mode and ordered the CROs to compensate those who were affected by the trials, but it could not be implemented because there was no proper regulation in place. Things have got worse since with the Parliamentary Standing Committee report revealing the failures of the system in sharp relief.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> &quot;The Committee is of the firm opinion that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO, the Central Drug Standard Control Organisation.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> For decades together it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder -- the consumer -- has never been ensured,&quot; the parliamentary report said &quot;Our topline is suffering. We have about 30% revenue erosion because our approvals are stuck, and though in countries like Singapore and Korea the cost of doing business are 40% upwards of India, regulation wise it is still a very easy market,&quot; said Nidhi Saxena, founder, Karmic Life sciences.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Karmic is making Singapore as its base to expand in other Asian regions. Drug makers say the flight of CROs is bad news for patients and the future of R&amp;D in India.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> &quot;Science is much more complicated than simple and the regulators should understand that,&quot; says Swati Piramal, director Piramal Healthcare Limited. &quot;There is complete paralysis of regulation, and we cannot have policy that takes us backwards, a good industry needs a good regulation,&quot; she added. </div>', 'credit_writer' => 'The Economic Times, 13 June, 2012, http://economictimes.indiatimes.com/news/news-by-industry/healthcare/biotech/healthcare/hit-by-red-tape-clinical-trial-companies-eye-south-east-asia-for-expansion/ar', 'article_img' => '', 'article_img_thumb' => '', 'status' => (int) 1, 'show_on_home' => (int) 1, 'lang' => 'EN', 'category_id' => (int) 16, 'tag_keyword' => '', 'seo_url' => 'hit-by-red-tape-clinical-trial-companies-eye-south-east-asia-for-expansion-divya-rajagopal-15652', '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) 15652, '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) 15525, 'metaTitle' => 'LATEST NEWS UPDATES | Hit by red tape, clinical trial companies eye South-East Asia for expansion-Divya Rajagopal', 'metaKeywords' => 'Health,Law and Justice,medicines', 'metaDesc' => ' -The Economic Times &nbsp; Pushed to the wall by an overly cautious drug regulator and an alarmist Indian government, clinical trial companies are looking at South East Asian countries to expand their business and escape the red tape of Indian authorities.&nbsp; Clinical research...', 'disp' => '<div style="text-align: justify">-The Economic Times</div><div style="text-align: justify">&nbsp;</div><div style="text-align: justify">Pushed to the wall by an overly cautious drug regulator and an alarmist Indian government, clinical trial companies are looking at South East Asian countries to expand their business and escape the red tape of Indian authorities.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Clinical research companies (CROs), that were aspiring to become billion- dollar companies by 2010, had to rework their plans after a Parliamentary Standing Committee report questioned the allegedly unfair and unethical trials conducted on Indian patients .&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">In the past one year, approvals for trials have dropped significantly after companies realised that it would be difficult to operate in India. But eager governments in other South Asian countries are opening their doors to these companies and inviting them to set up shop.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">CRO officials say that countries such as Cambodia, Vietnam, Bangkok and Thailand are much more conducive for doing clinical trials.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&quot;South East Asia is a big hub, there is adequate patient population , the disease profile is similar to India and the governments are responsive towards pharma companies ,&quot; said RK Shanghavi, a pharma consultant based in Mumbai .&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Cost is another big factor. In India, doctors charge anywhere between Rs 10,000 and Rs 2 lakh per patient for conducting a clinical trial, while in Cambodia it is Rs 10,000 per doctor, says Shanghavi.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Last month, Ahmedabad-based Lambda Research Labs opened its first centre in Thailand after a request by the Thai government. It has tied up with Government Pharmaceutical Organisation, a state-run pharma company, to set up a clinical trial unit and train its workforce.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&quot;Indian drug makers want to launch their products in a country like Bangkok, and hence their government wants the trial to be conducted in their own country,&quot; said Kiran Marthak of Lambda.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">In India, the Drugs Controller General of India (DGCI) has become defunct after the health ministry decided to set up the New Drug Advisory Committee (NDAC) with the responsibility for giving approvals for drug trials.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">But CROs say the new body has virtually stopped giving approvals. In 2011, only 98 drugs were approved compared with 224 in 2010.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">So far in 2012, the number of approvals is nine. The government started delaying approvals after a series of reports erupted on botched up drug trails by CRO's , which raised ethical concerns. Organisations came under probe for allegedly carrying out drug trails without the appropriate consent of patients.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Some organisations faced a ban and the drug controller was also severely criticised for issuing licenses to such organisations . The matter reached Parliament where questions were raised about the health ministry's role in protecting trial patients. These incidents rattled the health ministry.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">The drug controller went into a damage control mode and ordered the CROs to compensate those who were affected by the trials, but it could not be implemented because there was no proper regulation in place. Things have got worse since with the Parliamentary Standing Committee report revealing the failures of the system in sharp relief.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&quot;The Committee is of the firm opinion that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO, the Central Drug Standard Control Organisation.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">For decades together it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder -- the consumer -- has never been ensured,&quot; the parliamentary report said &quot;Our topline is suffering. We have about 30% revenue erosion because our approvals are stuck, and though in countries like Singapore and Korea the cost of doing business are 40% upwards of India, regulation wise it is still a very easy market,&quot; said Nidhi Saxena, founder, Karmic Life sciences.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Karmic is making Singapore as its base to expand in other Asian regions. Drug makers say the flight of CROs is bad news for patients and the future of R&amp;D in India.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&quot;Science is much more complicated than simple and the regulators should understand that,&quot; says Swati Piramal, director Piramal Healthcare Limited. &quot;There is complete paralysis of regulation, and we cannot have policy that takes us backwards, a good industry needs a good regulation,&quot; she added.</div>', 'lang' => 'English', 'SITE_URL' => 'https://im4change.in/', 'site_title' => 'im4change', 'adminprix' => 'admin' ] $article_current = object(App\Model\Entity\Article) { 'id' => (int) 15525, 'title' => 'Hit by red tape, clinical trial companies eye South-East Asia for expansion-Divya Rajagopal', 'subheading' => '', 'description' => '<div style="text-align: justify"> -The Economic Times </div> <div style="text-align: justify"> &nbsp; </div> <div style="text-align: justify"> Pushed to the wall by an overly cautious drug regulator and an alarmist Indian government, clinical trial companies are looking at South East Asian countries to expand their business and escape the red tape of Indian authorities.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Clinical research companies (CROs), that were aspiring to become billion- dollar companies by 2010, had to rework their plans after a Parliamentary Standing Committee report questioned the allegedly unfair and unethical trials conducted on Indian patients .&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> In the past one year, approvals for trials have dropped significantly after companies realised that it would be difficult to operate in India. But eager governments in other South Asian countries are opening their doors to these companies and inviting them to set up shop.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> CRO officials say that countries such as Cambodia, Vietnam, Bangkok and Thailand are much more conducive for doing clinical trials.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> &quot;South East Asia is a big hub, there is adequate patient population , the disease profile is similar to India and the governments are responsive towards pharma companies ,&quot; said RK Shanghavi, a pharma consultant based in Mumbai .&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Cost is another big factor. In India, doctors charge anywhere between Rs 10,000 and Rs 2 lakh per patient for conducting a clinical trial, while in Cambodia it is Rs 10,000 per doctor, says Shanghavi.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Last month, Ahmedabad-based Lambda Research Labs opened its first centre in Thailand after a request by the Thai government. It has tied up with Government Pharmaceutical Organisation, a state-run pharma company, to set up a clinical trial unit and train its workforce.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> &quot;Indian drug makers want to launch their products in a country like Bangkok, and hence their government wants the trial to be conducted in their own country,&quot; said Kiran Marthak of Lambda.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> In India, the Drugs Controller General of India (DGCI) has become defunct after the health ministry decided to set up the New Drug Advisory Committee (NDAC) with the responsibility for giving approvals for drug trials.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> But CROs say the new body has virtually stopped giving approvals. In 2011, only 98 drugs were approved compared with 224 in 2010.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> So far in 2012, the number of approvals is nine. The government started delaying approvals after a series of reports erupted on botched up drug trails by CRO's , which raised ethical concerns. Organisations came under probe for allegedly carrying out drug trails without the appropriate consent of patients.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Some organisations faced a ban and the drug controller was also severely criticised for issuing licenses to such organisations . The matter reached Parliament where questions were raised about the health ministry's role in protecting trial patients. These incidents rattled the health ministry.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> The drug controller went into a damage control mode and ordered the CROs to compensate those who were affected by the trials, but it could not be implemented because there was no proper regulation in place. Things have got worse since with the Parliamentary Standing Committee report revealing the failures of the system in sharp relief.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> &quot;The Committee is of the firm opinion that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO, the Central Drug Standard Control Organisation.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> For decades together it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder -- the consumer -- has never been ensured,&quot; the parliamentary report said &quot;Our topline is suffering. We have about 30% revenue erosion because our approvals are stuck, and though in countries like Singapore and Korea the cost of doing business are 40% upwards of India, regulation wise it is still a very easy market,&quot; said Nidhi Saxena, founder, Karmic Life sciences.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Karmic is making Singapore as its base to expand in other Asian regions. Drug makers say the flight of CROs is bad news for patients and the future of R&amp;D in India.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> &quot;Science is much more complicated than simple and the regulators should understand that,&quot; says Swati Piramal, director Piramal Healthcare Limited. &quot;There is complete paralysis of regulation, and we cannot have policy that takes us backwards, a good industry needs a good regulation,&quot; she added. </div>', 'credit_writer' => 'The Economic Times, 13 June, 2012, http://economictimes.indiatimes.com/news/news-by-industry/healthcare/biotech/healthcare/hit-by-red-tape-clinical-trial-companies-eye-south-east-asia-for-expansion/ar', 'article_img' => '', 'article_img_thumb' => '', 'status' => (int) 1, 'show_on_home' => (int) 1, 'lang' => 'EN', 'category_id' => (int) 16, 'tag_keyword' => '', 'seo_url' => 'hit-by-red-tape-clinical-trial-companies-eye-south-east-asia-for-expansion-divya-rajagopal-15652', '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) 15652, '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) {} ], 'category' => object(App\Model\Entity\Category) {}, '[new]' => false, '[accessible]' => [ '*' => true, 'id' => false ], '[dirty]' => [], '[original]' => [], '[virtual]' => [], '[hasErrors]' => false, '[errors]' => [], '[invalid]' => [], '[repository]' => 'Articles' } $articleid = (int) 15525 $metaTitle = 'LATEST NEWS UPDATES | Hit by red tape, clinical trial companies eye South-East Asia for expansion-Divya Rajagopal' $metaKeywords = 'Health,Law and Justice,medicines' $metaDesc = ' -The Economic Times &nbsp; Pushed to the wall by an overly cautious drug regulator and an alarmist Indian government, clinical trial companies are looking at South East Asian countries to expand their business and escape the red tape of Indian authorities.&nbsp; Clinical research...' $disp = '<div style="text-align: justify">-The Economic Times</div><div style="text-align: justify">&nbsp;</div><div style="text-align: justify">Pushed to the wall by an overly cautious drug regulator and an alarmist Indian government, clinical trial companies are looking at South East Asian countries to expand their business and escape the red tape of Indian authorities.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Clinical research companies (CROs), that were aspiring to become billion- dollar companies by 2010, had to rework their plans after a Parliamentary Standing Committee report questioned the allegedly unfair and unethical trials conducted on Indian patients .&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">In the past one year, approvals for trials have dropped significantly after companies realised that it would be difficult to operate in India. But eager governments in other South Asian countries are opening their doors to these companies and inviting them to set up shop.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">CRO officials say that countries such as Cambodia, Vietnam, Bangkok and Thailand are much more conducive for doing clinical trials.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&quot;South East Asia is a big hub, there is adequate patient population , the disease profile is similar to India and the governments are responsive towards pharma companies ,&quot; said RK Shanghavi, a pharma consultant based in Mumbai .&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Cost is another big factor. In India, doctors charge anywhere between Rs 10,000 and Rs 2 lakh per patient for conducting a clinical trial, while in Cambodia it is Rs 10,000 per doctor, says Shanghavi.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Last month, Ahmedabad-based Lambda Research Labs opened its first centre in Thailand after a request by the Thai government. It has tied up with Government Pharmaceutical Organisation, a state-run pharma company, to set up a clinical trial unit and train its workforce.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&quot;Indian drug makers want to launch their products in a country like Bangkok, and hence their government wants the trial to be conducted in their own country,&quot; said Kiran Marthak of Lambda.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">In India, the Drugs Controller General of India (DGCI) has become defunct after the health ministry decided to set up the New Drug Advisory Committee (NDAC) with the responsibility for giving approvals for drug trials.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">But CROs say the new body has virtually stopped giving approvals. In 2011, only 98 drugs were approved compared with 224 in 2010.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">So far in 2012, the number of approvals is nine. The government started delaying approvals after a series of reports erupted on botched up drug trails by CRO's , which raised ethical concerns. Organisations came under probe for allegedly carrying out drug trails without the appropriate consent of patients.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Some organisations faced a ban and the drug controller was also severely criticised for issuing licenses to such organisations . The matter reached Parliament where questions were raised about the health ministry's role in protecting trial patients. These incidents rattled the health ministry.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">The drug controller went into a damage control mode and ordered the CROs to compensate those who were affected by the trials, but it could not be implemented because there was no proper regulation in place. Things have got worse since with the Parliamentary Standing Committee report revealing the failures of the system in sharp relief.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&quot;The Committee is of the firm opinion that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO, the Central Drug Standard Control Organisation.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">For decades together it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder -- the consumer -- has never been ensured,&quot; the parliamentary report said &quot;Our topline is suffering. We have about 30% revenue erosion because our approvals are stuck, and though in countries like Singapore and Korea the cost of doing business are 40% upwards of India, regulation wise it is still a very easy market,&quot; said Nidhi Saxena, founder, Karmic Life sciences.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Karmic is making Singapore as its base to expand in other Asian regions. Drug makers say the flight of CROs is bad news for patients and the future of R&amp;D in India.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&quot;Science is much more complicated than simple and the regulators should understand that,&quot; says Swati Piramal, director Piramal Healthcare Limited. &quot;There is complete paralysis of regulation, and we cannot have policy that takes us backwards, a good industry needs a good regulation,&quot; she added.</div>' $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/hit-by-red-tape-clinical-trial-companies-eye-south-east-asia-for-expansion-divya-rajagopal-15652.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 | Hit by red tape, clinical trial companies eye South-East Asia for expansion-Divya Rajagopal | Im4change.org</title> <meta name="description" content=" -The Economic Times Pushed to the wall by an overly cautious drug regulator and an alarmist Indian government, clinical trial companies are looking at South East Asian countries to expand their business and escape the red tape of Indian authorities. Clinical research..."/> <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>Hit by red tape, clinical trial companies eye South-East Asia for expansion-Divya Rajagopal</strong></h1> </td> </tr> <tr> <td width="100%" style="font-family:Arial, 'Segoe Script', 'Segoe UI', sans-serif, serif"><font size="3"> <div style="text-align: justify">-The Economic Times</div><div style="text-align: justify"> </div><div style="text-align: justify">Pushed to the wall by an overly cautious drug regulator and an alarmist Indian government, clinical trial companies are looking at South East Asian countries to expand their business and escape the red tape of Indian authorities. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">Clinical research companies (CROs), that were aspiring to become billion- dollar companies by 2010, had to rework their plans after a Parliamentary Standing Committee report questioned the allegedly unfair and unethical trials conducted on Indian patients . </div><div style="text-align: justify"><br /></div><div style="text-align: justify">In the past one year, approvals for trials have dropped significantly after companies realised that it would be difficult to operate in India. But eager governments in other South Asian countries are opening their doors to these companies and inviting them to set up shop. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">CRO officials say that countries such as Cambodia, Vietnam, Bangkok and Thailand are much more conducive for doing clinical trials. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">"South East Asia is a big hub, there is adequate patient population , the disease profile is similar to India and the governments are responsive towards pharma companies ," said RK Shanghavi, a pharma consultant based in Mumbai . </div><div style="text-align: justify"><br /></div><div style="text-align: justify">Cost is another big factor. In India, doctors charge anywhere between Rs 10,000 and Rs 2 lakh per patient for conducting a clinical trial, while in Cambodia it is Rs 10,000 per doctor, says Shanghavi. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">Last month, Ahmedabad-based Lambda Research Labs opened its first centre in Thailand after a request by the Thai government. It has tied up with Government Pharmaceutical Organisation, a state-run pharma company, to set up a clinical trial unit and train its workforce. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">"Indian drug makers want to launch their products in a country like Bangkok, and hence their government wants the trial to be conducted in their own country," said Kiran Marthak of Lambda. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">In India, the Drugs Controller General of India (DGCI) has become defunct after the health ministry decided to set up the New Drug Advisory Committee (NDAC) with the responsibility for giving approvals for drug trials. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">But CROs say the new body has virtually stopped giving approvals. In 2011, only 98 drugs were approved compared with 224 in 2010. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">So far in 2012, the number of approvals is nine. The government started delaying approvals after a series of reports erupted on botched up drug trails by CRO's , which raised ethical concerns. Organisations came under probe for allegedly carrying out drug trails without the appropriate consent of patients. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">Some organisations faced a ban and the drug controller was also severely criticised for issuing licenses to such organisations . The matter reached Parliament where questions were raised about the health ministry's role in protecting trial patients. These incidents rattled the health ministry. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">The drug controller went into a damage control mode and ordered the CROs to compensate those who were affected by the trials, but it could not be implemented because there was no proper regulation in place. Things have got worse since with the Parliamentary Standing Committee report revealing the failures of the system in sharp relief. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">"The Committee is of the firm opinion that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO, the Central Drug Standard Control Organisation. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">For decades together it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder -- the consumer -- has never been ensured," the parliamentary report said "Our topline is suffering. We have about 30% revenue erosion because our approvals are stuck, and though in countries like Singapore and Korea the cost of doing business are 40% upwards of India, regulation wise it is still a very easy market," said Nidhi Saxena, founder, Karmic Life sciences. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">Karmic is making Singapore as its base to expand in other Asian regions. Drug makers say the flight of CROs is bad news for patients and the future of R&D in India. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">"Science is much more complicated than simple and the regulators should understand that," says Swati Piramal, director Piramal Healthcare Limited. "There is complete paralysis of regulation, and we cannot have policy that takes us backwards, a good industry needs a good regulation," she added.</div> </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 $message = 'Unable to emit headers. Headers sent in file=/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Debugger.php line=853'Cake\Http\ResponseEmitter::emit() - CORE/src/Http/ResponseEmitter.php, line 48 Cake\Http\Server::emit() - CORE/src/Http/Server.php, line 141 [main] - ROOT/webroot/index.php, line 39
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'' : 'none');"><b>Notice</b> (8)</a>: Undefined variable: urlPrefix [<b>APP/Template/Layout/printlayout.ctp</b>, line <b>8</b>]<div id="cakeErr6824456cea179-trace" class="cake-stack-trace" style="display: none;"><a href="javascript:void(0);" onclick="document.getElementById('cakeErr6824456cea179-code').style.display = (document.getElementById('cakeErr6824456cea179-code').style.display == 'none' ? '' : 'none')">Code</a> <a href="javascript:void(0);" onclick="document.getElementById('cakeErr6824456cea179-context').style.display = (document.getElementById('cakeErr6824456cea179-context').style.display == 'none' ? '' : 'none')">Context</a><pre id="cakeErr6824456cea179-code" class="cake-code-dump" style="display: none;"><code><span style="color: #000000"><span style="color: #0000BB"></span><span style="color: #007700"><</span><span style="color: #0000BB">head</span><span style="color: #007700">> </span></span></code> <span class="code-highlight"><code><span style="color: #000000"> <link rel="canonical" href="<span style="color: #0000BB"><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">Configure</span><span style="color: #007700">::</span><span style="color: #0000BB">read</span><span style="color: #007700">(</span><span style="color: #DD0000">'SITE_URL'</span><span style="color: #007700">); </span><span style="color: #0000BB">?><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">$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="cakeErr6824456cea179-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) 15525, 'title' => 'Hit by red tape, clinical trial companies eye South-East Asia for expansion-Divya Rajagopal', 'subheading' => '', 'description' => '<div style="text-align: justify"> -The Economic Times </div> <div style="text-align: justify"> &nbsp; </div> <div style="text-align: justify"> Pushed to the wall by an overly cautious drug regulator and an alarmist Indian government, clinical trial companies are looking at South East Asian countries to expand their business and escape the red tape of Indian authorities.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Clinical research companies (CROs), that were aspiring to become billion- dollar companies by 2010, had to rework their plans after a Parliamentary Standing Committee report questioned the allegedly unfair and unethical trials conducted on Indian patients .&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> In the past one year, approvals for trials have dropped significantly after companies realised that it would be difficult to operate in India. But eager governments in other South Asian countries are opening their doors to these companies and inviting them to set up shop.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> CRO officials say that countries such as Cambodia, Vietnam, Bangkok and Thailand are much more conducive for doing clinical trials.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> &quot;South East Asia is a big hub, there is adequate patient population , the disease profile is similar to India and the governments are responsive towards pharma companies ,&quot; said RK Shanghavi, a pharma consultant based in Mumbai .&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Cost is another big factor. In India, doctors charge anywhere between Rs 10,000 and Rs 2 lakh per patient for conducting a clinical trial, while in Cambodia it is Rs 10,000 per doctor, says Shanghavi.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Last month, Ahmedabad-based Lambda Research Labs opened its first centre in Thailand after a request by the Thai government. It has tied up with Government Pharmaceutical Organisation, a state-run pharma company, to set up a clinical trial unit and train its workforce.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> &quot;Indian drug makers want to launch their products in a country like Bangkok, and hence their government wants the trial to be conducted in their own country,&quot; said Kiran Marthak of Lambda.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> In India, the Drugs Controller General of India (DGCI) has become defunct after the health ministry decided to set up the New Drug Advisory Committee (NDAC) with the responsibility for giving approvals for drug trials.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> But CROs say the new body has virtually stopped giving approvals. In 2011, only 98 drugs were approved compared with 224 in 2010.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> So far in 2012, the number of approvals is nine. The government started delaying approvals after a series of reports erupted on botched up drug trails by CRO's , which raised ethical concerns. Organisations came under probe for allegedly carrying out drug trails without the appropriate consent of patients.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Some organisations faced a ban and the drug controller was also severely criticised for issuing licenses to such organisations . The matter reached Parliament where questions were raised about the health ministry's role in protecting trial patients. These incidents rattled the health ministry.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> The drug controller went into a damage control mode and ordered the CROs to compensate those who were affected by the trials, but it could not be implemented because there was no proper regulation in place. Things have got worse since with the Parliamentary Standing Committee report revealing the failures of the system in sharp relief.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> &quot;The Committee is of the firm opinion that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO, the Central Drug Standard Control Organisation.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> For decades together it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder -- the consumer -- has never been ensured,&quot; the parliamentary report said &quot;Our topline is suffering. We have about 30% revenue erosion because our approvals are stuck, and though in countries like Singapore and Korea the cost of doing business are 40% upwards of India, regulation wise it is still a very easy market,&quot; said Nidhi Saxena, founder, Karmic Life sciences.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Karmic is making Singapore as its base to expand in other Asian regions. Drug makers say the flight of CROs is bad news for patients and the future of R&amp;D in India.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> &quot;Science is much more complicated than simple and the regulators should understand that,&quot; says Swati Piramal, director Piramal Healthcare Limited. &quot;There is complete paralysis of regulation, and we cannot have policy that takes us backwards, a good industry needs a good regulation,&quot; she added. </div>', 'credit_writer' => 'The Economic Times, 13 June, 2012, http://economictimes.indiatimes.com/news/news-by-industry/healthcare/biotech/healthcare/hit-by-red-tape-clinical-trial-companies-eye-south-east-asia-for-expansion/ar', 'article_img' => '', 'article_img_thumb' => '', 'status' => (int) 1, 'show_on_home' => (int) 1, 'lang' => 'EN', 'category_id' => (int) 16, 'tag_keyword' => '', 'seo_url' => 'hit-by-red-tape-clinical-trial-companies-eye-south-east-asia-for-expansion-divya-rajagopal-15652', '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) 15652, '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) 15525, 'metaTitle' => 'LATEST NEWS UPDATES | Hit by red tape, clinical trial companies eye South-East Asia for expansion-Divya Rajagopal', 'metaKeywords' => 'Health,Law and Justice,medicines', 'metaDesc' => ' -The Economic Times &nbsp; Pushed to the wall by an overly cautious drug regulator and an alarmist Indian government, clinical trial companies are looking at South East Asian countries to expand their business and escape the red tape of Indian authorities.&nbsp; Clinical research...', 'disp' => '<div style="text-align: justify">-The Economic Times</div><div style="text-align: justify">&nbsp;</div><div style="text-align: justify">Pushed to the wall by an overly cautious drug regulator and an alarmist Indian government, clinical trial companies are looking at South East Asian countries to expand their business and escape the red tape of Indian authorities.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Clinical research companies (CROs), that were aspiring to become billion- dollar companies by 2010, had to rework their plans after a Parliamentary Standing Committee report questioned the allegedly unfair and unethical trials conducted on Indian patients .&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">In the past one year, approvals for trials have dropped significantly after companies realised that it would be difficult to operate in India. But eager governments in other South Asian countries are opening their doors to these companies and inviting them to set up shop.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">CRO officials say that countries such as Cambodia, Vietnam, Bangkok and Thailand are much more conducive for doing clinical trials.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&quot;South East Asia is a big hub, there is adequate patient population , the disease profile is similar to India and the governments are responsive towards pharma companies ,&quot; said RK Shanghavi, a pharma consultant based in Mumbai .&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Cost is another big factor. In India, doctors charge anywhere between Rs 10,000 and Rs 2 lakh per patient for conducting a clinical trial, while in Cambodia it is Rs 10,000 per doctor, says Shanghavi.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Last month, Ahmedabad-based Lambda Research Labs opened its first centre in Thailand after a request by the Thai government. It has tied up with Government Pharmaceutical Organisation, a state-run pharma company, to set up a clinical trial unit and train its workforce.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&quot;Indian drug makers want to launch their products in a country like Bangkok, and hence their government wants the trial to be conducted in their own country,&quot; said Kiran Marthak of Lambda.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">In India, the Drugs Controller General of India (DGCI) has become defunct after the health ministry decided to set up the New Drug Advisory Committee (NDAC) with the responsibility for giving approvals for drug trials.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">But CROs say the new body has virtually stopped giving approvals. In 2011, only 98 drugs were approved compared with 224 in 2010.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">So far in 2012, the number of approvals is nine. The government started delaying approvals after a series of reports erupted on botched up drug trails by CRO's , which raised ethical concerns. Organisations came under probe for allegedly carrying out drug trails without the appropriate consent of patients.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Some organisations faced a ban and the drug controller was also severely criticised for issuing licenses to such organisations . The matter reached Parliament where questions were raised about the health ministry's role in protecting trial patients. These incidents rattled the health ministry.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">The drug controller went into a damage control mode and ordered the CROs to compensate those who were affected by the trials, but it could not be implemented because there was no proper regulation in place. Things have got worse since with the Parliamentary Standing Committee report revealing the failures of the system in sharp relief.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&quot;The Committee is of the firm opinion that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO, the Central Drug Standard Control Organisation.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">For decades together it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder -- the consumer -- has never been ensured,&quot; the parliamentary report said &quot;Our topline is suffering. We have about 30% revenue erosion because our approvals are stuck, and though in countries like Singapore and Korea the cost of doing business are 40% upwards of India, regulation wise it is still a very easy market,&quot; said Nidhi Saxena, founder, Karmic Life sciences.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Karmic is making Singapore as its base to expand in other Asian regions. Drug makers say the flight of CROs is bad news for patients and the future of R&amp;D in India.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&quot;Science is much more complicated than simple and the regulators should understand that,&quot; says Swati Piramal, director Piramal Healthcare Limited. &quot;There is complete paralysis of regulation, and we cannot have policy that takes us backwards, a good industry needs a good regulation,&quot; she added.</div>', 'lang' => 'English', 'SITE_URL' => 'https://im4change.in/', 'site_title' => 'im4change', 'adminprix' => 'admin' ] $article_current = object(App\Model\Entity\Article) { 'id' => (int) 15525, 'title' => 'Hit by red tape, clinical trial companies eye South-East Asia for expansion-Divya Rajagopal', 'subheading' => '', 'description' => '<div style="text-align: justify"> -The Economic Times </div> <div style="text-align: justify"> &nbsp; </div> <div style="text-align: justify"> Pushed to the wall by an overly cautious drug regulator and an alarmist Indian government, clinical trial companies are looking at South East Asian countries to expand their business and escape the red tape of Indian authorities.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Clinical research companies (CROs), that were aspiring to become billion- dollar companies by 2010, had to rework their plans after a Parliamentary Standing Committee report questioned the allegedly unfair and unethical trials conducted on Indian patients .&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> In the past one year, approvals for trials have dropped significantly after companies realised that it would be difficult to operate in India. But eager governments in other South Asian countries are opening their doors to these companies and inviting them to set up shop.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> CRO officials say that countries such as Cambodia, Vietnam, Bangkok and Thailand are much more conducive for doing clinical trials.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> &quot;South East Asia is a big hub, there is adequate patient population , the disease profile is similar to India and the governments are responsive towards pharma companies ,&quot; said RK Shanghavi, a pharma consultant based in Mumbai .&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Cost is another big factor. In India, doctors charge anywhere between Rs 10,000 and Rs 2 lakh per patient for conducting a clinical trial, while in Cambodia it is Rs 10,000 per doctor, says Shanghavi.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Last month, Ahmedabad-based Lambda Research Labs opened its first centre in Thailand after a request by the Thai government. It has tied up with Government Pharmaceutical Organisation, a state-run pharma company, to set up a clinical trial unit and train its workforce.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> &quot;Indian drug makers want to launch their products in a country like Bangkok, and hence their government wants the trial to be conducted in their own country,&quot; said Kiran Marthak of Lambda.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> In India, the Drugs Controller General of India (DGCI) has become defunct after the health ministry decided to set up the New Drug Advisory Committee (NDAC) with the responsibility for giving approvals for drug trials.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> But CROs say the new body has virtually stopped giving approvals. In 2011, only 98 drugs were approved compared with 224 in 2010.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> So far in 2012, the number of approvals is nine. The government started delaying approvals after a series of reports erupted on botched up drug trails by CRO's , which raised ethical concerns. Organisations came under probe for allegedly carrying out drug trails without the appropriate consent of patients.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Some organisations faced a ban and the drug controller was also severely criticised for issuing licenses to such organisations . The matter reached Parliament where questions were raised about the health ministry's role in protecting trial patients. These incidents rattled the health ministry.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> The drug controller went into a damage control mode and ordered the CROs to compensate those who were affected by the trials, but it could not be implemented because there was no proper regulation in place. Things have got worse since with the Parliamentary Standing Committee report revealing the failures of the system in sharp relief.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> &quot;The Committee is of the firm opinion that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO, the Central Drug Standard Control Organisation.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> For decades together it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder -- the consumer -- has never been ensured,&quot; the parliamentary report said &quot;Our topline is suffering. We have about 30% revenue erosion because our approvals are stuck, and though in countries like Singapore and Korea the cost of doing business are 40% upwards of India, regulation wise it is still a very easy market,&quot; said Nidhi Saxena, founder, Karmic Life sciences.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Karmic is making Singapore as its base to expand in other Asian regions. Drug makers say the flight of CROs is bad news for patients and the future of R&amp;D in India.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> &quot;Science is much more complicated than simple and the regulators should understand that,&quot; says Swati Piramal, director Piramal Healthcare Limited. &quot;There is complete paralysis of regulation, and we cannot have policy that takes us backwards, a good industry needs a good regulation,&quot; she added. </div>', 'credit_writer' => 'The Economic Times, 13 June, 2012, http://economictimes.indiatimes.com/news/news-by-industry/healthcare/biotech/healthcare/hit-by-red-tape-clinical-trial-companies-eye-south-east-asia-for-expansion/ar', 'article_img' => '', 'article_img_thumb' => '', 'status' => (int) 1, 'show_on_home' => (int) 1, 'lang' => 'EN', 'category_id' => (int) 16, 'tag_keyword' => '', 'seo_url' => 'hit-by-red-tape-clinical-trial-companies-eye-south-east-asia-for-expansion-divya-rajagopal-15652', '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) 15652, '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) {} ], 'category' => object(App\Model\Entity\Category) {}, '[new]' => false, '[accessible]' => [ '*' => true, 'id' => false ], '[dirty]' => [], '[original]' => [], '[virtual]' => [], '[hasErrors]' => false, '[errors]' => [], '[invalid]' => [], '[repository]' => 'Articles' } $articleid = (int) 15525 $metaTitle = 'LATEST NEWS UPDATES | Hit by red tape, clinical trial companies eye South-East Asia for expansion-Divya Rajagopal' $metaKeywords = 'Health,Law and Justice,medicines' $metaDesc = ' -The Economic Times &nbsp; Pushed to the wall by an overly cautious drug regulator and an alarmist Indian government, clinical trial companies are looking at South East Asian countries to expand their business and escape the red tape of Indian authorities.&nbsp; Clinical research...' $disp = '<div style="text-align: justify">-The Economic Times</div><div style="text-align: justify">&nbsp;</div><div style="text-align: justify">Pushed to the wall by an overly cautious drug regulator and an alarmist Indian government, clinical trial companies are looking at South East Asian countries to expand their business and escape the red tape of Indian authorities.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Clinical research companies (CROs), that were aspiring to become billion- dollar companies by 2010, had to rework their plans after a Parliamentary Standing Committee report questioned the allegedly unfair and unethical trials conducted on Indian patients .&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">In the past one year, approvals for trials have dropped significantly after companies realised that it would be difficult to operate in India. But eager governments in other South Asian countries are opening their doors to these companies and inviting them to set up shop.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">CRO officials say that countries such as Cambodia, Vietnam, Bangkok and Thailand are much more conducive for doing clinical trials.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&quot;South East Asia is a big hub, there is adequate patient population , the disease profile is similar to India and the governments are responsive towards pharma companies ,&quot; said RK Shanghavi, a pharma consultant based in Mumbai .&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Cost is another big factor. In India, doctors charge anywhere between Rs 10,000 and Rs 2 lakh per patient for conducting a clinical trial, while in Cambodia it is Rs 10,000 per doctor, says Shanghavi.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Last month, Ahmedabad-based Lambda Research Labs opened its first centre in Thailand after a request by the Thai government. It has tied up with Government Pharmaceutical Organisation, a state-run pharma company, to set up a clinical trial unit and train its workforce.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&quot;Indian drug makers want to launch their products in a country like Bangkok, and hence their government wants the trial to be conducted in their own country,&quot; said Kiran Marthak of Lambda.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">In India, the Drugs Controller General of India (DGCI) has become defunct after the health ministry decided to set up the New Drug Advisory Committee (NDAC) with the responsibility for giving approvals for drug trials.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">But CROs say the new body has virtually stopped giving approvals. In 2011, only 98 drugs were approved compared with 224 in 2010.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">So far in 2012, the number of approvals is nine. The government started delaying approvals after a series of reports erupted on botched up drug trails by CRO's , which raised ethical concerns. Organisations came under probe for allegedly carrying out drug trails without the appropriate consent of patients.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Some organisations faced a ban and the drug controller was also severely criticised for issuing licenses to such organisations . The matter reached Parliament where questions were raised about the health ministry's role in protecting trial patients. These incidents rattled the health ministry.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">The drug controller went into a damage control mode and ordered the CROs to compensate those who were affected by the trials, but it could not be implemented because there was no proper regulation in place. Things have got worse since with the Parliamentary Standing Committee report revealing the failures of the system in sharp relief.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&quot;The Committee is of the firm opinion that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO, the Central Drug Standard Control Organisation.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">For decades together it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder -- the consumer -- has never been ensured,&quot; the parliamentary report said &quot;Our topline is suffering. We have about 30% revenue erosion because our approvals are stuck, and though in countries like Singapore and Korea the cost of doing business are 40% upwards of India, regulation wise it is still a very easy market,&quot; said Nidhi Saxena, founder, Karmic Life sciences.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Karmic is making Singapore as its base to expand in other Asian regions. Drug makers say the flight of CROs is bad news for patients and the future of R&amp;D in India.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&quot;Science is much more complicated than simple and the regulators should understand that,&quot; says Swati Piramal, director Piramal Healthcare Limited. &quot;There is complete paralysis of regulation, and we cannot have policy that takes us backwards, a good industry needs a good regulation,&quot; she added.</div>' $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/hit-by-red-tape-clinical-trial-companies-eye-south-east-asia-for-expansion-divya-rajagopal-15652.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 | Hit by red tape, clinical trial companies eye South-East Asia for expansion-Divya Rajagopal | Im4change.org</title> <meta name="description" content=" -The Economic Times Pushed to the wall by an overly cautious drug regulator and an alarmist Indian government, clinical trial companies are looking at South East Asian countries to expand their business and escape the red tape of Indian authorities. Clinical research..."/> <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>Hit by red tape, clinical trial companies eye South-East Asia for expansion-Divya Rajagopal</strong></h1> </td> </tr> <tr> <td width="100%" style="font-family:Arial, 'Segoe Script', 'Segoe UI', sans-serif, serif"><font size="3"> <div style="text-align: justify">-The Economic Times</div><div style="text-align: justify"> </div><div style="text-align: justify">Pushed to the wall by an overly cautious drug regulator and an alarmist Indian government, clinical trial companies are looking at South East Asian countries to expand their business and escape the red tape of Indian authorities. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">Clinical research companies (CROs), that were aspiring to become billion- dollar companies by 2010, had to rework their plans after a Parliamentary Standing Committee report questioned the allegedly unfair and unethical trials conducted on Indian patients . </div><div style="text-align: justify"><br /></div><div style="text-align: justify">In the past one year, approvals for trials have dropped significantly after companies realised that it would be difficult to operate in India. But eager governments in other South Asian countries are opening their doors to these companies and inviting them to set up shop. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">CRO officials say that countries such as Cambodia, Vietnam, Bangkok and Thailand are much more conducive for doing clinical trials. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">"South East Asia is a big hub, there is adequate patient population , the disease profile is similar to India and the governments are responsive towards pharma companies ," said RK Shanghavi, a pharma consultant based in Mumbai . </div><div style="text-align: justify"><br /></div><div style="text-align: justify">Cost is another big factor. In India, doctors charge anywhere between Rs 10,000 and Rs 2 lakh per patient for conducting a clinical trial, while in Cambodia it is Rs 10,000 per doctor, says Shanghavi. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">Last month, Ahmedabad-based Lambda Research Labs opened its first centre in Thailand after a request by the Thai government. It has tied up with Government Pharmaceutical Organisation, a state-run pharma company, to set up a clinical trial unit and train its workforce. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">"Indian drug makers want to launch their products in a country like Bangkok, and hence their government wants the trial to be conducted in their own country," said Kiran Marthak of Lambda. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">In India, the Drugs Controller General of India (DGCI) has become defunct after the health ministry decided to set up the New Drug Advisory Committee (NDAC) with the responsibility for giving approvals for drug trials. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">But CROs say the new body has virtually stopped giving approvals. In 2011, only 98 drugs were approved compared with 224 in 2010. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">So far in 2012, the number of approvals is nine. The government started delaying approvals after a series of reports erupted on botched up drug trails by CRO's , which raised ethical concerns. Organisations came under probe for allegedly carrying out drug trails without the appropriate consent of patients. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">Some organisations faced a ban and the drug controller was also severely criticised for issuing licenses to such organisations . The matter reached Parliament where questions were raised about the health ministry's role in protecting trial patients. These incidents rattled the health ministry. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">The drug controller went into a damage control mode and ordered the CROs to compensate those who were affected by the trials, but it could not be implemented because there was no proper regulation in place. Things have got worse since with the Parliamentary Standing Committee report revealing the failures of the system in sharp relief. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">"The Committee is of the firm opinion that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO, the Central Drug Standard Control Organisation. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">For decades together it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder -- the consumer -- has never been ensured," the parliamentary report said "Our topline is suffering. We have about 30% revenue erosion because our approvals are stuck, and though in countries like Singapore and Korea the cost of doing business are 40% upwards of India, regulation wise it is still a very easy market," said Nidhi Saxena, founder, Karmic Life sciences. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">Karmic is making Singapore as its base to expand in other Asian regions. Drug makers say the flight of CROs is bad news for patients and the future of R&D in India. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">"Science is much more complicated than simple and the regulators should understand that," says Swati Piramal, director Piramal Healthcare Limited. "There is complete paralysis of regulation, and we cannot have policy that takes us backwards, a good industry needs a good regulation," she added.</div> </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>' } $reasonPhrase = 'OK'header - [internal], line ?? Cake\Http\ResponseEmitter::emitStatusLine() - CORE/src/Http/ResponseEmitter.php, line 148 Cake\Http\ResponseEmitter::emit() - CORE/src/Http/ResponseEmitter.php, line 54 Cake\Http\Server::emit() - CORE/src/Http/Server.php, line 141 [main] - ROOT/webroot/index.php, line 39
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$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('cakeErr6824456cea179-trace').style.display = (document.getElementById('cakeErr6824456cea179-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="cakeErr6824456cea179-trace" class="cake-stack-trace" style="display: none;"><a href="javascript:void(0);" onclick="document.getElementById('cakeErr6824456cea179-code').style.display = (document.getElementById('cakeErr6824456cea179-code').style.display == 'none' ? '' : 'none')">Code</a> <a href="javascript:void(0);" onclick="document.getElementById('cakeErr6824456cea179-context').style.display = (document.getElementById('cakeErr6824456cea179-context').style.display == 'none' ? '' : 'none')">Context</a><pre id="cakeErr6824456cea179-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">$article_current</span><span style="color: #007700">-></span><span style="color: #0000BB">seo_url</span><span style="color: #007700">; </span><span style="color: #0000BB">?></span>.html"/> </span></code></span> <code><span style="color: #000000"><span style="color: #0000BB"> </span><span style="color: #007700"><</span><span style="color: #0000BB">meta http</span><span style="color: #007700">-</span><span style="color: #0000BB">equiv</span><span style="color: #007700">=</span><span style="color: #DD0000">"Content-Type" </span><span style="color: #0000BB">content</span><span style="color: #007700">=</span><span style="color: #DD0000">"text/html; charset=utf-8"</span><span style="color: #007700">/> </span></span></code></pre><pre id="cakeErr6824456cea179-context" class="cake-context" style="display: none;">$viewFile = '/home/brlfuser/public_html/src/Template/Layout/printlayout.ctp' $dataForView = [ 'article_current' => object(App\Model\Entity\Article) { 'id' => (int) 15525, 'title' => 'Hit by red tape, clinical trial companies eye South-East Asia for expansion-Divya Rajagopal', 'subheading' => '', 'description' => '<div style="text-align: justify"> -The Economic Times </div> <div style="text-align: justify"> &nbsp; </div> <div style="text-align: justify"> Pushed to the wall by an overly cautious drug regulator and an alarmist Indian government, clinical trial companies are looking at South East Asian countries to expand their business and escape the red tape of Indian authorities.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Clinical research companies (CROs), that were aspiring to become billion- dollar companies by 2010, had to rework their plans after a Parliamentary Standing Committee report questioned the allegedly unfair and unethical trials conducted on Indian patients .&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> In the past one year, approvals for trials have dropped significantly after companies realised that it would be difficult to operate in India. But eager governments in other South Asian countries are opening their doors to these companies and inviting them to set up shop.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> CRO officials say that countries such as Cambodia, Vietnam, Bangkok and Thailand are much more conducive for doing clinical trials.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> &quot;South East Asia is a big hub, there is adequate patient population , the disease profile is similar to India and the governments are responsive towards pharma companies ,&quot; said RK Shanghavi, a pharma consultant based in Mumbai .&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Cost is another big factor. In India, doctors charge anywhere between Rs 10,000 and Rs 2 lakh per patient for conducting a clinical trial, while in Cambodia it is Rs 10,000 per doctor, says Shanghavi.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Last month, Ahmedabad-based Lambda Research Labs opened its first centre in Thailand after a request by the Thai government. It has tied up with Government Pharmaceutical Organisation, a state-run pharma company, to set up a clinical trial unit and train its workforce.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> &quot;Indian drug makers want to launch their products in a country like Bangkok, and hence their government wants the trial to be conducted in their own country,&quot; said Kiran Marthak of Lambda.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> In India, the Drugs Controller General of India (DGCI) has become defunct after the health ministry decided to set up the New Drug Advisory Committee (NDAC) with the responsibility for giving approvals for drug trials.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> But CROs say the new body has virtually stopped giving approvals. In 2011, only 98 drugs were approved compared with 224 in 2010.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> So far in 2012, the number of approvals is nine. The government started delaying approvals after a series of reports erupted on botched up drug trails by CRO's , which raised ethical concerns. Organisations came under probe for allegedly carrying out drug trails without the appropriate consent of patients.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Some organisations faced a ban and the drug controller was also severely criticised for issuing licenses to such organisations . The matter reached Parliament where questions were raised about the health ministry's role in protecting trial patients. These incidents rattled the health ministry.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> The drug controller went into a damage control mode and ordered the CROs to compensate those who were affected by the trials, but it could not be implemented because there was no proper regulation in place. Things have got worse since with the Parliamentary Standing Committee report revealing the failures of the system in sharp relief.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> &quot;The Committee is of the firm opinion that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO, the Central Drug Standard Control Organisation.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> For decades together it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder -- the consumer -- has never been ensured,&quot; the parliamentary report said &quot;Our topline is suffering. We have about 30% revenue erosion because our approvals are stuck, and though in countries like Singapore and Korea the cost of doing business are 40% upwards of India, regulation wise it is still a very easy market,&quot; said Nidhi Saxena, founder, Karmic Life sciences.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Karmic is making Singapore as its base to expand in other Asian regions. Drug makers say the flight of CROs is bad news for patients and the future of R&amp;D in India.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> &quot;Science is much more complicated than simple and the regulators should understand that,&quot; says Swati Piramal, director Piramal Healthcare Limited. &quot;There is complete paralysis of regulation, and we cannot have policy that takes us backwards, a good industry needs a good regulation,&quot; she added. </div>', 'credit_writer' => 'The Economic Times, 13 June, 2012, http://economictimes.indiatimes.com/news/news-by-industry/healthcare/biotech/healthcare/hit-by-red-tape-clinical-trial-companies-eye-south-east-asia-for-expansion/ar', 'article_img' => '', 'article_img_thumb' => '', 'status' => (int) 1, 'show_on_home' => (int) 1, 'lang' => 'EN', 'category_id' => (int) 16, 'tag_keyword' => '', 'seo_url' => 'hit-by-red-tape-clinical-trial-companies-eye-south-east-asia-for-expansion-divya-rajagopal-15652', '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) 15652, '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) 15525, 'metaTitle' => 'LATEST NEWS UPDATES | Hit by red tape, clinical trial companies eye South-East Asia for expansion-Divya Rajagopal', 'metaKeywords' => 'Health,Law and Justice,medicines', 'metaDesc' => ' -The Economic Times &nbsp; Pushed to the wall by an overly cautious drug regulator and an alarmist Indian government, clinical trial companies are looking at South East Asian countries to expand their business and escape the red tape of Indian authorities.&nbsp; Clinical research...', 'disp' => '<div style="text-align: justify">-The Economic Times</div><div style="text-align: justify">&nbsp;</div><div style="text-align: justify">Pushed to the wall by an overly cautious drug regulator and an alarmist Indian government, clinical trial companies are looking at South East Asian countries to expand their business and escape the red tape of Indian authorities.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Clinical research companies (CROs), that were aspiring to become billion- dollar companies by 2010, had to rework their plans after a Parliamentary Standing Committee report questioned the allegedly unfair and unethical trials conducted on Indian patients .&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">In the past one year, approvals for trials have dropped significantly after companies realised that it would be difficult to operate in India. But eager governments in other South Asian countries are opening their doors to these companies and inviting them to set up shop.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">CRO officials say that countries such as Cambodia, Vietnam, Bangkok and Thailand are much more conducive for doing clinical trials.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&quot;South East Asia is a big hub, there is adequate patient population , the disease profile is similar to India and the governments are responsive towards pharma companies ,&quot; said RK Shanghavi, a pharma consultant based in Mumbai .&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Cost is another big factor. In India, doctors charge anywhere between Rs 10,000 and Rs 2 lakh per patient for conducting a clinical trial, while in Cambodia it is Rs 10,000 per doctor, says Shanghavi.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Last month, Ahmedabad-based Lambda Research Labs opened its first centre in Thailand after a request by the Thai government. It has tied up with Government Pharmaceutical Organisation, a state-run pharma company, to set up a clinical trial unit and train its workforce.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&quot;Indian drug makers want to launch their products in a country like Bangkok, and hence their government wants the trial to be conducted in their own country,&quot; said Kiran Marthak of Lambda.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">In India, the Drugs Controller General of India (DGCI) has become defunct after the health ministry decided to set up the New Drug Advisory Committee (NDAC) with the responsibility for giving approvals for drug trials.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">But CROs say the new body has virtually stopped giving approvals. In 2011, only 98 drugs were approved compared with 224 in 2010.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">So far in 2012, the number of approvals is nine. The government started delaying approvals after a series of reports erupted on botched up drug trails by CRO's , which raised ethical concerns. Organisations came under probe for allegedly carrying out drug trails without the appropriate consent of patients.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Some organisations faced a ban and the drug controller was also severely criticised for issuing licenses to such organisations . The matter reached Parliament where questions were raised about the health ministry's role in protecting trial patients. These incidents rattled the health ministry.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">The drug controller went into a damage control mode and ordered the CROs to compensate those who were affected by the trials, but it could not be implemented because there was no proper regulation in place. Things have got worse since with the Parliamentary Standing Committee report revealing the failures of the system in sharp relief.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&quot;The Committee is of the firm opinion that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO, the Central Drug Standard Control Organisation.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">For decades together it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder -- the consumer -- has never been ensured,&quot; the parliamentary report said &quot;Our topline is suffering. We have about 30% revenue erosion because our approvals are stuck, and though in countries like Singapore and Korea the cost of doing business are 40% upwards of India, regulation wise it is still a very easy market,&quot; said Nidhi Saxena, founder, Karmic Life sciences.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Karmic is making Singapore as its base to expand in other Asian regions. Drug makers say the flight of CROs is bad news for patients and the future of R&amp;D in India.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&quot;Science is much more complicated than simple and the regulators should understand that,&quot; says Swati Piramal, director Piramal Healthcare Limited. &quot;There is complete paralysis of regulation, and we cannot have policy that takes us backwards, a good industry needs a good regulation,&quot; she added.</div>', 'lang' => 'English', 'SITE_URL' => 'https://im4change.in/', 'site_title' => 'im4change', 'adminprix' => 'admin' ] $article_current = object(App\Model\Entity\Article) { 'id' => (int) 15525, 'title' => 'Hit by red tape, clinical trial companies eye South-East Asia for expansion-Divya Rajagopal', 'subheading' => '', 'description' => '<div style="text-align: justify"> -The Economic Times </div> <div style="text-align: justify"> &nbsp; </div> <div style="text-align: justify"> Pushed to the wall by an overly cautious drug regulator and an alarmist Indian government, clinical trial companies are looking at South East Asian countries to expand their business and escape the red tape of Indian authorities.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Clinical research companies (CROs), that were aspiring to become billion- dollar companies by 2010, had to rework their plans after a Parliamentary Standing Committee report questioned the allegedly unfair and unethical trials conducted on Indian patients .&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> In the past one year, approvals for trials have dropped significantly after companies realised that it would be difficult to operate in India. But eager governments in other South Asian countries are opening their doors to these companies and inviting them to set up shop.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> CRO officials say that countries such as Cambodia, Vietnam, Bangkok and Thailand are much more conducive for doing clinical trials.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> &quot;South East Asia is a big hub, there is adequate patient population , the disease profile is similar to India and the governments are responsive towards pharma companies ,&quot; said RK Shanghavi, a pharma consultant based in Mumbai .&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Cost is another big factor. In India, doctors charge anywhere between Rs 10,000 and Rs 2 lakh per patient for conducting a clinical trial, while in Cambodia it is Rs 10,000 per doctor, says Shanghavi.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Last month, Ahmedabad-based Lambda Research Labs opened its first centre in Thailand after a request by the Thai government. It has tied up with Government Pharmaceutical Organisation, a state-run pharma company, to set up a clinical trial unit and train its workforce.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> &quot;Indian drug makers want to launch their products in a country like Bangkok, and hence their government wants the trial to be conducted in their own country,&quot; said Kiran Marthak of Lambda.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> In India, the Drugs Controller General of India (DGCI) has become defunct after the health ministry decided to set up the New Drug Advisory Committee (NDAC) with the responsibility for giving approvals for drug trials.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> But CROs say the new body has virtually stopped giving approvals. In 2011, only 98 drugs were approved compared with 224 in 2010.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> So far in 2012, the number of approvals is nine. The government started delaying approvals after a series of reports erupted on botched up drug trails by CRO's , which raised ethical concerns. Organisations came under probe for allegedly carrying out drug trails without the appropriate consent of patients.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Some organisations faced a ban and the drug controller was also severely criticised for issuing licenses to such organisations . The matter reached Parliament where questions were raised about the health ministry's role in protecting trial patients. These incidents rattled the health ministry.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> The drug controller went into a damage control mode and ordered the CROs to compensate those who were affected by the trials, but it could not be implemented because there was no proper regulation in place. Things have got worse since with the Parliamentary Standing Committee report revealing the failures of the system in sharp relief.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> &quot;The Committee is of the firm opinion that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO, the Central Drug Standard Control Organisation.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> For decades together it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder -- the consumer -- has never been ensured,&quot; the parliamentary report said &quot;Our topline is suffering. We have about 30% revenue erosion because our approvals are stuck, and though in countries like Singapore and Korea the cost of doing business are 40% upwards of India, regulation wise it is still a very easy market,&quot; said Nidhi Saxena, founder, Karmic Life sciences.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Karmic is making Singapore as its base to expand in other Asian regions. Drug makers say the flight of CROs is bad news for patients and the future of R&amp;D in India.&nbsp; </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> &quot;Science is much more complicated than simple and the regulators should understand that,&quot; says Swati Piramal, director Piramal Healthcare Limited. &quot;There is complete paralysis of regulation, and we cannot have policy that takes us backwards, a good industry needs a good regulation,&quot; she added. </div>', 'credit_writer' => 'The Economic Times, 13 June, 2012, http://economictimes.indiatimes.com/news/news-by-industry/healthcare/biotech/healthcare/hit-by-red-tape-clinical-trial-companies-eye-south-east-asia-for-expansion/ar', 'article_img' => '', 'article_img_thumb' => '', 'status' => (int) 1, 'show_on_home' => (int) 1, 'lang' => 'EN', 'category_id' => (int) 16, 'tag_keyword' => '', 'seo_url' => 'hit-by-red-tape-clinical-trial-companies-eye-south-east-asia-for-expansion-divya-rajagopal-15652', '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) 15652, '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) {} ], 'category' => object(App\Model\Entity\Category) {}, '[new]' => false, '[accessible]' => [ '*' => true, 'id' => false ], '[dirty]' => [], '[original]' => [], '[virtual]' => [], '[hasErrors]' => false, '[errors]' => [], '[invalid]' => [], '[repository]' => 'Articles' } $articleid = (int) 15525 $metaTitle = 'LATEST NEWS UPDATES | Hit by red tape, clinical trial companies eye South-East Asia for expansion-Divya Rajagopal' $metaKeywords = 'Health,Law and Justice,medicines' $metaDesc = ' -The Economic Times &nbsp; Pushed to the wall by an overly cautious drug regulator and an alarmist Indian government, clinical trial companies are looking at South East Asian countries to expand their business and escape the red tape of Indian authorities.&nbsp; Clinical research...' $disp = '<div style="text-align: justify">-The Economic Times</div><div style="text-align: justify">&nbsp;</div><div style="text-align: justify">Pushed to the wall by an overly cautious drug regulator and an alarmist Indian government, clinical trial companies are looking at South East Asian countries to expand their business and escape the red tape of Indian authorities.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Clinical research companies (CROs), that were aspiring to become billion- dollar companies by 2010, had to rework their plans after a Parliamentary Standing Committee report questioned the allegedly unfair and unethical trials conducted on Indian patients .&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">In the past one year, approvals for trials have dropped significantly after companies realised that it would be difficult to operate in India. But eager governments in other South Asian countries are opening their doors to these companies and inviting them to set up shop.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">CRO officials say that countries such as Cambodia, Vietnam, Bangkok and Thailand are much more conducive for doing clinical trials.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&quot;South East Asia is a big hub, there is adequate patient population , the disease profile is similar to India and the governments are responsive towards pharma companies ,&quot; said RK Shanghavi, a pharma consultant based in Mumbai .&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Cost is another big factor. In India, doctors charge anywhere between Rs 10,000 and Rs 2 lakh per patient for conducting a clinical trial, while in Cambodia it is Rs 10,000 per doctor, says Shanghavi.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Last month, Ahmedabad-based Lambda Research Labs opened its first centre in Thailand after a request by the Thai government. It has tied up with Government Pharmaceutical Organisation, a state-run pharma company, to set up a clinical trial unit and train its workforce.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&quot;Indian drug makers want to launch their products in a country like Bangkok, and hence their government wants the trial to be conducted in their own country,&quot; said Kiran Marthak of Lambda.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">In India, the Drugs Controller General of India (DGCI) has become defunct after the health ministry decided to set up the New Drug Advisory Committee (NDAC) with the responsibility for giving approvals for drug trials.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">But CROs say the new body has virtually stopped giving approvals. In 2011, only 98 drugs were approved compared with 224 in 2010.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">So far in 2012, the number of approvals is nine. The government started delaying approvals after a series of reports erupted on botched up drug trails by CRO's , which raised ethical concerns. Organisations came under probe for allegedly carrying out drug trails without the appropriate consent of patients.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Some organisations faced a ban and the drug controller was also severely criticised for issuing licenses to such organisations . The matter reached Parliament where questions were raised about the health ministry's role in protecting trial patients. These incidents rattled the health ministry.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">The drug controller went into a damage control mode and ordered the CROs to compensate those who were affected by the trials, but it could not be implemented because there was no proper regulation in place. Things have got worse since with the Parliamentary Standing Committee report revealing the failures of the system in sharp relief.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&quot;The Committee is of the firm opinion that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO, the Central Drug Standard Control Organisation.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">For decades together it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder -- the consumer -- has never been ensured,&quot; the parliamentary report said &quot;Our topline is suffering. We have about 30% revenue erosion because our approvals are stuck, and though in countries like Singapore and Korea the cost of doing business are 40% upwards of India, regulation wise it is still a very easy market,&quot; said Nidhi Saxena, founder, Karmic Life sciences.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Karmic is making Singapore as its base to expand in other Asian regions. Drug makers say the flight of CROs is bad news for patients and the future of R&amp;D in India.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&quot;Science is much more complicated than simple and the regulators should understand that,&quot; says Swati Piramal, director Piramal Healthcare Limited. &quot;There is complete paralysis of regulation, and we cannot have policy that takes us backwards, a good industry needs a good regulation,&quot; she added.</div>' $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/hit-by-red-tape-clinical-trial-companies-eye-south-east-asia-for-expansion-divya-rajagopal-15652.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 | Hit by red tape, clinical trial companies eye South-East Asia for expansion-Divya Rajagopal | Im4change.org</title> <meta name="description" content=" -The Economic Times Pushed to the wall by an overly cautious drug regulator and an alarmist Indian government, clinical trial companies are looking at South East Asian countries to expand their business and escape the red tape of Indian authorities. 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But eager governments in other South Asian countries are opening their doors to these companies and inviting them to set up shop. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">CRO officials say that countries such as Cambodia, Vietnam, Bangkok and Thailand are much more conducive for doing clinical trials. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">"South East Asia is a big hub, there is adequate patient population , the disease profile is similar to India and the governments are responsive towards pharma companies ," said RK Shanghavi, a pharma consultant based in Mumbai . </div><div style="text-align: justify"><br /></div><div style="text-align: justify">Cost is another big factor. In India, doctors charge anywhere between Rs 10,000 and Rs 2 lakh per patient for conducting a clinical trial, while in Cambodia it is Rs 10,000 per doctor, says Shanghavi. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">Last month, Ahmedabad-based Lambda Research Labs opened its first centre in Thailand after a request by the Thai government. It has tied up with Government Pharmaceutical Organisation, a state-run pharma company, to set up a clinical trial unit and train its workforce. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">"Indian drug makers want to launch their products in a country like Bangkok, and hence their government wants the trial to be conducted in their own country," said Kiran Marthak of Lambda. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">In India, the Drugs Controller General of India (DGCI) has become defunct after the health ministry decided to set up the New Drug Advisory Committee (NDAC) with the responsibility for giving approvals for drug trials. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">But CROs say the new body has virtually stopped giving approvals. In 2011, only 98 drugs were approved compared with 224 in 2010. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">So far in 2012, the number of approvals is nine. The government started delaying approvals after a series of reports erupted on botched up drug trails by CRO's , which raised ethical concerns. Organisations came under probe for allegedly carrying out drug trails without the appropriate consent of patients. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">Some organisations faced a ban and the drug controller was also severely criticised for issuing licenses to such organisations . The matter reached Parliament where questions were raised about the health ministry's role in protecting trial patients. These incidents rattled the health ministry. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">The drug controller went into a damage control mode and ordered the CROs to compensate those who were affected by the trials, but it could not be implemented because there was no proper regulation in place. Things have got worse since with the Parliamentary Standing Committee report revealing the failures of the system in sharp relief. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">"The Committee is of the firm opinion that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO, the Central Drug Standard Control Organisation. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">For decades together it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder -- the consumer -- has never been ensured," the parliamentary report said "Our topline is suffering. We have about 30% revenue erosion because our approvals are stuck, and though in countries like Singapore and Korea the cost of doing business are 40% upwards of India, regulation wise it is still a very easy market," said Nidhi Saxena, founder, Karmic Life sciences. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">Karmic is making Singapore as its base to expand in other Asian regions. Drug makers say the flight of CROs is bad news for patients and the future of R&D in India. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">"Science is much more complicated than simple and the regulators should understand that," says Swati Piramal, director Piramal Healthcare Limited. 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But eager governments in other South Asian countries are opening their doors to these companies and inviting them to set up shop. </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> CRO officials say that countries such as Cambodia, Vietnam, Bangkok and Thailand are much more conducive for doing clinical trials. </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> "South East Asia is a big hub, there is adequate patient population , the disease profile is similar to India and the governments are responsive towards pharma companies ," said RK Shanghavi, a pharma consultant based in Mumbai . </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Cost is another big factor. In India, doctors charge anywhere between Rs 10,000 and Rs 2 lakh per patient for conducting a clinical trial, while in Cambodia it is Rs 10,000 per doctor, says Shanghavi. </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Last month, Ahmedabad-based Lambda Research Labs opened its first centre in Thailand after a request by the Thai government. It has tied up with Government Pharmaceutical Organisation, a state-run pharma company, to set up a clinical trial unit and train its workforce. </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> "Indian drug makers want to launch their products in a country like Bangkok, and hence their government wants the trial to be conducted in their own country," said Kiran Marthak of Lambda. </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> In India, the Drugs Controller General of India (DGCI) has become defunct after the health ministry decided to set up the New Drug Advisory Committee (NDAC) with the responsibility for giving approvals for drug trials. </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> But CROs say the new body has virtually stopped giving approvals. In 2011, only 98 drugs were approved compared with 224 in 2010. </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> So far in 2012, the number of approvals is nine. The government started delaying approvals after a series of reports erupted on botched up drug trails by CRO's , which raised ethical concerns. Organisations came under probe for allegedly carrying out drug trails without the appropriate consent of patients. </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Some organisations faced a ban and the drug controller was also severely criticised for issuing licenses to such organisations . The matter reached Parliament where questions were raised about the health ministry's role in protecting trial patients. These incidents rattled the health ministry. </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> The drug controller went into a damage control mode and ordered the CROs to compensate those who were affected by the trials, but it could not be implemented because there was no proper regulation in place. Things have got worse since with the Parliamentary Standing Committee report revealing the failures of the system in sharp relief. </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> "The Committee is of the firm opinion that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO, the Central Drug Standard Control Organisation. </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> For decades together it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder -- the consumer -- has never been ensured," the parliamentary report said "Our topline is suffering. We have about 30% revenue erosion because our approvals are stuck, and though in countries like Singapore and Korea the cost of doing business are 40% upwards of India, regulation wise it is still a very easy market," said Nidhi Saxena, founder, Karmic Life sciences. </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Karmic is making Singapore as its base to expand in other Asian regions. Drug makers say the flight of CROs is bad news for patients and the future of R&D in India. </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> "Science is much more complicated than simple and the regulators should understand that," says Swati Piramal, director Piramal Healthcare Limited. 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Clinical research...', 'disp' => '<div style="text-align: justify">-The Economic Times</div><div style="text-align: justify"> </div><div style="text-align: justify">Pushed to the wall by an overly cautious drug regulator and an alarmist Indian government, clinical trial companies are looking at South East Asian countries to expand their business and escape the red tape of Indian authorities. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">Clinical research companies (CROs), that were aspiring to become billion- dollar companies by 2010, had to rework their plans after a Parliamentary Standing Committee report questioned the allegedly unfair and unethical trials conducted on Indian patients . </div><div style="text-align: justify"><br /></div><div style="text-align: justify">In the past one year, approvals for trials have dropped significantly after companies realised that it would be difficult to operate in India. But eager governments in other South Asian countries are opening their doors to these companies and inviting them to set up shop. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">CRO officials say that countries such as Cambodia, Vietnam, Bangkok and Thailand are much more conducive for doing clinical trials. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">"South East Asia is a big hub, there is adequate patient population , the disease profile is similar to India and the governments are responsive towards pharma companies ," said RK Shanghavi, a pharma consultant based in Mumbai . </div><div style="text-align: justify"><br /></div><div style="text-align: justify">Cost is another big factor. In India, doctors charge anywhere between Rs 10,000 and Rs 2 lakh per patient for conducting a clinical trial, while in Cambodia it is Rs 10,000 per doctor, says Shanghavi. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">Last month, Ahmedabad-based Lambda Research Labs opened its first centre in Thailand after a request by the Thai government. It has tied up with Government Pharmaceutical Organisation, a state-run pharma company, to set up a clinical trial unit and train its workforce. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">"Indian drug makers want to launch their products in a country like Bangkok, and hence their government wants the trial to be conducted in their own country," said Kiran Marthak of Lambda. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">In India, the Drugs Controller General of India (DGCI) has become defunct after the health ministry decided to set up the New Drug Advisory Committee (NDAC) with the responsibility for giving approvals for drug trials. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">But CROs say the new body has virtually stopped giving approvals. In 2011, only 98 drugs were approved compared with 224 in 2010. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">So far in 2012, the number of approvals is nine. The government started delaying approvals after a series of reports erupted on botched up drug trails by CRO's , which raised ethical concerns. Organisations came under probe for allegedly carrying out drug trails without the appropriate consent of patients. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">Some organisations faced a ban and the drug controller was also severely criticised for issuing licenses to such organisations . The matter reached Parliament where questions were raised about the health ministry's role in protecting trial patients. These incidents rattled the health ministry. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">The drug controller went into a damage control mode and ordered the CROs to compensate those who were affected by the trials, but it could not be implemented because there was no proper regulation in place. Things have got worse since with the Parliamentary Standing Committee report revealing the failures of the system in sharp relief. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">"The Committee is of the firm opinion that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO, the Central Drug Standard Control Organisation. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">For decades together it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder -- the consumer -- has never been ensured," the parliamentary report said "Our topline is suffering. We have about 30% revenue erosion because our approvals are stuck, and though in countries like Singapore and Korea the cost of doing business are 40% upwards of India, regulation wise it is still a very easy market," said Nidhi Saxena, founder, Karmic Life sciences. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">Karmic is making Singapore as its base to expand in other Asian regions. Drug makers say the flight of CROs is bad news for patients and the future of R&D in India. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">"Science is much more complicated than simple and the regulators should understand that," says Swati Piramal, director Piramal Healthcare Limited. "There is complete paralysis of regulation, and we cannot have policy that takes us backwards, a good industry needs a good regulation," she added.</div>', 'lang' => 'English', 'SITE_URL' => 'https://im4change.in/', 'site_title' => 'im4change', 'adminprix' => 'admin' ] $article_current = object(App\Model\Entity\Article) { 'id' => (int) 15525, 'title' => 'Hit by red tape, clinical trial companies eye South-East Asia for expansion-Divya Rajagopal', 'subheading' => '', 'description' => '<div style="text-align: justify"> -The Economic Times </div> <div style="text-align: justify"> </div> <div style="text-align: justify"> Pushed to the wall by an overly cautious drug regulator and an alarmist Indian government, clinical trial companies are looking at South East Asian countries to expand their business and escape the red tape of Indian authorities. </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Clinical research companies (CROs), that were aspiring to become billion- dollar companies by 2010, had to rework their plans after a Parliamentary Standing Committee report questioned the allegedly unfair and unethical trials conducted on Indian patients . </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> In the past one year, approvals for trials have dropped significantly after companies realised that it would be difficult to operate in India. But eager governments in other South Asian countries are opening their doors to these companies and inviting them to set up shop. </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> CRO officials say that countries such as Cambodia, Vietnam, Bangkok and Thailand are much more conducive for doing clinical trials. </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> "South East Asia is a big hub, there is adequate patient population , the disease profile is similar to India and the governments are responsive towards pharma companies ," said RK Shanghavi, a pharma consultant based in Mumbai . </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Cost is another big factor. In India, doctors charge anywhere between Rs 10,000 and Rs 2 lakh per patient for conducting a clinical trial, while in Cambodia it is Rs 10,000 per doctor, says Shanghavi. </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Last month, Ahmedabad-based Lambda Research Labs opened its first centre in Thailand after a request by the Thai government. It has tied up with Government Pharmaceutical Organisation, a state-run pharma company, to set up a clinical trial unit and train its workforce. </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> "Indian drug makers want to launch their products in a country like Bangkok, and hence their government wants the trial to be conducted in their own country," said Kiran Marthak of Lambda. </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> In India, the Drugs Controller General of India (DGCI) has become defunct after the health ministry decided to set up the New Drug Advisory Committee (NDAC) with the responsibility for giving approvals for drug trials. </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> But CROs say the new body has virtually stopped giving approvals. In 2011, only 98 drugs were approved compared with 224 in 2010. </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> So far in 2012, the number of approvals is nine. The government started delaying approvals after a series of reports erupted on botched up drug trails by CRO's , which raised ethical concerns. Organisations came under probe for allegedly carrying out drug trails without the appropriate consent of patients. </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Some organisations faced a ban and the drug controller was also severely criticised for issuing licenses to such organisations . The matter reached Parliament where questions were raised about the health ministry's role in protecting trial patients. These incidents rattled the health ministry. </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> The drug controller went into a damage control mode and ordered the CROs to compensate those who were affected by the trials, but it could not be implemented because there was no proper regulation in place. Things have got worse since with the Parliamentary Standing Committee report revealing the failures of the system in sharp relief. </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> "The Committee is of the firm opinion that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO, the Central Drug Standard Control Organisation. </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> For decades together it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder -- the consumer -- has never been ensured," the parliamentary report said "Our topline is suffering. We have about 30% revenue erosion because our approvals are stuck, and though in countries like Singapore and Korea the cost of doing business are 40% upwards of India, regulation wise it is still a very easy market," said Nidhi Saxena, founder, Karmic Life sciences. </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> Karmic is making Singapore as its base to expand in other Asian regions. Drug makers say the flight of CROs is bad news for patients and the future of R&D in India. </div> <div style="text-align: justify"> <br /> </div> <div style="text-align: justify"> "Science is much more complicated than simple and the regulators should understand that," says Swati Piramal, director Piramal Healthcare Limited. 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Clinical research...' $disp = '<div style="text-align: justify">-The Economic Times</div><div style="text-align: justify"> </div><div style="text-align: justify">Pushed to the wall by an overly cautious drug regulator and an alarmist Indian government, clinical trial companies are looking at South East Asian countries to expand their business and escape the red tape of Indian authorities. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">Clinical research companies (CROs), that were aspiring to become billion- dollar companies by 2010, had to rework their plans after a Parliamentary Standing Committee report questioned the allegedly unfair and unethical trials conducted on Indian patients . </div><div style="text-align: justify"><br /></div><div style="text-align: justify">In the past one year, approvals for trials have dropped significantly after companies realised that it would be difficult to operate in India. But eager governments in other South Asian countries are opening their doors to these companies and inviting them to set up shop. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">CRO officials say that countries such as Cambodia, Vietnam, Bangkok and Thailand are much more conducive for doing clinical trials. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">"South East Asia is a big hub, there is adequate patient population , the disease profile is similar to India and the governments are responsive towards pharma companies ," said RK Shanghavi, a pharma consultant based in Mumbai . </div><div style="text-align: justify"><br /></div><div style="text-align: justify">Cost is another big factor. In India, doctors charge anywhere between Rs 10,000 and Rs 2 lakh per patient for conducting a clinical trial, while in Cambodia it is Rs 10,000 per doctor, says Shanghavi. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">Last month, Ahmedabad-based Lambda Research Labs opened its first centre in Thailand after a request by the Thai government. It has tied up with Government Pharmaceutical Organisation, a state-run pharma company, to set up a clinical trial unit and train its workforce. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">"Indian drug makers want to launch their products in a country like Bangkok, and hence their government wants the trial to be conducted in their own country," said Kiran Marthak of Lambda. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">In India, the Drugs Controller General of India (DGCI) has become defunct after the health ministry decided to set up the New Drug Advisory Committee (NDAC) with the responsibility for giving approvals for drug trials. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">But CROs say the new body has virtually stopped giving approvals. In 2011, only 98 drugs were approved compared with 224 in 2010. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">So far in 2012, the number of approvals is nine. The government started delaying approvals after a series of reports erupted on botched up drug trails by CRO's , which raised ethical concerns. Organisations came under probe for allegedly carrying out drug trails without the appropriate consent of patients. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">Some organisations faced a ban and the drug controller was also severely criticised for issuing licenses to such organisations . The matter reached Parliament where questions were raised about the health ministry's role in protecting trial patients. These incidents rattled the health ministry. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">The drug controller went into a damage control mode and ordered the CROs to compensate those who were affected by the trials, but it could not be implemented because there was no proper regulation in place. Things have got worse since with the Parliamentary Standing Committee report revealing the failures of the system in sharp relief. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">"The Committee is of the firm opinion that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO, the Central Drug Standard Control Organisation. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">For decades together it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder -- the consumer -- has never been ensured," the parliamentary report said "Our topline is suffering. We have about 30% revenue erosion because our approvals are stuck, and though in countries like Singapore and Korea the cost of doing business are 40% upwards of India, regulation wise it is still a very easy market," said Nidhi Saxena, founder, Karmic Life sciences. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">Karmic is making Singapore as its base to expand in other Asian regions. Drug makers say the flight of CROs is bad news for patients and the future of R&D in India. </div><div style="text-align: justify"><br /></div><div style="text-align: justify">"Science is much more complicated than simple and the regulators should understand that," says Swati Piramal, director Piramal Healthcare Limited. "There is complete paralysis of regulation, and we cannot have policy that takes us backwards, a good industry needs a good regulation," she added.</div>' $lang = 'English' $SITE_URL = 'https://im4change.in/' $site_title = 'im4change' $adminprix = 'admin'
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Hit by red tape, clinical trial companies eye South-East Asia for expansion-Divya Rajagopal |
-The Economic Times Pushed to the wall by an overly cautious drug regulator and an alarmist Indian government, clinical trial companies are looking at South East Asian countries to expand their business and escape the red tape of Indian authorities. Clinical research companies (CROs), that were aspiring to become billion- dollar companies by 2010, had to rework their plans after a Parliamentary Standing Committee report questioned the allegedly unfair and unethical trials conducted on Indian patients . In the past one year, approvals for trials have dropped significantly after companies realised that it would be difficult to operate in India. But eager governments in other South Asian countries are opening their doors to these companies and inviting them to set up shop. CRO officials say that countries such as Cambodia, Vietnam, Bangkok and Thailand are much more conducive for doing clinical trials. "South East Asia is a big hub, there is adequate patient population , the disease profile is similar to India and the governments are responsive towards pharma companies ," said RK Shanghavi, a pharma consultant based in Mumbai . Cost is another big factor. In India, doctors charge anywhere between Rs 10,000 and Rs 2 lakh per patient for conducting a clinical trial, while in Cambodia it is Rs 10,000 per doctor, says Shanghavi. Last month, Ahmedabad-based Lambda Research Labs opened its first centre in Thailand after a request by the Thai government. It has tied up with Government Pharmaceutical Organisation, a state-run pharma company, to set up a clinical trial unit and train its workforce. "Indian drug makers want to launch their products in a country like Bangkok, and hence their government wants the trial to be conducted in their own country," said Kiran Marthak of Lambda. In India, the Drugs Controller General of India (DGCI) has become defunct after the health ministry decided to set up the New Drug Advisory Committee (NDAC) with the responsibility for giving approvals for drug trials. But CROs say the new body has virtually stopped giving approvals. In 2011, only 98 drugs were approved compared with 224 in 2010. So far in 2012, the number of approvals is nine. The government started delaying approvals after a series of reports erupted on botched up drug trails by CRO's , which raised ethical concerns. Organisations came under probe for allegedly carrying out drug trails without the appropriate consent of patients. Some organisations faced a ban and the drug controller was also severely criticised for issuing licenses to such organisations . The matter reached Parliament where questions were raised about the health ministry's role in protecting trial patients. These incidents rattled the health ministry. The drug controller went into a damage control mode and ordered the CROs to compensate those who were affected by the trials, but it could not be implemented because there was no proper regulation in place. Things have got worse since with the Parliamentary Standing Committee report revealing the failures of the system in sharp relief. "The Committee is of the firm opinion that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO, the Central Drug Standard Control Organisation. For decades together it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder -- the consumer -- has never been ensured," the parliamentary report said "Our topline is suffering. We have about 30% revenue erosion because our approvals are stuck, and though in countries like Singapore and Korea the cost of doing business are 40% upwards of India, regulation wise it is still a very easy market," said Nidhi Saxena, founder, Karmic Life sciences. Karmic is making Singapore as its base to expand in other Asian regions. Drug makers say the flight of CROs is bad news for patients and the future of R&D in India. "Science is much more complicated than simple and the regulators should understand that," says Swati Piramal, director Piramal Healthcare Limited. "There is complete paralysis of regulation, and we cannot have policy that takes us backwards, a good industry needs a good regulation," she added.
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