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


        trigger_error($message, E_USER_DEPRECATED);

    }
$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: 150
 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) 150,
		'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' => 'index',
		'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) 97,
		'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) 150,
	'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/drugs-on-hold-over-doubts-about-indian-trials-4674746.html'
		[protected] base => ''
		[protected] webroot => '/'
		[protected] here => '/latest-news-updates/drugs-on-hold-over-doubts-about-indian-trials-4674746.html'
		[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::index() - APP/Controller/ArtileDetailController.php, line 150
Cake\Controller\Controller::invokeAction() - CORE/src/Controller/Controller.php, line 610
Cake\Http\ActionDispatcher::_invoke() - CORE/src/Http/ActionDispatcher.php, line 120
Cake\Http\ActionDispatcher::dispatch() - CORE/src/Http/ActionDispatcher.php, line 94
Cake\Http\BaseApplication::__invoke() - CORE/src/Http/BaseApplication.php, line 235
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\RoutingMiddleware::__invoke() - CORE/src/Routing/Middleware/RoutingMiddleware.php, line 162
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\AssetMiddleware::__invoke() - CORE/src/Routing/Middleware/AssetMiddleware.php, line 97
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Error\Middleware\ErrorHandlerMiddleware::__invoke() - CORE/src/Error/Middleware/ErrorHandlerMiddleware.php, line 96
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51
Cake\Http\Server::run() - CORE/src/Http/Server.php, line 98

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


        trigger_error($message, E_USER_DEPRECATED);

    }
$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: 151
 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) 151,
		'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' => 'index',
		'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) 97,
		'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) 151,
	'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/drugs-on-hold-over-doubts-about-indian-trials-4674746.html'
		[protected] base => ''
		[protected] webroot => '/'
		[protected] here => '/latest-news-updates/drugs-on-hold-over-doubts-about-indian-trials-4674746.html'
		[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::index() - APP/Controller/ArtileDetailController.php, line 151
Cake\Controller\Controller::invokeAction() - CORE/src/Controller/Controller.php, line 610
Cake\Http\ActionDispatcher::_invoke() - CORE/src/Http/ActionDispatcher.php, line 120
Cake\Http\ActionDispatcher::dispatch() - CORE/src/Http/ActionDispatcher.php, line 94
Cake\Http\BaseApplication::__invoke() - CORE/src/Http/BaseApplication.php, line 235
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\RoutingMiddleware::__invoke() - CORE/src/Routing/Middleware/RoutingMiddleware.php, line 162
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\AssetMiddleware::__invoke() - CORE/src/Routing/Middleware/AssetMiddleware.php, line 97
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Error\Middleware\ErrorHandlerMiddleware::__invoke() - CORE/src/Error/Middleware/ErrorHandlerMiddleware.php, line 96
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51
Cake\Http\Server::run() - CORE/src/Http/Server.php, line 98

Warning (512): Unable to emit headers. Headers sent in file=/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Debugger.php line=853 [CORE/src/Http/ResponseEmitter.php, line 48]
Code Context
            if (Configure::read('debug')) {

                trigger_error($message, E_USER_WARNING);

            } 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>
<!--[if lt IE 7 ]>
<html class="ie ie6" lang='en'> <![endif]-->
<!--[if IE 7 ]>
<html class="ie ie7" lang='en'> <![endif]-->
<!--[if IE 8 ]>
<html class="ie ie8" lang='en'> <![endif]-->
<!--[if (gte IE 9)|!(IE)]><!-->
<html lang='en'>
<!--<![endif]-->
<head><meta http-equiv="Content-Type" content="text/html; charset=utf-8">
    
    <title>
        LATEST NEWS UPDATES | Drugs on hold over doubts about Indian trials    </title>
    <meta name="description" content="
-The Telegraph


Regulators in several European countries are suspending marketing approval for 25 generic drugs because of concerns over the quality of data from human studies conducted by an Indian contract research company, a French medical safety agency said on Friday.


Drug..."/>
    <meta name="keywords" content="healthcare,medicines,Access to Medicines,generic medicines,generic medicine,drug trial,Health"/>
    <meta name="news_keywords" content="healthcare,medicines,Access to Medicines,generic medicines,generic medicine,drug trial,Health">
   
    <link rel="alternate" type="application/rss+xml" title="ROR" href="/ror.xml"/>
    <link rel="alternate" type="application/rss+xml" title="RSS 2.0" href="/feeds/"/>
    <link rel="stylesheet" href="/css/bootstrap.min.css?1697864993"/>    <link rel="stylesheet" href="/css/style.css?v=1.1.2"/>    <link rel="stylesheet" href="/css/style-inner.css?1577045210"/>    <link rel="stylesheet" id="Oswald-css"
          href="https://fonts.googleapis.com/css?family=Oswald%3Aregular%2C700&amp;ver=3.8.1" type="text/css"
          media="all">
    <link rel="stylesheet" href="/css/jquery.modal.min.css?1578285302"/>    <script src="/js/jquery-1.10.2.js?1575549704"></script>    <script src="/js/jquery-migrate.min.js?1575549704"></script>    <link rel="shortcut icon" href="/favicon.ico" title="Favicon">
    <link rel="stylesheet" href="/css/jquery-ui.css?1580720609"/>    <script src="/js/jquery-ui.js?1575549704"></script>    <link rel="preload" as="style" href="https://www.im4change.org/css/custom.css" onload="this.rel='stylesheet'" media="all" crossorigin="anonymous">
<link rel="preload" as="style" href="https://www.im4change.org/css/jquery.modal.min.css" onload="this.rel='stylesheet'" media="all" crossorigin="anonymous">
<link rel="preload" as="style" href="https://www.im4change.org/css/jquery-ui.css" onload="this.rel='stylesheet'" media="all" crossorigin="anonymous">
<link rel="preload" as="style" href="https://www.im4change.org/css/li-scroller.css" onload="this.rel='stylesheet'" media="all" crossorigin="anonymous">
<!-- <link rel="preload" as="style" href="https://www.im4change.org/css/style.css" onload="this.rel='stylesheet'" media="all" crossorigin="anonymous"> -->
<link rel="preload" as="style" href="https://www.im4change.org/css/style-inner.css" onload="this.rel='stylesheet'" media="all" crossorigin="anonymous">

<link rel='dns-prefetch' href="//im4change.org/css/custom.css" crossorigin >

<link rel="preload" as="script" href="https://www.im4change.org/js/bootstrap.js">
<link rel="preload" as="script" href="https://www.im4change.org/js/jquery.li-scroller.1.0.js">
<link rel="preload" as="script" href="https://www.im4change.org/js/jquery.modal.min.js">
<link rel="preload" as="script" href="https://www.im4change.org/js/jquery.ui.totop.js">
<link rel="preload" as="script" href="https://www.im4change.org/js/jquery-1.10.2.js">
<link rel="preload" as="script" href="https://www.im4change.org/js/jquery-migrate.min.js">
<link rel="preload" as="script" href="https://www.im4change.org/js/jquery-ui.js">
<link rel="preload" as="script" href="https://www.im4change.org/js/setting.js">
<link rel="preload" as="script" href="https://www.im4change.org/js/tie-scripts.js">
    <!--[if IE]>
    <script type="text/javascript">jQuery(document).ready(function () {
        jQuery(".menu-item").has("ul").children("a").attr("aria-haspopup", "true");
    });</script>
    <![endif]-->
    <!--[if lt IE 9]>
    <script src="/js/html5.js"></script>
    <script src="/js/selectivizr-min.js"></script>
    <![endif]-->
    <!--[if IE 8]>
    <link rel="stylesheet" type="text/css" media="all" href="/css/ie8.css"/>
    <![endif]-->
    <meta property="og:title" content="LATEST NEWS UPDATES | Drugs on hold over doubts about Indian trials" />
     <meta property="og:url" content="https://im4change.in/latest-news-updates/drugs-on-hold-over-doubts-about-indian-trials-4674746.html" />
     <meta property="og:type" content="article" />
     <meta property="og:description" content="
-The Telegraph


Regulators in several European countries are suspending marketing approval for 25 generic drugs because of concerns over the quality of data from human studies conducted by an Indian contract research company, a French medical safety agency said on Friday.


Drug..." />
     <meta property="og:image" content="" />
      <meta property="fb:app_id" content="0" />
    <meta name="viewport" content="width=device-width, initial-scale=1, maximum-scale=1, user-scalable=no">

       <link rel="apple-touch-icon-precomposed" sizes="144x144" href="https://im4change.in/images/apple1.png">
    <link rel="apple-touch-icon-precomposed" sizes="120x120" href="https://im4change.in/images/apple2.png">
    <link rel="apple-touch-icon-precomposed" sizes="72x72" href="https://im4change.in/images/apple3.png">
    <link rel="apple-touch-icon-precomposed" href="https://im4change.in/images/apple4.png">

    <style>
    .gsc-results-wrapper-overlay{
        top: 38% !important;
        height: 50% !important;
    }
    .gsc-search-button-v2{
        border-color: #035588 !important;
        background-color: #035588 !important;
    }

   .gsib_a{
        height: 30px !important;
          padding: 2px 8px 1px 6px !important;
    }

   
    .gsc-search-button-v2{
        height: 41px !important;
    }
    input.gsc-input{
        background: none !important;
    }
    @media only screen and (max-width: 600px) {
        .gsc-results-wrapper-overlay{
            top: 11% !important;
            width: 87% !important;
            left: 9% !important;
            height: 43% !important;
        }

        .gsc-search-button-v2{
            padding: 10px 10px !important;
        
        }
        .gsc-input-box{
            height: 28px !important;
        }
       /* .gsib_a {
            padding: 0px 9px 4px 9px !important;
        }*/
    }
    @media only screen and (min-width: 1200px) and (max-width: 1920px) {
        table.gsc-search-box{
            width: 15% !important;
            float: right !important;
            margin-top: -118px !important;
        }

        .gsc-search-button-v2 {
            
            padding: 6px !important;
           
        }
    }


</style>

    <script>
        $(function () {
            $("#accordion").accordion({
                event: "click hoverintent"
            });
        });

        /*
         * hoverIntent | Copyright 2011 Brian Cherne
         * http://cherne.net/brian/resources/jquery.hoverIntent.html
         * modified by the jQuery UI team
         */
        $.event.special.hoverintent = {
            setup: function () {
                $(this).bind("mouseover", jQuery.event.special.hoverintent.handler);
            },
            teardown: function () {
                $(this).unbind("mouseover", jQuery.event.special.hoverintent.handler);
            },
            handler: function (event) {
                var currentX, currentY, timeout,
                    args = arguments,
                    target = $(event.target),
                    previousX = event.pageX,
                    previousY = event.pageY;

                function track(event) {
                    currentX = event.pageX;
                    currentY = event.pageY;
                }
                ;

                function clear() {
                    target
                        .unbind("mousemove", track)
                        .unbind("mouseout", clear);
                    clearTimeout(timeout);
                }

                function handler() {
                    var prop,
                        orig = event;
                    if ((Math.abs(previousX - currentX) +
                        Math.abs(previousY - currentY)) < 7) {
                        clear();
                        event = $.Event("hoverintent");
                        for (prop in orig) {
                            if (!(prop in event)) {
                                event[prop] = orig[prop];
                            }
                        }
                        // Prevent accessing the original event since the new event
                        // is fired asynchronously and the old event is no longer
                        // usable (#6028)
                        delete event.originalEvent;
                        target.trigger(event);
                    } else {
                        previousX = currentX;
                        previousY = currentY;
                        timeout = setTimeout(handler, 100);
                    }
                }

                timeout = setTimeout(handler, 100);
                target.bind({
                    mousemove: track,
                    mouseout: clear
                });
            }
        };
    </script>
    <script type="text/javascript">
        var _gaq = _gaq || [];
        _gaq.push(['_setAccount', 'UA-472075-3']);
        _gaq.push(['_trackPageview']);

        (function () {
            var ga = document.createElement('script');
            ga.type = 'text/javascript';
            ga.async = true;
            ga.src = ('https:' == document.location.protocol ? 'https://ssl' : 'http://www') + '.google-analytics.com/ga.js';
            var s = document.getElementsByTagName('script')[0];
            s.parentNode.insertBefore(ga, s);
        })();
    </script>
    <link rel="stylesheet" href="/css/custom.css?v=1.16"/>    <script src="/js/jquery.ui.totop.js?1575549704"></script>    <script src="/js/setting.js?1575549704"></script>    <link rel="manifest" href="/manifest.json">
    <meta name="theme-color" content="#616163" />
    <meta name="apple-mobile-web-app-capable" content="yes">
    <meta name="apple-mobile-web-app-status-bar-style" content="black">
    <meta name="apple-mobile-web-app-title" content="im4change">
    <link rel="apple-touch-icon" href="/icons/logo-192x192.png">
</head>
<body id="top" class="home inner blog">
<div class="background-cover"></div>
<div class="wrapper animated">
    <header id="theme-header" class="header_inner" style="position: relative;">
        <div class="logo inner_logo" style="left:20px !important">
                <a title="Home" href="https://im4change.in/">
                    <img src="https://im4change.in/images/logo2.jpg?1582080632" class="logo_image" alt="im4change"/>                </a>
        </div>
        <div class="langhindi" style="color: #000;display:none;"
             href="https://im4change.in/">
            <a class="more-link" href="https://im4change.in/">Home</a>
                        <a href="https://im4change.in/hindi/" class="langbutton ">हिन्दी</a>
                    </div>
        <nav class="fade-in animated2" id="main-nav">
            <div class="container">
                <div class="main-menu">
    <ul class="menu" id="menu-main">
        <li class="menu-item  menu-item-type-custom  menu-item-object-custom  menu-item-has-children"
            style="left: -40px;"><a
                 target="_blank" href="https://im4change.in/">Home</a>
        </li>
        <li class="menu-item mega-menu menu-item-type-taxonomy mega-menu menu-item-object-category mega-menu menu-item-has-children parent-list"
            style=" margin-left: -40px;"><a href="#">KNOWLEDGE GATEWAY <span class="sub-indicator"></span>
            </a>
            <div class="mega-menu-block background_menu" style="padding-top:25px;">
                <div class="container">
                    <div class="mega-menu-content">
                                                                   <div class="mega-menu-item">
                                                 <h3><b>Farm Crisis</b></h3>
                                                                                                    <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/farm-crisis/farmers039-suicides-14.html"
                                                       class="left postionrel">Farm Suicides                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/farm-crisis/unemployment-30.html"
                                                       class="left postionrel">Unemployment                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/farm-crisis/rural-distress-70.html"
                                                       class="left postionrel">Rural distress                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/farm-crisis/migration-34.html"
                                                       class="left postionrel">Migration                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/farm-crisis/key-facts-72.html"
                                                       class="left postionrel">Key Facts                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/farm-crisis/debt-trap-15.html"
                                                       class="left postionrel">Debt Trap                                                       </a>
                                                </p>
                                                                                                
                                              </div> 
                                            
                                                                                        <div class="mega-menu-item">
                                                 <h3><b>Empowerment</b></h3>
                                                                                                    <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/empowerment/union-budget-73.html"
                                                       class="left postionrel">Union Budget And Other Economic Policies                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/empowerment/forest-and-tribal-rights-61.html"
                                                       class="left postionrel">Forest and Tribal Rights                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/empowerment/right-to-education-60.html"
                                                       class="left postionrel">Right to Education                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/empowerment/right-to-food-59.html"
                                                       class="left postionrel">Right to Food                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/empowerment/displacement-3279.html"
                                                       class="left postionrel">Displacement                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/empowerment/right-to-work-mg-nrega-39.html"
                                                       class="left postionrel">Right to Work (MG-NREGA)                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/empowerment/gender-3280.html"
                                                       class="left postionrel">GENDER                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/empowerment/right-to-information-58.html"
                                                       class="left postionrel">Right to Information                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/empowerment/social-audit-48.html"
                                                       class="left postionrel">Social Audit                                                       </a>
                                                </p>
                                                                                                
                                              </div> 
                                            
                                                                                        <div class="mega-menu-item">
                                                 <h3><b>Hunger / HDI</b></h3>
                                                                                                    <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/hunger-hdi/poverty-and-inequality-20499.html"
                                                       class="left postionrel">Poverty and inequality                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/hunger-hdi/malnutrition-41.html"
                                                       class="left postionrel">Malnutrition                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/hunger-hdi/public-health-51.html"
                                                       class="left postionrel">Public Health                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/hunger-hdi/education-50.html"
                                                       class="left postionrel">Education                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/hunger-hdi/hunger-overview-40.html"
                                                       class="left postionrel">Hunger Overview                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/hunger-hdi/hdi-overview-45.html"
                                                       class="left postionrel">HDI Overview                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/hunger-hdi/pds-ration-food-security-42.html"
                                                       class="left postionrel">PDS/ Ration/ Food Security                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/hunger-hdi/sdgs-113.html"
                                                       class="left postionrel">SDGs                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/hunger-hdi/mid-day-meal-scheme-mdms-53.html"
                                                       class="left postionrel">Mid Day Meal Scheme (MDMS)                                                       </a>
                                                </p>
                                                                                                
                                              </div> 
                                            
                                                                                        <div class="mega-menu-item">
                                                 <h3><b>Environment</b></h3>
                                                                                                    <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/environment/time-bomb-ticking-52.html"
                                                       class="left postionrel">Time Bomb Ticking                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/environment/water-and-sanitation-55.html"
                                                       class="left postionrel">Water and Sanitation                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/environment/impact-on-agriculture-54.html"
                                                       class="left postionrel">Impact on Agriculture                                                       </a>
                                                </p>
                                                                                                
                                              </div> 
                                            
                                                                                        <div class="mega-menu-item">
                                                 <h3><b>Law & Justice</b></h3>
                                                                                                    <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/law-justice/social-justice-20500.html"
                                                       class="left postionrel">Social Justice                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/law-justice/access-to-justice-47.html"
                                                       class="left postionrel">Access to Justice                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/law-justice/human-rights-56.html"
                                                       class="left postionrel">Human Rights                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/law-justice/corruption-35.html"
                                                       class="left postionrel">Corruption                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/law-justice/general-insecurity-46.html"
                                                       class="left postionrel">General Insecurity                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/law-justice/disaster-relief-49.html"
                                                       class="left postionrel">Disaster &amp; Relief                                                       </a>
                                                </p>
                                                                                                
                                              </div> 
                                            
                                                                                        
                    </div>
                </div>
            </div>
        </li>
        <li class="menu-item  menu-item-type-post_type  menu-item-object-page "><a  target="_blank" href="https://im4change.in/nceus_reports.php">NCEUS reports</a>
            
        </li>
        <li class="menu-item  menu-item-type-custom  menu-item-object-custom  menu-item-has-children parent-list ">
            <a  target="_blank" href="https://im4change.in/about-us-9.html">About Us <span
                    class="sub-indicator"></span></a>
            <ul class="sub-menu aboutmenu">
                <li class="menu-item  menu-item-type-post_type  menu-item-object-page"><a
                        target="_blank" href="https://im4change.in/objectives-8.html">Objectives</a>
                </li>
                <li class="menu-item  menu-item-type-post_type  menu-item-object-page"><a
                         target="_blank" href="https://im4change.in/contactus.php">Contact
                        Us</a></li>
                <li class="menu-item  menu-item-type-post_type  menu-item-object-page"><a
                         target="_blank" href="https://im4change.in/about-us-9.html">About
                        Us</a></li>
            </ul>
        </li>
        <li class="menu-item  menu-item-type-custom  menu-item-object-custom  menu-item-has-children ">
            <a  target="_blank" href="https://im4change.in/fellowships.php" title="Fellowships">Fellowships</a>
        </li>
        <li class="menu-item  menu-item-type-custom  menu-item-object-custom  menu-item-has-children  "><a
                 target="_blank" href="https://im4change.in/media-workshops.php">Workshops</a>
        </li>
        <li class="menu-item  menu-item-type-custom  menu-item-object-custom  menu-item-has-children  "><a
                 target="_blank" href="https://im4change.in/research.php">Research</a></li>
        <li class="menu-item  menu-item-type-custom  menu-item-object-custom  menu-item-has-children   "><a
                 target="_blank" href="https://im4change.in/links-64">Partners</a></li>
        <li class="menu-item  menu-item-type-custom  menu-item-object-custom  menu-item-has-children"
            id="menu-item-539"><a  target="_blank" href="https://im4change.in/hindi/"
                                  class="langbutton langlinkfont17">हिन्दी</a></li>
    </ul>
</div>            </div>


                        <!--  <div style="float: right;">
                            <script async src="https://cse.google.com/cse.js?cx=18b4f2e0f11bed3dd"></script>
                            <div class="gcse-search"></div>
                        </div> -->
                       
            <div class="search-block" style=" margin-left: 8px; margin-right: 7px;">
                <form method="get" id="searchform" name="searchform"
                      action="https://im4change.in/search"
                      onsubmit="return searchvalidate();">
                    <button class="search-button" type="submit" value="Search"></button>
                    <input type="text" id="s" name="qryStr" value=""
                           onfocus="if (this.value == 'Search...') {this.value = '';}"
                           onblur="if (this.value == '') {this.value = 'Search...';}">
                </form>
            </div>
        </nav>
    </header>
    <div class="container">
        <div id="main-content" class=" main1 container fade-in animated3 sidebar-narrow-left">
            <div class="content-wrap">
                <div class="content" style="width: 900px;min-height: 500px;">
                    <section class="cat-box recent-box innerCatRecent">
    <h1 class="cat-box-title">Drugs on hold over doubts about Indian trials</h1>
    <a href="JavaScript:void(0);" onclick="return shareArticle(26708);">
        <img src="https://im4change.in/images/email.png?1582080630" border="0" width="24" align="right" alt="Share this article"/>    </a>

    <a href="https://im4change.in/latest-news-updates/drugs-on-hold-over-doubts-about-indian-trials-4674746/print"
       rel="nofollow">
        <img src="https://im4change.in/images/icon-print.png?1582080630" border="0" width="24" align="right" alt="Share this article"/>
    </a>
</section>
<section class="recent-box innerCatRecent">
    <small class="pb-1"><span class="dateIcn">
    	<img src="https://im4change.in/images/published.svg?1582080666" alt="published"/> 
		 Published on</span><span class="text-date"> Dec 7, 2014</span>
        &nbsp; <span
                class="dateIcn">
		 	<img src="https://im4change.in/images/modified.svg?1582080666" alt="modified"/>    	 Modified on </span><span class="text-date"> Dec 7, 2014</span>
    </small>
</section>
<div class="clear"></div>
<div style="padding-top: 10px;">
    <div class="innerLineHeight">
        <div class="middleContent innerInput latest-news-updates">
            <table>
                <tr>
                    <td>
                                                <div>
                            <div align="justify">-The Telegraph</div><p align="justify">Regulators in several European countries are suspending marketing approval for 25 generic drugs because of concerns over the quality of data from human studies conducted by an Indian contract research company, a French medical safety agency said on Friday.</p><p align="justify">Drug regulators in Belgium, France, Germany and Luxembourg have decided to suspend the marketing authorisation for the generic drugs after they discovered &quot;irregularities&quot; in documents relating to human studies conducted by GVK Bio in Hyderabad.</p><p align="justify">&quot;This decision is taken as a precaution. No element at this stage has led to establish a true risk to human health or a lack of efficacy of these drugs,&quot; France's National Agency for Medication Safety and Health Products, or ANSM, said on its website.</p><p align="justify">The suspended drugs have equivalents made by international drug makers that can be used as alternatives, so patients will not have to interrupt their treatment, the ANSM said.</p><p align="justify">While the European regulators' decisions have no implications for the marketing of these generic drugs in India, a Delhi-based pharmacology expert said, they highlight concerns that human studies of drugs in India have often breached rules that make up good clinical practice.</p><p align="justify">GVK Bio had between 2008 and 2014 conducted bio-equivalence studies that were intended to show that the generic drugs have the same pharmacological behaviour in humans as their original branded versions.</p><p align="justify">During site inspections of GVK Bio in Hyderabad, ANSM inspectors reported finding irregularities in electrocardiogram documents related to the studies.</p><p align="justify">While electrocardiograms themselves do not show bio-equivalence, they are used to monitor the volunteers who are given the drugs being studied. The irregularities show lack of compliance with good clinical practices, the French agency said.</p><p align="justify">GVK Bio's CEO, Manni Kantipudi, disputed the French watchdog's findings and said that electrocardiograms were not an important component of the drug efficacy studies.</p><p align="justify">While the ANSM did not provide details of the purported irregularities, GVK Bio's response to the regulators' decisions suggests there were concerns that multiple electrocardiograms, claimed as belonging to multiple volunteers, had appeared to belong to a single volunteer.</p><p align="justify">GVK Bio said in a statement on its website that it had submitted independent cardiology assessments of electrocardiograms indicating they belonged to multiple volunteers &quot;and it is difficult to conclude that they belonged to the same volunteer&quot;.</p><p align="justify">The ANSM did not name the 25 generic drugs, but given the nature of bio-equivalence studies, they are likely to be generic drugs manufactured by Indian companies seeking marketing approvals in Europe.</p><p align="justify">A pharmacology specialist who has been tracking clinical trials said the regulators' decisions affect marketing approvals for the 25 generic drugs only in Europe, but &quot;brings India a bad name&quot;.</p><p align="justify">&quot;This is really an issue between the Indian (drug) exporters, their contract research organisation and European regulators,&quot; said Chandra Gulhati, editor of the Monthly Index of Medical Specialities, India.</p><p align="justify">GVK Bio, Gulhati said, had also been embroiled in controversy six years ago when a man in his mid-20s who had taken part in a bio-equivalence study run by the company died.</p><p align="justify">While it emerged that the volunteer had taken part in several bio-equivalence studies too close to one another, Gulhati said, those who recruit volunteers for human studies should take the responsibility of ensuring that the volunteers rigorously follow guidelines.</p><p align="justify">Kantipudi said the ANSM had drawn its conclusions about the electrocardiograms relating to the 25 generic drugs without taking into account the company's views.</p><p align="justify">&quot;We have agreed to redo the studies, I'm fine with that, but don't say that there was gross manipulation of the ECGs,&quot; Kantipudi was quoted as saying.</p><p align="justify">He said the company had received board approval to spend $5.7-$6.5 million for new studies.</p><p align="justify">The European Medicines Agency separately released a statement saying it would &quot;issue a recommendation on whether the marketing authorisations of the concerned medicines should be maintained, varied, suspended or withdrawn across the EU&quot;. That recommendation is expected in January 2015.</p><p align="justify">German watchdog BfArM said it was investigating 176 approvals given to 28 drug makers. It did not name the drugs or companies affected.</p><p align="justify">BfArM said it was ordering drug makers whose approvals had been found to have been based on data from GVK trials to stop distributing the drugs concerned until they could provide data from new studies.</p><p align="justify">The ANSM said several drug makers, whom it did not identify, had offered to carry out new studies which, if positive, could allow the drugs back on the market again.</p><p align="justify">Kantipudi said GVK Bio had started conducting new studies for five to six of its clients. About 35 of the company's 400 clients have been affected by the European regulator's move, he said.</p><p align="justify">He said the US Food and Drug Administration had inspected the company's Hyderabad plant in June, after the French regulator's audit, and was satisfied with electrocardiogram-related data. No other regulator had contacted the company since then, he added.</p><p align="justify">The quality of Indian pharmaceuticals has come under fire this year, with regulators in Europe and the US citing problems ranging from data manipulation to sanitation and banning the import of certain products from several firms.</p><p align="justify"><em>Additional reporting by Reuters</em></p>                                                           
                        </div>
                    </td>
                </tr>
            </table>
        </div>
    </div>
</div>
<div class="clear"></div>
    <br><a href="http://www.telegraphindia.com/1141207/jsp/nation/story_2471.jsp#.VIPWAHs_-BE" class="re" target="_blank">The Telegraph, 7 December, 2014, http://www.telegraphindia.com/1141207/jsp/nation/story_2471.jsp#.VIPWAHs_-BE</a><div class="clear"></div>
    <div style="padding-top: 18px;">
        <p class="post-tag">Tagged with:
                            <a class="tagcloud5"
                   href="https://im4change.in/search?qryStr=healthcare"
                   title="healthcare">
                    healthcare                </a>
                                <a class="tagcloud5"
                   href="https://im4change.in/search?qryStr=medicines"
                   title="medicines">
                    medicines                </a>
                                <a class="tagcloud5"
                   href="https://im4change.in/search?qryStr=Access to Medicines"
                   title="Access to Medicines">
                    Access to Medicines                </a>
                                <a class="tagcloud5"
                   href="https://im4change.in/search?qryStr=generic medicines"
                   title="generic medicines">
                    generic medicines                </a>
                                <a class="tagcloud5"
                   href="https://im4change.in/search?qryStr=generic medicine"
                   title="generic medicine">
                    generic medicine                </a>
                                <a class="tagcloud5"
                   href="https://im4change.in/search?qryStr=drug trial"
                   title="drug trial">
                    drug trial                </a>
                                <a class="tagcloud5"
                   href="https://im4change.in/search?qryStr=Health"
                   title="Health">
                    Health                </a>
                        </p>
    </div>
<div class="clear"></div>
    <br><br>
    <div class="widget-top">
        <h4>Related Articles</h4>
        <div class="stripe-line"></div>
    </div>
    <div class="widget-container">
        <ul id="recentcomments">
                            <li class="recentcomments">
                    <a href="https://im4change.in/latest-news-updates/fifth-report-from-gambia-implicates-indian-drug-maker-for-contaminated-syrups-banjot-kaur.html"
                       title="Fifth Report From Gambia Implicates Indian Drug Maker for Contaminated Syrups - Banjot Kaur">
                        Fifth Report From Gambia Implicates Indian Drug Maker for Contaminated Syrups - Banjot Kaur                    </a>
                </li>
                                <li class="recentcomments">
                    <a href="https://im4change.in/latest-news-updates/india-may-have-seen-steepest-dip-in-multidimensional-poverty-among-110-nations-as-per-undp-data-nikhil-rampal.html"
                       title="India may have seen steepest dip in multidimensional poverty among 110 nations as per UNDP data - Nikhil Rampal">
                        India may have seen steepest dip in multidimensional poverty among 110 nations as per UNDP data - Nikhil Rampal                    </a>
                </li>
                                <li class="recentcomments">
                    <a href="https://im4change.in/latest-news-updates/health-among-top-three-priorities-for-indian-voters-after-jobs-and-education-survey-shows-oliver-heath-jyoti-mishra-louise-tillin-sandhya-venkateswaran.html"
                       title="Health among top three priorities for Indian voters after jobs and education, survey shows - Oliver Heath, Jyoti Mishra, Louise Tillin & Sandhya Venkateswaran">
                        Health among top three priorities for Indian voters after jobs and education, survey shows - Oliver Heath, Jyoti Mishra, Louise Tillin & Sandhya Venkateswaran                    </a>
                </li>
                                <li class="recentcomments">
                    <a href="https://im4change.in/latest-news-updates/india-s-stretched-health-care-system-fails-millions-in-rural-areas-battling-sickle-cell-disease-abc.html"
                       title="India's stretched health care system fails millions in rural areas battling sickle cell disease - ABC">
                        India's stretched health care system fails millions in rural areas battling sickle cell disease - ABC                    </a>
                </li>
                                <li class="recentcomments">
                    <a href="https://im4change.in/latest-news-updates/prevalence-of-zero-food-among-infants-and-young-children-in-india-patterns-of-change-across-the-states-and-union-territories-of-india-1993-2021-the-lancet.html"
                       title="Prevalence of Zero-Food among infants and young children in India - The Lancet ">
                        Prevalence of Zero-Food among infants and young children in India - The Lancet                     </a>
                </li>
                
        </ul>
    </div>
    <div class="comment-respond" id="respond">
    <a name="commentbox">&nbsp;</a>
    <h3 class="comment-reply-title" id="reply-title">Write Comments</h3>
    <form method="post" accept-charset="utf-8" role="form" action="/latest-news-updates/drugs-on-hold-over-doubts-about-indian-trials-4674746.html"><div style="display:none;"><input type="hidden" name="_method" value="POST"/></div>    <form class="comment-form" id="commentform" method="post" action="#commentbox" onSubmit="return validate()"
          name="cmtform">
        <input type="hidden" name="cmttype" value="articlecmt"/>
        <input type="hidden" name="article_id" value="26708"/>
        <p class="comment-notes">Your email address will not be published. Required fields are marked <span
                    class="required">*</span></p>
                <p class="comment-form-author">
            <label for="commenterName">Name</label>
            <span class="required">*</span>
            <input type="text" aria-required="true" size="30"
                   value=""
                   name="commenterName" id="commenterName" required="true">
        </p>
        <p class="comment-form-email">
            <label for="commenterEmail">Email</label> <span class="required">*</span>
            <input aria-required="true" size="30" name="commenterEmail" id="commenterEmail" type="email"
                   value=""
                   required="true">
        </p>
        <p class="comment-form-contact">
            <label for="commenterPh">Contact No.</label>
            <input type="text" size="30"
                   value=""
                   name="commenterPh" id="commenterPh">
        </p>
        <p class="comment-form-comment">
            <label for="comment">Comment</label>
            <textarea aria-required="true" required="true" rows="8" cols="45" name="comment"
                      id="comment"></textarea>
        </p>
        <p class="comment-form-comment">
            <label for="comment">Type the characters you see in the image below <span class="required">*</span><br><img
                        class="captchaImg"
                        src="https://im4change.in/securimage_show_art.php?tk=1200701697" alt="captcha"/>
            </label>
        </p>
        <input type="text" name="vrcode" required="true"/>

        <p class="form-submit" style="width: 200px;">
            <input type="submit" value="Post Comment" id="submit" name="submit">
        </p></form>
</div>
<style>
    .ui-widget-content {
        height: auto !important;
    }
</style>
<div id="share-modal"></div>
<style>
    .middleContent a{
        background-color: rgba(108,172,228,.2);
    }
    .middleContent a:hover{
        background-color: #418fde;
        border-color: #418fde;
        color: #000;
        }
</style>
<script>
    function shareArticle(article_id) {
        var options = {
            modal: true,
            height: 'auto',
            width: 600 + 'px'
        };
        $('#share-modal').html("");
        $('#share-modal').load('https://im4change.in/share_article?article_id=' + article_id).dialog(options).dialog('open');
    }

    function postShare() {
        var param = 'article_id=' + $("#article_id").val();
        param = param + '&y_name=' + $("#y_name").val();
        param = param + '&y_email=' + $("#y_email").val();
        param = param + '&f_name=' + $("#f_name").val();
        param = param + '&f_email=' + $("#f_email").val();
        param = param + '&y_msg=' + $("#y_msg").val();

        $.ajax({
            type: "POST",
            url: 'https://im4change.in/post_share_article',
            data: param,
            success: function (response) {
                $('#share-modal').html("Thank You, Your message posted to ");
            }
        });
        return false;
    }
</script>                </div>
            </div>
            <!-- Right Side Section Start -->
<!-- MAP Section START -->
<aside class="sidebar indexMarg">
    <div class="ad-cell">
        <a href="https://im4change.in/statemap.php" title="">
            <img src="https://im4change.in/images/map_new_version.png?1582080666" alt="India State Map" class="indiamap" width="232" height="252"/>        </a>
        <div class="rightmapbox">
            <div id="sideOne" class="docltitle"><a href="https://im4change.in/state-report/india/36" target="_blank">DOCUMENTS/
                    REPORTS</a></div>
            <div id="sideTwo" class="statetitle"><a href="https://im4change.in/states.php"target="_blank">STATE DATA/
                    HDRs.</a></div>
        </div>
        <div class="widget widgePadTop"></div>
    </div>
</aside>
<!-- MAP Section END -->
<aside class="sidebar sidePadbottom">
    <div class="rightsmlbox1" >
        <a href="https://im4change.in/knowledge_gateway" target="_blank" style="color: #035588;
    font-size: 17px;">
            KNOWLEDGE GATEWAY
        </a>
    </div>
    <div class="rightsmlbox1">

        <div>
            <p class="rightsmlbox1_title">
                <a href="https://im4change.in/newsletter" target="_blank">
                    NEWSLETTER
                </a>
            </p>
        </div>
    </div>
        <div class="rightsmlbox1" style="height: 325px;">
        <div>
            <p class="rightsmlbox1_title">
                Interview with Prof. Ravi Srivastava
            </p>
            <p class="rightsmlbox1_title">
                <a href="https://im4change.in/video/interview-with-prof-ravi-srivastava-on-current-economic-crisis">
                <img width="250" height="200" src="/images/interview_video_home.jpg" alt="Interview with Prof. Ravi Srivastava"/>
                </a>
                <!--
                <iframe width="250" height="200" src="https://www.youtube.com/embed/MmaTlntk-wc" frameborder="0" allow="accelerometer; autoplay; encrypted-media; gyroscope; picture-in-picture" allowfullscreen=""></iframe>-->
               
            </p>
            <a href="https://im4change.in/videogallery" class="more-link CatArchalAnch1" target="_blank">
                                More videos
                            </a>
        </div>
    </div>
    
        <div class="rightsmlbox1">
        <div>
            <!--div id="sstory" class="rightboxicons"></div--->
            <p class="rightsmlbox1_title"><a href="https://im4change.in/list-success-stories"  target="_blank">Success Stories</a></p>
        </div>
    </div>
    <div class="rightsmlbox1">
        <div>
            <p class="rightsmlbox1_title"><a
                        href="https://im4change.in/interviews"  target="_blank">Interviews</a>
            </p>
        </div>
    </div>

    <div class="rightsmlbox1">
        <div>
            <p class="rightsmlbox1_title"><a href="https://www.commoncause.in/page.php?id=10" >Donate</a></p>
        </div>
    </div>
    <div class="rightsmlbox1">
        <div>
            <p class="rightsmlbox1_title"><a
        href="https://im4change.in/marquee"
        class="isf_link more-link" title="India Focus?" style="border: 4px solid #fdd922;width: 90%;background-color: #fdd922;text-align: center;color: #000000;font-size:18px"  target="_blank">India Focus</a></p>        </div>
    </div>

    <div class="rightsmlbox1" style="height: 104px !important;">
        <a href="https://im4change.in/quarterly_reports.php" target="_blank">
            Quarterly Reports on Effect of Economic Slowdown on Employment in India (2008 - 2015)
        </a>
    </div>
    
<!--     <div class="rightsmlbox1">
        <a href="https://play.google.com/store/apps/details?id=com.im4.im4change" target="_blank">
            
        </a></div> -->
    <!-- <section class="cat-box recent-box secMarg">
        <h2 class="cat-box-title">Most Visited</h2>
    </section> -->
    <!-- accordion Starts here -->
    <!-- <div id="accordion" class="accordMarg">
            </div> -->
    <!-- accordion ends here -->
    <!-- Widget Tag Cloud Starts here -->
    <div id="tag_cloud-2" class="widget widget_tag_cloud">
        <section class="cat-box recent-box secMarg">
                <h2 class="cat-box-title">MOST VISITED TAGS</h2>
            </section>
        <div class="widget-top wiPdTp">
           
            <div class="stripe-line"></div>
        </div>
        <div class="widget-container">
            <div class="tagcloud">
                                    <a href="https://im4change.in/search?qryStr=Agriculture"
                       target="_blank" class="tag-link-4 font4">Agriculture</a>
                                        <a href="https://im4change.in/search?qryStr=Food Security"
                       target="_blank" class="tag-link-4 font4">Food Security</a>
                                        <a href="https://im4change.in/search?qryStr=Law and Justice"
                       target="_blank" class="tag-link-4 font4">Law and Justice</a>
                                        <a href="https://im4change.in/search?qryStr=Health"
                       target="_blank" class="tag-link-4 font4">Health</a>
                                        <a href="https://im4change.in/search?qryStr=Right to Food"
                       target="_blank" class="tag-link-4 font4">Right to Food</a>
                                        <a href="https://im4change.in/search?qryStr=Corruption"
                       target="_blank" class="tag-link-4 font4">Corruption</a>
                                        <a href="https://im4change.in/search?qryStr=farming"
                       target="_blank" class="tag-link-4 font4">farming</a>
                                        <a href="https://im4change.in/search?qryStr=Environment"
                       target="_blank" class="tag-link-4 font4">Environment</a>
                                        <a href="https://im4change.in/search?qryStr=Right to Information"
                       target="_blank" class="tag-link-4 font4">Right to Information</a>
                                        <a href="https://im4change.in/search?qryStr=NREGS"
                       target="_blank" class="tag-link-4 font4">NREGS</a>
                                        <a href="https://im4change.in/search?qryStr=Human Rights"
                       target="_blank" class="tag-link-4 font4">Human Rights</a>
                                        <a href="https://im4change.in/search?qryStr=Governance"
                       target="_blank" class="tag-link-4 font4">Governance</a>
                                        <a href="https://im4change.in/search?qryStr=PDS"
                       target="_blank" class="tag-link-4 font4">PDS</a>
                                        <a href="https://im4change.in/search?qryStr=COVID-19"
                       target="_blank" class="tag-link-4 font4">COVID-19</a>
                                        <a href="https://im4change.in/search?qryStr=Land Acquisition"
                       target="_blank" class="tag-link-4 font4">Land Acquisition</a>
                                        <a href="https://im4change.in/search?qryStr=mgnrega"
                       target="_blank" class="tag-link-4 font4">mgnrega</a>
                                        <a href="https://im4change.in/search?qryStr=Farmers"
                       target="_blank" class="tag-link-4 font4">Farmers</a>
                                        <a href="https://im4change.in/search?qryStr=transparency"
                       target="_blank" class="tag-link-4 font4">transparency</a>
                                        <a href="https://im4change.in/search?qryStr=Gender"
                       target="_blank" class="tag-link-4 font4">Gender</a>
                                        <a href="https://im4change.in/search?qryStr=Poverty"
                       target="_blank" class="tag-link-4 font4">Poverty</a>
                                    
                                <a href="https://im4change.in/search?qryStr=Farm Laws" target="_blank" class="tag-link-4 font4">Farm Laws
                </a>
                <a href="https://im4change.in/search?qryStr=Citizenship Amendment Act" target="_blank" class="tag-link-4 font4">Citizenship Amendment Act
                </a>
                <a href="https://im4change.in/search?qryStr=CAA NPR NRIC" target="_blank" class="tag-link-4 font4">CAA NPR NRIC
                </a>
                <a href="https://im4change.in/search?qryStr=Job Losses" target="_blank" class="tag-link-4 font4">Job Losses
                </a>
                <a href="https://im4change.in/search?qryStr=Migrant Workers" target="_blank" class="tag-link-4 font4">Migrant Workers
                </a>
                <a href="https://im4change.in/search?qryStr=Unemployment" target="_blank" class="tag-link-4 font4">Unemployment
                </a>
                <a href="https://im4change.in/search?qryStr=PMGKAY" target="_blank" class="tag-link-4 font4">PMGKAY
                </a>
                <a href="https://im4change.in/search?qryStr=PM-KISAN" target="_blank" class="tag-link-4 font4">PM-KISAN
                </a>
                <a href="https://im4change.in/search?qryStr=PM-CARES" target="_blank" class="tag-link-4 font4">PM-CARES
                </a>
                <a href="https://im4change.in/search?qryStr=LFPR" target="_blank" class="tag-link-4 font4">LFPR
                </a>
                
            </div>
        </div>
    </div>
    <!-- Widget Tag Cloud Ends here -->
</aside>
<!-- Right Side Section End -->
        </div>
        <section class="cat-box cats-review-box footerSec">
    <h2 class="cat-box-title vSec CatArcha">Video
        Archives</h2>
    <h2 class="cat-box-title CatArchaTitle">Archives</h2>
    <div class="cat-box-content">
        <div class="reviews-cat">
            <div class="CatArchaDiv1">
                <div class="CatArchaDiv2">
                    <ul>
                                                    <li>
                                <a href="https://im4change.in/news-alerts-57/moving-upstream-luni-fellowship.html"  target="_blank">
                                     Moving Upstream: Luni – Fellowship                                </a>
                            </li>
                                                        <li>
                                <a href="https://im4change.in/news-alerts-57/135-million-indians-exited-multidimensional-poverty-as-per-government-figures-is-that-the-same-as-poverty-reduction.html"  target="_blank">
                                     135 Million Indians Exited “Multidimensional" Poverty as per Government...                                </a>
                            </li>
                                                        <li>
                                <a href="https://im4change.in/news-alerts-57/explainer-why-are-tomato-prices-on-fire.html"  target="_blank">
                                     Explainer: Why are Tomato Prices on Fire?                                </a>
                            </li>
                                                        <li>
                                <a href="https://im4change.in/news-alerts-57/nsso-survey-only-39-1-of-all-households-have-drinking-water-within-dwelling-46-7-of-rural-households-use-firewood-for-cooking.html"  target="_blank">
                                     NSSO Survey: Only 39.1% of all Households have Drinking...                                </a>
                            </li>
                                                    <li class="CatArchalLi1">
                            <a href="https://im4change.in/news-alerts-57"
                               class="more-link CatArchalAnch1"  target="_blank">
                                More...
                            </a>
                        </li>
                    </ul>
                </div>
                                    <div class="CatArchaWidth">
                        <img class="CatArchaImg"
                             src="https://img.youtube.com/vi/I51LYnP8BOk/1.jpg"
                             alt=" Im4Change.org हिंदी वेबसाइट का परिचय. Short Video on im4change.org...">
                        <p class="CatArchaPPad">
                            <a href="https://im4change.in/video/Short-Video-on-im4change-Hindi-website-Inclusive-Media-for-Change"  target="_blank">
                                 Im4Change.org हिंदी वेबसाइट का परिचय. Short Video on im4change.org...                            </a>
                        </p>
                    </div>
                                        <div class="CatArchaWidth">
                        <img class="CatArchaImg"
                             src="https://img.youtube.com/vi/kNqha-SwfIY/1.jpg"
                             alt=" "Session 1: Scope of IDEA and AgriStack" in Exploring...">
                        <p class="CatArchaPPad">
                            <a href="https://im4change.in/video/Session-1- Scope-of-IDEA-and-AgriStack-in-Exploring-Digitalisation-in-Agriculture-29-April-2022"  target="_blank">
                                 "Session 1: Scope of IDEA and AgriStack" in Exploring...                            </a>
                        </p>
                    </div>
                                        <div class="CatArchaWidth">
                        <img class="CatArchaImg"
                             src="https://img.youtube.com/vi/6kIVjlgZItk/1.jpg"
                             alt=" "Session 2: Farmer Centric Digitalisation in Agriculture" in Exploring...">
                        <p class="CatArchaPPad">
                            <a href="https://im4change.in/video/Session-2-Farmer-Centric-Digitalisation-in-Agriculture-in-Exploring-Digitalisation-in-Agriculture-29-April-2022"  target="_blank">
                                 "Session 2: Farmer Centric Digitalisation in Agriculture" in Exploring...                            </a>
                        </p>
                    </div>
                                        <div class="CatArchaWidth">
                        <img class="CatArchaImg"
                             src="https://img.youtube.com/vi/2BeHTu0y7xc/1.jpg"
                             alt=" "Session 3: Future of Digitalisation in Agriculture" in Exploring...">
                        <p class="CatArchaPPad">
                            <a href="https://im4change.in/video/Session-3-Future-of-Digitalisation-in-Agriculture-in-Exploring-Digitalisation-in-Agriculture-29-April-2022"  target="_blank">
                                 "Session 3: Future of Digitalisation in Agriculture" in Exploring...                            </a>
                        </p>
                    </div>
                    


                <div class="divWidth">
                    <ul class="divWidthMarg">
                                                    <li>
                                <a href="https://im4change.in/video/Public-Spending-on-Agriculture-in-India-Source-Foundation-for-Agrarian-Studies"
                                   title="Public Spending on Agriculture in India (Source: Foundation for Agrarian Studies)"  target="_blank">
                                     Public Spending on Agriculture in India (Source: Foundation for...</a>
                            </li>
                                                        <li>
                                <a href="https://im4change.in/video/Agrarian-Change-Seminar-Protests-against-the-New-Farm-Laws-in-India-by-Prof-Vikas-Rawal-JNU-Source-Journal-Of-Agrarian-Change"
                                   title="Agrarian Change Seminar: 'Protests against the New Farm Laws in India' by Prof. Vikas Rawal, JNU (Source: Journal Of Agrarian Change) "  target="_blank">
                                     Agrarian Change Seminar: 'Protests against the New Farm Laws...</a>
                            </li>
                                                        <li>
                                <a href="https://im4change.in/video/Webinar-Ramrao-The-Story-of-India-Farm-Crisis-Source-Azim-Premji-University"
                                   title="Webinar: Ramrao - The Story of India's Farm Crisis (Source: Azim Premji University)"  target="_blank">
                                     Webinar: Ramrao - The Story of India's Farm Crisis...</a>
                            </li>
                                                        <li>
                                <a href="https://im4change.in/video/water-and-agricultural-transformation-in-India"
                                   title="Water and Agricultural Transformation in India: A Symbiotic Relationship (Source: IGIDR)"  target="_blank">
                                     Water and Agricultural Transformation in India: A Symbiotic Relationship...</a>
                            </li>
                                                    <li class="CatArchalLi1">
                            <a href="https://im4change.in/videogallery"
                               class="more-link CatArchalAnch1"  target="_blank">
                                More...
                            </a>
                        </li>
                    </ul>
                </div>
            </div>
        </div>
    </div>
</section>    </div>
    <div class="clear"></div>
    <!-- Footer option Starts here -->
    <div class="footer-bottom fade-in animated4">
        <div class="container">
            <div class="social-icons icon_flat">
                <p class="SocialMargTop"> Website Developed by <a target="_blank" title="Web Development"
                                                                  class="wot right"
                                                                  href="http://www.ravinderkhurana.com/" rel="nofollow">
                                                                  RAVINDErkHURANA.com</a></p>
            </div>
            <div class="alignleft">
                <a
     target="_blank" href="https://im4change.in/objectives-8.html"
    class="link"
    title="Objectives">Objectives</a> | <a
     target="_blank" href="https://im4change.in/about-us-9.html"
    class="link" title="About Us">About Us</a> | <a
     target="_blank" href="https://im4change.in/media-workshops.php"
    class="ucwords">Workshops</a> | <a
     target="_blank" href="https://im4change.in/disclaimer/disclaimer-149.html"
    title="Disclaimer">Disclaimer</a>            </div>
        </div>
    </div>
    <!-- Footer option ends here -->
</div>
<div id="connect">
    <a target="_blank"
       href="http://www.facebook.com/sharer.php?u=https://im4change.in/latest-news-updates/drugs-on-hold-over-doubts-about-indian-trials-4674746.html"
       title="Share on Facebook">
        <img src="https://im4change.in/images/Facebook.png?1582080640" alt="share on Facebook" class="ImgBorder"/>
    </a><br/>
    <a target="_blank"
       href="http://twitter.com/share?text=Im4change&amp;url=https://im4change.in/latest-news-updates/drugs-on-hold-over-doubts-about-indian-trials-4674746.html"
       title="Share on Twitter">
        <img src="https://im4change.in/images/twitter.png?1582080632" alt="Twitter" class="ImgBorder"/>    </a>
    <br/>
    <a href="/feeds" title="RSS Feed" target="_blank">
        <img src="https://im4change.in/images/rss.png?1582080632" alt="RSS" class="ImgBorder"/>
    </a>
    <br/>
    <a class="feedback-link" id="feedbackFormLink" href="#">
        <img src="https://im4change.in/images/feedback.png?1582080630" alt="Feedback" class="ImgBorder"/>
    </a> <br/>
    <a href="javascript:function iprl5(){var d=document,z=d.createElement('scr'+'ipt'),b=d.body,l=d.location;try{if(!b)throw(0);d.title='(Saving...) '+d.title;z.setAttribute('src',l.protocol+'//www.instapaper.com/j/WKrH3R7ORD5p?u='+encodeURIComponent(l.href)+'&amp;t='+(new Date().getTime()));b.appendChild(z);}catch(e){alert('Please wait until the page has loaded.');}}iprl5();void(0)"
       class="bookmarklet" onclick="return explain_bookmarklet();">
        <img src="https://im4change.in/images/read-it-later.png?1582080632" alt="Read Later" class="ImgBorder"/>    </a>
</div>
<!-- Feedback form Starts here -->
<div id="feedbackForm" class="overlay_form" class="ImgBorder">
    <h2>Contact Form</h2>
    <div id="contactform1">
        <div id="formleft">
            <form id="submitform" action="/contactus.php" method="post">
                <input type="hidden" name="submitform" value="submitform"/>
                <input type="hidden" name="salt_key" value="a0e0f2c6a0644a70e57ad2c96829709a"/>
                <input type="hidden" name="ref" value="feedback"/>
                <fieldset>
                    <label>Name :</label>
                    <input type="text" name="name" class="tbox" required/>
                </fieldset>
                <fieldset>
                    <label>Email :</label>
                    <input type="text" name="email" class="tbox" required/>
                </fieldset>
                <fieldset>
                    <label>Message :</label>
                    <textarea rows="5" cols="20" name="message" required></textarea>
                </fieldset>
                <fieldset>
                    Please enter security code
                    <div class="clear"></div>
                    <input type="text" name="vrcode" class="tbox"/>
                </fieldset>
                <fieldset>
                    <input type="submit" class="button" value="Submit"/>
                    &nbsp; &nbsp; &nbsp; <a href="#" id="closefeedbakcformLink">Close</a>
                </fieldset>
            </form>
        </div>
        <div class="clearfix"></div>
    </div>
</div>
<div id="donate_popup" class="modal" style="max-width: 800px;">
    <table width="100%" border="1">
        <tr>
            <td colspan="2" align="center">
                <b>Support im4change</b>
            </td>
        </tr>
        <tr>
            <td width="25%" valign="middle">
                <img src="https://im4change.in/images/logo2.jpg?1582080632" alt="" width="100%"/>            </td>
            <td style="padding-left:10px;padding-top:10px;">
                <form action="https://im4change.in/donate" method="get">
                    <table width="100%" cellpadding="2" cellspacing="2">
                        <tr>
                            <td width="33%" style="font-family: 'Script Font', cursive, Arial;font-size: 20px;font-weight: 700;">
                                10
                            </td>
                            <td width="33%" style="font-family: 'Script Font', cursive, Arial;font-size: 20px;font-weight: 700;">
                                100
                            </td>
                            <td width="33%" style="font-family: 'Script Font', cursive, Arial;font-size: 20px;font-weight: 700;">
                                1000
                            </td>
                        </tr>
                        <tr>
                            <td colspan="3">
                                &nbsp;
                            </td>
                        </tr>
                        <tr>
                            <td  style="font-family: 'Script Font', cursive, Arial;font-size: 20px;font-weight: 700;">
                                50
                            </td>
                            <td  style="font-family: 'Script Font', cursive, Arial;font-size: 20px;font-weight: 700;">
                                500
                            </td>
                            <td  style="font-family: 'Script Font', cursive, Arial;font-size: 20px;font-weight: 700;">
                                <input type="text" name="price" placeholder="?" style="font-family: 'Script Font', cursive, Arial;font-size: 20px;font-weight: 700;">
                            </td>
                        </tr>
                        <tr>
                            <td colspan="3">
                                &nbsp;
                            </td>
                        </tr>
                        <tr>
                            <td colspan="3" align="right">
                                <input type="button" name="Pay" value="Pay"
                                       style="width: 200px;background-color: rgb(205, 35, 36);color: #ffffff;"/>
                            </td>
                        </tr>
                    </table>
                </form>
            </td>
        </tr>
    </table>
</div><script type='text/javascript'>

    /* <![CDATA[ */

    var tievar = {'go_to': 'Go to...'};

    /* ]]> */

</script>
<script src="/js/tie-scripts.js?1575549704"></script><script src="/js/bootstrap.js?1575549704"></script><script src="/js/jquery.modal.min.js?1578284310"></script><script>
    $(document).ready(function() {
        // tell the autocomplete function to get its data from our php script
        $('#s').autocomplete({
            source: "/autocomplete"
        });
    });
</script>
<script src="/vj-main-sw-register.js" async></script>

<script>function init(){var imgDefer=document.getElementsByTagName('img');for(var i=0;i<imgDefer.length;i++){if(imgDefer[i].getAttribute('data-src')){imgDefer[i].setAttribute('src',imgDefer[i].getAttribute('data-src'))}}}
window.onload=init;</script>
</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

Warning (2): Cannot modify header information - headers already sent by (output started at /home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Debugger.php:853) [CORE/src/Http/ResponseEmitter.php, line 148]
Code Context
            $response->getStatusCode(),

            ($reasonPhrase ? ' ' . $reasonPhrase : '')

        ));
$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>
<!--[if lt IE 7 ]>
<html class="ie ie6" lang='en'> <![endif]-->
<!--[if IE 7 ]>
<html class="ie ie7" lang='en'> <![endif]-->
<!--[if IE 8 ]>
<html class="ie ie8" lang='en'> <![endif]-->
<!--[if (gte IE 9)|!(IE)]><!-->
<html lang='en'>
<!--<![endif]-->
<head><meta http-equiv="Content-Type" content="text/html; charset=utf-8">
    
    <title>
        LATEST NEWS UPDATES | Drugs on hold over doubts about Indian trials    </title>
    <meta name="description" content="
-The Telegraph


Regulators in several European countries are suspending marketing approval for 25 generic drugs because of concerns over the quality of data from human studies conducted by an Indian contract research company, a French medical safety agency said on Friday.


Drug..."/>
    <meta name="keywords" content="healthcare,medicines,Access to Medicines,generic medicines,generic medicine,drug trial,Health"/>
    <meta name="news_keywords" content="healthcare,medicines,Access to Medicines,generic medicines,generic medicine,drug trial,Health">
   
    <link rel="alternate" type="application/rss+xml" title="ROR" href="/ror.xml"/>
    <link rel="alternate" type="application/rss+xml" title="RSS 2.0" href="/feeds/"/>
    <link rel="stylesheet" href="/css/bootstrap.min.css?1697864993"/>    <link rel="stylesheet" href="/css/style.css?v=1.1.2"/>    <link rel="stylesheet" href="/css/style-inner.css?1577045210"/>    <link rel="stylesheet" id="Oswald-css"
          href="https://fonts.googleapis.com/css?family=Oswald%3Aregular%2C700&amp;ver=3.8.1" type="text/css"
          media="all">
    <link rel="stylesheet" href="/css/jquery.modal.min.css?1578285302"/>    <script src="/js/jquery-1.10.2.js?1575549704"></script>    <script src="/js/jquery-migrate.min.js?1575549704"></script>    <link rel="shortcut icon" href="/favicon.ico" title="Favicon">
    <link rel="stylesheet" href="/css/jquery-ui.css?1580720609"/>    <script src="/js/jquery-ui.js?1575549704"></script>    <link rel="preload" as="style" href="https://www.im4change.org/css/custom.css" onload="this.rel='stylesheet'" media="all" crossorigin="anonymous">
<link rel="preload" as="style" href="https://www.im4change.org/css/jquery.modal.min.css" onload="this.rel='stylesheet'" media="all" crossorigin="anonymous">
<link rel="preload" as="style" href="https://www.im4change.org/css/jquery-ui.css" onload="this.rel='stylesheet'" media="all" crossorigin="anonymous">
<link rel="preload" as="style" href="https://www.im4change.org/css/li-scroller.css" onload="this.rel='stylesheet'" media="all" crossorigin="anonymous">
<!-- <link rel="preload" as="style" href="https://www.im4change.org/css/style.css" onload="this.rel='stylesheet'" media="all" crossorigin="anonymous"> -->
<link rel="preload" as="style" href="https://www.im4change.org/css/style-inner.css" onload="this.rel='stylesheet'" media="all" crossorigin="anonymous">

<link rel='dns-prefetch' href="//im4change.org/css/custom.css" crossorigin >

<link rel="preload" as="script" href="https://www.im4change.org/js/bootstrap.js">
<link rel="preload" as="script" href="https://www.im4change.org/js/jquery.li-scroller.1.0.js">
<link rel="preload" as="script" href="https://www.im4change.org/js/jquery.modal.min.js">
<link rel="preload" as="script" href="https://www.im4change.org/js/jquery.ui.totop.js">
<link rel="preload" as="script" href="https://www.im4change.org/js/jquery-1.10.2.js">
<link rel="preload" as="script" href="https://www.im4change.org/js/jquery-migrate.min.js">
<link rel="preload" as="script" href="https://www.im4change.org/js/jquery-ui.js">
<link rel="preload" as="script" href="https://www.im4change.org/js/setting.js">
<link rel="preload" as="script" href="https://www.im4change.org/js/tie-scripts.js">
    <!--[if IE]>
    <script type="text/javascript">jQuery(document).ready(function () {
        jQuery(".menu-item").has("ul").children("a").attr("aria-haspopup", "true");
    });</script>
    <![endif]-->
    <!--[if lt IE 9]>
    <script src="/js/html5.js"></script>
    <script src="/js/selectivizr-min.js"></script>
    <![endif]-->
    <!--[if IE 8]>
    <link rel="stylesheet" type="text/css" media="all" href="/css/ie8.css"/>
    <![endif]-->
    <meta property="og:title" content="LATEST NEWS UPDATES | Drugs on hold over doubts about Indian trials" />
     <meta property="og:url" content="https://im4change.in/latest-news-updates/drugs-on-hold-over-doubts-about-indian-trials-4674746.html" />
     <meta property="og:type" content="article" />
     <meta property="og:description" content="
-The Telegraph


Regulators in several European countries are suspending marketing approval for 25 generic drugs because of concerns over the quality of data from human studies conducted by an Indian contract research company, a French medical safety agency said on Friday.


Drug..." />
     <meta property="og:image" content="" />
      <meta property="fb:app_id" content="0" />
    <meta name="viewport" content="width=device-width, initial-scale=1, maximum-scale=1, user-scalable=no">

       <link rel="apple-touch-icon-precomposed" sizes="144x144" href="https://im4change.in/images/apple1.png">
    <link rel="apple-touch-icon-precomposed" sizes="120x120" href="https://im4change.in/images/apple2.png">
    <link rel="apple-touch-icon-precomposed" sizes="72x72" href="https://im4change.in/images/apple3.png">
    <link rel="apple-touch-icon-precomposed" href="https://im4change.in/images/apple4.png">

    <style>
    .gsc-results-wrapper-overlay{
        top: 38% !important;
        height: 50% !important;
    }
    .gsc-search-button-v2{
        border-color: #035588 !important;
        background-color: #035588 !important;
    }

   .gsib_a{
        height: 30px !important;
          padding: 2px 8px 1px 6px !important;
    }

   
    .gsc-search-button-v2{
        height: 41px !important;
    }
    input.gsc-input{
        background: none !important;
    }
    @media only screen and (max-width: 600px) {
        .gsc-results-wrapper-overlay{
            top: 11% !important;
            width: 87% !important;
            left: 9% !important;
            height: 43% !important;
        }

        .gsc-search-button-v2{
            padding: 10px 10px !important;
        
        }
        .gsc-input-box{
            height: 28px !important;
        }
       /* .gsib_a {
            padding: 0px 9px 4px 9px !important;
        }*/
    }
    @media only screen and (min-width: 1200px) and (max-width: 1920px) {
        table.gsc-search-box{
            width: 15% !important;
            float: right !important;
            margin-top: -118px !important;
        }

        .gsc-search-button-v2 {
            
            padding: 6px !important;
           
        }
    }


</style>

    <script>
        $(function () {
            $("#accordion").accordion({
                event: "click hoverintent"
            });
        });

        /*
         * hoverIntent | Copyright 2011 Brian Cherne
         * http://cherne.net/brian/resources/jquery.hoverIntent.html
         * modified by the jQuery UI team
         */
        $.event.special.hoverintent = {
            setup: function () {
                $(this).bind("mouseover", jQuery.event.special.hoverintent.handler);
            },
            teardown: function () {
                $(this).unbind("mouseover", jQuery.event.special.hoverintent.handler);
            },
            handler: function (event) {
                var currentX, currentY, timeout,
                    args = arguments,
                    target = $(event.target),
                    previousX = event.pageX,
                    previousY = event.pageY;

                function track(event) {
                    currentX = event.pageX;
                    currentY = event.pageY;
                }
                ;

                function clear() {
                    target
                        .unbind("mousemove", track)
                        .unbind("mouseout", clear);
                    clearTimeout(timeout);
                }

                function handler() {
                    var prop,
                        orig = event;
                    if ((Math.abs(previousX - currentX) +
                        Math.abs(previousY - currentY)) < 7) {
                        clear();
                        event = $.Event("hoverintent");
                        for (prop in orig) {
                            if (!(prop in event)) {
                                event[prop] = orig[prop];
                            }
                        }
                        // Prevent accessing the original event since the new event
                        // is fired asynchronously and the old event is no longer
                        // usable (#6028)
                        delete event.originalEvent;
                        target.trigger(event);
                    } else {
                        previousX = currentX;
                        previousY = currentY;
                        timeout = setTimeout(handler, 100);
                    }
                }

                timeout = setTimeout(handler, 100);
                target.bind({
                    mousemove: track,
                    mouseout: clear
                });
            }
        };
    </script>
    <script type="text/javascript">
        var _gaq = _gaq || [];
        _gaq.push(['_setAccount', 'UA-472075-3']);
        _gaq.push(['_trackPageview']);

        (function () {
            var ga = document.createElement('script');
            ga.type = 'text/javascript';
            ga.async = true;
            ga.src = ('https:' == document.location.protocol ? 'https://ssl' : 'http://www') + '.google-analytics.com/ga.js';
            var s = document.getElementsByTagName('script')[0];
            s.parentNode.insertBefore(ga, s);
        })();
    </script>
    <link rel="stylesheet" href="/css/custom.css?v=1.16"/>    <script src="/js/jquery.ui.totop.js?1575549704"></script>    <script src="/js/setting.js?1575549704"></script>    <link rel="manifest" href="/manifest.json">
    <meta name="theme-color" content="#616163" />
    <meta name="apple-mobile-web-app-capable" content="yes">
    <meta name="apple-mobile-web-app-status-bar-style" content="black">
    <meta name="apple-mobile-web-app-title" content="im4change">
    <link rel="apple-touch-icon" href="/icons/logo-192x192.png">
</head>
<body id="top" class="home inner blog">
<div class="background-cover"></div>
<div class="wrapper animated">
    <header id="theme-header" class="header_inner" style="position: relative;">
        <div class="logo inner_logo" style="left:20px !important">
                <a title="Home" href="https://im4change.in/">
                    <img src="https://im4change.in/images/logo2.jpg?1582080632" class="logo_image" alt="im4change"/>                </a>
        </div>
        <div class="langhindi" style="color: #000;display:none;"
             href="https://im4change.in/">
            <a class="more-link" href="https://im4change.in/">Home</a>
                        <a href="https://im4change.in/hindi/" class="langbutton ">हिन्दी</a>
                    </div>
        <nav class="fade-in animated2" id="main-nav">
            <div class="container">
                <div class="main-menu">
    <ul class="menu" id="menu-main">
        <li class="menu-item  menu-item-type-custom  menu-item-object-custom  menu-item-has-children"
            style="left: -40px;"><a
                 target="_blank" href="https://im4change.in/">Home</a>
        </li>
        <li class="menu-item mega-menu menu-item-type-taxonomy mega-menu menu-item-object-category mega-menu menu-item-has-children parent-list"
            style=" margin-left: -40px;"><a href="#">KNOWLEDGE GATEWAY <span class="sub-indicator"></span>
            </a>
            <div class="mega-menu-block background_menu" style="padding-top:25px;">
                <div class="container">
                    <div class="mega-menu-content">
                                                                   <div class="mega-menu-item">
                                                 <h3><b>Farm Crisis</b></h3>
                                                                                                    <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/farm-crisis/farmers039-suicides-14.html"
                                                       class="left postionrel">Farm Suicides                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/farm-crisis/unemployment-30.html"
                                                       class="left postionrel">Unemployment                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/farm-crisis/rural-distress-70.html"
                                                       class="left postionrel">Rural distress                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/farm-crisis/migration-34.html"
                                                       class="left postionrel">Migration                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/farm-crisis/key-facts-72.html"
                                                       class="left postionrel">Key Facts                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/farm-crisis/debt-trap-15.html"
                                                       class="left postionrel">Debt Trap                                                       </a>
                                                </p>
                                                                                                
                                              </div> 
                                            
                                                                                        <div class="mega-menu-item">
                                                 <h3><b>Empowerment</b></h3>
                                                                                                    <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/empowerment/union-budget-73.html"
                                                       class="left postionrel">Union Budget And Other Economic Policies                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/empowerment/forest-and-tribal-rights-61.html"
                                                       class="left postionrel">Forest and Tribal Rights                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/empowerment/right-to-education-60.html"
                                                       class="left postionrel">Right to Education                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/empowerment/right-to-food-59.html"
                                                       class="left postionrel">Right to Food                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/empowerment/displacement-3279.html"
                                                       class="left postionrel">Displacement                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/empowerment/right-to-work-mg-nrega-39.html"
                                                       class="left postionrel">Right to Work (MG-NREGA)                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/empowerment/gender-3280.html"
                                                       class="left postionrel">GENDER                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/empowerment/right-to-information-58.html"
                                                       class="left postionrel">Right to Information                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/empowerment/social-audit-48.html"
                                                       class="left postionrel">Social Audit                                                       </a>
                                                </p>
                                                                                                
                                              </div> 
                                            
                                                                                        <div class="mega-menu-item">
                                                 <h3><b>Hunger / HDI</b></h3>
                                                                                                    <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/hunger-hdi/poverty-and-inequality-20499.html"
                                                       class="left postionrel">Poverty and inequality                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/hunger-hdi/malnutrition-41.html"
                                                       class="left postionrel">Malnutrition                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/hunger-hdi/public-health-51.html"
                                                       class="left postionrel">Public Health                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/hunger-hdi/education-50.html"
                                                       class="left postionrel">Education                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/hunger-hdi/hunger-overview-40.html"
                                                       class="left postionrel">Hunger Overview                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/hunger-hdi/hdi-overview-45.html"
                                                       class="left postionrel">HDI Overview                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/hunger-hdi/pds-ration-food-security-42.html"
                                                       class="left postionrel">PDS/ Ration/ Food Security                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/hunger-hdi/sdgs-113.html"
                                                       class="left postionrel">SDGs                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/hunger-hdi/mid-day-meal-scheme-mdms-53.html"
                                                       class="left postionrel">Mid Day Meal Scheme (MDMS)                                                       </a>
                                                </p>
                                                                                                
                                              </div> 
                                            
                                                                                        <div class="mega-menu-item">
                                                 <h3><b>Environment</b></h3>
                                                                                                    <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/environment/time-bomb-ticking-52.html"
                                                       class="left postionrel">Time Bomb Ticking                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/environment/water-and-sanitation-55.html"
                                                       class="left postionrel">Water and Sanitation                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/environment/impact-on-agriculture-54.html"
                                                       class="left postionrel">Impact on Agriculture                                                       </a>
                                                </p>
                                                                                                
                                              </div> 
                                            
                                                                                        <div class="mega-menu-item">
                                                 <h3><b>Law & Justice</b></h3>
                                                                                                    <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/law-justice/social-justice-20500.html"
                                                       class="left postionrel">Social Justice                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/law-justice/access-to-justice-47.html"
                                                       class="left postionrel">Access to Justice                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/law-justice/human-rights-56.html"
                                                       class="left postionrel">Human Rights                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/law-justice/corruption-35.html"
                                                       class="left postionrel">Corruption                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/law-justice/general-insecurity-46.html"
                                                       class="left postionrel">General Insecurity                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/law-justice/disaster-relief-49.html"
                                                       class="left postionrel">Disaster &amp; Relief                                                       </a>
                                                </p>
                                                                                                
                                              </div> 
                                            
                                                                                        
                    </div>
                </div>
            </div>
        </li>
        <li class="menu-item  menu-item-type-post_type  menu-item-object-page "><a  target="_blank" href="https://im4change.in/nceus_reports.php">NCEUS reports</a>
            
        </li>
        <li class="menu-item  menu-item-type-custom  menu-item-object-custom  menu-item-has-children parent-list ">
            <a  target="_blank" href="https://im4change.in/about-us-9.html">About Us <span
                    class="sub-indicator"></span></a>
            <ul class="sub-menu aboutmenu">
                <li class="menu-item  menu-item-type-post_type  menu-item-object-page"><a
                        target="_blank" href="https://im4change.in/objectives-8.html">Objectives</a>
                </li>
                <li class="menu-item  menu-item-type-post_type  menu-item-object-page"><a
                         target="_blank" href="https://im4change.in/contactus.php">Contact
                        Us</a></li>
                <li class="menu-item  menu-item-type-post_type  menu-item-object-page"><a
                         target="_blank" href="https://im4change.in/about-us-9.html">About
                        Us</a></li>
            </ul>
        </li>
        <li class="menu-item  menu-item-type-custom  menu-item-object-custom  menu-item-has-children ">
            <a  target="_blank" href="https://im4change.in/fellowships.php" title="Fellowships">Fellowships</a>
        </li>
        <li class="menu-item  menu-item-type-custom  menu-item-object-custom  menu-item-has-children  "><a
                 target="_blank" href="https://im4change.in/media-workshops.php">Workshops</a>
        </li>
        <li class="menu-item  menu-item-type-custom  menu-item-object-custom  menu-item-has-children  "><a
                 target="_blank" href="https://im4change.in/research.php">Research</a></li>
        <li class="menu-item  menu-item-type-custom  menu-item-object-custom  menu-item-has-children   "><a
                 target="_blank" href="https://im4change.in/links-64">Partners</a></li>
        <li class="menu-item  menu-item-type-custom  menu-item-object-custom  menu-item-has-children"
            id="menu-item-539"><a  target="_blank" href="https://im4change.in/hindi/"
                                  class="langbutton langlinkfont17">हिन्दी</a></li>
    </ul>
</div>            </div>


                        <!--  <div style="float: right;">
                            <script async src="https://cse.google.com/cse.js?cx=18b4f2e0f11bed3dd"></script>
                            <div class="gcse-search"></div>
                        </div> -->
                       
            <div class="search-block" style=" margin-left: 8px; margin-right: 7px;">
                <form method="get" id="searchform" name="searchform"
                      action="https://im4change.in/search"
                      onsubmit="return searchvalidate();">
                    <button class="search-button" type="submit" value="Search"></button>
                    <input type="text" id="s" name="qryStr" value=""
                           onfocus="if (this.value == 'Search...') {this.value = '';}"
                           onblur="if (this.value == '') {this.value = 'Search...';}">
                </form>
            </div>
        </nav>
    </header>
    <div class="container">
        <div id="main-content" class=" main1 container fade-in animated3 sidebar-narrow-left">
            <div class="content-wrap">
                <div class="content" style="width: 900px;min-height: 500px;">
                    <section class="cat-box recent-box innerCatRecent">
    <h1 class="cat-box-title">Drugs on hold over doubts about Indian trials</h1>
    <a href="JavaScript:void(0);" onclick="return shareArticle(26708);">
        <img src="https://im4change.in/images/email.png?1582080630" border="0" width="24" align="right" alt="Share this article"/>    </a>

    <a href="https://im4change.in/latest-news-updates/drugs-on-hold-over-doubts-about-indian-trials-4674746/print"
       rel="nofollow">
        <img src="https://im4change.in/images/icon-print.png?1582080630" border="0" width="24" align="right" alt="Share this article"/>
    </a>
</section>
<section class="recent-box innerCatRecent">
    <small class="pb-1"><span class="dateIcn">
    	<img src="https://im4change.in/images/published.svg?1582080666" alt="published"/> 
		 Published on</span><span class="text-date"> Dec 7, 2014</span>
        &nbsp; <span
                class="dateIcn">
		 	<img src="https://im4change.in/images/modified.svg?1582080666" alt="modified"/>    	 Modified on </span><span class="text-date"> Dec 7, 2014</span>
    </small>
</section>
<div class="clear"></div>
<div style="padding-top: 10px;">
    <div class="innerLineHeight">
        <div class="middleContent innerInput latest-news-updates">
            <table>
                <tr>
                    <td>
                                                <div>
                            <div align="justify">-The Telegraph</div><p align="justify">Regulators in several European countries are suspending marketing approval for 25 generic drugs because of concerns over the quality of data from human studies conducted by an Indian contract research company, a French medical safety agency said on Friday.</p><p align="justify">Drug regulators in Belgium, France, Germany and Luxembourg have decided to suspend the marketing authorisation for the generic drugs after they discovered &quot;irregularities&quot; in documents relating to human studies conducted by GVK Bio in Hyderabad.</p><p align="justify">&quot;This decision is taken as a precaution. No element at this stage has led to establish a true risk to human health or a lack of efficacy of these drugs,&quot; France's National Agency for Medication Safety and Health Products, or ANSM, said on its website.</p><p align="justify">The suspended drugs have equivalents made by international drug makers that can be used as alternatives, so patients will not have to interrupt their treatment, the ANSM said.</p><p align="justify">While the European regulators' decisions have no implications for the marketing of these generic drugs in India, a Delhi-based pharmacology expert said, they highlight concerns that human studies of drugs in India have often breached rules that make up good clinical practice.</p><p align="justify">GVK Bio had between 2008 and 2014 conducted bio-equivalence studies that were intended to show that the generic drugs have the same pharmacological behaviour in humans as their original branded versions.</p><p align="justify">During site inspections of GVK Bio in Hyderabad, ANSM inspectors reported finding irregularities in electrocardiogram documents related to the studies.</p><p align="justify">While electrocardiograms themselves do not show bio-equivalence, they are used to monitor the volunteers who are given the drugs being studied. The irregularities show lack of compliance with good clinical practices, the French agency said.</p><p align="justify">GVK Bio's CEO, Manni Kantipudi, disputed the French watchdog's findings and said that electrocardiograms were not an important component of the drug efficacy studies.</p><p align="justify">While the ANSM did not provide details of the purported irregularities, GVK Bio's response to the regulators' decisions suggests there were concerns that multiple electrocardiograms, claimed as belonging to multiple volunteers, had appeared to belong to a single volunteer.</p><p align="justify">GVK Bio said in a statement on its website that it had submitted independent cardiology assessments of electrocardiograms indicating they belonged to multiple volunteers &quot;and it is difficult to conclude that they belonged to the same volunteer&quot;.</p><p align="justify">The ANSM did not name the 25 generic drugs, but given the nature of bio-equivalence studies, they are likely to be generic drugs manufactured by Indian companies seeking marketing approvals in Europe.</p><p align="justify">A pharmacology specialist who has been tracking clinical trials said the regulators' decisions affect marketing approvals for the 25 generic drugs only in Europe, but &quot;brings India a bad name&quot;.</p><p align="justify">&quot;This is really an issue between the Indian (drug) exporters, their contract research organisation and European regulators,&quot; said Chandra Gulhati, editor of the Monthly Index of Medical Specialities, India.</p><p align="justify">GVK Bio, Gulhati said, had also been embroiled in controversy six years ago when a man in his mid-20s who had taken part in a bio-equivalence study run by the company died.</p><p align="justify">While it emerged that the volunteer had taken part in several bio-equivalence studies too close to one another, Gulhati said, those who recruit volunteers for human studies should take the responsibility of ensuring that the volunteers rigorously follow guidelines.</p><p align="justify">Kantipudi said the ANSM had drawn its conclusions about the electrocardiograms relating to the 25 generic drugs without taking into account the company's views.</p><p align="justify">&quot;We have agreed to redo the studies, I'm fine with that, but don't say that there was gross manipulation of the ECGs,&quot; Kantipudi was quoted as saying.</p><p align="justify">He said the company had received board approval to spend $5.7-$6.5 million for new studies.</p><p align="justify">The European Medicines Agency separately released a statement saying it would &quot;issue a recommendation on whether the marketing authorisations of the concerned medicines should be maintained, varied, suspended or withdrawn across the EU&quot;. That recommendation is expected in January 2015.</p><p align="justify">German watchdog BfArM said it was investigating 176 approvals given to 28 drug makers. It did not name the drugs or companies affected.</p><p align="justify">BfArM said it was ordering drug makers whose approvals had been found to have been based on data from GVK trials to stop distributing the drugs concerned until they could provide data from new studies.</p><p align="justify">The ANSM said several drug makers, whom it did not identify, had offered to carry out new studies which, if positive, could allow the drugs back on the market again.</p><p align="justify">Kantipudi said GVK Bio had started conducting new studies for five to six of its clients. About 35 of the company's 400 clients have been affected by the European regulator's move, he said.</p><p align="justify">He said the US Food and Drug Administration had inspected the company's Hyderabad plant in June, after the French regulator's audit, and was satisfied with electrocardiogram-related data. No other regulator had contacted the company since then, he added.</p><p align="justify">The quality of Indian pharmaceuticals has come under fire this year, with regulators in Europe and the US citing problems ranging from data manipulation to sanitation and banning the import of certain products from several firms.</p><p align="justify"><em>Additional reporting by Reuters</em></p>                                                           
                        </div>
                    </td>
                </tr>
            </table>
        </div>
    </div>
</div>
<div class="clear"></div>
    <br><a href="http://www.telegraphindia.com/1141207/jsp/nation/story_2471.jsp#.VIPWAHs_-BE" class="re" target="_blank">The Telegraph, 7 December, 2014, http://www.telegraphindia.com/1141207/jsp/nation/story_2471.jsp#.VIPWAHs_-BE</a><div class="clear"></div>
    <div style="padding-top: 18px;">
        <p class="post-tag">Tagged with:
                            <a class="tagcloud5"
                   href="https://im4change.in/search?qryStr=healthcare"
                   title="healthcare">
                    healthcare                </a>
                                <a class="tagcloud5"
                   href="https://im4change.in/search?qryStr=medicines"
                   title="medicines">
                    medicines                </a>
                                <a class="tagcloud5"
                   href="https://im4change.in/search?qryStr=Access to Medicines"
                   title="Access to Medicines">
                    Access to Medicines                </a>
                                <a class="tagcloud5"
                   href="https://im4change.in/search?qryStr=generic medicines"
                   title="generic medicines">
                    generic medicines                </a>
                                <a class="tagcloud5"
                   href="https://im4change.in/search?qryStr=generic medicine"
                   title="generic medicine">
                    generic medicine                </a>
                                <a class="tagcloud5"
                   href="https://im4change.in/search?qryStr=drug trial"
                   title="drug trial">
                    drug trial                </a>
                                <a class="tagcloud5"
                   href="https://im4change.in/search?qryStr=Health"
                   title="Health">
                    Health                </a>
                        </p>
    </div>
<div class="clear"></div>
    <br><br>
    <div class="widget-top">
        <h4>Related Articles</h4>
        <div class="stripe-line"></div>
    </div>
    <div class="widget-container">
        <ul id="recentcomments">
                            <li class="recentcomments">
                    <a href="https://im4change.in/latest-news-updates/fifth-report-from-gambia-implicates-indian-drug-maker-for-contaminated-syrups-banjot-kaur.html"
                       title="Fifth Report From Gambia Implicates Indian Drug Maker for Contaminated Syrups - Banjot Kaur">
                        Fifth Report From Gambia Implicates Indian Drug Maker for Contaminated Syrups - Banjot Kaur                    </a>
                </li>
                                <li class="recentcomments">
                    <a href="https://im4change.in/latest-news-updates/india-may-have-seen-steepest-dip-in-multidimensional-poverty-among-110-nations-as-per-undp-data-nikhil-rampal.html"
                       title="India may have seen steepest dip in multidimensional poverty among 110 nations as per UNDP data - Nikhil Rampal">
                        India may have seen steepest dip in multidimensional poverty among 110 nations as per UNDP data - Nikhil Rampal                    </a>
                </li>
                                <li class="recentcomments">
                    <a href="https://im4change.in/latest-news-updates/health-among-top-three-priorities-for-indian-voters-after-jobs-and-education-survey-shows-oliver-heath-jyoti-mishra-louise-tillin-sandhya-venkateswaran.html"
                       title="Health among top three priorities for Indian voters after jobs and education, survey shows - Oliver Heath, Jyoti Mishra, Louise Tillin & Sandhya Venkateswaran">
                        Health among top three priorities for Indian voters after jobs and education, survey shows - Oliver Heath, Jyoti Mishra, Louise Tillin & Sandhya Venkateswaran                    </a>
                </li>
                                <li class="recentcomments">
                    <a href="https://im4change.in/latest-news-updates/india-s-stretched-health-care-system-fails-millions-in-rural-areas-battling-sickle-cell-disease-abc.html"
                       title="India's stretched health care system fails millions in rural areas battling sickle cell disease - ABC">
                        India's stretched health care system fails millions in rural areas battling sickle cell disease - ABC                    </a>
                </li>
                                <li class="recentcomments">
                    <a href="https://im4change.in/latest-news-updates/prevalence-of-zero-food-among-infants-and-young-children-in-india-patterns-of-change-across-the-states-and-union-territories-of-india-1993-2021-the-lancet.html"
                       title="Prevalence of Zero-Food among infants and young children in India - The Lancet ">
                        Prevalence of Zero-Food among infants and young children in India - The Lancet                     </a>
                </li>
                
        </ul>
    </div>
    <div class="comment-respond" id="respond">
    <a name="commentbox">&nbsp;</a>
    <h3 class="comment-reply-title" id="reply-title">Write Comments</h3>
    <form method="post" accept-charset="utf-8" role="form" action="/latest-news-updates/drugs-on-hold-over-doubts-about-indian-trials-4674746.html"><div style="display:none;"><input type="hidden" name="_method" value="POST"/></div>    <form class="comment-form" id="commentform" method="post" action="#commentbox" onSubmit="return validate()"
          name="cmtform">
        <input type="hidden" name="cmttype" value="articlecmt"/>
        <input type="hidden" name="article_id" value="26708"/>
        <p class="comment-notes">Your email address will not be published. Required fields are marked <span
                    class="required">*</span></p>
                <p class="comment-form-author">
            <label for="commenterName">Name</label>
            <span class="required">*</span>
            <input type="text" aria-required="true" size="30"
                   value=""
                   name="commenterName" id="commenterName" required="true">
        </p>
        <p class="comment-form-email">
            <label for="commenterEmail">Email</label> <span class="required">*</span>
            <input aria-required="true" size="30" name="commenterEmail" id="commenterEmail" type="email"
                   value=""
                   required="true">
        </p>
        <p class="comment-form-contact">
            <label for="commenterPh">Contact No.</label>
            <input type="text" size="30"
                   value=""
                   name="commenterPh" id="commenterPh">
        </p>
        <p class="comment-form-comment">
            <label for="comment">Comment</label>
            <textarea aria-required="true" required="true" rows="8" cols="45" name="comment"
                      id="comment"></textarea>
        </p>
        <p class="comment-form-comment">
            <label for="comment">Type the characters you see in the image below <span class="required">*</span><br><img
                        class="captchaImg"
                        src="https://im4change.in/securimage_show_art.php?tk=1200701697" alt="captcha"/>
            </label>
        </p>
        <input type="text" name="vrcode" required="true"/>

        <p class="form-submit" style="width: 200px;">
            <input type="submit" value="Post Comment" id="submit" name="submit">
        </p></form>
</div>
<style>
    .ui-widget-content {
        height: auto !important;
    }
</style>
<div id="share-modal"></div>
<style>
    .middleContent a{
        background-color: rgba(108,172,228,.2);
    }
    .middleContent a:hover{
        background-color: #418fde;
        border-color: #418fde;
        color: #000;
        }
</style>
<script>
    function shareArticle(article_id) {
        var options = {
            modal: true,
            height: 'auto',
            width: 600 + 'px'
        };
        $('#share-modal').html("");
        $('#share-modal').load('https://im4change.in/share_article?article_id=' + article_id).dialog(options).dialog('open');
    }

    function postShare() {
        var param = 'article_id=' + $("#article_id").val();
        param = param + '&y_name=' + $("#y_name").val();
        param = param + '&y_email=' + $("#y_email").val();
        param = param + '&f_name=' + $("#f_name").val();
        param = param + '&f_email=' + $("#f_email").val();
        param = param + '&y_msg=' + $("#y_msg").val();

        $.ajax({
            type: "POST",
            url: 'https://im4change.in/post_share_article',
            data: param,
            success: function (response) {
                $('#share-modal').html("Thank You, Your message posted to ");
            }
        });
        return false;
    }
</script>                </div>
            </div>
            <!-- Right Side Section Start -->
<!-- MAP Section START -->
<aside class="sidebar indexMarg">
    <div class="ad-cell">
        <a href="https://im4change.in/statemap.php" title="">
            <img src="https://im4change.in/images/map_new_version.png?1582080666" alt="India State Map" class="indiamap" width="232" height="252"/>        </a>
        <div class="rightmapbox">
            <div id="sideOne" class="docltitle"><a href="https://im4change.in/state-report/india/36" target="_blank">DOCUMENTS/
                    REPORTS</a></div>
            <div id="sideTwo" class="statetitle"><a href="https://im4change.in/states.php"target="_blank">STATE DATA/
                    HDRs.</a></div>
        </div>
        <div class="widget widgePadTop"></div>
    </div>
</aside>
<!-- MAP Section END -->
<aside class="sidebar sidePadbottom">
    <div class="rightsmlbox1" >
        <a href="https://im4change.in/knowledge_gateway" target="_blank" style="color: #035588;
    font-size: 17px;">
            KNOWLEDGE GATEWAY
        </a>
    </div>
    <div class="rightsmlbox1">

        <div>
            <p class="rightsmlbox1_title">
                <a href="https://im4change.in/newsletter" target="_blank">
                    NEWSLETTER
                </a>
            </p>
        </div>
    </div>
        <div class="rightsmlbox1" style="height: 325px;">
        <div>
            <p class="rightsmlbox1_title">
                Interview with Prof. Ravi Srivastava
            </p>
            <p class="rightsmlbox1_title">
                <a href="https://im4change.in/video/interview-with-prof-ravi-srivastava-on-current-economic-crisis">
                <img width="250" height="200" src="/images/interview_video_home.jpg" alt="Interview with Prof. Ravi Srivastava"/>
                </a>
                <!--
                <iframe width="250" height="200" src="https://www.youtube.com/embed/MmaTlntk-wc" frameborder="0" allow="accelerometer; autoplay; encrypted-media; gyroscope; picture-in-picture" allowfullscreen=""></iframe>-->
               
            </p>
            <a href="https://im4change.in/videogallery" class="more-link CatArchalAnch1" target="_blank">
                                More videos
                            </a>
        </div>
    </div>
    
        <div class="rightsmlbox1">
        <div>
            <!--div id="sstory" class="rightboxicons"></div--->
            <p class="rightsmlbox1_title"><a href="https://im4change.in/list-success-stories"  target="_blank">Success Stories</a></p>
        </div>
    </div>
    <div class="rightsmlbox1">
        <div>
            <p class="rightsmlbox1_title"><a
                        href="https://im4change.in/interviews"  target="_blank">Interviews</a>
            </p>
        </div>
    </div>

    <div class="rightsmlbox1">
        <div>
            <p class="rightsmlbox1_title"><a href="https://www.commoncause.in/page.php?id=10" >Donate</a></p>
        </div>
    </div>
    <div class="rightsmlbox1">
        <div>
            <p class="rightsmlbox1_title"><a
        href="https://im4change.in/marquee"
        class="isf_link more-link" title="India Focus?" style="border: 4px solid #fdd922;width: 90%;background-color: #fdd922;text-align: center;color: #000000;font-size:18px"  target="_blank">India Focus</a></p>        </div>
    </div>

    <div class="rightsmlbox1" style="height: 104px !important;">
        <a href="https://im4change.in/quarterly_reports.php" target="_blank">
            Quarterly Reports on Effect of Economic Slowdown on Employment in India (2008 - 2015)
        </a>
    </div>
    
<!--     <div class="rightsmlbox1">
        <a href="https://play.google.com/store/apps/details?id=com.im4.im4change" target="_blank">
            
        </a></div> -->
    <!-- <section class="cat-box recent-box secMarg">
        <h2 class="cat-box-title">Most Visited</h2>
    </section> -->
    <!-- accordion Starts here -->
    <!-- <div id="accordion" class="accordMarg">
            </div> -->
    <!-- accordion ends here -->
    <!-- Widget Tag Cloud Starts here -->
    <div id="tag_cloud-2" class="widget widget_tag_cloud">
        <section class="cat-box recent-box secMarg">
                <h2 class="cat-box-title">MOST VISITED TAGS</h2>
            </section>
        <div class="widget-top wiPdTp">
           
            <div class="stripe-line"></div>
        </div>
        <div class="widget-container">
            <div class="tagcloud">
                                    <a href="https://im4change.in/search?qryStr=Agriculture"
                       target="_blank" class="tag-link-4 font4">Agriculture</a>
                                        <a href="https://im4change.in/search?qryStr=Food Security"
                       target="_blank" class="tag-link-4 font4">Food Security</a>
                                        <a href="https://im4change.in/search?qryStr=Law and Justice"
                       target="_blank" class="tag-link-4 font4">Law and Justice</a>
                                        <a href="https://im4change.in/search?qryStr=Health"
                       target="_blank" class="tag-link-4 font4">Health</a>
                                        <a href="https://im4change.in/search?qryStr=Right to Food"
                       target="_blank" class="tag-link-4 font4">Right to Food</a>
                                        <a href="https://im4change.in/search?qryStr=Corruption"
                       target="_blank" class="tag-link-4 font4">Corruption</a>
                                        <a href="https://im4change.in/search?qryStr=farming"
                       target="_blank" class="tag-link-4 font4">farming</a>
                                        <a href="https://im4change.in/search?qryStr=Environment"
                       target="_blank" class="tag-link-4 font4">Environment</a>
                                        <a href="https://im4change.in/search?qryStr=Right to Information"
                       target="_blank" class="tag-link-4 font4">Right to Information</a>
                                        <a href="https://im4change.in/search?qryStr=NREGS"
                       target="_blank" class="tag-link-4 font4">NREGS</a>
                                        <a href="https://im4change.in/search?qryStr=Human Rights"
                       target="_blank" class="tag-link-4 font4">Human Rights</a>
                                        <a href="https://im4change.in/search?qryStr=Governance"
                       target="_blank" class="tag-link-4 font4">Governance</a>
                                        <a href="https://im4change.in/search?qryStr=PDS"
                       target="_blank" class="tag-link-4 font4">PDS</a>
                                        <a href="https://im4change.in/search?qryStr=COVID-19"
                       target="_blank" class="tag-link-4 font4">COVID-19</a>
                                        <a href="https://im4change.in/search?qryStr=Land Acquisition"
                       target="_blank" class="tag-link-4 font4">Land Acquisition</a>
                                        <a href="https://im4change.in/search?qryStr=mgnrega"
                       target="_blank" class="tag-link-4 font4">mgnrega</a>
                                        <a href="https://im4change.in/search?qryStr=Farmers"
                       target="_blank" class="tag-link-4 font4">Farmers</a>
                                        <a href="https://im4change.in/search?qryStr=transparency"
                       target="_blank" class="tag-link-4 font4">transparency</a>
                                        <a href="https://im4change.in/search?qryStr=Gender"
                       target="_blank" class="tag-link-4 font4">Gender</a>
                                        <a href="https://im4change.in/search?qryStr=Poverty"
                       target="_blank" class="tag-link-4 font4">Poverty</a>
                                    
                                <a href="https://im4change.in/search?qryStr=Farm Laws" target="_blank" class="tag-link-4 font4">Farm Laws
                </a>
                <a href="https://im4change.in/search?qryStr=Citizenship Amendment Act" target="_blank" class="tag-link-4 font4">Citizenship Amendment Act
                </a>
                <a href="https://im4change.in/search?qryStr=CAA NPR NRIC" target="_blank" class="tag-link-4 font4">CAA NPR NRIC
                </a>
                <a href="https://im4change.in/search?qryStr=Job Losses" target="_blank" class="tag-link-4 font4">Job Losses
                </a>
                <a href="https://im4change.in/search?qryStr=Migrant Workers" target="_blank" class="tag-link-4 font4">Migrant Workers
                </a>
                <a href="https://im4change.in/search?qryStr=Unemployment" target="_blank" class="tag-link-4 font4">Unemployment
                </a>
                <a href="https://im4change.in/search?qryStr=PMGKAY" target="_blank" class="tag-link-4 font4">PMGKAY
                </a>
                <a href="https://im4change.in/search?qryStr=PM-KISAN" target="_blank" class="tag-link-4 font4">PM-KISAN
                </a>
                <a href="https://im4change.in/search?qryStr=PM-CARES" target="_blank" class="tag-link-4 font4">PM-CARES
                </a>
                <a href="https://im4change.in/search?qryStr=LFPR" target="_blank" class="tag-link-4 font4">LFPR
                </a>
                
            </div>
        </div>
    </div>
    <!-- Widget Tag Cloud Ends here -->
</aside>
<!-- Right Side Section End -->
        </div>
        <section class="cat-box cats-review-box footerSec">
    <h2 class="cat-box-title vSec CatArcha">Video
        Archives</h2>
    <h2 class="cat-box-title CatArchaTitle">Archives</h2>
    <div class="cat-box-content">
        <div class="reviews-cat">
            <div class="CatArchaDiv1">
                <div class="CatArchaDiv2">
                    <ul>
                                                    <li>
                                <a href="https://im4change.in/news-alerts-57/moving-upstream-luni-fellowship.html"  target="_blank">
                                     Moving Upstream: Luni – Fellowship                                </a>
                            </li>
                                                        <li>
                                <a href="https://im4change.in/news-alerts-57/135-million-indians-exited-multidimensional-poverty-as-per-government-figures-is-that-the-same-as-poverty-reduction.html"  target="_blank">
                                     135 Million Indians Exited “Multidimensional" Poverty as per Government...                                </a>
                            </li>
                                                        <li>
                                <a href="https://im4change.in/news-alerts-57/explainer-why-are-tomato-prices-on-fire.html"  target="_blank">
                                     Explainer: Why are Tomato Prices on Fire?                                </a>
                            </li>
                                                        <li>
                                <a href="https://im4change.in/news-alerts-57/nsso-survey-only-39-1-of-all-households-have-drinking-water-within-dwelling-46-7-of-rural-households-use-firewood-for-cooking.html"  target="_blank">
                                     NSSO Survey: Only 39.1% of all Households have Drinking...                                </a>
                            </li>
                                                    <li class="CatArchalLi1">
                            <a href="https://im4change.in/news-alerts-57"
                               class="more-link CatArchalAnch1"  target="_blank">
                                More...
                            </a>
                        </li>
                    </ul>
                </div>
                                    <div class="CatArchaWidth">
                        <img class="CatArchaImg"
                             src="https://img.youtube.com/vi/I51LYnP8BOk/1.jpg"
                             alt=" Im4Change.org हिंदी वेबसाइट का परिचय. Short Video on im4change.org...">
                        <p class="CatArchaPPad">
                            <a href="https://im4change.in/video/Short-Video-on-im4change-Hindi-website-Inclusive-Media-for-Change"  target="_blank">
                                 Im4Change.org हिंदी वेबसाइट का परिचय. Short Video on im4change.org...                            </a>
                        </p>
                    </div>
                                        <div class="CatArchaWidth">
                        <img class="CatArchaImg"
                             src="https://img.youtube.com/vi/kNqha-SwfIY/1.jpg"
                             alt=" "Session 1: Scope of IDEA and AgriStack" in Exploring...">
                        <p class="CatArchaPPad">
                            <a href="https://im4change.in/video/Session-1- Scope-of-IDEA-and-AgriStack-in-Exploring-Digitalisation-in-Agriculture-29-April-2022"  target="_blank">
                                 "Session 1: Scope of IDEA and AgriStack" in Exploring...                            </a>
                        </p>
                    </div>
                                        <div class="CatArchaWidth">
                        <img class="CatArchaImg"
                             src="https://img.youtube.com/vi/6kIVjlgZItk/1.jpg"
                             alt=" "Session 2: Farmer Centric Digitalisation in Agriculture" in Exploring...">
                        <p class="CatArchaPPad">
                            <a href="https://im4change.in/video/Session-2-Farmer-Centric-Digitalisation-in-Agriculture-in-Exploring-Digitalisation-in-Agriculture-29-April-2022"  target="_blank">
                                 "Session 2: Farmer Centric Digitalisation in Agriculture" in Exploring...                            </a>
                        </p>
                    </div>
                                        <div class="CatArchaWidth">
                        <img class="CatArchaImg"
                             src="https://img.youtube.com/vi/2BeHTu0y7xc/1.jpg"
                             alt=" "Session 3: Future of Digitalisation in Agriculture" in Exploring...">
                        <p class="CatArchaPPad">
                            <a href="https://im4change.in/video/Session-3-Future-of-Digitalisation-in-Agriculture-in-Exploring-Digitalisation-in-Agriculture-29-April-2022"  target="_blank">
                                 "Session 3: Future of Digitalisation in Agriculture" in Exploring...                            </a>
                        </p>
                    </div>
                    


                <div class="divWidth">
                    <ul class="divWidthMarg">
                                                    <li>
                                <a href="https://im4change.in/video/Public-Spending-on-Agriculture-in-India-Source-Foundation-for-Agrarian-Studies"
                                   title="Public Spending on Agriculture in India (Source: Foundation for Agrarian Studies)"  target="_blank">
                                     Public Spending on Agriculture in India (Source: Foundation for...</a>
                            </li>
                                                        <li>
                                <a href="https://im4change.in/video/Agrarian-Change-Seminar-Protests-against-the-New-Farm-Laws-in-India-by-Prof-Vikas-Rawal-JNU-Source-Journal-Of-Agrarian-Change"
                                   title="Agrarian Change Seminar: 'Protests against the New Farm Laws in India' by Prof. Vikas Rawal, JNU (Source: Journal Of Agrarian Change) "  target="_blank">
                                     Agrarian Change Seminar: 'Protests against the New Farm Laws...</a>
                            </li>
                                                        <li>
                                <a href="https://im4change.in/video/Webinar-Ramrao-The-Story-of-India-Farm-Crisis-Source-Azim-Premji-University"
                                   title="Webinar: Ramrao - The Story of India's Farm Crisis (Source: Azim Premji University)"  target="_blank">
                                     Webinar: Ramrao - The Story of India's Farm Crisis...</a>
                            </li>
                                                        <li>
                                <a href="https://im4change.in/video/water-and-agricultural-transformation-in-India"
                                   title="Water and Agricultural Transformation in India: A Symbiotic Relationship (Source: IGIDR)"  target="_blank">
                                     Water and Agricultural Transformation in India: A Symbiotic Relationship...</a>
                            </li>
                                                    <li class="CatArchalLi1">
                            <a href="https://im4change.in/videogallery"
                               class="more-link CatArchalAnch1"  target="_blank">
                                More...
                            </a>
                        </li>
                    </ul>
                </div>
            </div>
        </div>
    </div>
</section>    </div>
    <div class="clear"></div>
    <!-- Footer option Starts here -->
    <div class="footer-bottom fade-in animated4">
        <div class="container">
            <div class="social-icons icon_flat">
                <p class="SocialMargTop"> Website Developed by <a target="_blank" title="Web Development"
                                                                  class="wot right"
                                                                  href="http://www.ravinderkhurana.com/" rel="nofollow">
                                                                  RAVINDErkHURANA.com</a></p>
            </div>
            <div class="alignleft">
                <a
     target="_blank" href="https://im4change.in/objectives-8.html"
    class="link"
    title="Objectives">Objectives</a> | <a
     target="_blank" href="https://im4change.in/about-us-9.html"
    class="link" title="About Us">About Us</a> | <a
     target="_blank" href="https://im4change.in/media-workshops.php"
    class="ucwords">Workshops</a> | <a
     target="_blank" href="https://im4change.in/disclaimer/disclaimer-149.html"
    title="Disclaimer">Disclaimer</a>            </div>
        </div>
    </div>
    <!-- Footer option ends here -->
</div>
<div id="connect">
    <a target="_blank"
       href="http://www.facebook.com/sharer.php?u=https://im4change.in/latest-news-updates/drugs-on-hold-over-doubts-about-indian-trials-4674746.html"
       title="Share on Facebook">
        <img src="https://im4change.in/images/Facebook.png?1582080640" alt="share on Facebook" class="ImgBorder"/>
    </a><br/>
    <a target="_blank"
       href="http://twitter.com/share?text=Im4change&amp;url=https://im4change.in/latest-news-updates/drugs-on-hold-over-doubts-about-indian-trials-4674746.html"
       title="Share on Twitter">
        <img src="https://im4change.in/images/twitter.png?1582080632" alt="Twitter" class="ImgBorder"/>    </a>
    <br/>
    <a href="/feeds" title="RSS Feed" target="_blank">
        <img src="https://im4change.in/images/rss.png?1582080632" alt="RSS" class="ImgBorder"/>
    </a>
    <br/>
    <a class="feedback-link" id="feedbackFormLink" href="#">
        <img src="https://im4change.in/images/feedback.png?1582080630" alt="Feedback" class="ImgBorder"/>
    </a> <br/>
    <a href="javascript:function iprl5(){var d=document,z=d.createElement('scr'+'ipt'),b=d.body,l=d.location;try{if(!b)throw(0);d.title='(Saving...) '+d.title;z.setAttribute('src',l.protocol+'//www.instapaper.com/j/WKrH3R7ORD5p?u='+encodeURIComponent(l.href)+'&amp;t='+(new Date().getTime()));b.appendChild(z);}catch(e){alert('Please wait until the page has loaded.');}}iprl5();void(0)"
       class="bookmarklet" onclick="return explain_bookmarklet();">
        <img src="https://im4change.in/images/read-it-later.png?1582080632" alt="Read Later" class="ImgBorder"/>    </a>
</div>
<!-- Feedback form Starts here -->
<div id="feedbackForm" class="overlay_form" class="ImgBorder">
    <h2>Contact Form</h2>
    <div id="contactform1">
        <div id="formleft">
            <form id="submitform" action="/contactus.php" method="post">
                <input type="hidden" name="submitform" value="submitform"/>
                <input type="hidden" name="salt_key" value="a0e0f2c6a0644a70e57ad2c96829709a"/>
                <input type="hidden" name="ref" value="feedback"/>
                <fieldset>
                    <label>Name :</label>
                    <input type="text" name="name" class="tbox" required/>
                </fieldset>
                <fieldset>
                    <label>Email :</label>
                    <input type="text" name="email" class="tbox" required/>
                </fieldset>
                <fieldset>
                    <label>Message :</label>
                    <textarea rows="5" cols="20" name="message" required></textarea>
                </fieldset>
                <fieldset>
                    Please enter security code
                    <div class="clear"></div>
                    <input type="text" name="vrcode" class="tbox"/>
                </fieldset>
                <fieldset>
                    <input type="submit" class="button" value="Submit"/>
                    &nbsp; &nbsp; &nbsp; <a href="#" id="closefeedbakcformLink">Close</a>
                </fieldset>
            </form>
        </div>
        <div class="clearfix"></div>
    </div>
</div>
<div id="donate_popup" class="modal" style="max-width: 800px;">
    <table width="100%" border="1">
        <tr>
            <td colspan="2" align="center">
                <b>Support im4change</b>
            </td>
        </tr>
        <tr>
            <td width="25%" valign="middle">
                <img src="https://im4change.in/images/logo2.jpg?1582080632" alt="" width="100%"/>            </td>
            <td style="padding-left:10px;padding-top:10px;">
                <form action="https://im4change.in/donate" method="get">
                    <table width="100%" cellpadding="2" cellspacing="2">
                        <tr>
                            <td width="33%" style="font-family: 'Script Font', cursive, Arial;font-size: 20px;font-weight: 700;">
                                10
                            </td>
                            <td width="33%" style="font-family: 'Script Font', cursive, Arial;font-size: 20px;font-weight: 700;">
                                100
                            </td>
                            <td width="33%" style="font-family: 'Script Font', cursive, Arial;font-size: 20px;font-weight: 700;">
                                1000
                            </td>
                        </tr>
                        <tr>
                            <td colspan="3">
                                &nbsp;
                            </td>
                        </tr>
                        <tr>
                            <td  style="font-family: 'Script Font', cursive, Arial;font-size: 20px;font-weight: 700;">
                                50
                            </td>
                            <td  style="font-family: 'Script Font', cursive, Arial;font-size: 20px;font-weight: 700;">
                                500
                            </td>
                            <td  style="font-family: 'Script Font', cursive, Arial;font-size: 20px;font-weight: 700;">
                                <input type="text" name="price" placeholder="?" style="font-family: 'Script Font', cursive, Arial;font-size: 20px;font-weight: 700;">
                            </td>
                        </tr>
                        <tr>
                            <td colspan="3">
                                &nbsp;
                            </td>
                        </tr>
                        <tr>
                            <td colspan="3" align="right">
                                <input type="button" name="Pay" value="Pay"
                                       style="width: 200px;background-color: rgb(205, 35, 36);color: #ffffff;"/>
                            </td>
                        </tr>
                    </table>
                </form>
            </td>
        </tr>
    </table>
</div><script type='text/javascript'>

    /* <![CDATA[ */

    var tievar = {'go_to': 'Go to...'};

    /* ]]> */

</script>
<script src="/js/tie-scripts.js?1575549704"></script><script src="/js/bootstrap.js?1575549704"></script><script src="/js/jquery.modal.min.js?1578284310"></script><script>
    $(document).ready(function() {
        // tell the autocomplete function to get its data from our php script
        $('#s').autocomplete({
            source: "/autocomplete"
        });
    });
</script>
<script src="/vj-main-sw-register.js" async></script>

<script>function init(){var imgDefer=document.getElementsByTagName('img');for(var i=0;i<imgDefer.length;i++){if(imgDefer[i].getAttribute('data-src')){imgDefer[i].setAttribute('src',imgDefer[i].getAttribute('data-src'))}}}
window.onload=init;</script>
</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

Warning (2): Cannot modify header information - headers already sent by (output started at /home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Debugger.php:853) [CORE/src/Http/ResponseEmitter.php, line 181]
Code Context
                    $value

                ), $first);

                $first = false;
$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>
<!--[if lt IE 7 ]>
<html class="ie ie6" lang='en'> <![endif]-->
<!--[if IE 7 ]>
<html class="ie ie7" lang='en'> <![endif]-->
<!--[if IE 8 ]>
<html class="ie ie8" lang='en'> <![endif]-->
<!--[if (gte IE 9)|!(IE)]><!-->
<html lang='en'>
<!--<![endif]-->
<head><meta http-equiv="Content-Type" content="text/html; charset=utf-8">
    
    <title>
        LATEST NEWS UPDATES | Drugs on hold over doubts about Indian trials    </title>
    <meta name="description" content="
-The Telegraph


Regulators in several European countries are suspending marketing approval for 25 generic drugs because of concerns over the quality of data from human studies conducted by an Indian contract research company, a French medical safety agency said on Friday.


Drug..."/>
    <meta name="keywords" content="healthcare,medicines,Access to Medicines,generic medicines,generic medicine,drug trial,Health"/>
    <meta name="news_keywords" content="healthcare,medicines,Access to Medicines,generic medicines,generic medicine,drug trial,Health">
   
    <link rel="alternate" type="application/rss+xml" title="ROR" href="/ror.xml"/>
    <link rel="alternate" type="application/rss+xml" title="RSS 2.0" href="/feeds/"/>
    <link rel="stylesheet" href="/css/bootstrap.min.css?1697864993"/>    <link rel="stylesheet" href="/css/style.css?v=1.1.2"/>    <link rel="stylesheet" href="/css/style-inner.css?1577045210"/>    <link rel="stylesheet" id="Oswald-css"
          href="https://fonts.googleapis.com/css?family=Oswald%3Aregular%2C700&amp;ver=3.8.1" type="text/css"
          media="all">
    <link rel="stylesheet" href="/css/jquery.modal.min.css?1578285302"/>    <script src="/js/jquery-1.10.2.js?1575549704"></script>    <script src="/js/jquery-migrate.min.js?1575549704"></script>    <link rel="shortcut icon" href="/favicon.ico" title="Favicon">
    <link rel="stylesheet" href="/css/jquery-ui.css?1580720609"/>    <script src="/js/jquery-ui.js?1575549704"></script>    <link rel="preload" as="style" href="https://www.im4change.org/css/custom.css" onload="this.rel='stylesheet'" media="all" crossorigin="anonymous">
<link rel="preload" as="style" href="https://www.im4change.org/css/jquery.modal.min.css" onload="this.rel='stylesheet'" media="all" crossorigin="anonymous">
<link rel="preload" as="style" href="https://www.im4change.org/css/jquery-ui.css" onload="this.rel='stylesheet'" media="all" crossorigin="anonymous">
<link rel="preload" as="style" href="https://www.im4change.org/css/li-scroller.css" onload="this.rel='stylesheet'" media="all" crossorigin="anonymous">
<!-- <link rel="preload" as="style" href="https://www.im4change.org/css/style.css" onload="this.rel='stylesheet'" media="all" crossorigin="anonymous"> -->
<link rel="preload" as="style" href="https://www.im4change.org/css/style-inner.css" onload="this.rel='stylesheet'" media="all" crossorigin="anonymous">

<link rel='dns-prefetch' href="//im4change.org/css/custom.css" crossorigin >

<link rel="preload" as="script" href="https://www.im4change.org/js/bootstrap.js">
<link rel="preload" as="script" href="https://www.im4change.org/js/jquery.li-scroller.1.0.js">
<link rel="preload" as="script" href="https://www.im4change.org/js/jquery.modal.min.js">
<link rel="preload" as="script" href="https://www.im4change.org/js/jquery.ui.totop.js">
<link rel="preload" as="script" href="https://www.im4change.org/js/jquery-1.10.2.js">
<link rel="preload" as="script" href="https://www.im4change.org/js/jquery-migrate.min.js">
<link rel="preload" as="script" href="https://www.im4change.org/js/jquery-ui.js">
<link rel="preload" as="script" href="https://www.im4change.org/js/setting.js">
<link rel="preload" as="script" href="https://www.im4change.org/js/tie-scripts.js">
    <!--[if IE]>
    <script type="text/javascript">jQuery(document).ready(function () {
        jQuery(".menu-item").has("ul").children("a").attr("aria-haspopup", "true");
    });</script>
    <![endif]-->
    <!--[if lt IE 9]>
    <script src="/js/html5.js"></script>
    <script src="/js/selectivizr-min.js"></script>
    <![endif]-->
    <!--[if IE 8]>
    <link rel="stylesheet" type="text/css" media="all" href="/css/ie8.css"/>
    <![endif]-->
    <meta property="og:title" content="LATEST NEWS UPDATES | Drugs on hold over doubts about Indian trials" />
     <meta property="og:url" content="https://im4change.in/latest-news-updates/drugs-on-hold-over-doubts-about-indian-trials-4674746.html" />
     <meta property="og:type" content="article" />
     <meta property="og:description" content="
-The Telegraph


Regulators in several European countries are suspending marketing approval for 25 generic drugs because of concerns over the quality of data from human studies conducted by an Indian contract research company, a French medical safety agency said on Friday.


Drug..." />
     <meta property="og:image" content="" />
      <meta property="fb:app_id" content="0" />
    <meta name="viewport" content="width=device-width, initial-scale=1, maximum-scale=1, user-scalable=no">

       <link rel="apple-touch-icon-precomposed" sizes="144x144" href="https://im4change.in/images/apple1.png">
    <link rel="apple-touch-icon-precomposed" sizes="120x120" href="https://im4change.in/images/apple2.png">
    <link rel="apple-touch-icon-precomposed" sizes="72x72" href="https://im4change.in/images/apple3.png">
    <link rel="apple-touch-icon-precomposed" href="https://im4change.in/images/apple4.png">

    <style>
    .gsc-results-wrapper-overlay{
        top: 38% !important;
        height: 50% !important;
    }
    .gsc-search-button-v2{
        border-color: #035588 !important;
        background-color: #035588 !important;
    }

   .gsib_a{
        height: 30px !important;
          padding: 2px 8px 1px 6px !important;
    }

   
    .gsc-search-button-v2{
        height: 41px !important;
    }
    input.gsc-input{
        background: none !important;
    }
    @media only screen and (max-width: 600px) {
        .gsc-results-wrapper-overlay{
            top: 11% !important;
            width: 87% !important;
            left: 9% !important;
            height: 43% !important;
        }

        .gsc-search-button-v2{
            padding: 10px 10px !important;
        
        }
        .gsc-input-box{
            height: 28px !important;
        }
       /* .gsib_a {
            padding: 0px 9px 4px 9px !important;
        }*/
    }
    @media only screen and (min-width: 1200px) and (max-width: 1920px) {
        table.gsc-search-box{
            width: 15% !important;
            float: right !important;
            margin-top: -118px !important;
        }

        .gsc-search-button-v2 {
            
            padding: 6px !important;
           
        }
    }


</style>

    <script>
        $(function () {
            $("#accordion").accordion({
                event: "click hoverintent"
            });
        });

        /*
         * hoverIntent | Copyright 2011 Brian Cherne
         * http://cherne.net/brian/resources/jquery.hoverIntent.html
         * modified by the jQuery UI team
         */
        $.event.special.hoverintent = {
            setup: function () {
                $(this).bind("mouseover", jQuery.event.special.hoverintent.handler);
            },
            teardown: function () {
                $(this).unbind("mouseover", jQuery.event.special.hoverintent.handler);
            },
            handler: function (event) {
                var currentX, currentY, timeout,
                    args = arguments,
                    target = $(event.target),
                    previousX = event.pageX,
                    previousY = event.pageY;

                function track(event) {
                    currentX = event.pageX;
                    currentY = event.pageY;
                }
                ;

                function clear() {
                    target
                        .unbind("mousemove", track)
                        .unbind("mouseout", clear);
                    clearTimeout(timeout);
                }

                function handler() {
                    var prop,
                        orig = event;
                    if ((Math.abs(previousX - currentX) +
                        Math.abs(previousY - currentY)) < 7) {
                        clear();
                        event = $.Event("hoverintent");
                        for (prop in orig) {
                            if (!(prop in event)) {
                                event[prop] = orig[prop];
                            }
                        }
                        // Prevent accessing the original event since the new event
                        // is fired asynchronously and the old event is no longer
                        // usable (#6028)
                        delete event.originalEvent;
                        target.trigger(event);
                    } else {
                        previousX = currentX;
                        previousY = currentY;
                        timeout = setTimeout(handler, 100);
                    }
                }

                timeout = setTimeout(handler, 100);
                target.bind({
                    mousemove: track,
                    mouseout: clear
                });
            }
        };
    </script>
    <script type="text/javascript">
        var _gaq = _gaq || [];
        _gaq.push(['_setAccount', 'UA-472075-3']);
        _gaq.push(['_trackPageview']);

        (function () {
            var ga = document.createElement('script');
            ga.type = 'text/javascript';
            ga.async = true;
            ga.src = ('https:' == document.location.protocol ? 'https://ssl' : 'http://www') + '.google-analytics.com/ga.js';
            var s = document.getElementsByTagName('script')[0];
            s.parentNode.insertBefore(ga, s);
        })();
    </script>
    <link rel="stylesheet" href="/css/custom.css?v=1.16"/>    <script src="/js/jquery.ui.totop.js?1575549704"></script>    <script src="/js/setting.js?1575549704"></script>    <link rel="manifest" href="/manifest.json">
    <meta name="theme-color" content="#616163" />
    <meta name="apple-mobile-web-app-capable" content="yes">
    <meta name="apple-mobile-web-app-status-bar-style" content="black">
    <meta name="apple-mobile-web-app-title" content="im4change">
    <link rel="apple-touch-icon" href="/icons/logo-192x192.png">
</head>
<body id="top" class="home inner blog">
<div class="background-cover"></div>
<div class="wrapper animated">
    <header id="theme-header" class="header_inner" style="position: relative;">
        <div class="logo inner_logo" style="left:20px !important">
                <a title="Home" href="https://im4change.in/">
                    <img src="https://im4change.in/images/logo2.jpg?1582080632" class="logo_image" alt="im4change"/>                </a>
        </div>
        <div class="langhindi" style="color: #000;display:none;"
             href="https://im4change.in/">
            <a class="more-link" href="https://im4change.in/">Home</a>
                        <a href="https://im4change.in/hindi/" class="langbutton ">हिन्दी</a>
                    </div>
        <nav class="fade-in animated2" id="main-nav">
            <div class="container">
                <div class="main-menu">
    <ul class="menu" id="menu-main">
        <li class="menu-item  menu-item-type-custom  menu-item-object-custom  menu-item-has-children"
            style="left: -40px;"><a
                 target="_blank" href="https://im4change.in/">Home</a>
        </li>
        <li class="menu-item mega-menu menu-item-type-taxonomy mega-menu menu-item-object-category mega-menu menu-item-has-children parent-list"
            style=" margin-left: -40px;"><a href="#">KNOWLEDGE GATEWAY <span class="sub-indicator"></span>
            </a>
            <div class="mega-menu-block background_menu" style="padding-top:25px;">
                <div class="container">
                    <div class="mega-menu-content">
                                                                   <div class="mega-menu-item">
                                                 <h3><b>Farm Crisis</b></h3>
                                                                                                    <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/farm-crisis/farmers039-suicides-14.html"
                                                       class="left postionrel">Farm Suicides                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/farm-crisis/unemployment-30.html"
                                                       class="left postionrel">Unemployment                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/farm-crisis/rural-distress-70.html"
                                                       class="left postionrel">Rural distress                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/farm-crisis/migration-34.html"
                                                       class="left postionrel">Migration                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/farm-crisis/key-facts-72.html"
                                                       class="left postionrel">Key Facts                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/farm-crisis/debt-trap-15.html"
                                                       class="left postionrel">Debt Trap                                                       </a>
                                                </p>
                                                                                                
                                              </div> 
                                            
                                                                                        <div class="mega-menu-item">
                                                 <h3><b>Empowerment</b></h3>
                                                                                                    <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/empowerment/union-budget-73.html"
                                                       class="left postionrel">Union Budget And Other Economic Policies                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/empowerment/forest-and-tribal-rights-61.html"
                                                       class="left postionrel">Forest and Tribal Rights                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/empowerment/right-to-education-60.html"
                                                       class="left postionrel">Right to Education                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/empowerment/right-to-food-59.html"
                                                       class="left postionrel">Right to Food                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/empowerment/displacement-3279.html"
                                                       class="left postionrel">Displacement                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/empowerment/right-to-work-mg-nrega-39.html"
                                                       class="left postionrel">Right to Work (MG-NREGA)                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/empowerment/gender-3280.html"
                                                       class="left postionrel">GENDER                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/empowerment/right-to-information-58.html"
                                                       class="left postionrel">Right to Information                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/empowerment/social-audit-48.html"
                                                       class="left postionrel">Social Audit                                                       </a>
                                                </p>
                                                                                                
                                              </div> 
                                            
                                                                                        <div class="mega-menu-item">
                                                 <h3><b>Hunger / HDI</b></h3>
                                                                                                    <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/hunger-hdi/poverty-and-inequality-20499.html"
                                                       class="left postionrel">Poverty and inequality                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/hunger-hdi/malnutrition-41.html"
                                                       class="left postionrel">Malnutrition                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/hunger-hdi/public-health-51.html"
                                                       class="left postionrel">Public Health                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/hunger-hdi/education-50.html"
                                                       class="left postionrel">Education                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/hunger-hdi/hunger-overview-40.html"
                                                       class="left postionrel">Hunger Overview                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/hunger-hdi/hdi-overview-45.html"
                                                       class="left postionrel">HDI Overview                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/hunger-hdi/pds-ration-food-security-42.html"
                                                       class="left postionrel">PDS/ Ration/ Food Security                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/hunger-hdi/sdgs-113.html"
                                                       class="left postionrel">SDGs                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/hunger-hdi/mid-day-meal-scheme-mdms-53.html"
                                                       class="left postionrel">Mid Day Meal Scheme (MDMS)                                                       </a>
                                                </p>
                                                                                                
                                              </div> 
                                            
                                                                                        <div class="mega-menu-item">
                                                 <h3><b>Environment</b></h3>
                                                                                                    <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/environment/time-bomb-ticking-52.html"
                                                       class="left postionrel">Time Bomb Ticking                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/environment/water-and-sanitation-55.html"
                                                       class="left postionrel">Water and Sanitation                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/environment/impact-on-agriculture-54.html"
                                                       class="left postionrel">Impact on Agriculture                                                       </a>
                                                </p>
                                                                                                
                                              </div> 
                                            
                                                                                        <div class="mega-menu-item">
                                                 <h3><b>Law & Justice</b></h3>
                                                                                                    <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/law-justice/social-justice-20500.html"
                                                       class="left postionrel">Social Justice                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/law-justice/access-to-justice-47.html"
                                                       class="left postionrel">Access to Justice                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/law-justice/human-rights-56.html"
                                                       class="left postionrel">Human Rights                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/law-justice/corruption-35.html"
                                                       class="left postionrel">Corruption                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/law-justice/general-insecurity-46.html"
                                                       class="left postionrel">General Insecurity                                                       </a>
                                                </p>
                                                                                                        <p style="padding-left:5px;">
                                                    <a  target="_blank" href="https://im4change.in/law-justice/disaster-relief-49.html"
                                                       class="left postionrel">Disaster &amp; Relief                                                       </a>
                                                </p>
                                                                                                
                                              </div> 
                                            
                                                                                        
                    </div>
                </div>
            </div>
        </li>
        <li class="menu-item  menu-item-type-post_type  menu-item-object-page "><a  target="_blank" href="https://im4change.in/nceus_reports.php">NCEUS reports</a>
            
        </li>
        <li class="menu-item  menu-item-type-custom  menu-item-object-custom  menu-item-has-children parent-list ">
            <a  target="_blank" href="https://im4change.in/about-us-9.html">About Us <span
                    class="sub-indicator"></span></a>
            <ul class="sub-menu aboutmenu">
                <li class="menu-item  menu-item-type-post_type  menu-item-object-page"><a
                        target="_blank" href="https://im4change.in/objectives-8.html">Objectives</a>
                </li>
                <li class="menu-item  menu-item-type-post_type  menu-item-object-page"><a
                         target="_blank" href="https://im4change.in/contactus.php">Contact
                        Us</a></li>
                <li class="menu-item  menu-item-type-post_type  menu-item-object-page"><a
                         target="_blank" href="https://im4change.in/about-us-9.html">About
                        Us</a></li>
            </ul>
        </li>
        <li class="menu-item  menu-item-type-custom  menu-item-object-custom  menu-item-has-children ">
            <a  target="_blank" href="https://im4change.in/fellowships.php" title="Fellowships">Fellowships</a>
        </li>
        <li class="menu-item  menu-item-type-custom  menu-item-object-custom  menu-item-has-children  "><a
                 target="_blank" href="https://im4change.in/media-workshops.php">Workshops</a>
        </li>
        <li class="menu-item  menu-item-type-custom  menu-item-object-custom  menu-item-has-children  "><a
                 target="_blank" href="https://im4change.in/research.php">Research</a></li>
        <li class="menu-item  menu-item-type-custom  menu-item-object-custom  menu-item-has-children   "><a
                 target="_blank" href="https://im4change.in/links-64">Partners</a></li>
        <li class="menu-item  menu-item-type-custom  menu-item-object-custom  menu-item-has-children"
            id="menu-item-539"><a  target="_blank" href="https://im4change.in/hindi/"
                                  class="langbutton langlinkfont17">हिन्दी</a></li>
    </ul>
</div>            </div>


                        <!--  <div style="float: right;">
                            <script async src="https://cse.google.com/cse.js?cx=18b4f2e0f11bed3dd"></script>
                            <div class="gcse-search"></div>
                        </div> -->
                       
            <div class="search-block" style=" margin-left: 8px; margin-right: 7px;">
                <form method="get" id="searchform" name="searchform"
                      action="https://im4change.in/search"
                      onsubmit="return searchvalidate();">
                    <button class="search-button" type="submit" value="Search"></button>
                    <input type="text" id="s" name="qryStr" value=""
                           onfocus="if (this.value == 'Search...') {this.value = '';}"
                           onblur="if (this.value == '') {this.value = 'Search...';}">
                </form>
            </div>
        </nav>
    </header>
    <div class="container">
        <div id="main-content" class=" main1 container fade-in animated3 sidebar-narrow-left">
            <div class="content-wrap">
                <div class="content" style="width: 900px;min-height: 500px;">
                    <section class="cat-box recent-box innerCatRecent">
    <h1 class="cat-box-title">Drugs on hold over doubts about Indian trials</h1>
    <a href="JavaScript:void(0);" onclick="return shareArticle(26708);">
        <img src="https://im4change.in/images/email.png?1582080630" border="0" width="24" align="right" alt="Share this article"/>    </a>

    <a href="https://im4change.in/latest-news-updates/drugs-on-hold-over-doubts-about-indian-trials-4674746/print"
       rel="nofollow">
        <img src="https://im4change.in/images/icon-print.png?1582080630" border="0" width="24" align="right" alt="Share this article"/>
    </a>
</section>
<section class="recent-box innerCatRecent">
    <small class="pb-1"><span class="dateIcn">
    	<img src="https://im4change.in/images/published.svg?1582080666" alt="published"/> 
		 Published on</span><span class="text-date"> Dec 7, 2014</span>
        &nbsp; <span
                class="dateIcn">
		 	<img src="https://im4change.in/images/modified.svg?1582080666" alt="modified"/>    	 Modified on </span><span class="text-date"> Dec 7, 2014</span>
    </small>
</section>
<div class="clear"></div>
<div style="padding-top: 10px;">
    <div class="innerLineHeight">
        <div class="middleContent innerInput latest-news-updates">
            <table>
                <tr>
                    <td>
                                                <div>
                            <div align="justify">-The Telegraph</div><p align="justify">Regulators in several European countries are suspending marketing approval for 25 generic drugs because of concerns over the quality of data from human studies conducted by an Indian contract research company, a French medical safety agency said on Friday.</p><p align="justify">Drug regulators in Belgium, France, Germany and Luxembourg have decided to suspend the marketing authorisation for the generic drugs after they discovered &quot;irregularities&quot; in documents relating to human studies conducted by GVK Bio in Hyderabad.</p><p align="justify">&quot;This decision is taken as a precaution. No element at this stage has led to establish a true risk to human health or a lack of efficacy of these drugs,&quot; France's National Agency for Medication Safety and Health Products, or ANSM, said on its website.</p><p align="justify">The suspended drugs have equivalents made by international drug makers that can be used as alternatives, so patients will not have to interrupt their treatment, the ANSM said.</p><p align="justify">While the European regulators' decisions have no implications for the marketing of these generic drugs in India, a Delhi-based pharmacology expert said, they highlight concerns that human studies of drugs in India have often breached rules that make up good clinical practice.</p><p align="justify">GVK Bio had between 2008 and 2014 conducted bio-equivalence studies that were intended to show that the generic drugs have the same pharmacological behaviour in humans as their original branded versions.</p><p align="justify">During site inspections of GVK Bio in Hyderabad, ANSM inspectors reported finding irregularities in electrocardiogram documents related to the studies.</p><p align="justify">While electrocardiograms themselves do not show bio-equivalence, they are used to monitor the volunteers who are given the drugs being studied. The irregularities show lack of compliance with good clinical practices, the French agency said.</p><p align="justify">GVK Bio's CEO, Manni Kantipudi, disputed the French watchdog's findings and said that electrocardiograms were not an important component of the drug efficacy studies.</p><p align="justify">While the ANSM did not provide details of the purported irregularities, GVK Bio's response to the regulators' decisions suggests there were concerns that multiple electrocardiograms, claimed as belonging to multiple volunteers, had appeared to belong to a single volunteer.</p><p align="justify">GVK Bio said in a statement on its website that it had submitted independent cardiology assessments of electrocardiograms indicating they belonged to multiple volunteers &quot;and it is difficult to conclude that they belonged to the same volunteer&quot;.</p><p align="justify">The ANSM did not name the 25 generic drugs, but given the nature of bio-equivalence studies, they are likely to be generic drugs manufactured by Indian companies seeking marketing approvals in Europe.</p><p align="justify">A pharmacology specialist who has been tracking clinical trials said the regulators' decisions affect marketing approvals for the 25 generic drugs only in Europe, but &quot;brings India a bad name&quot;.</p><p align="justify">&quot;This is really an issue between the Indian (drug) exporters, their contract research organisation and European regulators,&quot; said Chandra Gulhati, editor of the Monthly Index of Medical Specialities, India.</p><p align="justify">GVK Bio, Gulhati said, had also been embroiled in controversy six years ago when a man in his mid-20s who had taken part in a bio-equivalence study run by the company died.</p><p align="justify">While it emerged that the volunteer had taken part in several bio-equivalence studies too close to one another, Gulhati said, those who recruit volunteers for human studies should take the responsibility of ensuring that the volunteers rigorously follow guidelines.</p><p align="justify">Kantipudi said the ANSM had drawn its conclusions about the electrocardiograms relating to the 25 generic drugs without taking into account the company's views.</p><p align="justify">&quot;We have agreed to redo the studies, I'm fine with that, but don't say that there was gross manipulation of the ECGs,&quot; Kantipudi was quoted as saying.</p><p align="justify">He said the company had received board approval to spend $5.7-$6.5 million for new studies.</p><p align="justify">The European Medicines Agency separately released a statement saying it would &quot;issue a recommendation on whether the marketing authorisations of the concerned medicines should be maintained, varied, suspended or withdrawn across the EU&quot;. That recommendation is expected in January 2015.</p><p align="justify">German watchdog BfArM said it was investigating 176 approvals given to 28 drug makers. It did not name the drugs or companies affected.</p><p align="justify">BfArM said it was ordering drug makers whose approvals had been found to have been based on data from GVK trials to stop distributing the drugs concerned until they could provide data from new studies.</p><p align="justify">The ANSM said several drug makers, whom it did not identify, had offered to carry out new studies which, if positive, could allow the drugs back on the market again.</p><p align="justify">Kantipudi said GVK Bio had started conducting new studies for five to six of its clients. About 35 of the company's 400 clients have been affected by the European regulator's move, he said.</p><p align="justify">He said the US Food and Drug Administration had inspected the company's Hyderabad plant in June, after the French regulator's audit, and was satisfied with electrocardiogram-related data. No other regulator had contacted the company since then, he added.</p><p align="justify">The quality of Indian pharmaceuticals has come under fire this year, with regulators in Europe and the US citing problems ranging from data manipulation to sanitation and banning the import of certain products from several firms.</p><p align="justify"><em>Additional reporting by Reuters</em></p>                                                           
                        </div>
                    </td>
                </tr>
            </table>
        </div>
    </div>
</div>
<div class="clear"></div>
    <br><a href="http://www.telegraphindia.com/1141207/jsp/nation/story_2471.jsp#.VIPWAHs_-BE" class="re" target="_blank">The Telegraph, 7 December, 2014, http://www.telegraphindia.com/1141207/jsp/nation/story_2471.jsp#.VIPWAHs_-BE</a><div class="clear"></div>
    <div style="padding-top: 18px;">
        <p class="post-tag">Tagged with:
                            <a class="tagcloud5"
                   href="https://im4change.in/search?qryStr=healthcare"
                   title="healthcare">
                    healthcare                </a>
                                <a class="tagcloud5"
                   href="https://im4change.in/search?qryStr=medicines"
                   title="medicines">
                    medicines                </a>
                                <a class="tagcloud5"
                   href="https://im4change.in/search?qryStr=Access to Medicines"
                   title="Access to Medicines">
                    Access to Medicines                </a>
                                <a class="tagcloud5"
                   href="https://im4change.in/search?qryStr=generic medicines"
                   title="generic medicines">
                    generic medicines                </a>
                                <a class="tagcloud5"
                   href="https://im4change.in/search?qryStr=generic medicine"
                   title="generic medicine">
                    generic medicine                </a>
                                <a class="tagcloud5"
                   href="https://im4change.in/search?qryStr=drug trial"
                   title="drug trial">
                    drug trial                </a>
                                <a class="tagcloud5"
                   href="https://im4change.in/search?qryStr=Health"
                   title="Health">
                    Health                </a>
                        </p>
    </div>
<div class="clear"></div>
    <br><br>
    <div class="widget-top">
        <h4>Related Articles</h4>
        <div class="stripe-line"></div>
    </div>
    <div class="widget-container">
        <ul id="recentcomments">
                            <li class="recentcomments">
                    <a href="https://im4change.in/latest-news-updates/fifth-report-from-gambia-implicates-indian-drug-maker-for-contaminated-syrups-banjot-kaur.html"
                       title="Fifth Report From Gambia Implicates Indian Drug Maker for Contaminated Syrups - Banjot Kaur">
                        Fifth Report From Gambia Implicates Indian Drug Maker for Contaminated Syrups - Banjot Kaur                    </a>
                </li>
                                <li class="recentcomments">
                    <a href="https://im4change.in/latest-news-updates/india-may-have-seen-steepest-dip-in-multidimensional-poverty-among-110-nations-as-per-undp-data-nikhil-rampal.html"
                       title="India may have seen steepest dip in multidimensional poverty among 110 nations as per UNDP data - Nikhil Rampal">
                        India may have seen steepest dip in multidimensional poverty among 110 nations as per UNDP data - Nikhil Rampal                    </a>
                </li>
                                <li class="recentcomments">
                    <a href="https://im4change.in/latest-news-updates/health-among-top-three-priorities-for-indian-voters-after-jobs-and-education-survey-shows-oliver-heath-jyoti-mishra-louise-tillin-sandhya-venkateswaran.html"
                       title="Health among top three priorities for Indian voters after jobs and education, survey shows - Oliver Heath, Jyoti Mishra, Louise Tillin & Sandhya Venkateswaran">
                        Health among top three priorities for Indian voters after jobs and education, survey shows - Oliver Heath, Jyoti Mishra, Louise Tillin & Sandhya Venkateswaran                    </a>
                </li>
                                <li class="recentcomments">
                    <a href="https://im4change.in/latest-news-updates/india-s-stretched-health-care-system-fails-millions-in-rural-areas-battling-sickle-cell-disease-abc.html"
                       title="India's stretched health care system fails millions in rural areas battling sickle cell disease - ABC">
                        India's stretched health care system fails millions in rural areas battling sickle cell disease - ABC                    </a>
                </li>
                                <li class="recentcomments">
                    <a href="https://im4change.in/latest-news-updates/prevalence-of-zero-food-among-infants-and-young-children-in-india-patterns-of-change-across-the-states-and-union-territories-of-india-1993-2021-the-lancet.html"
                       title="Prevalence of Zero-Food among infants and young children in India - The Lancet ">
                        Prevalence of Zero-Food among infants and young children in India - The Lancet                     </a>
                </li>
                
        </ul>
    </div>
    <div class="comment-respond" id="respond">
    <a name="commentbox">&nbsp;</a>
    <h3 class="comment-reply-title" id="reply-title">Write Comments</h3>
    <form method="post" accept-charset="utf-8" role="form" action="/latest-news-updates/drugs-on-hold-over-doubts-about-indian-trials-4674746.html"><div style="display:none;"><input type="hidden" name="_method" value="POST"/></div>    <form class="comment-form" id="commentform" method="post" action="#commentbox" onSubmit="return validate()"
          name="cmtform">
        <input type="hidden" name="cmttype" value="articlecmt"/>
        <input type="hidden" name="article_id" value="26708"/>
        <p class="comment-notes">Your email address will not be published. Required fields are marked <span
                    class="required">*</span></p>
                <p class="comment-form-author">
            <label for="commenterName">Name</label>
            <span class="required">*</span>
            <input type="text" aria-required="true" size="30"
                   value=""
                   name="commenterName" id="commenterName" required="true">
        </p>
        <p class="comment-form-email">
            <label for="commenterEmail">Email</label> <span class="required">*</span>
            <input aria-required="true" size="30" name="commenterEmail" id="commenterEmail" type="email"
                   value=""
                   required="true">
        </p>
        <p class="comment-form-contact">
            <label for="commenterPh">Contact No.</label>
            <input type="text" size="30"
                   value=""
                   name="commenterPh" id="commenterPh">
        </p>
        <p class="comment-form-comment">
            <label for="comment">Comment</label>
            <textarea aria-required="true" required="true" rows="8" cols="45" name="comment"
                      id="comment"></textarea>
        </p>
        <p class="comment-form-comment">
            <label for="comment">Type the characters you see in the image below <span class="required">*</span><br><img
                        class="captchaImg"
                        src="https://im4change.in/securimage_show_art.php?tk=1200701697" alt="captcha"/>
            </label>
        </p>
        <input type="text" name="vrcode" required="true"/>

        <p class="form-submit" style="width: 200px;">
            <input type="submit" value="Post Comment" id="submit" name="submit">
        </p></form>
</div>
<style>
    .ui-widget-content {
        height: auto !important;
    }
</style>
<div id="share-modal"></div>
<style>
    .middleContent a{
        background-color: rgba(108,172,228,.2);
    }
    .middleContent a:hover{
        background-color: #418fde;
        border-color: #418fde;
        color: #000;
        }
</style>
<script>
    function shareArticle(article_id) {
        var options = {
            modal: true,
            height: 'auto',
            width: 600 + 'px'
        };
        $('#share-modal').html("");
        $('#share-modal').load('https://im4change.in/share_article?article_id=' + article_id).dialog(options).dialog('open');
    }

    function postShare() {
        var param = 'article_id=' + $("#article_id").val();
        param = param + '&y_name=' + $("#y_name").val();
        param = param + '&y_email=' + $("#y_email").val();
        param = param + '&f_name=' + $("#f_name").val();
        param = param + '&f_email=' + $("#f_email").val();
        param = param + '&y_msg=' + $("#y_msg").val();

        $.ajax({
            type: "POST",
            url: 'https://im4change.in/post_share_article',
            data: param,
            success: function (response) {
                $('#share-modal').html("Thank You, Your message posted to ");
            }
        });
        return false;
    }
</script>                </div>
            </div>
            <!-- Right Side Section Start -->
<!-- MAP Section START -->
<aside class="sidebar indexMarg">
    <div class="ad-cell">
        <a href="https://im4change.in/statemap.php" title="">
            <img src="https://im4change.in/images/map_new_version.png?1582080666" alt="India State Map" class="indiamap" width="232" height="252"/>        </a>
        <div class="rightmapbox">
            <div id="sideOne" class="docltitle"><a href="https://im4change.in/state-report/india/36" target="_blank">DOCUMENTS/
                    REPORTS</a></div>
            <div id="sideTwo" class="statetitle"><a href="https://im4change.in/states.php"target="_blank">STATE DATA/
                    HDRs.</a></div>
        </div>
        <div class="widget widgePadTop"></div>
    </div>
</aside>
<!-- MAP Section END -->
<aside class="sidebar sidePadbottom">
    <div class="rightsmlbox1" >
        <a href="https://im4change.in/knowledge_gateway" target="_blank" style="color: #035588;
    font-size: 17px;">
            KNOWLEDGE GATEWAY
        </a>
    </div>
    <div class="rightsmlbox1">

        <div>
            <p class="rightsmlbox1_title">
                <a href="https://im4change.in/newsletter" target="_blank">
                    NEWSLETTER
                </a>
            </p>
        </div>
    </div>
        <div class="rightsmlbox1" style="height: 325px;">
        <div>
            <p class="rightsmlbox1_title">
                Interview with Prof. Ravi Srivastava
            </p>
            <p class="rightsmlbox1_title">
                <a href="https://im4change.in/video/interview-with-prof-ravi-srivastava-on-current-economic-crisis">
                <img width="250" height="200" src="/images/interview_video_home.jpg" alt="Interview with Prof. Ravi Srivastava"/>
                </a>
                <!--
                <iframe width="250" height="200" src="https://www.youtube.com/embed/MmaTlntk-wc" frameborder="0" allow="accelerometer; autoplay; encrypted-media; gyroscope; picture-in-picture" allowfullscreen=""></iframe>-->
               
            </p>
            <a href="https://im4change.in/videogallery" class="more-link CatArchalAnch1" target="_blank">
                                More videos
                            </a>
        </div>
    </div>
    
        <div class="rightsmlbox1">
        <div>
            <!--div id="sstory" class="rightboxicons"></div--->
            <p class="rightsmlbox1_title"><a href="https://im4change.in/list-success-stories"  target="_blank">Success Stories</a></p>
        </div>
    </div>
    <div class="rightsmlbox1">
        <div>
            <p class="rightsmlbox1_title"><a
                        href="https://im4change.in/interviews"  target="_blank">Interviews</a>
            </p>
        </div>
    </div>

    <div class="rightsmlbox1">
        <div>
            <p class="rightsmlbox1_title"><a href="https://www.commoncause.in/page.php?id=10" >Donate</a></p>
        </div>
    </div>
    <div class="rightsmlbox1">
        <div>
            <p class="rightsmlbox1_title"><a
        href="https://im4change.in/marquee"
        class="isf_link more-link" title="India Focus?" style="border: 4px solid #fdd922;width: 90%;background-color: #fdd922;text-align: center;color: #000000;font-size:18px"  target="_blank">India Focus</a></p>        </div>
    </div>

    <div class="rightsmlbox1" style="height: 104px !important;">
        <a href="https://im4change.in/quarterly_reports.php" target="_blank">
            Quarterly Reports on Effect of Economic Slowdown on Employment in India (2008 - 2015)
        </a>
    </div>
    
<!--     <div class="rightsmlbox1">
        <a href="https://play.google.com/store/apps/details?id=com.im4.im4change" target="_blank">
            
        </a></div> -->
    <!-- <section class="cat-box recent-box secMarg">
        <h2 class="cat-box-title">Most Visited</h2>
    </section> -->
    <!-- accordion Starts here -->
    <!-- <div id="accordion" class="accordMarg">
            </div> -->
    <!-- accordion ends here -->
    <!-- Widget Tag Cloud Starts here -->
    <div id="tag_cloud-2" class="widget widget_tag_cloud">
        <section class="cat-box recent-box secMarg">
                <h2 class="cat-box-title">MOST VISITED TAGS</h2>
            </section>
        <div class="widget-top wiPdTp">
           
            <div class="stripe-line"></div>
        </div>
        <div class="widget-container">
            <div class="tagcloud">
                                    <a href="https://im4change.in/search?qryStr=Agriculture"
                       target="_blank" class="tag-link-4 font4">Agriculture</a>
                                        <a href="https://im4change.in/search?qryStr=Food Security"
                       target="_blank" class="tag-link-4 font4">Food Security</a>
                                        <a href="https://im4change.in/search?qryStr=Law and Justice"
                       target="_blank" class="tag-link-4 font4">Law and Justice</a>
                                        <a href="https://im4change.in/search?qryStr=Health"
                       target="_blank" class="tag-link-4 font4">Health</a>
                                        <a href="https://im4change.in/search?qryStr=Right to Food"
                       target="_blank" class="tag-link-4 font4">Right to Food</a>
                                        <a href="https://im4change.in/search?qryStr=Corruption"
                       target="_blank" class="tag-link-4 font4">Corruption</a>
                                        <a href="https://im4change.in/search?qryStr=farming"
                       target="_blank" class="tag-link-4 font4">farming</a>
                                        <a href="https://im4change.in/search?qryStr=Environment"
                       target="_blank" class="tag-link-4 font4">Environment</a>
                                        <a href="https://im4change.in/search?qryStr=Right to Information"
                       target="_blank" class="tag-link-4 font4">Right to Information</a>
                                        <a href="https://im4change.in/search?qryStr=NREGS"
                       target="_blank" class="tag-link-4 font4">NREGS</a>
                                        <a href="https://im4change.in/search?qryStr=Human Rights"
                       target="_blank" class="tag-link-4 font4">Human Rights</a>
                                        <a href="https://im4change.in/search?qryStr=Governance"
                       target="_blank" class="tag-link-4 font4">Governance</a>
                                        <a href="https://im4change.in/search?qryStr=PDS"
                       target="_blank" class="tag-link-4 font4">PDS</a>
                                        <a href="https://im4change.in/search?qryStr=COVID-19"
                       target="_blank" class="tag-link-4 font4">COVID-19</a>
                                        <a href="https://im4change.in/search?qryStr=Land Acquisition"
                       target="_blank" class="tag-link-4 font4">Land Acquisition</a>
                                        <a href="https://im4change.in/search?qryStr=mgnrega"
                       target="_blank" class="tag-link-4 font4">mgnrega</a>
                                        <a href="https://im4change.in/search?qryStr=Farmers"
                       target="_blank" class="tag-link-4 font4">Farmers</a>
                                        <a href="https://im4change.in/search?qryStr=transparency"
                       target="_blank" class="tag-link-4 font4">transparency</a>
                                        <a href="https://im4change.in/search?qryStr=Gender"
                       target="_blank" class="tag-link-4 font4">Gender</a>
                                        <a href="https://im4change.in/search?qryStr=Poverty"
                       target="_blank" class="tag-link-4 font4">Poverty</a>
                                    
                                <a href="https://im4change.in/search?qryStr=Farm Laws" target="_blank" class="tag-link-4 font4">Farm Laws
                </a>
                <a href="https://im4change.in/search?qryStr=Citizenship Amendment Act" target="_blank" class="tag-link-4 font4">Citizenship Amendment Act
                </a>
                <a href="https://im4change.in/search?qryStr=CAA NPR NRIC" target="_blank" class="tag-link-4 font4">CAA NPR NRIC
                </a>
                <a href="https://im4change.in/search?qryStr=Job Losses" target="_blank" class="tag-link-4 font4">Job Losses
                </a>
                <a href="https://im4change.in/search?qryStr=Migrant Workers" target="_blank" class="tag-link-4 font4">Migrant Workers
                </a>
                <a href="https://im4change.in/search?qryStr=Unemployment" target="_blank" class="tag-link-4 font4">Unemployment
                </a>
                <a href="https://im4change.in/search?qryStr=PMGKAY" target="_blank" class="tag-link-4 font4">PMGKAY
                </a>
                <a href="https://im4change.in/search?qryStr=PM-KISAN" target="_blank" class="tag-link-4 font4">PM-KISAN
                </a>
                <a href="https://im4change.in/search?qryStr=PM-CARES" target="_blank" class="tag-link-4 font4">PM-CARES
                </a>
                <a href="https://im4change.in/search?qryStr=LFPR" target="_blank" class="tag-link-4 font4">LFPR
                </a>
                
            </div>
        </div>
    </div>
    <!-- Widget Tag Cloud Ends here -->
</aside>
<!-- Right Side Section End -->
        </div>
        <section class="cat-box cats-review-box footerSec">
    <h2 class="cat-box-title vSec CatArcha">Video
        Archives</h2>
    <h2 class="cat-box-title CatArchaTitle">Archives</h2>
    <div class="cat-box-content">
        <div class="reviews-cat">
            <div class="CatArchaDiv1">
                <div class="CatArchaDiv2">
                    <ul>
                                                    <li>
                                <a href="https://im4change.in/news-alerts-57/moving-upstream-luni-fellowship.html"  target="_blank">
                                     Moving Upstream: Luni – Fellowship                                </a>
                            </li>
                                                        <li>
                                <a href="https://im4change.in/news-alerts-57/135-million-indians-exited-multidimensional-poverty-as-per-government-figures-is-that-the-same-as-poverty-reduction.html"  target="_blank">
                                     135 Million Indians Exited “Multidimensional" Poverty as per Government...                                </a>
                            </li>
                                                        <li>
                                <a href="https://im4change.in/news-alerts-57/explainer-why-are-tomato-prices-on-fire.html"  target="_blank">
                                     Explainer: Why are Tomato Prices on Fire?                                </a>
                            </li>
                                                        <li>
                                <a href="https://im4change.in/news-alerts-57/nsso-survey-only-39-1-of-all-households-have-drinking-water-within-dwelling-46-7-of-rural-households-use-firewood-for-cooking.html"  target="_blank">
                                     NSSO Survey: Only 39.1% of all Households have Drinking...                                </a>
                            </li>
                                                    <li class="CatArchalLi1">
                            <a href="https://im4change.in/news-alerts-57"
                               class="more-link CatArchalAnch1"  target="_blank">
                                More...
                            </a>
                        </li>
                    </ul>
                </div>
                                    <div class="CatArchaWidth">
                        <img class="CatArchaImg"
                             src="https://img.youtube.com/vi/I51LYnP8BOk/1.jpg"
                             alt=" Im4Change.org हिंदी वेबसाइट का परिचय. Short Video on im4change.org...">
                        <p class="CatArchaPPad">
                            <a href="https://im4change.in/video/Short-Video-on-im4change-Hindi-website-Inclusive-Media-for-Change"  target="_blank">
                                 Im4Change.org हिंदी वेबसाइट का परिचय. Short Video on im4change.org...                            </a>
                        </p>
                    </div>
                                        <div class="CatArchaWidth">
                        <img class="CatArchaImg"
                             src="https://img.youtube.com/vi/kNqha-SwfIY/1.jpg"
                             alt=" "Session 1: Scope of IDEA and AgriStack" in Exploring...">
                        <p class="CatArchaPPad">
                            <a href="https://im4change.in/video/Session-1- Scope-of-IDEA-and-AgriStack-in-Exploring-Digitalisation-in-Agriculture-29-April-2022"  target="_blank">
                                 "Session 1: Scope of IDEA and AgriStack" in Exploring...                            </a>
                        </p>
                    </div>
                                        <div class="CatArchaWidth">
                        <img class="CatArchaImg"
                             src="https://img.youtube.com/vi/6kIVjlgZItk/1.jpg"
                             alt=" "Session 2: Farmer Centric Digitalisation in Agriculture" in Exploring...">
                        <p class="CatArchaPPad">
                            <a href="https://im4change.in/video/Session-2-Farmer-Centric-Digitalisation-in-Agriculture-in-Exploring-Digitalisation-in-Agriculture-29-April-2022"  target="_blank">
                                 "Session 2: Farmer Centric Digitalisation in Agriculture" in Exploring...                            </a>
                        </p>
                    </div>
                                        <div class="CatArchaWidth">
                        <img class="CatArchaImg"
                             src="https://img.youtube.com/vi/2BeHTu0y7xc/1.jpg"
                             alt=" "Session 3: Future of Digitalisation in Agriculture" in Exploring...">
                        <p class="CatArchaPPad">
                            <a href="https://im4change.in/video/Session-3-Future-of-Digitalisation-in-Agriculture-in-Exploring-Digitalisation-in-Agriculture-29-April-2022"  target="_blank">
                                 "Session 3: Future of Digitalisation in Agriculture" in Exploring...                            </a>
                        </p>
                    </div>
                    


                <div class="divWidth">
                    <ul class="divWidthMarg">
                                                    <li>
                                <a href="https://im4change.in/video/Public-Spending-on-Agriculture-in-India-Source-Foundation-for-Agrarian-Studies"
                                   title="Public Spending on Agriculture in India (Source: Foundation for Agrarian Studies)"  target="_blank">
                                     Public Spending on Agriculture in India (Source: Foundation for...</a>
                            </li>
                                                        <li>
                                <a href="https://im4change.in/video/Agrarian-Change-Seminar-Protests-against-the-New-Farm-Laws-in-India-by-Prof-Vikas-Rawal-JNU-Source-Journal-Of-Agrarian-Change"
                                   title="Agrarian Change Seminar: 'Protests against the New Farm Laws in India' by Prof. Vikas Rawal, JNU (Source: Journal Of Agrarian Change) "  target="_blank">
                                     Agrarian Change Seminar: 'Protests against the New Farm Laws...</a>
                            </li>
                                                        <li>
                                <a href="https://im4change.in/video/Webinar-Ramrao-The-Story-of-India-Farm-Crisis-Source-Azim-Premji-University"
                                   title="Webinar: Ramrao - The Story of India's Farm Crisis (Source: Azim Premji University)"  target="_blank">
                                     Webinar: Ramrao - The Story of India's Farm Crisis...</a>
                            </li>
                                                        <li>
                                <a href="https://im4change.in/video/water-and-agricultural-transformation-in-India"
                                   title="Water and Agricultural Transformation in India: A Symbiotic Relationship (Source: IGIDR)"  target="_blank">
                                     Water and Agricultural Transformation in India: A Symbiotic Relationship...</a>
                            </li>
                                                    <li class="CatArchalLi1">
                            <a href="https://im4change.in/videogallery"
                               class="more-link CatArchalAnch1"  target="_blank">
                                More...
                            </a>
                        </li>
                    </ul>
                </div>
            </div>
        </div>
    </div>
</section>    </div>
    <div class="clear"></div>
    <!-- Footer option Starts here -->
    <div class="footer-bottom fade-in animated4">
        <div class="container">
            <div class="social-icons icon_flat">
                <p class="SocialMargTop"> Website Developed by <a target="_blank" title="Web Development"
                                                                  class="wot right"
                                                                  href="http://www.ravinderkhurana.com/" rel="nofollow">
                                                                  RAVINDErkHURANA.com</a></p>
            </div>
            <div class="alignleft">
                <a
     target="_blank" href="https://im4change.in/objectives-8.html"
    class="link"
    title="Objectives">Objectives</a> | <a
     target="_blank" href="https://im4change.in/about-us-9.html"
    class="link" title="About Us">About Us</a> | <a
     target="_blank" href="https://im4change.in/media-workshops.php"
    class="ucwords">Workshops</a> | <a
     target="_blank" href="https://im4change.in/disclaimer/disclaimer-149.html"
    title="Disclaimer">Disclaimer</a>            </div>
        </div>
    </div>
    <!-- Footer option ends here -->
</div>
<div id="connect">
    <a target="_blank"
       href="http://www.facebook.com/sharer.php?u=https://im4change.in/latest-news-updates/drugs-on-hold-over-doubts-about-indian-trials-4674746.html"
       title="Share on Facebook">
        <img src="https://im4change.in/images/Facebook.png?1582080640" alt="share on Facebook" class="ImgBorder"/>
    </a><br/>
    <a target="_blank"
       href="http://twitter.com/share?text=Im4change&amp;url=https://im4change.in/latest-news-updates/drugs-on-hold-over-doubts-about-indian-trials-4674746.html"
       title="Share on Twitter">
        <img src="https://im4change.in/images/twitter.png?1582080632" alt="Twitter" class="ImgBorder"/>    </a>
    <br/>
    <a href="/feeds" title="RSS Feed" target="_blank">
        <img src="https://im4change.in/images/rss.png?1582080632" alt="RSS" class="ImgBorder"/>
    </a>
    <br/>
    <a class="feedback-link" id="feedbackFormLink" href="#">
        <img src="https://im4change.in/images/feedback.png?1582080630" alt="Feedback" class="ImgBorder"/>
    </a> <br/>
    <a href="javascript:function iprl5(){var d=document,z=d.createElement('scr'+'ipt'),b=d.body,l=d.location;try{if(!b)throw(0);d.title='(Saving...) '+d.title;z.setAttribute('src',l.protocol+'//www.instapaper.com/j/WKrH3R7ORD5p?u='+encodeURIComponent(l.href)+'&amp;t='+(new Date().getTime()));b.appendChild(z);}catch(e){alert('Please wait until the page has loaded.');}}iprl5();void(0)"
       class="bookmarklet" onclick="return explain_bookmarklet();">
        <img src="https://im4change.in/images/read-it-later.png?1582080632" alt="Read Later" class="ImgBorder"/>    </a>
</div>
<!-- Feedback form Starts here -->
<div id="feedbackForm" class="overlay_form" class="ImgBorder">
    <h2>Contact Form</h2>
    <div id="contactform1">
        <div id="formleft">
            <form id="submitform" action="/contactus.php" method="post">
                <input type="hidden" name="submitform" value="submitform"/>
                <input type="hidden" name="salt_key" value="a0e0f2c6a0644a70e57ad2c96829709a"/>
                <input type="hidden" name="ref" value="feedback"/>
                <fieldset>
                    <label>Name :</label>
                    <input type="text" name="name" class="tbox" required/>
                </fieldset>
                <fieldset>
                    <label>Email :</label>
                    <input type="text" name="email" class="tbox" required/>
                </fieldset>
                <fieldset>
                    <label>Message :</label>
                    <textarea rows="5" cols="20" name="message" required></textarea>
                </fieldset>
                <fieldset>
                    Please enter security code
                    <div class="clear"></div>
                    <input type="text" name="vrcode" class="tbox"/>
                </fieldset>
                <fieldset>
                    <input type="submit" class="button" value="Submit"/>
                    &nbsp; &nbsp; &nbsp; <a href="#" id="closefeedbakcformLink">Close</a>
                </fieldset>
            </form>
        </div>
        <div class="clearfix"></div>
    </div>
</div>
<div id="donate_popup" class="modal" style="max-width: 800px;">
    <table width="100%" border="1">
        <tr>
            <td colspan="2" align="center">
                <b>Support im4change</b>
            </td>
        </tr>
        <tr>
            <td width="25%" valign="middle">
                <img src="https://im4change.in/images/logo2.jpg?1582080632" alt="" width="100%"/>            </td>
            <td style="padding-left:10px;padding-top:10px;">
                <form action="https://im4change.in/donate" method="get">
                    <table width="100%" cellpadding="2" cellspacing="2">
                        <tr>
                            <td width="33%" style="font-family: 'Script Font', cursive, Arial;font-size: 20px;font-weight: 700;">
                                10
                            </td>
                            <td width="33%" style="font-family: 'Script Font', cursive, Arial;font-size: 20px;font-weight: 700;">
                                100
                            </td>
                            <td width="33%" style="font-family: 'Script Font', cursive, Arial;font-size: 20px;font-weight: 700;">
                                1000
                            </td>
                        </tr>
                        <tr>
                            <td colspan="3">
                                &nbsp;
                            </td>
                        </tr>
                        <tr>
                            <td  style="font-family: 'Script Font', cursive, Arial;font-size: 20px;font-weight: 700;">
                                50
                            </td>
                            <td  style="font-family: 'Script Font', cursive, Arial;font-size: 20px;font-weight: 700;">
                                500
                            </td>
                            <td  style="font-family: 'Script Font', cursive, Arial;font-size: 20px;font-weight: 700;">
                                <input type="text" name="price" placeholder="?" style="font-family: 'Script Font', cursive, Arial;font-size: 20px;font-weight: 700;">
                            </td>
                        </tr>
                        <tr>
                            <td colspan="3">
                                &nbsp;
                            </td>
                        </tr>
                        <tr>
                            <td colspan="3" align="right">
                                <input type="button" name="Pay" value="Pay"
                                       style="width: 200px;background-color: rgb(205, 35, 36);color: #ffffff;"/>
                            </td>
                        </tr>
                    </table>
                </form>
            </td>
        </tr>
    </table>
</div><script type='text/javascript'>

    /* <![CDATA[ */

    var tievar = {'go_to': 'Go to...'};

    /* ]]> */

</script>
<script src="/js/tie-scripts.js?1575549704"></script><script src="/js/bootstrap.js?1575549704"></script><script src="/js/jquery.modal.min.js?1578284310"></script><script>
    $(document).ready(function() {
        // tell the autocomplete function to get its data from our php script
        $('#s').autocomplete({
            source: "/autocomplete"
        });
    });
</script>
<script src="/vj-main-sw-register.js" async></script>

<script>function init(){var imgDefer=document.getElementsByTagName('img');for(var i=0;i<imgDefer.length;i++){if(imgDefer[i].getAttribute('data-src')){imgDefer[i].setAttribute('src',imgDefer[i].getAttribute('data-src'))}}}
window.onload=init;</script>
</body>
</html>'

}
$cookies = []
$values = [
	(int) 0 => 'text/html; charset=UTF-8'
]
$name = 'Content-Type'
$first = true
$value = 'text/html; charset=UTF-8'
header - [internal], line ??
Cake\Http\ResponseEmitter::emitHeaders() - CORE/src/Http/ResponseEmitter.php, line 181
Cake\Http\ResponseEmitter::emit() - CORE/src/Http/ResponseEmitter.php, line 55
Cake\Http\Server::emit() - CORE/src/Http/Server.php, line 141
[main] - ROOT/webroot/index.php, line 39

Home हिन्दी

Drugs on hold over doubts about Indian trials

Published on Dec 7, 2014   Modified on Dec 7, 2014

-The Telegraph Regulators in several European countries are suspending marketing approval for 25 generic drugs because of concerns over the quality of data from human studies conducted by an Indian contract research company, a French medical safety agency said on Friday. Drug regulators in Belgium, France, Germany and Luxembourg have decided to suspend the marketing authorisation for the generic drugs after they discovered "irregularities" in documents relating to human studies conducted by GVK Bio in Hyderabad. "This decision is taken as a precaution. No element at this stage has led to establish a true risk to human health or a lack of efficacy of these drugs," France's National Agency for Medication Safety and Health Products, or ANSM, said on its website. The suspended drugs have equivalents made by international drug makers that can be used as alternatives, so patients will not have to interrupt their treatment, the ANSM said. While the European regulators' decisions have no implications for the marketing of these generic drugs in India, a Delhi-based pharmacology expert said, they highlight concerns that human studies of drugs in India have often breached rules that make up good clinical practice. GVK Bio had between 2008 and 2014 conducted bio-equivalence studies that were intended to show that the generic drugs have the same pharmacological behaviour in humans as their original branded versions. During site inspections of GVK Bio in Hyderabad, ANSM inspectors reported finding irregularities in electrocardiogram documents related to the studies. While electrocardiograms themselves do not show bio-equivalence, they are used to monitor the volunteers who are given the drugs being studied. The irregularities show lack of compliance with good clinical practices, the French agency said. GVK Bio's CEO, Manni Kantipudi, disputed the French watchdog's findings and said that electrocardiograms were not an important component of the drug efficacy studies. While the ANSM did not provide details of the purported irregularities, GVK Bio's response to the regulators' decisions suggests there were concerns that multiple electrocardiograms, claimed as belonging to multiple volunteers, had appeared to belong to a single volunteer. GVK Bio said in a statement on its website that it had submitted independent cardiology assessments of electrocardiograms indicating they belonged to multiple volunteers "and it is difficult to conclude that they belonged to the same volunteer". The ANSM did not name the 25 generic drugs, but given the nature of bio-equivalence studies, they are likely to be generic drugs manufactured by Indian companies seeking marketing approvals in Europe. A pharmacology specialist who has been tracking clinical trials said the regulators' decisions affect marketing approvals for the 25 generic drugs only in Europe, but "brings India a bad name". "This is really an issue between the Indian (drug) exporters, their contract research organisation and European regulators," said Chandra Gulhati, editor of the Monthly Index of Medical Specialities, India. GVK Bio, Gulhati said, had also been embroiled in controversy six years ago when a man in his mid-20s who had taken part in a bio-equivalence study run by the company died. While it emerged that the volunteer had taken part in several bio-equivalence studies too close to one another, Gulhati said, those who recruit volunteers for human studies should take the responsibility of ensuring that the volunteers rigorously follow guidelines. Kantipudi said the ANSM had drawn its conclusions about the electrocardiograms relating to the 25 generic drugs without taking into account the company's views. "We have agreed to redo the studies, I'm fine with that, but don't say that there was gross manipulation of the ECGs," Kantipudi was quoted as saying. He said the company had received board approval to spend $5.7-$6.5 million for new studies. The European Medicines Agency separately released a statement saying it would "issue a recommendation on whether the marketing authorisations of the concerned medicines should be maintained, varied, suspended or withdrawn across the EU". That recommendation is expected in January 2015. German watchdog BfArM said it was investigating 176 approvals given to 28 drug makers. It did not name the drugs or companies affected. BfArM said it was ordering drug makers whose approvals had been found to have been based on data from GVK trials to stop distributing the drugs concerned until they could provide data from new studies. The ANSM said several drug makers, whom it did not identify, had offered to carry out new studies which, if positive, could allow the drugs back on the market again. Kantipudi said GVK Bio had started conducting new studies for five to six of its clients. About 35 of the company's 400 clients have been affected by the European regulator's move, he said. He said the US Food and Drug Administration had inspected the company's Hyderabad plant in June, after the French regulator's audit, and was satisfied with electrocardiogram-related data. No other regulator had contacted the company since then, he added. The quality of Indian pharmaceuticals has come under fire this year, with regulators in Europe and the US citing problems ranging from data manipulation to sanitation and banning the import of certain products from several firms. Additional reporting by Reuters

The Telegraph, 7 December, 2014, http://www.telegraphindia.com/1141207/jsp/nation/story_2471.jsp#.VIPWAHs_-BE

Tagged with: healthcare medicines Access to Medicines generic medicines generic medicine drug trial Health

Related Articles

• Fifth Report From Gambia Implicates Indian Drug Maker for Contaminated Syrups - Banjot Kaur
• India may have seen steepest dip in multidimensional poverty among 110 nations as per UNDP data - Nikhil Rampal
• Health among top three priorities for Indian voters after jobs and education, survey shows - Oliver Heath, Jyoti Mishra, Louise Tillin & Sandhya Venkateswaran
• India's stretched health care system fails millions in rural areas battling sickle cell disease - ABC
• Prevalence of Zero-Food among infants and young children in India - The Lancet 

 

Write Comments

Your email address will not be published. Required fields are marked *

Name *

Email *

Contact No.

Comment

Type the characters you see in the image below *

Video Archives

Archives

• Moving Upstream: Luni – Fellowship
• 135 Million Indians Exited “Multidimensional" Poverty as per Government...
• Explainer: Why are Tomato Prices on Fire?
• NSSO Survey: Only 39.1% of all Households have Drinking...
• More...

Im4Change.org हिंदी वेबसाइट का परिचय. Short Video on im4change.org...

"Session 1: Scope of IDEA and AgriStack" in Exploring...

"Session 2: Farmer Centric Digitalisation in Agriculture" in Exploring...

"Session 3: Future of Digitalisation in Agriculture" in Exploring...

• Public Spending on Agriculture in India (Source: Foundation for...
• Agrarian Change Seminar: 'Protests against the New Farm Laws...
• Webinar: Ramrao - The Story of India's Farm Crisis...
• Water and Agricultural Transformation in India: A Symbiotic Relationship...
• More...

Website Developed by RAVINDErkHURANA.com

Objectives | About Us | Workshops | Disclaimer

Support im4change
	10 100 1000   50 500