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/generics-vs-big-pharma-reloaded-shamnad-basheer-4680628.html'
		[protected] base => ''
		[protected] webroot => '/'
		[protected] here => '/latest-news-updates/generics-vs-big-pharma-reloaded-shamnad-basheer-4680628.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/generics-vs-big-pharma-reloaded-shamnad-basheer-4680628.html'
		[protected] base => ''
		[protected] webroot => '/'
		[protected] here => '/latest-news-updates/generics-vs-big-pharma-reloaded-shamnad-basheer-4680628.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 | Generics vs big pharma, reloaded -Shamnad Basheer    </title>
    <meta name="description" content="
-The Hindu

The proposal to extend the time limit for State-level drug regulatory approvals from four to 10 years could hit the generics market

In a scathing letter to the Government of India, the Indian Pharmaceutical Alliance (IPA) took issue with what..."/>
    <meta name="keywords" content="Intellectual Property Rights,Patent justice,Patented Medicines,generic medicine,generic medicines,IPRs"/>
    <meta name="news_keywords" content="Intellectual Property Rights,Patent justice,Patented Medicines,generic medicine,generic medicines,IPRs">
   
    <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 | Generics vs big pharma, reloaded -Shamnad Basheer" />
     <meta property="og:url" content="https://im4change.in/latest-news-updates/generics-vs-big-pharma-reloaded-shamnad-basheer-4680628.html" />
     <meta property="og:type" content="article" />
     <meta property="og:description" content="
-The Hindu

The proposal to extend the time limit for State-level drug regulatory approvals from four to 10 years could hit the generics market

In a scathing letter to the Government of India, the Indian Pharmaceutical Alliance (IPA) took issue with what..." />
     <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">Generics vs big pharma, reloaded -Shamnad Basheer</h1>
    <a href="JavaScript:void(0);" onclick="return shareArticle(32551);">
        <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/generics-vs-big-pharma-reloaded-shamnad-basheer-4680628/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"> Nov 23, 2016</span>
        &nbsp; <span
                class="dateIcn">
		 	<img src="https://im4change.in/images/modified.svg?1582080666" alt="modified"/>    	 Modified on </span><span class="text-date"> Nov 23, 2016</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 Hindu<br /><br /><em>The proposal to extend the time limit for State-level drug regulatory approvals from four to 10 years could hit the generics market<br /></em><br />In a scathing letter to the Government of India, the Indian Pharmaceutical Alliance (IPA) took issue with what it considered to be a backdoor extension for data exclusivity norms in the country. It pointed to the recent government proposal to change the four-year time limit for State-level drug regulatory approvals to 10 years, arguing that this effectively results in a long and damaging data exclusivity.<br /><br />Data exclusivity is a kind of intellectual property protection wherein clinical trial and other data submitted by an originator drug company cannot be used or relied upon by a drug regulatory authority to approve a generic version of that drug for a certain period of time. The notion is that without such protection, the originator company lacks the necessary commercial incentive to conduct expensive trials and take a potential drug to the market. Blocking generic entry for some years will, the theory goes, help drug companies invest in clinical trials.<br /><br /><em>Skewing the pharma market?<br /></em><br />India has long resisted U.S. and EU pressure to institute data exclusivity norms, seeing it as a barrier to generic entry and more affordable drug prices. However, a rather curious provision in the Drugs and Cosmetics Act (DCA) could arguably constitute a de facto kind of data exclusivity.<br /><br />Under the Act as it stands now, a new drug continues to remain &ldquo;new&rdquo; even after it has been approved once by the Central regulator (Drugs Controller General of India, or DGCI) upon submission of local clinical trial data establishing safety and efficacy in India. However, it loses &ldquo;newness&rdquo; after four years, which means a drug manufacturer can short-circuit the process and go directly to a State regulatory authority and procure drug approval. It is this four-year period that is now sought to be enhanced to 10 years, an extension that the IPA argues constitutes an enhancement of data exclusivity norms in favour of large pharma companies, particularly MNCs. Others insist that there is no such data exclusivity norm in India.<br /><br />Who is right? And who is wrong? This depends in large part on the kind of data that generic companies have to submit in order to gain approval for their follow-on drugs. If they are forced to submit the same kind of clinical trial data that originators have submitted to the regulatory authority, then this does amount to data exclusivity. For almost all generics will simply wait for the term (four years) to expire rather than undertake the expensive process of generating clinical trial data afresh, not to mention the sheer immorality of repeating animal studies and subjecting human volunteers to safety and efficacy tests in relation to the same drug molecule.<br /><br />It is for this reason that world over, generic drugs are approved upon a simple showing of bio-equivalence: that the claimed molecule is the same as the one already approved. And therefore, there is no sense in having the generic applicant repeat all clinical trials afresh. However, bio-equivalence cannot be had for the asking but must be demonstrated through rigorous studies/data.<br /><br />Unfortunately, our Act is not very clear on the kind of studies/data that a generic applicant is meant to submit, not least because it is one of the worst drafted pieces of legislation, leaving the bulk of substantive norms in the &ldquo;rules&rdquo; and various forms and schedules running to a good 500 pages!<br /><br />Little wonder then that a number of state regulators do not insist on bio-equivalence studies or any other studies for that matter prior to approving a drug for manufacture in that State. Therefore, any substance held out as a drug (even a complex cancer drug) is likely to make the cut&hellip; be it a piece of chalk, cheese or china!<br /><br />And this precisely is why in our rather complicated federal structure of drug regulation, comprising both a Central authority, namely the DCGI, and a vast array of State-level regulators, drug manufacturers opt to simply wait for four years and then approach State authorities rather than risking a more rigorous Central clearance.<br /><br />However, this does not mean that all is well on the Central regulatory front. A damning parliamentary committee report some years ago found that in the vast majority of cases, the DCGI doesn&rsquo;t even insist on separate local clinical trial data for new drugs. Rather they routinely dispense with the requirement of local clinical trials under a broad &ldquo;public interest&rdquo; exception.<br /><br /><em>Lax regulatory standards<br /></em><br />In the end, one needs to ask: why have this four-year or 10-year time lag at all for generic drug approval? Shouldn&rsquo;t generic drugs be approved on Day One, so long as they are able to demonstrate (through bio-equivalence studies and the like) that they are as robust as the new drug that has already been approved once? Why maintain this legal fiction that a drug will remain &ldquo;new&rdquo; even after it has been validly approved once (for up to four years or 10 years as the case may be)?<br /><br />Unfortunately, our drug regulatory regime is callous at best, and murderous at worst, plagued with glaring gaps that are routinely exploited by drug majors &mdash; a fact amply demonstrated by a well-researched public interest petition (PIL) by whistle-blower Dinesh Thakur. Unfortunately, the apex court declined to admit his PIL and we lost out on an opportunity to compel a healthier drug regulatory regime.<br /><br />Pollution is easy to understand. Drug regulatory standards not so. Which may perhaps explain why courts routinely entertain PILs on the former, but shy away from the latter. Even when lax regulation on the latter count is far more dangerous than pollution. For, with each passing day, we&rsquo;re suffering a regime that kills, albeit all too softly, through a laxity in the law. A laxity that the layman may not immediately grasp. But one which a responsible government (and even judges) should make it their business to study and understand, before it is too late.<br /><em><br />Shamnad Basheer is Honorary Research Professor of Intellectual Property Law at Nirma University and founder of SpicyIP.</em></div>                                                           
                        </div>
                    </td>
                </tr>
            </table>
        </div>
    </div>
</div>
<div class="clear"></div>
    <br><a href="http://www.thehindu.com/opinion/op-ed/Generics-vs-big-pharma-reloaded/article16681172.ece?homepage=true" class="re" target="_blank">The Hindu, 23 November, 2016, http://www.thehindu.com/opinion/op-ed/Generics-vs-big-pharma-reloaded/article16681172.ece?homepage=true</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=Intellectual Property Rights"
                   title="Intellectual Property Rights">
                    Intellectual Property Rights                </a>
                                <a class="tagcloud5"
                   href="https://im4change.in/search?qryStr=Patent justice"
                   title="Patent justice">
                    Patent justice                </a>
                                <a class="tagcloud5"
                   href="https://im4change.in/search?qryStr=Patented Medicines"
                   title="Patented Medicines">
                    Patented 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=generic medicines"
                   title="generic medicines">
                    generic medicines                </a>
                                <a class="tagcloud5"
                   href="https://im4change.in/search?qryStr=IPRs"
                   title="IPRs">
                    IPRs                </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/explained-the-legal-battle-over-the-potatoes-used-to-make-lay-s-chips-flavia-lopes.html"
                       title="Explained: The legal battle over the potatoes used to make Lay’s chips -Flavia Lopes">
                        Explained: The legal battle over the potatoes used to make Lay’s chips -Flavia Lopes                    </a>
                </li>
                                <li class="recentcomments">
                    <a href="https://im4change.in/latest-news-updates/expired-pill-editorial-on-new-drugs-and-cosmetics-bill.html"
                       title="Expired pill: Editorial on new drugs and cosmetics bill">
                        Expired pill: Editorial on new drugs and cosmetics bill                    </a>
                </li>
                                <li class="recentcomments">
                    <a href="https://im4change.in/latest-news-updates/ngos-protest-commerce-ministry-inaction-on-wto-covid-19-vaccine-proposal-jacob-koshy.html"
                       title="NGOs protest Commerce Ministry inaction on WTO COVID-19 vaccine proposal -Jacob Koshy">
                        NGOs protest Commerce Ministry inaction on WTO COVID-19 vaccine proposal -Jacob Koshy                    </a>
                </li>
                                <li class="recentcomments">
                    <a href="https://im4change.in/latest-news-updates/with-new-moefcc-memo-are-indian-policy-makers-supporting-big-biotech-indra-shekhar-singh.html"
                       title="With New MoEFCC Memo, Are Indian Policy Makers Supporting 'Big Biotech'? -Indra Shekhar Singh">
                        With New MoEFCC Memo, Are Indian Policy Makers Supporting 'Big Biotech'? -Indra Shekhar Singh                    </a>
                </li>
                                <li class="recentcomments">
                    <a href="https://im4change.in/news-alerts-57/is-the-govt-doing-enough-for-the-jan-aushadhi-scheme.html"
                       title="Is the govt. doing enough for the Jan Aushadhi scheme?">
                        Is the govt. doing enough for the Jan Aushadhi scheme?                    </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/generics-vs-big-pharma-reloaded-shamnad-basheer-4680628.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="32551"/>
        <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=729166922" 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/generics-vs-big-pharma-reloaded-shamnad-basheer-4680628.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/generics-vs-big-pharma-reloaded-shamnad-basheer-4680628.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 | Generics vs big pharma, reloaded -Shamnad Basheer    </title>
    <meta name="description" content="
-The Hindu

The proposal to extend the time limit for State-level drug regulatory approvals from four to 10 years could hit the generics market

In a scathing letter to the Government of India, the Indian Pharmaceutical Alliance (IPA) took issue with what..."/>
    <meta name="keywords" content="Intellectual Property Rights,Patent justice,Patented Medicines,generic medicine,generic medicines,IPRs"/>
    <meta name="news_keywords" content="Intellectual Property Rights,Patent justice,Patented Medicines,generic medicine,generic medicines,IPRs">
   
    <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 | Generics vs big pharma, reloaded -Shamnad Basheer" />
     <meta property="og:url" content="https://im4change.in/latest-news-updates/generics-vs-big-pharma-reloaded-shamnad-basheer-4680628.html" />
     <meta property="og:type" content="article" />
     <meta property="og:description" content="
-The Hindu

The proposal to extend the time limit for State-level drug regulatory approvals from four to 10 years could hit the generics market

In a scathing letter to the Government of India, the Indian Pharmaceutical Alliance (IPA) took issue with what..." />
     <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">Generics vs big pharma, reloaded -Shamnad Basheer</h1>
    <a href="JavaScript:void(0);" onclick="return shareArticle(32551);">
        <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/generics-vs-big-pharma-reloaded-shamnad-basheer-4680628/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"> Nov 23, 2016</span>
        &nbsp; <span
                class="dateIcn">
		 	<img src="https://im4change.in/images/modified.svg?1582080666" alt="modified"/>    	 Modified on </span><span class="text-date"> Nov 23, 2016</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 Hindu<br /><br /><em>The proposal to extend the time limit for State-level drug regulatory approvals from four to 10 years could hit the generics market<br /></em><br />In a scathing letter to the Government of India, the Indian Pharmaceutical Alliance (IPA) took issue with what it considered to be a backdoor extension for data exclusivity norms in the country. It pointed to the recent government proposal to change the four-year time limit for State-level drug regulatory approvals to 10 years, arguing that this effectively results in a long and damaging data exclusivity.<br /><br />Data exclusivity is a kind of intellectual property protection wherein clinical trial and other data submitted by an originator drug company cannot be used or relied upon by a drug regulatory authority to approve a generic version of that drug for a certain period of time. The notion is that without such protection, the originator company lacks the necessary commercial incentive to conduct expensive trials and take a potential drug to the market. Blocking generic entry for some years will, the theory goes, help drug companies invest in clinical trials.<br /><br /><em>Skewing the pharma market?<br /></em><br />India has long resisted U.S. and EU pressure to institute data exclusivity norms, seeing it as a barrier to generic entry and more affordable drug prices. However, a rather curious provision in the Drugs and Cosmetics Act (DCA) could arguably constitute a de facto kind of data exclusivity.<br /><br />Under the Act as it stands now, a new drug continues to remain &ldquo;new&rdquo; even after it has been approved once by the Central regulator (Drugs Controller General of India, or DGCI) upon submission of local clinical trial data establishing safety and efficacy in India. However, it loses &ldquo;newness&rdquo; after four years, which means a drug manufacturer can short-circuit the process and go directly to a State regulatory authority and procure drug approval. It is this four-year period that is now sought to be enhanced to 10 years, an extension that the IPA argues constitutes an enhancement of data exclusivity norms in favour of large pharma companies, particularly MNCs. Others insist that there is no such data exclusivity norm in India.<br /><br />Who is right? And who is wrong? This depends in large part on the kind of data that generic companies have to submit in order to gain approval for their follow-on drugs. If they are forced to submit the same kind of clinical trial data that originators have submitted to the regulatory authority, then this does amount to data exclusivity. For almost all generics will simply wait for the term (four years) to expire rather than undertake the expensive process of generating clinical trial data afresh, not to mention the sheer immorality of repeating animal studies and subjecting human volunteers to safety and efficacy tests in relation to the same drug molecule.<br /><br />It is for this reason that world over, generic drugs are approved upon a simple showing of bio-equivalence: that the claimed molecule is the same as the one already approved. And therefore, there is no sense in having the generic applicant repeat all clinical trials afresh. However, bio-equivalence cannot be had for the asking but must be demonstrated through rigorous studies/data.<br /><br />Unfortunately, our Act is not very clear on the kind of studies/data that a generic applicant is meant to submit, not least because it is one of the worst drafted pieces of legislation, leaving the bulk of substantive norms in the &ldquo;rules&rdquo; and various forms and schedules running to a good 500 pages!<br /><br />Little wonder then that a number of state regulators do not insist on bio-equivalence studies or any other studies for that matter prior to approving a drug for manufacture in that State. Therefore, any substance held out as a drug (even a complex cancer drug) is likely to make the cut&hellip; be it a piece of chalk, cheese or china!<br /><br />And this precisely is why in our rather complicated federal structure of drug regulation, comprising both a Central authority, namely the DCGI, and a vast array of State-level regulators, drug manufacturers opt to simply wait for four years and then approach State authorities rather than risking a more rigorous Central clearance.<br /><br />However, this does not mean that all is well on the Central regulatory front. A damning parliamentary committee report some years ago found that in the vast majority of cases, the DCGI doesn&rsquo;t even insist on separate local clinical trial data for new drugs. Rather they routinely dispense with the requirement of local clinical trials under a broad &ldquo;public interest&rdquo; exception.<br /><br /><em>Lax regulatory standards<br /></em><br />In the end, one needs to ask: why have this four-year or 10-year time lag at all for generic drug approval? Shouldn&rsquo;t generic drugs be approved on Day One, so long as they are able to demonstrate (through bio-equivalence studies and the like) that they are as robust as the new drug that has already been approved once? Why maintain this legal fiction that a drug will remain &ldquo;new&rdquo; even after it has been validly approved once (for up to four years or 10 years as the case may be)?<br /><br />Unfortunately, our drug regulatory regime is callous at best, and murderous at worst, plagued with glaring gaps that are routinely exploited by drug majors &mdash; a fact amply demonstrated by a well-researched public interest petition (PIL) by whistle-blower Dinesh Thakur. Unfortunately, the apex court declined to admit his PIL and we lost out on an opportunity to compel a healthier drug regulatory regime.<br /><br />Pollution is easy to understand. Drug regulatory standards not so. Which may perhaps explain why courts routinely entertain PILs on the former, but shy away from the latter. Even when lax regulation on the latter count is far more dangerous than pollution. For, with each passing day, we&rsquo;re suffering a regime that kills, albeit all too softly, through a laxity in the law. A laxity that the layman may not immediately grasp. But one which a responsible government (and even judges) should make it their business to study and understand, before it is too late.<br /><em><br />Shamnad Basheer is Honorary Research Professor of Intellectual Property Law at Nirma University and founder of SpicyIP.</em></div>                                                           
                        </div>
                    </td>
                </tr>
            </table>
        </div>
    </div>
</div>
<div class="clear"></div>
    <br><a href="http://www.thehindu.com/opinion/op-ed/Generics-vs-big-pharma-reloaded/article16681172.ece?homepage=true" class="re" target="_blank">The Hindu, 23 November, 2016, http://www.thehindu.com/opinion/op-ed/Generics-vs-big-pharma-reloaded/article16681172.ece?homepage=true</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=Intellectual Property Rights"
                   title="Intellectual Property Rights">
                    Intellectual Property Rights                </a>
                                <a class="tagcloud5"
                   href="https://im4change.in/search?qryStr=Patent justice"
                   title="Patent justice">
                    Patent justice                </a>
                                <a class="tagcloud5"
                   href="https://im4change.in/search?qryStr=Patented Medicines"
                   title="Patented Medicines">
                    Patented 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=generic medicines"
                   title="generic medicines">
                    generic medicines                </a>
                                <a class="tagcloud5"
                   href="https://im4change.in/search?qryStr=IPRs"
                   title="IPRs">
                    IPRs                </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/explained-the-legal-battle-over-the-potatoes-used-to-make-lay-s-chips-flavia-lopes.html"
                       title="Explained: The legal battle over the potatoes used to make Lay’s chips -Flavia Lopes">
                        Explained: The legal battle over the potatoes used to make Lay’s chips -Flavia Lopes                    </a>
                </li>
                                <li class="recentcomments">
                    <a href="https://im4change.in/latest-news-updates/expired-pill-editorial-on-new-drugs-and-cosmetics-bill.html"
                       title="Expired pill: Editorial on new drugs and cosmetics bill">
                        Expired pill: Editorial on new drugs and cosmetics bill                    </a>
                </li>
                                <li class="recentcomments">
                    <a href="https://im4change.in/latest-news-updates/ngos-protest-commerce-ministry-inaction-on-wto-covid-19-vaccine-proposal-jacob-koshy.html"
                       title="NGOs protest Commerce Ministry inaction on WTO COVID-19 vaccine proposal -Jacob Koshy">
                        NGOs protest Commerce Ministry inaction on WTO COVID-19 vaccine proposal -Jacob Koshy                    </a>
                </li>
                                <li class="recentcomments">
                    <a href="https://im4change.in/latest-news-updates/with-new-moefcc-memo-are-indian-policy-makers-supporting-big-biotech-indra-shekhar-singh.html"
                       title="With New MoEFCC Memo, Are Indian Policy Makers Supporting 'Big Biotech'? -Indra Shekhar Singh">
                        With New MoEFCC Memo, Are Indian Policy Makers Supporting 'Big Biotech'? -Indra Shekhar Singh                    </a>
                </li>
                                <li class="recentcomments">
                    <a href="https://im4change.in/news-alerts-57/is-the-govt-doing-enough-for-the-jan-aushadhi-scheme.html"
                       title="Is the govt. doing enough for the Jan Aushadhi scheme?">
                        Is the govt. doing enough for the Jan Aushadhi scheme?                    </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/generics-vs-big-pharma-reloaded-shamnad-basheer-4680628.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="32551"/>
        <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=729166922" 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/generics-vs-big-pharma-reloaded-shamnad-basheer-4680628.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/generics-vs-big-pharma-reloaded-shamnad-basheer-4680628.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 | Generics vs big pharma, reloaded -Shamnad Basheer    </title>
    <meta name="description" content="
-The Hindu

The proposal to extend the time limit for State-level drug regulatory approvals from four to 10 years could hit the generics market

In a scathing letter to the Government of India, the Indian Pharmaceutical Alliance (IPA) took issue with what..."/>
    <meta name="keywords" content="Intellectual Property Rights,Patent justice,Patented Medicines,generic medicine,generic medicines,IPRs"/>
    <meta name="news_keywords" content="Intellectual Property Rights,Patent justice,Patented Medicines,generic medicine,generic medicines,IPRs">
   
    <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 | Generics vs big pharma, reloaded -Shamnad Basheer" />
     <meta property="og:url" content="https://im4change.in/latest-news-updates/generics-vs-big-pharma-reloaded-shamnad-basheer-4680628.html" />
     <meta property="og:type" content="article" />
     <meta property="og:description" content="
-The Hindu

The proposal to extend the time limit for State-level drug regulatory approvals from four to 10 years could hit the generics market

In a scathing letter to the Government of India, the Indian Pharmaceutical Alliance (IPA) took issue with what..." />
     <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">Generics vs big pharma, reloaded -Shamnad Basheer</h1>
    <a href="JavaScript:void(0);" onclick="return shareArticle(32551);">
        <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/generics-vs-big-pharma-reloaded-shamnad-basheer-4680628/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"> Nov 23, 2016</span>
        &nbsp; <span
                class="dateIcn">
		 	<img src="https://im4change.in/images/modified.svg?1582080666" alt="modified"/>    	 Modified on </span><span class="text-date"> Nov 23, 2016</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 Hindu<br /><br /><em>The proposal to extend the time limit for State-level drug regulatory approvals from four to 10 years could hit the generics market<br /></em><br />In a scathing letter to the Government of India, the Indian Pharmaceutical Alliance (IPA) took issue with what it considered to be a backdoor extension for data exclusivity norms in the country. It pointed to the recent government proposal to change the four-year time limit for State-level drug regulatory approvals to 10 years, arguing that this effectively results in a long and damaging data exclusivity.<br /><br />Data exclusivity is a kind of intellectual property protection wherein clinical trial and other data submitted by an originator drug company cannot be used or relied upon by a drug regulatory authority to approve a generic version of that drug for a certain period of time. The notion is that without such protection, the originator company lacks the necessary commercial incentive to conduct expensive trials and take a potential drug to the market. Blocking generic entry for some years will, the theory goes, help drug companies invest in clinical trials.<br /><br /><em>Skewing the pharma market?<br /></em><br />India has long resisted U.S. and EU pressure to institute data exclusivity norms, seeing it as a barrier to generic entry and more affordable drug prices. However, a rather curious provision in the Drugs and Cosmetics Act (DCA) could arguably constitute a de facto kind of data exclusivity.<br /><br />Under the Act as it stands now, a new drug continues to remain &ldquo;new&rdquo; even after it has been approved once by the Central regulator (Drugs Controller General of India, or DGCI) upon submission of local clinical trial data establishing safety and efficacy in India. However, it loses &ldquo;newness&rdquo; after four years, which means a drug manufacturer can short-circuit the process and go directly to a State regulatory authority and procure drug approval. It is this four-year period that is now sought to be enhanced to 10 years, an extension that the IPA argues constitutes an enhancement of data exclusivity norms in favour of large pharma companies, particularly MNCs. Others insist that there is no such data exclusivity norm in India.<br /><br />Who is right? And who is wrong? This depends in large part on the kind of data that generic companies have to submit in order to gain approval for their follow-on drugs. If they are forced to submit the same kind of clinical trial data that originators have submitted to the regulatory authority, then this does amount to data exclusivity. For almost all generics will simply wait for the term (four years) to expire rather than undertake the expensive process of generating clinical trial data afresh, not to mention the sheer immorality of repeating animal studies and subjecting human volunteers to safety and efficacy tests in relation to the same drug molecule.<br /><br />It is for this reason that world over, generic drugs are approved upon a simple showing of bio-equivalence: that the claimed molecule is the same as the one already approved. And therefore, there is no sense in having the generic applicant repeat all clinical trials afresh. However, bio-equivalence cannot be had for the asking but must be demonstrated through rigorous studies/data.<br /><br />Unfortunately, our Act is not very clear on the kind of studies/data that a generic applicant is meant to submit, not least because it is one of the worst drafted pieces of legislation, leaving the bulk of substantive norms in the &ldquo;rules&rdquo; and various forms and schedules running to a good 500 pages!<br /><br />Little wonder then that a number of state regulators do not insist on bio-equivalence studies or any other studies for that matter prior to approving a drug for manufacture in that State. Therefore, any substance held out as a drug (even a complex cancer drug) is likely to make the cut&hellip; be it a piece of chalk, cheese or china!<br /><br />And this precisely is why in our rather complicated federal structure of drug regulation, comprising both a Central authority, namely the DCGI, and a vast array of State-level regulators, drug manufacturers opt to simply wait for four years and then approach State authorities rather than risking a more rigorous Central clearance.<br /><br />However, this does not mean that all is well on the Central regulatory front. A damning parliamentary committee report some years ago found that in the vast majority of cases, the DCGI doesn&rsquo;t even insist on separate local clinical trial data for new drugs. Rather they routinely dispense with the requirement of local clinical trials under a broad &ldquo;public interest&rdquo; exception.<br /><br /><em>Lax regulatory standards<br /></em><br />In the end, one needs to ask: why have this four-year or 10-year time lag at all for generic drug approval? Shouldn&rsquo;t generic drugs be approved on Day One, so long as they are able to demonstrate (through bio-equivalence studies and the like) that they are as robust as the new drug that has already been approved once? Why maintain this legal fiction that a drug will remain &ldquo;new&rdquo; even after it has been validly approved once (for up to four years or 10 years as the case may be)?<br /><br />Unfortunately, our drug regulatory regime is callous at best, and murderous at worst, plagued with glaring gaps that are routinely exploited by drug majors &mdash; a fact amply demonstrated by a well-researched public interest petition (PIL) by whistle-blower Dinesh Thakur. Unfortunately, the apex court declined to admit his PIL and we lost out on an opportunity to compel a healthier drug regulatory regime.<br /><br />Pollution is easy to understand. Drug regulatory standards not so. Which may perhaps explain why courts routinely entertain PILs on the former, but shy away from the latter. Even when lax regulation on the latter count is far more dangerous than pollution. For, with each passing day, we&rsquo;re suffering a regime that kills, albeit all too softly, through a laxity in the law. A laxity that the layman may not immediately grasp. But one which a responsible government (and even judges) should make it their business to study and understand, before it is too late.<br /><em><br />Shamnad Basheer is Honorary Research Professor of Intellectual Property Law at Nirma University and founder of SpicyIP.</em></div>                                                           
                        </div>
                    </td>
                </tr>
            </table>
        </div>
    </div>
</div>
<div class="clear"></div>
    <br><a href="http://www.thehindu.com/opinion/op-ed/Generics-vs-big-pharma-reloaded/article16681172.ece?homepage=true" class="re" target="_blank">The Hindu, 23 November, 2016, http://www.thehindu.com/opinion/op-ed/Generics-vs-big-pharma-reloaded/article16681172.ece?homepage=true</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=Intellectual Property Rights"
                   title="Intellectual Property Rights">
                    Intellectual Property Rights                </a>
                                <a class="tagcloud5"
                   href="https://im4change.in/search?qryStr=Patent justice"
                   title="Patent justice">
                    Patent justice                </a>
                                <a class="tagcloud5"
                   href="https://im4change.in/search?qryStr=Patented Medicines"
                   title="Patented Medicines">
                    Patented 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=generic medicines"
                   title="generic medicines">
                    generic medicines                </a>
                                <a class="tagcloud5"
                   href="https://im4change.in/search?qryStr=IPRs"
                   title="IPRs">
                    IPRs                </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/explained-the-legal-battle-over-the-potatoes-used-to-make-lay-s-chips-flavia-lopes.html"
                       title="Explained: The legal battle over the potatoes used to make Lay’s chips -Flavia Lopes">
                        Explained: The legal battle over the potatoes used to make Lay’s chips -Flavia Lopes                    </a>
                </li>
                                <li class="recentcomments">
                    <a href="https://im4change.in/latest-news-updates/expired-pill-editorial-on-new-drugs-and-cosmetics-bill.html"
                       title="Expired pill: Editorial on new drugs and cosmetics bill">
                        Expired pill: Editorial on new drugs and cosmetics bill                    </a>
                </li>
                                <li class="recentcomments">
                    <a href="https://im4change.in/latest-news-updates/ngos-protest-commerce-ministry-inaction-on-wto-covid-19-vaccine-proposal-jacob-koshy.html"
                       title="NGOs protest Commerce Ministry inaction on WTO COVID-19 vaccine proposal -Jacob Koshy">
                        NGOs protest Commerce Ministry inaction on WTO COVID-19 vaccine proposal -Jacob Koshy                    </a>
                </li>
                                <li class="recentcomments">
                    <a href="https://im4change.in/latest-news-updates/with-new-moefcc-memo-are-indian-policy-makers-supporting-big-biotech-indra-shekhar-singh.html"
                       title="With New MoEFCC Memo, Are Indian Policy Makers Supporting 'Big Biotech'? -Indra Shekhar Singh">
                        With New MoEFCC Memo, Are Indian Policy Makers Supporting 'Big Biotech'? -Indra Shekhar Singh                    </a>
                </li>
                                <li class="recentcomments">
                    <a href="https://im4change.in/news-alerts-57/is-the-govt-doing-enough-for-the-jan-aushadhi-scheme.html"
                       title="Is the govt. doing enough for the Jan Aushadhi scheme?">
                        Is the govt. doing enough for the Jan Aushadhi scheme?                    </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/generics-vs-big-pharma-reloaded-shamnad-basheer-4680628.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="32551"/>
        <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=729166922" 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/generics-vs-big-pharma-reloaded-shamnad-basheer-4680628.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/generics-vs-big-pharma-reloaded-shamnad-basheer-4680628.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

Generics vs big pharma, reloaded -Shamnad Basheer

Published on Nov 23, 2016   Modified on Nov 23, 2016

-The Hindu The proposal to extend the time limit for State-level drug regulatory approvals from four to 10 years could hit the generics market In a scathing letter to the Government of India, the Indian Pharmaceutical Alliance (IPA) took issue with what it considered to be a backdoor extension for data exclusivity norms in the country. It pointed to the recent government proposal to change the four-year time limit for State-level drug regulatory approvals to 10 years, arguing that this effectively results in a long and damaging data exclusivity. Data exclusivity is a kind of intellectual property protection wherein clinical trial and other data submitted by an originator drug company cannot be used or relied upon by a drug regulatory authority to approve a generic version of that drug for a certain period of time. The notion is that without such protection, the originator company lacks the necessary commercial incentive to conduct expensive trials and take a potential drug to the market. Blocking generic entry for some years will, the theory goes, help drug companies invest in clinical trials. Skewing the pharma market? India has long resisted U.S. and EU pressure to institute data exclusivity norms, seeing it as a barrier to generic entry and more affordable drug prices. However, a rather curious provision in the Drugs and Cosmetics Act (DCA) could arguably constitute a de facto kind of data exclusivity. Under the Act as it stands now, a new drug continues to remain “new” even after it has been approved once by the Central regulator (Drugs Controller General of India, or DGCI) upon submission of local clinical trial data establishing safety and efficacy in India. However, it loses “newness” after four years, which means a drug manufacturer can short-circuit the process and go directly to a State regulatory authority and procure drug approval. It is this four-year period that is now sought to be enhanced to 10 years, an extension that the IPA argues constitutes an enhancement of data exclusivity norms in favour of large pharma companies, particularly MNCs. Others insist that there is no such data exclusivity norm in India. Who is right? And who is wrong? This depends in large part on the kind of data that generic companies have to submit in order to gain approval for their follow-on drugs. If they are forced to submit the same kind of clinical trial data that originators have submitted to the regulatory authority, then this does amount to data exclusivity. For almost all generics will simply wait for the term (four years) to expire rather than undertake the expensive process of generating clinical trial data afresh, not to mention the sheer immorality of repeating animal studies and subjecting human volunteers to safety and efficacy tests in relation to the same drug molecule. It is for this reason that world over, generic drugs are approved upon a simple showing of bio-equivalence: that the claimed molecule is the same as the one already approved. And therefore, there is no sense in having the generic applicant repeat all clinical trials afresh. However, bio-equivalence cannot be had for the asking but must be demonstrated through rigorous studies/data. Unfortunately, our Act is not very clear on the kind of studies/data that a generic applicant is meant to submit, not least because it is one of the worst drafted pieces of legislation, leaving the bulk of substantive norms in the “rules” and various forms and schedules running to a good 500 pages! Little wonder then that a number of state regulators do not insist on bio-equivalence studies or any other studies for that matter prior to approving a drug for manufacture in that State. Therefore, any substance held out as a drug (even a complex cancer drug) is likely to make the cut… be it a piece of chalk, cheese or china! And this precisely is why in our rather complicated federal structure of drug regulation, comprising both a Central authority, namely the DCGI, and a vast array of State-level regulators, drug manufacturers opt to simply wait for four years and then approach State authorities rather than risking a more rigorous Central clearance. However, this does not mean that all is well on the Central regulatory front. A damning parliamentary committee report some years ago found that in the vast majority of cases, the DCGI doesn’t even insist on separate local clinical trial data for new drugs. Rather they routinely dispense with the requirement of local clinical trials under a broad “public interest” exception. Lax regulatory standards In the end, one needs to ask: why have this four-year or 10-year time lag at all for generic drug approval? Shouldn’t generic drugs be approved on Day One, so long as they are able to demonstrate (through bio-equivalence studies and the like) that they are as robust as the new drug that has already been approved once? Why maintain this legal fiction that a drug will remain “new” even after it has been validly approved once (for up to four years or 10 years as the case may be)? Unfortunately, our drug regulatory regime is callous at best, and murderous at worst, plagued with glaring gaps that are routinely exploited by drug majors — a fact amply demonstrated by a well-researched public interest petition (PIL) by whistle-blower Dinesh Thakur. Unfortunately, the apex court declined to admit his PIL and we lost out on an opportunity to compel a healthier drug regulatory regime. Pollution is easy to understand. Drug regulatory standards not so. Which may perhaps explain why courts routinely entertain PILs on the former, but shy away from the latter. Even when lax regulation on the latter count is far more dangerous than pollution. For, with each passing day, we’re suffering a regime that kills, albeit all too softly, through a laxity in the law. A laxity that the layman may not immediately grasp. But one which a responsible government (and even judges) should make it their business to study and understand, before it is too late. Shamnad Basheer is Honorary Research Professor of Intellectual Property Law at Nirma University and founder of SpicyIP.

The Hindu, 23 November, 2016, http://www.thehindu.com/opinion/op-ed/Generics-vs-big-pharma-reloaded/article16681172.ece?homepage=true

Tagged with: Intellectual Property Rights Patent justice Patented Medicines generic medicine generic medicines IPRs

Related Articles

• Explained: The legal battle over the potatoes used to make Lay’s chips -Flavia Lopes
• Expired pill: Editorial on new drugs and cosmetics bill
• NGOs protest Commerce Ministry inaction on WTO COVID-19 vaccine proposal -Jacob Koshy
• With New MoEFCC Memo, Are Indian Policy Makers Supporting 'Big Biotech'? -Indra Shekhar Singh
• Is the govt. doing enough for the Jan Aushadhi scheme?

 

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