Deprecated (16384): The ArrayAccess methods will be removed in 4.0.0.Use getParam(), getData() and getQuery() instead. - /home/brlfuser/public_html/src/Controller/ArtileDetailController.php, line: 73
You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php. [CORE/src/Core/functions.php, line 311]
deprecationWarning - CORE/src/Core/functions.php, line 311
Cake\Http\ServerRequest::offsetGet() - CORE/src/Http/ServerRequest.php, line 2421
App\Controller\ArtileDetailController::printArticle() - APP/Controller/ArtileDetailController.php, line 73
Cake\Controller\Controller::invokeAction() - CORE/src/Controller/Controller.php, line 610
Cake\Http\ActionDispatcher::_invoke() - CORE/src/Http/ActionDispatcher.php, line 120
Cake\Http\ActionDispatcher::dispatch() - CORE/src/Http/ActionDispatcher.php, line 94
Cake\Http\BaseApplication::__invoke() - CORE/src/Http/BaseApplication.php, line 235
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\RoutingMiddleware::__invoke() - CORE/src/Routing/Middleware/RoutingMiddleware.php, line 162
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\AssetMiddleware::__invoke() - CORE/src/Routing/Middleware/AssetMiddleware.php, line 88
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Error\Middleware\ErrorHandlerMiddleware::__invoke() - CORE/src/Error/Middleware/ErrorHandlerMiddleware.php, line 96
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51
Cake\Http\Server::run() - CORE/src/Http/Server.php, line 98
Deprecated (16384): The ArrayAccess methods will be removed in 4.0.0.Use getParam(), getData() and getQuery() instead. - /home/brlfuser/public_html/src/Controller/ArtileDetailController.php, line: 74
You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php. [CORE/src/Core/functions.php, line 311]
deprecationWarning - CORE/src/Core/functions.php, line 311
Cake\Http\ServerRequest::offsetGet() - CORE/src/Http/ServerRequest.php, line 2421
App\Controller\ArtileDetailController::printArticle() - APP/Controller/ArtileDetailController.php, line 74
Cake\Controller\Controller::invokeAction() - CORE/src/Controller/Controller.php, line 610
Cake\Http\ActionDispatcher::_invoke() - CORE/src/Http/ActionDispatcher.php, line 120
Cake\Http\ActionDispatcher::dispatch() - CORE/src/Http/ActionDispatcher.php, line 94
Cake\Http\BaseApplication::__invoke() - CORE/src/Http/BaseApplication.php, line 235
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\RoutingMiddleware::__invoke() - CORE/src/Routing/Middleware/RoutingMiddleware.php, line 162
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\AssetMiddleware::__invoke() - CORE/src/Routing/Middleware/AssetMiddleware.php, line 88
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Error\Middleware\ErrorHandlerMiddleware::__invoke() - CORE/src/Error/Middleware/ErrorHandlerMiddleware.php, line 96
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51
Cake\Http\Server::run() - CORE/src/Http/Server.php, line 98
Warning (512): Unable to emit headers. Headers sent in file=/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Debugger.php line=853 [CORE/src/Http/ResponseEmitter.php, line 48]
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 PUBLIC "-//W3C//DTD XHTML 1.0 Transitional//EN"
"http://www.w3.org/TR/xhtml1/DTD/xhtml1-transitional.dtd">
<html xmlns="http://www.w3.org/1999/xhtml">
<head>
<link rel="canonical" href="https://im4change.in/<pre class="cake-error"><a href="javascript:void(0);" onclick="document.getElementById('cakeErr67f3ef819c338-trace').style.display = (document.getElementById('cakeErr67f3ef819c338-trace').style.display == 'none' ? '' : 'none');"><b>Notice</b> (8)</a>: Undefined variable: urlPrefix [<b>APP/Template/Layout/printlayout.ctp</b>, line <b>8</b>]<div id="cakeErr67f3ef819c338-trace" class="cake-stack-trace" style="display: none;"><a href="javascript:void(0);" onclick="document.getElementById('cakeErr67f3ef819c338-code').style.display = (document.getElementById('cakeErr67f3ef819c338-code').style.display == 'none' ? '' : 'none')">Code</a> <a href="javascript:void(0);" onclick="document.getElementById('cakeErr67f3ef819c338-context').style.display = (document.getElementById('cakeErr67f3ef819c338-context').style.display == 'none' ? '' : 'none')">Context</a><pre id="cakeErr67f3ef819c338-code" class="cake-code-dump" style="display: none;"><code><span style="color: #000000"><span style="color: #0000BB"></span><span style="color: #007700"><</span><span style="color: #0000BB">head</span><span style="color: #007700">>
</span></span></code>
<span class="code-highlight"><code><span style="color: #000000"> <link rel="canonical" href="<span style="color: #0000BB"><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">Configure</span><span style="color: #007700">::</span><span style="color: #0000BB">read</span><span style="color: #007700">(</span><span style="color: #DD0000">'SITE_URL'</span><span style="color: #007700">); </span><span style="color: #0000BB">?><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">$urlPrefix</span><span style="color: #007700">;</span><span style="color: #0000BB">?><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">$article_current</span><span style="color: #007700">-></span><span style="color: #0000BB">category</span><span style="color: #007700">-></span><span style="color: #0000BB">slug</span><span style="color: #007700">; </span><span style="color: #0000BB">?></span>/<span style="color: #0000BB"><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">$article_current</span><span style="color: #007700">-></span><span style="color: #0000BB">seo_url</span><span style="color: #007700">; </span><span style="color: #0000BB">?></span>.html"/>
</span></code></span>
<code><span style="color: #000000"><span style="color: #0000BB"> </span><span style="color: #007700"><</span><span style="color: #0000BB">meta http</span><span style="color: #007700">-</span><span style="color: #0000BB">equiv</span><span style="color: #007700">=</span><span style="color: #DD0000">"Content-Type" </span><span style="color: #0000BB">content</span><span style="color: #007700">=</span><span style="color: #DD0000">"text/html; charset=utf-8"</span><span style="color: #007700">/>
</span></span></code></pre><pre id="cakeErr67f3ef819c338-context" class="cake-context" style="display: none;">$viewFile = '/home/brlfuser/public_html/src/Template/Layout/printlayout.ctp'
$dataForView = [
'article_current' => object(App\Model\Entity\Article) {
'id' => (int) 17692,
'title' => 'Centre planning major changes in rules for clinical trials',
'subheading' => '',
'description' => '<div align="justify">
-The Hindu<br />
<br />
<em>Drugs Controller must be told of adverse events within 24 hours<br />
</em><br />
Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs &amp; Cosmetics Act, 1940, and its Rules. These would make it mandatory for the Investigator to report all serious adverse events, including deaths, to the Drugs Controller General of India (DGCI), as well as the sponsor and the ethics committee, within 24 hours of occurrence.<br />
<br />
The DGCI will constitute a committee of experts to analyse the report of the Investigator, the sponsor, and the ethics committee, to arrive at the exact cause of the injury or death, and it shall then recommend the exact quantum of compensation in case of trial-related injury or deaths within three months.<br />
<br />
As per the existing procedure, all serious adverse events (SAEs) are reported by the Investigator to the sponsor and the company within 24 hours and to the ethics committee in 7 days. The sponsor then submits the information to the DCGI and some other investigators within 14 days. It is the institutional ethics committee or the independent ethics committee that decides on the cause of the injury or death, and announces compensation accordingly.<br />
<br />
There is also a proposal which makes it mandatory for the sponsor to provide medical care to the person who suffers injury during trial, for as long as required.<br />
<br />
There will be a specific provision in the Rules for payment of compensation to the affected persons/their nominees, for trial-related injuries and deaths.<br />
<br />
To capture the socio-economic background of the persons participating in the trial, it is proposed to modify the Informed Consent Form to capture qualifications, occupation, annual income, and address of the person concerned. Requirements and guidelines for registration of the ethics committee would be prescribed in the Rules.<br />
<br />
However, this method has drawn a lot of flak, as there have been complaints related to violation of ethics, and prejudiced reports of the ethics committee. Even the existing manner of securing consent from the subjects has been questioned by rights-based health activists.<br />
<br />
As per the available data, the number of serious adverse events in clinical trials reported during 2010, 2011, and up to June 2012, stood at 668, 438 and 211, respectively.<br />
<br />
However, deaths due to clinical trials were 22 and 16 in 2010 and 2011, respectively.<br />
<br />
The Union Ministry of Health &amp; Family Welfare has already moved amendments to the Rules, wherein 12 New Drug Advisory Committees, consisting of leading experts from the government medical colleges and institutes from all States in the country, have been constituted to advise the DGCI in matters related to approval of clinical trials and new medicines.<br />
<br />
Applications of Investigational New Drugs (IND), which have never earlier been used in human beings, are evaluated by the IND committee, chaired by the Director General of the Indian Council of Medical Research. Deaths may occur during clinical trials due to various reasons, including life-threatening diseases like cancer, cardio-vascular conditions like congestive heart failure, and stroke.<br />
<br />
They can also be due to the side-effects of the medicines or their administration to critically or terminally ill patients.
</div>',
'credit_writer' => 'The Hindu, 28 October, 2012, http://www.thehindu.com/todays-paper/tp-national/centre-planning-major-changes-in-rules-for-clinical-trials/article4039661.ece',
'article_img' => '',
'article_img_thumb' => '',
'status' => (int) 1,
'show_on_home' => (int) 1,
'lang' => 'EN',
'category_id' => (int) 16,
'tag_keyword' => '',
'seo_url' => 'centre-planning-major-changes-in-rules-for-clinical-trials-17821',
'meta_title' => null,
'meta_keywords' => null,
'meta_description' => null,
'noindex' => (int) 0,
'publish_date' => object(Cake\I18n\FrozenDate) {},
'most_visit_section_id' => null,
'article_big_img' => null,
'liveid' => (int) 17821,
'created' => object(Cake\I18n\FrozenTime) {},
'modified' => object(Cake\I18n\FrozenTime) {},
'edate' => '',
'tags' => [
[maximum depth reached]
],
'category' => object(App\Model\Entity\Category) {},
'[new]' => false,
'[accessible]' => [
[maximum depth reached]
],
'[dirty]' => [[maximum depth reached]],
'[original]' => [[maximum depth reached]],
'[virtual]' => [[maximum depth reached]],
'[hasErrors]' => false,
'[errors]' => [[maximum depth reached]],
'[invalid]' => [[maximum depth reached]],
'[repository]' => 'Articles'
},
'articleid' => (int) 17692,
'metaTitle' => 'LATEST NEWS UPDATES | Centre planning major changes in rules for clinical trials',
'metaKeywords' => 'medicines,Health',
'metaDesc' => '
-The Hindu
Drugs Controller must be told of adverse events within 24 hours
Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs &amp; Cosmetics Act, 1940, and its Rules....',
'disp' => '<div align="justify">-The Hindu<br /><br /><em>Drugs Controller must be told of adverse events within 24 hours<br /></em><br />Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs &amp; Cosmetics Act, 1940, and its Rules. These would make it mandatory for the Investigator to report all serious adverse events, including deaths, to the Drugs Controller General of India (DGCI), as well as the sponsor and the ethics committee, within 24 hours of occurrence.<br /><br />The DGCI will constitute a committee of experts to analyse the report of the Investigator, the sponsor, and the ethics committee, to arrive at the exact cause of the injury or death, and it shall then recommend the exact quantum of compensation in case of trial-related injury or deaths within three months.<br /><br />As per the existing procedure, all serious adverse events (SAEs) are reported by the Investigator to the sponsor and the company within 24 hours and to the ethics committee in 7 days. The sponsor then submits the information to the DCGI and some other investigators within 14 days. It is the institutional ethics committee or the independent ethics committee that decides on the cause of the injury or death, and announces compensation accordingly.<br /><br />There is also a proposal which makes it mandatory for the sponsor to provide medical care to the person who suffers injury during trial, for as long as required.<br /><br />There will be a specific provision in the Rules for payment of compensation to the affected persons/their nominees, for trial-related injuries and deaths.<br /><br />To capture the socio-economic background of the persons participating in the trial, it is proposed to modify the Informed Consent Form to capture qualifications, occupation, annual income, and address of the person concerned. Requirements and guidelines for registration of the ethics committee would be prescribed in the Rules.<br /><br />However, this method has drawn a lot of flak, as there have been complaints related to violation of ethics, and prejudiced reports of the ethics committee. Even the existing manner of securing consent from the subjects has been questioned by rights-based health activists.<br /><br />As per the available data, the number of serious adverse events in clinical trials reported during 2010, 2011, and up to June 2012, stood at 668, 438 and 211, respectively.<br /><br />However, deaths due to clinical trials were 22 and 16 in 2010 and 2011, respectively.<br /><br />The Union Ministry of Health &amp; Family Welfare has already moved amendments to the Rules, wherein 12 New Drug Advisory Committees, consisting of leading experts from the government medical colleges and institutes from all States in the country, have been constituted to advise the DGCI in matters related to approval of clinical trials and new medicines.<br /><br />Applications of Investigational New Drugs (IND), which have never earlier been used in human beings, are evaluated by the IND committee, chaired by the Director General of the Indian Council of Medical Research. Deaths may occur during clinical trials due to various reasons, including life-threatening diseases like cancer, cardio-vascular conditions like congestive heart failure, and stroke.<br /><br />They can also be due to the side-effects of the medicines or their administration to critically or terminally ill patients.</div>',
'lang' => 'English',
'SITE_URL' => 'https://im4change.in/',
'site_title' => 'im4change',
'adminprix' => 'admin'
]
$article_current = object(App\Model\Entity\Article) {
'id' => (int) 17692,
'title' => 'Centre planning major changes in rules for clinical trials',
'subheading' => '',
'description' => '<div align="justify">
-The Hindu<br />
<br />
<em>Drugs Controller must be told of adverse events within 24 hours<br />
</em><br />
Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs &amp; Cosmetics Act, 1940, and its Rules. These would make it mandatory for the Investigator to report all serious adverse events, including deaths, to the Drugs Controller General of India (DGCI), as well as the sponsor and the ethics committee, within 24 hours of occurrence.<br />
<br />
The DGCI will constitute a committee of experts to analyse the report of the Investigator, the sponsor, and the ethics committee, to arrive at the exact cause of the injury or death, and it shall then recommend the exact quantum of compensation in case of trial-related injury or deaths within three months.<br />
<br />
As per the existing procedure, all serious adverse events (SAEs) are reported by the Investigator to the sponsor and the company within 24 hours and to the ethics committee in 7 days. The sponsor then submits the information to the DCGI and some other investigators within 14 days. It is the institutional ethics committee or the independent ethics committee that decides on the cause of the injury or death, and announces compensation accordingly.<br />
<br />
There is also a proposal which makes it mandatory for the sponsor to provide medical care to the person who suffers injury during trial, for as long as required.<br />
<br />
There will be a specific provision in the Rules for payment of compensation to the affected persons/their nominees, for trial-related injuries and deaths.<br />
<br />
To capture the socio-economic background of the persons participating in the trial, it is proposed to modify the Informed Consent Form to capture qualifications, occupation, annual income, and address of the person concerned. Requirements and guidelines for registration of the ethics committee would be prescribed in the Rules.<br />
<br />
However, this method has drawn a lot of flak, as there have been complaints related to violation of ethics, and prejudiced reports of the ethics committee. Even the existing manner of securing consent from the subjects has been questioned by rights-based health activists.<br />
<br />
As per the available data, the number of serious adverse events in clinical trials reported during 2010, 2011, and up to June 2012, stood at 668, 438 and 211, respectively.<br />
<br />
However, deaths due to clinical trials were 22 and 16 in 2010 and 2011, respectively.<br />
<br />
The Union Ministry of Health &amp; Family Welfare has already moved amendments to the Rules, wherein 12 New Drug Advisory Committees, consisting of leading experts from the government medical colleges and institutes from all States in the country, have been constituted to advise the DGCI in matters related to approval of clinical trials and new medicines.<br />
<br />
Applications of Investigational New Drugs (IND), which have never earlier been used in human beings, are evaluated by the IND committee, chaired by the Director General of the Indian Council of Medical Research. Deaths may occur during clinical trials due to various reasons, including life-threatening diseases like cancer, cardio-vascular conditions like congestive heart failure, and stroke.<br />
<br />
They can also be due to the side-effects of the medicines or their administration to critically or terminally ill patients.
</div>',
'credit_writer' => 'The Hindu, 28 October, 2012, http://www.thehindu.com/todays-paper/tp-national/centre-planning-major-changes-in-rules-for-clinical-trials/article4039661.ece',
'article_img' => '',
'article_img_thumb' => '',
'status' => (int) 1,
'show_on_home' => (int) 1,
'lang' => 'EN',
'category_id' => (int) 16,
'tag_keyword' => '',
'seo_url' => 'centre-planning-major-changes-in-rules-for-clinical-trials-17821',
'meta_title' => null,
'meta_keywords' => null,
'meta_description' => null,
'noindex' => (int) 0,
'publish_date' => object(Cake\I18n\FrozenDate) {},
'most_visit_section_id' => null,
'article_big_img' => null,
'liveid' => (int) 17821,
'created' => object(Cake\I18n\FrozenTime) {},
'modified' => object(Cake\I18n\FrozenTime) {},
'edate' => '',
'tags' => [
(int) 0 => object(Cake\ORM\Entity) {},
(int) 1 => object(Cake\ORM\Entity) {}
],
'category' => object(App\Model\Entity\Category) {},
'[new]' => false,
'[accessible]' => [
'*' => true,
'id' => false
],
'[dirty]' => [],
'[original]' => [],
'[virtual]' => [],
'[hasErrors]' => false,
'[errors]' => [],
'[invalid]' => [],
'[repository]' => 'Articles'
}
$articleid = (int) 17692
$metaTitle = 'LATEST NEWS UPDATES | Centre planning major changes in rules for clinical trials'
$metaKeywords = 'medicines,Health'
$metaDesc = '
-The Hindu
Drugs Controller must be told of adverse events within 24 hours
Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs &amp; Cosmetics Act, 1940, and its Rules....'
$disp = '<div align="justify">-The Hindu<br /><br /><em>Drugs Controller must be told of adverse events within 24 hours<br /></em><br />Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs &amp; Cosmetics Act, 1940, and its Rules. These would make it mandatory for the Investigator to report all serious adverse events, including deaths, to the Drugs Controller General of India (DGCI), as well as the sponsor and the ethics committee, within 24 hours of occurrence.<br /><br />The DGCI will constitute a committee of experts to analyse the report of the Investigator, the sponsor, and the ethics committee, to arrive at the exact cause of the injury or death, and it shall then recommend the exact quantum of compensation in case of trial-related injury or deaths within three months.<br /><br />As per the existing procedure, all serious adverse events (SAEs) are reported by the Investigator to the sponsor and the company within 24 hours and to the ethics committee in 7 days. The sponsor then submits the information to the DCGI and some other investigators within 14 days. It is the institutional ethics committee or the independent ethics committee that decides on the cause of the injury or death, and announces compensation accordingly.<br /><br />There is also a proposal which makes it mandatory for the sponsor to provide medical care to the person who suffers injury during trial, for as long as required.<br /><br />There will be a specific provision in the Rules for payment of compensation to the affected persons/their nominees, for trial-related injuries and deaths.<br /><br />To capture the socio-economic background of the persons participating in the trial, it is proposed to modify the Informed Consent Form to capture qualifications, occupation, annual income, and address of the person concerned. Requirements and guidelines for registration of the ethics committee would be prescribed in the Rules.<br /><br />However, this method has drawn a lot of flak, as there have been complaints related to violation of ethics, and prejudiced reports of the ethics committee. Even the existing manner of securing consent from the subjects has been questioned by rights-based health activists.<br /><br />As per the available data, the number of serious adverse events in clinical trials reported during 2010, 2011, and up to June 2012, stood at 668, 438 and 211, respectively.<br /><br />However, deaths due to clinical trials were 22 and 16 in 2010 and 2011, respectively.<br /><br />The Union Ministry of Health &amp; Family Welfare has already moved amendments to the Rules, wherein 12 New Drug Advisory Committees, consisting of leading experts from the government medical colleges and institutes from all States in the country, have been constituted to advise the DGCI in matters related to approval of clinical trials and new medicines.<br /><br />Applications of Investigational New Drugs (IND), which have never earlier been used in human beings, are evaluated by the IND committee, chaired by the Director General of the Indian Council of Medical Research. Deaths may occur during clinical trials due to various reasons, including life-threatening diseases like cancer, cardio-vascular conditions like congestive heart failure, and stroke.<br /><br />They can also be due to the side-effects of the medicines or their administration to critically or terminally ill patients.</div>'
$lang = 'English'
$SITE_URL = 'https://im4change.in/'
$site_title = 'im4change'
$adminprix = 'admin'</pre><pre class="stack-trace">include - APP/Template/Layout/printlayout.ctp, line 8
Cake\View\View::_evaluate() - CORE/src/View/View.php, line 1413
Cake\View\View::_render() - CORE/src/View/View.php, line 1374
Cake\View\View::renderLayout() - CORE/src/View/View.php, line 927
Cake\View\View::render() - CORE/src/View/View.php, line 885
Cake\Controller\Controller::render() - CORE/src/Controller/Controller.php, line 791
Cake\Http\ActionDispatcher::_invoke() - CORE/src/Http/ActionDispatcher.php, line 126
Cake\Http\ActionDispatcher::dispatch() - CORE/src/Http/ActionDispatcher.php, line 94
Cake\Http\BaseApplication::__invoke() - CORE/src/Http/BaseApplication.php, line 235
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\RoutingMiddleware::__invoke() - CORE/src/Routing/Middleware/RoutingMiddleware.php, line 162
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\AssetMiddleware::__invoke() - CORE/src/Routing/Middleware/AssetMiddleware.php, line 88
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Error\Middleware\ErrorHandlerMiddleware::__invoke() - CORE/src/Error/Middleware/ErrorHandlerMiddleware.php, line 96
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51</pre></div></pre>latest-news-updates/centre-planning-major-changes-in-rules-for-clinical-trials-17821.html"/>
<meta http-equiv="Content-Type" content="text/html; charset=utf-8"/>
<link href="https://im4change.in/css/control.css" rel="stylesheet" type="text/css"
media="all"/>
<title>LATEST NEWS UPDATES | Centre planning major changes in rules for clinical trials | Im4change.org</title>
<meta name="description" content="
-The Hindu
Drugs Controller must be told of adverse events within 24 hours
Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs & Cosmetics Act, 1940, and its Rules...."/>
<script src="https://im4change.in/js/jquery-1.10.2.js"></script>
<script type="text/javascript" src="https://im4change.in/js/jquery-migrate.min.js"></script>
<script language="javascript" type="text/javascript">
$(document).ready(function () {
var img = $("img")[0]; // Get my img elem
var pic_real_width, pic_real_height;
$("<img/>") // Make in memory copy of image to avoid css issues
.attr("src", $(img).attr("src"))
.load(function () {
pic_real_width = this.width; // Note: $(this).width() will not
pic_real_height = this.height; // work for in memory images.
});
});
</script>
<style type="text/css">
@media screen {
div.divFooter {
display: block;
}
}
@media print {
.printbutton {
display: none !important;
}
}
</style>
</head>
<body>
<table cellpadding="0" cellspacing="0" border="0" width="98%" align="center">
<tr>
<td class="top_bg">
<div class="divFooter">
<img src="https://im4change.in/images/logo1.jpg" height="59" border="0"
alt="Resource centre on India's rural distress" style="padding-top:14px;"/>
</div>
</td>
</tr>
<tr>
<td id="topspace"> </td>
</tr>
<tr id="topspace">
<td> </td>
</tr>
<tr>
<td height="50" style="border-bottom:1px solid #000; padding-top:10px;" class="printbutton">
<form><input type="button" value=" Print this page "
onclick="window.print();return false;"/></form>
</td>
</tr>
<tr>
<td width="100%">
<h1 class="news_headlines" style="font-style:normal">
<strong>Centre planning major changes in rules for clinical trials</strong></h1>
</td>
</tr>
<tr>
<td width="100%" style="font-family:Arial, 'Segoe Script', 'Segoe UI', sans-serif, serif"><font size="3">
<div align="justify">-The Hindu<br /><br /><em>Drugs Controller must be told of adverse events within 24 hours<br /></em><br />Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs & Cosmetics Act, 1940, and its Rules. These would make it mandatory for the Investigator to report all serious adverse events, including deaths, to the Drugs Controller General of India (DGCI), as well as the sponsor and the ethics committee, within 24 hours of occurrence.<br /><br />The DGCI will constitute a committee of experts to analyse the report of the Investigator, the sponsor, and the ethics committee, to arrive at the exact cause of the injury or death, and it shall then recommend the exact quantum of compensation in case of trial-related injury or deaths within three months.<br /><br />As per the existing procedure, all serious adverse events (SAEs) are reported by the Investigator to the sponsor and the company within 24 hours and to the ethics committee in 7 days. The sponsor then submits the information to the DCGI and some other investigators within 14 days. It is the institutional ethics committee or the independent ethics committee that decides on the cause of the injury or death, and announces compensation accordingly.<br /><br />There is also a proposal which makes it mandatory for the sponsor to provide medical care to the person who suffers injury during trial, for as long as required.<br /><br />There will be a specific provision in the Rules for payment of compensation to the affected persons/their nominees, for trial-related injuries and deaths.<br /><br />To capture the socio-economic background of the persons participating in the trial, it is proposed to modify the Informed Consent Form to capture qualifications, occupation, annual income, and address of the person concerned. Requirements and guidelines for registration of the ethics committee would be prescribed in the Rules.<br /><br />However, this method has drawn a lot of flak, as there have been complaints related to violation of ethics, and prejudiced reports of the ethics committee. Even the existing manner of securing consent from the subjects has been questioned by rights-based health activists.<br /><br />As per the available data, the number of serious adverse events in clinical trials reported during 2010, 2011, and up to June 2012, stood at 668, 438 and 211, respectively.<br /><br />However, deaths due to clinical trials were 22 and 16 in 2010 and 2011, respectively.<br /><br />The Union Ministry of Health & Family Welfare has already moved amendments to the Rules, wherein 12 New Drug Advisory Committees, consisting of leading experts from the government medical colleges and institutes from all States in the country, have been constituted to advise the DGCI in matters related to approval of clinical trials and new medicines.<br /><br />Applications of Investigational New Drugs (IND), which have never earlier been used in human beings, are evaluated by the IND committee, chaired by the Director General of the Indian Council of Medical Research. Deaths may occur during clinical trials due to various reasons, including life-threatening diseases like cancer, cardio-vascular conditions like congestive heart failure, and stroke.<br /><br />They can also be due to the side-effects of the medicines or their administration to critically or terminally ill patients.</div> </font>
</td>
</tr>
<tr>
<td> </td>
</tr>
<tr>
<td height="50" style="border-top:1px solid #000; border-bottom:1px solid #000;padding-top:10px;">
<form><input type="button" value=" Print this page "
onclick="window.print();return false;"/></form>
</td>
</tr>
</table></body>
</html>'
}
$maxBufferLength = (int) 8192
$file = '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Debugger.php'
$line = (int) 853
$message = 'Unable to emit headers. Headers sent in file=/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Debugger.php line=853'
Cake\Http\ResponseEmitter::emit() - CORE/src/Http/ResponseEmitter.php, line 48
Cake\Http\Server::emit() - CORE/src/Http/Server.php, line 141
[main] - ROOT/webroot/index.php, line 39
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]
$response = object(Cake\Http\Response) {
'status' => (int) 200,
'contentType' => 'text/html',
'headers' => [
'Content-Type' => [
[maximum depth reached]
]
],
'file' => null,
'fileRange' => [],
'cookies' => object(Cake\Http\Cookie\CookieCollection) {},
'cacheDirectives' => [],
'body' => '<!DOCTYPE html PUBLIC "-//W3C//DTD XHTML 1.0 Transitional//EN"
"http://www.w3.org/TR/xhtml1/DTD/xhtml1-transitional.dtd">
<html xmlns="http://www.w3.org/1999/xhtml">
<head>
<link rel="canonical" href="https://im4change.in/<pre class="cake-error"><a href="javascript:void(0);" onclick="document.getElementById('cakeErr67f3ef819c338-trace').style.display = (document.getElementById('cakeErr67f3ef819c338-trace').style.display == 'none' ? '' : 'none');"><b>Notice</b> (8)</a>: Undefined variable: urlPrefix [<b>APP/Template/Layout/printlayout.ctp</b>, line <b>8</b>]<div id="cakeErr67f3ef819c338-trace" class="cake-stack-trace" style="display: none;"><a href="javascript:void(0);" onclick="document.getElementById('cakeErr67f3ef819c338-code').style.display = (document.getElementById('cakeErr67f3ef819c338-code').style.display == 'none' ? '' : 'none')">Code</a> <a href="javascript:void(0);" onclick="document.getElementById('cakeErr67f3ef819c338-context').style.display = (document.getElementById('cakeErr67f3ef819c338-context').style.display == 'none' ? '' : 'none')">Context</a><pre id="cakeErr67f3ef819c338-code" class="cake-code-dump" style="display: none;"><code><span style="color: #000000"><span style="color: #0000BB"></span><span style="color: #007700"><</span><span style="color: #0000BB">head</span><span style="color: #007700">>
</span></span></code>
<span class="code-highlight"><code><span style="color: #000000"> <link rel="canonical" href="<span style="color: #0000BB"><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">Configure</span><span style="color: #007700">::</span><span style="color: #0000BB">read</span><span style="color: #007700">(</span><span style="color: #DD0000">'SITE_URL'</span><span style="color: #007700">); </span><span style="color: #0000BB">?><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">$urlPrefix</span><span style="color: #007700">;</span><span style="color: #0000BB">?><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">$article_current</span><span style="color: #007700">-></span><span style="color: #0000BB">category</span><span style="color: #007700">-></span><span style="color: #0000BB">slug</span><span style="color: #007700">; </span><span style="color: #0000BB">?></span>/<span style="color: #0000BB"><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">$article_current</span><span style="color: #007700">-></span><span style="color: #0000BB">seo_url</span><span style="color: #007700">; </span><span style="color: #0000BB">?></span>.html"/>
</span></code></span>
<code><span style="color: #000000"><span style="color: #0000BB"> </span><span style="color: #007700"><</span><span style="color: #0000BB">meta http</span><span style="color: #007700">-</span><span style="color: #0000BB">equiv</span><span style="color: #007700">=</span><span style="color: #DD0000">"Content-Type" </span><span style="color: #0000BB">content</span><span style="color: #007700">=</span><span style="color: #DD0000">"text/html; charset=utf-8"</span><span style="color: #007700">/>
</span></span></code></pre><pre id="cakeErr67f3ef819c338-context" class="cake-context" style="display: none;">$viewFile = '/home/brlfuser/public_html/src/Template/Layout/printlayout.ctp'
$dataForView = [
'article_current' => object(App\Model\Entity\Article) {
'id' => (int) 17692,
'title' => 'Centre planning major changes in rules for clinical trials',
'subheading' => '',
'description' => '<div align="justify">
-The Hindu<br />
<br />
<em>Drugs Controller must be told of adverse events within 24 hours<br />
</em><br />
Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs &amp; Cosmetics Act, 1940, and its Rules. These would make it mandatory for the Investigator to report all serious adverse events, including deaths, to the Drugs Controller General of India (DGCI), as well as the sponsor and the ethics committee, within 24 hours of occurrence.<br />
<br />
The DGCI will constitute a committee of experts to analyse the report of the Investigator, the sponsor, and the ethics committee, to arrive at the exact cause of the injury or death, and it shall then recommend the exact quantum of compensation in case of trial-related injury or deaths within three months.<br />
<br />
As per the existing procedure, all serious adverse events (SAEs) are reported by the Investigator to the sponsor and the company within 24 hours and to the ethics committee in 7 days. The sponsor then submits the information to the DCGI and some other investigators within 14 days. It is the institutional ethics committee or the independent ethics committee that decides on the cause of the injury or death, and announces compensation accordingly.<br />
<br />
There is also a proposal which makes it mandatory for the sponsor to provide medical care to the person who suffers injury during trial, for as long as required.<br />
<br />
There will be a specific provision in the Rules for payment of compensation to the affected persons/their nominees, for trial-related injuries and deaths.<br />
<br />
To capture the socio-economic background of the persons participating in the trial, it is proposed to modify the Informed Consent Form to capture qualifications, occupation, annual income, and address of the person concerned. Requirements and guidelines for registration of the ethics committee would be prescribed in the Rules.<br />
<br />
However, this method has drawn a lot of flak, as there have been complaints related to violation of ethics, and prejudiced reports of the ethics committee. Even the existing manner of securing consent from the subjects has been questioned by rights-based health activists.<br />
<br />
As per the available data, the number of serious adverse events in clinical trials reported during 2010, 2011, and up to June 2012, stood at 668, 438 and 211, respectively.<br />
<br />
However, deaths due to clinical trials were 22 and 16 in 2010 and 2011, respectively.<br />
<br />
The Union Ministry of Health &amp; Family Welfare has already moved amendments to the Rules, wherein 12 New Drug Advisory Committees, consisting of leading experts from the government medical colleges and institutes from all States in the country, have been constituted to advise the DGCI in matters related to approval of clinical trials and new medicines.<br />
<br />
Applications of Investigational New Drugs (IND), which have never earlier been used in human beings, are evaluated by the IND committee, chaired by the Director General of the Indian Council of Medical Research. Deaths may occur during clinical trials due to various reasons, including life-threatening diseases like cancer, cardio-vascular conditions like congestive heart failure, and stroke.<br />
<br />
They can also be due to the side-effects of the medicines or their administration to critically or terminally ill patients.
</div>',
'credit_writer' => 'The Hindu, 28 October, 2012, http://www.thehindu.com/todays-paper/tp-national/centre-planning-major-changes-in-rules-for-clinical-trials/article4039661.ece',
'article_img' => '',
'article_img_thumb' => '',
'status' => (int) 1,
'show_on_home' => (int) 1,
'lang' => 'EN',
'category_id' => (int) 16,
'tag_keyword' => '',
'seo_url' => 'centre-planning-major-changes-in-rules-for-clinical-trials-17821',
'meta_title' => null,
'meta_keywords' => null,
'meta_description' => null,
'noindex' => (int) 0,
'publish_date' => object(Cake\I18n\FrozenDate) {},
'most_visit_section_id' => null,
'article_big_img' => null,
'liveid' => (int) 17821,
'created' => object(Cake\I18n\FrozenTime) {},
'modified' => object(Cake\I18n\FrozenTime) {},
'edate' => '',
'tags' => [
[maximum depth reached]
],
'category' => object(App\Model\Entity\Category) {},
'[new]' => false,
'[accessible]' => [
[maximum depth reached]
],
'[dirty]' => [[maximum depth reached]],
'[original]' => [[maximum depth reached]],
'[virtual]' => [[maximum depth reached]],
'[hasErrors]' => false,
'[errors]' => [[maximum depth reached]],
'[invalid]' => [[maximum depth reached]],
'[repository]' => 'Articles'
},
'articleid' => (int) 17692,
'metaTitle' => 'LATEST NEWS UPDATES | Centre planning major changes in rules for clinical trials',
'metaKeywords' => 'medicines,Health',
'metaDesc' => '
-The Hindu
Drugs Controller must be told of adverse events within 24 hours
Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs &amp; Cosmetics Act, 1940, and its Rules....',
'disp' => '<div align="justify">-The Hindu<br /><br /><em>Drugs Controller must be told of adverse events within 24 hours<br /></em><br />Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs &amp; Cosmetics Act, 1940, and its Rules. These would make it mandatory for the Investigator to report all serious adverse events, including deaths, to the Drugs Controller General of India (DGCI), as well as the sponsor and the ethics committee, within 24 hours of occurrence.<br /><br />The DGCI will constitute a committee of experts to analyse the report of the Investigator, the sponsor, and the ethics committee, to arrive at the exact cause of the injury or death, and it shall then recommend the exact quantum of compensation in case of trial-related injury or deaths within three months.<br /><br />As per the existing procedure, all serious adverse events (SAEs) are reported by the Investigator to the sponsor and the company within 24 hours and to the ethics committee in 7 days. The sponsor then submits the information to the DCGI and some other investigators within 14 days. It is the institutional ethics committee or the independent ethics committee that decides on the cause of the injury or death, and announces compensation accordingly.<br /><br />There is also a proposal which makes it mandatory for the sponsor to provide medical care to the person who suffers injury during trial, for as long as required.<br /><br />There will be a specific provision in the Rules for payment of compensation to the affected persons/their nominees, for trial-related injuries and deaths.<br /><br />To capture the socio-economic background of the persons participating in the trial, it is proposed to modify the Informed Consent Form to capture qualifications, occupation, annual income, and address of the person concerned. Requirements and guidelines for registration of the ethics committee would be prescribed in the Rules.<br /><br />However, this method has drawn a lot of flak, as there have been complaints related to violation of ethics, and prejudiced reports of the ethics committee. Even the existing manner of securing consent from the subjects has been questioned by rights-based health activists.<br /><br />As per the available data, the number of serious adverse events in clinical trials reported during 2010, 2011, and up to June 2012, stood at 668, 438 and 211, respectively.<br /><br />However, deaths due to clinical trials were 22 and 16 in 2010 and 2011, respectively.<br /><br />The Union Ministry of Health &amp; Family Welfare has already moved amendments to the Rules, wherein 12 New Drug Advisory Committees, consisting of leading experts from the government medical colleges and institutes from all States in the country, have been constituted to advise the DGCI in matters related to approval of clinical trials and new medicines.<br /><br />Applications of Investigational New Drugs (IND), which have never earlier been used in human beings, are evaluated by the IND committee, chaired by the Director General of the Indian Council of Medical Research. Deaths may occur during clinical trials due to various reasons, including life-threatening diseases like cancer, cardio-vascular conditions like congestive heart failure, and stroke.<br /><br />They can also be due to the side-effects of the medicines or their administration to critically or terminally ill patients.</div>',
'lang' => 'English',
'SITE_URL' => 'https://im4change.in/',
'site_title' => 'im4change',
'adminprix' => 'admin'
]
$article_current = object(App\Model\Entity\Article) {
'id' => (int) 17692,
'title' => 'Centre planning major changes in rules for clinical trials',
'subheading' => '',
'description' => '<div align="justify">
-The Hindu<br />
<br />
<em>Drugs Controller must be told of adverse events within 24 hours<br />
</em><br />
Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs &amp; Cosmetics Act, 1940, and its Rules. These would make it mandatory for the Investigator to report all serious adverse events, including deaths, to the Drugs Controller General of India (DGCI), as well as the sponsor and the ethics committee, within 24 hours of occurrence.<br />
<br />
The DGCI will constitute a committee of experts to analyse the report of the Investigator, the sponsor, and the ethics committee, to arrive at the exact cause of the injury or death, and it shall then recommend the exact quantum of compensation in case of trial-related injury or deaths within three months.<br />
<br />
As per the existing procedure, all serious adverse events (SAEs) are reported by the Investigator to the sponsor and the company within 24 hours and to the ethics committee in 7 days. The sponsor then submits the information to the DCGI and some other investigators within 14 days. It is the institutional ethics committee or the independent ethics committee that decides on the cause of the injury or death, and announces compensation accordingly.<br />
<br />
There is also a proposal which makes it mandatory for the sponsor to provide medical care to the person who suffers injury during trial, for as long as required.<br />
<br />
There will be a specific provision in the Rules for payment of compensation to the affected persons/their nominees, for trial-related injuries and deaths.<br />
<br />
To capture the socio-economic background of the persons participating in the trial, it is proposed to modify the Informed Consent Form to capture qualifications, occupation, annual income, and address of the person concerned. Requirements and guidelines for registration of the ethics committee would be prescribed in the Rules.<br />
<br />
However, this method has drawn a lot of flak, as there have been complaints related to violation of ethics, and prejudiced reports of the ethics committee. Even the existing manner of securing consent from the subjects has been questioned by rights-based health activists.<br />
<br />
As per the available data, the number of serious adverse events in clinical trials reported during 2010, 2011, and up to June 2012, stood at 668, 438 and 211, respectively.<br />
<br />
However, deaths due to clinical trials were 22 and 16 in 2010 and 2011, respectively.<br />
<br />
The Union Ministry of Health &amp; Family Welfare has already moved amendments to the Rules, wherein 12 New Drug Advisory Committees, consisting of leading experts from the government medical colleges and institutes from all States in the country, have been constituted to advise the DGCI in matters related to approval of clinical trials and new medicines.<br />
<br />
Applications of Investigational New Drugs (IND), which have never earlier been used in human beings, are evaluated by the IND committee, chaired by the Director General of the Indian Council of Medical Research. Deaths may occur during clinical trials due to various reasons, including life-threatening diseases like cancer, cardio-vascular conditions like congestive heart failure, and stroke.<br />
<br />
They can also be due to the side-effects of the medicines or their administration to critically or terminally ill patients.
</div>',
'credit_writer' => 'The Hindu, 28 October, 2012, http://www.thehindu.com/todays-paper/tp-national/centre-planning-major-changes-in-rules-for-clinical-trials/article4039661.ece',
'article_img' => '',
'article_img_thumb' => '',
'status' => (int) 1,
'show_on_home' => (int) 1,
'lang' => 'EN',
'category_id' => (int) 16,
'tag_keyword' => '',
'seo_url' => 'centre-planning-major-changes-in-rules-for-clinical-trials-17821',
'meta_title' => null,
'meta_keywords' => null,
'meta_description' => null,
'noindex' => (int) 0,
'publish_date' => object(Cake\I18n\FrozenDate) {},
'most_visit_section_id' => null,
'article_big_img' => null,
'liveid' => (int) 17821,
'created' => object(Cake\I18n\FrozenTime) {},
'modified' => object(Cake\I18n\FrozenTime) {},
'edate' => '',
'tags' => [
(int) 0 => object(Cake\ORM\Entity) {},
(int) 1 => object(Cake\ORM\Entity) {}
],
'category' => object(App\Model\Entity\Category) {},
'[new]' => false,
'[accessible]' => [
'*' => true,
'id' => false
],
'[dirty]' => [],
'[original]' => [],
'[virtual]' => [],
'[hasErrors]' => false,
'[errors]' => [],
'[invalid]' => [],
'[repository]' => 'Articles'
}
$articleid = (int) 17692
$metaTitle = 'LATEST NEWS UPDATES | Centre planning major changes in rules for clinical trials'
$metaKeywords = 'medicines,Health'
$metaDesc = '
-The Hindu
Drugs Controller must be told of adverse events within 24 hours
Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs &amp; Cosmetics Act, 1940, and its Rules....'
$disp = '<div align="justify">-The Hindu<br /><br /><em>Drugs Controller must be told of adverse events within 24 hours<br /></em><br />Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs &amp; Cosmetics Act, 1940, and its Rules. These would make it mandatory for the Investigator to report all serious adverse events, including deaths, to the Drugs Controller General of India (DGCI), as well as the sponsor and the ethics committee, within 24 hours of occurrence.<br /><br />The DGCI will constitute a committee of experts to analyse the report of the Investigator, the sponsor, and the ethics committee, to arrive at the exact cause of the injury or death, and it shall then recommend the exact quantum of compensation in case of trial-related injury or deaths within three months.<br /><br />As per the existing procedure, all serious adverse events (SAEs) are reported by the Investigator to the sponsor and the company within 24 hours and to the ethics committee in 7 days. The sponsor then submits the information to the DCGI and some other investigators within 14 days. It is the institutional ethics committee or the independent ethics committee that decides on the cause of the injury or death, and announces compensation accordingly.<br /><br />There is also a proposal which makes it mandatory for the sponsor to provide medical care to the person who suffers injury during trial, for as long as required.<br /><br />There will be a specific provision in the Rules for payment of compensation to the affected persons/their nominees, for trial-related injuries and deaths.<br /><br />To capture the socio-economic background of the persons participating in the trial, it is proposed to modify the Informed Consent Form to capture qualifications, occupation, annual income, and address of the person concerned. Requirements and guidelines for registration of the ethics committee would be prescribed in the Rules.<br /><br />However, this method has drawn a lot of flak, as there have been complaints related to violation of ethics, and prejudiced reports of the ethics committee. Even the existing manner of securing consent from the subjects has been questioned by rights-based health activists.<br /><br />As per the available data, the number of serious adverse events in clinical trials reported during 2010, 2011, and up to June 2012, stood at 668, 438 and 211, respectively.<br /><br />However, deaths due to clinical trials were 22 and 16 in 2010 and 2011, respectively.<br /><br />The Union Ministry of Health &amp; Family Welfare has already moved amendments to the Rules, wherein 12 New Drug Advisory Committees, consisting of leading experts from the government medical colleges and institutes from all States in the country, have been constituted to advise the DGCI in matters related to approval of clinical trials and new medicines.<br /><br />Applications of Investigational New Drugs (IND), which have never earlier been used in human beings, are evaluated by the IND committee, chaired by the Director General of the Indian Council of Medical Research. Deaths may occur during clinical trials due to various reasons, including life-threatening diseases like cancer, cardio-vascular conditions like congestive heart failure, and stroke.<br /><br />They can also be due to the side-effects of the medicines or their administration to critically or terminally ill patients.</div>'
$lang = 'English'
$SITE_URL = 'https://im4change.in/'
$site_title = 'im4change'
$adminprix = 'admin'</pre><pre class="stack-trace">include - APP/Template/Layout/printlayout.ctp, line 8
Cake\View\View::_evaluate() - CORE/src/View/View.php, line 1413
Cake\View\View::_render() - CORE/src/View/View.php, line 1374
Cake\View\View::renderLayout() - CORE/src/View/View.php, line 927
Cake\View\View::render() - CORE/src/View/View.php, line 885
Cake\Controller\Controller::render() - CORE/src/Controller/Controller.php, line 791
Cake\Http\ActionDispatcher::_invoke() - CORE/src/Http/ActionDispatcher.php, line 126
Cake\Http\ActionDispatcher::dispatch() - CORE/src/Http/ActionDispatcher.php, line 94
Cake\Http\BaseApplication::__invoke() - CORE/src/Http/BaseApplication.php, line 235
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\RoutingMiddleware::__invoke() - CORE/src/Routing/Middleware/RoutingMiddleware.php, line 162
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\AssetMiddleware::__invoke() - CORE/src/Routing/Middleware/AssetMiddleware.php, line 88
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Error\Middleware\ErrorHandlerMiddleware::__invoke() - CORE/src/Error/Middleware/ErrorHandlerMiddleware.php, line 96
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51</pre></div></pre>latest-news-updates/centre-planning-major-changes-in-rules-for-clinical-trials-17821.html"/>
<meta http-equiv="Content-Type" content="text/html; charset=utf-8"/>
<link href="https://im4change.in/css/control.css" rel="stylesheet" type="text/css"
media="all"/>
<title>LATEST NEWS UPDATES | Centre planning major changes in rules for clinical trials | Im4change.org</title>
<meta name="description" content="
-The Hindu
Drugs Controller must be told of adverse events within 24 hours
Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs & Cosmetics Act, 1940, and its Rules...."/>
<script src="https://im4change.in/js/jquery-1.10.2.js"></script>
<script type="text/javascript" src="https://im4change.in/js/jquery-migrate.min.js"></script>
<script language="javascript" type="text/javascript">
$(document).ready(function () {
var img = $("img")[0]; // Get my img elem
var pic_real_width, pic_real_height;
$("<img/>") // Make in memory copy of image to avoid css issues
.attr("src", $(img).attr("src"))
.load(function () {
pic_real_width = this.width; // Note: $(this).width() will not
pic_real_height = this.height; // work for in memory images.
});
});
</script>
<style type="text/css">
@media screen {
div.divFooter {
display: block;
}
}
@media print {
.printbutton {
display: none !important;
}
}
</style>
</head>
<body>
<table cellpadding="0" cellspacing="0" border="0" width="98%" align="center">
<tr>
<td class="top_bg">
<div class="divFooter">
<img src="https://im4change.in/images/logo1.jpg" height="59" border="0"
alt="Resource centre on India's rural distress" style="padding-top:14px;"/>
</div>
</td>
</tr>
<tr>
<td id="topspace"> </td>
</tr>
<tr id="topspace">
<td> </td>
</tr>
<tr>
<td height="50" style="border-bottom:1px solid #000; padding-top:10px;" class="printbutton">
<form><input type="button" value=" Print this page "
onclick="window.print();return false;"/></form>
</td>
</tr>
<tr>
<td width="100%">
<h1 class="news_headlines" style="font-style:normal">
<strong>Centre planning major changes in rules for clinical trials</strong></h1>
</td>
</tr>
<tr>
<td width="100%" style="font-family:Arial, 'Segoe Script', 'Segoe UI', sans-serif, serif"><font size="3">
<div align="justify">-The Hindu<br /><br /><em>Drugs Controller must be told of adverse events within 24 hours<br /></em><br />Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs & Cosmetics Act, 1940, and its Rules. These would make it mandatory for the Investigator to report all serious adverse events, including deaths, to the Drugs Controller General of India (DGCI), as well as the sponsor and the ethics committee, within 24 hours of occurrence.<br /><br />The DGCI will constitute a committee of experts to analyse the report of the Investigator, the sponsor, and the ethics committee, to arrive at the exact cause of the injury or death, and it shall then recommend the exact quantum of compensation in case of trial-related injury or deaths within three months.<br /><br />As per the existing procedure, all serious adverse events (SAEs) are reported by the Investigator to the sponsor and the company within 24 hours and to the ethics committee in 7 days. The sponsor then submits the information to the DCGI and some other investigators within 14 days. It is the institutional ethics committee or the independent ethics committee that decides on the cause of the injury or death, and announces compensation accordingly.<br /><br />There is also a proposal which makes it mandatory for the sponsor to provide medical care to the person who suffers injury during trial, for as long as required.<br /><br />There will be a specific provision in the Rules for payment of compensation to the affected persons/their nominees, for trial-related injuries and deaths.<br /><br />To capture the socio-economic background of the persons participating in the trial, it is proposed to modify the Informed Consent Form to capture qualifications, occupation, annual income, and address of the person concerned. Requirements and guidelines for registration of the ethics committee would be prescribed in the Rules.<br /><br />However, this method has drawn a lot of flak, as there have been complaints related to violation of ethics, and prejudiced reports of the ethics committee. Even the existing manner of securing consent from the subjects has been questioned by rights-based health activists.<br /><br />As per the available data, the number of serious adverse events in clinical trials reported during 2010, 2011, and up to June 2012, stood at 668, 438 and 211, respectively.<br /><br />However, deaths due to clinical trials were 22 and 16 in 2010 and 2011, respectively.<br /><br />The Union Ministry of Health & Family Welfare has already moved amendments to the Rules, wherein 12 New Drug Advisory Committees, consisting of leading experts from the government medical colleges and institutes from all States in the country, have been constituted to advise the DGCI in matters related to approval of clinical trials and new medicines.<br /><br />Applications of Investigational New Drugs (IND), which have never earlier been used in human beings, are evaluated by the IND committee, chaired by the Director General of the Indian Council of Medical Research. Deaths may occur during clinical trials due to various reasons, including life-threatening diseases like cancer, cardio-vascular conditions like congestive heart failure, and stroke.<br /><br />They can also be due to the side-effects of the medicines or their administration to critically or terminally ill patients.</div> </font>
</td>
</tr>
<tr>
<td> </td>
</tr>
<tr>
<td height="50" style="border-top:1px solid #000; border-bottom:1px solid #000;padding-top:10px;">
<form><input type="button" value=" Print this page "
onclick="window.print();return false;"/></form>
</td>
</tr>
</table></body>
</html>'
}
$reasonPhrase = 'OK'
header - [internal], line ??
Cake\Http\ResponseEmitter::emitStatusLine() - CORE/src/Http/ResponseEmitter.php, line 148
Cake\Http\ResponseEmitter::emit() - CORE/src/Http/ResponseEmitter.php, line 54
Cake\Http\Server::emit() - CORE/src/Http/Server.php, line 141
[main] - ROOT/webroot/index.php, line 39
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]
$response = object(Cake\Http\Response) {
'status' => (int) 200,
'contentType' => 'text/html',
'headers' => [
'Content-Type' => [
[maximum depth reached]
]
],
'file' => null,
'fileRange' => [],
'cookies' => object(Cake\Http\Cookie\CookieCollection) {},
'cacheDirectives' => [],
'body' => '<!DOCTYPE html PUBLIC "-//W3C//DTD XHTML 1.0 Transitional//EN"
"http://www.w3.org/TR/xhtml1/DTD/xhtml1-transitional.dtd">
<html xmlns="http://www.w3.org/1999/xhtml">
<head>
<link rel="canonical" href="https://im4change.in/<pre class="cake-error"><a href="javascript:void(0);" onclick="document.getElementById('cakeErr67f3ef819c338-trace').style.display = (document.getElementById('cakeErr67f3ef819c338-trace').style.display == 'none' ? '' : 'none');"><b>Notice</b> (8)</a>: Undefined variable: urlPrefix [<b>APP/Template/Layout/printlayout.ctp</b>, line <b>8</b>]<div id="cakeErr67f3ef819c338-trace" class="cake-stack-trace" style="display: none;"><a href="javascript:void(0);" onclick="document.getElementById('cakeErr67f3ef819c338-code').style.display = (document.getElementById('cakeErr67f3ef819c338-code').style.display == 'none' ? '' : 'none')">Code</a> <a href="javascript:void(0);" onclick="document.getElementById('cakeErr67f3ef819c338-context').style.display = (document.getElementById('cakeErr67f3ef819c338-context').style.display == 'none' ? '' : 'none')">Context</a><pre id="cakeErr67f3ef819c338-code" class="cake-code-dump" style="display: none;"><code><span style="color: #000000"><span style="color: #0000BB"></span><span style="color: #007700"><</span><span style="color: #0000BB">head</span><span style="color: #007700">>
</span></span></code>
<span class="code-highlight"><code><span style="color: #000000"> <link rel="canonical" href="<span style="color: #0000BB"><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">Configure</span><span style="color: #007700">::</span><span style="color: #0000BB">read</span><span style="color: #007700">(</span><span style="color: #DD0000">'SITE_URL'</span><span style="color: #007700">); </span><span style="color: #0000BB">?><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">$urlPrefix</span><span style="color: #007700">;</span><span style="color: #0000BB">?><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">$article_current</span><span style="color: #007700">-></span><span style="color: #0000BB">category</span><span style="color: #007700">-></span><span style="color: #0000BB">slug</span><span style="color: #007700">; </span><span style="color: #0000BB">?></span>/<span style="color: #0000BB"><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">$article_current</span><span style="color: #007700">-></span><span style="color: #0000BB">seo_url</span><span style="color: #007700">; </span><span style="color: #0000BB">?></span>.html"/>
</span></code></span>
<code><span style="color: #000000"><span style="color: #0000BB"> </span><span style="color: #007700"><</span><span style="color: #0000BB">meta http</span><span style="color: #007700">-</span><span style="color: #0000BB">equiv</span><span style="color: #007700">=</span><span style="color: #DD0000">"Content-Type" </span><span style="color: #0000BB">content</span><span style="color: #007700">=</span><span style="color: #DD0000">"text/html; charset=utf-8"</span><span style="color: #007700">/>
</span></span></code></pre><pre id="cakeErr67f3ef819c338-context" class="cake-context" style="display: none;">$viewFile = '/home/brlfuser/public_html/src/Template/Layout/printlayout.ctp'
$dataForView = [
'article_current' => object(App\Model\Entity\Article) {
'id' => (int) 17692,
'title' => 'Centre planning major changes in rules for clinical trials',
'subheading' => '',
'description' => '<div align="justify">
-The Hindu<br />
<br />
<em>Drugs Controller must be told of adverse events within 24 hours<br />
</em><br />
Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs &amp; Cosmetics Act, 1940, and its Rules. These would make it mandatory for the Investigator to report all serious adverse events, including deaths, to the Drugs Controller General of India (DGCI), as well as the sponsor and the ethics committee, within 24 hours of occurrence.<br />
<br />
The DGCI will constitute a committee of experts to analyse the report of the Investigator, the sponsor, and the ethics committee, to arrive at the exact cause of the injury or death, and it shall then recommend the exact quantum of compensation in case of trial-related injury or deaths within three months.<br />
<br />
As per the existing procedure, all serious adverse events (SAEs) are reported by the Investigator to the sponsor and the company within 24 hours and to the ethics committee in 7 days. The sponsor then submits the information to the DCGI and some other investigators within 14 days. It is the institutional ethics committee or the independent ethics committee that decides on the cause of the injury or death, and announces compensation accordingly.<br />
<br />
There is also a proposal which makes it mandatory for the sponsor to provide medical care to the person who suffers injury during trial, for as long as required.<br />
<br />
There will be a specific provision in the Rules for payment of compensation to the affected persons/their nominees, for trial-related injuries and deaths.<br />
<br />
To capture the socio-economic background of the persons participating in the trial, it is proposed to modify the Informed Consent Form to capture qualifications, occupation, annual income, and address of the person concerned. Requirements and guidelines for registration of the ethics committee would be prescribed in the Rules.<br />
<br />
However, this method has drawn a lot of flak, as there have been complaints related to violation of ethics, and prejudiced reports of the ethics committee. Even the existing manner of securing consent from the subjects has been questioned by rights-based health activists.<br />
<br />
As per the available data, the number of serious adverse events in clinical trials reported during 2010, 2011, and up to June 2012, stood at 668, 438 and 211, respectively.<br />
<br />
However, deaths due to clinical trials were 22 and 16 in 2010 and 2011, respectively.<br />
<br />
The Union Ministry of Health &amp; Family Welfare has already moved amendments to the Rules, wherein 12 New Drug Advisory Committees, consisting of leading experts from the government medical colleges and institutes from all States in the country, have been constituted to advise the DGCI in matters related to approval of clinical trials and new medicines.<br />
<br />
Applications of Investigational New Drugs (IND), which have never earlier been used in human beings, are evaluated by the IND committee, chaired by the Director General of the Indian Council of Medical Research. Deaths may occur during clinical trials due to various reasons, including life-threatening diseases like cancer, cardio-vascular conditions like congestive heart failure, and stroke.<br />
<br />
They can also be due to the side-effects of the medicines or their administration to critically or terminally ill patients.
</div>',
'credit_writer' => 'The Hindu, 28 October, 2012, http://www.thehindu.com/todays-paper/tp-national/centre-planning-major-changes-in-rules-for-clinical-trials/article4039661.ece',
'article_img' => '',
'article_img_thumb' => '',
'status' => (int) 1,
'show_on_home' => (int) 1,
'lang' => 'EN',
'category_id' => (int) 16,
'tag_keyword' => '',
'seo_url' => 'centre-planning-major-changes-in-rules-for-clinical-trials-17821',
'meta_title' => null,
'meta_keywords' => null,
'meta_description' => null,
'noindex' => (int) 0,
'publish_date' => object(Cake\I18n\FrozenDate) {},
'most_visit_section_id' => null,
'article_big_img' => null,
'liveid' => (int) 17821,
'created' => object(Cake\I18n\FrozenTime) {},
'modified' => object(Cake\I18n\FrozenTime) {},
'edate' => '',
'tags' => [
[maximum depth reached]
],
'category' => object(App\Model\Entity\Category) {},
'[new]' => false,
'[accessible]' => [
[maximum depth reached]
],
'[dirty]' => [[maximum depth reached]],
'[original]' => [[maximum depth reached]],
'[virtual]' => [[maximum depth reached]],
'[hasErrors]' => false,
'[errors]' => [[maximum depth reached]],
'[invalid]' => [[maximum depth reached]],
'[repository]' => 'Articles'
},
'articleid' => (int) 17692,
'metaTitle' => 'LATEST NEWS UPDATES | Centre planning major changes in rules for clinical trials',
'metaKeywords' => 'medicines,Health',
'metaDesc' => '
-The Hindu
Drugs Controller must be told of adverse events within 24 hours
Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs &amp; Cosmetics Act, 1940, and its Rules....',
'disp' => '<div align="justify">-The Hindu<br /><br /><em>Drugs Controller must be told of adverse events within 24 hours<br /></em><br />Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs &amp; Cosmetics Act, 1940, and its Rules. These would make it mandatory for the Investigator to report all serious adverse events, including deaths, to the Drugs Controller General of India (DGCI), as well as the sponsor and the ethics committee, within 24 hours of occurrence.<br /><br />The DGCI will constitute a committee of experts to analyse the report of the Investigator, the sponsor, and the ethics committee, to arrive at the exact cause of the injury or death, and it shall then recommend the exact quantum of compensation in case of trial-related injury or deaths within three months.<br /><br />As per the existing procedure, all serious adverse events (SAEs) are reported by the Investigator to the sponsor and the company within 24 hours and to the ethics committee in 7 days. The sponsor then submits the information to the DCGI and some other investigators within 14 days. It is the institutional ethics committee or the independent ethics committee that decides on the cause of the injury or death, and announces compensation accordingly.<br /><br />There is also a proposal which makes it mandatory for the sponsor to provide medical care to the person who suffers injury during trial, for as long as required.<br /><br />There will be a specific provision in the Rules for payment of compensation to the affected persons/their nominees, for trial-related injuries and deaths.<br /><br />To capture the socio-economic background of the persons participating in the trial, it is proposed to modify the Informed Consent Form to capture qualifications, occupation, annual income, and address of the person concerned. Requirements and guidelines for registration of the ethics committee would be prescribed in the Rules.<br /><br />However, this method has drawn a lot of flak, as there have been complaints related to violation of ethics, and prejudiced reports of the ethics committee. Even the existing manner of securing consent from the subjects has been questioned by rights-based health activists.<br /><br />As per the available data, the number of serious adverse events in clinical trials reported during 2010, 2011, and up to June 2012, stood at 668, 438 and 211, respectively.<br /><br />However, deaths due to clinical trials were 22 and 16 in 2010 and 2011, respectively.<br /><br />The Union Ministry of Health &amp; Family Welfare has already moved amendments to the Rules, wherein 12 New Drug Advisory Committees, consisting of leading experts from the government medical colleges and institutes from all States in the country, have been constituted to advise the DGCI in matters related to approval of clinical trials and new medicines.<br /><br />Applications of Investigational New Drugs (IND), which have never earlier been used in human beings, are evaluated by the IND committee, chaired by the Director General of the Indian Council of Medical Research. Deaths may occur during clinical trials due to various reasons, including life-threatening diseases like cancer, cardio-vascular conditions like congestive heart failure, and stroke.<br /><br />They can also be due to the side-effects of the medicines or their administration to critically or terminally ill patients.</div>',
'lang' => 'English',
'SITE_URL' => 'https://im4change.in/',
'site_title' => 'im4change',
'adminprix' => 'admin'
]
$article_current = object(App\Model\Entity\Article) {
'id' => (int) 17692,
'title' => 'Centre planning major changes in rules for clinical trials',
'subheading' => '',
'description' => '<div align="justify">
-The Hindu<br />
<br />
<em>Drugs Controller must be told of adverse events within 24 hours<br />
</em><br />
Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs &amp; Cosmetics Act, 1940, and its Rules. These would make it mandatory for the Investigator to report all serious adverse events, including deaths, to the Drugs Controller General of India (DGCI), as well as the sponsor and the ethics committee, within 24 hours of occurrence.<br />
<br />
The DGCI will constitute a committee of experts to analyse the report of the Investigator, the sponsor, and the ethics committee, to arrive at the exact cause of the injury or death, and it shall then recommend the exact quantum of compensation in case of trial-related injury or deaths within three months.<br />
<br />
As per the existing procedure, all serious adverse events (SAEs) are reported by the Investigator to the sponsor and the company within 24 hours and to the ethics committee in 7 days. The sponsor then submits the information to the DCGI and some other investigators within 14 days. It is the institutional ethics committee or the independent ethics committee that decides on the cause of the injury or death, and announces compensation accordingly.<br />
<br />
There is also a proposal which makes it mandatory for the sponsor to provide medical care to the person who suffers injury during trial, for as long as required.<br />
<br />
There will be a specific provision in the Rules for payment of compensation to the affected persons/their nominees, for trial-related injuries and deaths.<br />
<br />
To capture the socio-economic background of the persons participating in the trial, it is proposed to modify the Informed Consent Form to capture qualifications, occupation, annual income, and address of the person concerned. Requirements and guidelines for registration of the ethics committee would be prescribed in the Rules.<br />
<br />
However, this method has drawn a lot of flak, as there have been complaints related to violation of ethics, and prejudiced reports of the ethics committee. Even the existing manner of securing consent from the subjects has been questioned by rights-based health activists.<br />
<br />
As per the available data, the number of serious adverse events in clinical trials reported during 2010, 2011, and up to June 2012, stood at 668, 438 and 211, respectively.<br />
<br />
However, deaths due to clinical trials were 22 and 16 in 2010 and 2011, respectively.<br />
<br />
The Union Ministry of Health &amp; Family Welfare has already moved amendments to the Rules, wherein 12 New Drug Advisory Committees, consisting of leading experts from the government medical colleges and institutes from all States in the country, have been constituted to advise the DGCI in matters related to approval of clinical trials and new medicines.<br />
<br />
Applications of Investigational New Drugs (IND), which have never earlier been used in human beings, are evaluated by the IND committee, chaired by the Director General of the Indian Council of Medical Research. Deaths may occur during clinical trials due to various reasons, including life-threatening diseases like cancer, cardio-vascular conditions like congestive heart failure, and stroke.<br />
<br />
They can also be due to the side-effects of the medicines or their administration to critically or terminally ill patients.
</div>',
'credit_writer' => 'The Hindu, 28 October, 2012, http://www.thehindu.com/todays-paper/tp-national/centre-planning-major-changes-in-rules-for-clinical-trials/article4039661.ece',
'article_img' => '',
'article_img_thumb' => '',
'status' => (int) 1,
'show_on_home' => (int) 1,
'lang' => 'EN',
'category_id' => (int) 16,
'tag_keyword' => '',
'seo_url' => 'centre-planning-major-changes-in-rules-for-clinical-trials-17821',
'meta_title' => null,
'meta_keywords' => null,
'meta_description' => null,
'noindex' => (int) 0,
'publish_date' => object(Cake\I18n\FrozenDate) {},
'most_visit_section_id' => null,
'article_big_img' => null,
'liveid' => (int) 17821,
'created' => object(Cake\I18n\FrozenTime) {},
'modified' => object(Cake\I18n\FrozenTime) {},
'edate' => '',
'tags' => [
(int) 0 => object(Cake\ORM\Entity) {},
(int) 1 => object(Cake\ORM\Entity) {}
],
'category' => object(App\Model\Entity\Category) {},
'[new]' => false,
'[accessible]' => [
'*' => true,
'id' => false
],
'[dirty]' => [],
'[original]' => [],
'[virtual]' => [],
'[hasErrors]' => false,
'[errors]' => [],
'[invalid]' => [],
'[repository]' => 'Articles'
}
$articleid = (int) 17692
$metaTitle = 'LATEST NEWS UPDATES | Centre planning major changes in rules for clinical trials'
$metaKeywords = 'medicines,Health'
$metaDesc = '
-The Hindu
Drugs Controller must be told of adverse events within 24 hours
Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs &amp; Cosmetics Act, 1940, and its Rules....'
$disp = '<div align="justify">-The Hindu<br /><br /><em>Drugs Controller must be told of adverse events within 24 hours<br /></em><br />Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs &amp; Cosmetics Act, 1940, and its Rules. These would make it mandatory for the Investigator to report all serious adverse events, including deaths, to the Drugs Controller General of India (DGCI), as well as the sponsor and the ethics committee, within 24 hours of occurrence.<br /><br />The DGCI will constitute a committee of experts to analyse the report of the Investigator, the sponsor, and the ethics committee, to arrive at the exact cause of the injury or death, and it shall then recommend the exact quantum of compensation in case of trial-related injury or deaths within three months.<br /><br />As per the existing procedure, all serious adverse events (SAEs) are reported by the Investigator to the sponsor and the company within 24 hours and to the ethics committee in 7 days. The sponsor then submits the information to the DCGI and some other investigators within 14 days. It is the institutional ethics committee or the independent ethics committee that decides on the cause of the injury or death, and announces compensation accordingly.<br /><br />There is also a proposal which makes it mandatory for the sponsor to provide medical care to the person who suffers injury during trial, for as long as required.<br /><br />There will be a specific provision in the Rules for payment of compensation to the affected persons/their nominees, for trial-related injuries and deaths.<br /><br />To capture the socio-economic background of the persons participating in the trial, it is proposed to modify the Informed Consent Form to capture qualifications, occupation, annual income, and address of the person concerned. Requirements and guidelines for registration of the ethics committee would be prescribed in the Rules.<br /><br />However, this method has drawn a lot of flak, as there have been complaints related to violation of ethics, and prejudiced reports of the ethics committee. Even the existing manner of securing consent from the subjects has been questioned by rights-based health activists.<br /><br />As per the available data, the number of serious adverse events in clinical trials reported during 2010, 2011, and up to June 2012, stood at 668, 438 and 211, respectively.<br /><br />However, deaths due to clinical trials were 22 and 16 in 2010 and 2011, respectively.<br /><br />The Union Ministry of Health &amp; Family Welfare has already moved amendments to the Rules, wherein 12 New Drug Advisory Committees, consisting of leading experts from the government medical colleges and institutes from all States in the country, have been constituted to advise the DGCI in matters related to approval of clinical trials and new medicines.<br /><br />Applications of Investigational New Drugs (IND), which have never earlier been used in human beings, are evaluated by the IND committee, chaired by the Director General of the Indian Council of Medical Research. Deaths may occur during clinical trials due to various reasons, including life-threatening diseases like cancer, cardio-vascular conditions like congestive heart failure, and stroke.<br /><br />They can also be due to the side-effects of the medicines or their administration to critically or terminally ill patients.</div>'
$lang = 'English'
$SITE_URL = 'https://im4change.in/'
$site_title = 'im4change'
$adminprix = 'admin'</pre><pre class="stack-trace">include - APP/Template/Layout/printlayout.ctp, line 8
Cake\View\View::_evaluate() - CORE/src/View/View.php, line 1413
Cake\View\View::_render() - CORE/src/View/View.php, line 1374
Cake\View\View::renderLayout() - CORE/src/View/View.php, line 927
Cake\View\View::render() - CORE/src/View/View.php, line 885
Cake\Controller\Controller::render() - CORE/src/Controller/Controller.php, line 791
Cake\Http\ActionDispatcher::_invoke() - CORE/src/Http/ActionDispatcher.php, line 126
Cake\Http\ActionDispatcher::dispatch() - CORE/src/Http/ActionDispatcher.php, line 94
Cake\Http\BaseApplication::__invoke() - CORE/src/Http/BaseApplication.php, line 235
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\RoutingMiddleware::__invoke() - CORE/src/Routing/Middleware/RoutingMiddleware.php, line 162
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\AssetMiddleware::__invoke() - CORE/src/Routing/Middleware/AssetMiddleware.php, line 88
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Error\Middleware\ErrorHandlerMiddleware::__invoke() - CORE/src/Error/Middleware/ErrorHandlerMiddleware.php, line 96
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51</pre></div></pre>latest-news-updates/centre-planning-major-changes-in-rules-for-clinical-trials-17821.html"/>
<meta http-equiv="Content-Type" content="text/html; charset=utf-8"/>
<link href="https://im4change.in/css/control.css" rel="stylesheet" type="text/css"
media="all"/>
<title>LATEST NEWS UPDATES | Centre planning major changes in rules for clinical trials | Im4change.org</title>
<meta name="description" content="
-The Hindu
Drugs Controller must be told of adverse events within 24 hours
Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs & Cosmetics Act, 1940, and its Rules...."/>
<script src="https://im4change.in/js/jquery-1.10.2.js"></script>
<script type="text/javascript" src="https://im4change.in/js/jquery-migrate.min.js"></script>
<script language="javascript" type="text/javascript">
$(document).ready(function () {
var img = $("img")[0]; // Get my img elem
var pic_real_width, pic_real_height;
$("<img/>") // Make in memory copy of image to avoid css issues
.attr("src", $(img).attr("src"))
.load(function () {
pic_real_width = this.width; // Note: $(this).width() will not
pic_real_height = this.height; // work for in memory images.
});
});
</script>
<style type="text/css">
@media screen {
div.divFooter {
display: block;
}
}
@media print {
.printbutton {
display: none !important;
}
}
</style>
</head>
<body>
<table cellpadding="0" cellspacing="0" border="0" width="98%" align="center">
<tr>
<td class="top_bg">
<div class="divFooter">
<img src="https://im4change.in/images/logo1.jpg" height="59" border="0"
alt="Resource centre on India's rural distress" style="padding-top:14px;"/>
</div>
</td>
</tr>
<tr>
<td id="topspace"> </td>
</tr>
<tr id="topspace">
<td> </td>
</tr>
<tr>
<td height="50" style="border-bottom:1px solid #000; padding-top:10px;" class="printbutton">
<form><input type="button" value=" Print this page "
onclick="window.print();return false;"/></form>
</td>
</tr>
<tr>
<td width="100%">
<h1 class="news_headlines" style="font-style:normal">
<strong>Centre planning major changes in rules for clinical trials</strong></h1>
</td>
</tr>
<tr>
<td width="100%" style="font-family:Arial, 'Segoe Script', 'Segoe UI', sans-serif, serif"><font size="3">
<div align="justify">-The Hindu<br /><br /><em>Drugs Controller must be told of adverse events within 24 hours<br /></em><br />Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs & Cosmetics Act, 1940, and its Rules. These would make it mandatory for the Investigator to report all serious adverse events, including deaths, to the Drugs Controller General of India (DGCI), as well as the sponsor and the ethics committee, within 24 hours of occurrence.<br /><br />The DGCI will constitute a committee of experts to analyse the report of the Investigator, the sponsor, and the ethics committee, to arrive at the exact cause of the injury or death, and it shall then recommend the exact quantum of compensation in case of trial-related injury or deaths within three months.<br /><br />As per the existing procedure, all serious adverse events (SAEs) are reported by the Investigator to the sponsor and the company within 24 hours and to the ethics committee in 7 days. The sponsor then submits the information to the DCGI and some other investigators within 14 days. It is the institutional ethics committee or the independent ethics committee that decides on the cause of the injury or death, and announces compensation accordingly.<br /><br />There is also a proposal which makes it mandatory for the sponsor to provide medical care to the person who suffers injury during trial, for as long as required.<br /><br />There will be a specific provision in the Rules for payment of compensation to the affected persons/their nominees, for trial-related injuries and deaths.<br /><br />To capture the socio-economic background of the persons participating in the trial, it is proposed to modify the Informed Consent Form to capture qualifications, occupation, annual income, and address of the person concerned. Requirements and guidelines for registration of the ethics committee would be prescribed in the Rules.<br /><br />However, this method has drawn a lot of flak, as there have been complaints related to violation of ethics, and prejudiced reports of the ethics committee. Even the existing manner of securing consent from the subjects has been questioned by rights-based health activists.<br /><br />As per the available data, the number of serious adverse events in clinical trials reported during 2010, 2011, and up to June 2012, stood at 668, 438 and 211, respectively.<br /><br />However, deaths due to clinical trials were 22 and 16 in 2010 and 2011, respectively.<br /><br />The Union Ministry of Health & Family Welfare has already moved amendments to the Rules, wherein 12 New Drug Advisory Committees, consisting of leading experts from the government medical colleges and institutes from all States in the country, have been constituted to advise the DGCI in matters related to approval of clinical trials and new medicines.<br /><br />Applications of Investigational New Drugs (IND), which have never earlier been used in human beings, are evaluated by the IND committee, chaired by the Director General of the Indian Council of Medical Research. Deaths may occur during clinical trials due to various reasons, including life-threatening diseases like cancer, cardio-vascular conditions like congestive heart failure, and stroke.<br /><br />They can also be due to the side-effects of the medicines or their administration to critically or terminally ill patients.</div> </font>
</td>
</tr>
<tr>
<td> </td>
</tr>
<tr>
<td height="50" style="border-top:1px solid #000; border-bottom:1px solid #000;padding-top:10px;">
<form><input type="button" value=" Print this page "
onclick="window.print();return false;"/></form>
</td>
</tr>
</table></body>
</html>'
}
$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
Notice (8): Undefined variable: urlPrefix [APP/Template/Layout/printlayout.ctp, line 8]
$viewFile = '/home/brlfuser/public_html/src/Template/Layout/printlayout.ctp'
$dataForView = [
'article_current' => object(App\Model\Entity\Article) {
'id' => (int) 17692,
'title' => 'Centre planning major changes in rules for clinical trials',
'subheading' => '',
'description' => '<div align="justify">
-The Hindu<br />
<br />
<em>Drugs Controller must be told of adverse events within 24 hours<br />
</em><br />
Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs & Cosmetics Act, 1940, and its Rules. These would make it mandatory for the Investigator to report all serious adverse events, including deaths, to the Drugs Controller General of India (DGCI), as well as the sponsor and the ethics committee, within 24 hours of occurrence.<br />
<br />
The DGCI will constitute a committee of experts to analyse the report of the Investigator, the sponsor, and the ethics committee, to arrive at the exact cause of the injury or death, and it shall then recommend the exact quantum of compensation in case of trial-related injury or deaths within three months.<br />
<br />
As per the existing procedure, all serious adverse events (SAEs) are reported by the Investigator to the sponsor and the company within 24 hours and to the ethics committee in 7 days. The sponsor then submits the information to the DCGI and some other investigators within 14 days. It is the institutional ethics committee or the independent ethics committee that decides on the cause of the injury or death, and announces compensation accordingly.<br />
<br />
There is also a proposal which makes it mandatory for the sponsor to provide medical care to the person who suffers injury during trial, for as long as required.<br />
<br />
There will be a specific provision in the Rules for payment of compensation to the affected persons/their nominees, for trial-related injuries and deaths.<br />
<br />
To capture the socio-economic background of the persons participating in the trial, it is proposed to modify the Informed Consent Form to capture qualifications, occupation, annual income, and address of the person concerned. Requirements and guidelines for registration of the ethics committee would be prescribed in the Rules.<br />
<br />
However, this method has drawn a lot of flak, as there have been complaints related to violation of ethics, and prejudiced reports of the ethics committee. Even the existing manner of securing consent from the subjects has been questioned by rights-based health activists.<br />
<br />
As per the available data, the number of serious adverse events in clinical trials reported during 2010, 2011, and up to June 2012, stood at 668, 438 and 211, respectively.<br />
<br />
However, deaths due to clinical trials were 22 and 16 in 2010 and 2011, respectively.<br />
<br />
The Union Ministry of Health & Family Welfare has already moved amendments to the Rules, wherein 12 New Drug Advisory Committees, consisting of leading experts from the government medical colleges and institutes from all States in the country, have been constituted to advise the DGCI in matters related to approval of clinical trials and new medicines.<br />
<br />
Applications of Investigational New Drugs (IND), which have never earlier been used in human beings, are evaluated by the IND committee, chaired by the Director General of the Indian Council of Medical Research. Deaths may occur during clinical trials due to various reasons, including life-threatening diseases like cancer, cardio-vascular conditions like congestive heart failure, and stroke.<br />
<br />
They can also be due to the side-effects of the medicines or their administration to critically or terminally ill patients.
</div>',
'credit_writer' => 'The Hindu, 28 October, 2012, http://www.thehindu.com/todays-paper/tp-national/centre-planning-major-changes-in-rules-for-clinical-trials/article4039661.ece',
'article_img' => '',
'article_img_thumb' => '',
'status' => (int) 1,
'show_on_home' => (int) 1,
'lang' => 'EN',
'category_id' => (int) 16,
'tag_keyword' => '',
'seo_url' => 'centre-planning-major-changes-in-rules-for-clinical-trials-17821',
'meta_title' => null,
'meta_keywords' => null,
'meta_description' => null,
'noindex' => (int) 0,
'publish_date' => object(Cake\I18n\FrozenDate) {},
'most_visit_section_id' => null,
'article_big_img' => null,
'liveid' => (int) 17821,
'created' => object(Cake\I18n\FrozenTime) {},
'modified' => object(Cake\I18n\FrozenTime) {},
'edate' => '',
'tags' => [
[maximum depth reached]
],
'category' => object(App\Model\Entity\Category) {},
'[new]' => false,
'[accessible]' => [
[maximum depth reached]
],
'[dirty]' => [[maximum depth reached]],
'[original]' => [[maximum depth reached]],
'[virtual]' => [[maximum depth reached]],
'[hasErrors]' => false,
'[errors]' => [[maximum depth reached]],
'[invalid]' => [[maximum depth reached]],
'[repository]' => 'Articles'
},
'articleid' => (int) 17692,
'metaTitle' => 'LATEST NEWS UPDATES | Centre planning major changes in rules for clinical trials',
'metaKeywords' => 'medicines,Health',
'metaDesc' => '
-The Hindu
Drugs Controller must be told of adverse events within 24 hours
Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs & Cosmetics Act, 1940, and its Rules....',
'disp' => '<div align="justify">-The Hindu<br /><br /><em>Drugs Controller must be told of adverse events within 24 hours<br /></em><br />Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs & Cosmetics Act, 1940, and its Rules. These would make it mandatory for the Investigator to report all serious adverse events, including deaths, to the Drugs Controller General of India (DGCI), as well as the sponsor and the ethics committee, within 24 hours of occurrence.<br /><br />The DGCI will constitute a committee of experts to analyse the report of the Investigator, the sponsor, and the ethics committee, to arrive at the exact cause of the injury or death, and it shall then recommend the exact quantum of compensation in case of trial-related injury or deaths within three months.<br /><br />As per the existing procedure, all serious adverse events (SAEs) are reported by the Investigator to the sponsor and the company within 24 hours and to the ethics committee in 7 days. The sponsor then submits the information to the DCGI and some other investigators within 14 days. It is the institutional ethics committee or the independent ethics committee that decides on the cause of the injury or death, and announces compensation accordingly.<br /><br />There is also a proposal which makes it mandatory for the sponsor to provide medical care to the person who suffers injury during trial, for as long as required.<br /><br />There will be a specific provision in the Rules for payment of compensation to the affected persons/their nominees, for trial-related injuries and deaths.<br /><br />To capture the socio-economic background of the persons participating in the trial, it is proposed to modify the Informed Consent Form to capture qualifications, occupation, annual income, and address of the person concerned. Requirements and guidelines for registration of the ethics committee would be prescribed in the Rules.<br /><br />However, this method has drawn a lot of flak, as there have been complaints related to violation of ethics, and prejudiced reports of the ethics committee. Even the existing manner of securing consent from the subjects has been questioned by rights-based health activists.<br /><br />As per the available data, the number of serious adverse events in clinical trials reported during 2010, 2011, and up to June 2012, stood at 668, 438 and 211, respectively.<br /><br />However, deaths due to clinical trials were 22 and 16 in 2010 and 2011, respectively.<br /><br />The Union Ministry of Health & Family Welfare has already moved amendments to the Rules, wherein 12 New Drug Advisory Committees, consisting of leading experts from the government medical colleges and institutes from all States in the country, have been constituted to advise the DGCI in matters related to approval of clinical trials and new medicines.<br /><br />Applications of Investigational New Drugs (IND), which have never earlier been used in human beings, are evaluated by the IND committee, chaired by the Director General of the Indian Council of Medical Research. Deaths may occur during clinical trials due to various reasons, including life-threatening diseases like cancer, cardio-vascular conditions like congestive heart failure, and stroke.<br /><br />They can also be due to the side-effects of the medicines or their administration to critically or terminally ill patients.</div>',
'lang' => 'English',
'SITE_URL' => 'https://im4change.in/',
'site_title' => 'im4change',
'adminprix' => 'admin'
]
$article_current = object(App\Model\Entity\Article) {
'id' => (int) 17692,
'title' => 'Centre planning major changes in rules for clinical trials',
'subheading' => '',
'description' => '<div align="justify">
-The Hindu<br />
<br />
<em>Drugs Controller must be told of adverse events within 24 hours<br />
</em><br />
Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs & Cosmetics Act, 1940, and its Rules. These would make it mandatory for the Investigator to report all serious adverse events, including deaths, to the Drugs Controller General of India (DGCI), as well as the sponsor and the ethics committee, within 24 hours of occurrence.<br />
<br />
The DGCI will constitute a committee of experts to analyse the report of the Investigator, the sponsor, and the ethics committee, to arrive at the exact cause of the injury or death, and it shall then recommend the exact quantum of compensation in case of trial-related injury or deaths within three months.<br />
<br />
As per the existing procedure, all serious adverse events (SAEs) are reported by the Investigator to the sponsor and the company within 24 hours and to the ethics committee in 7 days. The sponsor then submits the information to the DCGI and some other investigators within 14 days. It is the institutional ethics committee or the independent ethics committee that decides on the cause of the injury or death, and announces compensation accordingly.<br />
<br />
There is also a proposal which makes it mandatory for the sponsor to provide medical care to the person who suffers injury during trial, for as long as required.<br />
<br />
There will be a specific provision in the Rules for payment of compensation to the affected persons/their nominees, for trial-related injuries and deaths.<br />
<br />
To capture the socio-economic background of the persons participating in the trial, it is proposed to modify the Informed Consent Form to capture qualifications, occupation, annual income, and address of the person concerned. Requirements and guidelines for registration of the ethics committee would be prescribed in the Rules.<br />
<br />
However, this method has drawn a lot of flak, as there have been complaints related to violation of ethics, and prejudiced reports of the ethics committee. Even the existing manner of securing consent from the subjects has been questioned by rights-based health activists.<br />
<br />
As per the available data, the number of serious adverse events in clinical trials reported during 2010, 2011, and up to June 2012, stood at 668, 438 and 211, respectively.<br />
<br />
However, deaths due to clinical trials were 22 and 16 in 2010 and 2011, respectively.<br />
<br />
The Union Ministry of Health & Family Welfare has already moved amendments to the Rules, wherein 12 New Drug Advisory Committees, consisting of leading experts from the government medical colleges and institutes from all States in the country, have been constituted to advise the DGCI in matters related to approval of clinical trials and new medicines.<br />
<br />
Applications of Investigational New Drugs (IND), which have never earlier been used in human beings, are evaluated by the IND committee, chaired by the Director General of the Indian Council of Medical Research. Deaths may occur during clinical trials due to various reasons, including life-threatening diseases like cancer, cardio-vascular conditions like congestive heart failure, and stroke.<br />
<br />
They can also be due to the side-effects of the medicines or their administration to critically or terminally ill patients.
</div>',
'credit_writer' => 'The Hindu, 28 October, 2012, http://www.thehindu.com/todays-paper/tp-national/centre-planning-major-changes-in-rules-for-clinical-trials/article4039661.ece',
'article_img' => '',
'article_img_thumb' => '',
'status' => (int) 1,
'show_on_home' => (int) 1,
'lang' => 'EN',
'category_id' => (int) 16,
'tag_keyword' => '',
'seo_url' => 'centre-planning-major-changes-in-rules-for-clinical-trials-17821',
'meta_title' => null,
'meta_keywords' => null,
'meta_description' => null,
'noindex' => (int) 0,
'publish_date' => object(Cake\I18n\FrozenDate) {},
'most_visit_section_id' => null,
'article_big_img' => null,
'liveid' => (int) 17821,
'created' => object(Cake\I18n\FrozenTime) {},
'modified' => object(Cake\I18n\FrozenTime) {},
'edate' => '',
'tags' => [
(int) 0 => object(Cake\ORM\Entity) {},
(int) 1 => object(Cake\ORM\Entity) {}
],
'category' => object(App\Model\Entity\Category) {},
'[new]' => false,
'[accessible]' => [
'*' => true,
'id' => false
],
'[dirty]' => [],
'[original]' => [],
'[virtual]' => [],
'[hasErrors]' => false,
'[errors]' => [],
'[invalid]' => [],
'[repository]' => 'Articles'
}
$articleid = (int) 17692
$metaTitle = 'LATEST NEWS UPDATES | Centre planning major changes in rules for clinical trials'
$metaKeywords = 'medicines,Health'
$metaDesc = '
-The Hindu
Drugs Controller must be told of adverse events within 24 hours
Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs & Cosmetics Act, 1940, and its Rules....'
$disp = '<div align="justify">-The Hindu<br /><br /><em>Drugs Controller must be told of adverse events within 24 hours<br /></em><br />Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs & Cosmetics Act, 1940, and its Rules. These would make it mandatory for the Investigator to report all serious adverse events, including deaths, to the Drugs Controller General of India (DGCI), as well as the sponsor and the ethics committee, within 24 hours of occurrence.<br /><br />The DGCI will constitute a committee of experts to analyse the report of the Investigator, the sponsor, and the ethics committee, to arrive at the exact cause of the injury or death, and it shall then recommend the exact quantum of compensation in case of trial-related injury or deaths within three months.<br /><br />As per the existing procedure, all serious adverse events (SAEs) are reported by the Investigator to the sponsor and the company within 24 hours and to the ethics committee in 7 days. The sponsor then submits the information to the DCGI and some other investigators within 14 days. It is the institutional ethics committee or the independent ethics committee that decides on the cause of the injury or death, and announces compensation accordingly.<br /><br />There is also a proposal which makes it mandatory for the sponsor to provide medical care to the person who suffers injury during trial, for as long as required.<br /><br />There will be a specific provision in the Rules for payment of compensation to the affected persons/their nominees, for trial-related injuries and deaths.<br /><br />To capture the socio-economic background of the persons participating in the trial, it is proposed to modify the Informed Consent Form to capture qualifications, occupation, annual income, and address of the person concerned. Requirements and guidelines for registration of the ethics committee would be prescribed in the Rules.<br /><br />However, this method has drawn a lot of flak, as there have been complaints related to violation of ethics, and prejudiced reports of the ethics committee. Even the existing manner of securing consent from the subjects has been questioned by rights-based health activists.<br /><br />As per the available data, the number of serious adverse events in clinical trials reported during 2010, 2011, and up to June 2012, stood at 668, 438 and 211, respectively.<br /><br />However, deaths due to clinical trials were 22 and 16 in 2010 and 2011, respectively.<br /><br />The Union Ministry of Health & Family Welfare has already moved amendments to the Rules, wherein 12 New Drug Advisory Committees, consisting of leading experts from the government medical colleges and institutes from all States in the country, have been constituted to advise the DGCI in matters related to approval of clinical trials and new medicines.<br /><br />Applications of Investigational New Drugs (IND), which have never earlier been used in human beings, are evaluated by the IND committee, chaired by the Director General of the Indian Council of Medical Research. Deaths may occur during clinical trials due to various reasons, including life-threatening diseases like cancer, cardio-vascular conditions like congestive heart failure, and stroke.<br /><br />They can also be due to the side-effects of the medicines or their administration to critically or terminally ill patients.</div>'
$lang = 'English'
$SITE_URL = 'https://im4change.in/'
$site_title = 'im4change'
$adminprix = 'admin'
include - APP/Template/Layout/printlayout.ctp, line 8
Cake\View\View::_evaluate() - CORE/src/View/View.php, line 1413
Cake\View\View::_render() - CORE/src/View/View.php, line 1374
Cake\View\View::renderLayout() - CORE/src/View/View.php, line 927
Cake\View\View::render() - CORE/src/View/View.php, line 885
Cake\Controller\Controller::render() - CORE/src/Controller/Controller.php, line 791
Cake\Http\ActionDispatcher::_invoke() - CORE/src/Http/ActionDispatcher.php, line 126
Cake\Http\ActionDispatcher::dispatch() - CORE/src/Http/ActionDispatcher.php, line 94
Cake\Http\BaseApplication::__invoke() - CORE/src/Http/BaseApplication.php, line 235
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\RoutingMiddleware::__invoke() - CORE/src/Routing/Middleware/RoutingMiddleware.php, line 162
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\AssetMiddleware::__invoke() - CORE/src/Routing/Middleware/AssetMiddleware.php, line 88
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Error\Middleware\ErrorHandlerMiddleware::__invoke() - CORE/src/Error/Middleware/ErrorHandlerMiddleware.php, line 96
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51
latest-news-updates/centre-planning-major-changes-in-rules-for-clinical-trials-17821.html"/>
LATEST NEWS UPDATES | Centre planning major changes in rules for clinical trials | Im4change.org
Centre planning major changes in rules for clinical trials
-The Hindu
Drugs Controller must be told of adverse events within 24 hours
Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs & Cosmetics Act, 1940, and its Rules. These would make it mandatory for the Investigator to report all serious adverse events, including deaths, to the Drugs Controller General of India (DGCI), as well as the sponsor and the ethics committee, within 24 hours of occurrence.
The DGCI will constitute a committee of experts to analyse the report of the Investigator, the sponsor, and the ethics committee, to arrive at the exact cause of the injury or death, and it shall then recommend the exact quantum of compensation in case of trial-related injury or deaths within three months.
As per the existing procedure, all serious adverse events (SAEs) are reported by the Investigator to the sponsor and the company within 24 hours and to the ethics committee in 7 days. The sponsor then submits the information to the DCGI and some other investigators within 14 days. It is the institutional ethics committee or the independent ethics committee that decides on the cause of the injury or death, and announces compensation accordingly.
There is also a proposal which makes it mandatory for the sponsor to provide medical care to the person who suffers injury during trial, for as long as required.
There will be a specific provision in the Rules for payment of compensation to the affected persons/their nominees, for trial-related injuries and deaths.
To capture the socio-economic background of the persons participating in the trial, it is proposed to modify the Informed Consent Form to capture qualifications, occupation, annual income, and address of the person concerned. Requirements and guidelines for registration of the ethics committee would be prescribed in the Rules.
However, this method has drawn a lot of flak, as there have been complaints related to violation of ethics, and prejudiced reports of the ethics committee. Even the existing manner of securing consent from the subjects has been questioned by rights-based health activists.
As per the available data, the number of serious adverse events in clinical trials reported during 2010, 2011, and up to June 2012, stood at 668, 438 and 211, respectively.
However, deaths due to clinical trials were 22 and 16 in 2010 and 2011, respectively.
The Union Ministry of Health & Family Welfare has already moved amendments to the Rules, wherein 12 New Drug Advisory Committees, consisting of leading experts from the government medical colleges and institutes from all States in the country, have been constituted to advise the DGCI in matters related to approval of clinical trials and new medicines.
Applications of Investigational New Drugs (IND), which have never earlier been used in human beings, are evaluated by the IND committee, chaired by the Director General of the Indian Council of Medical Research. Deaths may occur during clinical trials due to various reasons, including life-threatening diseases like cancer, cardio-vascular conditions like congestive heart failure, and stroke.
They can also be due to the side-effects of the medicines or their administration to critically or terminally ill patients.
