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


        trigger_error($message, E_USER_DEPRECATED);

    }
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 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php.'
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deprecationWarning - CORE/src/Core/functions.php, line 311
Cake\Http\ServerRequest::offsetGet() - CORE/src/Http/ServerRequest.php, line 2421
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Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
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Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51
Cake\Http\Server::run() - CORE/src/Http/Server.php, line 98

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


        trigger_error($message, E_USER_DEPRECATED);

    }
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 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php.'
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deprecationWarning - CORE/src/Core/functions.php, line 311
Cake\Http\ServerRequest::offsetGet() - CORE/src/Http/ServerRequest.php, line 2421
App\Controller\ArtileDetailController::index() - APP/Controller/ArtileDetailController.php, line 151
Cake\Controller\Controller::invokeAction() - CORE/src/Controller/Controller.php, line 610
Cake\Http\ActionDispatcher::_invoke() - CORE/src/Http/ActionDispatcher.php, line 120
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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
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Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Error\Middleware\ErrorHandlerMiddleware::__invoke() - CORE/src/Error/Middleware/ErrorHandlerMiddleware.php, line 96
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51
Cake\Http\Server::run() - CORE/src/Http/Server.php, line 98

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

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        LATEST NEWS UPDATES | CDSCO drafting new norms for financial compensation-Mahim Pratap Singh    </title>
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-The Hindu

In the year 2011, 438 people died due to Serious Adverse Events (SAEs) during medicine trials in India, but pharmaceutical companies provided financial compensation in only 16 such cases.

The total amount paid in compensation in all the 16 cases..."/>
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-The Hindu

In the year 2011, 438 people died due to Serious Adverse Events (SAEs) during medicine trials in India, but pharmaceutical companies provided financial compensation in only 16 such cases.

The total amount paid in compensation in all the 16 cases..." />
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                            <div align="justify">-The Hindu<br /><br />In the year 2011, 438 people died due to Serious Adverse Events (SAEs) during medicine trials in India, but pharmaceutical companies provided financial compensation in only 16 such cases.<br /><br />The total amount paid in compensation in all the 16 cases adds up to Rs. 34.88 lakh, with the highest amount being Rs. 5 lakh, and the lowest being Rs. 50,000.<br /><br />This makes 2011 only the second year, for which data are available, when any compensation was paid in cases of deaths caused during medicine trials, the previous year being 2010, when 22 such cases were compensated.<br /><br />According to documents available with The Hindu , the largest amount in compensation was paid by Sun Pharma. The company paid Rs. 15 lakh in compensation in five cases (Rs. 3 lakh each).<br /><br />Next in line was US-based Clinical Research Organization (CRO) ICON PLC, (6.52 lakh in three cases), followed by Pfizer Inc (6.5 lakh in two cases) and German pharma and medical-care giant Fresenius (Rs. 1 lakh in two cases).<br /><br />Delhi-based CRO Apothecaries (Rs. 2.16 lakh), Multinational Clinical Research bigwig Lambda (Rs. 2 lakh), French firm Sanofi (Rs. 1 lakh), and Indian firm Veeda Clinical Research (Rs. 50,000), each paid compensation to one case of death.<br /><br />The information was provided by the office of the Drug Controller General (India) to medical rights activist, Anand Rai.<br /><br />The information provided by the DCG (I) doesn&rsquo;t tell if the compensation was paid by the foreign firms or their Indian subsidiaries.<br /><br />According to official data, between January 2007 and January 2012, Serious Adverse Events (SAEs) during medicine trials killed 2193 people all across India.<br /><br />The year-wise break-up of the deaths are: 132 (2007), 288 (2008), 637 (2009), 688 (2010), 438 (2011) and 30 (January, 2012).<br /><br />However, compensation was provided only to 22 victims in 2010 and 16 in 2011.<br /><br />&ldquo;It is shocking that only 3 per cent of the cases have been compensated. It is a mockery of the human rights of trial subjects in India. But sadly, the Central Drugs Standard Control Organization&rsquo;s (CDSCO&rsquo;s) new draft guidelines on financial compensation only address part of the problem,&rdquo; says Dr. Rai, who secured the information under the Right to Information Act.<br /><br />At present, financial compensation isn&rsquo;t mandated by law in India, and is only mentioned as a Good Clinical Practice (GCP) in paragraph 2.4.7 of the Indian Council of Medical Research&rsquo;s GCP Guidelines for Clinical Trials in India.<br /><br />The CDSCO&rsquo;s new draft guidelines for financial compensation seek to fill this major gap in the existing Drugs and Cosmetic Act, 1940.<br /><br />The total amount paid in compensation in all the 16 cases in 2011 adds up to Rs. 34.88 lakh<br /><br />Sun Pharma paid Rs. 15 lakh in compensation in five cases of Rs. 3 lakh each<br /><br /></div>                                                           
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    <br><a href="http://www.thehindu.com/todays-paper/tp-national/article3793837.ece" class="re" target="_blank">The Hindu, 19 August, 2012, http://www.thehindu.com/todays-paper/tp-national/article3793837.ece</a><div class="clear"></div>
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In the year 2011, 438 people died due to Serious Adverse Events (SAEs) during medicine trials in India, but pharmaceutical companies provided financial compensation in only 16 such cases.

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    <h1 class="cat-box-title">CDSCO drafting new norms for financial compensation-Mahim Pratap Singh</h1>
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		 Published on</span><span class="text-date"> Aug 21, 2012</span>
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                            <div align="justify">-The Hindu<br /><br />In the year 2011, 438 people died due to Serious Adverse Events (SAEs) during medicine trials in India, but pharmaceutical companies provided financial compensation in only 16 such cases.<br /><br />The total amount paid in compensation in all the 16 cases adds up to Rs. 34.88 lakh, with the highest amount being Rs. 5 lakh, and the lowest being Rs. 50,000.<br /><br />This makes 2011 only the second year, for which data are available, when any compensation was paid in cases of deaths caused during medicine trials, the previous year being 2010, when 22 such cases were compensated.<br /><br />According to documents available with The Hindu , the largest amount in compensation was paid by Sun Pharma. The company paid Rs. 15 lakh in compensation in five cases (Rs. 3 lakh each).<br /><br />Next in line was US-based Clinical Research Organization (CRO) ICON PLC, (6.52 lakh in three cases), followed by Pfizer Inc (6.5 lakh in two cases) and German pharma and medical-care giant Fresenius (Rs. 1 lakh in two cases).<br /><br />Delhi-based CRO Apothecaries (Rs. 2.16 lakh), Multinational Clinical Research bigwig Lambda (Rs. 2 lakh), French firm Sanofi (Rs. 1 lakh), and Indian firm Veeda Clinical Research (Rs. 50,000), each paid compensation to one case of death.<br /><br />The information was provided by the office of the Drug Controller General (India) to medical rights activist, Anand Rai.<br /><br />The information provided by the DCG (I) doesn&rsquo;t tell if the compensation was paid by the foreign firms or their Indian subsidiaries.<br /><br />According to official data, between January 2007 and January 2012, Serious Adverse Events (SAEs) during medicine trials killed 2193 people all across India.<br /><br />The year-wise break-up of the deaths are: 132 (2007), 288 (2008), 637 (2009), 688 (2010), 438 (2011) and 30 (January, 2012).<br /><br />However, compensation was provided only to 22 victims in 2010 and 16 in 2011.<br /><br />&ldquo;It is shocking that only 3 per cent of the cases have been compensated. It is a mockery of the human rights of trial subjects in India. But sadly, the Central Drugs Standard Control Organization&rsquo;s (CDSCO&rsquo;s) new draft guidelines on financial compensation only address part of the problem,&rdquo; says Dr. Rai, who secured the information under the Right to Information Act.<br /><br />At present, financial compensation isn&rsquo;t mandated by law in India, and is only mentioned as a Good Clinical Practice (GCP) in paragraph 2.4.7 of the Indian Council of Medical Research&rsquo;s GCP Guidelines for Clinical Trials in India.<br /><br />The CDSCO&rsquo;s new draft guidelines for financial compensation seek to fill this major gap in the existing Drugs and Cosmetic Act, 1940.<br /><br />The total amount paid in compensation in all the 16 cases in 2011 adds up to Rs. 34.88 lakh<br /><br />Sun Pharma paid Rs. 15 lakh in compensation in five cases of Rs. 3 lakh each<br /><br /></div>                                                           
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    <br><a href="http://www.thehindu.com/todays-paper/tp-national/article3793837.ece" class="re" target="_blank">The Hindu, 19 August, 2012, http://www.thehindu.com/todays-paper/tp-national/article3793837.ece</a><div class="clear"></div>
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        LATEST NEWS UPDATES | CDSCO drafting new norms for financial compensation-Mahim Pratap Singh    </title>
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In the year 2011, 438 people died due to Serious Adverse Events (SAEs) during medicine trials in India, but pharmaceutical companies provided financial compensation in only 16 such cases.

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In the year 2011, 438 people died due to Serious Adverse Events (SAEs) during medicine trials in India, but pharmaceutical companies provided financial compensation in only 16 such cases.

The total amount paid in compensation in all the 16 cases..." />
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    <h1 class="cat-box-title">CDSCO drafting new norms for financial compensation-Mahim Pratap Singh</h1>
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                            <div align="justify">-The Hindu<br /><br />In the year 2011, 438 people died due to Serious Adverse Events (SAEs) during medicine trials in India, but pharmaceutical companies provided financial compensation in only 16 such cases.<br /><br />The total amount paid in compensation in all the 16 cases adds up to Rs. 34.88 lakh, with the highest amount being Rs. 5 lakh, and the lowest being Rs. 50,000.<br /><br />This makes 2011 only the second year, for which data are available, when any compensation was paid in cases of deaths caused during medicine trials, the previous year being 2010, when 22 such cases were compensated.<br /><br />According to documents available with The Hindu , the largest amount in compensation was paid by Sun Pharma. The company paid Rs. 15 lakh in compensation in five cases (Rs. 3 lakh each).<br /><br />Next in line was US-based Clinical Research Organization (CRO) ICON PLC, (6.52 lakh in three cases), followed by Pfizer Inc (6.5 lakh in two cases) and German pharma and medical-care giant Fresenius (Rs. 1 lakh in two cases).<br /><br />Delhi-based CRO Apothecaries (Rs. 2.16 lakh), Multinational Clinical Research bigwig Lambda (Rs. 2 lakh), French firm Sanofi (Rs. 1 lakh), and Indian firm Veeda Clinical Research (Rs. 50,000), each paid compensation to one case of death.<br /><br />The information was provided by the office of the Drug Controller General (India) to medical rights activist, Anand Rai.<br /><br />The information provided by the DCG (I) doesn&rsquo;t tell if the compensation was paid by the foreign firms or their Indian subsidiaries.<br /><br />According to official data, between January 2007 and January 2012, Serious Adverse Events (SAEs) during medicine trials killed 2193 people all across India.<br /><br />The year-wise break-up of the deaths are: 132 (2007), 288 (2008), 637 (2009), 688 (2010), 438 (2011) and 30 (January, 2012).<br /><br />However, compensation was provided only to 22 victims in 2010 and 16 in 2011.<br /><br />&ldquo;It is shocking that only 3 per cent of the cases have been compensated. It is a mockery of the human rights of trial subjects in India. But sadly, the Central Drugs Standard Control Organization&rsquo;s (CDSCO&rsquo;s) new draft guidelines on financial compensation only address part of the problem,&rdquo; says Dr. Rai, who secured the information under the Right to Information Act.<br /><br />At present, financial compensation isn&rsquo;t mandated by law in India, and is only mentioned as a Good Clinical Practice (GCP) in paragraph 2.4.7 of the Indian Council of Medical Research&rsquo;s GCP Guidelines for Clinical Trials in India.<br /><br />The CDSCO&rsquo;s new draft guidelines for financial compensation seek to fill this major gap in the existing Drugs and Cosmetic Act, 1940.<br /><br />The total amount paid in compensation in all the 16 cases in 2011 adds up to Rs. 34.88 lakh<br /><br />Sun Pharma paid Rs. 15 lakh in compensation in five cases of Rs. 3 lakh each<br /><br /></div>                                                           
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    <br><a href="http://www.thehindu.com/todays-paper/tp-national/article3793837.ece" class="re" target="_blank">The Hindu, 19 August, 2012, http://www.thehindu.com/todays-paper/tp-national/article3793837.ece</a><div class="clear"></div>
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CDSCO drafting new norms for financial compensation-Mahim Pratap Singh

Published on Aug 21, 2012   Modified on Aug 21, 2012

-The Hindu In the year 2011, 438 people died due to Serious Adverse Events (SAEs) during medicine trials in India, but pharmaceutical companies provided financial compensation in only 16 such cases. The total amount paid in compensation in all the 16 cases adds up to Rs. 34.88 lakh, with the highest amount being Rs. 5 lakh, and the lowest being Rs. 50,000. This makes 2011 only the second year, for which data are available, when any compensation was paid in cases of deaths caused during medicine trials, the previous year being 2010, when 22 such cases were compensated. According to documents available with The Hindu , the largest amount in compensation was paid by Sun Pharma. The company paid Rs. 15 lakh in compensation in five cases (Rs. 3 lakh each). Next in line was US-based Clinical Research Organization (CRO) ICON PLC, (6.52 lakh in three cases), followed by Pfizer Inc (6.5 lakh in two cases) and German pharma and medical-care giant Fresenius (Rs. 1 lakh in two cases). Delhi-based CRO Apothecaries (Rs. 2.16 lakh), Multinational Clinical Research bigwig Lambda (Rs. 2 lakh), French firm Sanofi (Rs. 1 lakh), and Indian firm Veeda Clinical Research (Rs. 50,000), each paid compensation to one case of death. The information was provided by the office of the Drug Controller General (India) to medical rights activist, Anand Rai. The information provided by the DCG (I) doesn’t tell if the compensation was paid by the foreign firms or their Indian subsidiaries. According to official data, between January 2007 and January 2012, Serious Adverse Events (SAEs) during medicine trials killed 2193 people all across India. The year-wise break-up of the deaths are: 132 (2007), 288 (2008), 637 (2009), 688 (2010), 438 (2011) and 30 (January, 2012). However, compensation was provided only to 22 victims in 2010 and 16 in 2011. “It is shocking that only 3 per cent of the cases have been compensated. It is a mockery of the human rights of trial subjects in India. But sadly, the Central Drugs Standard Control Organization’s (CDSCO’s) new draft guidelines on financial compensation only address part of the problem,” says Dr. Rai, who secured the information under the Right to Information Act. At present, financial compensation isn’t mandated by law in India, and is only mentioned as a Good Clinical Practice (GCP) in paragraph 2.4.7 of the Indian Council of Medical Research’s GCP Guidelines for Clinical Trials in India. The CDSCO’s new draft guidelines for financial compensation seek to fill this major gap in the existing Drugs and Cosmetic Act, 1940. The total amount paid in compensation in all the 16 cases in 2011 adds up to Rs. 34.88 lakh Sun Pharma paid Rs. 15 lakh in compensation in five cases of Rs. 3 lakh each

The Hindu, 19 August, 2012, http://www.thehindu.com/todays-paper/tp-national/article3793837.ece

Tagged with: Law and Justice medicines Health

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