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
App\Controller\ArtileDetailController::index() - APP/Controller/ArtileDetailController.php, line 150
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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

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
Cake\Http\ActionDispatcher::dispatch() - CORE/src/Http/ActionDispatcher.php, line 94
Cake\Http\BaseApplication::__invoke() - CORE/src/Http/BaseApplication.php, line 235
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\RoutingMiddleware::__invoke() - CORE/src/Routing/Middleware/RoutingMiddleware.php, line 162
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\AssetMiddleware::__invoke() - CORE/src/Routing/Middleware/AssetMiddleware.php, line 97
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Error\Middleware\ErrorHandlerMiddleware::__invoke() - CORE/src/Error/Middleware/ErrorHandlerMiddleware.php, line 96
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51
Cake\Http\Server::run() - CORE/src/Http/Server.php, line 98

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

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        LATEST NEWS UPDATES | Generic medicines in a digital age -Dinesh S Thakur &amp; Prashant Reddy T    </title>
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We need a legal mechanism to ensure that all generics are of the same standard as the innovator product

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We need a legal mechanism to ensure that all generics are of the same standard as the innovator product

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                            <div align="justify">-The Hindu<br /><br /><em>We need a legal mechanism to ensure that all generics are of the same standard as the innovator product<br /></em><br />The Prime Minister&rsquo;s recent announcement on making it mandatory for doctors to prescribe only the generic name, and not brand name of a drug, has led to a flutter. If enacted, the move will make it illegal for Indian doctors to write out a prescription for the trademark of the drug, forcing them to mention the chemical name instead. If implemented properly, the hope is that pharmacists will fill the prescription with the cheapest generic drug in the market rather than being forced to dispense a more expensive brand as prescribed. Whether pharmacists will play by the book is anybody&rsquo;s guess.<br /><br /><em>Are all generic drugs equal?<br /></em><br />A more pressing question at this stage is whether all generic medicines in India are of equal quality. The U.S. and the European Union have ensured that generic drugs are therapeutically equal to the innovator drug by making bioequivalence (BE) testing compulsory. This means that generic formulations are tested on healthy volunteers to ensure that they have the same physiological characteristics as their innovator counterparts. These BE studies are much cheaper and carry little risk when compared to clinical trials conducted by the company that gets approval for the innovator product. Once bioequivalence is established, a generic drug is legally certified to be of the same quality to replace the innovator product and can therefore be interchanged for the innovator product. Even the World Health Organisation (WHO) and M&eacute;decins Sans Fronti&egrave;res (MSF) purchase only bioequivalent drugs for their programmes. Until earlier this month, India mandated BE studies for only those formulations seeking approval within four years of the innovator product getting approval. As a result, most generic drug manufacturers sought marketing approval from the fifth year onwards, effectively evading the requirement of conducting BE studies. On April 3, the Ministry of Health finally amended the Drugs &amp; Cosmetics Rules to make BE testing of all highly soluble drugs compulsory. It is a much welcome move.<br /><br />What of the quality of generics approved prior to April 3? Did the manufacturers of these generic drugs voluntarily conduct BE studies? We do not know. If there is no proof of bioequivalence, should doctors be forced to make this choice? The ethical answer is a simple no. If the government wants to make the prescription of generics compulsory, it needs to put in place a legal mechanism to guarantee that all generics, especially those introduced prior to April 3, are bioequivalent to the innovator product. It would be unconscionable to restrict doctors to prescribe drugs which they know do not work as promised.<br /><br />At the very least, the government should require companies to self-certify their drugs to indicate whether they are in fact bioequivalent. A simple logo on the drug&rsquo;s packaging to indicate whether a drug has been tested for proof of bioequivalence, along with the trial ID number listed on the Clinical Trials Registry India, should be made mandatory.<br /><br />Even presuming successful BE studies, a drug can fail for a variety of reasons. It may lack stability and break down due to heat or humidity. These substandard drugs are a dangerous problem, especially in government-run hospitals.<br /><br /><em>Drug quality in India<br /></em><br />According to the government&rsquo;s most recent survey of the quality of drugs in India, 10% of all drugs from &lsquo;government sources&rsquo; tested NSQ, or not of standard quality. A NSQ drug will compromise patient health. These numbers are shocking. An earlier report of the Comptroller and Auditor General had revealed that the Armed Forces Medical Stores Depot, which serves armed forces personnel, had reported the percentage of locally procured drugs that were substandard at as high as 32% in one year!<br /><br />Please <a href="http://www.thehindu.com/opinion/op-ed/generic-medicines-in-a-digital-age/article18279695.ece?homepage=true" title="http://www.thehindu.com/opinion/op-ed/generic-medicines-in-a-digital-age/article18279695.ece?homepage=true">click here</a> to read more. <br /></div>                                                           
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    <br><a href="http://www.thehindu.com/opinion/op-ed/generic-medicines-in-a-digital-age/article18279695.ece?homepage=true" class="re" target="_blank">The Hindu, 29 April, 2017, http://www.thehindu.com/opinion/op-ed/generic-medicines-in-a-digital-age/article18279695.ece?homepage=true</a><div class="clear"></div>
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    <h1 class="cat-box-title">Generic medicines in a digital age -Dinesh S Thakur &amp; Prashant Reddy T</h1>
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                            <div align="justify">-The Hindu<br /><br /><em>We need a legal mechanism to ensure that all generics are of the same standard as the innovator product<br /></em><br />The Prime Minister&rsquo;s recent announcement on making it mandatory for doctors to prescribe only the generic name, and not brand name of a drug, has led to a flutter. If enacted, the move will make it illegal for Indian doctors to write out a prescription for the trademark of the drug, forcing them to mention the chemical name instead. If implemented properly, the hope is that pharmacists will fill the prescription with the cheapest generic drug in the market rather than being forced to dispense a more expensive brand as prescribed. Whether pharmacists will play by the book is anybody&rsquo;s guess.<br /><br /><em>Are all generic drugs equal?<br /></em><br />A more pressing question at this stage is whether all generic medicines in India are of equal quality. The U.S. and the European Union have ensured that generic drugs are therapeutically equal to the innovator drug by making bioequivalence (BE) testing compulsory. This means that generic formulations are tested on healthy volunteers to ensure that they have the same physiological characteristics as their innovator counterparts. These BE studies are much cheaper and carry little risk when compared to clinical trials conducted by the company that gets approval for the innovator product. Once bioequivalence is established, a generic drug is legally certified to be of the same quality to replace the innovator product and can therefore be interchanged for the innovator product. Even the World Health Organisation (WHO) and M&eacute;decins Sans Fronti&egrave;res (MSF) purchase only bioequivalent drugs for their programmes. Until earlier this month, India mandated BE studies for only those formulations seeking approval within four years of the innovator product getting approval. As a result, most generic drug manufacturers sought marketing approval from the fifth year onwards, effectively evading the requirement of conducting BE studies. On April 3, the Ministry of Health finally amended the Drugs &amp; Cosmetics Rules to make BE testing of all highly soluble drugs compulsory. It is a much welcome move.<br /><br />What of the quality of generics approved prior to April 3? Did the manufacturers of these generic drugs voluntarily conduct BE studies? We do not know. If there is no proof of bioequivalence, should doctors be forced to make this choice? The ethical answer is a simple no. If the government wants to make the prescription of generics compulsory, it needs to put in place a legal mechanism to guarantee that all generics, especially those introduced prior to April 3, are bioequivalent to the innovator product. It would be unconscionable to restrict doctors to prescribe drugs which they know do not work as promised.<br /><br />At the very least, the government should require companies to self-certify their drugs to indicate whether they are in fact bioequivalent. A simple logo on the drug&rsquo;s packaging to indicate whether a drug has been tested for proof of bioequivalence, along with the trial ID number listed on the Clinical Trials Registry India, should be made mandatory.<br /><br />Even presuming successful BE studies, a drug can fail for a variety of reasons. It may lack stability and break down due to heat or humidity. These substandard drugs are a dangerous problem, especially in government-run hospitals.<br /><br /><em>Drug quality in India<br /></em><br />According to the government&rsquo;s most recent survey of the quality of drugs in India, 10% of all drugs from &lsquo;government sources&rsquo; tested NSQ, or not of standard quality. A NSQ drug will compromise patient health. These numbers are shocking. An earlier report of the Comptroller and Auditor General had revealed that the Armed Forces Medical Stores Depot, which serves armed forces personnel, had reported the percentage of locally procured drugs that were substandard at as high as 32% in one year!<br /><br />Please <a href="http://www.thehindu.com/opinion/op-ed/generic-medicines-in-a-digital-age/article18279695.ece?homepage=true" title="http://www.thehindu.com/opinion/op-ed/generic-medicines-in-a-digital-age/article18279695.ece?homepage=true">click here</a> to read more. <br /></div>                                                           
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    <br><a href="http://www.thehindu.com/opinion/op-ed/generic-medicines-in-a-digital-age/article18279695.ece?homepage=true" class="re" target="_blank">The Hindu, 29 April, 2017, http://www.thehindu.com/opinion/op-ed/generic-medicines-in-a-digital-age/article18279695.ece?homepage=true</a><div class="clear"></div>
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                            <div align="justify">-The Hindu<br /><br /><em>We need a legal mechanism to ensure that all generics are of the same standard as the innovator product<br /></em><br />The Prime Minister&rsquo;s recent announcement on making it mandatory for doctors to prescribe only the generic name, and not brand name of a drug, has led to a flutter. If enacted, the move will make it illegal for Indian doctors to write out a prescription for the trademark of the drug, forcing them to mention the chemical name instead. If implemented properly, the hope is that pharmacists will fill the prescription with the cheapest generic drug in the market rather than being forced to dispense a more expensive brand as prescribed. Whether pharmacists will play by the book is anybody&rsquo;s guess.<br /><br /><em>Are all generic drugs equal?<br /></em><br />A more pressing question at this stage is whether all generic medicines in India are of equal quality. The U.S. and the European Union have ensured that generic drugs are therapeutically equal to the innovator drug by making bioequivalence (BE) testing compulsory. This means that generic formulations are tested on healthy volunteers to ensure that they have the same physiological characteristics as their innovator counterparts. These BE studies are much cheaper and carry little risk when compared to clinical trials conducted by the company that gets approval for the innovator product. Once bioequivalence is established, a generic drug is legally certified to be of the same quality to replace the innovator product and can therefore be interchanged for the innovator product. Even the World Health Organisation (WHO) and M&eacute;decins Sans Fronti&egrave;res (MSF) purchase only bioequivalent drugs for their programmes. Until earlier this month, India mandated BE studies for only those formulations seeking approval within four years of the innovator product getting approval. As a result, most generic drug manufacturers sought marketing approval from the fifth year onwards, effectively evading the requirement of conducting BE studies. On April 3, the Ministry of Health finally amended the Drugs &amp; Cosmetics Rules to make BE testing of all highly soluble drugs compulsory. It is a much welcome move.<br /><br />What of the quality of generics approved prior to April 3? Did the manufacturers of these generic drugs voluntarily conduct BE studies? We do not know. If there is no proof of bioequivalence, should doctors be forced to make this choice? The ethical answer is a simple no. If the government wants to make the prescription of generics compulsory, it needs to put in place a legal mechanism to guarantee that all generics, especially those introduced prior to April 3, are bioequivalent to the innovator product. It would be unconscionable to restrict doctors to prescribe drugs which they know do not work as promised.<br /><br />At the very least, the government should require companies to self-certify their drugs to indicate whether they are in fact bioequivalent. A simple logo on the drug&rsquo;s packaging to indicate whether a drug has been tested for proof of bioequivalence, along with the trial ID number listed on the Clinical Trials Registry India, should be made mandatory.<br /><br />Even presuming successful BE studies, a drug can fail for a variety of reasons. It may lack stability and break down due to heat or humidity. These substandard drugs are a dangerous problem, especially in government-run hospitals.<br /><br /><em>Drug quality in India<br /></em><br />According to the government&rsquo;s most recent survey of the quality of drugs in India, 10% of all drugs from &lsquo;government sources&rsquo; tested NSQ, or not of standard quality. A NSQ drug will compromise patient health. These numbers are shocking. An earlier report of the Comptroller and Auditor General had revealed that the Armed Forces Medical Stores Depot, which serves armed forces personnel, had reported the percentage of locally procured drugs that were substandard at as high as 32% in one year!<br /><br />Please <a href="http://www.thehindu.com/opinion/op-ed/generic-medicines-in-a-digital-age/article18279695.ece?homepage=true" title="http://www.thehindu.com/opinion/op-ed/generic-medicines-in-a-digital-age/article18279695.ece?homepage=true">click here</a> to read more. <br /></div>                                                           
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    <br><a href="http://www.thehindu.com/opinion/op-ed/generic-medicines-in-a-digital-age/article18279695.ece?homepage=true" class="re" target="_blank">The Hindu, 29 April, 2017, http://www.thehindu.com/opinion/op-ed/generic-medicines-in-a-digital-age/article18279695.ece?homepage=true</a><div class="clear"></div>
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Home हिन्दी

Generic medicines in a digital age -Dinesh S Thakur & Prashant Reddy T

Published on Apr 29, 2017   Modified on Apr 29, 2017

-The Hindu We need a legal mechanism to ensure that all generics are of the same standard as the innovator product The Prime Minister’s recent announcement on making it mandatory for doctors to prescribe only the generic name, and not brand name of a drug, has led to a flutter. If enacted, the move will make it illegal for Indian doctors to write out a prescription for the trademark of the drug, forcing them to mention the chemical name instead. If implemented properly, the hope is that pharmacists will fill the prescription with the cheapest generic drug in the market rather than being forced to dispense a more expensive brand as prescribed. Whether pharmacists will play by the book is anybody’s guess. Are all generic drugs equal? A more pressing question at this stage is whether all generic medicines in India are of equal quality. The U.S. and the European Union have ensured that generic drugs are therapeutically equal to the innovator drug by making bioequivalence (BE) testing compulsory. This means that generic formulations are tested on healthy volunteers to ensure that they have the same physiological characteristics as their innovator counterparts. These BE studies are much cheaper and carry little risk when compared to clinical trials conducted by the company that gets approval for the innovator product. Once bioequivalence is established, a generic drug is legally certified to be of the same quality to replace the innovator product and can therefore be interchanged for the innovator product. Even the World Health Organisation (WHO) and Médecins Sans Frontières (MSF) purchase only bioequivalent drugs for their programmes. Until earlier this month, India mandated BE studies for only those formulations seeking approval within four years of the innovator product getting approval. As a result, most generic drug manufacturers sought marketing approval from the fifth year onwards, effectively evading the requirement of conducting BE studies. On April 3, the Ministry of Health finally amended the Drugs & Cosmetics Rules to make BE testing of all highly soluble drugs compulsory. It is a much welcome move. What of the quality of generics approved prior to April 3? Did the manufacturers of these generic drugs voluntarily conduct BE studies? We do not know. If there is no proof of bioequivalence, should doctors be forced to make this choice? The ethical answer is a simple no. If the government wants to make the prescription of generics compulsory, it needs to put in place a legal mechanism to guarantee that all generics, especially those introduced prior to April 3, are bioequivalent to the innovator product. It would be unconscionable to restrict doctors to prescribe drugs which they know do not work as promised. At the very least, the government should require companies to self-certify their drugs to indicate whether they are in fact bioequivalent. A simple logo on the drug’s packaging to indicate whether a drug has been tested for proof of bioequivalence, along with the trial ID number listed on the Clinical Trials Registry India, should be made mandatory. Even presuming successful BE studies, a drug can fail for a variety of reasons. It may lack stability and break down due to heat or humidity. These substandard drugs are a dangerous problem, especially in government-run hospitals. Drug quality in India According to the government’s most recent survey of the quality of drugs in India, 10% of all drugs from ‘government sources’ tested NSQ, or not of standard quality. A NSQ drug will compromise patient health. These numbers are shocking. An earlier report of the Comptroller and Auditor General had revealed that the Armed Forces Medical Stores Depot, which serves armed forces personnel, had reported the percentage of locally procured drugs that were substandard at as high as 32% in one year! Please click here to read more.

The Hindu, 29 April, 2017, http://www.thehindu.com/opinion/op-ed/generic-medicines-in-a-digital-age/article18279695.ece?homepage=true

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

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