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\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 | &#039;Many combination drugs not approved by regulator&#039; -Afshan Yasmeen    </title>
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-The Hindu

Study raises safety, efficacy concerns; call for ban of irrational formulations

Of the 110 anti-TB (tuberculosis) Fixed Dose Combinations (FDCs) available in India, only 32 (less than 30%) have been approved by the Central Drugs Standard Control Organisation (CDSCO), the..."/>
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-The Hindu

Study raises safety, efficacy concerns; call for ban of irrational formulations

Of the 110 anti-TB (tuberculosis) Fixed Dose Combinations (FDCs) available in India, only 32 (less than 30%) have been approved by the Central Drugs Standard Control Organisation (CDSCO), the..." />
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                            <div align="justify">-The Hindu<br /><br /><em>Study raises safety, efficacy concerns; call for ban of irrational formulations<br /></em><br />Of the 110 anti-TB (tuberculosis) Fixed Dose Combinations (FDCs) available in India, only 32 (less than 30%) have been approved by the Central Drugs Standard Control Organisation (CDSCO), the country&rsquo;s drug regulator. In the case of malaria FDCs, only eight out of 20 (40%), have been approved.<br /><br />These statistics, that give rise to safety and efficacy concerns, have been brought out in a study published online in the journal Tropical Medicine and International Health by researchers from the Manipal College of Pharmaceutical Sciences.<br /><br />An FDC or combination product is a formulation with more than one active pharmaceutical ingredient (API) in a fixed ratio of doses formulated into a single dosage form.<br /><br /><em>Proportion, sales<br /></em><br />Aimed at assessing the proportion and sales of unapproved FDCs of anti-tubercular, antimalarial and antiretroviral (anti-HIV/AIDS) medicines available in India, the study analysed the available FDCs for these diseases and screened them against the CDSCO database of approved FDCs.<br /><br />Swapnil J. Dengale from the Department of Pharmaceutical Quality Assurance in the Manipal College of Pharmaceutical Sciences, the corresponding author of the study, told The Hindu that &ldquo;an opaque regulatory framework and ambiguity over licensing powers have contributed to the problem. The rationality of unapproved FDCs should be reviewed and irrational formulations should be banned.&rdquo;<br /><br />Please <a href="https://www.thehindu.com/news/national/many-combination-drugs-not-approved-by-regulator/article25712141.ece?homepage=true" title="https://www.thehindu.com/news/national/many-combination-drugs-not-approved-by-regulator/article25712141.ece?homepage=true">click here</a> to read more. <br /></div>                                                           
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    <br><a href="https://www.thehindu.com/news/national/many-combination-drugs-not-approved-by-regulator/article25712141.ece?homepage=true" class="re" target="_blank">The Hindu, 10 December, 2018, https://www.thehindu.com/news/national/many-combination-drugs-not-approved-by-regulator/article25712141.ece?homepage=true</a><div class="clear"></div>
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Study raises safety, efficacy concerns; call for ban of irrational formulations

Of the 110 anti-TB (tuberculosis) Fixed Dose Combinations (FDCs) available in India, only 32 (less than 30%) have been approved by the Central Drugs Standard Control Organisation (CDSCO), the..."/>
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Study raises safety, efficacy concerns; call for ban of irrational formulations

Of the 110 anti-TB (tuberculosis) Fixed Dose Combinations (FDCs) available in India, only 32 (less than 30%) have been approved by the Central Drugs Standard Control Organisation (CDSCO), the..." />
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    <h1 class="cat-box-title">&#039;Many combination drugs not approved by regulator&#039; -Afshan Yasmeen</h1>
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                            <div align="justify">-The Hindu<br /><br /><em>Study raises safety, efficacy concerns; call for ban of irrational formulations<br /></em><br />Of the 110 anti-TB (tuberculosis) Fixed Dose Combinations (FDCs) available in India, only 32 (less than 30%) have been approved by the Central Drugs Standard Control Organisation (CDSCO), the country&rsquo;s drug regulator. In the case of malaria FDCs, only eight out of 20 (40%), have been approved.<br /><br />These statistics, that give rise to safety and efficacy concerns, have been brought out in a study published online in the journal Tropical Medicine and International Health by researchers from the Manipal College of Pharmaceutical Sciences.<br /><br />An FDC or combination product is a formulation with more than one active pharmaceutical ingredient (API) in a fixed ratio of doses formulated into a single dosage form.<br /><br /><em>Proportion, sales<br /></em><br />Aimed at assessing the proportion and sales of unapproved FDCs of anti-tubercular, antimalarial and antiretroviral (anti-HIV/AIDS) medicines available in India, the study analysed the available FDCs for these diseases and screened them against the CDSCO database of approved FDCs.<br /><br />Swapnil J. Dengale from the Department of Pharmaceutical Quality Assurance in the Manipal College of Pharmaceutical Sciences, the corresponding author of the study, told The Hindu that &ldquo;an opaque regulatory framework and ambiguity over licensing powers have contributed to the problem. The rationality of unapproved FDCs should be reviewed and irrational formulations should be banned.&rdquo;<br /><br />Please <a href="https://www.thehindu.com/news/national/many-combination-drugs-not-approved-by-regulator/article25712141.ece?homepage=true" title="https://www.thehindu.com/news/national/many-combination-drugs-not-approved-by-regulator/article25712141.ece?homepage=true">click here</a> to read more. <br /></div>                                                           
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    <br><a href="https://www.thehindu.com/news/national/many-combination-drugs-not-approved-by-regulator/article25712141.ece?homepage=true" class="re" target="_blank">The Hindu, 10 December, 2018, https://www.thehindu.com/news/national/many-combination-drugs-not-approved-by-regulator/article25712141.ece?homepage=true</a><div class="clear"></div>
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-The Hindu

Study raises safety, efficacy concerns; call for ban of irrational formulations

Of the 110 anti-TB (tuberculosis) Fixed Dose Combinations (FDCs) available in India, only 32 (less than 30%) have been approved by the Central Drugs Standard Control Organisation (CDSCO), the..."/>
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Study raises safety, efficacy concerns; call for ban of irrational formulations

Of the 110 anti-TB (tuberculosis) Fixed Dose Combinations (FDCs) available in India, only 32 (less than 30%) have been approved by the Central Drugs Standard Control Organisation (CDSCO), the..." />
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    <h1 class="cat-box-title">&#039;Many combination drugs not approved by regulator&#039; -Afshan Yasmeen</h1>
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                            <div align="justify">-The Hindu<br /><br /><em>Study raises safety, efficacy concerns; call for ban of irrational formulations<br /></em><br />Of the 110 anti-TB (tuberculosis) Fixed Dose Combinations (FDCs) available in India, only 32 (less than 30%) have been approved by the Central Drugs Standard Control Organisation (CDSCO), the country&rsquo;s drug regulator. In the case of malaria FDCs, only eight out of 20 (40%), have been approved.<br /><br />These statistics, that give rise to safety and efficacy concerns, have been brought out in a study published online in the journal Tropical Medicine and International Health by researchers from the Manipal College of Pharmaceutical Sciences.<br /><br />An FDC or combination product is a formulation with more than one active pharmaceutical ingredient (API) in a fixed ratio of doses formulated into a single dosage form.<br /><br /><em>Proportion, sales<br /></em><br />Aimed at assessing the proportion and sales of unapproved FDCs of anti-tubercular, antimalarial and antiretroviral (anti-HIV/AIDS) medicines available in India, the study analysed the available FDCs for these diseases and screened them against the CDSCO database of approved FDCs.<br /><br />Swapnil J. Dengale from the Department of Pharmaceutical Quality Assurance in the Manipal College of Pharmaceutical Sciences, the corresponding author of the study, told The Hindu that &ldquo;an opaque regulatory framework and ambiguity over licensing powers have contributed to the problem. The rationality of unapproved FDCs should be reviewed and irrational formulations should be banned.&rdquo;<br /><br />Please <a href="https://www.thehindu.com/news/national/many-combination-drugs-not-approved-by-regulator/article25712141.ece?homepage=true" title="https://www.thehindu.com/news/national/many-combination-drugs-not-approved-by-regulator/article25712141.ece?homepage=true">click here</a> to read more. <br /></div>                                                           
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    <br><a href="https://www.thehindu.com/news/national/many-combination-drugs-not-approved-by-regulator/article25712141.ece?homepage=true" class="re" target="_blank">The Hindu, 10 December, 2018, https://www.thehindu.com/news/national/many-combination-drugs-not-approved-by-regulator/article25712141.ece?homepage=true</a><div class="clear"></div>
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'Many combination drugs not approved by regulator' -Afshan Yasmeen

Published on Dec 11, 2018   Modified on Dec 11, 2018

-The Hindu Study raises safety, efficacy concerns; call for ban of irrational formulations Of the 110 anti-TB (tuberculosis) Fixed Dose Combinations (FDCs) available in India, only 32 (less than 30%) have been approved by the Central Drugs Standard Control Organisation (CDSCO), the country’s drug regulator. In the case of malaria FDCs, only eight out of 20 (40%), have been approved. These statistics, that give rise to safety and efficacy concerns, have been brought out in a study published online in the journal Tropical Medicine and International Health by researchers from the Manipal College of Pharmaceutical Sciences. An FDC or combination product is a formulation with more than one active pharmaceutical ingredient (API) in a fixed ratio of doses formulated into a single dosage form. Proportion, sales Aimed at assessing the proportion and sales of unapproved FDCs of anti-tubercular, antimalarial and antiretroviral (anti-HIV/AIDS) medicines available in India, the study analysed the available FDCs for these diseases and screened them against the CDSCO database of approved FDCs. Swapnil J. Dengale from the Department of Pharmaceutical Quality Assurance in the Manipal College of Pharmaceutical Sciences, the corresponding author of the study, told The Hindu that “an opaque regulatory framework and ambiguity over licensing powers have contributed to the problem. The rationality of unapproved FDCs should be reviewed and irrational formulations should be banned.” Please click here to read more.

The Hindu, 10 December, 2018, https://www.thehindu.com/news/national/many-combination-drugs-not-approved-by-regulator/article25712141.ece?homepage=true

Tagged with: Fixed Dose Combinations (FDCs) Public Health

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