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]
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::printArticle() - APP/Controller/ArtileDetailController.php, line 73
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Cake\Http\ActionDispatcher::_invoke() - CORE/src/Http/ActionDispatcher.php, line 120
Cake\Http\ActionDispatcher::dispatch() - CORE/src/Http/ActionDispatcher.php, line 94
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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: 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]
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::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]
Code Context
            if (Configure::read('debug')) {

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    <link rel="canonical" href="https://im4change.in/<pre class="cake-error"><a href="javascript:void(0);" onclick="document.getElementById('cakeErr68051048e4d2d-trace').style.display = (document.getElementById('cakeErr68051048e4d2d-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="cakeErr68051048e4d2d-trace" class="cake-stack-trace" style="display: none;"><a href="javascript:void(0);" onclick="document.getElementById('cakeErr68051048e4d2d-code').style.display = (document.getElementById('cakeErr68051048e4d2d-code').style.display == 'none' ? '' : 'none')">Code</a> <a href="javascript:void(0);" onclick="document.getElementById('cakeErr68051048e4d2d-context').style.display = (document.getElementById('cakeErr68051048e4d2d-context').style.display == 'none' ? '' : 'none')">Context</a><pre id="cakeErr68051048e4d2d-code" class="cake-code-dump" style="display: none;"><code><span style="color: #000000"><span style="color: #0000BB"></span><span style="color: #007700">&lt;</span><span style="color: #0000BB">head</span><span style="color: #007700">&gt;
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The Union health ministry today banned the manufacture and sale of a drug called letrozole to treat infertility in women, four years after its own drug regulators had waived safety studies and relaxed rules to approve the medicine.
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In a statement notifying the ban, the ministry said the drug &amp;ldquo;is likely to involve risk to human beings and safer alternatives are available&amp;rdquo;.
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The drug has been used to treat breast cancer in post-menopausal women for years in several countries, including India. The health ministry&amp;rsquo;s drug regulators approved letrozole for infertility therapy in April 2007 after an Indian company, Sun Pharmaceutical Industries, conducted clinical trials with the compound. They ignored a warning by the original manufacturer, Novartis, that said the drug should not be given to pre-menopausal women because of its health risks.
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Documents released by the health ministry in 2008, in response to queries by CPM leader Brinda Karat, have suggested that drug regulators had waived safety studies and relaxed rules so that approval was given after trials on 55 women, instead of 100 as required under rules.
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Some gynaecologists who have prescribed letrozole for infertility estimate that several thousands of women across the country may have received this medicine over the past four years. One infertility specialist said she was surprised by the ban announced today.
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&amp;ldquo;This is really disturbing. Why did our drug authorities approve the medicine in the first place?&amp;rdquo; said Reeta Biliangady, clinical director of a fertility clinic in Bangalore, who estimates she has prescribed letrozole to nearly 300 women over the past four years. &amp;ldquo;Maybe we need an Anna Hazare to watch over drug regulators,&amp;rdquo; Biliangady said.
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When the health ministry documents indicating irregularities emerged, Sun Pharmaceutical officials said the company had fulfilled &amp;ldquo;all regulatory requirements for approval of the drug&amp;rdquo;, as was reported in The Telegraph on September 8, 2008.
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&lt;div style=&quot;text-align: justify&quot;&gt;
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A senior drug regulator claimed that the safety studies were waived because other studies had already been done outside India on letrozole&amp;rsquo;s effectiveness to treat infertility. The regulator also said the number 100 in a clinical trial was not sacrosanct.
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Neither company officials nor drug regulators were available for comment today.
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&amp;ldquo;A wrong has been undone today,&amp;rdquo; said Chandra Gulhati, the editor of the Monthly Index of Medical Specialities, India, an independent drugs journal which had first exposed the illegal promotion of letrozole for infertility in India nearly eight years ago.
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In 2005, Novartis, the original manufacturer of the compound, after discussions with a Canadian health agency, issued a cautionary note warning doctors that the use of letrozole for infertility could lead to problems in embryos or foetuses.
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&amp;ldquo;There have been post-market reports of congenital anomalies in infants of mothers exposed to (letrozole) for the treatment of infertility,&amp;rdquo; the company said in its statement.
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The health ministry has not explained the circumstances that led to its decision to ban letrozole for induction of ovulation &amp;ldquo;with immediate effect&amp;rdquo;.
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An infertility specialist in Pune said she began prescribing letrozole after company officials assured doctors in 2007 it had been approved by drug regulators.
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&amp;ldquo;How can doctors be expected to know what&amp;rsquo;s going on in the drug approval process?&amp;rdquo; asked Bharati Dhorepatil, the chairperson of the clinical research division of the Federation of the Obstetrics and Gynaeological Societies of India.
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The Union health ministry today banned the manufacture and sale of a drug called letrozole to treat infertility in women, four years after its own drug regulators had waived safety studies and relaxed rules to approve the medicine.





In a statement...&#039;,
	&#039;disp&#039; =&gt; &#039;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;The Union health ministry today banned the manufacture and sale of a drug called letrozole to treat infertility in women, four years after its own drug regulators had waived safety studies and relaxed rules to approve the medicine.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;In a statement notifying the ban, the ministry said the drug &amp;ldquo;is likely to involve risk to human beings and safer alternatives are available&amp;rdquo;.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;The drug has been used to treat breast cancer in post-menopausal women for years in several countries, including India. The health ministry&amp;rsquo;s drug regulators approved letrozole for infertility therapy in April 2007 after an Indian company, Sun Pharmaceutical Industries, conducted clinical trials with the compound. They ignored a warning by the original manufacturer, Novartis, that said the drug should not be given to pre-menopausal women because of its health risks.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;Documents released by the health ministry in 2008, in response to queries by CPM leader Brinda Karat, have suggested that drug regulators had waived safety studies and relaxed rules so that approval was given after trials on 55 women, instead of 100 as required under rules.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;Some gynaecologists who have prescribed letrozole for infertility estimate that several thousands of women across the country may have received this medicine over the past four years. One infertility specialist said she was surprised by the ban announced today.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&amp;ldquo;This is really disturbing. Why did our drug authorities approve the medicine in the first place?&amp;rdquo; said Reeta Biliangady, clinical director of a fertility clinic in Bangalore, who estimates she has prescribed letrozole to nearly 300 women over the past four years. &amp;ldquo;Maybe we need an Anna Hazare to watch over drug regulators,&amp;rdquo; Biliangady said.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;When the health ministry documents indicating irregularities emerged, Sun Pharmaceutical officials said the company had fulfilled &amp;ldquo;all regulatory requirements for approval of the drug&amp;rdquo;, as was reported in The Telegraph on September 8, 2008.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;A senior drug regulator claimed that the safety studies were waived because other studies had already been done outside India on letrozole&amp;rsquo;s effectiveness to treat infertility. The regulator also said the number 100 in a clinical trial was not sacrosanct.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;Neither company officials nor drug regulators were available for comment today.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&amp;ldquo;A wrong has been undone today,&amp;rdquo; said Chandra Gulhati, the editor of the Monthly Index of Medical Specialities, India, an independent drugs journal which had first exposed the illegal promotion of letrozole for infertility in India nearly eight years ago.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;In 2005, Novartis, the original manufacturer of the compound, after discussions with a Canadian health agency, issued a cautionary note warning doctors that the use of letrozole for infertility could lead to problems in embryos or foetuses.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&amp;ldquo;There have been post-market reports of congenital anomalies in infants of mothers exposed to (letrozole) for the treatment of infertility,&amp;rdquo; the company said in its statement.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;The health ministry has not explained the circumstances that led to its decision to ban letrozole for induction of ovulation &amp;ldquo;with immediate effect&amp;rdquo;.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;An infertility specialist in Pune said she began prescribing letrozole after company officials assured doctors in 2007 it had been approved by drug regulators.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&amp;ldquo;How can doctors be expected to know what&amp;rsquo;s going on in the drug approval process?&amp;rdquo; asked Bharati Dhorepatil, the chairperson of the clinical research division of the Federation of the Obstetrics and Gynaeological Societies of India.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&#039;,
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The Union health ministry today banned the manufacture and sale of a drug called letrozole to treat infertility in women, four years after its own drug regulators had waived safety studies and relaxed rules to approve the medicine.
&lt;/div&gt;
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&lt;br /&gt;
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In a statement notifying the ban, the ministry said the drug &amp;ldquo;is likely to involve risk to human beings and safer alternatives are available&amp;rdquo;.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
The drug has been used to treat breast cancer in post-menopausal women for years in several countries, including India. The health ministry&amp;rsquo;s drug regulators approved letrozole for infertility therapy in April 2007 after an Indian company, Sun Pharmaceutical Industries, conducted clinical trials with the compound. They ignored a warning by the original manufacturer, Novartis, that said the drug should not be given to pre-menopausal women because of its health risks.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
Documents released by the health ministry in 2008, in response to queries by CPM leader Brinda Karat, have suggested that drug regulators had waived safety studies and relaxed rules so that approval was given after trials on 55 women, instead of 100 as required under rules.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
Some gynaecologists who have prescribed letrozole for infertility estimate that several thousands of women across the country may have received this medicine over the past four years. One infertility specialist said she was surprised by the ban announced today.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&amp;ldquo;This is really disturbing. Why did our drug authorities approve the medicine in the first place?&amp;rdquo; said Reeta Biliangady, clinical director of a fertility clinic in Bangalore, who estimates she has prescribed letrozole to nearly 300 women over the past four years. &amp;ldquo;Maybe we need an Anna Hazare to watch over drug regulators,&amp;rdquo; Biliangady said.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
When the health ministry documents indicating irregularities emerged, Sun Pharmaceutical officials said the company had fulfilled &amp;ldquo;all regulatory requirements for approval of the drug&amp;rdquo;, as was reported in The Telegraph on September 8, 2008.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
A senior drug regulator claimed that the safety studies were waived because other studies had already been done outside India on letrozole&amp;rsquo;s effectiveness to treat infertility. The regulator also said the number 100 in a clinical trial was not sacrosanct.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
Neither company officials nor drug regulators were available for comment today.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&amp;ldquo;A wrong has been undone today,&amp;rdquo; said Chandra Gulhati, the editor of the Monthly Index of Medical Specialities, India, an independent drugs journal which had first exposed the illegal promotion of letrozole for infertility in India nearly eight years ago.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
In 2005, Novartis, the original manufacturer of the compound, after discussions with a Canadian health agency, issued a cautionary note warning doctors that the use of letrozole for infertility could lead to problems in embryos or foetuses.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&amp;ldquo;There have been post-market reports of congenital anomalies in infants of mothers exposed to (letrozole) for the treatment of infertility,&amp;rdquo; the company said in its statement.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
The health ministry has not explained the circumstances that led to its decision to ban letrozole for induction of ovulation &amp;ldquo;with immediate effect&amp;rdquo;.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
An infertility specialist in Pune said she began prescribing letrozole after company officials assured doctors in 2007 it had been approved by drug regulators.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&amp;ldquo;How can doctors be expected to know what&amp;rsquo;s going on in the drug approval process?&amp;rdquo; asked Bharati Dhorepatil, the chairperson of the clinical research division of the Federation of the Obstetrics and Gynaeological Societies of India.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
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The Union health ministry today banned the manufacture and sale of a drug called letrozole to treat infertility in women, four years after its own drug regulators had waived safety studies and relaxed rules to approve the medicine.





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$disp = &#039;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;The Union health ministry today banned the manufacture and sale of a drug called letrozole to treat infertility in women, four years after its own drug regulators had waived safety studies and relaxed rules to approve the medicine.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;In a statement notifying the ban, the ministry said the drug &amp;ldquo;is likely to involve risk to human beings and safer alternatives are available&amp;rdquo;.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;The drug has been used to treat breast cancer in post-menopausal women for years in several countries, including India. The health ministry&amp;rsquo;s drug regulators approved letrozole for infertility therapy in April 2007 after an Indian company, Sun Pharmaceutical Industries, conducted clinical trials with the compound. They ignored a warning by the original manufacturer, Novartis, that said the drug should not be given to pre-menopausal women because of its health risks.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;Documents released by the health ministry in 2008, in response to queries by CPM leader Brinda Karat, have suggested that drug regulators had waived safety studies and relaxed rules so that approval was given after trials on 55 women, instead of 100 as required under rules.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;Some gynaecologists who have prescribed letrozole for infertility estimate that several thousands of women across the country may have received this medicine over the past four years. 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Why did our drug authorities approve the medicine in the first place?&amp;rdquo; said Reeta Biliangady, clinical director of a fertility clinic in Bangalore, who estimates she has prescribed letrozole to nearly 300 women over the past four years. &amp;ldquo;Maybe we need an Anna Hazare to watch over drug regulators,&amp;rdquo; Biliangady said.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;When the health ministry documents indicating irregularities emerged, Sun Pharmaceutical officials said the company had fulfilled &amp;ldquo;all regulatory requirements for approval of the drug&amp;rdquo;, as was reported in The Telegraph on September 8, 2008.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;A senior drug regulator claimed that the safety studies were waived because other studies had already been done outside India on letrozole&amp;rsquo;s effectiveness to treat infertility. The regulator also said the number 100 in a clinical trial was not sacrosanct.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;Neither company officials nor drug regulators were available for comment today.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&amp;ldquo;A wrong has been undone today,&amp;rdquo; said Chandra Gulhati, the editor of the Monthly Index of Medical Specialities, India, an independent drugs journal which had first exposed the illegal promotion of letrozole for infertility in India nearly eight years ago.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;In 2005, Novartis, the original manufacturer of the compound, after discussions with a Canadian health agency, issued a cautionary note warning doctors that the use of letrozole for infertility could lead to problems in embryos or foetuses.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&amp;ldquo;There have been post-market reports of congenital anomalies in infants of mothers exposed to (letrozole) for the treatment of infertility,&amp;rdquo; the company said in its statement.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;The health ministry has not explained the circumstances that led to its decision to ban letrozole for induction of ovulation &amp;ldquo;with immediate effect&amp;rdquo;.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;An infertility specialist in Pune said she began prescribing letrozole after company officials assured doctors in 2007 it had been approved by drug regulators.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&amp;ldquo;How can doctors be expected to know what&amp;rsquo;s going on in the drug approval process?&amp;rdquo; asked Bharati Dhorepatil, the chairperson of the clinical research division of the Federation of the Obstetrics and Gynaeological Societies of India.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&#039;
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The Union health ministry today banned the manufacture and sale of a drug called letrozole to treat infertility in women, four years after its own drug regulators had waived safety studies and relaxed rules to approve the medicine.





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                <strong>Fertility drug ban after 4 years of use by GS Mudur</strong></h1>
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                <div style="text-align: justify"><br /></div><div style="text-align: justify">The Union health ministry today banned the manufacture and sale of a drug called letrozole to treat infertility in women, four years after its own drug regulators had waived safety studies and relaxed rules to approve the medicine.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">In a statement notifying the ban, the ministry said the drug &ldquo;is likely to involve risk to human beings and safer alternatives are available&rdquo;.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">The drug has been used to treat breast cancer in post-menopausal women for years in several countries, including India. The health ministry&rsquo;s drug regulators approved letrozole for infertility therapy in April 2007 after an Indian company, Sun Pharmaceutical Industries, conducted clinical trials with the compound. They ignored a warning by the original manufacturer, Novartis, that said the drug should not be given to pre-menopausal women because of its health risks.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Documents released by the health ministry in 2008, in response to queries by CPM leader Brinda Karat, have suggested that drug regulators had waived safety studies and relaxed rules so that approval was given after trials on 55 women, instead of 100 as required under rules.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Some gynaecologists who have prescribed letrozole for infertility estimate that several thousands of women across the country may have received this medicine over the past four years. One infertility specialist said she was surprised by the ban announced today.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&ldquo;This is really disturbing. Why did our drug authorities approve the medicine in the first place?&rdquo; said Reeta Biliangady, clinical director of a fertility clinic in Bangalore, who estimates she has prescribed letrozole to nearly 300 women over the past four years. &ldquo;Maybe we need an Anna Hazare to watch over drug regulators,&rdquo; Biliangady said.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">When the health ministry documents indicating irregularities emerged, Sun Pharmaceutical officials said the company had fulfilled &ldquo;all regulatory requirements for approval of the drug&rdquo;, as was reported in The Telegraph on September 8, 2008.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">A senior drug regulator claimed that the safety studies were waived because other studies had already been done outside India on letrozole&rsquo;s effectiveness to treat infertility. The regulator also said the number 100 in a clinical trial was not sacrosanct.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Neither company officials nor drug regulators were available for comment today.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&ldquo;A wrong has been undone today,&rdquo; said Chandra Gulhati, the editor of the Monthly Index of Medical Specialities, India, an independent drugs journal which had first exposed the illegal promotion of letrozole for infertility in India nearly eight years ago.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">In 2005, Novartis, the original manufacturer of the compound, after discussions with a Canadian health agency, issued a cautionary note warning doctors that the use of letrozole for infertility could lead to problems in embryos or foetuses.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&ldquo;There have been post-market reports of congenital anomalies in infants of mothers exposed to (letrozole) for the treatment of infertility,&rdquo; the company said in its statement.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">The health ministry has not explained the circumstances that led to its decision to ban letrozole for induction of ovulation &ldquo;with immediate effect&rdquo;.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">An infertility specialist in Pune said she began prescribing letrozole after company officials assured doctors in 2007 it had been approved by drug regulators.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&ldquo;How can doctors be expected to know what&rsquo;s going on in the drug approval process?&rdquo; asked Bharati Dhorepatil, the chairperson of the clinical research division of the Federation of the Obstetrics and Gynaeological Societies of India.</div><div style="text-align: justify"><br /></div>               </font>
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The Union health ministry today banned the manufacture and sale of a drug called letrozole to treat infertility in women, four years after its own drug regulators had waived safety studies and relaxed rules to approve the medicine.
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In a statement notifying the ban, the ministry said the drug &amp;ldquo;is likely to involve risk to human beings and safer alternatives are available&amp;rdquo;.
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The drug has been used to treat breast cancer in post-menopausal women for years in several countries, including India. The health ministry&amp;rsquo;s drug regulators approved letrozole for infertility therapy in April 2007 after an Indian company, Sun Pharmaceutical Industries, conducted clinical trials with the compound. They ignored a warning by the original manufacturer, Novartis, that said the drug should not be given to pre-menopausal women because of its health risks.
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Documents released by the health ministry in 2008, in response to queries by CPM leader Brinda Karat, have suggested that drug regulators had waived safety studies and relaxed rules so that approval was given after trials on 55 women, instead of 100 as required under rules.
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Some gynaecologists who have prescribed letrozole for infertility estimate that several thousands of women across the country may have received this medicine over the past four years. One infertility specialist said she was surprised by the ban announced today.
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&amp;ldquo;This is really disturbing. Why did our drug authorities approve the medicine in the first place?&amp;rdquo; said Reeta Biliangady, clinical director of a fertility clinic in Bangalore, who estimates she has prescribed letrozole to nearly 300 women over the past four years. &amp;ldquo;Maybe we need an Anna Hazare to watch over drug regulators,&amp;rdquo; Biliangady said.
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When the health ministry documents indicating irregularities emerged, Sun Pharmaceutical officials said the company had fulfilled &amp;ldquo;all regulatory requirements for approval of the drug&amp;rdquo;, as was reported in The Telegraph on September 8, 2008.
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A senior drug regulator claimed that the safety studies were waived because other studies had already been done outside India on letrozole&amp;rsquo;s effectiveness to treat infertility. The regulator also said the number 100 in a clinical trial was not sacrosanct.
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Neither company officials nor drug regulators were available for comment today.
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&amp;ldquo;A wrong has been undone today,&amp;rdquo; said Chandra Gulhati, the editor of the Monthly Index of Medical Specialities, India, an independent drugs journal which had first exposed the illegal promotion of letrozole for infertility in India nearly eight years ago.
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In 2005, Novartis, the original manufacturer of the compound, after discussions with a Canadian health agency, issued a cautionary note warning doctors that the use of letrozole for infertility could lead to problems in embryos or foetuses.
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&amp;ldquo;There have been post-market reports of congenital anomalies in infants of mothers exposed to (letrozole) for the treatment of infertility,&amp;rdquo; the company said in its statement.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
The health ministry has not explained the circumstances that led to its decision to ban letrozole for induction of ovulation &amp;ldquo;with immediate effect&amp;rdquo;.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
An infertility specialist in Pune said she began prescribing letrozole after company officials assured doctors in 2007 it had been approved by drug regulators.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&amp;ldquo;How can doctors be expected to know what&amp;rsquo;s going on in the drug approval process?&amp;rdquo; asked Bharati Dhorepatil, the chairperson of the clinical research division of the Federation of the Obstetrics and Gynaeological Societies of India.
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&lt;br /&gt;
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The Union health ministry today banned the manufacture and sale of a drug called letrozole to treat infertility in women, four years after its own drug regulators had waived safety studies and relaxed rules to approve the medicine.





In a statement...&#039;,
	&#039;disp&#039; =&gt; &#039;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;The Union health ministry today banned the manufacture and sale of a drug called letrozole to treat infertility in women, four years after its own drug regulators had waived safety studies and relaxed rules to approve the medicine.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;In a statement notifying the ban, the ministry said the drug &amp;ldquo;is likely to involve risk to human beings and safer alternatives are available&amp;rdquo;.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;The drug has been used to treat breast cancer in post-menopausal women for years in several countries, including India. The health ministry&amp;rsquo;s drug regulators approved letrozole for infertility therapy in April 2007 after an Indian company, Sun Pharmaceutical Industries, conducted clinical trials with the compound. They ignored a warning by the original manufacturer, Novartis, that said the drug should not be given to pre-menopausal women because of its health risks.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;Documents released by the health ministry in 2008, in response to queries by CPM leader Brinda Karat, have suggested that drug regulators had waived safety studies and relaxed rules so that approval was given after trials on 55 women, instead of 100 as required under rules.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;Some gynaecologists who have prescribed letrozole for infertility estimate that several thousands of women across the country may have received this medicine over the past four years. One infertility specialist said she was surprised by the ban announced today.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&amp;ldquo;This is really disturbing. Why did our drug authorities approve the medicine in the first place?&amp;rdquo; said Reeta Biliangady, clinical director of a fertility clinic in Bangalore, who estimates she has prescribed letrozole to nearly 300 women over the past four years. &amp;ldquo;Maybe we need an Anna Hazare to watch over drug regulators,&amp;rdquo; Biliangady said.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;When the health ministry documents indicating irregularities emerged, Sun Pharmaceutical officials said the company had fulfilled &amp;ldquo;all regulatory requirements for approval of the drug&amp;rdquo;, as was reported in The Telegraph on September 8, 2008.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;A senior drug regulator claimed that the safety studies were waived because other studies had already been done outside India on letrozole&amp;rsquo;s effectiveness to treat infertility. The regulator also said the number 100 in a clinical trial was not sacrosanct.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;Neither company officials nor drug regulators were available for comment today.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&amp;ldquo;A wrong has been undone today,&amp;rdquo; said Chandra Gulhati, the editor of the Monthly Index of Medical Specialities, India, an independent drugs journal which had first exposed the illegal promotion of letrozole for infertility in India nearly eight years ago.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;In 2005, Novartis, the original manufacturer of the compound, after discussions with a Canadian health agency, issued a cautionary note warning doctors that the use of letrozole for infertility could lead to problems in embryos or foetuses.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&amp;ldquo;There have been post-market reports of congenital anomalies in infants of mothers exposed to (letrozole) for the treatment of infertility,&amp;rdquo; the company said in its statement.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;The health ministry has not explained the circumstances that led to its decision to ban letrozole for induction of ovulation &amp;ldquo;with immediate effect&amp;rdquo;.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;An infertility specialist in Pune said she began prescribing letrozole after company officials assured doctors in 2007 it had been approved by drug regulators.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&amp;ldquo;How can doctors be expected to know what&amp;rsquo;s going on in the drug approval process?&amp;rdquo; asked Bharati Dhorepatil, the chairperson of the clinical research division of the Federation of the Obstetrics and Gynaeological Societies of India.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&#039;,
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&lt;div style=&quot;text-align: justify&quot;&gt;
The Union health ministry today banned the manufacture and sale of a drug called letrozole to treat infertility in women, four years after its own drug regulators had waived safety studies and relaxed rules to approve the medicine.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
In a statement notifying the ban, the ministry said the drug &amp;ldquo;is likely to involve risk to human beings and safer alternatives are available&amp;rdquo;.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
The drug has been used to treat breast cancer in post-menopausal women for years in several countries, including India. The health ministry&amp;rsquo;s drug regulators approved letrozole for infertility therapy in April 2007 after an Indian company, Sun Pharmaceutical Industries, conducted clinical trials with the compound. They ignored a warning by the original manufacturer, Novartis, that said the drug should not be given to pre-menopausal women because of its health risks.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
Documents released by the health ministry in 2008, in response to queries by CPM leader Brinda Karat, have suggested that drug regulators had waived safety studies and relaxed rules so that approval was given after trials on 55 women, instead of 100 as required under rules.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
Some gynaecologists who have prescribed letrozole for infertility estimate that several thousands of women across the country may have received this medicine over the past four years. One infertility specialist said she was surprised by the ban announced today.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&amp;ldquo;This is really disturbing. Why did our drug authorities approve the medicine in the first place?&amp;rdquo; said Reeta Biliangady, clinical director of a fertility clinic in Bangalore, who estimates she has prescribed letrozole to nearly 300 women over the past four years. &amp;ldquo;Maybe we need an Anna Hazare to watch over drug regulators,&amp;rdquo; Biliangady said.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
When the health ministry documents indicating irregularities emerged, Sun Pharmaceutical officials said the company had fulfilled &amp;ldquo;all regulatory requirements for approval of the drug&amp;rdquo;, as was reported in The Telegraph on September 8, 2008.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
A senior drug regulator claimed that the safety studies were waived because other studies had already been done outside India on letrozole&amp;rsquo;s effectiveness to treat infertility. The regulator also said the number 100 in a clinical trial was not sacrosanct.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
Neither company officials nor drug regulators were available for comment today.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&amp;ldquo;A wrong has been undone today,&amp;rdquo; said Chandra Gulhati, the editor of the Monthly Index of Medical Specialities, India, an independent drugs journal which had first exposed the illegal promotion of letrozole for infertility in India nearly eight years ago.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
In 2005, Novartis, the original manufacturer of the compound, after discussions with a Canadian health agency, issued a cautionary note warning doctors that the use of letrozole for infertility could lead to problems in embryos or foetuses.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&amp;ldquo;There have been post-market reports of congenital anomalies in infants of mothers exposed to (letrozole) for the treatment of infertility,&amp;rdquo; the company said in its statement.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
The health ministry has not explained the circumstances that led to its decision to ban letrozole for induction of ovulation &amp;ldquo;with immediate effect&amp;rdquo;.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
An infertility specialist in Pune said she began prescribing letrozole after company officials assured doctors in 2007 it had been approved by drug regulators.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&amp;ldquo;How can doctors be expected to know what&amp;rsquo;s going on in the drug approval process?&amp;rdquo; asked Bharati Dhorepatil, the chairperson of the clinical research division of the Federation of the Obstetrics and Gynaeological Societies of India.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;&#039;,
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The Union health ministry today banned the manufacture and sale of a drug called letrozole to treat infertility in women, four years after its own drug regulators had waived safety studies and relaxed rules to approve the medicine.





In a statement...&#039;
$disp = &#039;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;The Union health ministry today banned the manufacture and sale of a drug called letrozole to treat infertility in women, four years after its own drug regulators had waived safety studies and relaxed rules to approve the medicine.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;In a statement notifying the ban, the ministry said the drug &amp;ldquo;is likely to involve risk to human beings and safer alternatives are available&amp;rdquo;.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;The drug has been used to treat breast cancer in post-menopausal women for years in several countries, including India. 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They ignored a warning by the original manufacturer, Novartis, that said the drug should not be given to pre-menopausal women because of its health risks.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;Documents released by the health ministry in 2008, in response to queries by CPM leader Brinda Karat, have suggested that drug regulators had waived safety studies and relaxed rules so that approval was given after trials on 55 women, instead of 100 as required under rules.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;Some gynaecologists who have prescribed letrozole for infertility estimate that several thousands of women across the country may have received this medicine over the past four years. One infertility specialist said she was surprised by the ban announced today.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&amp;ldquo;This is really disturbing. Why did our drug authorities approve the medicine in the first place?&amp;rdquo; said Reeta Biliangady, clinical director of a fertility clinic in Bangalore, who estimates she has prescribed letrozole to nearly 300 women over the past four years. &amp;ldquo;Maybe we need an Anna Hazare to watch over drug regulators,&amp;rdquo; Biliangady said.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;When the health ministry documents indicating irregularities emerged, Sun Pharmaceutical officials said the company had fulfilled &amp;ldquo;all regulatory requirements for approval of the drug&amp;rdquo;, as was reported in The Telegraph on September 8, 2008.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;A senior drug regulator claimed that the safety studies were waived because other studies had already been done outside India on letrozole&amp;rsquo;s effectiveness to treat infertility. The regulator also said the number 100 in a clinical trial was not sacrosanct.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;Neither company officials nor drug regulators were available for comment today.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&amp;ldquo;A wrong has been undone today,&amp;rdquo; said Chandra Gulhati, the editor of the Monthly Index of Medical Specialities, India, an independent drugs journal which had first exposed the illegal promotion of letrozole for infertility in India nearly eight years ago.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;In 2005, Novartis, the original manufacturer of the compound, after discussions with a Canadian health agency, issued a cautionary note warning doctors that the use of letrozole for infertility could lead to problems in embryos or foetuses.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&amp;ldquo;There have been post-market reports of congenital anomalies in infants of mothers exposed to (letrozole) for the treatment of infertility,&amp;rdquo; the company said in its statement.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;The health ministry has not explained the circumstances that led to its decision to ban letrozole for induction of ovulation &amp;ldquo;with immediate effect&amp;rdquo;.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;An infertility specialist in Pune said she began prescribing letrozole after company officials assured doctors in 2007 it had been approved by drug regulators.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&amp;ldquo;How can doctors be expected to know what&amp;rsquo;s going on in the drug approval process?&amp;rdquo; asked Bharati Dhorepatil, the chairperson of the clinical research division of the Federation of the Obstetrics and Gynaeological Societies of India.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&#039;
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The Union health ministry today banned the manufacture and sale of a drug called letrozole to treat infertility in women, four years after its own drug regulators had waived safety studies and relaxed rules to approve the medicine.





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                <strong>Fertility drug ban after 4 years of use by GS Mudur</strong></h1>
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                <div style="text-align: justify"><br /></div><div style="text-align: justify">The Union health ministry today banned the manufacture and sale of a drug called letrozole to treat infertility in women, four years after its own drug regulators had waived safety studies and relaxed rules to approve the medicine.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">In a statement notifying the ban, the ministry said the drug &ldquo;is likely to involve risk to human beings and safer alternatives are available&rdquo;.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">The drug has been used to treat breast cancer in post-menopausal women for years in several countries, including India. The health ministry&rsquo;s drug regulators approved letrozole for infertility therapy in April 2007 after an Indian company, Sun Pharmaceutical Industries, conducted clinical trials with the compound. They ignored a warning by the original manufacturer, Novartis, that said the drug should not be given to pre-menopausal women because of its health risks.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Documents released by the health ministry in 2008, in response to queries by CPM leader Brinda Karat, have suggested that drug regulators had waived safety studies and relaxed rules so that approval was given after trials on 55 women, instead of 100 as required under rules.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Some gynaecologists who have prescribed letrozole for infertility estimate that several thousands of women across the country may have received this medicine over the past four years. One infertility specialist said she was surprised by the ban announced today.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&ldquo;This is really disturbing. Why did our drug authorities approve the medicine in the first place?&rdquo; said Reeta Biliangady, clinical director of a fertility clinic in Bangalore, who estimates she has prescribed letrozole to nearly 300 women over the past four years. &ldquo;Maybe we need an Anna Hazare to watch over drug regulators,&rdquo; Biliangady said.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">When the health ministry documents indicating irregularities emerged, Sun Pharmaceutical officials said the company had fulfilled &ldquo;all regulatory requirements for approval of the drug&rdquo;, as was reported in The Telegraph on September 8, 2008.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">A senior drug regulator claimed that the safety studies were waived because other studies had already been done outside India on letrozole&rsquo;s effectiveness to treat infertility. The regulator also said the number 100 in a clinical trial was not sacrosanct.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Neither company officials nor drug regulators were available for comment today.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&ldquo;A wrong has been undone today,&rdquo; said Chandra Gulhati, the editor of the Monthly Index of Medical Specialities, India, an independent drugs journal which had first exposed the illegal promotion of letrozole for infertility in India nearly eight years ago.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">In 2005, Novartis, the original manufacturer of the compound, after discussions with a Canadian health agency, issued a cautionary note warning doctors that the use of letrozole for infertility could lead to problems in embryos or foetuses.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&ldquo;There have been post-market reports of congenital anomalies in infants of mothers exposed to (letrozole) for the treatment of infertility,&rdquo; the company said in its statement.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">The health ministry has not explained the circumstances that led to its decision to ban letrozole for induction of ovulation &ldquo;with immediate effect&rdquo;.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">An infertility specialist in Pune said she began prescribing letrozole after company officials assured doctors in 2007 it had been approved by drug regulators.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&ldquo;How can doctors be expected to know what&rsquo;s going on in the drug approval process?&rdquo; asked Bharati Dhorepatil, the chairperson of the clinical research division of the Federation of the Obstetrics and Gynaeological Societies of India.</div><div style="text-align: justify"><br /></div>               </font>
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The Union health ministry today banned the manufacture and sale of a drug called letrozole to treat infertility in women, four years after its own drug regulators had waived safety studies and relaxed rules to approve the medicine.
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The drug has been used to treat breast cancer in post-menopausal women for years in several countries, including India. The health ministry&amp;rsquo;s drug regulators approved letrozole for infertility therapy in April 2007 after an Indian company, Sun Pharmaceutical Industries, conducted clinical trials with the compound. They ignored a warning by the original manufacturer, Novartis, that said the drug should not be given to pre-menopausal women because of its health risks.
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Some gynaecologists who have prescribed letrozole for infertility estimate that several thousands of women across the country may have received this medicine over the past four years. One infertility specialist said she was surprised by the ban announced today.
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&amp;ldquo;This is really disturbing. Why did our drug authorities approve the medicine in the first place?&amp;rdquo; said Reeta Biliangady, clinical director of a fertility clinic in Bangalore, who estimates she has prescribed letrozole to nearly 300 women over the past four years. &amp;ldquo;Maybe we need an Anna Hazare to watch over drug regulators,&amp;rdquo; Biliangady said.
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When the health ministry documents indicating irregularities emerged, Sun Pharmaceutical officials said the company had fulfilled &amp;ldquo;all regulatory requirements for approval of the drug&amp;rdquo;, as was reported in The Telegraph on September 8, 2008.
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A senior drug regulator claimed that the safety studies were waived because other studies had already been done outside India on letrozole&amp;rsquo;s effectiveness to treat infertility. The regulator also said the number 100 in a clinical trial was not sacrosanct.
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Neither company officials nor drug regulators were available for comment today.
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&amp;ldquo;A wrong has been undone today,&amp;rdquo; said Chandra Gulhati, the editor of the Monthly Index of Medical Specialities, India, an independent drugs journal which had first exposed the illegal promotion of letrozole for infertility in India nearly eight years ago.
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In 2005, Novartis, the original manufacturer of the compound, after discussions with a Canadian health agency, issued a cautionary note warning doctors that the use of letrozole for infertility could lead to problems in embryos or foetuses.
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&amp;ldquo;There have been post-market reports of congenital anomalies in infants of mothers exposed to (letrozole) for the treatment of infertility,&amp;rdquo; the company said in its statement.
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The health ministry has not explained the circumstances that led to its decision to ban letrozole for induction of ovulation &amp;ldquo;with immediate effect&amp;rdquo;.
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An infertility specialist in Pune said she began prescribing letrozole after company officials assured doctors in 2007 it had been approved by drug regulators.
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&amp;ldquo;How can doctors be expected to know what&amp;rsquo;s going on in the drug approval process?&amp;rdquo; asked Bharati Dhorepatil, the chairperson of the clinical research division of the Federation of the Obstetrics and Gynaeological Societies of India.
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The Union health ministry today banned the manufacture and sale of a drug called letrozole to treat infertility in women, four years after its own drug regulators had waived safety studies and relaxed rules to approve the medicine.





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	&#039;disp&#039; =&gt; &#039;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;The Union health ministry today banned the manufacture and sale of a drug called letrozole to treat infertility in women, four years after its own drug regulators had waived safety studies and relaxed rules to approve the medicine.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;In a statement notifying the ban, the ministry said the drug &amp;ldquo;is likely to involve risk to human beings and safer alternatives are available&amp;rdquo;.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;The drug has been used to treat breast cancer in post-menopausal women for years in several countries, including India. The health ministry&amp;rsquo;s drug regulators approved letrozole for infertility therapy in April 2007 after an Indian company, Sun Pharmaceutical Industries, conducted clinical trials with the compound. They ignored a warning by the original manufacturer, Novartis, that said the drug should not be given to pre-menopausal women because of its health risks.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;Documents released by the health ministry in 2008, in response to queries by CPM leader Brinda Karat, have suggested that drug regulators had waived safety studies and relaxed rules so that approval was given after trials on 55 women, instead of 100 as required under rules.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;Some gynaecologists who have prescribed letrozole for infertility estimate that several thousands of women across the country may have received this medicine over the past four years. One infertility specialist said she was surprised by the ban announced today.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&amp;ldquo;This is really disturbing. Why did our drug authorities approve the medicine in the first place?&amp;rdquo; said Reeta Biliangady, clinical director of a fertility clinic in Bangalore, who estimates she has prescribed letrozole to nearly 300 women over the past four years. &amp;ldquo;Maybe we need an Anna Hazare to watch over drug regulators,&amp;rdquo; Biliangady said.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;When the health ministry documents indicating irregularities emerged, Sun Pharmaceutical officials said the company had fulfilled &amp;ldquo;all regulatory requirements for approval of the drug&amp;rdquo;, as was reported in The Telegraph on September 8, 2008.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;A senior drug regulator claimed that the safety studies were waived because other studies had already been done outside India on letrozole&amp;rsquo;s effectiveness to treat infertility. The regulator also said the number 100 in a clinical trial was not sacrosanct.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;Neither company officials nor drug regulators were available for comment today.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&amp;ldquo;A wrong has been undone today,&amp;rdquo; said Chandra Gulhati, the editor of the Monthly Index of Medical Specialities, India, an independent drugs journal which had first exposed the illegal promotion of letrozole for infertility in India nearly eight years ago.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;In 2005, Novartis, the original manufacturer of the compound, after discussions with a Canadian health agency, issued a cautionary note warning doctors that the use of letrozole for infertility could lead to problems in embryos or foetuses.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&amp;ldquo;There have been post-market reports of congenital anomalies in infants of mothers exposed to (letrozole) for the treatment of infertility,&amp;rdquo; the company said in its statement.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;The health ministry has not explained the circumstances that led to its decision to ban letrozole for induction of ovulation &amp;ldquo;with immediate effect&amp;rdquo;.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;An infertility specialist in Pune said she began prescribing letrozole after company officials assured doctors in 2007 it had been approved by drug regulators.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&amp;ldquo;How can doctors be expected to know what&amp;rsquo;s going on in the drug approval process?&amp;rdquo; asked Bharati Dhorepatil, the chairperson of the clinical research division of the Federation of the Obstetrics and Gynaeological Societies of India.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&#039;,
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The Union health ministry today banned the manufacture and sale of a drug called letrozole to treat infertility in women, four years after its own drug regulators had waived safety studies and relaxed rules to approve the medicine.
&lt;/div&gt;
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&lt;br /&gt;
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In a statement notifying the ban, the ministry said the drug &amp;ldquo;is likely to involve risk to human beings and safer alternatives are available&amp;rdquo;.
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&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
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&lt;div style=&quot;text-align: justify&quot;&gt;
The drug has been used to treat breast cancer in post-menopausal women for years in several countries, including India. The health ministry&amp;rsquo;s drug regulators approved letrozole for infertility therapy in April 2007 after an Indian company, Sun Pharmaceutical Industries, conducted clinical trials with the compound. They ignored a warning by the original manufacturer, Novartis, that said the drug should not be given to pre-menopausal women because of its health risks.
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&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
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&lt;div style=&quot;text-align: justify&quot;&gt;
Documents released by the health ministry in 2008, in response to queries by CPM leader Brinda Karat, have suggested that drug regulators had waived safety studies and relaxed rules so that approval was given after trials on 55 women, instead of 100 as required under rules.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
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&lt;div style=&quot;text-align: justify&quot;&gt;
Some gynaecologists who have prescribed letrozole for infertility estimate that several thousands of women across the country may have received this medicine over the past four years. One infertility specialist said she was surprised by the ban announced today.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&amp;ldquo;This is really disturbing. Why did our drug authorities approve the medicine in the first place?&amp;rdquo; said Reeta Biliangady, clinical director of a fertility clinic in Bangalore, who estimates she has prescribed letrozole to nearly 300 women over the past four years. &amp;ldquo;Maybe we need an Anna Hazare to watch over drug regulators,&amp;rdquo; Biliangady said.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
When the health ministry documents indicating irregularities emerged, Sun Pharmaceutical officials said the company had fulfilled &amp;ldquo;all regulatory requirements for approval of the drug&amp;rdquo;, as was reported in The Telegraph on September 8, 2008.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
A senior drug regulator claimed that the safety studies were waived because other studies had already been done outside India on letrozole&amp;rsquo;s effectiveness to treat infertility. The regulator also said the number 100 in a clinical trial was not sacrosanct.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
Neither company officials nor drug regulators were available for comment today.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&amp;ldquo;A wrong has been undone today,&amp;rdquo; said Chandra Gulhati, the editor of the Monthly Index of Medical Specialities, India, an independent drugs journal which had first exposed the illegal promotion of letrozole for infertility in India nearly eight years ago.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
In 2005, Novartis, the original manufacturer of the compound, after discussions with a Canadian health agency, issued a cautionary note warning doctors that the use of letrozole for infertility could lead to problems in embryos or foetuses.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&amp;ldquo;There have been post-market reports of congenital anomalies in infants of mothers exposed to (letrozole) for the treatment of infertility,&amp;rdquo; the company said in its statement.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
The health ministry has not explained the circumstances that led to its decision to ban letrozole for induction of ovulation &amp;ldquo;with immediate effect&amp;rdquo;.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
An infertility specialist in Pune said she began prescribing letrozole after company officials assured doctors in 2007 it had been approved by drug regulators.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&amp;ldquo;How can doctors be expected to know what&amp;rsquo;s going on in the drug approval process?&amp;rdquo; asked Bharati Dhorepatil, the chairperson of the clinical research division of the Federation of the Obstetrics and Gynaeological Societies of India.
&lt;/div&gt;
&lt;div style=&quot;text-align: justify&quot;&gt;
&lt;br /&gt;
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The Union health ministry today banned the manufacture and sale of a drug called letrozole to treat infertility in women, four years after its own drug regulators had waived safety studies and relaxed rules to approve the medicine.





In a statement...&#039;
$disp = &#039;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;The Union health ministry today banned the manufacture and sale of a drug called letrozole to treat infertility in women, four years after its own drug regulators had waived safety studies and relaxed rules to approve the medicine.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;In a statement notifying the ban, the ministry said the drug &amp;ldquo;is likely to involve risk to human beings and safer alternatives are available&amp;rdquo;.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;The drug has been used to treat breast cancer in post-menopausal women for years in several countries, including India. The health ministry&amp;rsquo;s drug regulators approved letrozole for infertility therapy in April 2007 after an Indian company, Sun Pharmaceutical Industries, conducted clinical trials with the compound. They ignored a warning by the original manufacturer, Novartis, that said the drug should not be given to pre-menopausal women because of its health risks.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;Documents released by the health ministry in 2008, in response to queries by CPM leader Brinda Karat, have suggested that drug regulators had waived safety studies and relaxed rules so that approval was given after trials on 55 women, instead of 100 as required under rules.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;Some gynaecologists who have prescribed letrozole for infertility estimate that several thousands of women across the country may have received this medicine over the past four years. One infertility specialist said she was surprised by the ban announced today.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&amp;ldquo;This is really disturbing. Why did our drug authorities approve the medicine in the first place?&amp;rdquo; said Reeta Biliangady, clinical director of a fertility clinic in Bangalore, who estimates she has prescribed letrozole to nearly 300 women over the past four years. &amp;ldquo;Maybe we need an Anna Hazare to watch over drug regulators,&amp;rdquo; Biliangady said.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;When the health ministry documents indicating irregularities emerged, Sun Pharmaceutical officials said the company had fulfilled &amp;ldquo;all regulatory requirements for approval of the drug&amp;rdquo;, as was reported in The Telegraph on September 8, 2008.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;A senior drug regulator claimed that the safety studies were waived because other studies had already been done outside India on letrozole&amp;rsquo;s effectiveness to treat infertility. The regulator also said the number 100 in a clinical trial was not sacrosanct.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;Neither company officials nor drug regulators were available for comment today.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&amp;ldquo;A wrong has been undone today,&amp;rdquo; said Chandra Gulhati, the editor of the Monthly Index of Medical Specialities, India, an independent drugs journal which had first exposed the illegal promotion of letrozole for infertility in India nearly eight years ago.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;In 2005, Novartis, the original manufacturer of the compound, after discussions with a Canadian health agency, issued a cautionary note warning doctors that the use of letrozole for infertility could lead to problems in embryos or foetuses.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&amp;ldquo;There have been post-market reports of congenital anomalies in infants of mothers exposed to (letrozole) for the treatment of infertility,&amp;rdquo; the company said in its statement.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;The health ministry has not explained the circumstances that led to its decision to ban letrozole for induction of ovulation &amp;ldquo;with immediate effect&amp;rdquo;.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;An infertility specialist in Pune said she began prescribing letrozole after company officials assured doctors in 2007 it had been approved by drug regulators.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&amp;ldquo;How can doctors be expected to know what&amp;rsquo;s going on in the drug approval process?&amp;rdquo; asked Bharati Dhorepatil, the chairperson of the clinical research division of the Federation of the Obstetrics and Gynaeological Societies of India.&lt;/div&gt;&lt;div style=&quot;text-align: justify&quot;&gt;&lt;br /&gt;&lt;/div&gt;&#039;
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The Union health ministry today banned the manufacture and sale of a drug called letrozole to treat infertility in women, four years after its own drug regulators had waived safety studies and relaxed rules to approve the medicine.





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                <strong>Fertility drug ban after 4 years of use by GS Mudur</strong></h1>
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                <div style="text-align: justify"><br /></div><div style="text-align: justify">The Union health ministry today banned the manufacture and sale of a drug called letrozole to treat infertility in women, four years after its own drug regulators had waived safety studies and relaxed rules to approve the medicine.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">In a statement notifying the ban, the ministry said the drug &ldquo;is likely to involve risk to human beings and safer alternatives are available&rdquo;.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">The drug has been used to treat breast cancer in post-menopausal women for years in several countries, including India. The health ministry&rsquo;s drug regulators approved letrozole for infertility therapy in April 2007 after an Indian company, Sun Pharmaceutical Industries, conducted clinical trials with the compound. They ignored a warning by the original manufacturer, Novartis, that said the drug should not be given to pre-menopausal women because of its health risks.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Documents released by the health ministry in 2008, in response to queries by CPM leader Brinda Karat, have suggested that drug regulators had waived safety studies and relaxed rules so that approval was given after trials on 55 women, instead of 100 as required under rules.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Some gynaecologists who have prescribed letrozole for infertility estimate that several thousands of women across the country may have received this medicine over the past four years. One infertility specialist said she was surprised by the ban announced today.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&ldquo;This is really disturbing. Why did our drug authorities approve the medicine in the first place?&rdquo; said Reeta Biliangady, clinical director of a fertility clinic in Bangalore, who estimates she has prescribed letrozole to nearly 300 women over the past four years. &ldquo;Maybe we need an Anna Hazare to watch over drug regulators,&rdquo; Biliangady said.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">When the health ministry documents indicating irregularities emerged, Sun Pharmaceutical officials said the company had fulfilled &ldquo;all regulatory requirements for approval of the drug&rdquo;, as was reported in The Telegraph on September 8, 2008.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">A senior drug regulator claimed that the safety studies were waived because other studies had already been done outside India on letrozole&rsquo;s effectiveness to treat infertility. The regulator also said the number 100 in a clinical trial was not sacrosanct.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Neither company officials nor drug regulators were available for comment today.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&ldquo;A wrong has been undone today,&rdquo; said Chandra Gulhati, the editor of the Monthly Index of Medical Specialities, India, an independent drugs journal which had first exposed the illegal promotion of letrozole for infertility in India nearly eight years ago.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">In 2005, Novartis, the original manufacturer of the compound, after discussions with a Canadian health agency, issued a cautionary note warning doctors that the use of letrozole for infertility could lead to problems in embryos or foetuses.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&ldquo;There have been post-market reports of congenital anomalies in infants of mothers exposed to (letrozole) for the treatment of infertility,&rdquo; the company said in its statement.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">The health ministry has not explained the circumstances that led to its decision to ban letrozole for induction of ovulation &ldquo;with immediate effect&rdquo;.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">An infertility specialist in Pune said she began prescribing letrozole after company officials assured doctors in 2007 it had been approved by drug regulators.</div><div style="text-align: justify"><br /></div><div style="text-align: justify">&ldquo;How can doctors be expected to know what&rsquo;s going on in the drug approval process?&rdquo; asked Bharati Dhorepatil, the chairperson of the clinical research division of the Federation of the Obstetrics and Gynaeological Societies of India.</div><div style="text-align: justify"><br /></div>               </font>
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The Union health ministry today banned the manufacture and sale of a drug called letrozole to treat infertility in women, four years after its own drug regulators had waived safety studies and relaxed rules to approve the medicine.
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In a statement notifying the ban, the ministry said the drug &ldquo;is likely to involve risk to human beings and safer alternatives are available&rdquo;.
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The drug has been used to treat breast cancer in post-menopausal women for years in several countries, including India. The health ministry&rsquo;s drug regulators approved letrozole for infertility therapy in April 2007 after an Indian company, Sun Pharmaceutical Industries, conducted clinical trials with the compound. They ignored a warning by the original manufacturer, Novartis, that said the drug should not be given to pre-menopausal women because of its health risks.
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&ldquo;A wrong has been undone today,&rdquo; said Chandra Gulhati, the editor of the Monthly Index of Medical Specialities, India, an independent drugs journal which had first exposed the illegal promotion of letrozole for infertility in India nearly eight years ago.
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The Union health ministry today banned the manufacture and sale of a drug called letrozole to treat infertility in women, four years after its own drug regulators had waived safety studies and relaxed rules to approve the medicine.
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<div style="text-align: justify">
<br />
</div>
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&ldquo;This is really disturbing. Why did our drug authorities approve the medicine in the first place?&rdquo; said Reeta Biliangady, clinical director of a fertility clinic in Bangalore, who estimates she has prescribed letrozole to nearly 300 women over the past four years. &ldquo;Maybe we need an Anna Hazare to watch over drug regulators,&rdquo; Biliangady said.
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<div style="text-align: justify">
<br />
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When the health ministry documents indicating irregularities emerged, Sun Pharmaceutical officials said the company had fulfilled &ldquo;all regulatory requirements for approval of the drug&rdquo;, as was reported in The Telegraph on September 8, 2008.
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Neither company officials nor drug regulators were available for comment today.
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&ldquo;A wrong has been undone today,&rdquo; said Chandra Gulhati, the editor of the Monthly Index of Medical Specialities, India, an independent drugs journal which had first exposed the illegal promotion of letrozole for infertility in India nearly eight years ago.
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<br />
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The Union health ministry today banned the manufacture and sale of a drug called letrozole to treat infertility in women, four years after its own drug regulators had waived safety studies and relaxed rules to approve the medicine.





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Fertility drug ban after 4 years of use by GS Mudur

The Union health ministry today banned the manufacture and sale of a drug called letrozole to treat infertility in women, four years after its own drug regulators had waived safety studies and relaxed rules to approve the medicine. In a statement notifying the ban, the ministry said the drug “is likely to involve risk to human beings and safer alternatives are available”. The drug has been used to treat breast cancer in post-menopausal women for years in several countries, including India. The health ministry’s drug regulators approved letrozole for infertility therapy in April 2007 after an Indian company, Sun Pharmaceutical Industries, conducted clinical trials with the compound. They ignored a warning by the original manufacturer, Novartis, that said the drug should not be given to pre-menopausal women because of its health risks. Documents released by the health ministry in 2008, in response to queries by CPM leader Brinda Karat, have suggested that drug regulators had waived safety studies and relaxed rules so that approval was given after trials on 55 women, instead of 100 as required under rules. Some gynaecologists who have prescribed letrozole for infertility estimate that several thousands of women across the country may have received this medicine over the past four years. One infertility specialist said she was surprised by the ban announced today. “This is really disturbing. Why did our drug authorities approve the medicine in the first place?” said Reeta Biliangady, clinical director of a fertility clinic in Bangalore, who estimates she has prescribed letrozole to nearly 300 women over the past four years. “Maybe we need an Anna Hazare to watch over drug regulators,” Biliangady said. When the health ministry documents indicating irregularities emerged, Sun Pharmaceutical officials said the company had fulfilled “all regulatory requirements for approval of the drug”, as was reported in The Telegraph on September 8, 2008. A senior drug regulator claimed that the safety studies were waived because other studies had already been done outside India on letrozole’s effectiveness to treat infertility. The regulator also said the number 100 in a clinical trial was not sacrosanct. Neither company officials nor drug regulators were available for comment today. “A wrong has been undone today,” said Chandra Gulhati, the editor of the Monthly Index of Medical Specialities, India, an independent drugs journal which had first exposed the illegal promotion of letrozole for infertility in India nearly eight years ago. In 2005, Novartis, the original manufacturer of the compound, after discussions with a Canadian health agency, issued a cautionary note warning doctors that the use of letrozole for infertility could lead to problems in embryos or foetuses. “There have been post-market reports of congenital anomalies in infants of mothers exposed to (letrozole) for the treatment of infertility,” the company said in its statement. The health ministry has not explained the circumstances that led to its decision to ban letrozole for induction of ovulation “with immediate effect”. An infertility specialist in Pune said she began prescribing letrozole after company officials assured doctors in 2007 it had been approved by drug regulators. “How can doctors be expected to know what’s going on in the drug approval process?” asked Bharati Dhorepatil, the chairperson of the clinical research division of the Federation of the Obstetrics and Gynaeological Societies of India.