19/11/04

More doubts cast on Indian generic AIDS drugs

Generic AIDS drugs have come under increased scrutiny from the WHO recently Copyright: Olivier Dargouge

By: Priya Shetty

We encourage you to republish this article online and in print, it’s free under our creative commons attribution license, but please follow some simple guidelines:

You have to credit our authors.
You have to credit SciDev.Net — where possible include our logo with a link back to the original article.
You can simply run the first few lines of the article and then add: “Read the full article on SciDev.Net” containing a link back to the original article.
If you want to also take images published in this story you will need to confirm with the original source if you're licensed to use them.
The easiest way to get the article on your site is to embed the code below.

For more information view our media page and republishing guidelines.

The full article is available here as HTML.

Press Ctrl-C to copy

<div class="article-wrap">
<div id="article-introduction">
<h1>More doubts cast on Indian generic AIDS drugs</h1>
<h4>By: Priya Shetty</h4>
</div>
<br />
<br />

<div id="article-body">
<p><P>An Indian pharmaceutical company, Hetero Drugs, is the latest to feel the effects of World Health Organisation’s (WHO) crackdown on generic AIDS drugs that fall short of WHO standards. </P><br />
<P>Following an inspection by the WHO last week, the company is withdrawing six of its generic versions of patented AIDS drugs from the WHO’s list of approved drugs.</P><br />
<P>The drugs are being withdrawn because the laboratories used to test the drugs’ ‘bioequivalence’ with the patented version did not meet the required standards. Hetero Drugs also acknowledged that the data produced in these centres had “deficiencies”. </P><br />
<P>The WHO says that although the pharmaceutical quality of the drugs was not in doubt, the laboratories to which the research was contracted out could not be relied on to provide accurate bioequivalence data.</P><br />
<P>The organisation says patients should stop using drugs that have been taken off the WHO list and use other approved products instead — provided that alternatives are available. It stresses, however, that it would be better to continue with drugs “whose bioequivalence is not proven but which have demonstrated quality and safety” than stop treatment completely. </P><br />
<P>Last week, another Indian pharmaceutical company, Ranbaxy, withdrew ten of its generic AIDS drugs for the same reason (see <a  href="/News/index.cfm?fuseaction=readnews&itemid=1729&language=1" target=_self rel="noopener noreferrer">Indian company withdraws ten AIDS drugs</A>). Ranbaxy’s AIDS drugs are widely used in countries in Africa, Asia and Latin America, and the WHO said it would not be easy to find alternatives. <BR><BR><a  href="http://mednet3.who.int/prequal/" target="_blank" onclick="pageTracker._trackPageview('/tracking/external/'+this.href);" rel="noopener noreferrer">Click here to access the WHO list of 48 approved antiretroviral products.</A></P></p>

</div>
<div class="quick-links-wrapper">
<h3>You might also like</h3>
[related-articles]
</div>
<p>This article was originally published on <a href="https://www.scidev.net" target="_blank">SciDev.Net</a>. Read the <a href="https://www.scidev.net/global/news/more-doubts-cast-on-indian-generic-aids-drugs/" target="_blank">original article</a>.</p>
<script type="text/javascript">
(function(e,t,n,r,i,s,o){e["GoogleAnalyticsObject"]=i;e[i]=e[i]||function(){(e[i].q=e[i].q||[]).push(arguments)},e[i].l=1*new Date;s=t.createElement(n),o=t.getElementsByTagName(n)[0];s.async=1;s.src=r;o.parentNode.insertBefore(s,o)})(window,document,"script","//www.google-analytics.com/ga.js","ga");var _gaq=_gaq||[];var _gaq=_gaq||[];_gaq.push(["_setAccount","UA-3223906-8"],["_trackEvent","article interaction","republished","https://www.scidev.net/global/news/more-doubts-cast-on-indian-generic-aids-drugs/",null,true])
</script>
</div>

An Indian pharmaceutical company, Hetero Drugs, is the latest to feel the effects of World Health Organisation’s (WHO) crackdown on generic AIDS drugs that fall short of WHO standards.

Following an inspection by the WHO last week, the company is withdrawing six of its generic versions of patented AIDS drugs from the WHO’s list of approved drugs.

The drugs are being withdrawn because the laboratories used to test the drugs’ ‘bioequivalence’ with the patented version did not meet the required standards. Hetero Drugs also acknowledged that the data produced in these centres had “deficiencies”.

The WHO says that although the pharmaceutical quality of the drugs was not in doubt, the laboratories to which the research was contracted out could not be relied on to provide accurate bioequivalence data.

The organisation says patients should stop using drugs that have been taken off the WHO list and use other approved products instead — provided that alternatives are available. It stresses, however, that it would be better to continue with drugs “whose bioequivalence is not proven but which have demonstrated quality and safety” than stop treatment completely.

Last week, another Indian pharmaceutical company, Ranbaxy, withdrew ten of its generic AIDS drugs for the same reason (see Indian company withdraws ten AIDS drugs). Ranbaxy’s AIDS drugs are widely used in countries in Africa, Asia and Latin America, and the WHO said it would not be easy to find alternatives.

Click here to access the WHO list of 48 approved antiretroviral products.