[e-drug] two generic ARVs back on WHO Prequalification list

["E-Drug" <e-drug@healthnet.org>]

E-DRUG: two generic ARVs back on WHO Prequalification list
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[After all the negative news, now some good news: 2 generic ARVs are back on the WHO prequalification list, after the manufacturer redid the bio-studies. The WHO PQ website is mednet3.who.int/prequal 
The new list of prequalified ARVs is at http://mednet3.who.int/prequal/hiv/hiv_suppliers.pdf
WB]

News Release WHO/87
30 November 2004

TWO CIPLA AIDS MEDICINES BACK ON WHO PREQUALIFICATION LIST

GENERIC MANUFACTURERS CONTINUE TO UPGRADE THEIR PRACTICES

Geneva -The World Health Organization (WHO) is reinstating two
antiretrovirals manufactured by Cipla Ltd., India, in its list of
prequalified medicines. The two medicines (which are used in the treatment
of AIDS) had been delisted by WHO in May this year due to non-compliance
with international standards at the contract research organizations (CROs)
hired by Cipla to conduct bioequivalence tests on the products.

As a consequence of WHO's delisting, the manufacturer carried out new
bioequivalence studies to confirm that the two medicines are as effective
as their respective brand-name counterparts. Further WHO scientific
assessment and inspections have validated the compliance of these new
studies, including the CROs involved, with all international requirements.

Dr LEE Jong-wook, WHO Director-General, welcomed the development. "This is
good news for patients and another important step forward in our progress
towards the 3 by 5 target," he said.

The two medicines - Lamivudine 150mg tablet from Cipla Ltd, Kurkumbh,
blister pack of 10; and Lamivudine 150mg plus Zidovudine 300mg tablet,
Cipla Ltd, Vikhroli, blister pack of 10 - are widely used by patients in
developing countries.

"This shows that generic manufacturers are reacting responsibly to recent
de-listings," said Vladimir Lepakhin, Assistant Director-General for Health
Technology and Pharmaceuticals. "The prequalification process does work. As
well as a list of validated products, it is also a much-needed capacity
building effort to promote quality and safety of medicines in developing
countries."

WHO will continue rigorous assessment and monitoring of antiretrovirals and
their manufacturers to promote the safety, efficacy and quality of these
products. At the same time, the agency is counting on companies to ensure
compliance with international standards at all levels of the
prequalification process and accelerate submission of quality data to allow
for quick turnaround on assessments and listings.

A number of new antiretrovirals - including fixed-dose combinations - are
currently in the pipeline for WHO assessment.

For more information, please contact: Daniela Bagozzi in Geneva, telephone
+41 22 791 4544, mobile +41 79 475 5490, E-mail: bagozzid@who.int. All WHO
Press Releases, Fact Sheets and Features can be obtained on the WHO home
page http://www.who.int/