Une bonne nouvelle: 2 produits de Cipla, Lamivudine 150mg et Lamivudine
150mg+Zidovudine 300mg, sont de retour sur la liste des produits
préqualifiés.
Ils avaient été retirés en mai dernier parce que la méthode utilisée
pour effectuer les tests de bioéquivalence par l'organisation que Cipla
avait employée ne correspondaient pas aux standards internationaux sur
lesquels se base l'OMS.
De nouvelles études de bioéquivalence ont été conduites et ont
confirmées que les deux produits sont aussi efficace que les produits
de marque équivalents.
GK
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WHO statement
EMBARGO 1300 Geneva time 1200 GMT
TWO CIPLA AIDS MEDICINES BACK ON WHO
PREQUALIFICATION LIST
GENERIC MANUFACTURERS CONTINUE TO UPGRADE THEIR PRACTICES
30 November 2004 — 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 equally
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.