The World Health Organization (WHO) has reinstated two antiretrovirals manufactured by Cipla Ltd., India, in its list of
prequalified medicines. The two medicines had been delisted by WHO in May this year due to non-compliance with international standards found at the contract research organisations (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 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.
The two medicines - the lamivudine 150mg tablet from Cipla Ltd, blister pack of 10; and lamivudine 150mg plus zidovudine 300mg tablet, Cipla Ltd, 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. "
Two other companies - Hetero and Ranbaxy - have withdrawn products from the prequalification list as a result of contract research organisation inspections and are currently carrying out new bioequivalence studies.
A number of new antiretrovirals - including fixed-dose combinations – are currently in the pipeline for WHO assessment.