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.