WHO removes three more AIDS drugs from prequalified list
A further three AIDS drugs have been removed by the WHO from the prequalified list. The antiretrovirals manufactured by Ranbaxy meet qualiy standards, but have been suspended by the WHO because the laboratory that carried out bioequivalence testing was found in a recent inspection to be non-compliant with international standards of good clinical and laboratory practices.
A further three AIDS drugs have been removed by the WHO from the prequalified list. The antiretrovirals manufactured by Ranbaxy meet qualiy standards, but have been suspended by the WHO because the laboratory that carried out bioequivalence testing was found in a recent inspection to be non-compliant with international standards of good clinical and laboratory practices.
The antiretrovirals in question are the triple fixed-dose combination pill containing lamivudine, stavudine and nevirapine in two different strengths and a lamivudine plus zidovudine tablet. They will remain off the list until Ranbaxy can submit data of new studies providing unequivocal evidence of the drugs' bioequivalence with the originator medicines.
Ranbaxy has undertaken to resubmit the products in question to a different laboratory for proof of bioequivalence. If and when those products and the laboratories are found to meet the specified requirements, WHO will reinstate them in its list of prequalified products.
The WHO is carrying out systematic inspections of contract research organisations which have done bioequivalence studies for prequalified medicines, starting with products for priority diseases. Although it is not standard procedure for prequalification assessments to include the inspection of laboratories where bioequivalence studies are done, WHO is committed to ensuring that the medicines it prequalifies for procurement in developing countries are of the highest standard.
Another inspection that took place in late May found similar non-compliance at a laboratory contracted by CIPLA to carry out bioequivalence studies of two AIDS medicines. However, another WHO inspection of a contract research organisation has found that the bioequivalence tests for the triple fixed-dose combination lamivudine, stavudine and nevirapine tablet manufactured by CIPLA were carried out properly in compliance with requested standards. This product will therefore continue to be included in the list of WHO prequalified products.