Removal of Antiretroviral Products from WHO Prequalification
11 November 2004 ¦ Department of Essential Drugs and Medicines Policy; Department of HIV/AIDS
Ranbaxy's voluntary withdrawal follows this year's removal by WHO of three other antiretroviral medicines manufactured by Ranbaxy and two antiretroviral medicines manufactured by Cipla, from the list of prequalified products. WHO removed these medicines from the list after inspections at the CROs (Contract Research Organizations) which conducted bioequivalence studies revealed serious discrepancies between the original results compiled by the CROs and the results presented to WHO, and non-compliance with international guidelines on Good Clinical Practices and Good Laboratory Practices.
Following the removal of these products from the list, WHO sent a warning letter to all manufacturers of HIV/AIDS medicines participating in the prequalification project (letter to all manufacturers). The letter urged companies to verify the data they had submitted to WHO, as well as compliance with Good Clinical Practices and Good Laboratory Practices at the sites where bioequivalence studies had been conducted.