Ranbaxy Laboratories Limited India has informed the World Health Organization (WHO) that it was voluntarily withdrawing all its antiretrovirals (all the product dossiers under assessment and all prequalified products) from WHO prequalification.
This action was taken after the company found discrepancies in the documentation relating to proof of the products' bioequivalence with originator medicines, WHO said in a release.
The seven prequalified medicines Ranbaxy is withdrawing are: Indinavir 400 mg capsule, blister (60, 100); Lamivudine 150 mg tablet, blister (60, 100); Lamivudine/Stavudine 150 mg/40 mg tablet, Al strip (10), 60 in box; Lamivudine/Stavudine 150 mg/30 mg tablet, Al strip (10), 60 in box; Nevirapine 200 mg tablet, blister (60, 100); Stavudine 30 mg capsule, Al strip (10), 60 in box; Zidovudine 300 mg tablet, blister (60, 100).
WHO said that 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 Contract Research Organizations (CROs) 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. 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, the release added.