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Ranbaxy withdraws all its antiretroviral medicines from WHO prequalification

Ranbaxy Laboratories Limited India has informed the World Health Organization (WHO) that it is 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. The company has already presented WHO with a plan indicating proposed dates for the submission of new study reports for these products. The first study is expected to be completed by December 2004.

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).

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.

In principle, patients should suspend the use of de-listed medicines and switch to other prequalified products. However, in many cases it will be difficult to find alternative prequalified products immediately. In this situation it is recommended that patients continue the use of de-listed products, as the risk of withholding treatment is higher than that of providing medicines whose bioequivalence is not proven but which have otherwise been prequalified. A switch to non-prequalified products is not recommended as their quality has not been documented by WHO.

Information on the practical implications of the withdrawal of the above-mentioned products from the list of prequalified products for treatment programmes can be accessed on the WHO prequalification project web site, where the list of alternative products prequalified by WHO may also be found. There currently remain 89 products on the WHO prequalified list, 54 of which are antiretrovirals for the treatment of HIV/AIDS.

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For more information contact:

Ms Daniela Bagozzi
Telephone: +41 22 791 4544
Mobile phone: +41 79 4755490
E-mail: bagozzid@who.int