Thursday, November 11, 2004

HIV/AIDS: generic antiretrovirals removed from list

Ranbaxy Laboratories, an Indian generic drug manufacturer, has voluntarily withdrawn seven antiretroviral drugs from the World Health Organisation's (WHO) list of approved HIV medicines.
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.
Translation ... it doesn't look like the generic version of the drugs were equivalent to the brand-name versions.

Earlier this year, WHO removed three other Ranbaxy manufactured antiretroviral drugs.

According to this, the company will be submitting studies which will prove the efficacy of the seven delisted drugs.

The "list" is the work of the WHO's "Prequalification Project".
The overall aim of this pilot project was to provide quality assessment on a selected number of pharmaceutical products that are considered for purchase by UN agencies involved in the procurement of drugs and diagnostics. (source)