WHO increases list of prequalified antiretrovirals

The World Health Organization (WHO) has reinstated seven antiretroviral (ARV) medicines manufactured by Ranbaxy Laboratories, which had previously been removed from the WHO list of prequalified medicines. At the same time, three new products produced by Aurobindo Pharma have been added to the list.

The addition of 10 medicines will benefit some AIDS sufferers by increasing the choice of quality products in countries which may have only limited capacity to control and monitor medicines. Approximately 6.5m people in low- and middle-income countries need ARV therapy.

The medicines were taken off the list because WHO inspections of independent laboratories used by the manufacturer to run bioequivalence studies had revealed practices that did not conform to international standards required by WHO.

Ranbaxy commissioned different laboratories to do new tests on the products' bioequivalence with the originator medicines. Subsequently, WHO ran the full range of quality, safety and efficacy checks on the medicines as well as thorough inspections of the new laboratories. The products and laboratories were all found to be satisfactory.