The United Nations health agency is reinstating two generic AIDS antiretroviral drugs it de-listed earlier this year after the Indian manufacturer carried out new studies to confirm that the medicines, widely used in developing countries, are as effective as their brand-name counterparts.
“This is good news for patients and another important step forward in our progress towards the 3 by 5 target," World Health Organization (WHO) Director-General Lee Jong-wook said today, referring to the agency’s initiative to get 3 million people living with HIV/AIDS in developing and middle-income countries on antiretroviral treatment (ART) by the end of 2005.
The two medicines - Lamivudine 150mg tablet from Cipla Ltd, Kurkumbh and Lamivudine 150mg plus Zidovudine 300mg tablet from Cipla Ltd, Vikhroli – were removed from the international list of medicines available to developing countries because the manufacturer had not ensured they were equivalent to the original medicines they were supposed to copy.
The manufacturer carried out new bioequivalence studies, and further WHO scientific assessment and inspections have validated the compliance of these new studies. In such tests, volunteers take the generic medicines and their blood is tested after a certain time to determine whether the concentration of the generics in their blood is similar to that of the brand-name medicines in other volunteers.
"This shows that generic manufacturers are reacting responsibly to recent de-listings," said Vladimir Lepakhin, WHO Assistant Director-General for Health Technology and Pharmaceuticals. "The prequalification process does work. As well as a list of validated products, it is also a much-needed capacity building effort to promote quality and safety of medicines in developing countries."
A number of new antiretrovirals - including fixed-dose combinations - are currently in the pipeline for WHO assessment.