Three generic HIV/AIDS medicines have been removed from the international list of medicines available to developing countries because the manufacturer had not ensured the drugs were equivalent to the original medicines they were supposed to copy, the United Nations health agency said today.
In bioequivalence 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 innovator or patented medicines in other volunteers.
After an inspection of Ranbaxy Laboratories Ltd. in Dewas, India, the UN World Health Organization (WHO) removed "the triple fixed-dose combination pill containing lamivudine, stavudine and nevirapine in two different strengths and a lamivudine plus zidovudine tablet" until the company can provide "unequivocal evidence" of bioequivalence.
WHO was following a European directive, which came into force in May, requiring inspections of laboratories doing bioequivalence studies.
The Ranbaxy products have met quality specifications and WHO said the company would submit them to a different laboratory for new tests.
An inspection in late May led to the removal of a lamivudine tablet made by Cipla Ltd. in Kurkumbh, India, and a combination lamivudine-zidovudine tablet made by Cipla in Vikhroli, India, WHO said.
Tests of Cipla's triple fixed-dose combination of lamivudine, stavudine and nevirapine in a tablet were properly carried out, however, and it was retained.