World Health Organization on Thursday said that three AIDS drug manufactured by Ranbaxy Lab would be removed from its list of prequalified products for being non-compliant with international standards of good clinical and laboratory practices.
WHO in a press release posted on its website said the ban would remain in vogue till such time as Ranbaxy is able to submit data of new studies providing unequivocal evidence of the antiretrovirals ' bioequivalence with the originator medicines.
Although it is not standard procedure for prequalification assessments to include the inspection of laboratories where bioequivalence studies are done, WHO is committed to ensuring that the medicines it prequalifies for procurement in developing countries are of the highest standard, the release said.
The Ranbaxy antiretrovirals are the triple fixed-dose combination pill containing lamivudine, stavudine and nevirapine in two different strengths and a lamivudine plus zidovudine tablet.
In late May, WHO had excluded two generic antiretroviral drugs manufactured by Cipla from its list of approved HIV medicines used more often in poor countries, saying a routine check found that the manufacturer had not proved they were biologically equivalent to the patented drugs. But later the apex organisation found the bioequivalence tests for triple fixed-dose combination lamivudine, stavudine and nevirapine tablet manufactured by Cipla were carried out properly in compliance with requested standards.
This product therefore continues to be included in the list.
Bioequivalence tests are conducted in volunteers whose blood is tested after receiving the test medicines, to determine whether the concentration of the test medicine (generic medicine) is similar to that of the innovator or patented medicine.
