An Indian pharmaceutical company, Hetero Drugs, is the latest to feel the effects of World Health Organisation's (WHO) crackdown on generic AIDS drugs that fall short of WHO standards.
Following an inspection by the WHO last week, the company is withdrawing six of its generic versions of patented AIDS drugs from the WHO's list of approved drugs.
The drugs are being withdrawn because the laboratories used to test the drugs' 'bioequivalence' with the patented version did not meet the required standards. Hetero Drugs also acknowledged that the data produced in these centres had "deficiencies".
The WHO says that although the pharmaceutical quality of the drugs was not in doubt, the laboratories to which the research was contracted out could not be relied on to provide accurate bioequivalence data.
The organisation says patients should stop using drugs that have been taken off the WHO list and use other approved products instead — provided that alternatives are available. It stresses, however, that it would be better to continue with drugs "whose bioequivalence is not proven but which have demonstrated quality and safety" than stop treatment completely.
Last week, another Indian pharmaceutical company, Ranbaxy, withdrew ten of its generic AIDS drugs for the same reason (see Indian company withdraws ten AIDS drugs). Ranbaxy's AIDS drugs are widely used in countries in Africa, Asia and Latin America, and the WHO said it would not be easy to find alternatives.
Click here to access the WHO list of 48 approved antiretroviral products.