Removal of generic drugs from WHO list a wake-up call

The removal of Indian-manufactured generic antiretroviral (ARV) drugs from the World Health Organisation's (WHO) list of approved HIV medicine this week should be a wake-up call for developing countries with slack regulatory authorities, experts warned.

The three drugs, made by India's Ranbaxy Laboratories, were removed following concerns raised over their biological equivalence to the patented versions.

According to WHO project manager Andre van Zyl, laboratories which had done bioequivalence studies for the approved drugs on the list were inspected "as part of WHO's ongoing monitoring process". Recent inspections revealed that a laboratory contracted by Ranbaxy did not comply with international standards.

This meant that "the medicines may or may not offer the same therapeutic benefits as the originals on which they are based," a WHO press release noted.

The non-compliant ARVs are the triple fixed-dose combination pill containing Lamivudine, Stavudine and Nevirapine in two different strengths, and a Lamivudine plus Zidovudine tablet.

Although the Ranbaxy triple combination pill was one of the recommended standard treatments for HIV-positive people, "there are similar products from different manufacturers which can be used as an alternative," van Zyl told PlusNews.

Earlier this year WHO removed two generic drugs made by Cipla, another Indian pharmaceutical company, from its approved list after an evaluation revealed similar non-compliance by a subcontracted laboratory.

Van Zyl urged developing countries with inadequate drug assessment procedures to be more cautious. "This shows that one has to be more rigorous and verify that what has been submitted by the manufacturer is what it purports to be. This is especially so when the products have a critical therapeutic outcome," he said.

While the WHO announcement was "certainly a cause for concern", the direct impact of this decision would vary from country to country, Andy Gray, senior pharmacology lecturer at the University of KwaZulu-Natal in South Africa, told PlusNews.

"If a country has its own stringent regulatory procedures, the WHO prequalification will not have a direct impact, as the data submitted to the country will be from a different source. The bioequivalence tests might have been done at a different site [from the one WHO inspected]" he added.

A bigger question was whether people currently on the Ranbaxy treatment would be allowed to continue using the drugs, Gray pointed out. Countries relying on Global AIDS Fund resources for their treatment programmes, for example, would not be able to continue using the drugs, as the Fund stipulated that only WHO-approved ARVs could be used.

Gray also questioned whether there was "truly a problem" with the drugs, or whether the removal had been "simply about paperwork".

Nevertheless, he noted, regulatory authorities in each country would have to play a greater role.