Generic anti-AIDS drugs withdrawn from WHO list

In a move that could affect HIV-positive people on treatment in developing countries, an Indian generic drug manufacturer voluntarily withdrew its drugs from the World Health Organisation's (WHO) list of approved HIV medicines.

The seven antiretroviral (ARV) drugs made by Ranbaxy Laboratories were removed after the company "found discrepancies" in documents proving their biological equivalence to the patented versions, a WHO statement said. In August this year, WHO withdrew three other drugs made by the company for the same reason.

The impact of Ranbaxy's decision on African countries embarking on treatment initiatives remains unclear.

"Of course, we are worried about the disruption of ARV programmes, particularly in developing countries - many have already ordered large quantities of drugs," WHO spokeswoman Daniela Bagozzi told PlusNews.

However, this did not mean there were "any real problems" with the drugs in terms of safety. The problem was that the medicines "may or may not offer the same therapeutic benefits" as the originals on which they were based, she noted.

WHO has advised that patients on treatment should discontinue using the de-listed drugs, but recommended that when alternative quality-controlled treatment could not be immediately found, patients should continue on the drug regimen, as interrupting treatment was "more dangerous".

According to Bagozzi, the WHO delisting did not bind countries to ban the Ranbaxy products. It was up to individual countries and their drug regulatory authorities to decide whether to continue using the drugs or not.

But countries relying on Global AIDS Fund resources for their treatment programmes would not be able to continue using the drugs, as the Fund has stipulated that only WHO-approved ARVs were to be used.

African treatment programmes funded by the Global Fund and using Ranbaxy drugs are: Benin, Central African Republic, Cote d'Ivoire, Malawi and Swaziland.

"Of all the HIV/AIDS grants we've given out, we estimate that about 10 countries are currently using Ranbaxy products," Global Fund spokesman Tim Clark, told PlusNews.

Meanwhile, Ranbaxy's announcement was unlikely to have "much of an impact" on Medecins Sans Frontieres' (MSF) treatment project in South Africa, as the initiative only used two of their drugs, and these could easily be replaced, Marta Darder, the MSF coordinator for access to essential medicines, told PlusNews.

For more information on the practical implications of the withdrawal of the Ranbaxy drugs from the WHO list:
http://mednet3.who.int/