Call for tougher HIV drug tests

A leading purchaser of medicines for the developing world yesterday called for tougher quality control inspections, to ensure that the growing international volume and diversity of HIV drugs met high standards.

Anil Soni, head of the Clinton Foundation, which will buy about $85m in antiretroviral therapies this year with donor support, said a loophole should be closed to ensure that drugs are regularly tested instead of only being systematically examined at the time of initial regulatory approval.

His comments came at a time of heightened attention to drug quality, after the US Department of Justice filed a motion alleging that Ranbaxy, the Indian generic drug manufacturer, had fabricated data and produced adulterated products including antiretrovirals purchased by the US for use in the developing world.

Shares have continued to slide at Ranbaxy, which has filed a response vigorously rejecting the department's claims, pledged its full co-operation with investigators and stressed that its own tests had found no evidence of fabricated data.

Denis Broun, head of the United Nations' Aids Programme in India, said: "Ranbaxy is one of the main suppliers of ARV for the National AIDS control programme. Their drugs have always been found of adequate quality."

Mr Soni would not comment on the Ranbaxy case, but said in general terms: "Quality control is not currently as consistent as we would like. We encourage and applaud efforts to ensure high quality levels."

The Clinton Foundation conducts its own tests on the drugs it buys, and has not identified any safety problems. But staff are concerned there are no common standards to conduct such testing on the estimated $1bn in HIV medicine purchases of drugs once they have been approved by the World Health Organisation or established regulators.

Steen Stottrup, interim head of pharmaceuticals procurement for the UN-backed Global Fund to fight Aids, TB and Malaria, one of the largest multilateral donors supporting HIV medicine purchases, said his organisation's board was set to discuss a review of quality assurance at its next meeting in November.

He said that countries it funded which bought antiretrovirals agreed to conduct quality tests, but that the Global Fund did not monitor whether they met their pledges or the results.

He said the Global Fund did its own testing on 25 different antiretroviral brands that it funded but which had not been approved by regulators, and had not identified any problems.