South Africa's delayed registration of antiretrovirals keeping cheaper drugs off the market

9 March 2010

Delays by South Africa's pharmaceutical regulators in registering antiretrovirals (ARVs) may keep cheaper, more patient-friendly drugs out of reach as the country prepares to launch the world's largest tender for medicines to treat HIV/AIDS, comments the United Nation's IRIN news service.

In a letter to Health Minister Aaron Motsoaledi, the South African HIV Clinicians Society called on the country's Medicines Control Council (MCC), to fast-track the approval of certain ARVs, the generic versions of others and fixed-dose ARV combinations that combine multiple ARVs into a single pill.

The new ARV tender will allow pharmaceutical companies to bid for supplying the biggest HIV treatment program in the world, but drugs without MCC approval are unlikely to be included in the tender process. Many activists have said that excluding these as yet unapproved drugs will lead to fewer companies applying for the tender and push up prices, while also depriving patients of fixed-dose combination therapy.

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