23 August 2001
Kampala — The Ugandan pharmaceutical industry is locked in a battle with authorities after its bid for permission to manufacture generic anti-HIV medication earlier this month was rejected as premature.
The health ministry says that while the industry may have the technology, issues of quality have to be addressed before the bid can be considered.
Among drugs the local companies propose to manufacture is the generic version of Combivir, which contains AZT and 3TC in a single pill.
The combination boosts the immune systems of those infected with the HIV virus.
"The threat of poor standards and counterfeits is too real to be ignored," said an official with the National Drug Authority.
The manufacturers argue that producing the generics would make them affordable to more than a million HIV-positive Ugandans who cannot afford the HIV/AIDS drugs on the market.
Their request came after Mulago Hospital said a batch of Nevirapine, imported for prescription to HIV-positive expecting mothers, was approaching its expiry date without being used as few Ugandans could afford the $170 charge for a monthly dose.
"It may be true that they have the production lines but you cannot ignore the reality; that even producing the correct weight of vitamin supplements is a problem for some of these manufacturers," said the official.
Authorities fear that such variations in quality could lead to the emergence of resistant strains in a short time, making years of research redundant.
The pharmaceutical companies suspect that in denying them licences, Uganda is bending to threats by global drug manufacturers who own the patents.
They have the support of advocacy groups for people living with HIV who see cost as a major obstacle to access. The local industry says Uganda should follow India, Brazil and Thailand, who produce generics without the consent of patent holders.
In a letter to the Ugandan government, GlaxoSmithKline warned that importing generics made by Cipla Pharmaceuticals of India, which compete with drugs it sells in some African countries, would be an infringement of patent rights.
Price cuts in December by GlaxoSmithKline and German pharmaceutical giant Boerhinger Ingelheim on some drugs sold in Uganda have not led to a significant increase in the number of people accessing them.
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