10 March 2010

Uganda: WHO Approves Luzira HIV Drug Factory

Kampala — The World Health Organisation (WHO) has finally approved the antiretroviral drugs manufactured in Kampala by Quality Chemicals Industries, a local pharmaceutical giant.

This means the company can produce for export and can benefit from contracts involving donor money. WHO only wants some minor details sorted out with the anti-malaria drugs produced by the same Luzira-based factory. "We inspected the industry in January and the preliminary report on compliancy with international drug production requirements stands at 75%," said Dr. Joaquim Saweka, the WHO country representative.

"For ARVs, they are pre-qualified to manufacture. We still have some details with Artemisinin-combined therapies before final signatures are appended." A source at Quality Chemicals said they were gearing up for mass production after WHO certified them.

The Ministry of Health had been pushing hard for this certification without which the drugs could not be accepted in the international market. Saweka congratulated Uganda on the pre-qualification step, saying with the experts' nod, the country now has the potential to not only supply its public but also the region.

"Once you are pre-qualified, you are internationally accepted. Global bodies like the Global Fund, Malaria Medicines Ventures, the US President's Emergency Plan for Aids Relief, and Medicines Sans Frontiers can buy drugs from you," he said. He explained that the process of certifying is long and critical. "The quality of drugs is not negotiable. They are life. However, my team tried to expedite the process."

The process, undertaken by an international committee, involves assessing the quality of the raw materials used, the production environment, the human resources and the packaging. President Yoweri Museveni inaugurated the sh60b hi-tech factory in Luzira in October 2007.

The factory, set up to manufacture ARVs and ant-malaria drugs, had already been locally licensed by the National Drug Authority and was supplying drugs to the local market. It becomes the first plant in sub-Saharan Africa approved by WHO outside South Africa. Its production is expected to reduce the monthly cost of ARVs from sh30,000 to sh16,000.

Sub-Saharan Africa is the region with the highest malaria infection rate, killing at least one million people each year. It is also the region with the highest number of HIV patients. By the end of 2008, an estimated 22 million adults and children on the continent were living with HIV. During that year, some 1.4 million Africans died from AIDS.

However, the drugs to prevent or treat these diseases were produced largely outside Africa, by large pharmaceutical companies in industrialised countries, at a high cost. With local production, it is expected that more people in Uganda and the region will access treatment at a low cost.

Quality Chemicals intends to export to neighbouring Kenya, Burundi, Rwanda, Tanzania, the Democratic Republic of Congo and Sudan.

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