Much excitement greeted the opening of Quality Chemicals in 2007, the first manufacturer of antiretroviral (ARV) medication in East Africa, but six months later the production lines are still idle.
The spacious factory, which cost about US$38 million and covers roughly 1,115 square metres, can produce around two million ARV tablets in an eight-hour shift, but the National Drug Authority (NDA) of Uganda has not yet granted it a license to produce the life-prolonging pills.
A long inspection process required for licensing and manufacturing the drugs has caused the delay, but factory officials expect it to be granted in the very near future.
Quality Chemicals managing director Emmanuel Katongole said the cost of their ARVs would be significantly lower than the $15 per month the government paid for imported generics; he also anticipated orders from the ministries of health in neighbouring Kenya, Rwanda and Tanzania.
But until the factory gets the go-ahead from the UN World Health Organisation (WHO), and ARVs from Quality Chemicals are added to its list of recommended drugs after a WHO-NDA joint inspection, neither governments nor non-governmental organisations (NGOs) will buy.
"There is an understanding that if Quality Chemicals produces commodities of international standards, approved by the WHO at a competitive price, then the Ministry of Health will procure," said Kenya Mugisha, director of clinical and community health services for the Ministry of Health. "But they must meet general manufacturing practices."
An estimated 300,000 Ugandans need the life-prolonging medication. About 50,000 of the 106,000 people receiving ARVs in Uganda are supported by the President's Emergency Plan for AIDS Relief (PEPFAR), a worldwide initiative by the US government to combat the spread of HIV/AIDS; most of the rest obtain their ARVs via the US-based Global Fund to Fight AIDS, Tuberculosis and Malaria, in conjunction with Uganda's Ministry of Health.
PEPFAR has strict procurement regulations and procedures that must be followed before its money can be spent on ARVs from Quality Chemicals, including an inspection by the US Food and Drug Administration (FDA), a regulatory body.
"There's no reason why it shouldn't happen, it's a question of making it happen," said Permilla Bartlett, the PEPFAR coordinator in Uganda. There is no FDA inspection planned in the near future, and even after an FDA inspection, "procurement has to follow certain regulations". PEPFAR already has procurement partners, so it may be difficult for Quality Chemicals to become a supplier.
Quality Chemicals will also produce the anti-malaria medication, Lumartem, which contains artemisinin and lumefantrine but is significantly cheaper than Coartem, the WHO-recommended first-line brand containing the same ingredients.