Universal Corporation Ltd., a Kenyan pharmaceutical company, becomes the first African manufacturer to get prequalification from the World Health Organization for a key antimalarial drug. Experts say this will help expand the drug’s supplier base, ensure quality, and add to the drug’s security of supply on the continent.
WHO prequalification assures the anti-malarial drug sulfadoxine-pyrimethamine, or SP, manufactured by Universal Corporation Ltd. is safe, efficacious, and of high quality.
The drug is used to help prevent malaria infection among children and pregnant people, who are among those at high risk of infection. According to the 2021 World Malaria Report, the WHO Africa region accounted for about 95% of all malaria cases and 96% of all malaria deaths globally — 80% of deaths due to the disease in the region are among children under 5. Meanwhile, out of the estimated 33.8 million pregnancies in 33 countries with moderate and high malaria transmission in the region, 34% or 11.6 million were exposed to the infection during pregnancy.
The drug is used in several malaria prevention intervention campaigns. It is used to prevent infection among children under 5 in areas of high risk of seasonal malaria in the Sahel. It is also used to prevent infection among infants and children, and among pregnant people in malaria-endemic areas.
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Ghana, Kenya, and Malawi are the only countries that can apply for the first round.
Unitaid spokesperson Hervé Verhoosel told Devex over email that for the drug, “price was not the main barrier we are addressing, as it has traditionally been cheap and accessible.” Instead, most of the challenges in the delivery and scale-up of malaria prevention interventions have to do with inadequate and unstable drug supply and reliance on imported or poor-quality drugs.
WHO prequalification helps address these issues, as it not only guarantees drug quality but also now the supply of the drug could come from the continent where it is most needed.
Reliance on drug imports poses supply risks for the continent, which became apparent during the COVID-19 pandemic. The crisis highlighted the need for the continent to boost its own drug manufacturing capabilities.
Following WHO prequalification, however, countries will need to adopt the product and funding will be needed for its procurement.
“The time needed to bring change will depend on the speed of country adoption of the intervention and availability of funding,” Verhoosel said.
Update, Sept. 1, 2022: This article has been updated to reflect that this is the first time an African manufacturer of sulfadoxine-pyrimethamine received a WHO prequalification.