Kenyan Pharmaceutical Company Achieves WHO Quality Guarantee for Malaria Drug, Boosting Local Production in Africa

A mother holds her son while he gives blood samples to be analysed as part of a malaria vaccine trial in Junju, Kenya.

Universal Corporation Limited, a Kenyan pharmaceutical firm, has achieved a significant milestone as the first African manufacturer to receive the World Health Organization’s (WHO) quality guarantee for a crucial malaria medication. This development is seen as a positive step towards reducing Africa’s dependency on imported drugs and strengthening the region’s self-sufficiency in providing vital healthcare solutions, addressing the prevalent issue of over 70% of medicines being imported to Africa, with only six out of numerous pharmaceutical companies in the region having WHO prequalification.

Challenges to quality local drug production in Africa have included high operating costs, limited technical expertise, insufficient investment in the pharmaceutical industry, and concerns related to drug regulation and quality, as substandard or falsified antimalarials contribute to an estimated 116,000 deaths in sub-Saharan Africa annually. The WHO’s approval signifies that a company’s manufacturing processes and quality control adhere to international standards, facilitating entry into new markets and attracting key purchasers, including major donor-driven organizations. As local production and fair distribution of drugs expand, efforts to combat malaria are expected to accelerate, providing hope for the almost 80% of malaria deaths in Africa that occur among children under five. Effective prevention therapies like the newly WHO-prequalified antimalarial drug Spaq have played a vital role in protecting more than 48 million children in over a dozen Sahelian countries in Africa. While malaria vaccines have begun rolling out across the continent, access remains limited, making antimalarial drugs a crucial component of malaria control. In addition to offering improved protection for children under five when used in combination with vaccines, this development underscores the renewed urgency for Africa to enhance its local production capacity, reducing vulnerabilities exposed during the COVID-19 pandemic. Malaria experts emphasize the importance of a locally produced malaria drug, especially in Africa, where over 95% of global malaria cases and deaths occur. Measures such as the African Continental Free Trade Area and the removal of trade barriers are key to supporting the competitiveness of African malaria medicine manufacturers in the face of Indian industry competitors. With collective support from governments, procurement agencies, and stakeholders, millions of children and pregnant women in Africa could be shielded from malaria if this agenda is prioritized.