The first African manufacturer to receive approval from the World Health Organization for a malaria medication is Kenya.

Universal Corporation Limited, a pharmaceutical company based in Kenya, has recently achieved a significant milestone by becoming the first manufacturer in Africa to obtain approval from the World Health Organization (WHO) for the production of a crucial malaria treatment.

The antimalarial drug, sulfadoxine-pyrimethamine plus amodiaquine (Spaq), is frequently used to prevent seasonal malaria in children during months of peak transmission periods such as rainy seasons. Previously, demand for drugs such as Spaq in Africa has been met through the importation of generic versions of the medicine from India and China.

Perviz Dhanani, the managing director of Universal Corporation Limited, stated that the WHO pre-qualification is a major milestone in decreasing dependence on imported medications and enhancing Africa’s ability to independently provide necessary healthcare solutions.

Over 70% of medications utilized in Africa are brought in, with only six out of hundreds of pharmaceutical companies in Africa meeting the standards for WHO “prequalification.”

Some of the barriers to quality local production of drugs include high operation costs, inadequate technical expertise, lack of investment in the pharmaceutical industry, and drug regulation and quality issues. Falsified or substandard antimalarials are estimated to cause up to 116,000 deaths in sub-Saharan Africa every year.

Revised: Being approved by the WHO can help pharmaceutical companies enter new markets and attract major buyers, such as donor organizations, by demonstrating compliance with international standards in manufacturing and quality control.

The anti-malaria research group Medicines for Malaria Venture (MMV) stated that producing drugs locally and distributing them fairly will help accelerate the elimination of malaria. Although the number of malaria cases in Africa has been decreasing over the last 20 years, funding for the disease has remained stagnant due to donor fatigue. This has raised concerns among health experts that progress made may be reversed.

Dr. André-Marie Tchouatieu, the director of access and product management at MMV, stated that drugs such as Spaq, which are cost-effective, are crucial in the fight against malaria. These drugs not only make treatment more accessible but also promote self-reliance in controlling malaria, reducing our dependence on outside assistance. This allows us to allocate resources strategically to strengthen our comprehensive approach in combating this destructive illness.

Malaria organizations report that in the Sahel region of Africa, preventative treatments like Spaq were successful in providing protection to over 48 million children last year, who make up nearly 80% of malaria-related deaths in Africa.

While malaria vaccines like RTS,S/AS01 are being distributed gradually throughout the continent, access remains restricted and antimalarial drugs continue to be heavily utilized. Certain research indicates that utilizing both Spaq and vaccines provides greater protection for children under the age of five compared to using only one method.

In recent times, there has been a growing sense of urgency in Africa to increase its local production capabilities. This has been prompted by disruptions in distribution and protectionist measures surrounding vaccines during the Covid pandemic, which have revealed the continent’s vulnerabilities. Experts on malaria have emphasized the importance of developing a drug that can be readily available in Africa, as the region accounts for over 95% of global malaria cases and deaths.

Pierre Hugo, director of access at MMV, stated that the goal is to guarantee a secure supply. Last year, the organization entered into a memorandum of understanding with the Africa Centres for Disease to assist African antimalarial drug producers in meeting the quality standards set by the WHO.

MMV and the Africa Centers for Disease Control and Prevention (Africa CDC) have advocated for the adoption of free trade agreements, such as the African Continental Free Trade Area, in African countries. This would enable the trade of manufactured medicines within the region without being subject to tariffs. According to experts, African producers of malaria medicine face competition from large-scale manufacturers in India, and the elimination of trade barriers could significantly impact their manufacturing efforts.

Joy Phumaphi, the executive secretary of the African Leaders Malaria Alliance, stated: “With the support and prioritization of this agenda by governments, procurement agencies, and other stakeholders, millions of children and pregnant women in Africa could be shielded from malaria.”


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