KENYA—Universal Corporation Limited (UCL), a Kenyan pharmaceutical company, has achieved a significant milestone as it becomes the first in Africa to receive certification from the World Health Organization (WHO) for the production of a life-saving malaria treatment.
As a result, UCL has been granted permission to manufacture sulfadoxine-pyrimethamine with amodiaquine (Spaq), a crucial antimalarial medication.
Spaq is frequently administered to combat seasonal malaria in children, especially during peak transmission periods such as rainy seasons.
Research studies have shown that combining Spaq with immunizations offers superior protection for children under the age of five compared to relying solely on a single intervention.
Notably, falsified or substandard antimalarials are estimated to be responsible for up to 116,000 deaths in Sub-Saharan Africa annually.
Alarmingly, children under the age of five account for approximately 80% of all malaria-related fatalities in Africa. Malaria organizations assert that preventive medications like Spaq effectively shielded over 48 million children in more than a dozen countries within Africa’s Sahel region last year.
The WHO has reported that over 70% of medicinal products used in Africa are imported, with only six of Africa’s numerous pharmaceutical enterprises achieving WHO prequalification.
Previously, importing generic versions from India and China met Africa’s demand for pharmaceuticals like Spaq.
Despite the rollout of malaria vaccines, such as RTS and AS01, across the continent, access remains limited, and antimalarial drugs continue to be relied upon.
Analysts argue that African malaria drug manufacturers must compete with their Indian counterparts, who produce such drugs on a large scale.
The removal of trade restrictions can be a decisive factor in either boosting or hindering production efforts.
Organizations like Medicines for Malaria Venture (MMV) and the Africa CDC advocate for implementing free trade agreements, such as the African Continental Free Trade Area, to enable the seamless trade of manufactured medications throughout the continent.
Joy Phumaphi, executive secretary of the African Leaders Malaria Alliance, emphasized that with the support and prioritization of this agenda by governments, procurement agencies, and other stakeholders, millions of African children and pregnant women can be shielded from malaria.
While the number of malaria cases in Africa has gradually declined over the past two decades, funding for the disease has stagnated recently due to donor fatigue, raising concerns that progress could be reversed.
High operating costs, a shortage of technical expertise, insufficient investment in the pharmaceutical sector, and challenges related to drug regulation and quality control pose significant obstacles to local medication production.
This WHO approval, which indicates that a company’s manufacturing processes and quality control meet international standards, can assist pharmaceutical companies in accessing new markets and attracting major buyers, including donor-driven organizations.
Perviz Dhanani, managing director of Universal Corporation Limited, underscored the critical role of WHO prequalification in reducing reliance on imported medications and enhancing Africa’s self-sufficiency in delivering vital healthcare solutions.
On his part, Pierre Hugo, director of access at MMV, highlighted that this approval ensures a secure supply, especially after MMV entered into a memorandum of understanding with the Africa Centres for Disease to help African antimalarial drug manufacturers meet WHO quality standards.
In light of disruptions in distribution and vaccine protectionism during the COVID-19 pandemic, there has been a renewed emphasis on increasing domestic manufacturing capacity in Africa.
Dr. André-Marie Tchouatieu, director of access and product management at MMV, asserted that “the production of cost-effective drugs like Spaq is nothing short of a lifeline in the battle against malaria.”
He added that affordability will not only enhance accessibility but also foster self-sufficiency in malaria management, reducing the dependence on foreign aid and allowing Africa to allocate resources more effectively in the fight against this devastating disease.
Malaria experts stress the need for a locally available solution given that Africa accounts for over 95% of global malaria incidence and fatalities.
With this approval, the anti-malaria research organization Medicines for Malaria Venture (MMV) believes local drug manufacturing and equitable distribution can significantly accelerate efforts to eliminate malaria.