According to the World Health Organisation (WHO), more than 50 million women in Africa become pregnant each year and are at risk of one of the deadliest malaria parasites globally. Presently, Africa is still completely reliant on imported drugs to treat malaria but that could soon change.
The UN health agency recently issued a quality certification to the first African manufacturer of a key antimalarial drug used to prevent infection in pregnant women and children.
Sulfadoxine/pyrimethamine (SP) is a well-tolerated, effective and affordable medicine used to prevent malaria in pregnant women and infants
The certification will enable Kenyan manufacturer Universal Corporation Ltd, (UCL) to mass produce SP. UCL’s pre-qualification was achieved with funding from the global health agency Unitaid and support from the Switzerland-based health non-profit, Medicines for Malaria Venture (MMV)
This breakthrough responds to the need for local production of quality medicines for use in Africa, a major gap that was critically highlighted when the COVID-19 pandemic left the continent with limited access to vital health products in 2020.
Pre-qualification is a service provided by WHO to assess the quality, safety, and efficacy of medicinal products. Quality assurance of UCL’s SP product opens a route for procurement by global scale-up partners that will improve access and help strengthen Africa’s ability to combat endemic diseases.
“Unitaid welcomes the certification of UCL to produce this quality-assured antimalarial medicine in Africa, where about 95 percent of all illness and death from malaria occurs. Reinforcing local production of medicines where they are needed most is critical to building stronger and more resilient health responses,” said Dr. Philippe Duneton, Executive Director of Unitaid.
Young children and pregnant women are among the most vulnerable to the burden of malaria, with children under five accounting for 80 percent of all malaria deaths in Africa. SP is a generally well-tolerated, effective, and affordable medicine used to prevent malaria, yet adequate delivery and scale-up of these interventions are hampered in part by inadequate and unstable supply and, until now, have completely relied on imported or poor-quality drugs.
“Researchers and manufacturers from the countries hardest hit by malaria must be at the forefront of efforts to defeat the disease, which is why we welcome this wonderful news,” said David Reddy, MMV’s CEO. “We congratulate Universal Corporation Ltd for becoming the first African manufacturer to receive WHO pre-qualification for SP for the prevention of malaria in pregnant women and infants and are delighted to have partnered with them in this effort.”