A quality pre-qualification has been isued by The World Health Organisation, WHO, to the first African manufacturer of a key antimalarial drug used to prevent infection in pregnant women and children.
This certification will enable Kenyan manufacturer Universal Corporation Ltd (UCL) to support regional efforts to combat malaria through local production of high-quality sulfadoxine-pyrimethamine (SP).
The pre-qualification was achieved with funding from global health agency Unitaid and support from MMV.
Pre-qualification is a service provided by WHO to assess the quality, safety and efficacy of medicinal products. The quality assurance of UCL’s SP product Wiwal® opens a route for procurement by global scale-up partners that will improve access and help strengthen Africa’s ability to combat endemic diseases.
Dr Philippe Duneton, Executive Director of Unitaid, stated, “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.”
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.
Clinically, 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.
According to Perviz Dhanani, Founder/MD of UCL, “UCL is committed to supplying the African continent with quality medicines that are most needed by the people who live here. We are not only the first pharmaceutical company to receive pre-qualification of sulfadoxine-pyrimethamine in Africa, but one of only five manufacturers in Africa to have received this quality certification for any product. We’re filling a much-needed gap.”
The lack of pre-qualified manufacturers in Africa raises concerns about the quality of medicines and supply insecurities that compromise the treatment of chronic and infectious diseases – risks that were clearly revealed when COVID-19 disrupted global supply chains and left Africa with limited access to vital products.
Increased supply of SP is crucial to the long-term success of Unitaid’s malaria chemoprevention strategy, which includes nearly US$ 160 million invested to date to optimize and scale up delivery of SP through seasonal delivery and intermittent preventive treatment in pregnant women and infants. With Unitaid funding, MMV is working to strengthen global supply chains and support appropriate use of quality medicines critical to the malaria response.
The news of Universal Corporation Ltd receiving a WHO Prequalification for sulfadoxine-pyrimethamine is incredible news,” said Ms Joy Phumaphi, Executive Secretary of the African Leaders Malaria Alliance and MMV Board member. “Ensuring the availability and accessibility of quality treatment for underserved communities, particularly women, newborns, and children who are disproportionately at high risk of death from malaria is a critical component to the full realization of the right to health.”
