Kenyan manufacturer Universal Corporation LTD (UCL) has become the first African manufacturer to be issued a World Health Organization quality certification of a key antimalarial drug used to prevent infection in pregnant women and children. 

This certification, known as prequalification, will enable UCL to support regional efforts to combat malaria through local production of high-quality sulfadoxine-pyrimethamine (SP).  

Prequalification is a service provided by WHO to assess the quality, safety and efficacy of medicinal products. Quality assurance of UCL’s SP product Wiwal opens a route for procurement that will improve access and help strengthen Africa’s ability to combat endemic diseases.

Young children and women are among the most vulnerable to the burden of malaria, with children under five accounting for 80% 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 this medicine is hampered in part by inadequate and unstable supply and, until now, a reliance on imported or poor-quality drugs.

Its prequalification was achieved with funding from global health agency Unitaid and support from the Medicines for Malaria Venture (MMV). 

“Unitaid welcomes the certification of UCL to produce this quality-assured antimalarial medicine in Africa, where about 95% of all illness and death from malaria occurs,” said Dr Philippe Duneton, Executive Director of Unitaid.

Reinforcing local production of medicines where they are needed most is critical to building stronger and more resilient health responses.”

Disproportionate impact of malaria in Africa 

According to the latest World Malaria Report, released in 2021, there were an estimated 241 million cases of malaria and 627,000 resulting deaths worldwide in 2020.

This represented about 14 million more cases in 2020 compared to 2019, and 69,000 more deaths. Approximately two-thirds of these additional deaths (47,000) were linked to disruptions in the provision of malaria prevention, diagnosis and treatment caused by the COVID-19 pandemic.

The WHO African Region continues to carry a disproportionately high share of the global malaria burden. 

Global health leaders praised the prequalification announcement, calling it “excellent news” to those disproportionately impacted by malaria. 

“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,” said Joy Phumaphi, Executive Secretary of the African Leaders Malaria Alliance and MMV Board member.

Lack of prequalified manufacturers raises concerns 

The lack of prequalified 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. 

Prequalification itself can be a long process, averaging 17 months in the process to reach product approval. 

UCL Founder and Managing Director Perviz Dhanani noted that in addition to being the first pharmaceutical company in Africa to receive prequalification for SP, it is also one of five manufacturers in Africa to receive quality certification for any product.

It is clear that the production of quality medicines on the African continent is critical not only for the safety of Africa’s people but also for supporting regional supply availability and diversification in global production of medicines.

“UCL is committed to supplying the African continent with quality medicines that are most needed by the people who live here. We’re filling a much-needed gap,” said Dhanani.

Increased supply of SP is crucial to the long-term success of Unitaid’s malaria 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. 

MMV is also working with Unitaid funding to support quality medicines critical to the malaria response. 

“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.

Image Credits: WHO, Elizabeth Poll/MMV, Munira Ismail_MSH.