Kenya manufacturer is first in Africa to get WHO approval for malaria drug

A Kenyan pharmaceutical company, Universal Corporation Limited, has become the first manufacturer in Africa to receive World Health Organization (WHO) approval to produce a lifesaving malaria drug.

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.

“This WHO pre-qualification is a significant step toward reducing the over-reliance on imported drugs and strengthening Africa’s self-sufficiency in providing essential healthcare solutions,” said Perviz Dhanani, managing director at Universal Corporation Limited.

More than 70% of drugs used in Africa are imported, and only six out of hundreds of pharmaceutical companies in Africa are WHO “prequalified”.

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.

Approval from WHO, indicating that a company’s manufacturing processes and quality control meet international standards, can make it easier for pharmaceutical companies to enter new markets and attract the biggest buyers of such treatments, including large donor-driven organisations.

Local production and equitable distribution of drugs will speed up efforts to eliminate malaria, said the anti-malaria research group Medicines for Malaria Venture (MMV). While the number of people living with malaria in Africa has decreased steadily over the past two decades, funding for the disease has plateaued in recent years amid donor fatigue, prompting concern among health experts that progress may be reversed.

“Cost-effective drugs like Spaq are nothing short of a lifeline in the battle against malaria,” said Dr André-Marie Tchouatieu, director of access and product management at MMV. “Their affordability not only increases accessibility but also fosters self-sufficiency in malaria control, reducing our reliance on external aid. This, in turn, empowers us to strategically allocate resources to bolster our comprehensive approach to fighting this devastating disease.”

Children under five account for almost 80% of malaria deaths in Africa, and malaria organisations say prevention therapies such as Spaq offered effective protection to more than 48 million children last year, in more than a dozen countries in Africa’s Sahel region.

Even as malaria vaccines such as RTS,S/AS01 are being rolled out gradually across the continent, access is still limited and antimalarial drugs are heavily relied on. Some studies suggest that using Spaq in combination with vaccines gives better protection among children under five than using just one intervention.

Africa has experienced renewed urgency to step up its local production capacity in recent years, after distribution disruptions and vaccine protectionism during the Covid pandemic exposed its vulnerabilities. Malaria experts have stressed the need for “a drug that’s closer to market” in Africa, where more than 95% of global malaria cases and deaths occur.

“It’s about ensuring supply security,” said Pierre Hugo, director of access at MMV. The organisation signed a memorandum of understanding with the Africa Centres for Disease last year to support African antimalarial drug manufacturers to meet WHO quality standards.

MMV and Africa CDC have pushed for African countries to implement free trade agreements like the African Continental Free Trade Area to allow for manufactured medicines to be traded within the region without tariff barriers. African malaria medicine producers must compete with industry competitors from India who produce such drugs at scale, experts say, and the removal of trade barriers can “make or break” manufacturing efforts.

Joy Phumaphi, executive secretary of the African Leaders Malaria Alliance, said: “If governments, procurement agencies, and other stakeholders support and prioritise this agenda, [millions] of children and pregnant women living in Africa could be protected from malaria.” – The Guardian

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