Poor-quality medical products are all too common in Africa, where substandard and falsified medicines kill nearly 500,000 people each year, according to the United Nations. The continent also has the highest prevalence of poor-quality medicines among low- and middle-income countries at 18.7 percent.
In Nigeria, the National Agency for Food and Drug Administration and Control (NAFDAC), the national regulating authority for medical products, is prioritizing local production of medicines to ensure a safer supply of quality-assured medical products to protect patients and communities across the country and continent.
Ensuring quality starts with ingredients
Like most countries in Africa forced to rely on expensive imports of medicines and active pharmaceutical ingredients (APIs), Nigeria is rethinking this model in favor of prioritizing African-made medicines to help reduce costs and improve health security.
To that end, in July 2024, NAFDAC partnered with the U.S. Agency for International Development (USAID), World Health Organization (WHO), U.S. Pharmacopeia (USP), Bill & Melinda Gates Foundation, and Nigeria Sovereign Investment Authority to host a regional workshop on API manufacturing to help expand the sector.
Combined with inactive ingredients, also known as excipients, APIs are essential building blocks of pharmaceutical products, but can be difficult to manufacture, especially in low- and middle-income countries, as they require complex manufacturing processes and expensive raw materials.
The NAFDAC workshop outlined next steps for producing APIs and excipients in Nigeria, highlighting the complexities of API regulations for participants, including manufacturers, scientists, researchers, and regulatory personnel. Topics included dossier preparation and review, quality management, analytical methods and stability, and more. In addition, the workshop highlighted a need for standardized equipment and machinery for API production, distribution, and storage and regulatory harmonization.
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Foundations of Good Manufacturing Practices (GMP)
Sign up for USAID’s free online course to learn the essentials of GMP, developed by PQM+
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African-made medicines create stronger supply chains
Improving the availability of locally produced medical products in Nigeria will promote a more diversified supply chain on the continent. Successful scale-up of production requires proactive, efficient regulation and policy to ensure that Nigerians have timely access to safe, effective, quality-assured medical products, including during public health emergencies.
NAFDAC has made tremendous progress in this area, earning WHO Maturity Level 3 – the mark of a well-functioning regulatory body – for medicines and imported vaccines, but excluding lot release for locally manufactured vaccines. NAFDAC is one of just eight ML3 regulators in Africa.
In addition, NAFDAC continues to assist manufacturers in gaining market authorization for locally made medical products. Thanks to support from NAFDAC and the USAID-funded Promoting the Quality of Medicines Plus (PQM+) program, implemented by USP, Nigerian-manufacturer Swiss Pharma Nigeria Limited became the first manufacturer in Nigeria and all of West Africa to recently receive WHO prequalification for two essential maternal and child health medicines.
Other Nigerian-based pharmaceutical companies are also expanding production. Emzor Pharmaceuticals announced plans to build a facility to produce APIs, with a special focus on antimalarials. Emzor is also the only African-based producer to manufacture misoprostol, an essential maternal health medicine, on the continent. In addition, a consortium of manufacturers led by Fidson Healthcare plans to focus on the production of analgesics, antibiotics, and some cardiovascular medicines moving forward.
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Manufacturing maternal health supplies
A manufacturing landscape of critical maternal health medicines produced in Africa
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Next steps
Nigeria’s ability to develop APIs and medical products locally will ultimately affect the future of its pharmaceutical industry. How the country sources pharmaceutical ingredients will either help or hinder health security, equity, and sustainability. Collaboration is key to building a strong manufacturing base and promoting long-term sustainability.
Increasing the supply of Nigerian-made medical products depends on multiple factors, including manufacturers’ access to raw materials and their ability to comply with good manufacturing practices. Success also relies on regulators to provide effective oversight and legislators to develop supportive policy frameworks to boost local manufacturing across the country. Finally, ongoing investment in regulatory systems, workforce capacity, and political commitment are necessary to ensure quality-assured medicines are available nationwide.
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Nigeria’s Presidential Initiative for Unlocking the Healthcare Value Chain
USP and Nigeria partner to expand medicine production
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