Health
Local Packaging of WHO-Approved HIV Tests, a Shift in Africa’s Diagnostic Capacity
By Chidinma Onwumere
Nigeria’s public health system has taken a further step toward strengthening diagnostic self-reliance with the local packaging of a WHO pre-qualified HIV Rapid Diagnostic Test (RDT) at a facility in Lagos. The development highlights a broader shift in how essential health commodities are produced, supplied, and regulated across the continent.
The HIV test in question, the Standard Q HIV 1 & 2 RDT was previously manufactured and distributed as a fully imported finished product. Through regulatory approval granted under the WHO Pre-Qualification Change Notification, local packaging is now authorised at Colexa Biosensor, a Nigerian facility, making it the only site in Africa currently approved to package a WHO-prequalified HIV RDT.
While the technical designation may appear procedural, its implications are significant. WHO pre-qualification is a globally recognised quality benchmark used by national governments and international donors to guide procurement decisions for public health programs. Any change to a pre-qualified product, including where it is packaged, requires rigorous assessment to ensure that quality, safety, and performance remain unchanged.
For Nigeria, the approval represents more than a regulatory milestone. It addresses a longstanding vulnerability in health systems across Africa: dependence on imported diagnostics and the fragility of global supply chains. During recent global disruptions, including the COVID-19 pandemic, many countries experienced delays in access to essential medical commodities, exposing the risks of over-reliance on distant manufacturing hubs.
By enabling local packaging of a WHO-approved HIV test, Nigeria improves its ability to respond more quickly to demand fluctuations, reduce lead times, and maintain continuity of supply for national HIV programs. The test has been evaluated and approved by the Federal Ministry of Health and the National AIDS and STI Control Programme and is listed on the National HIV Testing Algorithm, making it eligible for procurement by government agencies and international partners supporting HIV services in the country.
From a programme perspective, inclusion on the national algorithm is critical. It ensures that test kits used in public health settings meet required performance standards and align with national testing strategies. It also allows donor-funded programs, such as those supported by multilateral agencies and global health initiatives, to procure the product locally while maintaining compliance with international quality requirements.
The shift toward local packaging also brings economic and institutional benefits. Shorter supply chains can lower logistics costs, improve predictability, and create opportunities for skills transfer in quality management, regulatory compliance, and manufacturing operations. Importantly, local involvement does not replace global standards; rather, it requires demonstrable adherence to them. WHO-approved local packaging is contingent on standardised processes, full traceability, and the ability to consistently prove compliance through documentation and audits.
Health policy experts note that such approvals challenge persistent assumptions that high-quality diagnostic manufacturing must occur outside Africa. Instead, they suggest a growing recognition that African facilities, when supported by strong regulatory oversight and technical partnerships, can meet the same benchmarks applied globally.
Beyond HIV diagnostics, the Lagos facility also produces blood glucose meters and test strips, reflecting a parallel focus on non-communicable diseases such as diabetes, which are rising rapidly across Nigeria and the continent. This dual focus on communicable and non-communicable diseases aligns with evolving health priorities, as African countries face a growing burden of chronic illness alongside infectious diseases.
The broader significance of this development lies in its potential scalability. While the immediate impact is national, the regulatory pathway demonstrated in Nigeria could inform similar initiatives elsewhere in Africa. Regional health bodies and policymakers have long advocated for greater local production of essential medical products as part of health security and economic development strategies. However, progress has often been constrained by regulatory complexity, quality assurance requirements, and limited technical capacity.
By meeting WHO pre-qualification standards for local packaging, Nigeria offers a practical example of how these barriers can be addressed. It also underscores the importance of collaboration between global manufacturers, local operators, regulators, and international agencies in building sustainable diagnostic capacity.
As demand for HIV testing remains high, particularly among key populations and in underserved areas, reliable access to quality-assured diagnostics remains central to prevention, treatment, and surveillance efforts. Local packaging does not eliminate the need for global supply chains, but it can make them more resilient, responsive, and context-appropriate.
More broadly, the development contributes to an ongoing debate about how African countries can move beyond consumption toward greater participation in the value chain of global health products. In this sense, the local packaging of a WHO-approved HIV test is less about a single facility or product and more about what it represents: a gradual but meaningful shift toward health system self-reliance grounded in global standards
As African governments and development partners continue to prioritise pandemic preparedness, universal health coverage, and supply chain resilience, such models may play an increasingly important role in shaping the future of healthcare delivery on the continent.
By Modupe Gbadeyanka
As part of its efforts to safeguard public health in Nigeria, the National Agency for Food and Drug Administration and Control (NAFDAC) has strengthened its regulatory framework for blood and blood products.
A statement signed on Thursday by the Director General of NAFDAC, Prof Mojisola Adeyeye, disclosed that to achieve its goal, the agency will collaborate with relevant authorities and stakeholders to establish a robust regulatory framework that promotes the availability of safe, quality-assured and efficacious blood and blood products, while strengthening public confidence in Nigeria’s healthcare system.
NAFDAC said it intends to partner with government institutions, healthcare providers, blood establishments, development partners and other stakeholders for the robust oversight.
Mrs Adeyeye disclosed that already, her organisation has received the support of the Minister of Health and Social Welfare, Prof Ali Pate.
According to her, NAFDAC has been given the mandate to regulate blood and blood products in line with global best practices and the World Health Organisation (WHO) recommendation that these products be subject to oversight by National Regulatory Authorities (NRAs) for medicines.
She said blood and blood products are classified as essential medicines and must be consistently available with assured quality, safety and affordability, stressing that the aim is to protect patients throughout the blood transfusion chain.
Effective regulatory oversight will support the quality and safety of blood products from donor assessment and collection through testing, processing, storage, transportation and use, the NAFDAC chief noted.
Several African countries, including Egypt, Ghana, South Africa, Tanzania, Zimbabwe, Senegal and Rwanda, have already established regulatory oversight of blood and blood products by their NRAS, she added.
Mrs Adeyeye pointed out that NAFDAC’s renewed regulatory preparedness builds on its broader transformation into a modern, science-based regulatory authority.
Already, it has attained WHO Maturity Level 3, completed WHO Global Benchmarking ML3 re-assessment, obtained WHO prequalification for its drug laboratory, and established internationally accredited laboratory and quality management systems. These capabilities provide a strong foundation for the effective regulation of blood and blood products.
As part of its preparedness, NAFDAC has established a dedicated Vaccines, Biologicals and Medical Devices Registration and Regulation Directorate to oversee the registration and regulation of these products.
The agency established a Vaccines, Biologicals and Medical Devices Laboratory Services many years ago, but became a Directorate in 2024, responsible for quality control, including laboratory testing and lot release, while the Directorate of Evaluation and Research provides oversight of Good Manufacturing Practices. An ultra-modern laboratory facility is also being developed to further strengthen its capacity for the assessment and quality control of vaccines and biologics.
By Modupe Gbadeyanka
An organisation known as GoMed Nigeria is offering free reproductive health services to Nigerian students through a digital self-care platform.
This is being delivered through a partnership with the United Nations Population Fund (UNFPA) and the Lagos State Government.
The pilot scheme will be available to students of the University of Lagos. They will enjoy easier and more private access to essential health products, accurate information, and professional support.
Young Nigerians face some of the highest rates of unintended pregnancy and unmet need for contraception in the world.
Cost, distance, stigma, misinformation, and fears about confidentiality routinely stop students from seeking the products and guidance they need, with consequences that include unintended pregnancy, unsafe abortion, sexually transmitted infections and interrupted education.
The self-care platform is designed to remove each of these barriers. Through the platform, students receive free contraceptives and other sexual and reproductive health commodities provided through the Lagos State Ministry of Health and UNFPA, exclusive discounts on health essentials, and fast, discreet delivery directly to campus and student hostels.
Students can also access trusted sexual and reproductive health information and services through UNFPA’s SoftLife 247 and U-Plan platforms. Through U-PLAN, they can chat directly with qualified Family Planning Service Providers to receive accurate information and address their concerns. They can also confidently engage with GoMed’s registered pharmacists for confidential, judgement-free guidance on medicines and other health products.
“Students should be able to get reliable health information and essential products without cost, distance or fear of judgement becoming barriers.
“This platform brings free sexual and reproductive health commodities, other affordable health products and professional guidance together, with discreet delivery directly to students on campus,” the chief executive of GoMed Nigeria, Mr Anthony Edeki, said.
Also speaking, UNFPA in Nigeria Resident Representative, Muriel Mafico, said, “As the UN agency mandated for “Sexual and Reproductive Health and Rights”, we are committed to reducing preventable maternal deaths and addressing the unmet need for family planning, including by providing and overseeing access to life-saving commodities worldwide.
“Working alongside our partners, we’re helping roll out the digital Self-Care Platform—so that vital, life-changing information can reach more people, more easily. Together, we want to empower Nigeria’s next generation to make informed health choices and achieve stronger health outcomes and a brighter future.”
By Modupe Gbadeyanka
A financing framework to accelerate the electrification of health facilities nationwide has been approved by the federal government.
The approval was announced at the third meeting of the Inter-Ministerial Steering Committee (IMSC) of the Nigeria Power for Health Initiative (NPHI), a presidential programme jointly coordinated by the Federal Ministries of Power and Health and Social Welfare.
The committee was constituted to ensure reliable electricity in at least 30 per cent of Nigeria’s health facilities by the end of 2027.
At the meeting, chaired by the Minister of State for Health and Social Welfare, Mr Isiaq Salako, and co-chaired by the Minister of Power, Mr Joseph Tegbe, members of the Inter-Agency Technical Committee (IATC) presented the recommendations under consideration.
Speaking at the meeting, Mr Salako said the Steering Committee approved a financing framework to mobilise investment for healthcare electrification, alongside a facility energy management framework requiring participating hospitals to build sustainable systems for managing their energy infrastructure.
He said the committee also cleared eight (8) private sector proposals for further engagement, drawn from about 70 submissions received during the National Healthcare Electrification Investor Matchmaking Week in Lagos.
The Health Minister added that Energy Management Teams are already in place at federal tertiary hospitals, with state governments being encouraged to set up similar structures. The initiative will now be institutionalised through dedicated budgetary provisions and a full-time Project Coordination Unit to oversee implementation.
On his part, Mr Tegbe declared that the initiative must now move from announcements to actual project delivery.
Describing the NPHI as one of the President Bola Tinubu administration’s flagship programmes, he said the emphasis should shift towards commissioning completed projects that Nigerians can see for themselves, rather than further groundbreaking ceremonies and public messaging.
He emphasised the need for teaching hospitals, state hospitals, and primary healthcare centres to be fully energised, noting that the Rural Electrification Agency has already energised 5 Federal Teaching Hospitals and several other health facilities nationwide.
He also tied the initiative directly to patient outcomes, arguing that dependable power would end hospitals’ reliance on emergency generators, and pledged that the Ministry would continue to prioritise the initiative’s funding needs while ensuring value for money.
