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 Adedapo Adesanya
The National Health Insurance Authority (NHIA) says the number of Nigerians enrolled in health insurance has risen to more than 22 million.
The Director-General of NHIA, Mr Kelechi Ohiri, said this resulted from the implementation of the mandatory health insurance, which has gained momentum nationwide.
He said this on Wednesday at the Annual General Meeting of the Nigerian Association of Insurance and Pension Editors (NAIPE) in Lagos.
Mr Ohiri said enrolment had increased to 22.03 million, representing a 35 per cent year-on-year growth, attributing this to stronger collaboration with state social health insurance agencies, ministries, departments and agencies, organised labour, employers, the private sector, and the gradual implementation of the mandatory health insurance provisions of the NHIA Act.
He said that the country had moved beyond policy formulation to delivering measurable improvements in healthcare access, service quality and consumer protection in line with the federal government’s health sector reform agenda.
According to him, Nigeria already has the necessary policies and legislation to achieve Universal Health Coverage, positing that the key challenge was effective implementation.
“The decisive variable is now implementation- consistent, rigorous and accountable execution that converts political commitment into healthcare access for real Nigerians,” he said.
Mr Ohiri said that the transition from the former National Health Insurance Scheme to the NHIA had strengthened regulation, consumer protection, accountability and strategic purchasing, while providing the legal and operational framework for achieving Universal Health Coverage.
He added that improving the experience of enrollees remained central to the Authority’s reform agenda.
According to him, NHIA has strengthened its complaints management system, introduced faster resolution timelines, and intensified compliance monitoring of Health Maintenance Organisations (HMOs) and healthcare providers.
He further added that NHIA had sanctioned facilities that failed to meet the required standards, adding that his organisation had resolved 3,878 complaints, representing an 87 per cent resolution rate, while 95 per cent of the cases were concluded within prescribed timelines.
Mr Ohiri noted that more than N14.2 million had been refunded to enrollees, while non-compliant healthcare facilities had been sanctioned.
He said NHIA had also introduced service standards, including a one-hour treatment commencement target for enrollees requiring urgent care, to improve access to timely and quality healthcare services.
The NHIA boss further disclosed that capitation payments to healthcare providers had been increased by 93 per cent.
He said fee-for-service reimbursements rose by 378 per cent to enable providers to invest more in personnel, equipment and infrastructure.
According to him, 7,592 healthcare facilities have been assessed under the SafeCare quality framework as part of efforts to institutionalise continuous quality improvement across the country.
Mr Ohiri also highlighted interventions targeted at vulnerable groups, including support for more than 48,500 pregnant women, expanded maternal and newborn healthcare services, the Vulnerable Group Fund, and improved access to healthcare for pensioners and retirees.
He said Universal Health Coverage could only be achieved if every Nigerian, regardless of income or location, had access to quality healthcare services.
By Modupe Gbadeyanka
The new one-hour authorisation response time ultimatum policy introduced by the National Health Insurance Authority (NHIA) has received the full backing of SUNU Health Nigeria Limited.
This policy was introduced by the agency to ensure enrollees get prompt approval codes to access care.
Healthcare service providers have been urged to report any Health Maintenance Organisation (HMO) that violates this initiative through an email, with the HMO in copy and a timestamp attached as evidence of the request. They may proceed to offer services to enrollees thereafter.
Speaking at the company’s second-quarter Providers’ Forum for the Lagos-Ogun region in Lagos recently, the chief executive of SUNU Health, Dr Moyosore Olomola, expressed optimism that this policy would improve healthcare delivery in the country, especially for enrollees, who crave quality service.
At the event themed Improving Quality and Access to Care Through Stronger Provider Network, and held at the Nigerian Institute of Medical Research (NIMR) in Yaba, Lagos, Mr Olomola reaffirmed the HMO’s commitment to operating within legal and operational frameworks to guarantee adequate care for enrollees.
“Access to care and quality of care remain key priorities in our healthcare systems. We know quite well that deliberate collaboration, strategic partnerships, and a shared commitment to excellence are required to achieve these priorities.
“A strong provider network is doubtless the backbone of any effective healthcare system. It ensures that our mutual enrollees receive the right care, at the right time, in the right place, and at the right price,” Mr Olomola, represented at the programme by the organisation’s Chief Operating Officer (COO), Dr Faith Nwachi, stated.
He further assured that SUNU Health would strictly adhere to the one-hour authorisation limit, stressing that this aligns seamlessly with one of the organisation’s core values—promptness and its corporate slogan, Humanity is the centre of our initiatives.
In a bid to further improve access and quality of care, SUNU Health also demonstrated its new operational software and Mobile app, aptly named SUNU Legacy.
Also speaking at the event, the NHIA Lagos State Coordinator (Ikeja), Dr Bethuel-Kasimu Abraham, noted that the forum’s expected outcome is to significantly reduce delays in accessing medical care.
Other key expectations include ensuring continuity of care, improving patient outcomes, and strengthening accountability among HMOs.
Addressing specific pain points faced by enrollees, the NHIA Ogun State Coordinator, Mr Dare Adefeso, acknowledged that the agency had received complaints regarding out-of-stock drugs and the discrimination of enrollees by certain providers.
He affirmed that the NHIA is actively addressing these issues, stressing that moving forward, every facility must ensure enrollees are properly catered to regardless of their status, provided they have an active health insurance plan.
Corroborating the long-standing legacy of SUNU Health, the Ogun State Director of the National Orientation Agency (NOA), Mrs Aishat Tiamiyu, shared that her agency is responsible for public information dissemination and has been enrolled with SUNU Health for over 25 years.
Commending the HMO’s stellar service over two decades, she called for the immediate enrollment of new NOA staff into the scheme.
The Providers’ Forum remains one of the strategic channels employed by SUNU Health to consistently engage healthcare providers, understand their operational challenges, introduce new software updates, and solidify partnerships aimed at fostering premium healthcare delivery across Nigeria.
By Aduragbemi Omiyale
The National Agency for Food and Drug Administration and Control (NAFDAC) has announced the recall of a sexual enhancement product known as WAP Sensual Enhancement Capsules.
In a statement on Monday, the Nigerian agency disclosed that the recall is due to “undeclared pharmaceutical ingredients” in the product, whose country of origin is unknown, but is marketed and distributed online in the US through eBay.
It was emphasised that the recall is being “voluntarily” made by the manufacturer, Best Supplements Best Prices Company.
The detection of the undeclared pharmaceutical ingredients was made by the US Food and Drug Administration (FDA).
Laboratory analysis by the US FDA revealed that the product contained undeclared sildenafil, tadalafil, and flibanserin, which were not mentioned on the product label. Such substances may include phosphodiesterase type-5 (PDE-5) inhibitors or related compounds commonly used for the treatment of erectile dysfunction, the statement by NAFDAC stated.
Sildenafil and tadalafil are ingredients in FDA-approved prescription drugs used to treat erectile dysfunction.
It was noted that these undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Flibanserin is the active ingredient in an FDA-approved prescription drug used to treat low sexual desire in women. Flibanserin can cause drowsiness, sedation, dangerously low blood pressure, and fainting, especially when combined with alcohol.
Consumers have been encouraged to report compromised products (medicines or medical devices) to the nearest NAFDAC office, call 0800-162-3322, or send an email to sf******@********ov.ng.
