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
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.
By Modupe Gbadeyanka
Dr Obi Adigwe has been appointed as the pioneer National Coordinator of the National Health Technology and Data Analytics Office (NHTDAO).
The body was created by the Ministry of Health under the approval of President Bola Tinubu.
NHTDAO will be domiciled in the Office of the Coordinating Minister of Health and Social Welfare, a statement on Friday by the Special Adviser to the President on Information and Strategy, Mr Bayo Onanuga, stated.
The agency will serve as a meta-level national platform for coordinating the country’s digital-health agenda. It will reinforce, not replace, the existing statutory functions of relevant departments and agencies, it was emphasised.
The organisation will also harmonise and empower the public and private institutions across the health system, set the standards that connect them, and operationalise the National Digital Health Architecture, approved by the National Council on Health in November 2025.
It was stated that President Tinubu expects NHTDAO to accelerate Nigeria’s transition to a secure, interoperable and data-driven health system that improves outcomes for all citizens.
Mr Adigwe, as Director General of the National Institute for Pharmaceutical Research and Development, has leveraged science to catalyse interventions in artificial intelligence, translational research, and technology transfer.
He coordinated major projects, including the ¥300m Nanotechnology grant and the AFREXIMBank grant for Africa’s first API Training Facility. He led the roadmap development that underpinned an €18 million EU grant, the largest in Africa for the thematic area. During the last pandemic, Adigwe globally showcased African science by undertaking the world’s first analysis to debunk claims about the Covid Organics preparation.
The Office’s Steering Committee, which provides strategic direction and oversight, comprises:
- Professor Muhammad Ali Pate, Coordinating Minister of Health and Social Welfare (Co-chair)
- Mr Olaniyi Yusuf, Chairman of the Nigerian Economic Summit Group (Co-chair)
- Dr Iziaq Adekunle Salako, Minister of State for Health and Social Welfare (Alternate Co-chair)
- Ms Kachollom Daju, Permanent Secretary, Federal Ministry of Health and Social Welfare
- Mr Idris Alubankudi Saliu, Special Adviser to the President on Technology and Digital Economy
- Dr Muntaqa Umar-Sadiq, National Coordinator, SWAp Coordination Office
- Dr Abdu Mukhtar, National Coordinator, Presidential Initiative to Unlock Healthcare Value Chain
- Dr Muyi Aina, Executive Director, National Primary Health Care Development Agency
- Dr Kelechi Ohiri, Director General, National Health Insurance Authority
- Director, Health Planning, Research and Statistics, Ministry of Health and Social Welfare
- National Information Technology Development Agency Representative
- Six representatives of the State Commissioners of Health, one from each of the six geopolitical zones
- Pharm Hamza Buhari, Stakeholder representing Industry and Community.
-
Feature/OPED6 years agoDavos was Different this year
-
Travel/Tourism10 years ago
Lagos Seals Western Lodge Hotel In Ikorodu
-
Showbiz4 years agoEstranged Lover Releases Videos of Empress Njamah Bathing
-
Banking8 years agoSort Codes of GTBank Branches in Nigeria
-
Economy3 years agoSubsidy Removal: CNG at N130 Per Litre Cheaper Than Petrol—IPMAN
-
Banking3 years agoSort Codes of UBA Branches in Nigeria
-
Banking3 years agoFirst Bank Announces Planned Downtime
-
Sports3 years agoHighest Paid Nigerian Footballer – How Much Do Nigerian Footballers Earn