By Emmanuel Nnadozie Onwubiko
Nigeria is facing a public-health emergency that demands urgent, coordinated and decisive action. The widespread circulation of falsified, counterfeit, adulterated and substandard medicines, food products, alcoholic beverages and other regulated goods poses a grave threat to the lives and well-being of millions of citizens.
Anyone who actively follows social media discussions in Nigeria will have noticed growing public concern about the proliferation of these dangerous products and questions surrounding the effectiveness of the National Agency for Food and Drug Administration and Control (NAFDAC), the statutory institution responsible for regulating food, medicines and other products under its mandate.
If a properly designed, transparent and representative public-opinion survey were conducted to assess Nigerians’ confidence in NAFDAC’s performance, the results would provide valuable insights into the public’s perception of the agency. Although it would be premature to assert that more than 90 per cent of Nigerians believe the agency has failed without reliable survey evidence, the intensity of public concern is unmistakable.
One troubling indicator is the frequency of reports announcing arrests, raids and seizures involving suspected manufacturers, importers, distributors and sellers of counterfeit products. These enforcement operations demonstrate that NAFDAC is taking action against offenders. However, they also raise a fundamental question: why do these criminal networks continue to operate on such a scale, despite repeated interventions by the regulator?
The irony is that, while some Nigerians accuse the agency’s current leadership of failing to contain the menace, NAFDAC continues to announce significant enforcement successes. The problem, therefore, cannot be assessed solely by counting arrests or measuring the monetary value of seized goods. The more important questions are whether these operations are preventing dangerous products from reaching consumers, dismantling the networks responsible for their production and distribution, and producing a sustained reduction in the availability of falsified and substandard products.
Many Nigerians remember the public-health advocacy associated with the late Professor Dora Akunyili, whose leadership of NAFDAC became a defining period in the national campaign against counterfeit medicines. Her legacy continues to shape public expectations of the agency.
What Nigerians require today is a comparable sense of urgency, institutional courage and preventive action. The country needs a regulatory system capable of identifying and disrupting illegal manufacturing and distribution networks before their products reach pharmacies, markets, shops and households.
The objective must be prevention, not merely the seizure of dangerous products after they have entered circulation.
The rural challenge and the limits of enforcement
NAFDAC cannot effectively combat this crisis through market raids alone. Nigeria has a vast geographical area, a large population and an extensive network of formal and informal trading locations. These circumstances make comprehensive surveillance difficult, particularly where staffing, transport, laboratory capacity and funding are inadequate.
The geographical distribution of Nigeria’s population further complicates enforcement. Figures attributed to the World Bank and reported by Trading Economics indicate that Nigeria’s rural population accounted for approximately 44.97 per cent of the total population in 2024.
This proportion underscores the importance of extending regulatory oversight beyond major cities and commercial centres. Rural communities must not become neglected markets where dangerous products can circulate because regulatory personnel and resources are insufficient.
However, rural residence alone does not establish that consumers are more likely to encounter counterfeit medicines. Demonstrating such a disparity would require reliable market-surveillance data. Nevertheless, the difficulty of monitoring a country of Nigeria’s size makes a strong case for decentralised surveillance, better intelligence gathering and closer collaboration with state and local authorities.
NAFDAC must therefore combine its enforcement operations with preventive strategies, including inspections of manufacturing facilities, tighter oversight of importation, improved supply-chain traceability, stronger border controls and systematic monitoring of wholesalers and retailers.
The agency should also publish regular, accessible reports identifying the geographical distribution of enforcement operations, the products seized, the outcomes of prosecutions and the measures taken to prevent repeat offences. Such transparency would enable Nigerians to evaluate progress using measurable evidence rather than competing assertions.
What NAFDAC says it is doing
NAFDAC has outlined several initiatives intended to improve the quality and safety of medicines and other regulated products. These measures deserve examination because the effectiveness of the national response depends partly on the agency’s regulatory capacity, the implementation of its policies and the resources available to its personnel.
1. Regulation of active pharmaceutical ingredients
According to information attributed to NAFDAC, the agency began enforcing controls on active pharmaceutical ingredients (APIs) in 2019. These ingredients are the substances responsible for the therapeutic effects of medicines.
The reported measures include requiring drug master files containing information about the manufacturing processes, quality and safety of pharmaceutical ingredients. The agency also stated that requirements were being introduced for the identification and testing of active ingredients in imported and locally manufactured medicines.
Such controls are essential because the quality of a finished medicine depends significantly on the quality of its ingredients and the conditions under which it is manufactured.
NAFDAC has also reportedly encouraged local pharmaceutical innovation by offering five-year market exclusivity to qualifying innovative companies capable of meeting domestic demand. The precise scope and current status of this policy should be confirmed against the applicable regulatory guidelines.
2. Pre-shipment controls and product registration
NAFDAC has also described pre-shipment provisional registration measures intended to ensure that products entering Nigeria meet the required standards.
Pre-shipment controls can help identify unsafe or non-compliant goods before they enter the country. However, they must operate alongside effective post-shipment inspections, market surveillance and traceability mechanisms.
A product’s registration should never be treated as a permanent guarantee of quality. Manufacturers can change production practices, supply chains can be compromised, and counterfeiters can imitate the packaging and registration details of legitimate products.
The regulator must therefore ensure that compliance is monitored throughout a product’s lifecycle.
3. Deployment of testing and authentication technologies
NAFDAC has reported using technological tools to identify suspected substandard and falsified medicines. These include:
– TruScan Raman spectroscopy equipment;
– Global Pharma Health Fund (GPHF) Minilab testing kits; and
– Mobile Authentication Service (MAS) technology.
These tools can strengthen field inspections and help identify suspicious products. Nevertheless, their effectiveness depends on the availability of equipment, trained personnel, reliable testing procedures and access to properly equipped laboratories.
Rapid field tests are not a substitute for comprehensive laboratory analysis where more detailed examination is required. NAFDAC must ensure that suspicious products are subjected to appropriate confirmatory testing and that the results inform enforcement decisions.
4. Laboratory capacity and quality assurance
The agency has reported operating four laboratories with ISO/IEC 17025 accreditation for testing medicines, vaccines, diagnostic test kits and other biological products.
Laboratory accreditation is important because it provides assurance that testing is conducted under recognised quality-management and technical-competence requirements. The current accreditation status and precise scope of each laboratory should, however, be confirmed from the relevant accreditation records.
NAFDAC has also described measures to strengthen the assessment of products imported from countries including China and India. These reportedly include reviewing the qualifications of Clean Report of Inspection and Analysis agents and laboratories, as well as combining pre-shipment testing with post-shipment assessments.
Such measures are particularly important in a country that depends substantially on imported pharmaceutical products.
5. Surveillance studies and reported failure rates
Historical studies cited by NAFDAC provide some indication of the agency’s efforts to assess medicine quality.
A study conducted in 2005 in collaboration with the World Health Organization (WHO) and the United Kingdom’s Department for International Development reportedly found a counterfeit-medicine prevalence of 16.7 per cent, compared with 40 per cent in 2001.
Between 2010 and 2012, NAFDAC reportedly used TruScan equipment to assess 5,790 samples of antibiotics, antimalarials and antidiabetic medicines. The reported failure rate was 6.4 per cent.
Further studies of antimalarial medicines, conducted with Nigerian public-health programmes and the United States Pharmacopeia, reportedly recorded failure rates of 3.6 per cent among 800 samples in 2015 and 4.3 per cent among 900 samples in 2016. Subsequent rounds involving 897, 741 and 907 samples reportedly recorded failure rates below 2 per cent.
These findings should be interpreted cautiously. Different studies may use different sampling methods, locations, product categories and definitions of failure. A reduction in the failure rate of sampled products does not automatically establish a corresponding reduction in the overall prevalence of counterfeit medicines throughout Nigeria.
The important lesson is that surveillance must be continuous, representative and publicly reported. Nigerians need current evidence showing where the greatest risks exist and whether regulatory interventions are delivering sustained improvements.
6. Post-market surveillance and international cooperation
NAFDAC has also identified expanded post-market surveillance as a priority. The objective is to ensure that registered products continue to meet quality standards and to identify unregistered or falsified products circulating in the market.
The agency has reportedly considered strengthening cross-border cooperation with neighbouring countries to improve surveillance and reduce the movement of substandard and falsified products.
Such cooperation is essential because illegal pharmaceutical networks can operate across national borders. Information sharing, coordinated inspections and intelligence-led investigations can make it more difficult for offenders to exploit weaknesses in individual countries’ regulatory systems.
NAFDAC has also acknowledged resource constraints, including insufficient vehicles and personnel. These limitations should be addressed through appropriate budgetary allocations, improved logistics and cooperation with relevant government institutions.
Finally, the agency advises Nigerians to avoid purchasing medicines from unreliable online sellers, check product registration details and expiry dates, examine packaging for suspicious differences and report suspected falsified products to the nearest NAFDAC office.
These recommendations are useful, but consumer vigilance cannot substitute for effective regulation. The primary responsibility for preventing illegal production and distribution must remain with the relevant authorities and the businesses legally responsible for the products they manufacture, import or sell.
Recent enforcement operations expose the scale of the challenge
NAFDAC’s reported enforcement activities illustrate the continuing challenge of detecting and disrupting suspected counterfeit-product networks.
Suspected counterfeit alcoholic beverages in Lagos
In a reported operation at a residential property at 322B Meiran Road, Agbado, Oke Odo, Lagos State, NAFDAC officials reportedly discovered more than 100 sacks of empty alcoholic-beverage bottles suspected of being intended for reuse in the production of counterfeit drinks.
According to an account attributed to the agency, the bottles were stored in a secluded residential location and were discovered following intelligence received by enforcement personnel.
The agency’s Assistant Director in its Investigation and Enforcement Directorate, Kunle Ojo, reportedly explained that the bottles included containers associated with different alcoholic-beverage brands. Officials alleged that the bottles were being washed and supplied to suspected counterfeiters for reuse.
NAFDAC said the bottles were destroyed to prevent their reuse in illegal production.
The discovery raises serious questions about the supply chains supporting counterfeit alcoholic beverages. Reusing branded bottles can make it easier for unscrupulous operators to disguise products of unknown origin and quality as genuine commercial brands.
However, the discovery of empty bottles alone does not establish that every bottle was used in counterfeit production. The purpose of the operation, the evidence collected and any subsequent prosecutions should be reported accurately.
The agency also reportedly urged residents to notify its offices when they observe suspicious activities in their communities.
Suspected counterfeit production at a Lagos trade fair complex
In another reported operation, NAFDAC announced that it had uncovered a suspected counterfeit-production facility at Zamfara Plaza within the BBA Trade Fair Complex in Lagos State.
The agency reportedly arrested two suspects who were allegedly involved in relabelling or revalidating energy drinks and popular wine and whisky brands.
The operation was reported in October, although the precise date and circumstances should be confirmed against NAFDAC’s original announcement.
The allegations demonstrate the importance of inspecting informal storage facilities and trading locations where products may be repackaged, relabelled or otherwise manipulated outside authorised supply chains.
Nevertheless, allegations against arrested suspects must be distinguished from proven criminal conduct. Any prosecution and subsequent judicial findings should be reported as they become available.
Seizure of suspected counterfeit and unregistered medicines
NAFDAC has also reportedly uncovered warehouses in an uncompleted building in Apapa, Lagos, containing banned, suspected counterfeit and unregistered medicines valued at more than ₦3 billion.
The reported discovery included injectable antimalarial products, antibiotics, sachet medicines and blister-packed drugs, alongside perfumes, body oils and cooking oils.
The agency reportedly seized and evacuated the products to prevent their distribution.
If confirmed by official seizure records, the operation would demonstrate the potential scale of the challenge confronting regulators. The presence of medicines alongside other consumer products also reinforces the need for inspections that cover the full range of goods within NAFDAC’s regulatory mandate.
Yet the monetary value of seized products, although significant, is not by itself a reliable measure of the public-health impact of an operation. Nigerians also need information about the quantities recovered, the origins of the products, the distribution networks involved, the results of laboratory tests and the outcomes of investigations and prosecutions.
Repeated discoveries of suspected counterfeit products should prompt authorities to investigate the networks behind them rather than merely remove individual consignments from circulation.
The human cost of falsified medicines
The consequences of substandard and falsified medicines extend far beyond financial losses to manufacturers or regulatory agencies. They can result in treatment failure, prolonged illness, antimicrobial resistance, disability and preventable deaths.
The WHO has warned that substandard and falsified medical products represent a serious global public-health problem. Its widely cited estimate is that approximately one in ten medical products in low- and middle-income countries is substandard or falsified.
That estimate is a broad global indicator, not a finding that one in ten medicines sold in every country is necessarily counterfeit. Nevertheless, it demonstrates the scale of the risk and the importance of effective medicine-quality controls.
The economic consequences are also substantial. The WHO has cited an estimated annual cost of approximately US$30.5 billion associated with substandard and falsified medical products in low- and middle-income countries.
The effects can be particularly devastating in countries where infectious diseases remain significant causes of illness and death. Medicines that fail to contain the correct active ingredients or contain inadequate quantities of them can undermine treatment, delay recovery and contribute to drug resistance.
Figures attributed to the United Nations Office on Drugs and Crime have also highlighted the potential mortality burden associated with counterfeit and substandard medicines in sub-Saharan Africa. Estimates cited in public discussions include hundreds of thousands of deaths annually, with malaria and pneumonia treatments accounting for substantial portions of the reported burden.
Such figures require careful attribution and verification because mortality estimates vary according to the products examined, the diseases included, the methodology used and the period covered. They should not be presented as definitive counts of deaths directly confirmed to have resulted from counterfeit medicines.
Nigeria must nevertheless take the danger seriously. Where malaria, bacterial infections and other treatable illnesses remain major public-health concerns, unreliable medicines can undermine the work of health professionals and place vulnerable patients at additional risk.
The financial implications are equally troubling. Treating patients whose original illnesses have been aggravated by ineffective or contaminated medicines places additional pressure on households, hospitals and public-health budgets.
The danger is compounded by the complexity of pharmaceutical supply chains. Nigeria imports medicines and pharmaceutical ingredients from several countries while also relying on domestic manufacturers and distributors. Neither imported nor locally manufactured products should be presumed unsafe merely because of their origin. Every product must be assessed according to verifiable quality standards, and every manufacturer or supplier must be held accountable for compliance.
NAFDAC must therefore strengthen oversight of imported medicines while ensuring that local manufacturers operate under rigorous quality-control requirements.
Open drug markets: a structural problem requiring decisive reform
One of the most difficult challenges is the continued availability of medicines through poorly regulated or inadequately supervised trading networks.
In an article published in The Lancet concerning the circulation of counterfeit medicines in Nigeria, Omotayo Fatikun highlighted the role of open drug markets in the distribution of medicines outside adequately controlled supply chains.
The argument is that medicines sold through informal markets can enter the supply chains of pharmacies, hospitals, wholesalers and retailers, making it harder to establish the provenance and quality of individual products.
This is a serious regulatory concern. However, the existence of an open drug market does not automatically mean that every medicine sold there is counterfeit or substandard. Reform must distinguish between legitimate traders who comply with applicable requirements and operators who manufacture, import, distribute or sell unlawful products.
The appropriate response is to establish a system in which pharmaceutical wholesale and retail activities operate under clear licensing requirements, enforceable quality standards and effective inspection arrangements.
NAFDAC, the Pharmacy Council of Nigeria and other relevant authorities should work together to strengthen pharmaceutical distribution and ensure that medicines pass through traceable, properly regulated channels.
Where existing markets cannot meet the required standards, authorities should establish a clear transition plan towards compliant pharmaceutical trading centres. Such a plan should provide legitimate businesses with a pathway to compliance while ensuring that dangerous products are removed from circulation.
Simply shutting down markets without providing viable, properly regulated alternatives could disrupt access to essential medicines, particularly for people in communities with limited healthcare infrastructure. Reform must therefore combine enforcement with practical arrangements for lawful and affordable access to medicines.
A stronger legal and institutional response is needed
The scale of the reported problem demands more than occasional raids and public announcements. Nigeria needs an integrated strategy that combines prevention, intelligence, prosecution, public education and institutional accountability.
First, the Federal Government should assess whether NAFDAC has sufficient funding, personnel, vehicles, laboratory facilities and technological resources to carry out its statutory responsibilities. Where deficiencies exist, they should be addressed through transparent budgeting, measurable performance targets and independent oversight.
Second, enforcement must extend beyond the seizure of goods and arrest of suspects. Investigations should identify the financiers, manufacturers, importers, warehouse operators, distributors and other participants in illegal supply chains wherever the evidence supports their involvement.
Third, prosecutors and the courts should ensure that cases are handled efficiently and fairly. Where guilt is established, offenders should receive penalties proportionate to the seriousness of their conduct and the harm caused, in accordance with the law. The possibility of substantial criminal profits must not outweigh the deterrent effect of effective enforcement.
Fourth, the National Assembly should review the applicable legal framework to determine whether existing offences, penalties, investigative powers and enforcement mechanisms adequately address the present scale and sophistication of counterfeit-product operations.
Any proposed amendments should be evidence-based, consistent with constitutional protections and designed to strengthen deterrence without compromising due process.
Fifth, the government should invest in public awareness. Consumers need reliable information about purchasing medicines safely, verifying product registration, recognising suspicious packaging and reporting suspected violations. Pharmacists, healthcare professionals, community organisations, traditional leaders and local authorities should be included in this effort.
Finally, NAFDAC should publish regular performance reports covering inspections, seizures, laboratory findings, prosecutions, convictions and repeat offenders. These indicators would help establish whether the agency is reducing the threat over time rather than merely responding to individual incidents.
Conclusion: Nigerians deserve protection, not promises
The Human Rights Writers Association of Nigeria (HURIWA) and this writer support the establishment of properly regulated pharmaceutical wholesale markets and distribution systems capable of replacing unsafe and inadequately supervised trading practices.
Manufacturers, importers, wholesalers, retailers and other participants found to have engaged in unlawful activities should face the full consequences of the law. Where the evidence establishes deliberate conduct that places human lives at risk, the response must be firm, swift and proportionate.
The relevant legislation governing NAFDAC should be reviewed to determine whether stronger enforcement powers, better coordination and more effective penalties are necessary to confront the evolving threat. Any legislative reforms must be carefully designed, constitutionally sound and supported by evidence.
The welfare of Nigerians is not a favour bestowed by those in power. Section 14(2)(b) of the Constitution of the Federal Republic of Nigeria 1999, as amended, states that “the security and welfare of the people shall be the primary purpose of government.”
That constitutional principle must translate into practical protection for citizens who depend on medicines, food and other regulated products to live healthy and productive lives.
The Federal Government must ensure that NAFDAC has competent leadership, adequate resources and a clear strategy for preventing the manufacture and circulation of falsified, adulterated and substandard products. The agency must also demonstrate measurable results, while remaining accountable to the public it serves.
This is not a call for indiscriminate punishment or for treating every alleged offender as guilty before trial. It is a call for a regulatory and judicial system that can identify genuine offenders, establish responsibility through lawful investigations and ensure that those convicted receive appropriate penalties.
Counterfeit medicines and dangerous consumer products can destroy lives, undermine confidence in healthcare and impose enormous costs on families and the national economy. Those who knowingly profit from such activities must not be allowed to operate with impunity.
NAFDAC must strengthen its preventive capacity, government must provide the resources required, and the courts must administer justice without unnecessary delay.
Nigerians have endured this threat for far too long. The time for fragmented interventions and unsubstantiated assurances is over. The country needs sustained, transparent and measurable action to dismantle illegal supply chains and protect every citizen, regardless of location or economic circumstances.
The siege of falsified and dangerous products must end. Protecting the health and lives of Nigerians must be a national priority.
Emmanuel Nnadozie Onwubiko is the founder of the Human Rights Writers Association of Nigeria (HURIWA) and a former National Commissioner of the National Human Rights Commission of Nigeria.
