Reported by Simon Daniel Yusuph l Journalist at Weng Global
The Pharmaceutical Society of Nigeria (PSN) has called for tougher penalties against manufacturers, importers, distributors and sellers of counterfeit medicines, proposing a minimum fine of ₦25 million and a prison sentence of at least 15 years for certain offences under Nigeria’s counterfeit drugs legislation.
The proposal forms part of the society’s recommendations for amendments to the Counterfeit and Fake Drugs and Unwholesome Processed Foods (Miscellaneous Provisions) Act, which provides the legal framework for addressing the production, distribution and sale of fake, adulterated, banned, substandard and expired medicines, as well as unwholesome processed foods.
The proposed changes are intended to strengthen the legal consequences for offences that threaten public health and undermine confidence in Nigeria’s pharmaceutical supply chain.
The PSN’s recommendations come amid continuing efforts to strengthen the country’s regulatory framework for medicines and improve enforcement against the circulation of unsafe pharmaceutical products.
The society’s position was presented by its National President, Pharm. Ayuba Ibrahim Tanko, as part of submissions concerning proposed amendments to laws governing pharmaceutical regulation and the control of counterfeit medicines.
However, the proposed penalties should not be confused with existing punishments under the law. They represent recommendations for legislative changes, and their eventual implementation depends on the legislative process and the final provisions adopted by the National Assembly.
PSN Calls for Tougher Punishment for Fake Drug Offenders
The Pharmaceutical Society of Nigeria has argued for stronger sanctions against individuals and businesses involved in the production, importation, distribution and sale of counterfeit or substandard pharmaceutical products.
Under the proposed amendments, the society recommends a minimum fine of ₦25 million and imprisonment of at least 15 years for offences covered by the relevant provisions.
The recommendations distinguish between different categories of offences under the legislation, reflecting the need to establish penalties that correspond to the conduct involved.
The proposed changes also seek to make the consequences of violating pharmaceutical laws more substantial, particularly for people who knowingly introduce dangerous or ineffective medicines into the market.
Counterfeit medicines can expose patients to products that contain incorrect ingredients, insufficient quantities of active pharmaceutical substances or potentially harmful contaminants. Some products may also be packaged to resemble genuine medicines, making it difficult for consumers to identify them without appropriate verification.
The PSN’s position places the issue of criminal penalties within the wider debate over how Nigeria can improve medicine quality, strengthen regulatory enforcement and protect people who depend on pharmaceutical products for their health.
Although financial penalties and imprisonment are central to the society’s recommendations, effective enforcement will also depend on the ability of regulatory authorities and law enforcement agencies to identify offenders, gather evidence and secure successful prosecutions.
What the Proposed Amendment Seeks to Change
The Counterfeit and Fake Drugs and Unwholesome Processed Foods (Miscellaneous Provisions) Act provides for the prohibition of activities involving counterfeit, adulterated, banned, fake, substandard or expired medicines.
The legislation also addresses the sale and distribution of medicines through premises or locations that are not appropriately licensed or registered.
Under the existing framework, offences involving counterfeit medicines and the unlawful sale of drugs attract criminal penalties. The law also contains provisions relating to the seizure and forfeiture of prohibited products.
However, the PSN is advocating a stronger punishment regime as part of efforts to improve deterrence and reinforce the seriousness of offences involving unsafe pharmaceutical products.
The proposed amendment is particularly significant because counterfeit medicines are not simply a commercial or regulatory problem. They can directly affect patient safety, treatment outcomes and confidence in healthcare services.
A medicine that does not contain the correct active ingredient may fail to treat the condition for which it was purchased. A contaminated product may introduce additional health risks, while a medicine with an inadequate quantity of its active ingredient may fail to produce the expected therapeutic effect.
For patients managing serious illnesses, the consequences can be especially concerning.
Stronger penalties are therefore being proposed as one measure for discouraging the manufacture and distribution of products that fail to meet acceptable standards.
Nevertheless, increasing punishment alone cannot eliminate counterfeit medicines. The effectiveness of any amendment will depend on how the law is implemented, how quickly suspicious products are identified and how consistently offenders are held accountable.
Existing Nigerian Law Already Prohibits Counterfeit Medicines
Nigeria’s Counterfeit and Fake Drugs and Unwholesome Processed Foods (Miscellaneous Provisions) Act establishes offences involving the production, importation, manufacture, sale, distribution and possession of prohibited pharmaceutical products.
The legislation also covers activities that assist or facilitate the production and distribution of such products.
The law distinguishes these offences from the unlawful hawking or sale of medicines and poisons in places that are not licensed or registered by the appropriate authority.
Under the existing provisions reproduced in the legislation published by the National Agency for Food and Drug Administration and Control (NAFDAC), a person convicted of an offence involving counterfeit and fake drugs under Section 1 may face a fine of up to ₦500,000, imprisonment for a term of not less than five years and not more than 15 years, or both.
For offences under Section 2(1), relating to the hawking or sale of drugs or poisons in prohibited premises or places, the existing law provides for a fine of up to ₦500,000, imprisonment for at least two years, or both.
These provisions illustrate the distinction between the current statutory penalties and the tougher sanctions being advocated by the PSN.
The society’s recommendations would need to be considered through the appropriate legislative process before any new penalties could become enforceable.
The National Assembly would also need to ensure that the final provisions clearly define the relevant offences and establish the applicable punishments.
Until any amendment takes effect, the penalties provided by the applicable existing legislation remain distinct from proposals submitted for consideration.
Why Counterfeit Medicines Are a Public Health Concern
Counterfeit and substandard medicines present risks that extend beyond individual consumers to Nigeria’s wider healthcare system.
Medicines are expected to meet established standards relating to their ingredients, strength, quality, safety and performance. When products fail to meet those requirements, patients may not receive the treatment they need.
The risks can take different forms.
A counterfeit product may be deliberately misrepresented as a genuine medicine. A substandard product may fail to meet the required quality standards, while an expired medicine may no longer be suitable for use.
Adulterated medicines may also contain substances that compromise their safety or effectiveness.
For consumers, distinguishing between genuine and fake products can be difficult, particularly when packaging, labels and branding have been designed to imitate legitimate pharmaceutical products.
The problem can become more challenging when medicines are sold through informal channels or by individuals who lack the necessary authorisation to distribute them.
The consequences may include ineffective treatment, avoidable complications and additional financial pressure on households that must purchase replacement medicines or seek further medical attention.
Where treatment fails because a patient receives an ineffective or unsafe product, the resulting harm may also complicate the work of healthcare professionals attempting to diagnose and manage the underlying condition.
The circulation of counterfeit medicines can consequently undermine confidence in pharmacies, medicine suppliers and the wider healthcare system.
For these reasons, the PSN’s proposal places stronger legal sanctions within a broader effort to improve the integrity of Nigeria’s pharmaceutical market.
Role of NAFDAC and Other Regulatory Authorities
Effective action against counterfeit medicines requires cooperation between regulatory authorities, law enforcement agencies, licensed pharmaceutical professionals and other relevant institutions.
NAFDAC has a central role in regulating medicines and other products within its statutory responsibilities. Its functions include regulatory oversight and action against products that do not comply with applicable requirements.
The existing counterfeit drugs legislation also provides for enforcement structures, including federal and state task forces and a police squad.
These arrangements are intended to support efforts to identify prohibited products and address activities that violate the law.
However, enforcement can be complicated by the movement of medicines through multiple stages of the supply chain.
A product may pass through manufacturers, importers, wholesalers, distributors, retailers and other intermediaries before reaching the consumer. Establishing responsibility for a violation may therefore require investigators to examine records, trace suppliers and determine the circumstances under which the product entered circulation.
Effective enforcement also depends on the availability of reliable evidence, appropriate laboratory testing where necessary and the capacity to pursue cases through the courts.
The proposed penalties would have greater practical value if accompanied by consistent inspections, improved supply-chain monitoring and effective coordination among the relevant institutions.
Regulatory authorities must also be able to distinguish between deliberate criminal conduct and other compliance failures according to the applicable law and the evidence available in each case.
This distinction is important for ensuring that enforcement remains fair, transparent and consistent with due process.
Why Financial Penalties and Imprisonment Matter
The PSN’s proposal reflects the view that the penalties attached to serious pharmaceutical offences should be sufficiently substantial to discourage violations.
Financial penalties can impose direct costs on offenders, while imprisonment can remove convicted individuals from the market for a period determined by the courts.
However, the effectiveness of these sanctions depends on more than their severity.
If offences are rarely detected or prosecutions are unsuccessful, even substantial penalties may have limited deterrent effects. Conversely, a credible enforcement system that consistently identifies violations and secures lawful convictions can strengthen compliance.
The relationship between penalties and enforcement is therefore important when assessing the likely impact of the proposed amendments.
The final legislation would also need to provide clarity about the circumstances in which different punishments apply.
Clear provisions can help regulators, prosecutors, courts, pharmaceutical businesses and members of the public understand the legal consequences of specific offences.
For legitimate businesses, consistent enforcement can also help protect competition by reducing the advantage enjoyed by operators who sell illegal or substandard products while avoiding the costs associated with meeting regulatory requirements.
The wider objective is to support a pharmaceutical market in which medicines can be obtained through lawful channels and consumers can have greater confidence in the products available to them.
Implications for Patients, Pharmacies and Medicine Suppliers
The proposed changes could have implications for different groups across Nigeria’s healthcare and pharmaceutical sectors if the recommendations are adopted.
For patients, stronger enforcement could help reduce exposure to unsafe products, provided the penalties are supported by effective monitoring and prosecution.
For licensed pharmacies and legitimate medicine suppliers, the measures could strengthen efforts to address unfair competition from operators who distribute prohibited products.
For manufacturers and importers, the debate reinforces the importance of maintaining appropriate quality controls, accurate product documentation and compliance with applicable regulatory requirements.
Businesses operating in the pharmaceutical supply chain may also need to ensure that they can verify their suppliers and maintain records that support the traceability of the products they distribute.
However, the consequences of any amendment will depend on its final wording and implementation. It would be premature to assume that the proposed penalties have already changed the obligations of businesses or the punishments available to courts.
The legislative process provides an opportunity to examine whether the proposed sanctions are clear, proportionate to the offences and capable of being enforced effectively.
It also allows lawmakers to consider how the penalties would interact with existing pharmaceutical regulations and other relevant laws.
Legislative Process Will Determine the Final Penalties
The PSN’s recommendations form part of the ongoing consideration of amendments to Nigeria’s pharmaceutical regulatory framework.
The proposal does not, by itself, establish new criminal penalties. Recommendations submitted by a professional body must be considered through the relevant legislative procedures before they can become law.
Lawmakers will need to examine the proposed provisions, consider their implications and determine the wording of any amendment that proceeds through the legislative process.
The final outcome will depend on the provisions adopted and the completion of the necessary legal procedures.
The distinction between a proposal and an enacted law is essential when reporting changes to criminal penalties. Until the relevant amendment becomes legally effective, the proposed fines and prison terms should not be presented as punishments that have already replaced existing provisions.
The PSN’s recommendations nevertheless place the issue of counterfeit medicines and the adequacy of existing sanctions firmly within the legislative debate.
They also highlight the connection between pharmaceutical regulation, public health protection and the enforcement of criminal law.
What Happens Next?
The next important development will be the consideration of the proposed amendments by the relevant legislative authorities.
The recommendations will need to be assessed alongside the existing legal framework and any other proposals intended to strengthen the regulation of medicines and processed foods.
If lawmakers adopt changes to the law, the final text will determine the offences covered, the applicable penalties and the conditions under which those penalties can be imposed.
Regulatory authorities and law enforcement agencies would then be responsible for implementing the relevant provisions within their respective mandates.
For the public, the immediate priority remains obtaining medicines through legitimate and appropriately regulated channels, following professional medical advice and avoiding products whose authenticity or quality cannot be established.
Consumers who suspect that a medicine is counterfeit or unsafe should seek advice from a qualified healthcare professional and report their concerns through the appropriate regulatory channels.
Pharmaceutical professionals and businesses also have an important role in maintaining proper procurement and distribution practices and complying with applicable standards.
Ultimately, the proposed penalties will need to be assessed not only by the size of the fines or the length of prison sentences but also by whether the final law improves detection, prosecution and prevention.
The central question is whether stronger legal provisions, supported by effective enforcement, can help protect Nigerians from counterfeit and substandard medicines.
For the Pharmaceutical Society of Nigeria, tougher punishment is part of the proposed response. The effectiveness of that approach will depend on the final decisions of lawmakers and the ability of the relevant institutions to enforce the law consistently.
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Sources
- Pharmaceutical Society of Nigeria — position on proposed amendments to counterfeit drugs legislation, as reported by TV360 Nigeria.
- National Agency for Food and Drug Administration and Control — Counterfeit and Fake Drugs and Unwholesome Processed Foods (Miscellaneous Provisions) Act.
- National Assembly of Nigeria — legislative records concerning amendments to the counterfeit drugs legislation.
- Premium Times — reporting on legislative efforts to strengthen Nigeria’s legal framework against counterfeit medicines.
