NAFDAC threatens closure, prosecution of drug dealers over counterfeit medicines
The National Agency for Food and Drug Administration and Control (NAFDAC) has intensified its crackdown on counterfeit and substandard medicines, warning patent medicine dealers in Imo State that businesses involved in distributing unregistered, expired and falsified drugs risk closure, product forfeiture, heavy fines and criminal prosecution.
The enforcement drive comes amid concerns over illegal practices within Nigeria’s pharmaceutical distribution chain, including the circulation of expired medicines, tampering with product labels and the sale of unregistered substances, exposing consumers to potentially life-threatening health risks.
Director-General of NAFDAC, Prof. Mojisola Adeyeye, issued the warning in Owerri during a sensitisation workshop on pharmacovigilance and drug distribution safety organised for members of the Nigerian Association of Patent and Proprietary Medicine Dealers (NAPPMED).
Represented by the agency’s South-East Zonal Director, Dr Festus Ukadike, Adeyeye condemned operators who prioritise commercial gains over consumer safety, insisting that no financial consideration could justify the distribution of dangerous medicines.
She warned that the sale of unregistered medicines amounted to dealing in fake products, stressing that regulatory compliance was non-negotiable for operators across the pharmaceutical supply chain.
The NAFDAC chief identified illegal revalidation of expired medicines, alteration of product labels and procurement from unverified itinerant suppliers offering unusually low prices as major threats to the integrity of drug distribution in the country.
She also reiterated the prohibition of dangerous and unregistered substances, specifically identifying high-dose tramadol variants, unapproved mixtures known as anarcha and discontinued oral suspensions among products still being circulated illegally at the grassroots level.
“Expired medicines have no second life; once they have expired, they must never be given a second chance to endanger human lives,” she said.
To strengthen enforcement, the agency has deployed intelligence-driven surveillance operations and digital handheld scanners to monitor pharmaceutical supply chains, identify illegal warehouses and shut down premises operating outside regulatory requirements.
NAFDAC warned that operators found engaging in criminal alteration of expiry dates or distributing falsified medicines would face business closure, confiscation of products, administrative penalties and possible criminal prosecution.
Beyond enforcement, the agency is also targeting weaknesses in storage, procurement and distribution practices that allow substandard medicines to enter the retail market.
Assistant Chief Regulatory Officer at NAFDAC, Dr. Cletus Agwu, who delivered a presentation on Good Storage and Distribution Practices, urged wholesalers and patent medicine vendors to source products exclusively from authorised manufacturers and licensed distributors.
He emphasised the need for proper documentation, temperature control and quality assurance throughout the distribution chain, warning that poor storage conditions could compromise the effectiveness and safety of medicines even before their expiry dates.
“Whatever is not documented is not done,” Agwu said, underscoring the importance of traceability and accountability in pharmaceutical distribution.
In a separate presentation on pharmacovigilance, NAFDAC Imo State Coordinator, Mrs. Helen Okanya, called for stronger post-market surveillance through the reporting of suspected adverse drug reactions and substandard products.
She explained that no medicine was entirely free from potential risks, making continuous monitoring essential to identifying safety concerns after products had entered the market.
Okanya urged patent medicine dealers to use NAFDAC’s digital MedSafety App to report suspected adverse reactions and questionable medicines, assuring them that the reporting mechanism was designed to address public health risks rather than punish compliant operators.
She disclosed that the agency had extended similar sensitisation campaigns to patent medicine dealers in the Okigwe and Orlu Senatorial Districts.
Responding on behalf of the association, NAPPMED State Chairman, Mr. Cyprian Okonkwo, commended NAFDAC for the initiative, saying the workshop had improved members’ understanding of regulatory requirements, safe storage and their responsibilities towards consumers.
He pledged to extend the training across all 27 local government areas of Imo State, with particular emphasis on identifying and rejecting prohibited substances.
Okonkwo also assured the agency of the association’s continued cooperation in eliminating counterfeit and expired medicines from the distribution chain.
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