John Abiodun, Abuja
The National Agency for Food and Drug Administration and Control (NAFDAC) has warned patent medicine dealers in Imo State that businesses involved in the distribution of counterfeit, unregistered and expired medicines risk closure, product confiscation, heavy fines and criminal prosecution.
The warning forms part of the agency’s intensified crackdown on substandard and falsified medicines, amid growing concerns over illegal practices in Nigeria’s pharmaceutical distribution chain, including the sale of expired drugs, alteration of product labels and circulation of unregistered substances.
NAFDAC Director-General, Prof. Mojisola Adeyeye, issued the warning in Owerri during a sensitisation workshop on pharmacovigilance and safe drug distribution 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 drug dealers who place commercial interests above public health, insisting that no financial gain could justify the distribution of medicines capable of endangering human lives.
She described the sale of unregistered medicines as dealing in fake products and stressed that compliance with regulatory standards was mandatory for all operators in the pharmaceutical supply chain.
The NAFDAC boss identified the illegal revalidation of expired medicines, alteration of product labels and procurement from unverified itinerant suppliers offering unusually cheap products as major threats to the safety and integrity of drug distribution in the country.
She also reiterated the prohibition of dangerous and unregistered substances, particularly high-dose tramadol variants, unapproved mixtures known as anarcha and discontinued oral suspensions, which she said were 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.
Adeyeye disclosed that the agency had strengthened its enforcement operations through intelligence-driven surveillance and the deployment of digital handheld scanners to monitor pharmaceutical supply chains, identify illegal warehouses and shut down facilities operating outside approved regulatory standards.
She warned that dealers involved in falsifying expiry dates or distributing counterfeit medicines would face business closure, confiscation of products, administrative penalties and possible criminal prosecution.
Beyond enforcement, NAFDAC is also seeking to address weaknesses in the storage, procurement and distribution of medicines that allow substandard products to enter the retail market.
In a presentation on Good Storage and Distribution Practices, the agency’s Assistant Chief Regulatory Officer, Dr. Cletus Agwu, urged wholesalers and patent medicine vendors to obtain their products exclusively from authorised manufacturers and licensed distributors.
He stressed the importance of proper documentation, temperature control and quality assurance throughout the distribution chain, warning that inappropriate storage conditions could compromise the safety and effectiveness of medicines even before their expiry dates.
“Whatever is not documented is not done,” Agwu said, emphasising the need for traceability and accountability in pharmaceutical distribution.
Similarly, NAFDAC Imo State Coordinator, Mrs. Helen Okanya, called for improved post-market surveillance through the prompt reporting of suspected adverse drug reactions and substandard medicines.
In her presentation on pharmacovigilance, Okanya explained that no medicine was entirely without potential risks, making continuous monitoring necessary to identify safety concerns after products had entered the market.
She urged patent medicine dealers to adopt the agency’s digital MedSafety App for reporting suspected adverse reactions and questionable pharmaceutical products.
According to her, the reporting platform is intended to help identify and address public health risks rather than punish operators who comply with regulatory requirements.
Okanya added that NAFDAC had extended similar sensitisation campaigns to patent medicine dealers in the Okigwe and Orlu Senatorial Districts of the state.
Responding on behalf of the association, NAPPMED State Chairman, Mr. Cyprian Okonkwo, commended NAFDAC for organising the workshop, noting that it had improved members’ understanding of regulatory requirements, proper drug storage and their responsibilities towards consumers.
He pledged that the association would extend the training to members across all 27 local government areas of Imo State, with particular emphasis on identifying and rejecting prohibited substances.
Okonkwo also assured NAFDAC of the association’s continued cooperation in the fight against counterfeit, expired and substandard medicines.
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