Nigeria’s longstanding problem with counterfeit and substandard medicines is partly the result of gaps in the country’s pharmaceutical regulatory system, Mojisola Adeyeye, director-general of the National Agency for Food and Drug Administration and Control (NAFDAC), has said.
Adeyeye made the disclosure during an interview on Channels Television’s Sunrise Daily on Wednesday, amid renewed scrutiny of NAFDAC’s efforts to tackle the circulation of falsified and unapproved medicines and other regulated products.
According to her, changes in the regulation of patent medicine dealers over the years contributed to the expansion of open drug markets and allowed people without sufficient knowledge of medicines to enter the trade.
‘Decades ago, we had controlled patent medicine dealers and the Pharmacy Council of Nigeria was in charge,’ Adeyeye said.
She explained that responsibility for controlling patent medicine dealers was subsequently removed from the Pharmacy Council of Nigeria (PCN) for several years before being returned.
By then, she said, the market had become populated by traders who lacked adequate knowledge of medicines.
Adeyeye linked the development to the persistence of substandard and falsified medicines in the country, saying Nigeria had, in effect, created some of the conditions that allowed the problem to develop.
She, however, said the situation could not be reversed overnight because the weaknesses had accumulated over several decades.
‘The problems that have been there for decades, you can’t change it overnight, but we’re changing it,’ she said, adding that the transformation could take several years.
NAFDAC moves towards international standards
The NAFDAC chief also pointed to changes in the agency’s drug registration process as part of efforts to strengthen pharmaceutical regulation.
She said the agency now uses the Common Technical Document (CTD), an internationally recognised template for the registration of medicines.
According to Adeyeye, applying international standards to drug registration is necessary to strengthen the quality and safety of medicines entering the Nigerian market, although the process requires time.
The comments come as NAFDAC intensifies post-market surveillance and enforcement operations across the country.
The agency said its nationwide surveillance between May and July resulted in 7,210 products being mopped up across food and water, drugs and herbals, cosmetics, medical devices, vaccines and biologics, and chemicals.
Food and water accounted for 3,633 of the products removed, while drugs and herbals accounted for 2,459.
NAFDAC also said it had secured 64 convictions for counterfeiting, with prison terms ranging from one to seven years without an option of a fine.
Adeyeye said NAFDAC received 225 complaints relating to suspected counterfeit products in August, highlighting the continued scale of the problem facing regulators and consumers.
The agency’s intensified enforcement activities have also attracted resistance from some traders and businesses affected by its actions.
NAFDAC has shut premises and seized products suspected to be unregistered or non-compliant as part of its efforts to remove potentially harmful products from the market.
Its enforcement of the ban on alcoholic drinks packaged in sachets and PET or glass bottles below 200ml has also generated protests from some retailers, who have raised concerns about losses and the impact of the seizures on their businesses.
The regulatory pressure comes against the backdrop of a pharmaceutical market that remains heavily dependent on imports.
More than 70 percent of medicines consumed in Nigeria are imported, while local pharmaceutical manufacturers rely heavily on imported raw materials and active pharmaceutical ingredients, according to industry estimates according to reports.
This dependence exposes manufacturers to foreign exchange volatility and higher production costs, potentially adding pressure to medicine prices and availability.
For NAFDAC, however, Adeyeye said addressing the counterfeit medicine problem requires sustained regulatory reform rather than short-term interventions.
The agency has increasingly relied on post-market surveillance, intelligence gathering, laboratory testing, raids, seizures, prosecutions and public reporting to identify and remove non-compliant medicines from circulation.