The National Agency for Food and Drug Administration and Control (NAFDAC) has disclosed that more than 50% of certificates issued for pharmaceutical products imported into Nigeria are counterfeit.
This revelation was made by Prof. Mojisola Adeyeye, the Director-General of NAFDAC, during a stakeholders’ engagement meeting held in Abuja with regulators, policymakers, and law enforcement agencies.
A pharmaceutical product certificate, following the format recommended by the World Health Organisation (WHO), serves to authenticate the status of the pharmaceutical product and its applicant in the exporting nation.
Prof. Adeyeye elucidated, “The goal of the engagement meeting with the stakeholders is to ensure that medical products in circulation are of the right quality, safe, and efficacious.”
She emphasised that substandard and falsified products pose a significant threat to the accessibility of safe, effective, and affordable medicines, thus undermining the attainment of universal health coverage in Nigeria and across Africa.
“We have 55 countries in Africa and we belong to the Member States globally and we agreed to ensure that products coming to the region are of quality and WHO created a scheme called a certificate of pharmaceutical product, and what this means is that if we send a certificate of pharmaceutical product out to another country, we are assuring the receiving country that it will be of quality,” Adeyeye remarked.
She further pointed out the responsibility shared among stakeholders, particularly in scrutinising suppliers from regions like Southeast Asia, where a significant portion of medicines originate.
NAFDAC’s stringent measures against substandard products were underscored by Adeyeye, who highlighted the blacklisting and sanctioning of numerous companies found to compromise quality standards.
Addressing the prevalence of substandard and falsified medicines in Africa, Adeyeye attributed it partly to inadequate regulatory processes, citing that only a small fraction of national regulatory agencies have achieved maturity level three according to WHO standards.
“Only about 10 percent of national regulatory agencies have attained maturity level three. What leads to maturity level three is market control, and that is one of the nine models of maturity level three, so we have a lot of work to do in Africa.
“The NAFDAC’s mandate puts a burden on us to see a reduction in substandard and falsified medicines, both the ones that are locally manufactured and the ones that are imported.”
“NAFDAC is doing its best to fight substandard and falsified medicines and products based on three thematic areas, which are to prevent, detect, and respond. It is a community effort to fight this and we seek partnership to find out lapses so we can fight it.” Adeyeye affirmed.
In 2022, WHO certified NAFDAC as possessing a stable, well-functioning, and integrated regulatory system, earning it a maturity level 3 rating on the Global Benchmarking Tool. This recognition positions NAFDAC for inclusion in the transitional WHO-listed authority, a testament to its adherence to global standards in regulation.