The National Agency for Food and Drug Administration and Control (NAFDAC) has raised the alarm over fake certificates of pharmaceutical products being imported into Nigeria.
Speaking on Monday at the stakeholder engagement meeting with regulators, policymakers and law enforcement agencies in Abuja, the Director General of NAFDAC, Mojisola Adeyeye, revealed that more than 50 percent of such certificates are fake.
The certificate of a pharmaceutical product is expected to follow the guidelines of the World Health Organization (WHO) and establish the status of the product and the certificate applicant in the exporting country. According to Ms Adeyeye, substandard and counterfeit products threaten access. to safe, effective and affordable medicines, and undermine the achievement of universal health coverage in Nigeria and Africa.
He explained that the WHO created a scheme called Certificate of Pharmaceutical Product (CPP) and what this means is that “if we send a CPP to another country, we are assuring the receiving country that it will be of quality.”
According to Mrs. Adeyeye, most of the medicines imported into Nigeria come from South East Asia.
“We have a scheme where before the drugs that were approved leave that part of the world, we do pre-shipment tests, and that comes with the CPP to ensure quality, but that is not the case, because through our scheme “We have been able to stop more than 140 products that were approved for entry,” he said.
“We discovered that more than 50 percent of the CPPs that arrive in our country are fake. Part of those responsible are our people who go to China or India and we are going to take care of it.”
He said the agency is stricter than ever, so there are no shortcuts to be taken.
He noted that trade is a mutual agreement and if that agreement damages one part of the agreement, it will stop.
“If a company is suspected of making concessions, within two hours we will be there and close the company,” he said.
Ms Adeyeye expressed concern that the significant prevalence of counterfeit and substandard medicines in Africa represents a major threat to public health, adding that the prevalence of counterfeit medicines in the region is due to regulatory processes limited.
“Only about 10 percent of national regulatory agencies have reached 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,” he stated.
“The NAFDAC mandate places the burden on us to see a reduction in substandard and falsified medicines, both those manufactured locally and those imported.”
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Mrs. Adeyeye said the agency is doing everything possible to fight counterfeit and substandard medicines and products based on three thematic areas: prevent, detect and respond.
In 2022, WHO certified NAFDAC as a stable, well-functioning and integrated regulatory system in the level three maturity rating scale of the Global Benchmarking Tool.
According to the WHO, NAFDAC is eligible for inclusion in the transitional WHO Listed Authority, a list of regulatory authorities that must be globally recognized for meeting WHO and other international standards.