The National Agency for Food and Drug Administration and Control (NAFDAC) on Monday said over 50 per cent of imported pharmaceutical product certificates in Nigeria are counterfeit.
The Director-General of NAFDAC, Prof Mojisola Adeyeye made this known at the stakeholders’ engagement meeting with regulators, policymakers, and law enforcement agencies in Abuja.
The pharmaceutical product certificate, following the World Health Organization’s (WHO) guidelines, verifies both the status of the product and the applicant in the exporting country.
It is for a single product only since manufacturing arrangements and approved information for different dosage forms and different strengths can vary.
Prof Adeyeye said that substandard and falsified products threaten access to safe efficacious and affordable medicines, and undermine the achievement of universal health coverage in Nigeria, and Africa.
She highlighted that “WHO created a scheme called Certificate of Pharmaceutical Product (CPP)and what this means is that if we send a CPP out to another country, we are assuring the receiving country that it will be of quality.
“Most of our medicines come from South East Asia and we belong to the member states too. We have a scheme where before medicines that were approved leave that part of the world, we do pre-shipment testing, and that comes with CPP to assure us of quality, but that is not the case, because through our scheme we have been able to stop over 140 products that were approved from coming in.
“We found out that more than 50 per cent of the CPPs that come into our country are fake. Part of those responsible is our people that go to China or India and we are going to deal with it.“
She said the agency is more stringent than ever, hence there is no cutting of corners.
She noted that trade is a mutual agreement and if that agreement is harming one part of the agreement, it will be stopped.
“If a company is suspected to be compromising, in two hours we will be there, and we will shut the company down,” She said.
A major threat
The head of NAFDAC expressed concern that the significant prevalence of substandard and falsified medicines in Africa poses a substantial threat to public health.
According to her, the prevalence of substandard and falsified medicines in the region is due to limited regulation processes.
“Only about 10 per cent 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,” She said.
“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.”
Prof Adeyeye said the agency is doing its best to fight substandard and falsified medicines and products based on three thematic areas, which are to prevent, detect, and respond.
In 2022, the WHO certified NAFDAC as a stable, well-functioning, and integrated regulatory system maturity level 3 rating scale of the Global Benchmarking Tool.
According to WHO, NAFDAC is eligible for inclusion into the transitional WHO Listed Authority, a list that will comprise the world’s regulators of reference – that is, regulatory authority that should be globally recognised as meeting WHO and other international standards.