The National Agency for Food and Drug Administration and Control (NAFDAC) has revealed a concerning issue, stating that over 50% of certificates of pharmaceutical products imported into Nigeria are counterfeit. This revelation was made by the Director-General of NAFDAC, Prof Mojisola Adeyeye, during a stakeholders’ engagement meeting in Abuja with regulators, policymakers, and law enforcement agencies.
The certificate of a pharmaceutical product is issued according to the format recommended by the World Health Organisation (WHO). It serves to establish the status of the pharmaceutical product and the applicant for the certificate in the exporting country. Notably, each certificate is specific to a single product, as manufacturing arrangements and approved information for various dosage forms and strengths can vary.
Adeyeye emphasized that the primary objective of the engagement meeting with stakeholders is to ensure that medical products in circulation meet the required standards of quality, safety, and efficacy. She highlighted the critical importance of addressing the prevalence of substandard and falsified products, as they pose a significant threat to the accessibility of safe, efficacious, and affordable medicines. This issue, if left unattended, could undermine the achievement 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 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.
“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 the responsibility is our people that go to China or India and we are going to deal with it. It’s a Member States issue, and we are going to deal with it.
“We are very stringent than ever and there is no cutting of corners, we have blacklisted many companies, we have sanctioned them because we want people to respect our people. Trade is a mutual agreement and if that agreement is harming one part of the agreement, we will stop it. If a company is suspected to be compromising, in two hours we will be there, and we will shut the company down,” she noted.
The NAFDAC boss lamented that the relatively high prevalence of substandard and falsified medicines in Africa is a major 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.
“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,” she stated.
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.
The ML 4 status is the highest in the WHO’s classification of regulatory authorities for medical products.