Over 50% Certificates Of Imported Pharmaceutical Products Fake — NAFDAC

The National Agency for Food and Drug Administration and Control (NAFDAC) has disclosed that over 50 percent of certificates of imported pharmaceutical products into Nigeria are counterfeit.

The Director-General of NAFDAC, Prof. Mojisola Adeyeye, made this revelation during a stakeholders’ engagement meeting with regulators, policymakers, and law enforcement agencies held in Abuja on Monday.

The certificate of a pharmaceutical product follows the format recommended by the World Health Organization. It confirms the status of the pharmaceutical product and the applicant for the certificate in the exporting country.

This certificate is specific to a single product, given that manufacturing arrangements and approved information for various dosage forms and strengths can differ.

Adeyeye indicated that the objective of the meeting with stakeholders is to ensure that medical products available in the market are of appropriate quality, safe, and effective.

She also stated that substandard and falsified products pose a threat to the accessibility of safe, effective, and affordable medicines and hinder the attainment of universal health coverage in Nigeria and 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 who 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.

The World Health Organization (WHO) certified NAFDAC in 2022, affirming its stable, well-functioning, and integrated regulatory system with a maturity level 3 rating on the Global Benchmarking Tool scale.

NAFDAC meets the criteria for inclusion in the transitional WHO Listed Authority, a compilation of the world’s regulatory bodies of reference recognized for meeting WHO and other international standards.

Attaining ML 4 status signifies the highest level in the WHO’s classification of regulatory authorities for medical products.