Over 50% certificates of imported pharmaceutical products fake

The National Agency for Food and Drug Administration and Control said more than 50 per cent of certificates of pharmaceutical products that are imported into Nigeria are fake.

The Director-General of NAFDAC, Prof Mojisola Adeyeye, disclosed this at the stakeholders’ engagement meeting with regulators, policymakers, and law enforcement agencies on Monday in Abuja.

The certificate of a pharmaceutical product is issued in the format recommended by the World Health Organisation, and it establishes the status of the pharmaceutical product and the applicant for the certificate 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.

Adeyeye said 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 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.

“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.