Nigeria Targets WHO Maturity Level-4 Regulatory Standards

•NAFDAC, PCN blame thriving fake medicine market on policy inconsistency

Onyebuchi Ezigbo in Abuja

As part of efforts to promote and sustain global standards in the manufacturing and distribution of pharmaceutical products in Nigeria, National Agency for Food and Drug Administration and Control (NAFDAC) and Pharmacy Council of Nigeria (PCN) have resolved to ensure that the country attained Maturity Level-4 regulatory standards of the World Health Organisation (WHO).

Against the background of growing concern over the menace of dealers on fake and substandard pharmaceuticals in the country, NAFDAC and PCN said inconsistencies in government’s policy measures were responsible for the persistence of the illicit business.

After series of in-country capacity development and facility upgrade, Nigeria was able to attain WHO certification for the Maturity Level-3 last year.

However, WHO Maturity Level 4, within the Global Benchmarking Tool (GBT) framework, signifies a regulatory system operating at an advanced level of performance and continuous improvement.

It is the highest level in WHO’s classification of regulatory authorities for medical products.

Speaking at a joint press conference in Abuja on Tuesday to mark the reaffirmation of Nigeria’s attainment of the WHO Maturity Level- -3 regulatory standards, first achieved in 2024, Director General of NAFDAC, Professor Mojisola Adeyeye, said both PCN and NAFDAC were working collaboratively to ensure that safe medicines and pharmaceutical products were provided for Nigerians.

Adeyeye explained that with the attainment of Maturity Level-3 regulatory standards, Nigeria had now been placed in a respectable position globally as a country capable of manufacturing drugs and other pharmaceutical products of global standard.

She stated, “We are going for Maturity Level four. I mentioned that for level three we had about 267 sub indicators. For level four. We have 57 Level – 4 indicators. We have already closed 27 of them.

“So, we have about 30 indicators left. We have already started working on them. Why? Because of Nigeria? Why because we can, why? Because it is important for the image of this country.

“To whom much is given. Much is demanded. God has given us so much, maybe too much. Just like I said, we don’t want to bury it. That is why PCN and NAFDAC are working day and night first, to ensure that the medicines that our people use will not kill them or constitute public health hazard.”

Adeyeye said the two agencies were looking beyond the maturity level four certification to also have WHO Listed Authority (WLA) thereby enabling Nigeria to be categorised among countries with stringent regulatory authority.

The NAFDAC director-general also lamented the damage done through years of policy summersaults by successive administrations in the country, which failed to decisively deal with the regulation of drug distribution by allowing PCN to do its job as assigned by law.

Speaking on the recent nationwide enforcement drive against the sale of fake and substandard medicine and other products at the three big drug markets in Lagos, Onitsha, and Aba, Adeyeye said NAFDAC spent close to N1.5 billion to execute the exercise.

She said the agency was planning to disburse the remaining N200 million to its branches across the country to continue the enforcement exercise.

Registrar of PCN, Pharm. Ibrahim Ahmed, traced the manufacture and distribution of fake and substandard pharmaceutical products in the country to the ill-advised takeover of functions of PCN by non-professionals.

Ahmed said until recently, PCN was barred from enforcing drug distribution standards by a judicial order obtained by the illicit drug barons operating under the guise of Patent Medicine Dealers Association.

Ahmed said the drug merchants took advantage of the weak policies of the federal and state governments, which often transferred regulatory functions from PCN to non-professional bodies, thereby throwing the sector opening to all manner of abuses.

While recounting experiences during the Maturity Level-3 revalidation exercise carried out by the WHO team, Ahmed said the engagement had enabled the country to scale up training activities and to ensure better standards in the health sector

He said, “Indeed, it was a very rigorous exercise. It was an exercise that was put out to ascertain whether the standard we use for the regulation of the pharmaceutical landscape, which, of course, the ultimate product is the medicine, actually aligns with global standards.

“We are looking forward at moving ahead. What that means is that we are taking steps to improve what we are doing and to really justify this is the fact that recognizing the fact that facility licensure is very critical within the pharmaceutical landscape. Just yesterday, we commenced the retraining of all national pharmaceutical inspectors in this country.”

While answering questions on measures being taken to regulate online sale of pharmaceutical products, Ahmed said the council had commenced the licensing of facilities involved in sale of medicines with a view to checking abuses.

He stated, “We have commenced the licensing of facilities involved in sale of medicines and we have also put in place mechanism for enforcement, because people selling medicines online do not have a location, many of them, and they could, they are not bounded by borders.

“So, we recognise the fact that it’s a global thing, and because of that, he established the enforcement unit for this. We had to engage Interpol.”