Manufacturers pledge to work with NAFDAC on WHO status, vaccine production

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Lagos, Feb. 12, 2023 – Some pharmaceutical manufacturers have pledged to work with NAFDAC to attain  WHO Maturity Level 4 status and launch Nigeria into the league of Vaccines and Active Pharmaceutical Ingredients (APIs) producers in the world.

The manufacturers, led by Dr Fidelis Ayebae, the Chairman of Pharmaceutical Manufacturers Group of MAN (PMG-MAN), commended NAFDAC on the achievement on WHO Maturity Level 3.

He said that the group would do everything possible to support NAFDAC to continue to excel in creating an enabling environment for the industry to thrive.

‘’Let me assure you, ma, that if there is one body in foods and drugs and other related chemicals which are under your purview that want you to succeed more than anything else, that you can call success, it is PMG-MAN, he said.

Ayebae who is also the Managing Director/ Chief Executive Officer, of Fidson Healthcare Plc, promised to galvanize other chief executive officers of pharmaceutical companies in the country to collaborate with the regulatory body to make its oversight responsibility most effective to help the industry to grow.

He said that his body would form a technical committee with NAFDAC that would work with the Agency to ensure that the industry attained greater heights.

Prof Mojisola Adeyeye, the Director General of NAFDAC, while speaking at a hybrid stakeholders meeting organized by the Agency in Lagos on Pharmaceutical Traceability, said that the nation had to maintain the Maturity Level 3 attained last year by adhering strictly to the best global practices in regulatory responsibility.

‘’We are going to strengthen our operations and be more effective. We are going to get ML4. We are going to get marked for World Listed Authority apart from ML4.,’’ she said.

Adeyeye, in a statement signed by the Resident Media Consultant of NAFDAC, Sayo Akintola, said that although the Agency just met all the requirements of ML3, “but while doing that, we got some requirements also satisfied under ML4, but not all. Which means our journey is not going to be as difficult as it was for the last four plus years.’’

She said that WHO ML4 would further boost the trade aspect of the Nigeria’s pharmaceutical industry without diminishing its health implications for the Nigerian populace.

The NAFDAC boss said Nigerians would be more confident of the medicines that they were taking since the process embarked upon by the Agency was aimed at mitigating against substandard and falsified medicines.

She said that it took Ghana 13 years to get ML3, while it took Nigeria four years to attain the prestigious status, adding that achieving ML4 would really help the country’s manufacturing industry to grow.

‘’It will also help importers that are migrating from importation of pharmaceutical products to local manufacturing. It will help in terms of trade’’.

She said that NAFDAC would continue to do quality assessment that would lead to trade in the global arena, whether in West Africa or globally.

‘’That is what our journey towards ML4 is going to lead to,’’ she said.

Adeyeye said that the regulatory body would use the ML3 and the categorization of companies into low, medium and high risk based on compliance of Good Manufacturing Practice GMP to negotiate, discuss, with procurement agencies and government international partners like UNICEF so that more local manufacturing companies would be encouraged, and more liberation would be encouraged.

‘’If there is opportunity to trade or sell it means more companies will be doing liberation or doing partnership. What we want to ensure is that no substandard medicine is exported from Nigeria so that we can foster trade, we can increase our GDP, increase our forex, reduce unemployment, and make ourselves proud. Since this is on a global platform, we have to use international standard’’.

She said that during COVID-19 pandemic, a Nigerian entrepreneur produced medical masks that were exported to the U.S.

‘’We got the approval for these medical masks. They were exported to the US under Emergency Use Authorization. That’s the first medical product that Nigeria would make that would get to the shores of the US’’.

She said when it got to the US, they said no. Can anything good come out of Nigeria?

Adeyeye said the product was left at the port for about a month before it was examined, adding that they got it approved for Emergency Use Authorization and our pharmacists were so excited that a product from Nigeria could make it to a stringent regulatory country like the U.S.

‘’That is what I want to see with our products. We can do it. That is the path we are going with ML4.’’

She said that the nation was already preparing for vaccine and Active Pharmaceutical Ingredients (APIs) manufacturing with huge Federal Government’s support to upgrade NAFDAC vaccine laboratory.

Adeyeye said that the vaccine laboratory of NAFDAC was about 70 per cent completed and would be ready for use in the next six months.

She said that NAFDAC was the only agency in sub-Sahara Africa that had its own in house biologics and vaccine laboratory.

‘’We have a lot going for us as a country. We just have to get our acts together and start producing. I know it’s a lot of work’’.

Adeyeye said government was also supporting the manufacturers financially through intervention funds.

She said that COVID-19 thought Nigeria a lesson, stressing “that it has shown us that if you don’t have your own, you have to depend on others.

She said that the COFAD facilities targeted supplying vaccine to only 20 per cent of Nigeria’s population in their vaccine distribution to low-income countries.

‘’We didn’t even get to that level because of the low prevalence. But you can imagine if we had very high prevalence, but you never know what is around the corner.

“Whether it is pandemic or epidemic we need to manufacture our own vaccines’’.

Adeyeye couldn’t hide her excitement over the manufacturing of Active Pharmaceutical Ingredients, APIs, in the country.

‘’I want to say kudos to our companies, especially Emzor Pharmaceuticals that has started building the manufacturing facility.

“This is huge for us in Africa. It’s huge for Nigerians. It involves a lot of money but that is where the gains come in’’.

‘’Manufacturing of APIs has to be strategic. Everybody cannot be manufacturing antimalarial because our goal is not just for use here.

“It’s also for trade. When we build, they will come to Nigeria to buy,’’ she said. (GBN)

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