NAFDAC, pharmaceutical manufacturers, and importers of pharmaceutical products, agree to collaborate to achieve WHO ML4
…Begin local production of API vaccines
Major players in the nation’s pharmaceutical industry under the aegis of Pharmaceutical Manufacturers Group- Manufacturers Association of Nigeria (PMG-MAN) have pledged to collaborate with the National Agency for Food and Drug Administration and Control NAFDAC in its renewed efforts to attain the World Health Organization 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 the Chairman of PMG-MAN, Dr Fidelis Ayebae, commended the Agency on the achievement of WHO Maturity Level 3, stressing that the group would do everything humanly 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.
Dr Ayebae who is also the Managing Director/ Chief Executive Officer, of Fidson Healthcare Plc, vowed to galvanize other chief executive officers of pharmaceutical companies in the country to ensure that they have a collaborative relationship with the regulatory body to make its oversight
responsibility over the industry most effective and help the industry to grow. He added that his body would form a technical committee with NAFDAC that would work with the Agency to ensure that the industry attains greater heights.
The Director General of NAFDAC, Prof Mojisola Adeyeye, at a hybrid stakeholders meeting organized by the Agency in Lagos on Pharmaceutical Traceability disclosed that the nation has to maintain the Maturity Level 3 attained last year by continuing to adhere 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.
Prof Adeyeye, in a statement signed by the Resident Media Consultant of NAFDAC, Sayo Akintola, said that the Agency just met all the requirement of ML3, stressing that ‘’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 emphasized the importance of WHO ML4 which according to her 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 take since the process embarked upon by the Agency is aimed at mitigating against substandard and falsified medicines to a very low prevalence.
She disclosed that it took Ghana 13 years to get ML3 while it took Nigeria four years to attain the prestigious status, adding that achieving ML4 will 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 reiterated that NAFDAC will continue to do quality assessment that
will 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 further explained that the regulatory body will use the ML3 and 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, make ourselves proud. Since this is on a global platform, we have to use international standard’’.
During the COVID-19 Pandemic, Prof Mojisola Adeyeye explained, a Nigerian entrepreneur produced the 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? Prof 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 can 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 disclosed that the nation is already preparing for vaccine and Active Pharmaceutical Ingredients (APIs) manufacturing with huge Federal Government’s support to upgrade NAFDAC vaccine laboratory. She stated that the Agency vaccine laboratory is about 70 per cent completed and will be ready for use in the next six months.
Prof. Mojisola Adeyeye said that NAFDAC is the only agency in sub-
Sahara Africa that has its own inhouse 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’’. She however, said that government is also supporting manufacturing financially with the details being worked out, noting that the government also supported by giving intervention funds to some companies to rejig their infrastructure.
She opined that COVID-19 has thought us a lesson as a country, 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’’, she said, warning that, ‘’but you never know what is around the corner. Whether its pandemic or epidemic we need to manufacture our own vaccines’’.
In preparation for that, she said NAFDAC has been going through a lot of transformation from laboratory to registration to job evaluation and research. She said staff of the Agency have gone on two rounds of training in South Korea with the support of the WHO.
Sequel to the recognition of Nigeria as one of the six countries that can manufacture vaccines in February 2022, she said the Federal Government has entered into a Public Private Partnership arrangement with Bio-vaccine. She however, enthused that one or two private companies have also indicated serious interests to manufacture vaccines in Nigeria.
The NAFDAC boss urged manufacturers to know their chain. ‘’You must know your distributors, the wholesalers, retailers. It is when you know your chain that you can guarantee the quality, it will be easier to follow through and it will be easier to identify anybody that is trying to infiltrate that chain, infiltrate your trade’’.
Armed with a lot of reports, she said the Agency has done its survey which indicated that, ‘’whether imported or local, we have identified some substandard and falsified medicines. That is not where we wish to be.
We are doing all that we can right now to make sure that the occurrence of substandard falsified medicines is mitigated’’.
The NAFDAC boss however, warned that stringent sanctions will be meted out to perpetrators of the illicit business to send the right signals to manufacturers and importers that substandard and falsified medicines end up in treatment failures, antimicrobial resistance, increases morbidity and will not be tolerated.
Prof Mojisola Adeyeye, couldn’t hid 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 antimalarials 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.
