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The Director General of the National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye, has solicited the support of international partners in contributing to the establishment of vaccines manufacturing facilities in Nigeria.
The DG NAFDAC made the call at the 8th Nigeria Pharma Manufacturers’ Expo jointly organised in Lagos by the Pharmaceutical Manufacturing Group of the Manufacturers Association of Nigeria (PMG-MAN) and PGE Expo PVT Limited, where she acknowledged the continued support of international partners in the agency’s trajectory in attaining Maturity Level 3.
Prof Adeyeye told the array of international organisations with remarkable footprints in the healthcare space medicare around the world that their contributions would be immensely appreciated in the fill and finish modular vaccine manufacturing in Nigeria.
According to the NAFDAC boss, NAFDAC has nine functions and requirements to meet to become fully benchmarked for medicines and vaccines. She said that the agency had only been benchmarked in eight, leaving out the last one, which is Lot Release for vaccines.
‘We want to call on our international partners that have been of tremendous help. Without them we wouldn’t have been here. I want to challenge them to contribute, to fill and finish Modular Vaccine manufacturing so that we can get our Vaccine Lot Release,’ she reiterated, adding that Nigeria has all it takes for the attainment aside from the local vaccines manufacturing.
‘To get Lot Release -Maturity Level 4, we have figured it out in a way we have estimated. It’s not going to cost too much. We will share that with you. Because we cannot afford to go back to where we used to be,’ she said.
She recalled with nostalgia that NAFDAC used to manufacture vaccine, adding that ‘It’s high time we went back to vaccine manufacturing.’
She commended President Bola Ahmed Tinubu for his game changing Executive Order 2024 which brought life to NAFDAC’s persistent clamour for incentives for the local pharma manufacturers who had been operating under harsh economic conditions over the years.
‘I understand the stress our manufacturers are going through. Our manufacturers are patriots because they could have given up. I was championing incentives for the manufacturers until President Tinubu came on board with the Executive Order of 2024,’ she said, adding that ‘nobody heard of us outside the regulatory and manufacturing industry and the gain that we have attained from regulatory and industry were not brought to the surface until the President came up with the Executive Order’
She maintained that both the Coordinating Minister of Health and Social Welfare and his Minister of State for Health at that time also bought into the rationale that we needed to give incentives, noting that that was partly how the initiative of unlocking the value chain came up.
‘It has been a journey,’ she said, adding that she started with Good Manufacturing Practice Roadmap when NAFDAC inspectors went around the country for eight months for GMP compliance audit of over 165 companies. The initiative was funded by the USAID and executed by the United States Pharmacopeia.
‘We started the journey of not just the industry making products but making quality products because this is intricately tied to the way the patient’s positive health outcomes during treatment. There would not be treatment failure.’
This was during routine GMP inspection not during the roadmap
‘Where has it taken us – 2021 -2025, We went into our data matrix, and we realised that we had decreased import of products under ‘5 plus 5’ and the Ceiling Initiative by 70 per cent because our manufacturers took up the challenge and came up with “yes we can.”
She said the manufacturers were prepared to ensure that the health of our citizenry is top priority and their standing in the international market with quality products is enhanced.
Prof Adeyeye noted that this was made possible because NAFDAC kept improving the competence of NAFDAC staff, stating that ‘you cannot give what you don’t have.’
She added that these efforts had earned the agency recognition by international institutions. ‘We became a member of International Medical Device Forum in 2023. Our Lab in Yaba became WHO Pre-qualified in September 2023.’
She explained that WHO doesn’t give Maturity Level 3 as a one-off crown kind-of-thing. Rather, she said they come back and re-benchmarked the Agency to make sure that NAFDAC has remained strong, consistent and resilient. She said NAFDAC became the first agency in Sub Saharan Africa to be re-benchmarked successfully the first time.
‘All this is because of our industry. It’s because of our citizens, she said, adding that NAFDAC is one of the 194 regulatory agencies across the world, and the Agency is judged alike irrespective of size or economic status of the country.’
The Chairman of PMG-MAN, Mr Oluwatosin Jolayemi said the gathering is the only platform for complete pharma manufacturing expo in Central and West Africa, bringing together manufacturers, regulators, investors, development partners and other critical stakeholders to showcase industry capabilities, forge partnerships and shape the future of the industry.
Mr. Jolayemi, who also doubles as the Managing Director/ CEO of Daily Need limited, commended Prof Adeyeye for her steadfastness towards ensuring that the industry moves in the direction of international best practices in quality and GMP compliance.
He noted with delight that NAFDAC’s policies are beginning to change the ecosystem, stressing that the gains must be sustained.
He, however, called for an extension of the presidential executive order for another two years at the expiration in March 2027 on the premise that journey towards Medicine Security and Pharma Sovereignty is not a short-term intervention, adding that it requires policy consistency, investment, capability development and a predictable operating environment.
A total of 132 participating companies from the U.S. China, Argentina, Egypt, India, Rwanda, Austria, UAE, France, Germany, Indonesia and Nigeria amongst others took part in the two – day expo.
•PHOTO, R-L: Director General of the National Agency for Food and Drug Administration and Control NAFDAC, Prof Mojisola Adeyeye, Host, and Managing Director/CEO of May and Baker Limited, Mr. Patrick Ajah, and other guests at the event at the 8th Nigeria Pharma Manufacturers’ Expo jointly organised in Lagos by the Pharmaceutical Manufacturing Group of the Manufacturers Association of Nigeria (PMG-MAN) and PGE Expo PVT Limited.