-
Ceases registration of sachet alcohol
By Doris Obinna
The National Agency for Food and Drug Administration and Control (NAFDAC) has disclosed its plan to prioritise maternal, newborn, and child health (MNCH) and promote local manufacturing in the country.
Unveiling its strategic plan for the year, the agency emphasised the need to strengthen its regulatory system to safeguard public health. Declaring 2025 as the year for maternal, newborn, and child health and nutrition, NAFDAC disclosed its focus on preventing postpartum haemorrhage and maternal deaths, aiming to drastically reduce child morbidity.
At a press briefing in Lagos on Thursday, the Director-General of NAFDAC, Prof. Mojisola Adeyeye, reflected on the past seven years, highlighting the agency’s accomplishments and future goals. She also announced the cessation of sachet alcohol registration since February 2024 as part of efforts to curb its accessibility, especially among young people.
Outlining the agency’s five strategic plans, Adeyeye noted the focus areas: strong governance and leadership; maternal, newborn, and child health; institutionalisation of best practices; safety and quality of regulated products; and monitoring of the supply chain.
“A cornerstone of the strategic plan is addressing the agency’s greatest need: an adequately staffed workforce,” she said. Despite NAFDAC’s extensive regulatory responsibilities, it remains acutely understaffed. To meet the World Health Organization (WHO) Global Benchmarking requirements, the agency plans to engage volunteers while awaiting statutory approval for additional hires. Adeyeye stated that NAFDAC needs a total workforce of 10,000 but currently has only 2,000 staff nationwide.
Efforts to address staffing include stringent recruitment processes to ensure integrity and competence. However, funding constraints have limited the pace of expansion. The agency plans to prioritise the regulation of maternal health products like oxytocin, tranexamic acid, and carbetocin to prevent postpartum haemorrhage and reduce maternal mortality.
“For children, emphasis will be placed on the quality and availability of antimalarials, antibiotics, and ready-to-use therapeutic food (RUTF) for malnourished children. Manufacturers will be incentivised to produce paediatric medicines, supported by regulatory inspection and WHO prequalification processes,” Adeyeye added.
NAFDAC aims to reduce the prevalence of falsified and substandard products to less than five per cent through stringent post-marketing surveillance and inspections. Cluster registration of globally listed products and enhanced stakeholder engagement will ensure transparency and consumer safety.
The agency is also expanding its regulatory focus on herbal medicines, collaborating with the Nigerian Natural Medicine Development Agency (NNMDA) to develop a Nigerian herbal pharmacopoeia and traditional medicine formulary. Clinical trials for herbal products targeting malaria, diabetes, and hypertension are being planned.
On supply chain visibility and traceability, NAFDAC will expand its GS1-driven track-and-trace technology to MNCH&N commodities, ensuring visibility and protection from diversion or infiltration. This system, already applied to COVID-19 vaccines and antimalarials, will extend to high-risk foods and other critical medicines.
NAFDAC has achieved financial solvency, moving from a ₦3.2 billion debt in 2018 to a stable footing. Adeyeye also called for timely enforcement of the executive order on local content, urging manufacturers to adjust before the order expires.
To combat the smuggling of unregulated and counterfeit products, NAFDAC is enhancing surveillance at ports and borders, though understaffed borders remain a challenge. The agency plans to utilise pre-screened candidates to bolster manpower as soon as statutory approvals are granted.
Addressing the Human Metapneumovirus (HMPV) outbreak in China, Adeyeye emphasised a proactive approach to pandemic preparedness. While awaiting WHO guidance, the agency prioritises local manufacturing of medical devices and pharmaceuticals to mitigate overdependence on imports during health crises.