Nigeria’s quest to achieve medicine security is gradually gaining momentum, as more local pharmaceutical manufacturers have indicated readiness to pursue the World Health Organisation (WHO) prequalification for antimalarial medicines, effective from 2026.
With the country currently importing over 60 per cent of its essential medicines, and with only one pharmaceutical company – Swiss Pharma Nigeria (Swipha) – holding WHO prequalified antimalarial status, local manufacturers disclosed their intention to seek the global certification at a recent four-day Technical Support and Capacity Workshop for Pharmaceutical Companies. The workshop was organised by the National Institute for Pharmaceutical Research and Development (NIPRD) in Lagos under the National Malaria Elimination Programme and was sponsored by the World Bank.
This development also aligns with a directive by the National Agency for Food and Drug Administration and Control (NAFDAC), mandating all generic drug manufacturers to submit bioavailability and bioequivalence (BA/BE) study reports from January 2026, to ensure therapeutic equivalence with innovator products.
In an exclusive interview with Pharmanews, Pharm. Adesola Arowolo, lead consultant to NIPRD on Pharmaceutical Industry Technical Support, explained that the workshop was designed to demystify the WHO prequalification process and motivate companies to commence the journey. Based on feedback from participants, she projected that within the next three years, two or three additional Nigerian pharmaceutical companies could achieve WHO prequalification, depending on leadership commitment and investment decisions.
“From some of the interactions we’ve had, I believe that within three years, at least two or three more local pharmaceutical manufacturers could attain WHO prequalification, apart from the one we already have. However, this depends largely on management decisions,” she said.
Arowolo urged participants to act on the knowledge gained from the workshop and to leverage available technical and government support to strengthen public health outcomes and economic opportunities.
Speaking separately in an exclusive interview with Pharmanews on the objectives of the workshop, NIPRD Director-General, Dr Obi Adigwe, said the training was aimed at providing hands-on technical support to pharmaceutical companies on the WHO prequalification application process. According to him, manufacturers must understand critical requirements such as proper documentation, bioavailability and bioequivalence studies, and robust laboratory quality assurance systems.
Adigwe, who was was represented by his Technical Adviser on Pharma and Industry, Dr Mercy Aboh, identified several barriers limiting local manufacturers from attaining WHO prequalification, including poor awareness, funding constraints, outdated or non-standardised equipment, and inadequate technical capacity. He noted that many pharmaceutical managers do not fully understand the economic value and global trust associated with WHO prequalification, adding that the training revealed that most participants were previously unaware of the scale of benefits attached to the status.
The NIPRD DG also stressed the need for factory upgrades, observing that several long-established pharmaceutical companies still lack the modern equipment required for prequalification. He emphasised the importance of investing in advanced manufacturing technologies and continuous staff training to meet international standards.
On funding concerns, he acknowledged that the WHO prequalification process is capital-intensive but assured participants that the workshop had exposed them to various funding platforms and government-backed support mechanisms. He explained that once companies achieve proper documentation and technical readiness, they are better positioned to access available funding opportunities.
Corroborating this position, Pharm. Okoko Okefu Oyale, director and project manager for the IMPACT Project under the National Malaria Initiative, said WHO prequalification positions Nigerian manufacturers to compete both locally and internationally. According to him, prequalification enables companies to bid for donor-funded procurements and supply medicines to other countries, thereby expanding their market reach.
Oyale described the workshop as a foundational step and called for stronger collaboration among stakeholders, including the Federal Ministry of Health, NAFDAC, NIPRD, pharmaceutical value chain stakeholders, PMGMAN and local manufacturers. He highlighted the high cost of conducting bioavailability and bioequivalence studies, estimating about $100,000 per molecule and up to $200,000 for combination therapies such as artemether–lumefantrine. He questioned the ability of many companies to shoulder such costs without systemic support.
He further listed multiple taxation, high tariffs, active pharmaceutical ingredient (API) shortages, high utility costs, water supply challenges and staff overheads as additional constraints faced by manufacturers. He advocated incentives such as tax reliefs and broader inter-sectoral collaboration, suggesting that the Ministry of Health should coordinate efforts across its agencies, including NIPRD, NAFDAC and PVAC, to drive sector-wide reforms.
Some participants also shared their experiences from the workshop with Pharmanews, indicating their readiness to pursue the certification.
Pharm. Marianne Omaliko of Evans Baroque Ltd said her understanding of WHO prequalification prior to the workshop was limited, noting that although her company is WHO GMP-certified, it has no prequalified products.
“Evans Baroque now plans to pursue WHO prequalification for its artemether–lumefantrine product and commence bioavailability and bioequivalence studies by January 2026, in line with NAFDAC’s new requirements,” she said.
Similarly, Dr Christopher Akunyili of Mecure described the workshop as an eye-opener, stating that it broadened his understanding beyond basic regulatory compliance to the strategic and economic importance of WHO prequalification.
He said the revelation of an estimated $161 million collective revenue opportunity for prequalified antimalarial manufacturers underscored the urgency for action. According to him, “Mecure will intensify efforts towards WHO prequalification, leveraging its strengths in bioequivalence studies and engaging management on strategic positioning.”
Other pharmaceutical companies represented at the workshop included May & Baker Nigeria Ltd, Swipha, Zara Healthcare Ltd, Emzor Pharmaceutical Nigeria Plc, SKG Pharma Ltd, Drugfield, Orange Kalbe Ltd and Neimeth International Pharmaceuticals Ltd, bringing the total number of participating companies to ten.
