There is renewed hope for Nigeria’s healthcare system as more pharmaceutical companies indicate readiness to scale up the quality of locally manufactured antimalarial medicines for global acceptance through the attainment of World Health Organisation (WHO) Pre-qualification (PQ).
This development emerged at a four-day “Technical Support/Capacity Workshop for Pharmaceutical Companies” organised by the National Institute for Pharmaceutical Research and Development (NIPRD) under the National Malaria Elimination Programme, with support from the World Bank. The workshop held at Amber Residence, Lagos, from 16 to 19 December, 2025.
With Nigeria currently importing over 60 per cent of its essential medicines and only one company, Swiss Pharma Nigeria, having a WHO-prequalified antimalarial product, the workshop was designed to equip pharmaceutical manufacturers with the technical knowledge required to pursue global certification for safety, quality and efficacy. The training also aligns with the National Agency for Food and Drug Administration and Control (NAFDAC)’s directive mandating all generic drug manufacturers to submit bioequivalence (BE) study reports from January 2026 to ensure therapeutic equivalence with innovator products.
Speaking on the objective 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 PQ application process. According to him, manufacturers must understand key requirements such as proper documentation, bioavailability and bioequivalence studies, and laboratory quality assurance systems. Dr Adigwe was represented at the event by his Technical Adviser on Pharma and Industry, Dr Mercy Aboh.
He identified several barriers limiting local manufacturers from attaining WHO prequalification, including poor awareness, funding challenges, outdated or non-standardised equipment, and inadequate technical capacity.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 PQ, adding that the training revealed that most participants were previously unaware of the scale of benefits attached to the status.
Dr Adigwe also stressed the need for factory upgrades, noting that several long-established pharmaceutical companies still lack 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 PQ process is capital intensive but assured participants that the training exposed them to different funding platforms and government-backed support mechanisms. He explained that once companies have 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 PQ 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, the 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 financial capacity of many companies to shoulder such costs without systemic support.
He further listed multiple taxation, high tariffs, 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.
In a post-presentation briefing, Pharm. Adesola Arowolo, lead consultant to NIPRD on Pharmaceutical Industry Technical Support, said the workshop was designed to demystify the WHO prequalification process and motivate companies to begin 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 PQ, depending on internal leadership commitment and investment decisions. She urged participants to act on the knowledge gained and utilise available technical and government support to strengthen public health outcomes and economic opportunities.
Some participants shared their experiences from the training. Pharm. Marianne Omaliko of Evans Baroque Ltd said her understanding of WHO PQ prior to the workshop was limited, noting that although her company is WHO GMP-certified, it has no prequalified products. She disclosed that 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.
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. He added that Mecure would intensify efforts toward WHO PQ, 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.
