Local pharma: Nigeria targets global antimalarial market as NIPRD pushes WHO prequalification

By Chioma Obinna

Nigeria’s drive for stronger healthcare delivery and pharmaceutical self-reliance has received a major boost as the National Institute for Pharmaceutical Research and Development (NIPRD) steps up efforts to equip local drug manufacturers with the capacity to secure World Health Organisation prequalification for antimalarial medicines.

The move is expected to enhance quality, cut import dependence, and position the country for global competitiveness.

The renewed push came at a four-day Technical Support/Capacity Workshop for Pharmaceutical Companies organised by NIPRD under the National Malaria Elimination Programme (NMEP), with support from the World Bank.

At the workshop, regulators, policymakers, and pharmaceutical manufacturers addressed long-standing barriers preventing Nigerian-made antimalarials from competing globally.

Currently, Nigeria imports over 60 per cent of its essential medicines, with only Swiss Pharma Nigeria, Swipha, having a WHO-prequalified antimalarial product. Industry stakeholders say achieving wider WHO prequalification is critical to improving medicine quality, reducing import dependence, and opening access to donor-funded global markets.

Speaking at the workshop, Dr. Obi Adigwe, Director General of NIPRD, said the training aims to help manufacturers understand the WHO prequalification application process in practical terms.

“Issues such as proper documentation, bioavailability and bioequivalence studies, and quality assurance systems are non-negotiable if Nigerian products must gain global acceptance.”

Adigwe, who is the Technical Adviser on Pharma and Industry, Dr Mercy Aboh, identified poor awareness, funding constraints, outdated equipment, and limited technical capacity as major obstacles faced by local manufacturers.

“Many pharmaceutical managers do not yet appreciate the economic value and global trust that come with WHO prequalification.

From the discussions here, it became clear that several participants were unaware of the scale of opportunities attached to this status.”

Calling for factory upgrades, he remarked: “Continuous investment in modern manufacturing technology and staff training is no longer optional. It is essential for meeting WHO requirements.

“Once companies have the right documentation and technical readiness, they are better positioned to access available funding opportunities,” he said.

Corroborating his views, Director and Project Manager of the IMPACT project under the National Malaria Initiative, Pharm. Okoko Okefu Oyale said WHO prequalification would enable Nigerian manufacturers to compete beyond the local market.

“WHO prequalification opens the door to donor-funded procurements and allows Nigerian companies to supply medicines to other countries. It is both a public health and an economic opportunity.”

He described the workshop as a foundational step, calling for stronger collaboration among the Federal Ministry of Health, NAFDAC, NIPRD, PMGMAN, and other pharmaceutical value chain actors.

Oyale highlighted the high cost of bioavailability and bioequivalence studies, estimating about $100,000 per molecule and up to $200,000 for combination therapies such as artemether–lumefantrine.

“The question is whether many companies can shoulder this burden alone,” he said, adding that multiple taxation, high tariffs, API shortages, utility costs, and staff overheads continue to strain local manufacturers.

He advocated incentives such as tax reliefs and better inter-agency coordination to drive sector-wide reforms.

In a post-presentation briefing, Lead Consultant to NIPRD on Pharmaceutical Industry Technical Support, Pharm. Adesola Arowolo, said the workshop was structured to demystify the WHO prequalification process and motivate companies to take concrete steps.

“Based on feedback from participants, we believe that within the next three years, two or three additional Nigerian companies could achieve WHO prequalification. This will depend largely on leadership commitment and investment decisions.”

Participants at the workshop described the training as timely and eye-opening. Pharm. Marianne Omaliko of Evans Baroque Ltd said the programme clarified gaps in her company’s understanding of WHO prequalification.

“We are WHO GMP-certified, but we do not yet have any prequalified products,” she said. “Following this workshop, Evans Baroque plans to pursue WHO prequalification for our artemether–lumefantrine product and commence bioequivalence studies by January 2026.”

Similarly, Dr Christopher Akunyili of Mecure said the workshop expanded his perspective beyond regulatory compliance.

“It revealed the strategic and economic importance of WHO prequalification,” he said. “Learning about the estimated $161 million collective revenue opportunity for prequalified antimalarials makes it clear that urgent action is needed.”

Other 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 10.

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