In a renewed effort to strengthen medicine security and position local manufacturers for competitiveness in African and global markets, the Federal Government has provided technical support to selected indigenous pharmaceutical companies, bringing them closer to attaining World Health Organisation (WHO) prequalification – a critical benchmark for international quality standards and access to wider markets.
The milestone was recorded under a special project led by the National Institute of Pharmaceutical Research and Development (NIPRD) in collaboration with the National Malaria Elimination Programme, with support from the World Bank. The programme, themed “Meeting to Consolidate Technical Support/Capacity Building to the Pharma Industry; Ensuring Medicine Quality – Advanced Insights into WHO Prequalification,” was held recently at the Amber Residence, GRA, Ikeja, Lagos.
Speaking at the event, the Director-General of NIPRD, Obi P. Adigwe, described the outcome as “transformational”, noting that local manufacturers have moved from uncertainty to a firm commitment to meet WHO prequalification standards. Represented by Director Mboma Iheanyi, Adigwe observed that for years Nigeria’s pharmaceutical sector had been excluded from global procurement opportunities due to stringent WHO benchmarks, but expressed optimism that the tide is turning.
“Medicine security is not just a health metric; it is the bedrock of national sovereignty,” he said, stressing that reliance on imported medicines poses risks to equity, national security and economic stability. He noted that the project aligns with the Federal Government’s broader drive to strengthen the health sector value chain.
Adigwe explained that the intervention followed a four-phase structure, from mindset reorientation to final implementation, aimed at strengthening local manufacturing capacity. According to him, technical understanding among participating companies improved significantly, rising from 33.3 per cent to 86.7 per cent, while 13 out of 19 critical gaps identified at baseline have been addressed.
He emphasised that the achievement goes beyond compliance, representing a deliberate alignment of technical systems to deliver measurable outcomes.
Also speaking, NIPRD Lead for the IMPACT Project, Mr Okefu Oyale Okoko, said the progress marks a turning point for Nigeria’s pharmaceutical sector. He explained that companies are at varying levels of readiness but are steadily advancing towards WHO prequalification.
According to him, attaining WHO certification for artemether/lumefantrine-based antimalarial medicines, which has yet to be achieved by any African manufacturer, would be a landmark breakthrough. It would not only strengthen medicine security in Nigeria but also enable local firms to compete globally for supply contracts, positioning the country as a key player in Africa’s pharmaceutical landscape.
The project’s Lead Consultant, Pharm. Desola Arowolo, attributed the progress to a critical shift in mindset among participating companies. She noted that initial scepticism about achieving WHO prequalification gave way to confidence and commitment following technical support and gap analyses.
She explained that the process revealed many companies were already implementing sound practices but needed to refine and align them with global standards. This culminated in the co-creation of Common Technical Document (CTD) dossiers for antimalarial medicines, a key requirement for WHO prequalification.
Arowolo said the gains extend beyond technical readiness, pointing to improved access to quality medicines, reduced dependence on imports, and increased opportunities for economic growth and job creation. However, she identified funding as a major challenge, noting that scaling up production and meeting global standards require substantial investment and sustained support.
While the project began with a larger number of companies, it concluded with a smaller group that successfully completed this phase. Arowolo said future expansion would depend on the outcome of the project and stakeholder decisions.
With the current phase completed, the companies are expected to proceed independently towards full WHO prequalification, with expectations that several will ultimately succeed and compete effectively in the international market.
Representatives of the participating companies, including Mecure, Drugfield Pharmaceuticals Ltd, Evans Baroque Ltd, and Neimeth International Pharmaceuticals Ltd, commended the Federal Government and NIPRD for their support and called for additional assistance, particularly funding, to upgrade facilities and meet global benchmarks.
