The Federal Government, in collaboration with the National Institute for Pharmaceutical Research and Development (NIPRD), is intensifying efforts to guide indigenous pharmaceutical manufacturers toward achieving World Health Organisation (WHO) prequalification. This initiative aims to enhance the capacity of local producers to compete in African and global markets.
Intervention Project Overview
The push is being driven under a special intervention project led by NIPRD in partnership with the National Malaria Elimination Programme, with support from the World Bank. The programme, held in Lagos and themed “Meeting to Consolidate Technical Support/Capacity Building to the Pharma Industry; Ensuring Medicine Quality – Advanced Insights into WHO Prequalification,” brought together key stakeholders to align local production with global standards.
Although several companies participated in the project, only a few completed the current phase successfully. Future expansion is expected to depend on stakeholder decisions and overall project outcomes.
Progress and Future Steps
Following the just-concluded phase, NIPRD stated that participating manufacturers are expected to proceed independently toward full WHO prequalification. There is growing optimism that some firms will eventually meet the requirements and compete effectively in international markets.
Speaking at the event, Director-General of NIPRD, Obi Adigwe, represented by Mboma Iheanyi, noted that Nigeria’s pharmaceutical industry had long been excluded from global procurement opportunities due to stringent WHO standards. However, he highlighted that recent interventions signal a turning point.
Adigwe stressed that medicine security goes beyond healthcare, describing it as a critical component of national sovereignty. He warned that over-reliance on imports could undermine equity, national security, and economic stability. He described the progress recorded so far as transformational, noting that participating manufacturers had moved from uncertainty to a stronger commitment to meeting WHO prequalification standards.
Project Structure and Achievements
According to Adigwe, the project was structured into four phases, beginning with mindset reorientation and progressing to full implementation to strengthen local manufacturing capacity. He disclosed that technical understanding among participating companies improved significantly from 33.3 per cent to 86.7 per cent, while 13 out of 19 identified critical gaps have been addressed. Adigwe added that the achievement reflects more than regulatory compliance, describing it as a deliberate alignment of systems to deliver measurable outcomes within the pharmaceutical sector.
Also speaking, NIPRD Lead for the IMPACT Project, Okefu Okoko, said the progress marks a turning point for Nigeria’s pharmaceutical industry, noting that companies, though at varying levels of readiness, are steadily advancing toward WHO prequalification. He explained that achieving WHO certification for antimalarial medicines, yet to be attained by any African manufacturer, would represent a breakthrough, strengthening Nigeria’s medicine security while positioning local firms for global supply opportunities.
Mindset Shift and Challenges
The project’s Lead Consultant, Desola Arowolo, attributed the progress to a shift in mindset among participating companies, noting that initial scepticism had given way to confidence following technical support and gap assessments. She explained that while many firms already operated sound systems, alignment with global standards was required. This process, she added, led to the co-creation of Common Technical Document (CTD) dossiers for antimalarial medicines, a key requirement for WHO prequalification.
Arowolo noted that beyond improving technical readiness, the initiative has enhanced access to quality medicines, reduced dependence on imports, and created opportunities for economic growth and job creation. However, she identified funding as a major constraint, stressing that scaling up production and meeting global benchmarks would require sustained investment.
