Request for Consultants - Comprehensive Institutional Capacity Assessment of Local Manufacturers Producing Artemisinin-based Combination Therapies (ACTs) at the Presidential Initiative for Unlocking the Healthcare Value Chain (PVAC)

The Presidential Initiative for Unlocking the Healthcare Value Chain (PVAC) is a strategic government effort established by His Excellency, President Bola Ahmed Tinubu, as a cornerstone of the Renewed Hope Agenda in October 2023. Operating under the auspices of the Federal Ministry of Health & Social Welfare and the leadership of the Coordinating Minister of Health and Social Welfare, PVAC aims to unlock billions of dollars in new investment into Nigeria’s healthcare delivery system.

Applications are invited for:

Title: Request for Consultants: Comprehensive Institutional Capacity Assessment of Local Manufacturers Producing Artemisinin-based Combination Therapies (ACTs) in Nigeria

Location: Nigeria

Background

• Nigeria faces a significant burden from both communicable and non-communicable diseases, which strains the healthcare system and hinders economic development. Despite ongoing efforts to address these challenges, the country remains heavily reliant on imports for essential health commodities. 
• This dependency leads to high costs, supply chain vulnerabilities, and inconsistent availability of critical healthcare products. Strengthening local capacity and optimizing supply chain management is essential to improving the accessibility, affordability, and sustainability of healthcare products. This is key to advancing public health.
• Market shaping strategies have proven successful in other health sectors by leveraging economies of scale, improving quality control, and enhancing distribution efficiency. 
• Adopting this model for manufacturing and distributing essential health commodities could reduce costs, improve product consistency, and ensure more reliable supply chains. 
• However, transitioning from an import-dependent system to one with a robust local production capacity and an efficient pooled procurement system is a complex process. It requires a comprehensive, multi-faceted approach that addresses manufacturing capabilities, quality assurance mechanisms, supply chain optimization, workforce capacity building, and supportive policy frameworks.
• The Presidential Initiative for Unlocking Healthcare Value Chain (PVAC) and the National Malaria Elimination Programme (NMEP), with the support of the World Bank IMPACT, embarked on a project called “Enhancing Local Manufacturing and Supply Chain Management for Health Commodities and Supplies in Nigeria”. The aim of this project is to address these challenges through a phased approach that balances short-term and long-term objectives. 
• The strategies for addressing these challenges will include developing and laying the groundwork for local manufacturing of malaria commodities (including ACTs, RDTs, APIs, and LLINs), including enhancing production capacity, ensuring compliance with international quality standards, and fostering workforce development. 
• At the same time, the project will focus on optimizing the pooled procurement of imported malaria commodities to improve cost-effectiveness and distribution efficiency. 
• Over the medium to long term, these interventions will strengthen the entire health commodities value chain, create opportunities for economic growth, and support Nigeria's self-sufficiency in critical healthcare products. This comprehensive approach seeks to improve Nigeria's healthcare supply systems' efficiency and resilience while unlocking new economic opportunities within the country's health sector.
• The project duration is 1 year.

Objective

• The objective of this consultancy is to conduct an in-depth and holistic assessment of selected local pharmaceutical manufacturers engaged in the production of high-quality Artemisinin-based Combination Therapies (ACTs) in Nigeria. 
• The assessment aims to identify existing capacity gaps and institutional strengths across key operational domains. These include infrastructure, manufacturing processes, quality assurance and quality control (QA/QC) systems, regulatory compliance with both national and international standards (such as NAFDAC, WHO prequalification, and GMP guidelines), supply chain management, and human resource capacity.
• The consultancy will also explore the manufacturers’ ability to meet current and projected demand for ACTs, their access to financing and raw materials (including active pharmaceutical ingredients), and their readiness to participate in global health procurement mechanisms. 
• Findings from this assessment will inform strategic interventions aimed at strengthening local manufacturing capacity, enhancing Nigeria’s pharmaceutical self-reliance, and ensuring the sustainable availability of high-quality ACTs for malaria treatment.

Scope of Work
The consulting firm is expected to:

• Develop recommendations for critical policy and regulatory reforms required for the local manufacturing of ACTs.
  • Desk review of relevant documents, including existing policies, plans, and partner reports.
  • Analyze the best international practices in manufacturing ACTs.
  • Evaluate current policy incentives and support mechanisms.
• Conduct a comprehensive institutional capacity assessment of local manufacturers for ACT production through stakeholder engagement, facility visits, and assessment
  • Finalize the list of ACT local manufacturers with PVAC and NMEP.
  • Participate in the development and finalization of the assessment tools/questionnaires.
  • Collaborate with the National Malaria Elimination Program (NMEP) and regulatory institutions such as National Agency for Food and Drug Administration and Control (NAFDAC), National Institute for Pharmaceutical Research and Development (NIPRID), and private-sector pharmaceuticals.
  • Conduct site visits and inspections of shortlisted manufacturers, in collaboration with selected stakeholders, to assess facilities, equipment, and quality control measures, verifying compliance with regulatory standards and capacity for producing ACTs. (The number of local manufacturers will be agreed during preliminary meetings with PVAC)
• Conduct an analysis of findings and make the raw data available to PVAC and NMEP.
• Develop a comprehensive report highlighting the findings of the assessment and recommendations on the local manufacturers that have the required capacity to be part of the project.
• Participate in stakeholder workshops to validate findings of the assessment.

Project Rationale / Justification

• There is an urgent need to strengthen Nigeria’s local pharmaceutical manufacturing landscape, particularly in the production of Artemisinin-based Combination Therapies (ACTs), which remain the frontline treatment for malaria, which continues to pose a significant public health burden in the country. 
• Despite Nigeria’s large disease burden and growing demand for ACTs, reliance on imported medicines, inconsistent quality standards, and weak regulatory compliance among local manufacturers pose major risks to sustainable malaria control and elimination efforts. 
• This consultancy is, therefore, essential to comprehensively assess the capacity and readiness of selected local manufacturers, identify systemic gaps and strengths across critical domains such as infrastructure, regulatory compliance, quality assurance, and supply chain resilience, and provide evidence-based recommendations to inform national strategies. 
• Recognizing this critical need, PVAC is seeking the expertise of a qualified consultant to conduct this comprehensive assessment of local manufacturers’ institutional capacity to produce high quality ACTs.

Methodology

• This assessment will adopt a mixed-methods approach, combining qualitative and quantitative data collection and analysis to ensure a comprehensive understanding of the institutional and operational capacities of selected local pharmaceutical manufacturers producing Artemisinin-based Combination Therapies (ACTs) in Nigeria. The methodology will be structured around the following key phases:

Inception Phase:

• Conduct initial meetings with the National Malaria Elimination Program (NMEP), PVAC, and other key stakeholders to agree on the scope, objectives, and expected deliverables.
• Co-develop a detailed work plan including timelines, responsibilities, and deliverables.

Desk Review and Development of Assessment Tools:

• Review existing policies, strategic documents, partner reports, previous assessments, and international best practices on ACT manufacturing.
• Collaboratively develop and validate assessment tools and checklists with input from NMEP, PVAC, and other partners.

Stakeholder Engagement:

• Conduct Key Informant Interviews (KIIs) and consultations with key regulatory bodies (NAFDAC, NIPRID), professional associations, donors, and industry stakeholders to gather contextual insights and validate findings.

Field Visits and Capacity Assessment:

• Finalize the shortlist of ACT manufacturers in consultation with PVAC and NMEP.
• Conduct structured facility visits to assess infrastructure, manufacturing processes, QA/QC systems, and compliance with national and international standards.
• Use the finalized assessment tool to collect data across key operational domains including:
  • Infrastructure adequacy
  • Manufacturing technology and processes
  • Quality assurance and control systems
  • Regulatory compliance (NAFDAC, WHO prequalification, GMP)
  • Supply chain logistics (access to raw materials and APIs)
  • Financial capacity and access to capital
  • Human resource availability and technical competencies
  • Production capacity and demand responsiveness
• Engage local manufacturers’ staff to assess their perspectives on challenges and opportunities related to ACT production and scale-up.

Data Analysis:

• Compile and clean quantitative and qualitative data from site visits, interviews, and documents.
• Use thematic analysis to interpret qualitative data from KIIs and stakeholder interviews.
• Apply capacity scoring and gap analysis frameworks to quantitatively assess institutional readiness across predefined benchmarks.

Reporting and Validation:

• Draft a comprehensive assessment report detailing:
  • Current capacity of each manufacturer across operational domains
  • Identified gaps and institutional strengths
  • Recommendations for regulatory and policy reform
  • Suggested manufacturers with the capacity to participate in the project.
• Share raw data and findings with PVAC and NMEP in appropriate formats (e.g., Excel datasets, summary briefs).
• Present preliminary findings in a stakeholder validation workshop to ensure feedback and consensus-building.
• Finalize the report incorporating stakeholder feedback and submit both the narrative and data outputs.

Expected Outcomes
The expected outcomes include:

• An inception report outlining the agreed scope of work and implementation approach.
• A technical document presenting key recommendations to strengthen ACT manufacturing in Nigeria.
• A validated assessment tool/questionnaire for assessing local pharmaceutical manufacturers.
• A final assessment report detailing key findings, capacity gaps, and strategic recommendations.
• A cleaned and finalized dataset from the assessment, ready for analysis and dissemination.

Required Expertise
The consultancy firm is expected to possess the following qualifications and experience:

• Strong knowledge of Good Manufacturing Practices (GMP), WHO prequalification standards, and NAFDAC regulatory requirements.
• Demonstrated experience conducting quality assurance/quality control assessments in pharmaceutical settings.
• Familiarity with Nigeria’s pharmaceutical sector, policies, and health system.
• Experience in designing and administering assessment tools and questionnaires.
• Proficiency in both qualitative and quantitative data collection and analysis.
• Strong stakeholder engagement and facilitation skills, with experience in multi-sectoral consultations.
• Excellent report writing and presentation skills with the ability to synthesize findings into clear, actionable recommendations.
• Experience working with or engaging regulatory bodies such as NAFDAC, WHO, or NIPRID is an added advantage.

Selection Method

• The selection process will follow a Limited Consultant Qualification-Based Method (LCQBM). Under this approach, interested consulting firms will submit proposals in response to the Terms of Reference (TOR) issued by PVAC. As part of the evaluation, consulting firms must demonstrate their relevant experience and qualifications in managing similar projects. 
• Only the most qualified consulting firm with proven expertise in project management, monitoring & evaluation, and health supply chain optimization will be shortlisted and considered for final selection.

Duration of the Assignment

• The duration of this consultancy is 40 working days, over a period of 2 months.

Application Closing Date
2nd May, 2025.

Submission Requirements
Interested and qualified organizations are expected to submit the following documents:

• Technical Proposal: The technical proposal should include:
  • A clear methodology that demonstrates expertise in managing this project.
  • A track record and experience in implementing similar projects
  • At least 3 references from similar projects
• A valid CAC certificate.
• Financial Proposal – including clear budget narratives.

All required documents should be sent to: pvacprocurement@hscgroup.org using the Title as the subject of the email. Proposals sent after the deadline will not be considered.