Local Pharmaceutical Manufacturing Program

A program assessing domestic manufacturing capacity for essential medicines and medical supplies to internationally recognised quality standards. The program is at NBP-1 on the NBP readiness ladder and is recorded at concept confidence. Scope, cost and structure remain subject to the studies listed below.

Essential medicines are largely imported, which exposes supply to shipping and currency conditions. Domestic manufacturing requires quality systems that take time to establish.

Reduce exposure to supply interruption for essential medicines and retain a share of health expenditure within the domestic economy.

Study a phased approach beginning with formulation and packaging of established products under recognised quality standards, before assessing more complex manufacturing.

• Formulation and packaging capacity
• Quality assurance and laboratory systems
• Regulatory compliance capability
• Cold chain and distribution
• Technical workforce development

Location: To be determined, Africa

The national health system, patients dependent on continuity of supply, and the technical workforce.

• Technical scope to be established through pre-feasibility study
• Design standards to follow applicable national and international codes
• Environmental and social screening prior to design finalisation

• Reliable electricity
• Water quality
• Regulatory capacity
• Technical workforce
• Distribution and cold chain

Regional demand for essential medicines is substantial and stable; the constraint on local manufacturing is quality certification rather than market size.

Delivery and ownership structure to be determined at commercial structuring (NBP-6). Options include public delivery, partnership structures and concession models, assessed against value for money and risk allocation.

To be determined. Suitable capital categories will be assessed at NBP-6 and NBP-7 against the project’s risk profile and revenue characteristics.

Revenue and sustainability model under development. Where user charges are not viable, availability-based or budget-funded models will be assessed.

Classification: To be assigned following environmental and social screening.

Environmental assessment will be completed to the standard required by national regulation and applicable lender policy before any commitment is sought.

Social assessment will address land, livelihoods, resettlement risk, community consultation and equitable access to the resulting service.

1. 1Concept developmentCurrentScope, beneficiaries and components defined at concept level.
2. 2Pre-feasibilityNextTechnical and commercial viability tested at order-of-magnitude level.
3. 3FeasibilitySubsequentFull technical, financial, environmental and social case established.
4. 4Structuring & financingSubsequentDelivery model settled and capital matched to the opportunity.