Bangladesh has achieved substantial progress in public health outcomes over the past decade. Between 2011 and 2022, the under-five mortality rate declined from 48 to 31 per 1,000 live births, while the maternal mortality ratio improved significantly, from 237 per 100,000 live births in 2012 to 123 by 2020. These improvements are largely attributable to strengthened primary healthcare systems, with the Expanded Programme on Immunization (EPI) playing a pivotal role in reducing mortality associated with vaccine-preventable diseases. Despite these gains, the World Health Organization (WHO) Joint External Evaluation (JEE) conducted in 2016 identified significant deficiencies in Bangladesh’s health security framework - with particularly in pandemic preparedness, where limited access to critical countermeasures such as vaccines, therapeutics, and diagnostics (VTDs) was noted.
In response, the Government of Bangladesh (GoB) has initiated the “Vaccines, Therapeutics, and Diagnostics Manufacturing and Regulatory Strengthening Project,” as articulated in its approved Development Project Proposal (DPP). The initiative is designed to bolster Bangladesh's national health security through the establishment of domestic manufacturing capabilities for VTD and the progressive strengthening of the national regulatory authority — the Directorate General of Drug Administration (DGDA) — to achieve the WHO Global Benchmarking Tool (GBT) maturity level 3 and beyond.
The project encompasses the construction of a high-capacity manufacturing facility with an annual capacity of 58 million vials, supported by an in-house R&D centre for the development of diagnostic kits and biosimilar therapeutics. It also includes the development of a full-cycle vaccine production infrastructure, including seed banks and cell banks, alongside fill-and-finish capabilities. The facility design incorporates climate-resilient and environmentally sustainable technologies and promotes gender equity and social inclusion. Compliance with WHO Good Manufacturing Practices (GMPs) and the pursuit of relevant certifications are integral to this project.
Concurrently, the project aims to elevate DGDA’s regulatory framework from GBT maturity level 2 to level 3 by enhancing laboratory quality systems, regulatory inspection functions, and staff capacity across GMP, quality assurance, biosafety, and validation domains.
The project is aligned with the overarching impact of enhanced pandemic preparedness and reduced morbidity and mortality from vaccine-preventable diseases in Bangladesh. The intended outcome is the improved availability of domestically produced, safe, efficacious, and quality-assured VTDs.
Objective of the Assignment
The objective of this assignment is to undertake a comprehensive review of the Development Project Proposal (DPP) and provide evidence-based recommendations to ensure its strategic coherence, technical soundness, and alignment with national health priorities and global health security standards. The consultant will assess the DPP’s feasibility, cost-effectiveness, and potential to deliver sustainable outcomes in line with international best practices in pharmaceutical manufacturing and regulatory system strengthening. The review will also ensure that the proposed interventions make a meaningful contribution to Bangladesh’s broader vision of health sector resilience, self-reliance in vaccine and therapeutic production, and compliance with WHO and other global benchmarks and standards.