Online Desk: The Asian Development Bank (ADB) and the government of Bangladesh on Tuesday (November 28, 2023) signed a loan agreement for $336.5 million to establish domestic vaccine, therapeutics, and diagnostics manufacturing capacity and strengthen the national regulator to ensure vaccine supply security in Bangladesh.

Md. Shahriar Kader Siddiky, secretary, Economic Relations Division, and Edimon Ginting, ADB country director for Bangladesh signed the agreement on behalf of Bangladesh and ADB, respectively.

The vaccines, therapeutics, and diagnostics manufacturing and regulatory strengthening project will establish a vaccine, therapeutic, and diagnostics manufacturing facility and warehousing unit in Essential Drugs Company Limited’s (EDCL) existing location at Gopalganj, with a capacity to manufacture 58 million vials of vaccines per year, said the regional development bank.

An in-house research and development center will be established to support the production of diagnostic kits and packaging of biosimilar therapeutics.

It will also support the manufacture of at least two full-cycle vaccines by developing a seed bank, master cell bank, and working cell bank, in addition to at least five fill-and-finish vaccines.

“Bangladesh has attained remarkable success in implementing its vaccination programs supported by subsidized vaccines supplied through the Global Alliance for Vaccine and Immunization (GAVI). As Bangladesh graduates from the Least Developed Country status, the supply of vaccine from GAVI will gradually be phased out,” said Country Director Edimon Ginting.

“This project will help create vibrant ecosystem for vaccine production in the country, ensuring sustainable supply in the medium-term, and at the same time, building Bangladesh’s capacity to manage future pandemics better,” he added.

The manufacturing facility will incorporate features to promote gender equality and social inclusion as well as green and resilient production using less energy and materials while reducing waste and carbon missions.

The facility will seek certification from the World Health Organization (WHO) for good manufacturing practices (GMPs).

The ADB loan will support the Directorate General of Drug Administration (DGDA) to upgrade its regulatory capacity to WHO maturity level 3 and beyond. ADB will help strengthen laboratory quality management and regulatory inspection systems while improving testing capacity modalities in compliance with WHO’s Global Benchmarking Tool.

It will create a stable, well-functioning, and integrated regulatory system; help foster international collaboration and trade; and improve private sector participation in Bangladesh’s pharmaceutical industry.

The project will help EDCL and DGDA train their staff in essential GMPs, quality assurance, quality control, validation, and calibration programs in compliance with the biosafety levels, according to ADB.

The project is financed through ADB’s $9 billion Asia Pacific Vaccine Access Facility, launched in December 2020 to provide rapid and equitable vaccine-related support to ADB developing member countries.

It builds on ADB’s $940 million support to Bangladesh to purchase safe and effective vaccines against COVID-19 in June 2021.