When a mother takes her child for vaccination, she seldom considers the scientific processes behind the vaccine vial or the regulatory evaluations done beforehand. She simply believes in the vaccine’s safety and its ability to protect her child.
This trust serves as the foundation of public health. In Bangladesh, countless individuals depend on medicines and vaccines each day without witnessing the system ensuring their safety, effectiveness, and quality. At the core of this system lies the Directorate General of Drug Administration (DGDA), the national regulatory authority responsible for drugs in Bangladesh.
The DGDA, and consequently Bangladesh, is on the verge of a crucial achievement: reaching World Health Organization (WHO) Maturity Level 3 (ML3) for vaccine regulation. ML3 is an internationally recognized standard showcasing a stable, well-functioning regulatory system capable of consistently safeguarding public health. Only a limited number of national regulatory authorities worldwide have attained ML3 or the higher Maturity Level 4, with some also designated as WHO-listed authorities for specific regulatory functions.
In Bangladesh, the health and economy, as well as overall health security, are poised to benefit significantly from this certification. Nations with mature regulatory systems are better equipped to shield their populations from substandard and ineffective vaccines and other medical products. This boosts the confidence of patients and families in the safety, quality, and effectiveness of the vaccines and medications they receive, leading to improved health outcomes and enhanced human and economic development.
Enhanced regulation will also bolster Bangladesh’s standing in global health and life sciences markets, promoting economic diversity and long-term resilience. In 2025, Bangladesh spent approximately $120 million on vaccines from international suppliers, a figure projected to increase to around $400 million by 2030 with the expansion of routine immunization and introduction of new vaccines. Building the capacity to produce safe, quality-assured vaccines domestically will help reduce these costs, especially crucial as Bangladesh prepares to transition from Least Developed Country (LDC) status and the associated flexibilities in vaccine procurement.
A robust, well-regulated vaccine manufacturing sector will enhance Bangladesh’s ability to ensure prompt, reliable, and equitable access to vaccines during public health crises, bolstering overall health security. The Covid-19 pandemic highlighted the risks of relying solely on external vaccine supplies and emphasized the significance of combining robust regulatory systems with local manufacturing capabilities.
Despite these substantial benefits, delays in achieving ML3 status could hinder Bangladesh from fully realizing the health, economic, and health security advantages offered by a mature regulatory system, which the country is fully capable of unlocking.
Attaining ML3 for vaccine regulation would signify the successful conclusion of a journey and the commencement of a new phase. Since 2017, Bangladesh has enhanced its regulatory framework by enacting the Drugs and Cosmetics Act 2023, updating regulatory protocols, strengthening inspection and laboratory capacities, and investing in workforce development.
This progress reflects a joint commitment among government, industry, and development partners to enhance oversight in the pharmaceutical sector, recognizing that achieving ML3 for vaccine regulation will pave the way for extending similar regulatory maturity to essential medicines. In a country where about 98% of consumed medicines are locally produced, and pharmaceutical manufacturers export to approximately 150 countries, this is particularly crucial.
Nevertheless, the journey is ongoing, and the achievement is not yet guaranteed. To reach ML3 for vaccine regulation by 2027, five key priorities must be addressed.
Firstly, Bangladesh must sustain the momentum in implementing the ML3 Roadmap and the DGDA’s Institutional Development Plan to ensure timely completion of reforms yielding measurable outcomes.
Secondly, full operationalization of the Drugs and Cosmetics Act 2023 is essential through prompt approval and implementation of key drug regulations to establish the necessary regulatory framework for a mature and effective system.
Thirdly, the DGDA must be adequately staffed and structured to fulfill its mandate, including approving the revised organogram and filling critical human resource gaps.
Fourthly, regulatory functions must be supported by sufficient and sustainable financing. An efficient regulatory authority relies not only on sound policies but also on resources for effective implementation.
Fifthly, a high-level national task force should oversee the roadmap’s implementation, coordinate actions across ministries and agencies, and maintain progress toward the 2027 target.
This journey goes beyond achieving a global benchmark; it is about strengthening public trust, supporting a top-tier pharmaceutical sector, and enhancing health security. Ultimately, it is about ensuring that every mother bringing her child for vaccination can trust that the vaccine is safe and will safeguard her child.
