As Bangladesh enters a defining phase in its development journey, the forthcoming graduation from Least Developed Country (LDC) status, the emergence of a globally competitive pharmaceutical industry and the growing demand for vaccines across Asia present unprecedented opportunities. However, it must be noted that in today’s world, countries do not earn international trust by manufacturing vaccines alone. They earn it by demonstrating that every vaccine is developed, produced and regulated according to the highest scientific standards.
Bangladesh’s pharmaceutical industry has evolved into one of the country’s most successful manufacturing sectors, meeting nearly 98 percent of domestic demand for medicines while exporting pharmaceutical products to around 150 countries. Several companies have invested in biotechnology platforms and expressed interest in vaccine production. This ambition is timely and strategically important. The pandemic exposed the vulnerabilities of countries that depended entirely on imported vaccines. Export restrictions, disrupted supply chains and vaccine nationalism delayed access for many developing nations, including Bangladesh. Besides, the country’s annual expenditure on vaccines is expected to rise significantly as new vaccines are introduced and immunisation programmes expand. Local vaccine production could therefore strengthen health security, reduce import dependence, create high-skilled employment, promote biotechnology research and open new export opportunities.
However, vaccine manufacturing alone will not make Bangladesh a trusted global supplier. The missing link is a world-class regulatory system. This distinction is often overlooked in policy discussions. Factories manufacture vaccines, but regulators manufacture confidence. A vaccine’s value ultimately depends on the credibility of the institution that certifies its safety, quality, and effectiveness, because vaccines differ fundamentally from conventional medicines. Unlike chemically synthesised tablets, vaccines are biological products produced through complex processes involving living organisms or biological materials. Their quality depends not only on the final formulation but also on every stage of manufacturing—from seed selection and cell culture to fermentation, purification, filling, packaging and cold-chain management. Even small variations during production may affect their quality, safety or effectiveness.
For this reason, vaccine regulation extends far beyond granting a marketing licence. It encompasses scientific evaluation of clinical evidence, licensing manufacturing facilities, inspections for compliance with Good Manufacturing Practices (GMP), validation of manufacturing processes, independent laboratory testing, batch or lot release before distribution, post-marketing surveillance, pharmacovigilance, monitoring adverse events following immunisation and continuous benefit-risk assessment throughout a vaccine’s lifecycle. Vaccine regulation is therefore a continuous scientific process rather than a one-time administrative approval.
Recognising the central role of regulation, the World Health Organization (WHO) introduced the Global Benchmarking Tool (GBT) to assess the performance of national regulatory authorities (NRAs). The GBT evaluates whether regulatory authorities can consistently perform essential regulatory functions, including product registration, inspection, laboratory testing, clinical trial oversight, pharmacovigilance, market surveillance, lot release and regulatory governance. Based on this assessment, WHO classifies regulatory systems into four maturity levels.
For vaccine-producing countries, Maturity Level 3 (ML3) has become the internationally recognised minimum benchmark. It signifies that a regulatory authority functions as a stable, integrated and well-performing institution capable of consistently carrying out all essential regulatory functions. Yet WHO considers ML3 a milestone, not the destination. Maturity Level 4 (ML4) represents continuous improvement and regulatory excellence. The longer-term aspiration is to become a WHO Listed Authority (WLA), a regulatory authority whose scientific decisions are trusted and relied upon internationally. Bangladesh should embrace the same long-term vision.
The experience of successful vaccine-producing countries underscores the same lesson: regulatory strength must grow alongside manufacturing capacity. Although countries such as the United States, EU, India, China, South Korea, Indonesia and Egypt are in separate WHO regulatory authority lists, these countries strengthened their regulatory institutions to emerge as global vaccine producers. From the US Food and Drug Administration and the EU’s European Medicines Regulatory Network to India’s Central Drugs Standard Control Organisation, China’s National Medical Products Administration, South Korea’s Ministry of Food and Drug Safety, and Indonesia’s and Egypt’s respective drug authority, credible regulation has been fundamental to building global trust in their vaccines.
In the case of Bangladesh, its pharmaceutical industry has accumulated decades of manufacturing experience, internationally compliant production facilities, a skilled scientific workforce and an expanding biotechnology base. These strengths provide an excellent foundation for vaccine production. More importantly, Bangladesh has already initiated important reforms to strengthen its regulatory system. Over the past decade, the Directorate General of Drug Administration (DGDA), with technical support from WHO and development partners, has modernised regulatory procedures, strengthened GMP inspections, enhanced laboratory capacity and invested in workforce development. The enactment of the Drugs and Cosmetics Act, 2023 established a modern legal framework better aligned with contemporary pharmaceutical regulation.
These reforms have positioned Bangladesh on the threshold of achieving WHO ML3 for vaccine regulation. This landmark achievement would demonstrate Bangladesh’s capacity to perform essential vaccine regulatory functions to international standards, and strengthen global confidence, facilitate technology transfer, and attract collaboration and investment. However, ML3 should be viewed not as an endpoint but as a foundation for continuous improvement in scientific capacity, digital systems, laboratories, and regulatory excellence. Several priorities therefore deserve immediate attention.
First, the momentum of regulatory reform must be maintained. The WHO ML3 Roadmap and the DGDA’s institutional development plan should be implemented within clearly defined timelines and monitored at the highest level.
Second, the Drugs and Cosmetics Act, 2023 must be fully operationalised through the timely approval of supporting rules, regulations and implementation guidelines. Effective legislation is meaningful only when translated into practical regulatory action.
Third, Bangladesh must invest in regulatory science. Vaccine regulation requires highly specialised expertise in biotechnology, microbiology, immunology, pharmacology, epidemiology, toxicology, biostatistics and quality management. The DGDA’s revised organogram should be approved promptly, and vacancies for inspectors, laboratory scientists and regulatory assessors should be filled as a national priority.
Fourth, sustainable financing for advanced laboratories, digital information systems, sophisticated analytical equipment, international proficiency testing and continuous professional development at DGDA must be ensured. These investments cannot depend solely on short-term donor-funded projects. They require sustained domestic financing that reflects the strategic importance of regulation.
Fifth, Bangladesh must accelerate digital transformation so that electronic submissions, integrated regulatory information systems, digital inspection platforms and real-time pharmacovigilance databases are in place for efficient, transparent and internationally credible regulation.
Institutional independence is equally important. Regulatory decisions must be impartial and transparent, based exclusively on scientific evidence and public health considerations, and free from political or commercial influence to boost public confidence.
Additionally, a high-level national steering committee should oversee implementation of the regulatory reform agenda. Vaccine regulation involves multiple stakeholders, including the Ministry of Health and Family Welfare, DGDA, the Expanded Programme on Immunisation, research institutions, universities, manufacturers and development partners. Strong coordination across these institutions will be essential to sustain reform and achieve internationally recognised regulatory maturity.
Strong regulatory systems attract investment,facilitate technology transfer, support clinical research, expand pharmaceutical exports and enhance industrial competitiveness. In an increasingly knowledge-based global economy, regulatory credibility is becoming as valuable as manufacturing capacity itself. As Bangladesh enters the post-LDC era, a respected regulatory authority will be one of its most important strategic assets.
Dr Syed Abdul Hamid is professor in the Institute of Health Economics at the University of Dhaka.
Views expressed in this article are the author's own.
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