Bangladesh’s pharmaceutical industry has expanded rapidly in recent years, but several regulatory, technical, and infrastructure gaps continue to limit its ability to enter high-value international markets.
Despite strong domestic capacity, experts say a combination of incomplete testing facilities, slow API sector development, and compliance challenges is preventing local companies from fully realising their export potential. A major obstacle is the absence of internationally recognised clinical trial facilities.
Bangladesh still lacks the capacity to conduct United States Food and Drug Administration (USFDA)- or EU-approved bioequivalence and clinical trials, forcing companies to send samples to neighboring countries.
Industry experts say establishing an accredited Contract Research Organisation (CRO) would significantly reduce delays and costs, although Directorate General of Drug Administration (DGDA) sources note that private-sector capabilities are expanding.
Progress at the country’s first vaccine plant, Gozaria API Park in Munshiganj, is also slower than expected. Irregular gas supply has prevented several factories from beginning production, undermining efforts to reduce dependence on imported raw materials and limiting export competitiveness.
Another bottleneck is the National Drug Testing Laboratory (NDTL), which, despite WHO certification, does not test API samples.
Local producers must therefore send them abroad for analysis. Industry bodies argue that enabling API testing at NDTL would cut costs, ease export processes, and build customer confidence.
Finally, experts say that stronger enforcement of Good Manufacturing Practices (GMP) and current GMP (cGMP) is essential for competing in global markets, where quality standards are becoming increasingly stringent.
Pharma leaders warn that every month of delay in achieving ML-3 is a setback. Md Zakir Hossain, secretary general of Bangladesh Association of Pharmaceutical Industries (BAPI), said that each vaccine batch currently requires foreign testing, and local laboratories must meet global standards for exports to begin.
Once DGDA laboratories are accredited, WHO will recognise Bangladesh’s certification, allowing vaccines to be tested, certified, and exported directly from domestic facilities.
