The integrity of the antimicrobial supply chain in Bangladesh: assessing the regulatory environment and contextual challenges.

Most low- and middle-income countries lack the regulatory capacity to contain substandard and falsified (SF) medicines. Innovations for strengthening regulatory systems are needed to protect public health. We assessed the integrity of the antimicrobial supply chain in Bangladesh. We employed qualitative methods comprising policy content analysis, and literature and database reviews. Using a framework modified from the World Health Organization's and the United States Pharmacopoeia's, the Bangladesh National Drug Policy (BNDP), was evaluated for provisions on medicines quality assurance mechanisms. We used newspaper, peer-reviewed, and post-marketing surveillance reports to assess prevalence of SF antimicrobials. The BNDP contains provisions for quality assurance. Newspaper reports identified circulation of substandard antimicrobials. We identified only six peer-review studies testing antimicrobial product quality with three studies reporting out-of-specifications products. We suggest three strategies for strengthening the regulatory system: community-based surveillance, task shifting, and technology-enabled consumer participation.