Bangladesh

The Directorate General of Drug Administration (DGDA) is the primary regulatory authority responsible for overseeing the registration, import, manufacture, sale, and distribution of health products in Bangladesh, including pharmaceuticals, medical devices, diagnostics, and increasingly digital health technologies. The principal governing legislation is the Drug (Control) Ordinance of 1982, supplemented by the National Drug Policy (most recently updated in 2016) and a growing body of subsidiary regulations and guidelines. The approval process for health products requires submission of a formal registration dossier to the DGDA, followed by technical review by the Drug Control Committee (DCC), which advises the Director General on approval decisions. Products must demonstrate safety, efficacy, and quality, and importers or manufacturers must hold a valid license issued by the DGDA before any commercial activity is permitted.

Submission dossiers are generally expected to follow the ASEAN Common Technical Dossier (ACTD) format, though the DGDA also accepts documentation aligned with ICH Common Technical Document (CTD) standards, particularly for products seeking registration under multinational or donor-supported pathways. A licensed local representative or registered importer is mandatory for all foreign manufacturers seeking market authorization in Bangladesh. Applicants are typically required to provide a Certificate of Pharmaceutical Product (CPP) issued by the country of origin, Good Manufacturing Practice (GMP) certification, and evidence of registration in a reference regulatory jurisdiction. The DGDA has undertaken ongoing reforms to modernize its regulatory framework, including the development of dedicated regulations for medical devices and in-vitro diagnostics, piloting of an online submission portal, and efforts to strengthen post-market surveillance. The draft Medical Devices and Digital Health regulations remain under active development, reflecting the authority's intention to formalize oversight of these rapidly growing product categories.

Public procurement of health products in Bangladesh is centrally coordinated through the Ministry of Health and Family Welfare (MoHFW), with the Central Medical Stores Depot (CMSD) serving as the primary government body responsible for the bulk procurement and distribution of medicines, medical devices, and consumables for the public health system. Procurement is governed by the Public Procurement Act of 2006 and the Public Procurement Rules of 2008, administered by the Central Procurement Technical Unit (CPTU) under the Implementation Monitoring and Evaluation Division (IMED). National tenders are conducted through competitive bidding processes, and suppliers are required to be registered with the DGDA and meet specified quality and technical standards. The Essential Medicines List (EML) guides prioritization of publicly procured pharmaceuticals, and the government maintains strong price controls on essential medicines within the public sector. Sub-national procurement occurs at the district and upazila levels but is largely directed by centrally issued frameworks and allocations.

The private sector constitutes a significant and growing share of health product consumption in Bangladesh, driven by a large network of retail pharmacies, private hospitals, and diagnostic centers that source products through licensed importers and distributors operating outside the public tender system. Bangladesh benefits from substantial donor-funded procurement channeled through multilateral agencies including UNICEF, the Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID, and Gavi, the Vaccine Alliance, particularly for vaccines, HIV and tuberculosis commodities, family planning supplies, and essential diagnostics. These donor procurement streams often follow international competitive tendering standards such as those of the UN system and may operate parallel to or in coordination with government procurement mechanisms. Bangladesh has a strong domestic pharmaceutical manufacturing sector and maintains explicit local manufacturing preference policies, including provisions that favor locally produced products in public tenders where equivalent quality can be demonstrated, as well as import substitution policies embedded in the National Drug Policy that incentivize domestic production and restrict importation of products manufactured locally at adequate quality and scale.