Bangladesh

The Directorate General of Drug Administration (DGDA) serves as the primary regulatory authority for health products in Bangladesh, operating under the Ministry of Health and Family Welfare. The principal governing legislation is the Drugs Act of 1940 (as amended), supplemented by the Drug (Control) Ordinance of 1982, the Medical Device and IVD Regulation Policy (2019), and associated rules and circulars. All pharmaceutical products, medical devices, diagnostics, and increasingly digital health tools must be registered with the DGDA before importation, manufacture, or sale in Bangladesh. The approval process typically involves submission of a dossier, laboratory testing or document review, an expert committee evaluation, and issuance of a registration certificate. The DGDA also oversees post-market surveillance, pharmacovigilance, import licensing, and Good Manufacturing Practice (GMP) inspections.

Applicants seeking product registration are required to appoint a local authorized agent or in-country representative, who assumes regulatory responsibility for the product on behalf of the foreign manufacturer. Bangladesh generally follows the ASEAN Common Technical Dossier (ACTD) format for pharmaceutical submissions, though the DGDA also accepts dossiers aligned with the ICH Common Technical Document (CTD) format, particularly for products already registered in stringent regulatory authority (SRA) jurisdictions such as the US FDA, EMA, or WHO-prequalified products. Key submission requirements include a Certificate of Pharmaceutical Product (CPP) from the country of origin, GMP certification, product labeling compliant with Bangladeshi standards, and, for devices, technical files demonstrating conformity to relevant international standards (such as ISO 13485). Notably, Bangladesh benefits from TRIPS flexibilities as a Least Developed Country (LDC), allowing it to manufacture or import certain patented pharmaceuticals without license until at least 2033. Recent reforms have focused on strengthening the medical device regulatory framework, improving the DGDA's digital registration portal, and accelerating review pathways for WHO-prequalified or SRA-approved products.

Public procurement of health products in Bangladesh is primarily coordinated through the Directorate General of Health Services (DGHS) and the Directorate General of Family Planning (DGFP), both under the Ministry of Health and Family Welfare, with financial oversight from the Ministry of Finance. The Central Medical Stores Depot (CMSD) manages warehousing and distribution of centrally procured health commodities to public health facilities nationwide. Procurement follows the Public Procurement Act of 2006 and Public Procurement Rules of 2008, administered by the Central Procurement Technical Unit (CPTU) under the Implementation Monitoring and Evaluation Division (IMED). National tenders are published through the e-Government Procurement (e-GP) platform, and international competitive bidding is used for high-value or specialized commodities. Bangladesh operates a largely centralized procurement model at the national level, though district and upazila health facilities may conduct limited local procurement within prescribed thresholds.

Bangladesh receives substantial support from international donor and multilateral agencies, which fund a significant portion of health commodity procurement outside the government budget cycle. Key partners include UNICEF, the Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID through mechanisms such as GHSC-PSM, Gavi the Vaccine Alliance, and the World Bank. These channels often procure products directly through their own international procurement mechanisms, sometimes bypassing national tender processes, though they increasingly work toward alignment with government systems to strengthen supply chain sustainability. Bangladesh maintains a strong domestic pharmaceutical manufacturing sector, and government policy actively encourages local production through preferential procurement provisions for locally manufactured products, reduced import duties on raw materials for domestic manufacturers, and requirements for technology transfer where feasible. The government's ambition to position Bangladesh as a regional pharmaceutical hub further reinforces policies that favor local manufacturing capacity, particularly as LDC trade preferences evolve.