Bangladesh

The Directorate General of Drug Administration (DGDA) serves as the primary regulatory authority for all 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, which remains the cornerstone of pharmaceutical and medical product regulation. For medical devices and diagnostics, regulatory oversight is increasingly formalized under DGDA, though a dedicated standalone medical device regulation is still evolving. The general approval process requires submission of a product dossier, laboratory analysis, inspection of manufacturing facilities, and review by the DGDA's expert committee before a registration certificate is issued. Products are classified by risk level, and the review process varies accordingly, with essential medicines and domestically manufactured products often receiving expedited consideration.

All foreign manufacturers seeking market authorization in Bangladesh must appoint a locally registered importer or agent who serves as the legal representative and is accountable to DGDA. Dossier submissions are expected to follow Common Technical Document (CTD) format for pharmaceuticals, and DGDA increasingly references WHO guidelines and, where applicable, ASEAN Common Technical Dossier (ACTD) standards for regional harmonization purposes. For diagnostics and medical devices, submissions must include technical files, certificates of conformity (such as CE or ISO 13485), and evidence of approval in the country of origin. Notable recent reforms include Bangladesh's accession to the PIC/S (Pharmaceutical Inspection Co-operation Scheme) preparatory program, strengthened post-market surveillance frameworks, and ongoing efforts to update the regulatory framework for in vitro diagnostics and digital health products in line with global best practices.

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. The Central Medical Stores Depot (CMSD) plays a critical role in warehousing and distributing centrally procured medicines, consumables, and medical equipment to public health facilities at the national level. Procurement processes are 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). Tenders are typically issued through open competitive bidding, published on the government's e-Government Procurement (e-GP) portal, and evaluation criteria include price, product registration status, and supplier qualifications. District and upazila-level health facilities may conduct decentralized procurement for certain items, though large-scale procurement remains centralized.

Bangladesh receives substantial support from international donor and multilateral organizations, making the donor-funded procurement channel particularly significant. UNICEF, the Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID (through mechanisms such as GHSC-PSM), and Gavi, the Vaccine Alliance collectively finance and procure a significant portion of vaccines, essential medicines, diagnostics, and health commodities for public programs. These procurements often follow international competitive bidding standards and may bypass standard DGDA registration requirements for donor-funded products, subject to pre-qualification by WHO or other recognized bodies. The private sector, which accounts for a substantial share of health spending in Bangladesh, procures independently through licensed importers and distributors. Bangladesh has a strong domestic pharmaceutical manufacturing industry and maintains explicit policies favoring locally manufactured products in public tenders, including price preferences and prioritization of domestically produced essential medicines, reflecting the government's broader industrial and health self-sufficiency objectives.