Bangladesh

Bangladesh regulates pharmaceutical products through the Directorate General of Drug Administration (DGDA), an agency under the Ministry of Health and Family Welfare (MoHFW). The legal framework is anchored on the Drugs Act 1940, the Drugs (Control) Ordinance 1982 and the National Drug Policy 2016, with the Drug Control Committee (DCC) — chaired by the DGDA Director-General — as the statutory body that recommends marketing authorisation. Authorisation is evidenced by a Drug Registration Certificate (Form 1A), typically valid for 5 years. Bangladesh is a major generic manufacturing hub (>250 licensed manufacturers; ~98 % of domestic demand met locally; significant exports to >150 countries). Imports are tightly controlled — DGDA generally restricts registration of imported finished products where therapeutically equivalent locally manufactured alternatives exist, with limited carve-outs for biologics, vaccines, oncology and innovator products without local equivalents. Bangladesh continues to use the WTO TRIPS LDC pharmaceutical patent transition (extended to 2034) for generic production of patented molecules. Public-sector access runs via the Directorate General of Health Services (DGHS) Essential Drug List (EDL) and the Essential Drugs Company Limited (EDCL) for state-sector procurement, with no formal HTA body and no national reimbursement scheme — out-of-pocket spending dominates.