How to set up a Pharmaceutical business in Bangladesh
We help manufacturers, importers, distributors and pharmacies navigate drug licensing, product registration, GMP requirements and commercial agreements in Bangladesh’s fast-growing pharmaceutical sector.
A strong local industry under strict regulatory control
Bangladesh’s pharmaceutical industry meets most domestic demand and exports to many countries. Every stage of the business — manufacturing, import, wholesale, retail and advertising — is regulated by the Directorate General of Drug Administration (DGDA).
Before a single product can be sold, the company, the premises and each product generally require separate approvals. Planning the regulatory pathway early helps avoid costly delays in construction, equipment purchase and launch.
Key steps to get started
Company Formation
Incorporate with RJSC and obtain a trade licence, e-TIN and BIN.
Project Approval
Seek DGDA approval for the manufacturing project and site layout before construction.
Plant & GMP
Build and equip the plant in line with Good Manufacturing Practice and pass DGDA inspection.
Manufacturing Licence
Obtain the drug manufacturing licence for the approved facility.
Product Registration
Register each product (and its price, where applicable) with DGDA before marketing.
Import, Export & Distribution
IRC/ERC, import permissions for APIs and machinery, and wholesale/retail drug licences.
What you are likely to need
Depending on whether you manufacture, import or distribute, approvals commonly include:
- RJSC incorporation & trade licence
- e-TIN & VAT/BIN registration
- DGDA project / layout approval
- Drug manufacturing licence
- Product registration (DAR)
- Drug import permission
- Wholesale or retail drug licence
- Environmental Clearance Certificate (DoE)
- Fire licence & DIFE factory licence
- IRC & ERC
Key laws & regulators
- Drugs and Cosmetics Act, 2023
- National Drug Policy
- Companies Act, 1994
- Bangladesh Environment Conservation Act, 1995
- Bangladesh Labour Act, 2006
- Import and Export (Control) Act, 1950
- Trademarks Act, 2009 & Patents and Designs law
- Regulators: DGDA, DoE, DIFE, NBR, BIDA
Your legal partner from day one
We advise on the right structure — company, branch, liaison office or joint venture.
We handle name clearance, RJSC incorporation and constitutional documents.
We obtain sector licences, registrations and regulatory approvals.
We support ongoing filings, contracts, employment and disputes.
Frequently asked questions
Can a foreign company manufacture medicines in Bangladesh?
Yes, foreign investment in pharmaceutical manufacturing is possible, subject to DGDA licensing and investment registration. Joint ventures with local partners are also common.
Can I import finished medicines for sale?
Importing finished products is regulated and generally requires DGDA registration of the product and import permissions. We advise on eligibility case by case.
How long does product registration take?
Timelines vary with the product type and DGDA’s review schedule. Preparing a complete dossier at the outset is the best way to avoid delay.
Do you help with distribution and licensing agreements?
Yes. We draft and negotiate distribution, contract-manufacturing, licensing and technology-transfer agreements.
Speak with our legal team
Tell us about your matter. A Premier Law Services lawyer will review it and advise you on the right next step — in person at our Dhaka chamber or online.