Industries
Pharmaceutical
Licensing, product registration, distribution agreements, and intellectual property for pharmaceutical businesses.
In short
Tuhin & Partners advises pharmaceutical and healthcare businesses in Bangladesh on drug licensing and product registration with the Directorate General of Drug Administration (DGDA), manufacturing and import approvals, distribution and agency agreements, patent and trademark protection, pricing and labelling requirements, and clinical trial and regulatory compliance.
Key takeaways
- Manufacture, import and sale of medicines require licensing from the Directorate General of Drug Administration (DGDA).
- Each product is registered separately from the licensing of the business that makes or imports it.
- Bangladesh's pharmaceutical sector is a significant exporter, which brings the destination market's regulatory requirements into play alongside local ones.
- Tuhin & Partners advises on licensing, product registration, distribution agreements and IP protection.
Bangladesh’s pharmaceutical industry is a significant regional producer, operating under detailed licensing and approval regimes administered by the Directorate General of Drug Administration and other regulators.
We advise manufacturers, distributors, and investors on establishment and licensing, product registration, manufacturing and distribution agreements, and regulatory compliance, and handle the sector’s intellectual property work — trademarks, patents, licensing, and enforcement — alongside technology transfer and joint venture arrangements.
Common questions
Who regulates medicines in Bangladesh?
The Directorate General of Drug Administration (DGDA), under the Ministry of Health and Family Welfare, regulates the manufacture, import, registration, pricing and distribution of drugs in Bangladesh.
Can a foreign pharmaceutical company sell products in Bangladesh?
Yes, through import licensing and product registration with the DGDA, ordinarily working with a locally licensed importer or a local entity. Both the business licence and the individual product registrations are required before a product can be marketed.
How are pharmaceutical patents treated in Bangladesh?
Patent protection is available through the Department of Patents, Designs and Trade Marks, and Bangladesh has historically benefited from transitional arrangements available to least developed countries in respect of pharmaceutical products. Because that position is subject to change, the current status should be confirmed for any product strategy that depends on it.
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