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The Directorate General of Drug Administration (DGDA) is the national Regulatory authority responsible for overseeing pharmaceuticals, biologics, medical devices, and cosmetics in Bangladesh. It operates under the Ministry of Health and Family Welfare and ensures that all medicinal products manufactured, imported, exported, distributed, or marketed in the country meet required standards of safety, efficacy, and quality.

The agency’s primary objective is to protect public and animal health by ensuring the availability of safe, effective, and quality medicines, while also promoting their rational use through established Regulatory control systems. DGDA oversees the entire product lifecycle, including manufacturing, import and export, storage, distribution, and post-market surveillance, ensuring compliance at every stage.

DGDA derives its legal authority from the Drugs and Cosmetics Act, 2023, which replaces earlier frameworks such as the Drugs Act, 1940 and the Drugs (Control) Ordinance, 1982. This legislation aligns Bangladesh’s Regulatory system with international standards and expands its scope to include cosmetics and medical devices.

A key part of DGDA’s Regulatory system is the National Drug Control Laboratory (NDCL), which has been upgraded with advanced infrastructure and modern technologies. It is accredited under ISO/IEC 17025:2017, with recognition from national and international accreditation bodies such as the Bangladesh Accreditation Board (BAB) and the ANSI National Accreditation Board (ANAB), along with WHO prequalification for drug testing. NDCL supports quality assurance through specialized testing facilities for microbiology, vaccines, medical devices, traditional medicines, and cosmetics.

Overall, DGDA plays a vital role in protecting public health while supporting the growth and global competitiveness of Bangladesh’s pharmaceutical sector.

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