“The Drug and Cosmetics Act 2023”, Act No. 29 dated 18 September 2023 passed by the Bangladesh Parliament

Aiming to regulate the production, import, and sale of drugs and cosmetics and protect against the production and sale of adulterated drugs and cosmetics in the country, the Bangladesh Parliament passed the Drug and Cosmetics Act 2023. The new law repeals the Drugs Act, 1940 and the Drugs (Control) Ordinance, 1982.

In a change from previous practice, the responsible authority for overseeing both drugs and cosmetics is the Directorate General of Drug Administration (“DGDA”) (previously the Bangladesh Standards and Testing Institution had authority over cosmetics). The DGDA is now responsible for issuing licenses, regulating production, and controlling the quality of drugs and cosmetics.

Licensing

Cosmetics

Licenses and cosmetic registration certificates are now required to produce, distribute, import, or export cosmetics.

Research

To conduct analysis, research, or medical research, researchers are not required to have a license from the DGDA.

Import of raw materials and packaging for drugs

A license is required to import raw materials or packaging materials for drugs.

Drug manufacturing and sales

Besides needing a marketing authorization license and a drug registration license, drug manufacturers will need a license to produce, sell, store, distribute, and display drugs for sale. A license from the DGDA is also required for drug manufacturers to expand their business or for any new production.

The DGDA, as the licensing authority, cannot register a drug without the acknowledgment or permission of the Medicine Regulatory Committee. In case of an emergency situation like a pandemic or epidemic, the DGDA can initially give permission for drug production, without confirmation from the Medicine Regulatory Committee, but then must apply for permission within 90 days after approving such license.

The licensing authority may visit the office premises of drug manufacturers. Manufacturers must follow the World Health Organization’s Good Practice and Good Manufacturing Practice guidelines in terms of the quality control, production, distribution, supply, and storage of drugs.

Failure by a manufacturer to follow the instructions mentioned in the law or any other notification or official gazette published by the government could result in cancellation of their license. In such a case, the manufacturer has 30 days to appeal the decision.

Drug production licenses are valid for two years and are renewable. Drug registration license and marketing authorization licenses are valid for five years and are renewable.