Bangladesh Drug and Cosmetics Act 2023: Framework and Penalties

1. Key takeaways

The parent statute in force in Bangladesh is the Drug and Cosmetics Act, 2023, cited as Act No. 29 of 2023 and brought into force on 18 September 2023. It replaces in full the Drugs Act, 1940 (Act No. XXIII of 1940) and the Drugs (Control) Ordinance, 1982 (Ordinance No. VIII of 1982). Two features of the new law matter most to device manufacturers. First, medical devices, diagnostic reagents and software are written directly into the definition of a drug. Second, the catalogue of punishable conduct expands from six categories under the 1982 Ordinance to thirty categories. The Act is therefore not a device law at all. It is a medicines and cosmetics law that absorbed devices, and understanding that absorption explains almost every procedural feature downstream.

• One statute now governs drugs, devices, diagnostic reagents, software and cosmetics.
• The device definition sits in the definition clause, not in a dedicated chapter.
• Enforcement scope widened considerably, from six offence categories to thirty.
• Cosmetics regulation moved from BSTI to the DGDA under the same instrument.
• Guidance documents still quote the repealed 1940 Act in places, so citations require care.

2. Legal basis

The table below records the elements of the Act that a registration file normally has to cite. Where a figure originates in press reporting rather than in the gazetted text, that is stated in the table itself, because a media summary is not a defensible legal source in a submission or in a dispute.

3. Expert insights

Insight one: this is inheritance-style legislation, and old terminology survives in current guidance. One detail that is easily missed is that §4.9 of the DGDA Medical Device Registration Guidelines still states that sampling follows the procedure laid down in the Drugs Act, 1940, even though that Act has been replaced by the 2023 statute. The result is a transitional state best described as a new statutory framework carrying old statutory vocabulary. A manufacturer that copies the guideline wording verbatim into a submission will cite a repealed law. The correct practice is to follow the procedure as described while citing the instrument that actually confers the power today.

Insight two: devices were not a newly regulated object, but an object absorbed into medicines regulation. Many markets took the separate device law route, with a distinct statute or regulation for devices, as India, Malaysia, Thailand and Vietnam each have in their own way. Bangladesh took the opposite route. Devices were defined as drugs, and therefore the pharmaceutical administrative system, the penalty structure and the terminology all apply to devices automatically. The absence of a dedicated device statute is the starting point for understanding every step of the Bangladeshi process, including the fact that device applications are reviewed by a committee constituted within the medicines control structure.

Insight three: cosmetics were folded into the same instrument, which signals a regulator in expansion. The new Act transfers responsibility for the import, manufacture and sale of cosmetics from the Bangladesh Standards and Testing Institution (BSTI) to the DGDA. That provision has nothing directly to do with devices, yet it matters as a signal. A regulator that has just been handed a new product vertical is a regulator building enforcement capacity, and the direction of travel is toward stricter rather than looser practice. Manufacturers planning multi-year market entry should read the trend as structural rather than temporary.

4. Practical recommendations

• Cite the parent statute in four elements, always in the same order: title, act number, date in force and the provision relied on. The standard form is the Drug and Cosmetics Act, 2023 (Act No. 29 of 2023, in force 18 September 2023).
• When an older instrument is mentioned, mark it expressly as repealed, and state which Act replaced it. An unmarked reference to the 1940 Act in a current file invites a query at the earliest review point.
• Do not quote penalty figures as settled law in external documents. Describe them as the ranges reported in the media and note that the gazetted text governs, then obtain local counsel opinion for any matter of consequence.
• Identify the places where guidance still refers to the 1940 Act, and annotate them internally so that no team member lifts the reference into a live submission.
• State the premise that Bangladesh has no separate device statute at the front of the project file, so that reviewers and clients do not expect an independent device authority or an independent device appeal route.

5. Verification checklist

• □ Legal citations use all four elements: title, act number, date in force and provision
• □ References to superseded instruments are marked as replaced by Act No. 29 of 2023
• □ Penalty figures are attributed to media reporting, with a note that the gazetted text governs
• □ The old Act name appearing in §4.9 of the guidelines has been identified and is not cited as current law
• □ The project file states the premise that Bangladesh has no standalone device statute

Regulatory information verified as of 27 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across South Asia, including Bangladesh. Our team prepares dossiers to DGDA expectations, manages submissions and deficiency responses, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com