Pharmaceutical Drug Licence and DGDA Compliance in Bangladesh: Current Legal Guide

Scope of this amended guide. This is an operational legal overview for a manufacturer, importer, distributor, pharmacy, regulatory-affairs team, or counsel dealing with medicines in Bangladesh. It is an amendment of the existing LegalBD article, not a substitute for a product-specific DGDA determination. The governing statute should be checked before filing because DGDA forms, orders, guidelines, fees, and portals may change.

1. The regulator and the governing framework

The Directorate General of Drug Administration (DGDA) is the statutory regulator identified by the 2023 Act. The Act regulates manufacture, import, export, sale, stocking, storage, display, distribution, quality control, registration, marketing authorisation, inspections, clinical trials, pharmacovigilance, and related enforcement. The DGDA’s official law page also publishes the Act, older instruments, rules, policies, and administrative material.

• Primary law: Drugs and Cosmetics Act, 2023, Act No. 29 of 2023.
• Operational rules and orders: rules, gazettes, DGDA directions, licence conditions, forms, and current portal instructions made or published under the Act.
• Technical standards: the Act requires Good Practices for manufacture, quality control, distribution, supply, and storage, including WHO-aligned GxP material where applicable.
• Policy context: the National Drug Policy and essential-medicine decisions provide policy context; they do not replace a required licence, registration, or marketing authorisation.

For a filing, use the current source copy rather than an old blog, fee chart, or previously saved PDF. The DGDA portal currently exposes an ADLRS drug-licence service, a user manual for retail applicants, a Bangladesh Single Window reference, a medicines database, and a pharmacovigilance reporting link. Portal availability does not itself prove that an application is approved.

2. Licence before regulated activity

Section 14 prohibits manufacturing, selling, stocking, distributing, or displaying a drug for sale without a licence from the licensing authority or outside the licence conditions. The Act also restricts using an internet or web-based process to sell, stock, distribute, or display drugs without the required licence. A new manufacturing project or expansion requires prior approval from the licensing authority.

Section 16 permits the licensing authority to inspect premises and to grant or renew only where the premises is considered suitable under the Act and rules. The practical file should therefore be built around the exact activity and premises, not around a generic “pharmaceutical licence” label:

• identify whether the activity is manufacture, sale, stocking, distribution, import, export, or more than one;
• map each site, warehouse, outlet, responsible person, product category, and storage condition;
• assemble corporate, premises, technical, quality, storage, and personnel evidence requested by the current DGDA form or portal;
• keep a controlled copy of the submitted application, attachments, inspection records, correspondence, licence conditions, and renewal proof; and
• do not start a new project, expand a facility, or change quality-relevant infrastructure before checking whether DGDA approval is required.

Retail and wholesale applications

The DGDA has published a current official Form-7 application for a licence to sell, stock, exhibit for sale, and distribute drugs. The form asks for the premises, the mode of sale, supervision by pharmacist(s), product classes, and storage information. It is an example of the level of activity-specific detail required; applicants should use the version currently linked by DGDA rather than copy an old form into a new filing.

3. Licence duration, renewal, suspension, and review

Under section 15, a drug licence is valid for two years from its date of issue and is renewable. The Act says the renewal application should be made no later than 90 days before expiry. Fees and late fees are set or revised under the applicable rules or government gazette; this article intentionally gives no fixed fee because a historic number is not a reliable current quotation.

Section 18 identifies grounds that may support cancellation or temporary suspension, including breach of the Act, rules, or licence conditions; failure to follow GMP; false or withheld information; use of the licence for an unauthorised purpose; and unapproved physical changes that may affect quality. Before cancellation or suspension, the authority must give written notice with reasons and a time for response. Section 19 provides a review application or government appeal within 30 working days after a qualifying suspension and production-stop order. Preserve the notice, evidence, response, and proof of filing.

4. Registration and marketing authorisation are separate gates

A facility licence is not product approval. Section 22 prohibits manufacture, import, export, sale, distribution, stocking, or display of a drug without registration. A registered drug must also obtain a marketing authorisation certificate before distribution, marketing, or sale. The applicant must provide satisfactory quality, safety, and efficacy information requested by the licensing authority. Depending on the product and request, clinical-trial or bioequivalence information may be required; it should not be described as automatically mandatory for every generic.

Registration is valid for five years and is renewable. The marketing-authorisation certificate remains effective while the registration remains effective. Registration and renewal fees are governed by the applicable rules or gazette. The DGDA must publish and update a list of registered drugs, which is a useful verification point but not a substitute for checking the specific certificate, conditions, and current status.

A defensible product file

Before a submission, regulatory and legal teams should reconcile the product identity, generic and brand name, manufacturer, importer or marketing entity, manufacturing site, formulation, strength, dosage form, pack, labels, inserts, quality specifications, stability evidence, safety and efficacy evidence, and any requested clinical or bioequivalence material. Do not assume that a CTD module structure, a particular form number, a foreign certificate, or a review timeline applies unless the current DGDA instruction for that product category says so.

5. Import, raw materials, pricing, and quality systems

Section 41 prohibits drug import without a licence or outside its conditions, and requires prior licensing-authority approval for importing registered drugs. The Act permits the DGDA to verify GMP at an importing manufacturer’s premises where necessary. Section 42 separately restricts obtaining or importing registered-drug raw materials, packaging materials, semi-finished drugs, or other necessary materials without the required prior approval.

Section 17 requires WHO Good Practices for manufacture, quality control, distribution, supply, and storage. A workable compliance system should therefore maintain batch and release records, approved suppliers, deviations, complaints, recalls, change control, training, temperature or other storage records, and a documented investigation trail. These are operational controls, not a promise that any particular inspection outcome is guaranteed.

Section 30 allows the Government, by Gazette, to set maximum retail prices for listed and imported drugs and maximum selling prices for certain domestic drug raw materials. Do not use an old “MRP approval” table or a fixed price claim without checking the current Gazette and product category.

6. Pharmacovigilance and post-market duties

Section 66 makes pharmacovigilance a continuing duty for manufacturers, importers, marketers, hospitals, clinics, public-health programmes, and other relevant stakeholders. The responsible organisation must conduct monitoring and send required reports and data to the licensing authority, following the approved National Pharmacovigilance Guideline, Good Vigilance Practice, WHO, or another recognised standard as applicable. The DGDA’s National Guideline on the Pharmacovigilance System in Bangladesh, version 02, identifies DGDA as the National Pharmacovigilance Center and describes the ADRM and advisory structures.

At minimum, maintain a named safety contact, intake and triage procedure, case records, signal and escalation rules, regulatory reporting calendar, product complaint linkage, recall interface, and audit trail. This article does not provide clinical advice or a substitute for the current guideline’s reporting instructions.

7. Inspection, sampling, and response planning

The Act gives inspectors powers to inspect sites, records, storage, raw materials, packaging, and products; collect samples; enter and search in the circumstances stated by law; and seize or seal relevant items. Section 50 requires a seizure copy to be provided and specifies a controlled sample process. The Act describes four sample portions: one for the person from whom the sample was taken, one for analysis, one for the manufacturer/importer/marketer or warrantor where applicable, and one for the court.

Section 52 provides a route for challenging a Drug Analyst report with evidence and, where the court permits, re-analysis by the national control laboratory. A response plan should therefore:

1. identify the inspector and responsible company contact;
2. record the notice, inventory, seals, batch numbers, photographs, witnesses, and chain of custody;
3. secure the company’s sample and quality records without altering them;
4. obtain counsel and technical review promptly; and
5. meet every response, review, recall, and reporting deadline shown in the notice or Act.

8. Statutory and operational checklist

9. Visual workflow

10. Frequently asked questions

11. Official verification links

• Bangladesh Laws: Drugs and Cosmetics Act, 2023 (Act No. 29 of 2023)
• DGDA official laws and rules index
• DGDA drug-licence services, ADLRS, forms, and portals
• DGDA Form-7: retail/wholesale sale, stocking, display, and distribution application
• DGDA National Guideline on the Pharmacovigilance System in Bangladesh, version 02
• WHO pharmacovigilance resources

Disclaimer: This amended guide is for general information and document-planning purposes. It is not legal, regulatory, medical, or clinical advice. DGDA requirements, forms, fees, portals, and guidance should be checked immediately before filing or operating.