The Drug and Cosmetics Act, 2023, has been amended to mandate registration or prior approval with the Drugs and GDC before any dietary supplements, herbal or nutritional supplements, or related products can be imported, marketed, or sold in the country. Bangladesh Bank has also restricted LC and TT processing for imports of supplements without DGDA authorisation.
This guide explains the process of health supplement registration in Bangladesh with reference to the requirements of DGDA, documents required, labelling, licensing, GMP, and import compliance.
Regulatory Authority for Health Supplements in Bangladesh
Under the Drug and Cosmetics Act, 2023, the Directorate General of Drug Administration (DGDA) is responsible for the registration, import, and licensing of health supplements and their distribution control in Bangladesh. DGDA products are products related to nutrition, such as dietary supplements, herbal supplements, nutritional supplements, medical nutrition, and therapeutic nutrition that must be registered or approved prior to importation or commercialisation.
What Are Health Supplements Under Bangladesh Regulations?
According to the Drug and Cosmetics Act, 2023, Bangladesh regulates products as dietary supplements, food supplements, herbal supplements, nutritional supplements, medical nutrition, and therapeutic nutrition under the supervision of the Drug and Cosmetics Directorate (DGDA). Products in these categories must be registered or approved by DGDA before entering the country, being sold, or distributed in Bangladesh.
Compliance Checklist for Health Supplement Approval in Bangladesh
Prior to submitting an application to DGDA, companies should check:
- Classifying a product is confirmed in accordance with the Drug and Cosmetics Act, 2023.
- A local authorised representative/importer is appointed
- FSC/CPP is available and authenticated
- The GMP certificate is available
- Product composition and COA are prepared
- Stability data and manufacturing details are available
- Draft labelling complies with DGDA requirements
- Import and registration documents are complete
Health Supplements Registration Process in Bangladesh
Health supplements are prohibited for import and commercial distribution without DGDA approval. Here is the step-by-step approval process.
Step 1: Appoint a Local Authorised Representative
Any foreign manufacturer needs to have an importer/authorised person in Bangladesh for importing and submitting to the DGDA.
Step 2: Confirm Product Classification
The Drug and Cosmetics Act, 2023, must classify the product before submission.
Step 3: Prepare the Technical Dossier
The documents that are usually required are FSC/CPP, GMP certificate, COA, product composition, manufacturing information, stability data, and draft labelling.
Step 4: Submit the Application to DGDA
The application is submitted by the importer / authorised representative to DGDA for review.
Step 5: DGDA Evaluation and Approval
The application is sent for review to DGDA, who may have it reviewed by the Drug Control Committee (DCC) before it is approved or registered.
Step 6: Import and Commercial Distribution
Upon approval, the product can be sent for import clearance, distribution, and commercial sale in Bangladesh.
Documents Required for Health Supplements Registration in Bangladesh
DGDA demands administrative, technical, and quality documents for health supplement registration & import approval in Bangladesh.
- Application form and authorisation documents.
- A certificate of Pharmaceutical Product (CPP) and/or Free Sale Certificate (FSC).
- GMP certificate
- The composition and specifications of products.
- Certificate of Analysis (COA)
- Manufacturing process details
- Stability data
- Material Safety Data Sheet (MSDS)
- Create label and packaging artworks.
- The importer and wholesale license information.
DGDA Labelling Requirements for Health Supplements in Bangladesh
DGDA verifies product identification, composition, and compliance during product registration by reviewing the product labels.
Labels typically include:
- Product name
- Ingredient composition
- Dosage/Use directions
- Batch number
- The manufacturing date and the date it expired.
- Storage conditions
- Manufacturer and importer details
- Warning statements
DGDA Licensing Requirements for Health Supplements in Bangladesh
Bangladesh companies importing or distributing health supplements need to get relevant DGDA licenses and approvals prior to commercialisation.
Requirements typically include:
- Authorised local representative/importer
- Import authorization
- Wholesale or distribution license
- The product has to be registered or approved before use by DGDA.
- Valid trading license and company documents.
GMP Requirements for Health Supplements in Bangladesh
To verify the quality of manufacturing and product safety, the health supplement registration with DGDA is accompanied by a set of documents related to the GMP.
Common documents used in relation to GMP will be:
- GMP certificate
- Manufacturing site details
- Manufacturing process information
- Quality control procedures
- Product specifications
- Stability data
- Certificate of Analysis (COA)
Health Claims and Advertising Regulations in Bangladesh
The Drug and Cosmetics Act, 2023, regulates health supplement claims and advertisements. Prospective claims could need approval from the authority.
Companies should avoid:
- The treatment or cure of diseases claims
- Claims of efficacy that are misleading or exaggerated
- Claims that contradict the ingredients or purpose of the product
- Unauthorised therapeutic positioning
DGDA will review product claims during product registration, product labelling, and product commercialisation.
Import Regulations for Health Supplements in Bangladesh
Health supplements can be imported into Bangladesh only after obtaining approval or registration from DGDA. Bangladesh Bank also does not allow LC/TT for imports of Goods beyond DGDA.
Typical import requirements involve:
- Approval or registration by DGDA.
- Import authorization documents
- FSC/CPP and supporting certificates
- Commercial invoice and shipping papers
- Local importer or authorised representative information
Health Supplement Registration Timelines in Bangladesh
DGDA doesn’t have any deadlines for the registration of health supplements. Review timelines will vary depending on the completeness of the dossier, the authentication of documents, and regulatory evaluation.
There are a number of possible reasons for registration delays, including:
- Incomplete dossiers
- Missing FSC/CPP authentication
- Label inconsistencies
- Additional DGDA queries
- Pending DCC evaluation
Health Supplement Registration Costs in Bangladesh
Health supplement registration costs in Bangladesh may include:
- DGDA application and registration fees
- FSC/CPP authentication costs
- Bangladesh embassy attestation costs
- GMP documentation costs
- Label adaptation and translation costs
- Testing and stability documentation costs
- Local agent or importer service fees
Conclusion
The Drug and Cosmetics Control Act 2023 regulates health supplements in Bangladesh, and it is necessary to obtain the approval of DGDA before importing and commercialising. Companies need to harmonise the product classification, documentation, labelling, GMP records, and import requirements before entering the market.
Artixio assists global supplement companies in registering supplement products in Bangladesh, meeting the requirements of the Directorate of Medicines Administration (DGDA), obtaining import authorisation, reviewing the labelling, and developing the regulatory strategies for market access in a fast and compliant manner. To know more, you can get in touch with us at info@artixio.com.
FAQs
1. Do health supplements require DGDA registration in Bangladesh?
Yes. The drug and cosmetics-regulated supplements are required to be subject to approval/registration from DGDA before they can be imported and commercialised.
2. Are foreign manufacturers allowed to register supplements in Bangladesh?
Foreign manufacturers are required to secure an importer/exporter based in Bangladesh or an authorised representative for submission of documents to DGDA and import business.
3. Which documents are needed to register for a health supplement in Bangladesh?
Common documents are FSC/CPP, GMP certificate, COA, product composition, stability data, manufacturing data, and artwork for the label.
