“Product Inclusion with Trade Name Check is a crucial step in pharmaceutical product registration, governed by the Drug Control & Cosmetic Act, 2023. This process ensures the safety and efficacy of pharmaceuticals by evaluating them under specific trade names. Compliance with this legal mandate is essential for companies seeking authorization, ensuring adherence to regulatory standards and safeguarding public health.”
Issuing Authority
Name : Directorate General of Drug Administration
Address : Aushad Bhaban, Mohakhali, Dhaka-1212
Email : dgda.gov@gmail.com
Website : www.dgda.gov.bd
Renewal list of all documents
1. Application letter
2. Recipe Approval
3. Treasury Challan (Original Copy)
4. Text of Packing Materials (Draft)
5. Annexure
6. Accelerated Stability Study Data
7. Test examine and system
Step by step all process
Step 1 Application Collection and Submission: The applicant obtains the necessary application form from DGDA and fills it out. After completing the form, along with all required supporting documents, they submit it to the Dispatch.
Step 2 Initial Document Review: Upon receiving the application, the Dispatch forwards it to the Admin Officer. The Admin Officer meticulously checks all the submitted documents for completeness and accuracy before sending them to the Director.
Step 3 Director’s Review and Marking: The Director reviews the application thoroughly, ensuring it meets all necessary criteria. Once satisfied, the Director marks the application and passes it on to the Assistant Director through Dispatch for further processing.
Step 4 Name Verification: The Assistant Director then forwards the application to the Nominated Dealing Assistant. This assistant conducts a comprehensive name check to verify the applicant’s identity and background. Following the name check, the application is sent to the computer section by either the Assistant Director or the designated staff member (AD or DS) for further verification. Here, the applicant’s information undergoes a rigorous examination for accuracy.
Step 5 Approval and Conclusion: After successful verification, the Dealing Assistant receives the verification report and forwards it to the Dispatch. Finally, upon approval, the Dispatch notifies the applicant, concluding the application process.
Fee schedule
- Treasury Challan: BDT10,000
- In Addition:
- If INN product: BDT 15,000
- If BP/USP: BDT 5,000
Official timeline
7-10 days
Actual timeline