In the pharmaceutical manufacturing sector, project approval hinges on compliance with legal regulations such as the Drug and Cosmetic Act of 2023. This act sets forth stringent guidelines, ensuring that businesses adhere to safety and efficacy standards. Obtaining approval necessitates meticulous alignment with these legal provisions, underscoring the importance of regulatory compliance in the industry.
Issuing Authirity
Name : Directorate General of Drug Administration
Address : Aushad Bhaban, Mohakhali, Dhaka-1212
E-mail : dgda.gov@gmail.com
Website : www.dgda.gov.bd
Required list of all documents
- Name of the Project (To be included in the project profile)
- Address of the Project (To be included in the project profile)
- Educational Qualification and Technical Experience of the Promoter (Copy of the original)
- Organogram of the Proposed Company (Signed by the managing director)
- Type of the Company
- Total Investment of the Project (not less than 32 Crore)
- Source of Finance (Name of the Bank/Foreign Investor)
- Equity
- Annual Production Capacity in relation to Proposed Machinery (Decision taken by the owner)
- Present Status of the Project (Decision taken by the owner)
- Infra Structural Facilities (Decision taken by the owner)
- Other Facilities
- List of Machinery for Production
- Apparatus and Equipment for quality Control
- Production Program
- Requirement for Raw Materials and Packing Materials
- Technical Experts (QA/QC Manufacturing Agreement as per the NDP, 2005)
- Sales Forecast
- Earning Forecast
- Break-even analysis
- Logic for the Production of Items to be manufactured
- Lay Out plan of the Project (Signed by the Company’s Engineer)
- Nationality Certificate of the Promoters
- Bank Solvency Certificate
- Trade License
- NOC form Environment Department
- Registration of the project from BIDA/BSCIC or others (Depends on the proposed location of the company)
- TIN (Original copy duly attested by a First class gazetted officer, applicable in case of a limited company)
- Memorandum & Articles of Association of Association and Certificate of Incorporation (Original copy duly attested by a First class gazetted officer, applicable in case of a limited company)
- Land Document (Copy of the land registration)
- Master plan (If necessary)
- Site Plan (If necessary)
- ETP layout (If necessary)
- Process flow diagram of Oncology Product (If necessary)
Step by step all process
Step 1 Collection and Submission of Application: The applicant collects the prescribed Application Form or Application Template from the Directorate General of Drug Administration (DGDA) and submits the filled-in form to the Dispatch along with all supporting documents.
Step 2 Initial Processing by Admin Officer and Director: The Dispatch forwards the application to the Admin Officer, who checks the documents and marks them to the concerned officer. The application is then sent to the Director, who gives an initial signature and sends it to the Assistant Director.
Step 3 Review by Dealing Assistant and Concerned Officer: The Assistant Director sends the application to the Nominated Dealing Assistant (DA), who forwards it to the Concerned Officer for review and evaluation.
Step 4 Evaluation by Project Evaluation Committee (PEC): The Concerned Officer places the application before the Project Evaluation Committee (PEC) for review. After receiving the result from the PEC, the Director General (DG) signs the application.
Step 5 Final Processing and Approval: The signed application is sent back to the Assistant Director, who forwards it to the Dealing Assistant. The Dealing Assistant sends it back to the Assistant Director, who then forwards it to the Director and subsequently to the DG for final approval.
Step 6 Dispatch and Fee Schedule: The DG provides the final signature and sends the application to the Assistant Director. The Assistant Director forwards it to the Dealing Assistant, who then forwards the final approved application to the Dispatch for the fee schedule.
Fee Schedule
Pay order of Tk. Iakh
Official timeline
3 month
Actual timeline
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