The process of obtaining recipe approval for both introduced and non-introduced pharmaceutical products is a critical step in the registration process. This ensures that all products meet the stringent standards necessary for safety, efficacy, and quality. The legal framework governing this process includes the National Drug Policy of 2016 and the Drug & Cosmetic Act of 2023, which provide comprehensive guidelines and regulations to uphold public health and safety standards in the pharmaceutical industry.
Issuing Authoity
Name : Directorate General of Drug Administration
Address : Aushad Bhaban, Mohakhali, Dhaka-1212
Email : dgda.gov@gmail.com
Website : www.dgda.gov.bd
Required list of all documents
- Application letter [In the letterhead of the company]
- Form DA-1/88 [Along with the documents (1 set)]
- Form DA-2/88 [Along with the documents (21 sets for Non Introduced)]
- Treasury Challan [Original Copy from Bangladesh Bank]
- Drug Manufacturing Certificate
- List of Qualified Persons
- Applied Product must be approved by (DCC)
- Dosage Form and Type of Medicine
Step by step all process
Step 1 Collection and Submission of Application Form: The applicant collects the prescribed Application Form or Template from the Directorate General of Drug Administration (DGDA), completes it, and submits it to the Dispatch office along with all required supporting documents.
Step 2 Document Verification and Initial Review: The Dispatch office forwards the application to the Admin Officer for document verification. After thorough checking, the Admin Officer sends the documents to the Director for an initial review and signature.
Step 3 Forwarding to Assistant Director: The Director sends the initially reviewed documents to the Assistant Director, who then forwards them to the Nominated Dealing Assistant (DA).
Step 4 Local Committee Meeting and Decision Communication: The Nominated Dealing Assistant places the applications on the agenda for the Local Committee Meeting. The decisions from the meeting are sent back to the Director for further processing.
Step 5 Final Approval & Issuance: The Director compiles all the documents and forwards them to the Director General (DG) for final approval. The DG reviews and approves the documents. The approved documents are sent to the Dispatch office via the Nominated Dealing Assistant. The applicant then obtains the final approval from the Dispatch office, completing the application process.
Fee schedule
Recipe Testing fee: BDT 5,000
Pay order: BDT400
Official timeline
30-35 days
Actual timeline
Renewal process
Renewal list of all documents
- Recipe Approval (Copy)
- Treasury Challan (Original copy)
Step by step all process
Step 1 Submits the application with the treasury challan
Fee schedule
Official timeline
Actual timeline