API source validation service in Bangladesh
Required documents for API source validation in Bangladesh
1. Letter of Authorization (Attested by Bangladesh embassy/Chamber of Commerce)
2. Principal company profile (Attested by Bangladesh embassy/Chamber of Commerce)
3. Principal company manufacturing license (Attested by Bangladesh embassy/Chamber of Commerce)
4. Registered office address of the Manufacturer & the factory address (Attested by Bangladesh embassy/Chamber of Commerce)
5. GMP Certificate (Attested by Bangladesh embassy/Chamber of Commerce)
6. List of Countries where the API is being exported (Attested by Bangladesh embassy/Chamber of Commerce)
7. Certificate of Analysis (COA) with Specification of the API/RM (Attested by Bangladesh embassy/Chamber of Commerce)
8. Product list of the manufacturer (Attested by Bangladesh embassy/Chamber of Commerce)
9. Form-9 (mentioning the product name) – Signed by the manufacturer
Validity of Source validation certificate: 3 years
We provide Biosimilar API registration service in Bangladesh
English Translated Copy of DGDA Circular No. DGDA/BAPI-78/10/1044, Dated 31-10-2023
Government of the People’s Republic of Bangladesh
Directorate General of Drug Administration
Aushadh Vaban, Mohakhali, Dhaka-1212
www.dgda.gov.bd
No. DGDA/BAPI-78/10/1044; Date: 31/10/2023
Subject: Regarding Source Validation of Raw Materials and Block List Approval
In view of the above subject it is stated that, a meeting was held between Drug Administration and representatives of Bangladesh Association of Pharmaceutical Industries (BAPI) and Bangladesh Indenting Agents’ Association (BIAA) on September 24, 2023 chaired by Director General of Directorate General of Drug Administration regarding source validation of raw materials and block list approval. The following decision was taken in the said meeting:
- Source validation to be completed within 03 (three) months after submission of the application along with all required documents. Deficiency Letter to be given to applicant within 07 (seven) working days if there is/are any lacking/missing documents. Legal action will be taken against the applicant if there is any fake/counterfeited document submitted along with the application.
- In a single application, source validation of 10 (ten) items can be accomplished but the limit would not be applicable in case of old or previously validated organization / supplier items.
- In case of revalidation of source, source validation can be renewed after submission of all required documents and payment of required fees. At the time of the renewal of source validation, all items validated earlier can be mentioned in the application.
- After the approval of source validation, the information of valid source will be uploaded in the website of Directorate of Drug Administration within 07 (seven) working days.
- Approval of block list of API without source validation is extended till December 2023.
- The local agent (s) name should be mentioned in the source validation certificate and block list and no other local agent can issue indent apart from the approved local agent (s). In case of change of local agent (s), it should be informed to the Director General of Drug Administration.
- The working committee on source validation which was formed in 2018 should be updated. The meeting of the said committee will be organized in every six months.
All concerned are requested to implement the decision taken in the above meeting.
Major General Mohammad Yousuf
Director General
Directorate General of Drug Administration
Phone: 022222-80803
Email: dgda.gov@gmail.com
Distribution (not in order of seniority):
- President, Bangladesh Association of Pharmaceutical Industries
- President, Bangladesh Indenting Agents’ Association
- Proprietor, M/S. Pharma DRA
- Source Validation wing, Directorate General of Drug Administration, Dhaka
- Blocklist wing, Directorate General of Drug Administration, Dhaka
- PA to Director General, Directorate General of Drug Administration, Dhaka
