State approvals / Chhattisgarh / Food and Drug
Drug Manufacturing License (Registration and Renewal)
DepartmentFood and Drug
TypeNew
StagePre-Establishment
FeeNo fee
Applied—
Documents to submit
| # | Document | Condition | Required |
|---|---|---|---|
| 1 | Application Form-24/24-A and 27/27-A 2. Challan Form for INR 7,500/- per application and fees for the additional (@ INR 300/- per Item excluding first 10 items per section) proposed to be manufactured to be separately in Government account 3. Affidavit on behalf of the applicant (Proprietor / Partner / Managing Director / General Power of Attorney Holder) duly attested by the Oath Commissioner / Notary (as per the prescribed language). 4. List of the Plant & Machinery installed 5. List of the Laboratory Equipments provided 6. Certificate of registration from the Industry Department. (Attested photocopy) 7. Valid NOC from the Pollution Control Board (Attested photocopy) 8. Registration Papers of the Land in case of owner (Attested photocopy with recent copy of Farad from the Revenue Department). Or In case the Premises are Rented, Rent/Lease Agreement Deed (Attested photocopy) 9. Constitution of the firm (Attested photocopy) 10.COMPETENT PERSON (S) RESPONSIBLE FOR MANUFACTURING: i) Medical fitness certificate indicating complete investigation ii) Appointment letter of the employee-attested photocopy iii) Joining/acceptance letter of the employee-attested photocopy iv) Affidavit on behalf of the appointed competent person responsible for manufacturing (as per the prescribed language) v) Qualification certificate-degree/diploma/matriculation-attested photocopy (is) vi) Certificate of approval as manufacturing chemist by the competent drug authority-attested photocopy vii) Experience certificate on the letter pad bearing licence Nos. of the issuing firm original copy vili) Passport size Photograph. 11. COMPETENT PERSON (S) | — | Required |
- RESPONSIBLE FOR TESTING: i) Medical fitness certificate indicating complete investigation ii) Appointment letter of the employee-attested photocopy iii) Joining/acceptance letter of the employee-attested photocopy iv) Affidavit on behalf of the appointed competent person responsible for manufacturing (as per the prescribed language) v) Qualification certificate-degree/diploma/matriculation-attested photocopy (is) vi) Certificate of approval as Analytical chemist by the competent drug authority attested photocopy vii) Experience certificate on the letter pad bearing licence Nos. of the issuing firm original copy viii) Passport size Photographs 12. List of the items proposed to be manufactured section wise and category wise (Biological and Non-Biological) indicating the following details: i) Reference thereof ii) Ingredients, specification and qty. per unit dose iii) Brief of the manufacturing including critical steps, if any iv) Testing method-in case of non-pharmacopoeia drugs and ingredients v) proposed packing presentation and package material proposes to be used 13. Site Plan (to the scale), Location and Layout of the proposed premises clearly indicating size and definition of the area and details of the furniture and fixtures provides therein, Deawn and certified by theCompetent authority-Blue Print