State approvals / Himachal Pradesh / Department of Health and Safety Regulations
Granting and Renewal of Drug Manufacturing License
This approval is required by those who wish to secure a license for Granting and Renewal of Drug Manufacturing License
DepartmentDepartment of Health and Safety Regulations
TypeNew
StagePre-Operation
Time limit21 days
FeeNo fee
Applied—
Documents to submit
| # | Document | Condition | Required |
|---|---|---|---|
| 1 | Application Form-24/24-A/24-B and/or 27/27-A-in original 2. Challan for Rs. 7500 (application and inspection fee) per application and fee for the additional @ Rs.300 per Product (excluding first 10 products per Section) proposed to be manufactured to be deposited separately in Goverment Treasury Account as per the treasury codes corresponding to the area of operation 3. Constitution of the company/firm deed/Partnership deed Memorandum & Article of Association/ Partnership 4. Authorization/Resolution on behalf of the partnership firm/company in favour of person/applicant, applying for the grant of licenses. 5. Power of Attorney/ Resolution/ Declaration of the person(s) responsible for the conduct of the business and day to day activities of the firm/ company 6. Photo IDs (Adhaar, PAN, DIN), of the promoters, applicant and/or persons (as referred in S.No.4 and 5) 7. Affidavit on behalf of the applicant duly verified by the oath commissioner (as per the prescribed language) -regarding non conviction and person responsible for manufacturing and testing of drugs, conditions of the licenses etc. as required under the Drugs and Cosmetics Act, 1940 8. Affidavit on behalf of the applicant duly verified by the oath commissioner (as per the prescribed language)-regarding proposed formulation and claim thereof 9. Site/location plan and floor wise layout plan (to the scale) of the proposed premises clearly indicating size and definition of the area, duly drawn and certified by the competent authority-(2-copies) 10. List of the production machinery installed with their nos. indicating model, make and capacity. 11. List of the machinery installed in utilities viz. Water System, HVAC System, Boiler, Electrical, etc 12. List of the laboratory instruments/equipment with their nos, indicating model, make and capacity 13. List of the products proposed to be manufactured, section wise and category wise (as prescribed in Schedule C and C1 and other than those prescribed in Schedule C and C1)- as per the format 14 | — | Required |
- Proof of ownership: Registration papers of the land, rent/lease deed etc.-attested photocopy 15. Certificate of registration issued by the Industry Department, Himachal Pradesh-attested photocopy 16. NOC issued by the Pollution Control Board, Himachal Pradesh- attested photocopy