State approvals / Uttarakhand / Department of Medical Health and Family Welfare
Drug Manufacturing License
DepartmentDepartment of Medical Health and Family Welfare
TypeLicense
StagePre-Establishment
AppliedIntegrated With SWCS
Unit sizeMicro, Small, Medium, Large, Mega, Ultra-Mega, Super Ultra-Mega
Business locationUrban-Plain, Urban-Hilly, Rural-Plain, Rural-Hilly
Risk / pollution categoryHigh, Medium, Low, Red, Orange, Green, White
Investor typeForeign, Domestic
Document checklistApplication formFee structureProcedure (SOP)Timelines Apply on Invest Uttarakhand (SWCS)
Documents to submit
| # | Document | Condition | Required |
|---|---|---|---|
| 1 | Challan of requisite fee (For Drug Rs. 7500/- for each form and for cosmetic Rs. 3500/- and Rs. 300/- for Homeopathic) | — | Required |
| 2 | Affidavit (Rs 100/- stamp paper, ID proof and address proof) to the effect that so & so will be responsible for day to day conduct of the business of the firm or company etc. & the brand names of products does not infringe the trademark Act in any way | — | Required |
| 3 | Treasury Challan | — | Required |
| 4 | Map of the premises (Blueprint) | — | Required |
| 5 | Ownership documents of the premises | — | Required |
| 6 | Partnership Deep or Article & Memo of Association along with certificate of incorporation and list of present Directors, Resolution of Board of Directors | — | Required |
| 7 | Power of attorney & authorization letter to Authorized signatory | — | Required |
| 8 | List of manufacturing Equipment’s | — | Required |
| 9 | List of Lab Equipment’s | — | Required |
| 10 | Appointment Letters, ID proof and address proof, Joining Letters, Approval Certificates & affidavit of Manufacturing & Analytical Chemists (three Photographs per forms) | — | Required |
| 11 | NOC from UA Pollution Control Board | — | Required |
| 12 | Medical Examination report (Freedom from contagious diseases) from qualified Doctor along with his consent for regular periodical health check-up | — | Required |
| 13 | Potability test report of drinking water | — | Required |
| 14 | Consent letter from approved laboratory for sophisticated instrumental analysis | — | Required |
| 15 | List of firefighting equipment’s | — | Required |
| 16 | S.S.I. Registration | — | Required |
| 17 | Aadhar Card | — | Required |
| 18 | PAN no | — | Required |
More from Department of Medical Health and Family Welfare
- Approval for carrying out tests on drugs / cosmetics and raw materials used in their manufacture on behalf of licensees for manufacture for sale of drugs / cosmetics
- Approval for carrying out tests or analysis on ayurvedic, siddha and unani drugs or raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of ayurvedic, siddha and unani drugs
- Drug Manufacturing License(Retention)
- Issuance of duplicate licence to collect, process, test, store, banking and release of umbilical cord blood stem cells
- Issuance of duplicate licence to manufacture and store blood products for sale or distribution
- Issuance of duplicate licence to manufacture for sale or for distribution of drugs
- Issuance of duplicate licence to manufacture for sale or for distribution of homoeopathic medicines
- Issuance of duplicate licence to manufacture for sale or for distribution of large volume parenterals/sera and vaccines/recombinant DNA (R-DNA) derived drugs specified in schedules C and C (i) excluding those specified in schedule X
- Issuance of duplicate licence to operate a blood bank for collection, storage and processing of whole human blood and/or* its components for sale or distribution
- Issuance of duplicate licence to repack for sale or distribution of drugs being drugs
- Issuance of duplicate licence to sell by wholesale or to distribute drugs from a motor vehicle.
- Issuance of duplicate licence to sell, stock or exhibit [or offer] for sale, or distribute by wholesale, drugs
