State approvals / Odisha / Health and Family Welfare (H&FW) Department
Granting & renewal of Drug Manufacturing License
a)Drug license is a legal document which is required to do businesses related to the pharmaceutical industry, drugs & cosmetics. b)This approval is required for obtaining or renewing the license to manufacture drugs in Odisha
DepartmentHealth and Family Welfare (H&FW) Department
TypeNew
StagePre-Operation
Time limit90 days
FeeNo fee
AppliedApply on NSWS
Documents to submit
| # | Document | Condition | Required |
|---|---|---|---|
| 1 | Proof of Identity of the applicants (Copy of Passport/Aadhar Card/Driving License) 2. Constitution of Firm (ProprietoINRhip/PartneINRhip/Pvt. Ltd./Public Ltd./Registered Society/Govt. Agency) 3. Registered PartneINRhip Deed under I.G.R. Odisha/Articles of Association/ Memorandum of Association as per the Companies Act, 2013. 4. Resolution Copy passed by the Board of DirectoINR for obtaining of License. In case of Govt. Agencies, Legal Authorization from Competent Higher Authority 5. Power of Attorney/Letter of Authorization 6. Detailed list of manufacturing and analytical equipment with copies of the purchase bill 7. Copy of the Site Master File (SMF) 8. List of Standard Operating Procedures (SOPs) 9. Calibration Validation certificate of Equipment (wherever necessary) 10. List of drugs intended to be manufactured including formula, pack size and details of primary packing material, literature and insert (if any) draft label of product intended to be manufactured 11. Layout plan of the premises (blue print along with details of area of each section duly signed by applicant and owner of the house) 12. Design and lout of HVAC systems if application (validation thereof) 13. Documentary Evidence in support of OwneINRhip & Building 14. House Rent Agreement in case of Tenancy or declaration of House Owner if same as applicant for the specific purpose 15. Educational Certificate of the peINRons in-charge of Manufacturing, Testing and Quality Assurance 16. Consent Letter of peINRons in-charge of Manufacturing, Testing and Quality Assurance for their specific jobs 17. Experience Certificate of the peINRons in-charge of Manufacturing, Testing and Quality Assurance from their respective ex-employeINR 18. Declaration/Affidavit of their peINRons in-charge of Manufacturing, Testing and Quality Assurance regarding their non-engagement elsewhere & their previous engagements in the concerned fields 19. Line Diagram of the Air Handling Unit (AHU)/AC/De-Humidifier/Purified Water Supply/Portable Water Supply/Drainage/Return Air Vent, etc. 20. Fire Safety measures provided, no. of fire extinguisheINR provided with their validity and other steps taken for safety 21. Provisions made for disposal of Waste Water Management 22. Pollution Control Certificate 23. Consent Letter from an Approved Institution to carry out Tests & Analysis of Manufacturing Drugs and Raw Materials prior to release of the batch along with the copy of Valid License/thereof where the application had not provided own Testing facilities (which require sophisticated instruments) 24. Fire Safety Certificate obtained from Fire Officer 25. Compliance of Schedule M, M-I, M-II, M-III (as the case maybe) 26. Protocol for testing in case of Patent & Proprietary medicine (wherever necessary) 27. Stability studies data of drugs (Stability studies for all products is to be submitted in case of renewal of license. In case of grant of license only established pharmacopoeia products will be allowed. However, real time/accelerated studies has to be commenced immediately after the products are manufactured) 28. Permission obtained from the Municipal Authorities/ Panchayat Authorities/ Certificate in conformity with Factories Act from construction and starting the Unit 29. Clearance from Drugs Controller General (India), New Delhi, in case of new drugs (either Bulk drug or Formulation) New Drugs as defined under Rule 122E of Drugs and Cosmetics Rules, 1945 30. Technical Data in respect of the products for manufacture of drugs: (a) Technical Documents to be submitted for Bulk Drugs: (i) Manufacturing procedure of each product (ii) Flow chart with structural formula of reactions as per the Master Formula record and analytical procedure of each applied product with mode of procurement of official reference standards or working standards (iii) Official Monograph copies (iv) Consumption coefficients generated and their treatment followed (v) Specimen labels of all applied products (b) Technical Documents to be submitted for Formulation: (i) Consolidated list of Formulation with packing particulaINR separately category-wise, viz. Tablets, Capsules, Injectables, etc. (ii) Details of biopharmaceutical classification of each drug to be manufactured (Oral Dosage form) with result of bioequivalence study of drug (Oral Dosage form under category II & IV) (iii) Manufacturing & Analytical procedure of each product (not required in case of renewal) (iv) Specimen labels (v) Labels of the similar products moving in the market for formulation not included in the IP (vi) Copies of monographs of drugs which are not included in IP | Wherever applicable | If applicable |