State approvals / Puducherry / Drugs Control Department
Drug Manufacturing License
DepartmentDrugs Control Department
TypeNew
StagePre-Operation
Time limit45 days
FeeNo fee
AppliedApply on NSWS
Documents to submit
| # | Document | Condition | Required |
|---|---|---|---|
| 1 | Covering Letter | — | Required |
| 2 | Specific Power of Attorney in favour authorized signatory for submitting application on behalf of the company | — | Required |
| 3 | Site Plan and layout of the building with the name,address, scale, measurements of the area as per schedule- T requirement (For Ayurvedic, siddha ,unani) & as per Shedule – M Requirement(Allopathic Medicines) & as per Schedule-M-II requirement | — | Required |
| 4 | Self attested copies of documents pertaining to the possession of premises such as, Register ownership /rent /lease/allotment letter /Possession Letter, Tax Receipt, (Documents should be Registered with appropriate Authority ) | — | Required |
| 5 | Consent to establish from State pollution control Board | — | Required |
| 6 | List of Directors, Partners, Trustees, along with ROC Copy Registered Partnership deed, Trust deed | — | Required |
| 7 | List of Competent Technical Staff, with their qualification, Registration ,Experience, previous FDA Approvals,Etc | — | Required |
| 8 | Appointment/Acceptance Letter of Competent Technical staff of manufacturingSection | — | Required |
| 9 | Appointment/Acceptance Letter of Competent Technical staff of TestingSection | — | Required |
| 10 | Section wise List of plant and Machineries Yes | — | Required |
| 11 | NOC of department of industrial safety &Health | — | Required |
| 12 | Details of manufacturing Process, Process Flow Chart | — | Required |
| 13 | AHU installation and validation Certificate | — | Required |
| 14 | Water System installation and validation Certificate | — | Required |
| 15 | Site Master File | — | Required |
| 16 | Form 29 Licensed issued by SLA | — | Required |
| 17 | Form 10 Issued by CDSCO | Where required | If applicable |
| 18 | Constitution details of firms | — | Required |
| 19 | A copy of New Drug permission | If applicable. If not, justification | If applicable |
| 20 | Supporting data for BA/BE study whererequired | — | Required |
| 21 | Stability studies data | — | Required |
| 22 | Form 51 Undertaking | — | Required |
| 23 | List of SOPs | — | Required |
| 24 | Copy of Draft Labels | — | Required |
| 25 | Challan of Fees Paid To Be Upload | — | Required |
| 26 | Self declaration of technical person | — | Required |
| 27 | Any Other Document | — | Required |
| 28 | Application in Form 24 | — | Required |
| 29 | Self declaration of directors | — | Required |