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State approvals / Tripura / Drugs Control Administration

Drugs Manufacturing license

DepartmentDrugs Control Administration
TypeNew
StagePre-Operation
Time limit30 days
FeeNo fee
AppliedApply on NSWS
Apply on National Single Window System

Documents to submit

#DocumentConditionRequired
1 0 Covering Letter — Required
2 0 Specific Power of Attorney in favour authorized signatory for submitting application on behalf of the company — Required
3 0 Site Plan and layout of the building with the name, address, scale, measurements of the area as per Schedule–M Requirement — Required
4 0 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 0 Consent to establish from State Pollution Control Board — Required
6 0 List of Directors, Partners, Trustees, along with ROC Copy Registered Partnership deed, Trust deed — Required
7 0 List of Competent Technical Staff, with their qualification, Registration, Experience, previous FDA Approvals, etc — Required
8 0 Appointment/Acceptance Letter of Competent Technical staff of manufacturing Section — Required
9 0 Appointment/Acceptance Letter of Competent Technical staff of Testing Section — Required
10 0 Section wise List of plant and Machineries — Required
11 0 NOC of Department of Industrial Safety & Health — Required
12 0 HVAC installation and validation Certificate(s) — Required
13 0 Water System installation and validation Certificate(s) — Required
14 0 Site Master File — Required
15 0 Constitution details of firms — Required
16 0 List of SOPs/STPs — Required
17 0 Self declaration of technical person (Fresh) — Required
18 0 Self declaration of directors — Required
19 0 Copy of valid Test license in Form 29 — Required
20 0 Source of bulk drugs along with current regulatory status with copy of Form 46A/45A/CT-19/CT-22 (if obtained) — Required
21 0 Certificate of Analysis of the bulk drugs/drug substance — Required
22 0 Master Manufacturing Formula — Required
23 0 Manufacturing Procedure — Required
24 0 Product Development report with Excipient compatibility and forced degradation study — Required
25 0 Process validation report — Required
26 0 Finished product specification including impurity profile — Required
27 0 Finished Product Method of Analysis — Required
28 0 Finished product Analytical method validation report — Required
29 0 Finished Product Certificate of Analysis for three consecutive batches/three validation batches — Required
30 0 Stability study data report as per requirements mentioning batch size (should be presented in tabular form with details of Batch No, Batch size, Date of Manufacturing, Date of initiation, Packaging details) — Required
31 0 Comparative Dissolution Release Profile with the Approved formulation (in case of oral dosage form) — Required
32 0 Comparative evaluation of pharmaceutical equivalence with international brand(s) or approved Indian brands If applicable If applicable
33 0 Draft specimen of the label and carton — Required
34 0 Bio Equivalence protocol and report — Required
35 0 Justification on Bio equivalence study waiver If requested If applicable
36 0 Details of the approval of the New Drug in the country. In case of new drugs, copy of approval of new drug from CLAs in favour of the applicant in Form 46/CT-23 — Required
37 0 Form 10 Issued by CDSCO Where required If applicable
38 0 Form 51 Undertaking — Required
39 0 Challan of Fees Paid To Be Upload — Required
40 0 Any Other Document — Required
41 0 Application in prescribed legal (Form 24) — Required

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