State approvals / Tripura / Drugs Control Administration
Application for the grant of a licence to manufacture for sale of drugs other than those specified in Schedules C and C(1) : Form 27-D
DepartmentDrugs Control Administration
TypeNew
StagePre-Operation
FeeNo fee
AppliedApply on NSWS
Documents to submit
| # | Document | Condition | Required |
|---|---|---|---|
| 1 | Plan drawing of manufacturing unit/ factory details as per requirement of manufacturing. Detailed building plan Process Flow chart and write up. List of Machinery of Equipments along with capacity and other specification to be used in manufacturing. List of Instruments, Chemicals etc with their specifications which will be used for testing. Standard Operating Procedure (SOP) Land document- Sale deed/ lease deed/ rental agreement. List of products with proper name, trade name ,composition, colour, strength and other excipients used and pack size. Method of Analysis of the products proposed to manufactured Draft Labels of all the drugs to be manufactured. Name of technical staff with qualification and experience (Manufacturing & Testing) with supportive document. Trade Licence NOC from State Pollution Control Board NOC from Chief Inspector of Factories & Boilers List of standard/ reference Books | If any | If applicable |
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- Application for the grant of a licence to manufacture for sale of drugs other than those specified in Schedules C and C(1) : Form 27-A
- Application for the grant of a licence to manufacture for sale of drugs other than those specified in Schedules C and C(1) : Form 27-B
- Application for the grant of a licence to manufacture for sale of drugs other than those specified in Schedules C and C(1) : Form 27-C
- Application for the grant of a licence to manufacture for sale of drugs other than those specified in Schedules C and C(1) : Form 27-DA
- Application for the grant of a licence to manufacture for sale of drugs other than those specified in Schedules C and C(1) : Form 27-E
- Application for the grant of a licence to manufacture for sale of drugs other than those specified in Schedules C and C(1) : Form 27-F
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