State approvals / Gujarat / Health and Family Welfare Department

Drug Manufacturing License under Drugs and Cosmetics Act, 1940

An Act to regulate the import, manufacture, distribution and sale of drugs

DepartmentHealth and Family Welfare Department

TypeNew

StagePre-Operation

Time limit60 days

Fee₹7,500

AppliedApply on NSWS

Documents to submit

#	Document	Condition	Required
1	Application in form No.24 and 27 (Signed by all partners and directors)	—	Required
2	Additional Information Form (Signed by all partners and directors)	—	Required
3	Authorization letter	—	Required
4	MOA / partnership Detail/LLP	—	Required
5	List of Directors along with photo ID	—	Required
6	Approved plan copy	—	Required
7	Documents of possession of premises	—	Required
8	List of technical person with appointment letter, consent letter, degree certificate	—	Required
9	List of products	—	Required
10	Additional information form for product (Signed by all partners and directors)	—	Required
11	Draft label	—	Required
12	AHU Detail (Air Handling Unit) Qualification details and Schematic Diagram	—	Required
13	Water system Detail - Qualification details and Schematic Diagram	—	Required
14	List of Manufacturing equipment	—	Required
15	List of laboratory equipment	—	Required
16	Flow chart	—	Required
17	List of SOP	—	Required

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