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Which documents are required for getting manufacturing licenses in Karnataka?

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Sakala Mission Sakala Mission, Government of Karnataka verified
Answered on April 30,2022
List of Services Designated officer Stipulated time for designated officer Competent Officer Stipulated time for Competent Officer Appellate Authority Stipulated time for Appellate Authority
Grant of fresh drug manufacturing license Drugs Controller 60 Working Days Deputy Secretary, Health and Family Welfare 15 Working Days Principal Secretary, Health and Family Welfare 15 Working Days
Renewal of Drug Manufacturing License Drugs Controller 210 Working Days Deputy Secretary, Health and Family Welfare 15 Working Days Principal Secretary, Health and Family Welfare 15 Working Days

 

Name of the Department DRUGS CONTROL DEPARTMENT
Name of the Service Issue of Fresh Drug Manufacturing license
Whom to approach for this service (Designated Officer)? Additional Drugs Controller
Procedure involved to get this service The premises will be inspected for ascertaining the suitability and adequacy
Form to be submitted to get this service  
Who are eligible to get this service Person fulfilling the requirements stipulated under the Drugs and Cosmetic Act 1940 and Rules there under.
Documents to be enclosed with the request  
Fee/Charges to be paid to get the service NIL
Maximum number of days to wait to get this service delivered 60 Working Days
Whom to approach as a appeal (Competent Officer), if the service is not delivered in time or rejected by officer Drugs Controller
Maximum number of days to wait to get the decision of the Competent Officer 15 Working Days
Whom to approach as 2nd appeal (Appellate Authority), if the decision of the Competent officer is not acceptable or not implemented? Principal Secretary HFW
Maximum no. of days to wait to get the decision of Appellate Authority 15 Working Days
Other information drugs.kar.nic.in
Website (if online) dcd.kar.nic.in/idmla
Reference Document  

Work Flow 

Step Description No. of Days Designation
1 RECEIPT OF APPLICATION 2.00 Superintendent
2 INWARD PROCESSING 1.00 Superintendent
3 ALLOCATION OF FILE 2.00 Drug Controller
4 PRELIMINARY PROCESSING 5.00 Inspector
5 PRELIMINARY PROCESSING 5.00 Assistant Drug Controller
6 PRELIMINARY PROCESSING 5.00 Deputy Drug Controller
7 PRELIMINARY PROCESSING 4.00 Additional Drug Controller
8 PRELIMINARY PROCESSING 4.00 Drug Controller
9 INSPECTION REPORT 15.00 Inspector
10 FINAL PROCESSING 3.00 Inspector
11 FINAL PROCESSING 3.00 Assistant Drug Controller
12 FINAL PROCESSING 3.00 Deputy Drug Controller
13 FINAL PROCESSING 3.00 Additional Drug Controller
14 FINAL PROCESSING 3.00 Drug Controller
15 DISPATCH 2.00 Case Worker

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