FDA Maharashtra
Wednesday, 08-Feb-2012
You are here ->
Guidelines
->Grant of Drug and Cosmetic Manufacturing Licence in Own Premises
Grant of Drug and Cosmetic Manufacturing Licence in Own
Premises
Food and Drug Administration M.S. Grants Own Manufacturing Licences for Drugs (Allopathy, Homoepathy, Ayurvedic, Siddha,Unani ) and Cosmetics in Forms 25, 28, 25B, 25C,25D and 32
The Administration also grants Licences for Blood & Blood products Vaccines & Sera in Form 28C & 28D. However the said Licences have also to be approved by Central Licensing Approving Authority i.e. Drug Controller General of India.
Procedure to obtain Drug Manufacturing Licence (Fresh)
Stage 1
Approval of Layout Plan
For Approval of Lay out Plan the Applicant has to submit 3 Blueprint copies of plan to the concerned Licensing Authority.(in case of Licenses for Blood Products and Vaccines Sera 4 Blue print copies of plan to be submitted)
The plan should be as per the requirements prescribed for manufacturing premises in the Drugs and Cosmetics Act 1940.
The prescribed requirements as per the Act for Layout plan are given in the checklist.
The plan is scrutinized by panel of officers as per the requirements of the Drugs and Cosmetics Act 1940.
If necessary the premises is inspected by the concerned Inspector before plan Approval.
Finally after scrutiny and compliance as per requirements of the Act the layout plan is approved and two copies are given to the Applicant.
Down Load
Check List for Layout of Plan Approval
Allopathic Drugs
Check List for Layout of Plan Approval
Medical Devices
Check List for Layout of Plan Approval
Ayurvedic Drugs
Check List for Layout of Plan Approval
Cosmetics
Next
Important Content
Notification of Adjudicating Officers under FSSA 2006
Notification of Food Safety Officers and Designated Officers under FSSA 2006
Raids conducted by FDA
US FDA - Approved Units List
Schedule ‘M’ Complied Units
WHO - Approved Units List
Blood Bank
Cosmetic Manufacturers
List of Public Testing Laboratories
Food Labs
What's New
Food Safety and Standards Act
2006. Application Forms for Registration and Licensing
read more ...
..........................................
PUBLIC NOTICE
Not of Standard Frusemide Tablets B.NO.0310 Mfd by Endolabs Ltd (Not to use)
read more ...
..........................................
Minutes of meeting
dated 4.8.11 regarding FSSA 2006 (Marathi)
read more ...
..........................................
Minutes of meeting
dated 18.8.2011 regarding Implementation of FSSA 2006 (Marathi)
read more ...
..........................................
Press Note Food Safety
Standards Act 2006 will be implemented from 5/8/11 (Marathi)
read more ...
..........................................
SPECIFICATION OF EQUIPMENTS TO BE PURCHASED BY DCL MUMBAI
read more ...
..........................................
Grant of Drug and Cosmetic Manufacturing Licence in Own Premises
Grant of Drug and Cosmetic Manufacturing Licence in Loan Premises
Grant of Licence to manufacture drugs for purposes of examination, test analysis
Grant of Additional Product Permission
Grant of Drug Selling Licence
Grant of Certificates for Drug Section
Grant of Food Licence
Approval of Public Testing Laboratory and Blood Storage Centre
Grant of Authorisation under NDPS act
Grant of NDPS Licence
Disclaimer