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Tuesday, 07-Sep-2010
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 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

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