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 Grant of Drug Selling Licence

Food and Drug Administration M.S. Grants Selling Licenses for Drugs as per the provisions of Drugs Cosmetics Act-1940. For the sale of Allopathic, Homeopathic drugs in Form 20, 21, 20B, 21B, 20A, 21A, 20C, 20D, 20F, 20G, 20BB,21BB.

For the sale of Ayurvedic Drugs and Cosmetics no sale licence is required.


The Requirements of Sales premises are as follows:
Minimum carpet area:-
  • For Retail sale - 10 square meter
  • For Wholesale - 10 square meter
  • For Retail - Wholesale together - 15 square meter

  • Storage facilities

    Adequate storage facilities including cupboards with glass doors, racks refrigerator is required.


    Procedure to obtain Drug Selling Licence(Fresh)


    Stage1

    Application for grant of Selling Licence

    The applicant has to make application in the requisite Form viz 19, 19A,19B, 19AA details of Forms and pay

    Necessary fees as given in fee chart in Appendix A

    Fee can be paid in cash at Head Office/Division as well as any other District Officer.  The fee can also be paid through challan at  Government Treasury, Reserve bank of India, State Bank of India and State Bank of Hyderabad for Maratha Wada Region under Head of Account-

    0210 - Medical and Public Health.
    04 - Public Health
    104 - Fees and Fines, etc.

    Documents to be attached along with the application form:

    • Requisite Application Form.

    • Receipt for the fees paid or challan, as the case may be or their attested  copies.

    • Layout plan of selling premises in 3 copies.

    • Documents viz. rent receipt, purchase documents or its attested copies  showing lawful possession of the premises.

    • Documents relating to the constitution of the firm viz. Partnership-deed, memorandum and article of association etc.

    • Full particulars of the competent technical staff /registered persons along with copies of their educational qualification, experience and registration certificates.

    • Full name of the proprietor or the partners, as the case may be shall be provided  in the application. In case of private or  public limited concerns, full name of the Directors who sign the application and the authorised signatory, if any , shall be provided in the application.

    • Documents for the purchase of Refrigerator/Deep freezer (For Vaccines / Sera).


    Stage 2

    Inspection

    The application is scrutinized and premises inspected.


    Stage 3

    Grant of Licence

    If all conditions as prescribed by the act are complied licence is granted.


    Download
    Application Forms ( 19 ,19A , 19AA ,19B, 19C )
    Appendix A

    Procedure to Renew Drug Selling Licence

    Licenses in Forms 20, 21, 20B, 21B, 20A, 21A, 20C, 20D, 20F, 20G, 20BB, 21BB be renewed.


    Stage 1

    Application for renewal of Drug Selling Licence
    The applicant has to make application in the requisite Form 19, 19A, 19B, 19AA and pay Necessary fees as given in fee chart in Appendix A
    The mode of payment of fees is same as fresh licence.


    Documents to be enclosed along with application of renewal of licence :-

    • Copy of cash receipt or challan for payment of fees.

    • Xerox copy of Licence /Previous renewal certificate.

    • Documents viz. rent receipt, purchase documents or its attested copies showing lawful possession of the premises.

    • Full particulars of the competent technical staff /registered persons along with copies of their educational qualification, experience and registration certificates.

    Stage 2

    Inspection

    The application is scrutinized and premises inspected .


    Stage 3

    Grant of Licence

    If all conditions as prescribed by the act are complied licence is granted

    Download
    Application Forms (19 ,19A , 19AA ,19B , 19C )
    Appendix A
    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
    Drugs & Cosmetics declared - not of standard quality
    List of licensed retail pharmacy shops along with the names of working reistered Pharmacist
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