Wholesale License in India – Form 20B/21B & 19


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    Wholesale License (Form 20B, 21B)– Overview


    As per the provisions of the Drugs and Cosmetics Rules, the State Licensing Authority can grant a license for the sale or distribution of drugs in India. The license can be issued under Drugs and Cosmetics Rules to sell, stock, exhibit, or offer for sale or distribute drugs in India. The license can be issued for several products like drugs, biologicals, medical devices, and in-vitro diagnostics. State Licensing Authority (SLA) is the regulatory authority associated with this service. To obtain this license, an individual is required to apply to the State Licensing Authority. The Competent Authority would then carry out an inspection and then grant a license.

    What is Form 20B/21B and 19

    Form Names

    19

    This form is required to apply for the wholesale license.

    20B

    This form grants permission for drugs other than those specified in Schedule C, C (1), and X of Drugs & Cosmetics Act and Rules.

    21B

    This form grants permission for the drugs specified in Schedule C & C (1) of the Drugs & Cosmetics Act and Rules.

    Who Can Apply?


    The applicant who wishes to store, distribute and sale the drugs in wholesale.


    How To Apply?

    Creation of login ID on the respective State Licensing Authority website/portal
    Filing of online data on the portal
    Uploading of documents as per the checklist
    Payment of government fee on the portal
    Submission of application on the portal as well as hard copy in the respective State Licensing Authority

    Fee Involved

    For issuing a license, the applicant is required to pay 1500 INR for each license. The applicant must also submit a retention fee after every five years.

    Validity

    The license obtained would remain valid lifetime unless the regulatory authority suspends or cancels the license.

    Important Documents

    To obtain a license for the sale or distribution of drugs in India, the applicant must submit the following list of documents:
    Layout and area of the facility List of directors, proof of ownership Proof of ownership, and partnership deed Biodata and credentials of the registered pharmacist or competent person Invoices for refrigerator and air-conditioning system System generated form and affidavits

    Timeline to get Form 19 from

    The timeline for a wholesale license is 21 Working Days

    Essential Tips

    The applicant looking for permission license for the sale or distribution of drugs must ensure these essentials are followed

    The facility should meet the criteria of the State Master Development Plan, if any.


    The facility should not be less than 10 square meters.


    Proof of identities like aadhar card, pan card, and/or passport of directors and registered pharmacist.


    The registered pharmacist should have a graduate degree and one year of experience in dealing drugs.


    The owner should provide proof of ownership.

    Expert Advise

    The electric bill of the premises is a mandatory requirement.

    If the commercial facility exists on a Delhi Development Authority allotted plot or flat, the Municipal Corporation of Delhi must issue a conversion charge receipt and necessary documents.

    Frequently Asked Questions

    Can a wholesale license holder sell drugs in retail?

    No, they can only sell drugs in wholesale.

    Will the same wholesale license remain applicable during a change in constitution or shifting of premises?

    No, the individual must apply for the respective change and get a new wholesale license.

    Will an individual with no graduation degree but with more than five years of dealing with drugs be eligible to be a competent person?

    Yes, but the person should be SSLC passed and have a minimum of four years experience in dealing with drugs.

    Licensing Authority for Wholesale license?

    State Licensing Authorities.

    What is the validity of wholesale license?

    The license is valid perpetually; however, retention fee shall be submitted every 5 years.

    Is there common/single portal for applying wholesale license for each state?

    No. Each and every state have their own respective portal. e.g.

    • For Delhi: xlnIndia: https://xlnindia.gov.in/Home_xln.aspx
    • For UP: niveshmitra: https://niveshmitra.up.nic.in/
    • For Haryana: investharyana: https://investharyana.in/#/

    Is single wholesale license used for Drugs, Biological and Medical Devices?

    Yes. Wholesale license is same for medical device, drugs and Biologicals

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