License For Import Of Drugs & Cosmetics

  • Act/Rule/Legislation

  • Online Link to Act/Rule/Legislation

  • Initial Setup or Ongoing Maintenance

    Initial Setup only

  • Filing and Maintenance Requirements

    In terms of Section 10, a license is required to be obtained for import of drugs and cosmetics prescribed. Further, Registration Certificate in Form 40 and 41, as required for import of drugs, under Rules 24A and 27A is required to be obtained.



    Upon receipt of the license, the company is required to comply with the terms and conditions of the license.



    Further, a license in Form 11 is required for import of drugs (the import of which is otherwise prohibited under section 10) for the purpose of examination, test or analysis and complied with the conditions prescribed under Rule 33.

  • Penalty

    Whoever himself or by any other person on his behalf imports, —

    (a) any drug deemed to be adulterated or deemed to be a spurious drug or

    any spurious cosmetic or any cosmetic of the nature referred to in clause (ee) of section

    10 shall be punishable with imprisonment for a term which may extend to three years and a fine which may extend

    to five thousand rupees;

    (b) any drug or cosmetic other than a drug or cosmetic referred to in clause (a), the import of which is

    prohibited under section 10, shall be punishable with imprisonment for a term

    which may extend to six months, or with fine which may extend to five hundred rupees, or with both;

  • Application Guidelines / Responsible Persons / Comments

    1. An application shall be made to the Licencing Authority in Form 40, either by the manufacturer himself, having a valid wholesale License, for sale or distribution of drugs or by his authorized agent in India either having a valid License to manufacture for sale of a drug or having a valid wholesale License for sale or distribution of drugs.
    2. DETAILS TO BE CAPTURED IN FORM 40:
    The authorized signatory name, designation, department, along with the complete address of the Company.
    i) Authorized Signatory
    ii) The address of manufacturing premises shall be captured
    iii) The drug(s) name shall be captured
    iv) Fee structure for Import Registration under Form 40:
    - Fees and Form(s) and the undertakings as per Schedule D(I) (for registration of the manufacturing premises) and Schedule D(II) (for registration of the drugs):
    - Applicant shall make a payment of 1500 USD (or its equivalent to Indian Currency), as registration fee for the Manufacturing premises.
    - Applicant shall make an payment of 1000 USD (or its equivalent to Indian Currency), as registration fee for a single drug and additional fee of 1000 USD for each additional drug in case the manufacturing site remains the same. Fees shall be paid through a Challan in the Bank of Baroda, Kasturba Gandhi Marg, New Delhi- 110 001 or any other Bank, as notified, from time to time by the authority.
    v) Challan and Bank details:
    Fees shall be paid through a Challan in the Bank of Baroda,
    Kasturba Gandhi Marg, New Delhi-110 001 or any other Bank,
    as notified, from time to time by the authority.
    The pay order cheque to be in favour of Pay & Accounts Officer,
    DGHS, Nirman Bhavan, New Delhi-01
    Challan means-the receipt of the Cash paid into the bank, which
    is attested by the bank with seal and date.
    The fee to be credited under the following details

    Head of Account

    104 – Fees and Fines under the drugs and cosmetic rules
    1940. Conversion rate should be mentioned on the
    Challan.
    Electronic Payment: In case of any direct payment of fees by
    manufacturer in the country of origin through ECS (Electronic
    Clearance System) from any bank in the country of origin to Bank of
    Baroda, Kasturba Gandhi Marg, New Delhi-110 001, through the
    Electronic Code of the Bank in the Head of Account, ―104 – Fees and Fines‖ and Original receipt of the said transfer can be considered as an
    equivalent to bank Challan, subjected to approval by Bank of Baroda.
    Applicant is liable to pay 5000 USD (or its equivalent to Indian
    Currency) for Expenditure [Inspection fees + expenditure on
    inspection to be borned by company] as may be required for
    Inspection or Visit of manufacturing premises.
    The applicant shall be liable for the payment of testing fees
    directly to a testing laboratory approved by the central
    government in India or abroad, as required for examination
    testing and analysis of drugs.
    Applicant has to pay a fee of 300 USD (or its equivalent to Indian
    Currency) for a duplicate copy of the registration certificate, if
    the original is defaced, damaged or lost.
    Registration time provided further that if the application is
    complete in all respects and information specified in D (I) & D (II)
    are in order, the licencing authority shall within 9 months from
    the date of receipt of application issue such Registration
    Certificate, and in exceptional circumstances and for the reasons
    to be recorded in writing, the Registration Certificate may be
    issued within such extended period not exceeding 3 months as
    the licencing authority may deemed fit.

    Undertaking for the compliance of the terms and
    conditions required, by the applicant to obtain the
    registration certificate and to keep the validity of the
    registration certificate.

    The data specified in Schedule D (I) and Schedule D (II)
    shall be enclosed along with the covering letter and Table
    of content