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Drug License

Drug License Form

    Personal information:

    What is Drug License?

    In India, the business entity who works in the health care sector such as medicines, drugs or cosmetics shall obtain the Drug License from the appropriate authority. As per the Drugs and Cosmetics Act, License is issued by State/Central Drug Standard Control Organization.

    Drugs are used in the formation of medicines in a medically defined ratio. Drugs are used in medicines that cure disease and are used as per the needs to ensure the well-being of human beings. Therefore the preparation and use of such drugs in medicines is restrictive, and the staandards are set for using the correct amount of drugs that don’t harm the body by its overdose.

    Types of Drug Licenses Issued in India

    Drug License

    Manufacturing Drug License

    All the manufacturers of allopathic, cosmetics, ayurvedic products or any other medications or drugs as specified under the Drugs and Cosmetics Act 1940. This is the state license that is issued by the particular state government where the unit is situated.

    Drug License

    Loan Drug License

    The manufacturer of drugs who don’t possess land on his own rather willing to manufacture using his brand name on the land to which license is already issued.

    Drug License

    Import Drug License

    Any dealer importing the products for the manufacturing of drugs or is engaged in the business of importing drugs in India shall obtain this license.

    Drug License

    Multi-Drug License

    Multi-Drug license is acquired by the entity operating in more than one state having multiple units.

    Drug License

    Sale Drug License

    Sale drug license is acquired by the entity engaged in whether wholesale or retail business for distribution of drugs in India.

    Drug License

    Wholesale Drug License

    Wholesalers doing the business of pharmaceuticals shall obtain wholesale drug license from the central drugs standard control organization. 

    Key-Requirement to Obtain Drug License in India

    Following is the list of documents required for applying for drug license in India:

    1. Premise Area

    2. Storage

    3. Technical and expert staff

    Business entities dealing in medicines or drugs would need different types of drug licenses based on their business. Drug License being region-specific needs to be obtained by a single drug dealer having its multiple units in more than one state. Other than a migrant vendor, drug license shall be applied for every place where drugs are stocked and sold.

    Drug license holders have to make sure it complies with the terms and conditions. The license issued overlooking these terms and conditions can get cancelled or suspended. Authorities shall be notified about any change or modification if occurred in business.



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    How to Get Drug License?

    Following is the basic procedure to get Drug License in India:


    Based on business entity and type of license, the applicant shall apply online for registration


    Once the application form is done and registration is completed, the system will auto-generate unique registration number which can be used for future reference.


    Within 15 days of registration, necessary documents shall be submitted to the officer of the Drug Licensing Authority of a concerned district in hard copy.


    Following is the list of documents required for applying for drug license in India:

    1.Application form duly signed which has already been filed

    2. Copy of Challan as proof of depositing the requisite fee

    3. Identity proof such as PAN, Voter Id, Driving license, Passport, etc. in case an applicant is a proprietor

    4. In case the applicant is a partnership firm, Id proof of every partner along with the copy of partnership deed

    5. Copy of MOA, AOA, and COI in case of private/public/OPC

    6. CTC of Board Resolution for authorizing the company for obtaining the license.

    7. Appointment letter of the person who is being authorized by the company

    8. Proof of availability of storage space such as cold storage, refrigerator, etc.

    Additional documents if the applicant is registered pharmacist:

    Frequently Asked Questions (FAQs)

    The books of accounts, registers, forms and other documents shall be maintained in such manner as may be specified by the licensing authority at the time of issue of such license. It is the responsibility of the license holder to intimate every change and modification that occurred in its business.
    Yes, drug license is necessary for every unit operating in any part of India. For instance, in case the drug business has its unit in two separate states, it shall get the license for both such an operational unit.
    Following are the features of drug license:

    • Drug license is compulsory for drugs, medicine, or cosmetics business
    • The license shall be granted for a commercial premise
    • Drugs and cosmetics business shall comply with the requirement and conditions imposed by law and authorities
    • The license shall be displayed all the time in the place of business.

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