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Drug License Registration

Start your pharmaceutical or healthcare business with CorporateDoctors — your trusted partner for quick and hassle-free Drug License Registration. Get expert assistance for documentation, application filing, and government approvals — all in one smooth, 100% online process designed to make your operations legally compliant and credible.

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    What is a Drug License?

    A Drug License is a legal permit issued by the Central Drugs Standard Control Organization (CDSCO) and State Drug Control Authorities under the Drugs and Cosmetics Act, 1940.
    It is mandatory for anyone engaged in the business of manufacturing, distributing, importing, or selling drugs, cosmetics, and medical devices in India.

    Types of Drug Licenses in India

    Different licenses apply depending on the nature of the business:

    • For pharmacies/medical stores that sell drugs directly to consumers.
    • Issued by the State Drug Control Department.
    • Requires a registered pharmacist.
    • For businesses engaged in wholesale distribution of medicines.
    • Doesn’t always require a pharmacist, but a competent person with relevant qualification/experience is mandatory.
    • Required to manufacture drugs, cosmetics, or medical devices.
    • Granted by the State Licensing Authority.
    • Needs proper infrastructure, equipment, and qualified technical staff.
    • For importing drugs into India.
    • Issued by the CDSCO (Central Licensing Authority).
    • For chains of pharmacies operating in multiple states.

    Eligibility Criteria

    Premises must meet the space requirements:

    Retail: minimum 10 sq. meters.

    Wholesale: minimum 15 sq. meters.

    Adequate storage facilities (refrigerator, cold storage if required).

    Registered pharmacist/competent person with prescribed qualifications.

    Documents Required

    Proof of ownership/tenancy of premises

    Blueprint/layout of premises

    Identity & address proof of proprietor/partners/directors

    Qualification certificates of pharmacist/competent person

    Affidavit regarding non-conviction under the Drugs & Cosmetics Act

    Company incorporation documents (if applicable)

    Storage facility details

    Registration Process

    Step:-1
    Application Filing
    • Online through respective State Drug Control Department portal or CDSCO portal (for import/manufacturing).
    Step:-2
    Document Submission
    • Upload required documents & pay government fees.
    Step:-3
    Inspection
    • Drug Inspector visits premises for verification.
    Step:-4
    Approval/Rejection
    • If conditions are satisfied, license is granted.

    Validity & Renewal

    • Drug licenses are generally valid for 5 years (varies by state and license type).
    • Must be renewed before expiry to continue operations.

    Eligibility Criteria to Obtain a Drug Certificate in India

    • Applicants must be engaged in manufacture, sale, distribution, import, or wholesale/retail trade of drugs or cosmetics.
    • License type depends on the nature of business (Retail, Wholesale, Manufacturing, Import, etc.).
    • Retail License: Minimum 10 sq. meters area.
    • Wholesale License: Minimum 15 sq. meters area.
    • Adequate storage facilities like refrigerators, air-conditioners, cold storage (for vaccines, insulin, etc.).
    • Premises must comply with Good Storage Practices (GSP).
    • Retail Drug License:
    • Must employ a Registered Pharmacist approved by the State Pharmacy Council.
    • Wholesale Drug License:
    • Either a registered pharmacist OR
    • A graduate with at least 1 year of experience in drug sales/distribution OR
    • A person with 4 years of experience in drug sales/distribution.
    • Manufacturing License:
    • Must employ technical staff (pharmacists, chemists, biochemists, microbiologists, etc.) with required qualifications and experience.
    • Applicant can be:
    • Proprietorship
    • Partnership Firm
    • Private Limited or Limited Company
    • Business must be registered under law (GST, Shops & Establishment, ROC, etc.).
    • Applicant should not have been convicted under the Drugs and Cosmetics Act, 1940 or other related laws.
    • Must follow prescribed safety, hygiene, and record-keeping norms.
    • Adequate arrangements for inspection by the Drug Inspector.
    • For Import License: Approval from CDSCO; requires overseas manufacturer’s authorization.
    • For Manufacturing License: Must comply with Good Manufacturing Practices (GMP) under Schedule M of the Act.

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