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Wholesale Drug license

A Wholesale Drug License is a legal permit issued by the State Drug Control Authority under the Drugs and Cosmetics Act, 1940, which authorizes a business or individual to sell, distribute, or stock drugs and medicines on a wholesale basis to retailers, hospitals, clinics, or other licensed entities.

Key Highlights:

  • Purpose: To regulate the sale and distribution of pharmaceuticals and ensure that medicines reach consumers through authorized and safe channels.

  • Eligibility:

    • Premises should meet storage and hygiene standards.

    • Must have a qualified pharmacist or a person with relevant experience (as per rules).

    • Applicant must not have any criminal record related to drug regulations.

Documents Required:

  1. Proof of ownership or rent agreement of premises.

  2. Identity and address proof of the applicant.

  3. Qualification certificates of the competent person (pharmacist or experienced staff).

  4. Affidavit of non-conviction.

  5. Details of storage facilities (e.g., cold storage, refrigerators).

Who Needs It?

  1. Distributors

  2. Wholesalers

  3. Stockists

  4. Hospital supply chains

  5. Online pharmacy warehouses

Forms:

  • Form 20B – For wholesale of general (non-schedule X) drugs.

  • Form 21B – For wholesale of Schedule C and C1 drugs (like vaccines, serums).

A Wholesale Drug License ensures that only authorized and traceable businesses can distribute medicines, maintaining the integrity, safety, and legal compliance of the pharmaceutical supply chain.