Industry Specific
Procedure for Licence to Sell Drugs by Wholesale or to Distribute the Drugs from A Motor Vehicle
INTRODUCTION
Obtaining a licence to Sell Drugs by Wholesale or to Distribute the Same from A Motor Vehicle is mandatory in India but not required in a case where a public carrier or a hired vehicle is used for transportation or distribution of drugs, multi-step process governed by the Drugs and Cosmetics Act,1940, and overseen by the CDSCO (Central Drugs Standard Control Organisation) to ensure drug, safety and compliance.
Applicable Provisions
Rules: 62C, 62D of the Drugs and Cosmetics Rules, 1945
DOCUMENTS REQUIRED
- Incorporation certificate, MOA or AOA, Partnership deed as applicable
- Proof of the ownership
- Cover letter with name and designation of the applicant
- Challan of fees deposited for the license
- Declaration form in a given format
- Key plan and site plan of the premises (Blueprint)
- The documents of possession of the premises
- Affidavit regarding non-conviction under the Drugs and Cosmetic Act, 1940, signed by proprietors, partners, directors as the case may be
- Appointment letter on being appointed as a full-time registered pharmacist
PROCEDURE
Person intending to obtain a licence to sell drugs by wholesale or to distribute drugs from a motor vehicle shall make an application in Form 19-AA to the Licensing Authority. The application shall be accompanied by a fee of rupees five hundred (Rs. 500).
RENEWAL
Individual or Entity that already holds a valid wholesale drug license in Form 20BB and/or Form 21BB shall make an application in Form 19 AA to Licensing authority and such application shall be accompanied by fees of rupees five hundred (Rs. 500) for renewal of license to sell by wholesale or to distribute drugs from motor vehicle.
EXEMPTION
A licence shall not be required where a public carrier or a hired vehicle is used only for the transportation of drugs, and not for selling or distributing drugs from the vehicle.
VALIDITY
licence shall remain valid perpetually, subject to payment of a licence retention fee, which shall be equivalent to the fee required for grant of the licence. Such a retention fee must be paid before the expiry of every five years from the date of issue, unless the licence is suspended or cancelled by the Licensing Authority.
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