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    Drug License

    Whole Sale/ Retail Drug License

    Drug License is permission from the government to deal with drugs. There are two kinds of license, the retail license and wholesale license of for drug distribution or sale in India. This license is issued subject to certain conditions attached to premises and the competent person who shall be dealing with drugs.

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    Drug License

    Drug license is a permission granted by the competent authority under Drugs and Cosmetic Act, 1940 to carry out a business concerning drugs/medicines or cosmetics. In other words, no person can start or continue a business dealing with drugs or cosmetics in India, unless an appropriate license is obtained for the conduct of such activity. Under the purview of Drugs and Cosmetics Act, 1940 all types of drugs or cosmetics business is covered including allopathic, homeopathic, ayurvedic or unani drugs. To maintain the quality of drugs and cosmetics is the responsibility of all persons dealing with it. If any person consuming or using a drug or cosmetic suffers any harm from the negligence on the part of the manufacturer or seller the same is an offence, which is triable as an offence of grievous hurt under IPC.

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    Checklist for Issue of Retail or Whole Sale Drug License

    Competent Person/ Pharmacist

    The medicines need to be handled with by a specialist, and for that matter, there is a requirement of a qualified pharmacist in case of retail drug license and in case of wholesale a graduate with 1 years experience or undergraduate having four years experience is must

    Area of Pharmacy Shop

    For opening a pharmacy business, the carpet area of the pharmacy must be a minimum of 10 square meters, and in case the application is for both retail and wholesale pharmacy the minimum area prescribed in 15 square meters with height of 2.75 m. The premises must be adequately ventilated.

    Storage Facility of Drugs

    Medicines need to be stored at a clean, ventilated and cool storage facility, since some drugs, in particular, the vaccines need to be stored in a low-temperature freezing zone. Hence, facility of a refrigerator and air conditioner is essential for grant of a drug license in India

    Inspection by Drug Inspector

    Before the grant of a drug license, the drug inspector having jurisdiction of the area visits the premises where drug license is required and verify the particulars furnished with the application and if required take measurement of the premises and also interview the competent person.

    Drug License in India Registration Process

    Documentation - Step - 1

    The most important step in obtaining the drug License is the preparation of documents which includes, preparation of key plan and site plan and various affidavits and declaration as prescribed under law.

    Application Filling - Step - 2

    The drug License applications are filed online, these days including the payment of government fee. All documents are scanned and uploaded at the time of filing the application. However, filed documents are verified by the inspector.

    Inspector Visit - Step - 3

    After the application for grant of drug license is filed, the same is marked for inspection and thereafter the drug inspector personally visits the shop to verify the documents and correctness of information.

    Grant Of License - Step - 4

    After the Inspection is complete and in case personal interview is called for is cleared by the competent person and upon verification all information and documents furnished is correct the controller of drugs issues the Drug License.

    Note - Our Complete Drug License Service are available in Delhi only. 

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    March 22, 2021

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