Apply Drug License| Medical Store Licence Online | Drug License Process

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Drug License

Drug license is permission granted by the competent authority under the 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 the Drugs and Cosmetics Act, 1940 all types of drugs or cosmetics businesses are 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 offense, which is triable as an offense of grievous hurt under IPC.

Checklist For Issue Of Retail Or Whole Sale Drug License

• Competent Person/ Pharmacist: The medicines need to be handled 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 is 15 square meters. 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, the 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 the drug license is required and verify the particulars furnished with the application and if required take measurements of the premises and also interview the competent person.