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.
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. 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.