What is a Drug License?
Drugs helps in curing diseases which directly ensure the well-being of human being. For forming medicines, drugs are used in a medically prescribed ratio. Hence, standards are made by the government for using the drugs in the correct amount so that it does not harm the body by overdose. In India, the business which deals in drugs, medicines, or cosmetics must mandatorily obtain Drug License from the appropriate authority.
As per the Drugs and Cosmetics Act, 1940, a Drug License is granted either by the Central or State Drug Standard Control Organization. Obtaining Drug License Registration is mandatory before starting any business dealing in drugs, whether it is Ayurvedic Medicine, Allopathic Drugs, Homeopathy or Unani, to manufacture, distribute or sell the drugs.
If in case a business has an operating unit in two states or more states, it has to obtain a drug license for each state in which the business is being carried on. Registration for Drug license is location-specific. It means if the drugs are stocked or sold for sale and distribution at more than one place, then the application shall be made to every state, and license shall be issued, regarding each such place except for migrant vendors.
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.