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.
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.