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.
Documents Required For Drug License
List of Documents of Applicant for Drug License
- The Certificate of Incorporation or Registration
- MOA & AOA or Partnership Deed/ LLP Agreement
- Pan Card and Cancelled Cheque
- Photo, ID and Address Proof of Director
- Affidavit from Directors
- Bio-data of Competent Person as per Proforma
- Appointment Letter of Competent Person (CP)
- Qualification and Experience Certificate of CP
- Photo, ID and Address proof of Competent Person
Documents of Shareholders/Directors
- In case the premises is owned, then registered Sale Deed / Registered GPA / Conveyance Deed in the name of the owner
- In the case of unregistered Sale Deed / unregistered GPA, it must be supported with Electricity Bill / Water Bill/property tax receipt.
- In the case of a village, Khasra Khatauni documents are accepted
- If Rented: Registered Rent Agreement with Rent Receipt or,
- In the case of unregistered rent agreement, The Rent agreement must be supported with Electricity Bill / Water Bill/property tax receipt.
- No Objection Certificate from the owner of the premises
- Key Plan and Site Plan of the premises duly attested by an approved architect or mapmaker of the municipality
Drug License in India Registration Process
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.
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.
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
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.