Required to manufacture, sell, stock or distribute drugs, including retail pharmacies and online sellers. A qualified pharmacist or competent person is a precondition, not a formality.
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TIMELINE
30 to 60 working days
ISSUED BY
State Drug Control Authority
LICENCE TYPES
Retail, wholesale, manufacturing
PRECONDITION
Qualified pharmacist or competent person
What is included
Identification of the correct licence category
Verification of premises area and storage requirements
Pharmacist or competent person documentation
Preparation and filing of Form 19 or Form 24 as applicable
Coordination of drug inspector inspection
Licence grant and guidance on record keeping obligations
Documents you will need
Business and personnel documents
Business registration and constitution documents
Degree or diploma and registration certificate of the pharmacist
Appointment letter and consent of the pharmacist
Experience certificate for the competent person, for wholesale
Affidavit of non conviction under the Drugs and Cosmetics Act
Premises documents
Proof of premises with area measurement
Rent agreement and owner NOC
Blueprint or layout plan of the premises
Refrigerator and air conditioning purchase invoices
Cold storage arrangements, where applicable
How the filing runs
Identify the category
Retail, wholesale and manufacturing are separate licences with different premises, personnel and equipment requirements. Some businesses need more than one.
Meet the preconditions
Minimum premises area, cold storage where required, and a registered pharmacist for retail or a competent person for wholesale must be in place before applying.
File the application
The application is filed with the State Drug Control Authority with premises, personnel and equipment documentation.
Inspection and grant
A drug inspector inspects the premises and verifies personnel and storage. The licence is granted on satisfactory inspection.
The pharmacist requirement is real and it is checked
A retail drug licence requires a registered pharmacist physically present at the premises during business hours, and wholesale requires a competent person with prescribed qualification or experience. Arrangements where a pharmacist lends their registration without actually working there are common, and they are exactly what inspections target. Consequences run to cancellation of the licence and prosecution under the Drugs and Cosmetics Act, for both the licensee and the pharmacist. Recruit properly before applying, because the licence is granted on the basis that the person is genuinely engaged.
Online sale of medicines requires the underlying drug licences and is subject to additional conditions and evolving regulation. It is not a substitute for premises based licensing.