Typically 30 to 60 working days

Drug Licence

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.

Common questions

A retail drug licence, obtained in the name of the premises with a registered pharmacist engaged there.

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.

Yes. Prescribed minimum floor area applies and varies by licence type, with additional requirements where both retail and wholesale are carried on.

Yes. The licence attaches to the premises, so each location requires its own.

Those fall under separate categories with their own licensing requirements under the same Act and allied rules.

Opening a pharmacy or distribution business?

Tell us your premises and pharmacist status and we will confirm what is needed.

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