Licensing for pharmacies and businesses dealing in medicines.
ZegalWorks guides your drug licence application from premises checks to inspection, so your pharmacy or distribution business can open on time.
What is Drug Licence?
A drug licence is permission under the Drugs and Cosmetics Act, 1940 to sell, stock or distribute medicines. Retail pharmacies and medical stores need a retail licence, while distributors and stockists need a wholesale licence. The licence is issued by the state drug control authority.
Requirements typically include suitable premises with storage conditions, a registered pharmacist for retail sale and, for wholesale, a competent person. An inspection is part of the process, so preparing the premises and staff properly is what decides speed.
Who this is for
A good fit if you
- Plan to open a pharmacy or medical store
- Plan a wholesale or distribution business for medicines
- Run a clinic or hospital that needs a pharmacy
- Want to add a drug licence to an existing business
Something else may suit you better if
You do not sell or stock medicines. A drug licence does not apply.
You need to register a clinic itself. See clinical establishment licence.
You deal in cosmetics only. Different rules apply, which we can explain.
What you need
We confirm the exact list for your situation during your free consultation.
- Licence type
- Retail or wholesale, and for the kinds of drugs you will handle.
- Premises
- Suitable, documented premises with proper storage, such as refrigeration where needed.
- Qualified person
- A registered pharmacist for retail, and a competent person for wholesale, with their qualification documents.
- Business documents
- Constitution documents, PAN, ID and address proof.
- Fees and inspection
- Government fees, and an inspection by the drug control officer.
- Renewal
- Licences have a validity period and need to be renewed.
What ZegalWorks handles for you
- Assess. We confirm the licence type and the requirements for your state.
- Prepare. We check premises, staff documents and application forms.
- Apply. We file the application with the state drug control office.
- Inspect. We help you prepare for and answer the inspection.
- Maintain. We track renewals and updates for the pharmacist or premises.
How long it takes and what it costs
Timing depends on the state authority and when the inspection takes place.
Your total cost has two parts: our professional fee, and any government or statutory fees that apply. Government fees are set by the authority and vary by case, so we give you an itemised quote before you commit to anything. See our pricing page for packages.
Get a Tailored QuoteRelated services
Most businesses need more than one of these. They are all handled by the same ZegalWorks team.
Frequently Asked Questions
Direct answers to the questions we hear most.
Ready to get started?
Tell us about your business and we'll help you understand the right next steps, with no obligation.