Drug Licence
Retail and wholesale drug licences for pharmacies and medicine distributors.
Anyone manufacturing, selling, stocking or distributing drugs in India needs a licence under the Drugs and Cosmetics Act, 1940. It is issued by the state drugs control authority, and the category depends on what you do — retail, wholesale, manufacture or import.
Unlike most business registrations, this one turns on qualified personnel. A retail licence requires a registered pharmacist physically present at the premises, and no amount of documentation substitutes for that.
Charges on enquiry
This service is quoted case by case, because the work depends on your documents, the authority involved and the timeline you need. Send us a short note and we will confirm the professional charges and the government fees in writing before starting.
The licence categories
- Retail sale licence — for a pharmacy or chemist selling to consumers
- Wholesale licence — for distribution to retailers, hospitals and institutions
- Manufacturing licence — for producing drugs, with separate categories by drug type
- Loan licence — for manufacture at another licensed manufacturer’s premises
- Import licence — for bringing drugs into India
- Separate schedules apply to allopathic, ayurvedic, homeopathic and cosmetic products
The personnel requirement
A retail licence requires a registered pharmacist to be present during business hours. A wholesale licence requires either a registered pharmacist or a graduate with the prescribed experience in dealing in drugs.
The named person’s registration and appointment letter form part of the application, and the authority verifies both. A licence obtained on the basis of a pharmacist who does not actually attend is a serious contravention rather than a technicality.
Premises and storage conditions
- Minimum floor area prescribed for the licence category
- Adequate storage, with a refrigerator where thermolabile products are stocked
- Separate, clearly identified space for the drug business
- Proper record keeping of purchases and sales
- Compliance with conditions for Schedule H, H1 and X drugs
- Prescription records maintained where required for scheduled drugs
What the licence obliges you to do
Records of purchase and sale must be maintained and produced on inspection. Sales of Schedule H1 drugs require a separate register with prescriber and patient details, retained for the prescribed period.
Selling a prescription drug without a valid prescription is an offence under the Act, and enforcement has become considerably more active. The record keeping is what evidences compliance, so it is not paperwork for its own sake.
How we handle it
- 1 Identifying the category We confirm which licence category applies to your activity, since retail, wholesale and manufacture have distinct requirements.
- 2 Qualified person The registered pharmacist or qualified person is identified and their documentation assembled.
- 3 Premises assessment The premises are checked against the prescribed area and storage conditions before applying.
- 4 Application The application is filed with the state drugs control authority with the plans and personnel documents.
- 5 Inspection The drugs inspector inspects the premises. We tell you in advance what will be examined.
- 6 Licence issued The licence is granted for display at the premises, and we set the renewal reminder.
Frequently asked questions
Do I need a pharmacist to open a medical shop?
Yes. A retail licence requires a registered pharmacist present during business hours. There is no substitute for this and it is verified at inspection.
What is the difference between retail and wholesale licences?
Retail is for selling to consumers, wholesale for distributing to retailers and institutions. They have different premises and personnel requirements, and a business doing both needs both.
How long is a licence valid?
It is issued for a fixed term and must be renewed before expiry. Operating on a lapsed licence is treated as operating without one.
Can I sell online?
Online sale of medicines has been the subject of continuing regulatory development and litigation. The position should be confirmed for your specific model rather than assumed, as it has shifted more than once.
What records must I keep?
Purchase and sale records for all drugs, and a separate register with prescriber and patient details for Schedule H1 drugs, retained for the prescribed period and produced on inspection.
What is not included. Government fees, statutory charges, stamp duty, court and registry fees, digital signature costs and any third-party professional charges are separate and payable at actuals. GST applies on professional fees where indicated. Prices shown are indicative and may change without notice; we confirm the total in writing before any work begins — see our terms on pricing.
Talk to us about Drug Licence
Share your requirement and our team will confirm the documents needed, the exact charges and a realistic timeline — usually the same working day.
- Expert document checking before submission
- Regular status updates on WhatsApp
- Transparent professional charges
- Assistance in Marathi & English
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