Who issues a drug licence
The licensing authority of your state, working under the Drugs and Cosmetics Rules, 1945. In most states this is the Drugs Control Department or Drugs Controller, and the inspection is done by a Drugs Inspector.
There is no central drug licence for retail or wholesale sale, and no national fee. Each state runs its own portal, its own fee schedule and its own inspection practice, which is why generic online guidance so often does not match what your inspector actually asks for.
The licence is granted for specified premises. It is not a business-wide permission, so a second shop is a second application.
The licence types for selling medicines
Four forms cover most sale businesses. Which ones you need depends on whether you sell retail or wholesale, and on the schedule the drugs fall in.
| Form | What it covers |
|---|---|
| Form 20 | Retail sale of drugs other than those specified in Schedules C, C(1) and X |
| Form 21 | Retail sale of drugs specified in Schedules C and C(1), which are largely biological and special products needing particular storage |
| Form 20-B | Wholesale of drugs other than those specified in Schedules C, C(1) and X |
| Form 21-B | Wholesale of drugs specified in Schedules C and C(1) |
A typical chemist's shop therefore holds both Form 20 and Form 21, because it sells both categories, and a distributor holds Form 20-B and Form 21-B. Separate forms apply to the sale of drugs specified in Schedule X, which are controlled substances with their own storage and record conditions, and to restricted licences for a limited list of medicines sold by shops that are not pharmacies. We confirm the exact form set with your state authority before filing, because the combination is driven by your product list.
What this page does not cover
To be clear about scope: this page is about sale licences. We do not handle manufacturing licences, loan licences, cosmetics manufacture, blood bank licences or import registrations, and each of those is a different regulatory track with its own fees and inspections. If that is what you need, we will say so rather than take the file.
Who can hold a drug licence: the person requirement
This is the condition that stops most applications, and it is worth checking before you sign a lease.
Retail sale
Under the Rules, a drug supplied on the prescription of a registered medical practitioner must be supplied by or under the personal supervision of a registered pharmacist, and compounding must be under the direct and personal supervision of a registered pharmacist.
In practice that means a retail licence needs a pharmacist registered with the State Pharmacy Council, physically present at the premises, with a declaration from the pharmacist and their registration certificate in the application.
You do not need to be a pharmacist yourself to own a medical store. You need to employ one, and the licence records who it is, so a change of pharmacist is a change you have to report.
Wholesale
For a wholesale licence the premises must be in the charge of a competent person, and the Rules set out who qualifies:
- a registered pharmacist, or
- a person who has passed the matriculation examination with four years of experience in dealing with drugs, or
- a graduate with one year of experience in dealing with drugs.
The experience has to be evidenced, usually by an experience certificate from a licensed establishment, which is the document applicants most often cannot produce at short notice.
Premises conditions
The Rules set a minimum area, and your state adds its own expectations about storage.
- 10 square metres for a retail licence in Form 20 or 21, and 10 square metres for a wholesale licence in Form 20-B or 21-B.
- 15 square metres where retail and wholesale sale are carried on at the same premises.
- Storage for Schedule C and C(1) drugs, which is why a refrigerator is a practical requirement for most chemist shops, and states commonly expect a cold chain arrangement to be shown at inspection.
- Drugs in Schedule X kept under lock and key in a cupboard or drawer reserved solely for them, or in a part of the premises separated from the rest.
Measure the carpet area before you apply, and keep the rent agreement, the layout and the electricity bill consistent with what you state. An application describing an area the inspector cannot find is the fastest route to a rejection.
Documents required
Each state's portal asks for its own set, so treat this as the file we assemble and then adjust to your state.
| Document | Notes |
|---|---|
| Application in the prescribed form with the fee | Form 19 for a sale licence in most states |
| Constitution document | Incorporation certificate, partnership deed or proprietorship declaration, with a board resolution or authorisation for the signatory |
| PAN of the entity and identity proof of the proprietor, partners or directors | Standard |
| Proof of the premises | Ownership document, or rent agreement with the owner's consent and ownership proof |
| Site plan and key plan of the premises with dimensions | The area claim is checked against this |
| Registered pharmacist's registration certificate, appointment letter and declaration | Retail licences |
| Competent person's qualification and experience certificates, appointment letter and declaration | Wholesale licences |
| Refrigerator and storage details, with invoices | Where Schedule C and C(1) drugs are to be stored |
| Municipal trade licence and other local clearances | Where the state or the local body requires it: see trade licence |
| Affidavit or undertaking in the state's format | Commonly asked for |
If the entity itself is being set up, sequence it first: company registration, private limited company or a partnership, and then GST registration, because the licence is granted to the entity that will hold the stock.
Drug licence fees
Professional fee: fee on quote after a free review. The review covers the state, the licence forms, the person requirement and the premises. We quote once we know whether the pharmacist and the premises are already in place, because that is what determines how much of the work is ours.
Government fee: fixed by your state, under the Drugs and Cosmetics Rules, and charged for each licence form. There is no national figure and we do not publish one. A retail chemist needing both Form 20 and Form 21 pays the state's fee for each form, and the same applies to a wholesaler needing Form 20-B and Form 21-B. Some states also charge an inspection fee. We obtain the current figure for your state and your form set from the licensing authority and confirm it in writing before anything is filed.
Professional fees exclude GST at 18%. Government fees, where they apply, are paid at actuals to the department and are shown separately. Fees verified on 27 September 2026.
How the application runs
- Eligibility check. State, licence forms needed, the pharmacist or competent person, and the premises area. Nothing else matters until these four are settled.
- File preparation. Constitution and identity documents, premises proof, site and key plan, and the person's certificates and declarations.
- Application and fee on your state's drugs control portal, in the prescribed form with the state fee for each licence form.
- Inspection by the Drugs Inspector. The inspector visits the premises, checks the area, the storage and the presence of the qualified person, and may raise queries.
- Grant of the licence in the relevant forms, to be displayed at the premises.
Do not buy stock before the licence is granted. Holding drugs for sale without a licence is the thing the Act is designed to stop, and an inspector who finds stock on an unlicensed premises has a much larger problem in front of them than a pending application.
Validity, retention fee and renewal
The renewal model changed in 2017. Under the Drugs and Cosmetics (Tenth Amendment) Rules, 2017, notified on 27 October 2017, licences remain valid provided the licensee deposits a licence retention fee before the expiry of every succeeding five years from the date of issue, unless the licence is suspended or cancelled.
If the retention fee is not paid on time, the licensee may pay it with a late fee of 2 per cent of the retention fee for each month for the next six months, and if it is still not paid the licence is deemed to have been cancelled.
Two cautions. The retention fee amount, and the way a particular state applies this to sale licences in Forms 20, 21, 20-B and 21-B, are things we confirm with your licensing authority rather than assume. And the deemed cancellation at the end of the late-fee window is the harshest consequence in this area, so the five-year date belongs in a diary the day the licence is granted.
Records you must keep once you are licensed
The Rules put real record-keeping obligations on a licensee, and an inspection is usually a records inspection.
- Prescription register with the serial number, date, prescriber's details, the patient's details, the name and quantity of the drug supplied and the signature of the pharmacist, or a cash or credit memo where drugs are supplied in the original container.
- Separate register for Schedule H and H1 drugs, retained for three years.
- Purchase records showing the date, the supplier, the name of the drug, the batch number and the manufacturer.
- Prescription requirements: a prescription must be in writing, signed and dated by the prescriber, must state the name and address of the patient, and must indicate the total quantity to be supplied and the dose.
- Schedule X drugs kept and recorded under the conditions that schedule sets out.
Accounting records sit alongside these, and a pharmacy's stock and expiry management is an accounting problem as much as a regulatory one: see accounting service.
Changes after the licence is granted
The licence records the premises, the entity and the qualified person, so each of those changing is a filing.
- Change of premises is treated as a fresh application in most states, because the area, storage and inspection attach to the address.
- Change of pharmacist or competent person must be reported with the new person's certificates and declaration. Running a retail counter without the recorded pharmacist is the most common enforcement finding in this sector.
- Change of constitution, for example a proprietorship converting to a company, creates a new entity and normally means a new licence rather than an amendment.
- Adding wholesale to a retail shop, or the reverse, brings in the 15 square metre requirement and the additional licence forms.
Other licences a medical store needs
A drug licence is not the only thing on the wall.
| Registration | What it is for |
|---|---|
| Trade licence from the local body | Permission to carry on the trade at that address |
| Shop and establishment registration | Conditions of employment for your staff |
| GST registration | Required once turnover crosses the limit, and in practice for most pharmacies |
| Udyam registration | MSME status, free of government fee |
| FSSAI registration | If you also sell food items, including nutraceuticals and health supplements sold as food |
| Professional tax | Where your state levies it |
In Maharashtra, the Gumasta registration does much of the shop registration work. Outside Maharashtra the state's own Shops and Establishments Act applies.
Common reasons a drug licence application is rejected
- No registered pharmacist for a retail application, or a pharmacist who is not registered with the State Pharmacy Council of that state.
- Competent person's experience not evidenced for a wholesale application.
- Premises below the minimum area, or an area claim the site plan does not support.
- Retail and wholesale applied for on premises below 15 square metres.
- No cold storage arrangement where Schedule C and C(1) drugs are to be sold.
- Premises proof in another name without the owner's consent.
- The same person shown as the qualified person at two premises, which an inspector will check.
- Stock held before grant, which converts a paperwork problem into an enforcement one.
Why Regikart for a drug licence
Regikart is a CA and CS firm serving 250+ clients from offices in Kolkata (head office), Delhi and Bengaluru, working with clients across India online.
- Eligibility before paperwork. We check the pharmacist, the area and the form set first, because a file that fails on any of those cannot be saved by good drafting.
- State by state, not from a template. Fees, portals and inspection practice differ, and we get your state's current position from the licensing authority rather than publishing a national figure that does not exist.
- Honest about scope. Retail and wholesale sale licences only. We do not take manufacturing, cosmetics, blood bank or import work.
- The rest of the shop. Trade licence, shop and establishment registration, GST and your accounts from one team.