Drug License in India (2026): How to Get a Medical Store Licence — Forms, Fees and Rules

You cannot stock or sell allopathic medicines in India — not even paracetamol in a general store — without a drug licence from your state's drug controller. This guide is for anyone opening a medical store, pharmacy or pharma distribution business in 2026. It explains which licence forms you need, the fees as published in the Drugs Rules, the pharmacist and floor-area conditions, how to apply on ONDLS or your state portal, the documents inspectors ask for, and what a new medical store costs to set up and run.

Quick answer

A drug licence is issued by your state drug controller under the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945. A retail medical store needs Form 20 (general drugs) and Form 21 (Schedule C and C1 drugs); a wholesaler needs Form 20B and Form 21B. Apply in Form 19 on ONDLS (statedrugs.gov.in) or your state portal, paying ₹1,500 per licence form.

• Retail needs a registered pharmacist in charge; wholesale needs a competent person

• Minimum area: 10 square metres for retail or wholesale; 15 square metres for both

• No renewal: pay a retention fee every 5 years to keep the licence valid

• Each shop or godown needs its own licence

Which drug licence do you need?

Rule 61 of the Drugs Rules, 1945 sets out the sale licences. Most medical stores take two retail forms together; distributors take the two wholesale forms; many take all four.

The Delhi Drugs Control Department's published fee table charges ₹1,500 for each of Forms 20, 21, 20B and 21B, so a retail-only store pays about ₹3,000 and a store taking retail and wholesale licences pays about ₹6,000. Other states follow the same rule but may add their own processing charges. A duplicate licence costs ₹150.

Homoeopathic medicines use separate licences (Forms 20C and 20D), and manufacturing is licensed under different rules, often with central approval. This guide covers allopathic sale licences.

Eligibility: pharmacist, competent person and premises

Rule 64 sets the conditions the licensing authority must be satisfied about before granting a licence.

Retail (Form 20/21) — registered pharmacist. The shop must be in the charge of a person the authority considers competent; for a pharmacy, the Schedule N requirements apply, which in practice means a pharmacist registered with the State Pharmacy Council. Rule 65 adds that any medicine supplied on a doctor's prescription must be supplied by or under the personal supervision of a registered pharmacist. If the owner isn't a pharmacist, employ one — and tell the drug controller whenever the pharmacist changes.

Wholesale (Form 20B/21B) — competent person. The person in charge can be any one of:

• a registered pharmacist;
• someone who has passed matriculation (Class 10) with 4 years of experience in selling drugs; or
• a graduate with 1 year of experience in dealing with drugs.

Premises. At least 10 square metres for a retail or a wholesale licence, and 15 square metres when you take both at the same place. The premises must have proper storage to preserve the drugs — shelving away from damp and sunlight and, for vaccines, insulin and other cold-chain products, a refrigerator. Many states also check that the shop is in a commercial or mixed-use zone; Delhi, for instance, asks for proof of commercial use under its master plan.

Fit person. The authority can refuse a licence to anyone convicted under the Act or whose earlier licence was cancelled or suspended.

Documents required for a drug licence

Lists vary a little by state. The Delhi guidelines below are typical of what ONDLS and state portals ask for.

Documents to keep ready

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• Application in Form 19 (or 19A/19C) generated on the portal, with the online fee receipt
• Site plan and key plan of the premises, showing the area in square metres
• Proof of possession: sale deed or registered rent agreement with the owner's title papers
• Constitution proof: proprietor's declaration, partnership deed, LLP agreement or MoA/AoA with list of partners or directors
• Photo ID of the proprietor, partners or directors
• Affidavit of non-conviction under the Drugs and Cosmetics Act
• Retail: pharmacist's registration with the State Pharmacy Council, qualification certificate, appointment letter and consent/declaration
• Wholesale: competent person's qualification and experience certificate, appointment letter
• Proof that the premises can be used commercially, where the state requires it
• Purchase bill or proof of refrigerator, if applying for Form 21 / 21B

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How to apply for a drug licence: step by step

Getting a medical store licence

1. 1

   Find the right portal

   Most states take sale licence applications on the Online National Drugs Licensing System (ONDLS) at statedrugs.gov.in, built by C-DAC for CDSCO and the states. Some states, such as Gujarat (XLN portal), run their own system.

   Open ONDLS
2. 2

   Register the firm

   Create a user account with the firm's details, constitution and premises address.

3. 3

   Fill Form 19 and choose licence forms

   Select Form 20, 21, 20B and/or 21B as needed. Enter the pharmacist or competent person's details and storage arrangements.

   Tip: Apply for every form you'll need now — adding one later means a fresh application and another inspection.

4. 4

   Upload documents and pay

   Upload scanned documents and pay ₹1,500 per licence form online.

5. 5

   Inspection

   A drugs inspector visits to check the area, storage, refrigerator, signage and the pharmacist's presence. Keep original documents ready.

6. 6

   Grant and download

   Once approved, download the digitally signed licence from your account and display it in the shop.

The Drugs Rules don't fix a processing time for sale licences; it depends on your state's workload and inspection schedule. If your application is refused, rule 64 allows an appeal to the state government within 30 days of receiving the order.

Validity, retention fee and "renewal"

Older guides talk about renewing a drug licence every five years. Since rule 63 was substituted in October 2017, it works differently: a licence in Forms 20, 20A, 20B, 21, 21A, 21B and related forms remains valid indefinitely, provided you pay a licence retention fee before the end of every 5 years period from the date of issue. The retention fee equals the fee for granting that licence — ₹1,500 per form for most licences.

Miss the date and you pay a late fee of 2% of the licence fee per month (up to six months). If the fee is still unpaid after six months, the licence is deemed cancelled and you must apply afresh. Diary the date from your licence certificate.

Changes are not covered by retention. A change of premises, a change of constitution (such as proprietorship to partnership) or a new pharmacist must be reported, and some of these need a fresh licence.

Rules you must follow after you open

Day-to-day compliance for a licensed medical store

Every day

Registered pharmacist present when prescription drugs are sold

Every prescription sale

Cash or credit memo with patient, prescriber, drug, batch and manufacturer; keep copies 3 years

Schedule H, H1 and X

Sell only against a doctor's prescription; Schedule X prescriptions kept in duplicate

Every purchase

Buy only from licensed wholesalers; record supplier licence number and batch

Each 5 years

Pay the retention fee for every licence form

On any change

Report change of pharmacist, premises or constitution to the drug controller

Separate licences apply to each place where drugs are sold or stocked (rule 62), so a second branch or a separate godown needs its own. If you sell health supplements, protein powders, baby food or other food products, you also need FSSAI registration as a retailer. Register for GST once you cross the threshold — or earlier, since most distributors deal only with GST-registered buyers — and take free Udyam registration.

What a new medical store costs: worked example

Drug licence fees are a tiny part of the cost. The budget below is our illustrative estimate for a 150 sq ft (about 14 sq m) retail store in a tier-2 city; it is not an official figure, and rents, salaries and stock levels vary widely.

Monthly fixed costs — rent ₹30,000, pharmacist ₹25,000, helper ₹12,000, electricity ₹5,000, software and sundries ₹8,000 — come to about ₹80,000. Assume an average bill of ₹400 and a blended gross margin of 18% (an assumption; actual margins depend on your mix of branded, generic and OTC products and on price-controlled drugs). Each bill then contributes about ₹72, so break-even is 80,000 ÷ 72 ≈ 1,110 bills a month, or about 37 a day.

Try it — medical store break-even

Monthly Fixed CostsSelling Price per UnitVariable Cost per Unit

Contribution Margin / Unit₹72.00

Contribution Margin Ratio18%

Break-Even Revenue₹4,44,444.44

Break-Even Units1,112

Open the full Break Even Calculator (PDF, save, compare)

Common mistakes that delay or cost a licence

1. Applying with too little floor area. Measure carpet area; 10 square metres is the minimum for one type, 15 square metres for retail plus wholesale.
2. A pharmacist "on paper". Inspectors check presence; supplying prescription drugs without a pharmacist breaches the licence conditions.
3. Forgetting Form 21. Without it you cannot stock insulin, vaccines and other Schedule C/C(1) products.
4. Missing the retention fee. The late fee runs monthly, and after six months the licence is cancelled.
5. Opening a second outlet or godown under the same licence. Each place needs its own.
6. Paying agents for "instant" licences. The fee is set by rule 59; the inspection cannot be skipped.

Official links

• ONDLS — Online National Drugs Licensing SystemApply, track and download sale licences
• Drugs Rules, 1945 (CDSCO consolidated copy)Rules 59–65 cover sale licences
• CDSCOCentral regulator
• Delhi Drugs Control Department — licence guidelines and fee table
• Gujarat XLN drug licensing portal

What to do next

Line up the premises and pharmacist first — they decide whether the licence is granted. Then apply on ONDLS or your state portal, register for GST and Udyam, and test your sales targets with the break-even calculator. If you need finance for stock and fit-out, see our guide to Mudra loans.

This is general information, not legal or tax advice — confirm on the official source or with a professional.

Frequently asked questions

What is the fee for a drug license for a medical store?

Under rule 59 of the Drugs Rules, 1945, an application in Form 19 costs ₹1,500. States charge this for each licence form, so a typical retail chemist taking Form 20 and Form 21 pays about ₹3,000, and a shop also doing wholesale (20B and 21B) pays about ₹6,000. Restricted general-store licences cost ₹500. Check your state portal for the exact amount.

Can I open a medical store without being a pharmacist?

Yes. The owner does not have to be a pharmacist, but a retail licence in Form 20 or 21 is granted only if the shop is in charge of a registered pharmacist, and prescription medicines must be supplied under a registered pharmacist's personal supervision. Most owners employ one full-time. A wholesale licence needs a competent person, who may also be a matriculate or graduate with relevant experience.

How long is a drug license valid?

Sale licences no longer expire in the old sense. Under rule 63, a licence in Forms 20, 21, 20B, 21B and similar stays valid as long as you pay a retention fee — equal to the grant fee — before the end of every 5 years period from issue. Late payment attracts 2% of the licence fee per month (up to six months); after six months unpaid, the licence is treated as cancelled.

What is the minimum area required for a medical store licence?

Rule 64 requires at least 10 square metres for a retail licence (Form 20/21) or a wholesale licence (Form 20B/21B), and at least 15 square metres if you take retail and wholesale licences together at the same premises. The space must have proper storage, including a refrigerator for drugs that need cold storage.

How can I verify or download a drug license online?

In states that use ONDLS (statedrugs.gov.in), licence holders download the licence from their account after approval, and the portal offers licence search and tracking. States with their own systems, such as Gujarat's XLN portal, provide download and search there. Pharmacies must also display the licence in the shop, so you can check the licence number with the state drug controller.

Sources & verification

Figures on this page were checked against the sources below when it was last reviewed on 7 October 2026. Each rate and limit is stored once with its own official source and review date, and official update channels are monitored daily so changes are picked up. How we verify

1. 1.The Drugs Rules, 1945 (as amended, CDSCO consolidated copy) — CDSCO · accessed 7 October 2026
2. 2.Online National Drugs Licensing System (ONDLS) — CDSCO / C-DAC · accessed 7 October 2026
3. 3.Guidelines for grant / retention of licences for sale of drugs — Drugs Control Department, Govt. of NCT of Delhi · accessed 7 October 2026
4. 4.Drugs Control Department, Delhi — procedures for obtaining licences — Govt. of NCT of Delhi · accessed 7 October 2026
5. 5.XLN — Gujarat state drug licensing portal — Food & Drugs Control Administration, Gujarat · accessed 7 October 2026
6. 6.Rule 63, Drugs and Cosmetics Rules, 1945 — duration of licence — Indian Kanoon · accessed 7 October 2026