Drug License in India: Retail, Wholesale and Import Drug License Explained
A drug license is the permission your State Licensing Authority gives you, under the Drugs and Cosmetics Act, 1940 and its 1945 Rules, to sell or distribute medicines. Retail and wholesale licences come from the state. An import drug license is different: it is issued by CDSCO at the central level, and you cannot get it without holding a wholesale licence first.
Min. Premises
10 sq m (15 sq m combined)
Key Takeaways
Retail needs a registered pharmacist. Wholesale needs a "competent person", which is a wider test.
You apply on Form 19 and receive Form 20/21 (retail) or Form 20B/21B (wholesale).
Premises must be at least 10 sq m, or 15 sq m if retail and wholesale share one address.
Importing drugs adds a second layer: a Registration Certificate (Form 41) for the foreign manufacturer and an import licence in Form 10.
Fees, portals, and inspection practice vary by state. Confirm with your state FDA before paying.
Which Drug License Do You Need?
The answer depends on what you sell, to whom, and where the product comes from.
| Your Business |
Licence |
Issued By |
| Chemist shop selling to patients |
Form 20 and 21 |
State Licensing Authority |
| Distributor supplying chemists and hospitals |
Form 20B and 21B |
State Licensing Authority |
| Retail and wholesale from one address |
All four forms |
State Licensing Authority |
| Importing drugs for sale in India |
Form 10 (plus Form 41 registration) |
CDSCO |
| Manufacturing drugs |
Manufacturing licence |
State authority with CDSCO involvement |
The "21" forms cover Schedule C and C(1) products such as vaccines, sera, and biologicals. The "20" forms cover ordinary allopathic drugs. A pharmacy that stocks cold-chain items usually ends up holding both sets.
This page covers retail, wholesale, and import. Manufacturing has its own conditions and is outside its scope.
Retail and Wholesale Drug License Registration
Who Qualifies
Retail licence
The person in charge must be a registered pharmacist, enrolled with a State Pharmacy Council. The Pharmacy Council of India publishes the registration framework.
Wholesale licence
You name a competent person. The sources I reviewed describe the test as a registered pharmacist, or a graduate with at least a year of experience dealing in drugs, or a matriculate with four years of such experience.
A full-time pharmacist is a retail condition, not a wholesale one. That distinction saves many distributors from hiring a pharmacist they do not need.
Premises and Storage
10 sq m minimum for a retail-only or wholesale-only licence.
15 sq m where retail and wholesale licences sit on the same premises.
Storage must suit the product. Where you hold items that need cold storage, you are expected to have a refrigerator, and inspectors look for it.
Some states restrict licences on residential plots. Delhi's published checklist states this, so check your own state's rule before signing a lease.
Keep a floor plan and site plan handy. Inspectors compare what is on paper to what they see at the door.
Documents Required for Drug License in India
The exact list is set by each state, but this core set appears across checklists:
| Document |
Notes |
| Application on Form 19 |
Filed online in most states |
| Fee payment receipt |
System generated |
| Constitution proof |
Proprietorship declaration, partnership deed, LLP deed, or company incorporation papers |
| Identity and address proof of the proprietor, partners, or directors |
Self-attested |
| Premises ownership or rent agreement |
Matches the address on the application |
| Site plan and key plan |
Shows layout and storage area |
| Qualification proof of the pharmacist or competent person |
Registration certificate, or degree and experience papers |
| Appointment letter and declaration from that person |
Often a prescribed format |
| Affidavit of no prior conviction |
Prescribed format |
| Refrigerator purchase bill |
Where cold storage is needed |
Names and addresses must match across all of these.
Chemist Shop License Online Process
The sequence for a retail or wholesale licence:
1
Decide Which Forms You Need
Forms 20, 21, 20B, 21B.
2
Secure Premises and Qualified Person
Secure compliant premises and put the qualified person in place.
3
Log In to Your State's Portal
Log in to your state's drug licensing portal. Many states route through CDSCO's national licensing system, others run their own, so confirm which applies.
4
Fill Form 19 and Upload Documents
Use the documents list above.
5
Pay the Fee Online
Pay through the portal.
6
Prepare for Inspection
A drug inspector visits to verify area, storage, and qualified staff.
7
Receive the Licence on Approval
Timelines run from a few weeks to longer, depending on the state and how clean the file is.
Fees and Validity
Fees
| Application |
Commonly Cited Fee |
| Per form (retail or wholesale) |
₹1,500 |
| Retail shop applying for Forms 20 and 21 |
₹3,000 |
| Combined outlet applying for all four forms |
₹6,000 |
Sources commonly cite ₹1,500 per form. One other source puts the figure higher, and state variation is plausible, so treat ₹1,500 as a reference point and check the state portal.
Validity
On validity, the sources I reviewed describe the licence as perpetual subject to a retention fee payable every five years, with late payment attracting a monthly surcharge. Confirm the current retention rules with your state authority.
Import Drug License: The Central Layer
Importing medicines changes the regulator. CDSCO, not the state, controls this route, under Part IV of the Drugs and Cosmetics Rules, 1945.
The Sequence
1
Hold a Wholesale Licence
The Indian importer or agent needs a valid wholesale licence for sale or distribution (Forms 20B and 21B).
2
Register the Foreign Manufacturer and the Drug
The manufacturer or its authorised Indian agent applies in Form 40, and CDSCO issues a Registration Certificate in Form 41. This registers both the manufacturing premises and the specific drugs.
3
Apply for the Import Licence
The importer files Form 8 (Form 8A for Schedule X drugs) with the fee and supporting papers.
4
Receive Form 10
Form 10A for Schedule X drugs.
Documents Commonly Asked For
Form 8 signed and stamped by the Indian agent where one is used.
The Form 41 Registration Certificate.
A valid wholesale licence.
Form 9, the manufacturer's undertaking.
A Free Sale Certificate or Certificate of Pharmaceutical Product from the country of origin.
Product details, labels, and package inserts.
The names must align across Form 8, Form 9, and Form 41, a point CDSCO's own guidance stresses.
Validity
One source describes Form 10 as valid for three years or until the Registration Certificate expires, whichever comes first. Rules on validity have been amended over time, so verify the current position on cdsco.gov.in before planning renewals.
Cosmetics and Devices
Cosmetics imports are registered under the Cosmetics Rules, 2020, a separate framework from drug imports. For medical devices, the Medical Devices Rules, 2017 apply. One source notes that holders of Form 20B/21B wholesale licences keep a pathway for device sales under the 2022 amendment. Confirm your product's category with CDSCO before assuming which licence applies.
If you are importing, you will also need an IEC. Start with our
IEC registration service and read our
import export compliance guide.
Staying Compliant After You Get the Licence
A drug licence is conditional, not permanent in practice.
Keep the qualified person in place. If your pharmacist or competent person leaves, report it. Most states handle it as an amendment.
Display the licence prominently at the premises.
Sell only against valid prescriptions where the schedule requires it, and maintain registers for scheduled drugs.
Store by label. Temperature-sensitive stock stays in working cold storage, with the refrigerator maintained.
Pay retention fees on time.
Cooperate with inspections. Surprise visits are normal, and they are the main enforcement mechanism of state FDA compliance.
Common Mistakes That Delay or Sink Applications
These are the errors to avoid:
Wrong premises
Choosing premises that fail the area or location rule.
Pharmacist from another state
Naming a pharmacist who is registered in a different state.
Mismatched names
Mismatched names across the lease, constitution papers, and Form 19.
Wrong forms
Applying for Forms 20/20B when the product mix includes Schedule C items.
Import planning too early
Starting import planning without a wholesale licence.
Ignoring total cost
Treating the licence fee as the total cost and ignoring rent, refrigeration, and staff.
Frequently Asked Questions
Got questions? Find clear answers from our team:
It is the legal permission to sell, stock, or distribute drugs, granted under the Drugs and Cosmetics Act, 1940 and Rules, 1945.
The State Licensing Authority issues retail and wholesale licences. CDSCO issues import licences.
Yes, a registered pharmacist.
No. A competent person is required, and a registered pharmacist qualifies as one.
10 sq m for retail or wholesale alone, and 15 sq m for both at one address.
It is the application form used for retail and wholesale licences.
Forms 20 and 21 are retail licences for general drugs and Schedule C/C(1) drugs. Forms 20B and 21B are the wholesale equivalents.
Commonly cited at ₹1,500 per form, varying by state. Check your state portal.
Sources describe it as perpetual subject to a retention fee every five years. Confirm with your state.
It is a Form 10 licence from CDSCO to import drugs for sale in India, issued after the Form 41 Registration Certificate.
No. A valid wholesale licence is a prerequisite for the import route.
Sale and import of cosmetics fall under the Cosmetics Rules, 2020, with import registration handled separately from drugs.