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Drug License (Retail / Wholesale / Manufacturing)

License required to sell, stock, distribute, or manufacture drugs and medicines under the Drugs & Cosmetics Act, 1940.

Department: State Drug Control Administration / CDSCOProcessing: 15-45 working days

About this License

Drug License is mandatory for any business dealing with drugs, medicines, or cosmetics under the Drugs and Cosmetics Act, 1940 and Rules, 1945. Types include: Retail Drug License (for pharmacies), Wholesale Drug License (for distributors), Manufacturing Drug License (for producers), and Loan License (third-party manufacturing). Issued by the State Drug Control Department.

Application Process

Determine license type (Retail / Wholesale / Manufacturing) → Apply online on state drug control portal or CDSCO portal → Submit all required documents and details → Pay the applicable fee → Drug Inspector inspects premises → License issued upon approval

1

Determine Type

Choose Retail, Wholesale, or Manufacturing drug license

2

Online Application

Apply on state Drug Control Administration portal

3

Upload Documents

Submit all required documents including pharmacist details

4

Fee Payment

Pay license fee applicable for your state

5

Premises Inspection

Drug Inspector inspects the premises

6

Receive License

Drug license issued in Form 20/21 (retail) or Form 20B/21B (wholesale)

Eligibility Criteria

  • 1Must have a registered pharmacist (for retail license)
  • 2Adequate storage premises (separate for drugs, cold storage if needed)
  • 3Minimum 10 sq m retail / 15 sq m wholesale area
  • 4No conviction under the Drugs and Cosmetics Act
  • 5Qualified person for manufacturing (graduate in pharmacy/chemistry)

Documents Required

PAN Card of business entity
GST Registration certificate
Proof of premises (ownership/rental + layout plan)
Qualification certificates of pharmacist / qualified person
Appointment letter of registered pharmacist
Affidavit and undertaking
Previous drug license (for renewal)

Frequently Asked Questions

Q: What is the validity of a drug license?
A: The license is typically valid for 1 to 5 years, renewable before expiry.
Q: Is a registered pharmacist mandatory?
A: Yes, for a retail drug license, a registered pharmacist must be employed.
Q: What is the minimum area required?
A: Minimum 10 sq meters for retail and 15 sq meters for wholesale.

Quick Information

Estimated Cost
₹1,000 - ₹5,000 per year (varies by state)
Processing Time
15-45 working days
Validity
1 to 5 years as per application
Renewal
Every 1-5 years
Level
state
Department
State Drug Control Administration / CDSCO

Fee Structure

Retail Drug License (per year)₹1,000 - ₹3,000
Wholesale Drug License (per year)₹2,000 - ₹5,000
Manufacturing Drug License (per year)₹5,000 - ₹25,000

Tags

#drug-license#CDSCO#pharmacy#wholesale-drugs#retail-drugs
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