Drug License
Mandatory license for retail, wholesale, or manufacturing of pharmaceutical drugs, medicines, and cosmetics under the Drugs and Cosmetics Act, 1940.
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What is a Drug License?
A Drug License is issued by the State Drug Control Authority (SDCA) under the Drugs and Cosmetics Act, 1940 and Rules, 1945 to any establishment engaged in the manufacture, distribution, sale, or storage of pharmaceutical drugs, medicines, and cosmetics. Any pharmacy (medical shop), wholesale drug distributor, pharmaceutical manufacturer, or importer/exporter of drugs must hold a valid drug license. The license ensures drug safety, proper storage, and qualified supervision by a licensed pharmacist.
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Types of Drug Licenses
Retail Drug License
Form 20 & 21 for retail pharmacy (medical shop) for non-Schedule H/X drugs and Schedule H/X drugs.
Wholesale Drug License
Form 20B & 21B for wholesale distribution of drugs to pharmacies, hospitals, and clinics.
Manufacturing License
Form 25 & 28 for pharmaceutical manufacturing units under CDSCO / State SDCA.
Import / Export License
Central government license for importing/exporting pharmaceutical drugs and active ingredients.
Eligibility & Requirements
How to Obtain a Drug License
Drug license applications are filed with the State Drug Controller Office of the respective state.
1Step 1: Appoint Qualified Pharmacist
Appoint a registered pharmacist with D.Pharma / B.Pharma degree for retail or qualified technical staff for manufacturing.
2Step 2: Prepare Premises
Ensure proper storage facilities, refrigeration, and minimum area requirements as per Rules 64-65 of D&C Rules.
3Step 3: Submit Application Forms
File Form 19 (application) + Form 20 + Form 21 with the State Drugs Controlling Authority.
4Step 4: Premises Inspection
Drug Inspector visits and verifies premises, equipment, storage, and qualifications of pharmacist.
5Step 5: Drug License Certificate
State Drug Controller issues the Drug License in Form 20/21. Displays the license number.
Drug license processing takes 30–45 days. Premises must be fully ready before inspection to avoid rejection.
Documents Required
Business Documents
- PAN Card
- GST Certificate
- Partnership Deed / COI
- Address proof
Pharmacist / Technical Staff
- D.Pharma/B.Pharma certificate
- Pharmacist Registration Certificate
- Experience certificate
- Appointment letter
Premises
- Ownership deed / rental agreement
- NOC from landlord
- Premises layout plan
- Refrigeration equipment proof
Post-Registration Compliance
Annual Renewal
Drug License must be renewed annually (31st December deadline for most states). Late renewal attracts penalty.
Record Maintenance
Maintain purchase and sale records in prescribed registers (Form 17, Form 20) and make available for inspection.
Schedule H/X Control
Maintain separate records for Schedule H and Schedule X (narcotic/psychotropic) drugs. Strict quantity controls apply.
Qualified Presence
A registered pharmacist must be physically present during all business hours. Absence during inspection leads to suspension.
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