Drug License
A Drug License is a legal permit granted by the Drug Control Department (in India, under the Drugs and Cosmetics Act, 1940) that allows a business to manufacture, distribute, or sell drugs or pharmaceutical products. This license ensures that only authorized and qualified entities handle drugs, helping maintain public health and safety.
🏥 Types of Drug Licenses in India
|
License Type
|
Purpose
|
Who Needs It?
|
|---|---|---|
|
Retail Drug License (RDL)
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To sell drugs to end-users (patients)
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Pharmacies, chemist shops
|
|
Wholesale Drug License (WDL)
|
To sell drugs in bulk (to retailers, hospitals)
|
Distributors, stockists
|
|
Manufacturing License
|
To manufacture pharmaceutical products
|
Drug manufacturers
|
|
Loan License
|
For using another’s manufacturing facilities
|
Pharma marketers
|
|
Import License
|
To import drugs into India
|
Importers and exporters
|
|
Export License
|
To export drugs from India
|
Exporters (under CDSCO)
|
📄 Key Requirements to Obtain a Drug License
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Premises:
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Area: Min 10 sqm for retail; 15 sqm for wholesale or combined license.
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Storage: Refrigerator and air conditioner are mandatory.
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Qualified Personnel:
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Retail: Registered pharmacist with a pharmacy degree/diploma.
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Wholesale: B.Pharm or 1+ year experience in drug sales.
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Documentation:
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Identity and address proof of owner
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Rent agreement or property papers
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Blueprint/layout plan of premises
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Affidavits regarding non-conviction and compliance
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Registration certificate of pharmacist (for retail)
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Partnership deed/incorporation certificate (if applicable)
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Registration Portal
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Apply via state Drug Control Department portal
⏱️ Time & Validity
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Time to get license: ~30–60 days
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Validity: 5 years (renewable)
🧾 Fees (Indicative)
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Retail License: ₹3,000–5,000
-
Wholesale License: ₹5,000–10,000
-
Manufacturing License: Depends on scale & drug type
⚠️ Penalty for Non-Compliance
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Heavy fines
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Imprisonment (up to 5 years)
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Seizure of stock and permanent business shutdown
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