Starting a pharmacy, wholesale medicine business, or a manufacturing unit in India requires one crucial step — obtaining a Drug License. Under the Drugs and Cosmetics Act, 1940, it is mandatory for businesses to have a valid drug license before selling, distributing, or manufacturing drugs in India.
This guide will help you understand the eligibility, documents required, and the step-by-step process to apply for a drug license online in 2025.
What is a Drug License in India?
A Drug License is an approval issued by the State Drug Control Department or Central Drugs Standard Control Organization (CDSCO). It authorizes a business to legally manufacture, sell, or distribute medicines.
It ensures that only qualified professionals handle pharmaceutical products, protecting public health and preventing misuse.
Types of Drug Licenses
Depending on the nature of your business, you need to apply for the appropriate license:
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Retail Drug License (RDL): For pharmacies and medical shops.
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Wholesale Drug License (WDL): For businesses supplying medicines to retailers, distributors, and hospitals.
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Manufacturing License: For drug and cosmetic manufacturers.
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Loan License: For businesses using another manufacturer’s facility.
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Import License: For importing medicines into India.
Eligibility Criteria for Drug License
Before applying, ensure your business meets these conditions:
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Qualified Pharmacist: A registered pharmacist is mandatory for retail licenses.
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Business Premises: Minimum 10 sq. meters (retail/wholesale) and 15 sq. meters (combined).
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Storage Facility: Refrigerator & air conditioning for medicines requiring cold storage.
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Registered Business Entity: Proprietorship, partnership, LLP, or company.
Documents Required
Here’s the checklist of documents needed for online application:
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Identity proof of proprietor/partners/directors
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Premises proof (rent agreement/ownership papers)
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Pharmacist’s degree/diploma & registration certificate
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Appointment letter of pharmacist
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Business registration proof (Partnership deed/Company Incorporation)
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GST registration certificate
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Storage facility proof (Refrigerator & AC bills)
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Premises layout/site plan
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Affidavit of compliance under the Drugs and Cosmetics Act
Step-by-Step Process to Apply for Drug License Online (2025)
Step 1: Visit the Portal
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Go to the State Drug Control Department website or CDSCO SUGAM portal: https://cdscoonline.gov.in
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Register yourself and log in.
Step 2: Select License Type
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Choose between Retail, Wholesale, Manufacturing, or Import License.
Step 3: Fill the Application Form
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Enter details such as business name, address, pharmacist details, and storage facilities.
Step 4: Upload Documents
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Attach scanned copies of the required documents in PDF format.
Step 5: Pay Government Fees
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Fees depend on license type & state (₹3,000 – ₹10,000 approx.).
Step 6: Inspection by Drug Inspector
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A Drug Inspector will verify the premises, pharmacist, and compliance.
Step 7: License Issuance
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If approved, the license will be issued online within 30–60 days.
Validity & Renewal
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A drug license is valid for 5 years.
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Renewal must be done at least 30 days before expiry.
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Late renewal may lead to penalties or cancellation.
Penalties for Non-Compliance
Operating a medical or drug business without a valid license can result in:
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Heavy fines
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Business closure
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Legal action, including imprisonment
Why Choose Professional Help?
Applying for a drug license requires technical knowledge and compliance with regulations. PSR Compliance helps businesses with:
- End-to-end application support
- Document verification & filing
- Coordination with authorities
- License renewal services
📞 Call us: (+91) 70658 83416
📧 Email: support@psrcompliance.com
FAQs on Drug License (2025)
Q1. What is the minimum shop area required?
👉 10 sq. meters (retail/wholesale) and 15 sq. meters (combined).
Q2. What is the validity of a drug license in India?
👉 5 years from the date of issue.
Q3. Can I apply for a drug license online?
👉 Yes, via CDSCO SUGAM portal or state drug control websites.
Q4. Is pharmacist qualification mandatory?
👉 Yes, a registered pharmacist is compulsory for retail licenses.
Q5. How long does the approval take?
👉 30–60 days depending on inspection and compliance.
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