If you are planning to start a pharmacy, wholesale medicine business, or manufacturing unit, the first thing you need is a drug license. Without it, operating in the medical sector is not just risky but also illegal.
With the government’s digital platforms, applying for a drug license is now easier than ever. Let’s break down the step-by-step process for 2025.
Why is a Drug License Important?
A drug license ensures that medicines are sold, distributed, or manufactured only by authorized and qualified individuals. This protects both public health and your business reputation.
Types of Drug Licenses You Can Apply For
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Retail Drug License (for medical shops and pharmacies)
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Wholesale Drug License (for bulk supply and distribution)
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Manufacturing License (for producing drugs, cosmetics, or devices)
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Loan License (to use another manufacturer’s facility)
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Import License (for businesses importing drugs into India)
Who Can Apply?
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Individuals with proper business premises and required area.
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Pharmacists with B. Pharma/D. Pharma qualifications (retail).
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Competent persons with experience (wholesale).
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Companies with adequate storage and refrigeration facilities.
Required Documents
Before applying online, prepare these documents:
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Identity and address proof.
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Property proof or rental agreement of the premises.
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Educational certificates of pharmacist/competent person.
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Company incorporation or partnership deed.
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Affidavit of non-conviction.
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Proof of cold storage facilities.
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GST registration certificate.
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Premises layout and site plan.
Step-by-Step Application Guide (2025)
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Go to the State Drug Control Authority website or the CDSCO portal.
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Register online by creating an account.
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Choose your license type (retail, wholesale, manufacturing, etc.).
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Fill in details of your business, premises, and staff.
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Upload scanned documents in PDF/JPEG format.
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Pay the required application fees online.
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Wait for review and inspection scheduling.
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Drug Inspector will verify your premises.
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On approval, download your Drug License Certificate from the portal.
Fees and Timelines
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Fees usually range between ₹3,000 – ₹10,000.
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The approval process may take 30–60 days depending on inspection.
Renewal Process
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A license is valid for five years.
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Apply for renewal online before the expiry date to avoid penalties.
Key Tips for Faster Approval
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Double-check documents before uploading.
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Ensure your premises meet all requirements.
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Keep proper refrigeration and storage facilities ready for inspection.
Conclusion
Applying for a drug license online in India is straightforward if you follow the official process. However, many businesses face delays due to documentation errors or inspection issues.
That’s where PSR Compliance helps – from documentation to approvals, we guide you at every step to secure your license quickly.
📞 Contact us at (+91) 70658 83416
📧 support@psrcompliance.com
🌐 https://psrcompliance.com/
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