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Fri, Jan 02 2026
Raju Karn
India’s pharmaceutical market is one of the fastest-growing in the world, valued at over $65 billion in 2025 and expected to touch $130 billion by 2030. For global drug manufacturers and distributors, this is a massive opportunity — but accessing the Indian market legally begins with one key step: securing a Drug Import License through the Central Drugs Standard Control Organization (CDSCO).
This step-by-step guide will help you understand the exact process, documents required, application fees, and how to avoid common mistakes — whether you’re a multinational pharma company or an importer looking to scale in India.
Real-World Example: Pfizer’s Entry Strategy
Pharmaceutical giant Pfizer has successfully imported multiple drugs into India, including vaccines and innovative therapies, through CDSCO’s regulatory framework. Their compliance-first approach helped them streamline approvals, ensuring faster market penetration while building trust with Indian regulators.
A Drug Import License is a mandatory authorization issued by CDSCO that allows an individual or company to legally import drugs or pharmaceuticals into India.
Depending on the type of product, importers must obtain:
Form 10: For import of drugs for commercial sale
Form 11: For import of drugs for personal use, clinical trials, R&D, or testing
The license is issued under Rule 24 of the Drugs and Cosmetics Rules, 1945.
Anyone or any entity intending to import drugs into India for any of the following purposes:
Commercial sale (finished drugs, APIs)
Research & Development
Clinical trials
Testing or analysis
Hospital use or charitable purposes
Personal medical use (in special cases)
You need an import license for the following:
Finished drug formulations (tablets, syrups, injections)
Active Pharmaceutical Ingredients (APIs)
Biological products (vaccines, serums, hormones)
Narcotic & psychotropic drugs (regulated separately)
Blood products and diagnostics
New Drugs (require separate approval under NDCT Rules)
Here’s the checklist for importing commercial drugs into India:
Cover letter on company letterhead
Copy of wholesale/manufacturing drug license (Form 20B/21B)
Power of Attorney (POA) from foreign manufacturer
Import License Application (Form 8)
TR6 Challan for license fees
Authorization letter
Product labels & packaging artwork
Free Sale Certificate (FSC)
GMP certificate (Good Manufacturing Practices)
Certificate of Pharmaceutical Product (COPP)
Manufacturing license copy
Product composition and specification sheet
Stability data
Product master file (optional for complex formulations)
All documents must be notarized and, in some cases, apostilled or legalized
All applications must be submitted through the official CDSCO portal:
https://cdscoonline.gov.in
Register your organization on CDSCO portal
Login and select “Import License” module
Fill Form 8 (Application for Form 10)
Upload required documents in PDF format
Pay government fees via online challan (TR6)
Track application status via dashboard
Inspection & Approval by CDSCO officers
Download Form 10 (after approval)
Note: This excludes consultancy or document attestation fees.
Import License (Form 10) is generally valid for 3 years
Renewal must be applied at least 6 months before expiry
All imported drugs must be tested at a government-approved lab
❌ Missing power of attorney
❌ Improper formatting of foreign documents
❌ No CDSCO registration of the manufacturing site
❌ Submitting documents in the wrong format or without notarization
❌ Failure to pay proper fees per drug/site
Tip: Engage a CDSCO consultant like PSR Compliance to avoid rejections or delays.
At PSR Compliance, we assist with:
End-to-end CDSCO registration & licensing
Power of Attorney, legalization, and attestation
Technical documentation support
Timely tracking & follow-ups
Renewal & amendment services
Need help? Contact us today → www.psrcompliance.com/contact-us
🅰️ Yes, a separate Form 10 is needed per drug formulation and per manufacturing site.
🅰️ No. All foreign manufacturers and their products must be registered with CDSCO.
🅰️ Typically 45–90 days, depending on documentation and product complexity.
🅰️ Yes, CDSCO requires GMP certificate from the country of origin.
🅰️ Yes, you can use Form 11, but it’s subject to specific medical needs and approval.