Break Into India’s Pharma Market: Step-by-Step Guide to Getting a Drug Import License (2025)

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.

What is a Drug Import License?

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.

Who Needs a Drug Import License?

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)

Types of Drug Import Licenses in India

Which Drugs Require Import License?

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)

Documents Required for Drug Import License (Form 10)

Here’s the checklist for importing commercial drugs into India:

From Indian Applicant/Agent:

• 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

From Foreign Manufacturer:

• 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

CDSCO Online Application Process

All applications must be submitted through the official CDSCO portal:

https://cdscoonline.gov.in

Step-by-Step Process:

1. Register your organization on CDSCO portal

2. Login and select “Import License” module

3. Fill Form 8 (Application for Form 10)

4. Upload required documents in PDF format

5. Pay government fees via online challan (TR6)

6. Track application status via dashboard

7. Inspection & Approval by CDSCO officers

8. Download Form 10 (after approval)

Government Fees for Drug Import License

Note: This excludes consultancy or document attestation fees.

Validity & Renewal

• 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

Common Mistakes to Avoid

❌ 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.

Why Choose PSR Compliance?

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

FAQs About Drug Import License

Q1. Do I need a separate license for each drug?

🅰️ Yes, a separate Form 10 is needed per drug formulation and per manufacturing site.

Q2. Can I import drugs without a CDSCO registration?

🅰️ No. All foreign manufacturers and their products must be registered with CDSCO.

Q3. How long does the import license process take?

🅰️ Typically 45–90 days, depending on documentation and product complexity.

Q4. Is GMP certification necessary for import license?

🅰️ Yes, CDSCO requires GMP certificate from the country of origin.

Q5. Can I import a drug for personal use without Form 10?

🅰️ Yes, you can use Form 11, but it’s subject to specific medical needs and approval.

Related Blogs

• How to Register a Drug License with CDSCO in India – Step-by-Step Guide

• Wholesale Drug License – Process, Eligibility & Documents

• Want to Manufacture Medicines Without Owning a Plant? Here’s How a Loan License Makes It Possible

Want Help Getting Your Drug Import License?

Let our experts handle it for you — from document prep to CDSCO approval.

👉 Get in touch today: www.psrcompliance.com