Procedure for Import License for Drugs in India

Shreya Jain

Shreya Jain

Published on: Dec 20, 2025

Deepti Mudgal

Updated on: Dec 20, 2025

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Introduction

Obtaining a Drug Import License in India is a mandatory, multi-step process governed by the Drugs and Cosmetics Act, 1940, and overseen by the CDSCO (Central Drugs Standard Control Organization) to ensure drug quality, safety, and compliance.

Applicability Provisions

1. Sections 12 of Drugs and Cosmetics Act, 1940
2. Rules 24, 25, 25(A),28, 28A, 32, 37, 38, 31, 32A of Drugs and Cosmetics Rules, 1945

Mandatory Requirements

• Form 8: Drugs excluding those mentioned in Schedule X
• Form 8A: Drugs specified in Schedule X
• Form 9: Undertaking duly signed by or on behalf of the manufacturer
• Form 10: For drugs other than Schedule X drugs.
• Form 10A: For Schedule X drugs
• Form 41: Registration Certificate

Procedure

1. Registration Certificate (RC)

   Before applying for the Import License (Form 10/10A), the foreign manufacturer ‘s manufacturing site and the specific drugs intended for import shall first be registered with the CDSCO.

   • Application Form: Application for the Registration Certificate is made in Form 40 by the foreign manufacturer or their authorized Indian Agent.
   • Issuance: The Registration Certificate is granted in Form 41 and is generally valid for three years.
   • This application requires comprehensive documents from the foreign manufacturer, such as:
     • Power of Attorney (PoA) duly apostilled/attested by the Indian Embassy, authorizing the Indian agent/importer.
     • Manufacturing License from the country of origin.
     • Good Manufacturing Practices (GMP) Certificate.
     • Certificate of Pharmaceutical Product (COPP) or Free Sale Certificate (FSC).
     • Site Master File/Drug Master File.
2. Application for Import License

   Manufacturer or his Agent shall obtain a drug import license by making an application in Form 8 for drugs other than specified in Schedule X, and in Form 8A for drugs specified in schedule X, to Licensing authority along with licence fee of ten thousand rupees for a single drug and an additional fee at the rate of one thousand rupees for each additional drug accompanied with an undertaking in Form 9 duly signed by or on behalf of the manufacture.

3. Review and Inspection
   • Review: CDSCO officials review the application and supporting documents for completeness and compliance with the Drugs and Cosmetics Act, 1940 and Rules, 1945.
   • Inspection: In some cases, especially for new drugs or specific categories, the CDSCO may conduct a physical inspection of the foreign manufacturing premises.

Validity and Renewal

• Validity: The Drug Import License (Form 10/10A) is generally valid for three years from the date of its issue, or until the expiry of the Registration Certificate (Form 41), whichever is earlier.
• Renewal: An application for renewal should ideally be made three months before the expiry of the existing license.

Fees

To acquire Import License for importing r-DNA products, blood products, vaccines, or stem cells in India then the applicant shall pay INR 10,000 for the first product. An additional fee of INR 1,000 is required for each additional product.