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Any business that wishes to bring drugs, medicines, or cosmetics into India from another country must first obtain a valid Drug Import License. This authorization is issued by the Central Drugs Standard Control Organisation (CDSCO) and permits the import of pharmaceutical products for sale, distribution, or further manufacturing within the country. Since drug import is a regulated activity, it is closely monitored to ensure that only safe, quality-tested, and properly labelled products reach the Indian market.
With the Indian pharmaceutical industry growing rapidly and demand for specialty and innovator drugs rising, many businesses look to import formulations, bulk drugs, and medical devices that are not yet manufactured domestically. Under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, an importer must obtain a Import License in Form 10 (for drugs) or Form 10-A (for cosmetics) before bringing any consignment into the country, along with a valid import registration and wholesale license where applicable.
Depending on the nature of the products you wish to import, different categories of import license are required.
Issued for the import of drugs and formulations for sale or distribution in India.
Required for importing cosmetics into India, granted after registration with CDSCO.
A registration certificate for the foreign manufacturer, issued by CDSCO, that must precede the import license.
Applicable when importing new or investigational drugs for clinical trials or examination purposes.
A drug import license is required for any business that brings pharmaceutical drugs, formulations, or cosmetics into India from outside the country.
To be eligible for a drug import license, the applicant must meet the following criteria:
The following documents are required for drug import license application:
The following is a concise description of the procedure for obtaining a drug import license.
Get in touch with our experts to discuss the products you intend to import and your business plan.
File for CDSCO registration of the overseas manufacturing site, where the site does not already hold a valid certificate.
Compile product dossiers, manufacturer certificates, and premises details for the Form 10 / 10-A application.
Submit the application through the SUGAM portal along with the prescribed fee and supporting documents.
CDSCO examines the application and product data; any deficiency queries are answered through the portal.
On satisfactory review, the Import License is granted by the licensing authority.
The drug import license remains valid indefinitely, subject to compliance with periodic reporting and regulatory requirements. To maintain the license, businesses must:
We manage every step, document, and follow-up with CDSCO so you can focus on your import business.
We verify your eligibility and ensure all required documents are complete and valid.
Complete Form 10 / 10-A drafting and product dossier verification to ensure error-free submission.
Assistance in registering the overseas manufacturing site with CDSCO.
Guidance on setting up compliant storage premises for imported products.
Complete application filing through the CDSCO SUGAM online portal.
We respond to all deficiency queries from CDSCO on your behalf.
Regular follow-up with the authority to ensure timely processing of your application.
Assistance with post-license compliance, renewals, and regulatory updates.
Help with preparing and organizing all required documents for the application.
Talk to a First Auditor specialist today — get a clear fee quote and document checklist before you start.
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