CDSCO Registration

Drug CDSCO Registration

For drugs, CDSCO handles the central routes under the Drugs and Cosmetics Act, 1940 and Rules, 1945 and the New Drugs and Clinical Trials Rules, 2019: Registration Certificate for import of drugs (application Form 40, certificate Form 41) and import licence (application Form 8, licence Form 10; Forms 8A and 10A for Schedule X drugs), plus new-drug and clinical-trial permissions. A foreign manufacturer’s premises and each drug must first be registered before the import licence can be applied for.

We prepare Form 40 and documents, the agent and Site Master File and apply for import licence.

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Service Overview

What is Drug CDSCO Registration?

CDSCO registration for drugs means that a foreign manufacturer’s site and its drugs are registered with CDSCO through an Indian authorised agent holding a wholesale licence, after which an Indian importer obtains an import licence. The Registration Certificate (Form 41) is generally valid for three years, and the import licence (Form 10 or 10A) is generally valid for three years or until the Registration Certificate expires, whichever is earlier.

New drugs additionally need permission under the New Drugs and Clinical Trials Rules, 2019 before import or manufacture. Fees are in USD or INR equivalent: USD 1,500 for registration of premises or manufacturer per CDSCO guidance plus USD 1,000 for each drug per one source. Domestic manufacturing and sale licences follow separate state-level routes not covered here.

Drug CDSCO Registration

Who Needs This Service

Foreign drug manufacturers, their Indian authorised agents, pharmaceutical importers and companies introducing new drugs in India need this service.

Importers of Schedule X drugs use Forms 8A and 10A.

Domestic manufacturers use state licences.

Companies with new drugs also need permissions.

Key Benefits

Registration and import licence route clear
Form 40 and documents prepared
Agent and SMF support
Import licence application
Renewal tracking

Next Steps & Related Services

After licensing, import and keep records. Related services: MDR registration, GMP, IEC Code and Legal Agreement drafting.

Common Mistakes

Applying for import licence before registration.
Weak SMF.
No wholesale agent.
Missing fees in USD.
Ignoring validity.

Timeline, Costs & Practical Tips

Timelines vary by CDSCO scrutiny.

Practical tip: confirm current fees.

Additional Information

The Drugs and Cosmetics Rules, 1945 govern import and registration of drugs.

Practical Scenarios

Scenario 1:

A foreign pharma registers.

Scenario 2:

An importer applies for Form 10.

Scenario 3:

A company seeks new drug permission.

Written By

Raghav Sharma

Operations Executive

10+ Years Experience

As seen on

Raghav Sharma has 10+ years of experience covering Company Registration - Operation, MCA Services - Operation, Corporate Operation, Import Export Services - Operation, Goverment Licence Services - Operation, FSSAI - Operation, SEBI - Operation, Labour Compliance - Operation, Fund Raising - Operation, Licence & Certificate - Operations.

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Frequently asked questions

Need clarity?

Which form registers drugs for import?

Form 40 application and Form 41 certificate.

Which form is the import licence?

Form 10 (10A for Schedule X).

How long is Form 41 valid?

Generally three years.

Is registration needed before import licence?

Yes.

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