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Central Drugs Standard Control Organization

CDSCO / Drug License

Registration of medical devices, drugs, cosmetics, and diagnostics under CDSCO and MDR 2017. We manage the online portal, clinical evidence review, and CDSCO liaison.

✦ Drug License✦ Cosmetic License✦ Medical Devices✦ DCGI Approval✦ 0% Failure Rate

Governing Body

CDSCO / DCGI

Governing Act

Drugs & Cosmetics Act, 1940

Device Rules

Medical Devices Rules 2017

Processing Time

30 Days – 6 Months

Applicable To

Drugs, Cosmetics & Devices

Overview

Every Path Under CDSCO / Drug License

Our CDSCO specialists prepare your technical dossier, coordinate with your Indian Authorized Agent, and manage every query raised by CDSCO or DCGI until approval.

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Drug License

Pharma

Manufacturing or import license for pharmaceutical drugs and formulations under Drugs & Cosmetics Act.

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Cosmetic License

Cosmetics

Import or manufacturing license for cosmetic products sold in India under CDSCO regulations.

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Medical Device Registration

Medical

Registration for medical devices including Class A, B, C & D devices under MDR 2017.

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CDSCO Import License

Imports

Import license for drugs, cosmetics and medical devices under Form 10 / Form 8 procedures.

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DCGI Approval

New Drugs

Approval from Drug Controller General of India for new drugs, biologicals and clinical trials.

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Clinical Trial Approval

Research

CDSCO approval for conducting clinical trials in India for new drugs and medical devices.

How It Works

Our CDSCO / Drug License Process

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STEP 01

Classification Review

We determine the exact CDSCO category and device class applicable to your product.

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STEP 02

Dossier Preparation

We prepare your complete CTD-format technical dossier with quality and clinical data.

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STEP 03

CDSCO Portal Filing

Application filed via the Indian Authorized Agent along with GMP and CoPP documentation.

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STEP 04

License Granted

CDSCO/DCGI reviews and issues your registration or import license.

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30d–6m

Processing Time

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Device Classes (B–D)

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Free

Initial Consultation

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Failure Rate

Documentation

Documents You'll Need

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Company Registration & KYC

Certificate of Incorporation, GST, PAN, and KYC for the Indian Authorized Agent entity.

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Technical Dossier (CTD Format)

Complete Common Technical Document covering quality, non-clinical, and clinical data.

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GMP Certificate

Issued by the national regulatory authority of the manufacturing country.

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Certificate of Pharmaceutical Product

Confirming the product is authorized for sale in the country of manufacture.

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Clinical / Safety Data

As required for new drugs, new combinations, and biological products.

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Stability Data

Demonstrating quality and safety throughout the claimed shelf life.

Common Questions

CDSCO / Drug License FAQs

Yes, all drugs imported into India require either a registration certificate or import license from CDSCO/DCGI. The requirement varies by drug category and whether it's already approved in India.

CDSCO (Central Drugs Standard Control Organization) is the regulatory body. DCGI (Drug Controller General of India) is its head. Approvals for new drugs, clinical trials, and certain imports require DCGI approval.

Class A and B devices typically take 30–90 days. Class C and D devices take 3–6 months. We help prepare error-free dossiers to avoid rejection or delays.

Yes, cosmetics imported into India require a CDSCO import license. Products like hair dyes, sunscreens, and anti-dandruff shampoos are treated as drugs and need drug license.

Foreign manufacturers must appoint an Indian Authorized Agent (IAA) to apply on their behalf. We provide authorized agent services and manage the complete regulatory process end-to-end.

Ready to start your CDSCO / Drug License?

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