Health & Safety Compliance

CDSCO Registration
Drug & Medical Device License.

Regulatory approval for Drugs, Cosmetics, and Medical Devices in India. Complete compliance support for manufacturers and importers.

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  • Medical Device Registration (MD-14/15)
  • Drug Import License (Form 10)
  • Cosmetic Registration (Form 43)
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CDSCO Registration

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What is CDSCO?

Calculated Measures for Drug Safety. The Central Drugs Standard Control Organization (CDSCO) is the National Regulatory Authority (NRA) of India for pharmaceuticals and medical devices. Under the Directorate General of Health Services, Ministry of Health & Family Welfare, CDSCO is responsible for approving new drugs, conducting clinical trials, laying down standards for drugs, control over the quality of imported drugs, and coordination of the activities of State Drug Control Organizations.

Any business involved in the manufacturing, import, or sale of Drugs, Cosmetics, or notified Medical Devices in India requires appropriate licenses and approvals from CDSCO.

Regulatory Compliance

Why CDSCO approval matters.

Legal Mandate

Manufacturing or selling unapproved drugs/devices is a serious offense under the Drugs and Cosmetics Act, 1940.

Market Access

CDSCO approval is the gateway to the massive Indian healthcare market for both domestic and international manufacturers.

Consumer Trust

Compliance ensures that your products meet national safety and quality standards, building trust with doctors and patients.

Who Needs CDSCO License?

Key stakeholders.

  • Importers: Of drugs, cosmetics, and medical devices (Form 10/MD-15).
  • Manufacturers: For sale or distribution in India.
  • Wholesalers/Retailers: Drug sale licenses (Form 20B/21B).
  • Clinical Research: Organizations conducting clinical trials.

Documents Required

  • Site Master File: Detailed layout and process flow.
  • Business Proof: COI, MOA/AOA, Partnership Deed.
  • Technical Data: Product specs, testing methods, shelf life data.
  • Personnel: Details of competent technical staff (Pharmacist/Chemist).

Regulatory Support Process

End-to-end guidance for CDSCO approval.

01
Dossier Preparation
We compile the technical dossier (SMF, DMF) and prepare application forms as per CDSCO checklists.
02
Online Filing
We file the application online via the SUGAM portal and make official fee payments.
03
Query Resolution
We handle any technical queries raised by the Drug Inspector/Authority until approval.
04
Grant of License
Receipt of Form 20/21 or Import License Form 10 after successful verification.

Why Choose Legal In Simple?

Technical Expertise.

Pharma Experts

Our team includes qualified pharmacists and regulatory affairs experts.

End-to-End

From Wholesale Drug License to Medical Device Import License, we cover it all.

Error-Free

Precision in dossier compilation to minimize queries and rejection risks.

Timely Updates

We keep you informed at every stage of the government processing.

Frequently Asked Questions

1. What is the SUGAM Portal?
SUGAM is the online platform launched by CDSCO for filing, tracking, and processing applications for various services like Import/Registration of Drugs and Medical Devices.
2. Is a Drug License required for a pharmacy?
Yes, to open a retail pharmacy (Medical Store), you need to obtain a Drug License (Form 20/21) from the State Drug Control Department.
3. How are Medical Devices classified in India?
Medical devices are classified into four classes based on risk: Class A (Low Risk), Class B (Low-Moderate Risk), Class C (Moderate-High Risk), and Class D (High Risk).
4. What is the validity of a Drug License?
A Drug License is typically valid for 5 years from the date of issue, provided retention fees are paid periodically as per rules.
5. Can I import cosmetics into India?
Yes, but all imported cosmetic products must be registered with CDSCO in Form 43 before they can be imported and sold in India.
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