Overview
The CDSCO Drug License is a mandatory regulatory approval for businesses involved in the manufacture, import, sale, distribution, and marketing of drugs, cosmetics, and medical devices in India. CDSCO stands for the Central Drugs Standard Control Organization, the national regulatory authority under the Ministry of Health & Family Welfare, Government of India.
CDSCO regulates drug quality, safety, and efficacy to protect public health. Any business dealing with regulated drugs or medical products must obtain the appropriate CDSCO license before commencing operations. At Adviso Compliance, we provide complete CDSCO drug licensing services with expert regulatory guidance and end-to-end compliance support.
What is CDSCO?
The Central Drugs Standard Control Organization (CDSCO) is India’s central regulatory authority responsible for:
Approval of new drugs and formulations
Regulation of imported drugs and cosmetics
Licensing of medical devices
Monitoring drug safety and compliance
Ensuring quality standards for pharmaceuticals
CDSCO operates under the Drugs and Cosmetics Act, 1940 and related rules.
What is a CDSCO Drug License?
A CDSCO Drug License is a legal authorization issued to eligible entities allowing them to manufacture, import, or distribute drugs and medical products in India. The type of license required depends on the nature of business and product category.
Without a valid CDSCO license, dealing in regulated drugs or medical devices is illegal.
Who Needs a CDSCO Drug License?
CDSCO drug license is required for:
Drug manufacturers
Drug importers
Pharmaceutical distributors
Medical device manufacturers and importers
Cosmetic importers
Clinical trial sponsors
New drug applicants
Both Indian and foreign companies must comply with CDSCO regulations.
Types of CDSCO Licenses
CDSCO issues different licenses based on business activity:
Manufacturing Drug License
Required for manufacturing drugs or formulations in India.
Import Drug License
Required for importing drugs, cosmetics, or medical devices into India.
Medical Device License
Mandatory for manufacturing or importing notified medical devices.
Test License
Issued for testing and analysis purposes.
New Drug Approval
Required for introducing new drugs or formulations in India.
Why CDSCO Drug License is Important
CDSCO licensing is critical because it:
Ensures safety and quality of drugs
Is legally mandatory for regulated products
Prevents penalties and product seizure
Enables smooth customs clearance
Builds trust with healthcare institutions
Supports domestic and international trade
Operating without a license may lead to severe legal consequences.
Products Covered Under CDSCO Regulation
CDSCO regulates a wide range of products, including:
Pharmaceutical drugs
Active pharmaceutical ingredients (APIs)
Vaccines and injectables
Medical devices and equipment
Cosmetics and personal care products
Diagnostic kits
Each category has specific licensing requirements.
Documents Required for CDSCO Drug License
The documents required vary based on license type but generally include:
Company incorporation or registration certificate
Drug manufacturing or import details
Product composition and specifications
Manufacturing site details
GMP compliance certificates
Authorization letters
Free Sale Certificate (for imports)
Labeling and packaging details
Our experts ensure all documents meet CDSCO standards.
CDSCO Drug License Application Process
At Adviso Compliance, we follow a systematic approach:
Step 1: Product & Regulatory Assessment
We identify the applicable CDSCO license and compliance requirements.
Step 2: Document Preparation
All technical and legal documents are prepared and verified.
Step 3: Online Application Filing
Application is filed through the CDSCO online portal.
Step 4: Authority Review
CDSCO reviews the application and may request clarification.
Step 5: Inspection & Approval
Inspection may be conducted before final approval.
Step 6: License Issuance
Upon approval, CDSCO license is granted.
Timeline for CDSCO Drug License
The approval timeline depends on license type:
Import license: 30–60 working days
Manufacturing license: 45–90 working days
Medical device license: 30–75 working days
Timelines may vary based on documentation and inspection.
Validity & Renewal of CDSCO License
CDSCO licenses are usually valid for 5 years
Renewal must be applied before expiry
Continuous compliance is required
We assist with timely renewal and amendments.
Common Mistakes in CDSCO Licensing
Applications may face delays due to:
Incorrect product classification
Incomplete technical documentation
Labeling non-compliance
GMP deficiencies
With Adviso Compliance, these risks are minimized through expert handling.
Penalties for Non-Compliance
Non-compliance with CDSCO regulations may result in:
Heavy penalties and fines
Product seizure
License suspension or cancellation
Legal prosecution
Proper licensing ensures smooth and legal operations.
Why Choose Adviso Compliance for CDSCO Drug License?
Experienced pharmaceutical compliance professionals
End-to-end CDSCO licensing support
Accurate technical documentation
Authority coordination and follow-ups
Transparent pricing
PAN-India service support
We also assist with amendments, renewals, and audits.
Post-License Compliance Support
After obtaining CDSCO license, we assist with:
Ongoing regulatory compliance
Labeling and packaging updates
Product additions and modifications
Inspection and audit preparedness
FAQs – CDSCO Drug License
Yes, import of drugs and medical devices requires CDSCO approval.
Depending on license type, 30–90 working days.
Yes, FSC is mandatory for imported drugs.
Yes, through an authorized Indian agent.
Yes, licenses must be renewed before expiry.