CDSCO functions under the Directorate General of Health Services (DGHS), Ministry of Health & Family Welfare, Government of India. It regulates:

• Clinical trials
• New drugs and biologics
• Medical devices & diagnostics
• Import and manufacture licenses
• Ethics committee registration

The organization ensures that all regulated products and trials comply with Indian laws, international standards, and ethical guidelines.

Why Is CDSCO Approval Important?

CDSCO approval is mandatory for conducting regulated clinical research in India. It ensures:

• Patient safety and ethical compliance
• Scientific validity of clinical trials
• Regulatory acceptance of trial data
• Legal authorization to conduct studies
• Global credibility and compliance

Without CDSCO approval, clinical trial data may be considered invalid and non-compliant under Indian law.

When Is CDSCO Approval Required?

CDSCO approval is required for:

• Clinical trials involving new drugs or investigational products
• Bioavailability / bioequivalence (BA/BE) studies
• Clinical trials for medical devices
• Import of drugs or devices for research purposes
• New drug applications (NDAs)
• Fixed dose combinations (FDCs)
• Ethics committee registration