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Show Cause Notices

CDSCO enforcement actions are taken under the Drugs and Cosmetics Act 1940 and the Medical Devices Rules 2017. Appeals against CDSCO orders are made to the Central Licensing Authority or, ultimately, to the Courts.

Official source: D&C Act 1940, Sections 22–27B; MDR 2017, Chapter VIII

Show Cause Notices Overview

Show Cause Notices Overview

What is a show-cause notice? A show-cause notice is a formal CDSCO directive requiring a manufacturer, importer, or distributor to explain why enforcement action (suspension, cancellation, or seizure) should not be taken against them.

Grounds for issuance: Show-cause notices are issued when:

  • GMP inspection reveals significant non-conformities
  • Adverse events or safety issues are reported
  • Quality or testing failures are identified
  • Licensing conditions are violated
  • Complaint investigations confirm misconduct

Response requirements:

  • Manufacturer must respond within the specified timeframe (typically 10–15 days from receipt)
  • Response must address each observation in detail
  • Supporting documentation and evidence of corrective action required
  • Late or inadequate responses may result in immediate enforcement action

Possible outcomes:

  1. Closure if response satisfactorily addresses all observations
  2. Follow-up inspection to verify corrective action
  3. Escalation to suspension or cancellation of license
  4. Seizure of non-compliant devices

Official source: D&C Act 1940, Sections 22–27B; MDR 2017, Chapter VIII

Show Cause Notices Overview

A show-cause notice is an enforcement tool issued by CDSCO when non-compliance is identified. The notice requires the manufacturer, importer, or distributor to explain why their license should not be suspended or cancelled.

Key procedural points:

  • Issued following inspection or complaint-based investigation
  • Recipient typically has 10–15 days to respond with evidence and corrective actions
  • Response must address each non-conformity cited
  • CDSCO reviews the response and decides whether to:
    • Accept corrective actions and close the case
    • Proceed to license suspension or cancellation
    • Issue additional enforcement action

Failure to respond or inadequate response strengthens CDSCO's case for license suspension or cancellation.