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Suspension Cancellation

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

License Suspension & Cancellation Overview

License Suspension & Cancellation Overview

Suspension vs. Cancellation:

Suspension – Temporary withdrawal of manufacturing/import license:

  • Typically issued for significant but remediable non-compliance
  • Duration specified by CDSCO (typically 3–6 months)
  • License may be restored upon demonstration of corrective action
  • Further GMP inspection usually required before restoration

Cancellation – Permanent revocation of license:

  • Issued for severe, repeated, or unremediable non-compliance
  • Results in permanent loss of ability to manufacture/import
  • May be applied to one or all device classes covered by license
  • Difficult to overturn; new application required if reinstating

Grounds for suspension or cancellation:

  • Repeated GMP violations or failure to implement corrective action
  • Serious safety or quality defects
  • Failure to respond to show-cause notice adequately
  • Fraud, misrepresentation, or falsification of records
  • Non-compliance with licensing conditions

Procedure:

  1. Show-cause notice issued (10–15 days to respond)
  2. CDSCO reviews response and supporting documents
  3. If unsatisfied, suspension/cancellation order issued
  4. Order takes effect immediately or on specified date
  5. Manufacturer notified in writing with reasons

Appeals: Appeals against suspension or cancellation may be made to the Central Licensing Authority within 30 days of order, and subsequently to the Court.

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

License Suspension & Cancellation Overview

CDSCO may suspend or cancel a medical device manufacturing or import license under Sections 22–27B of the Drugs and Cosmetics Act 1940 and Chapter VIII of the Medical Devices Rules 2017.

License Suspension:

  • Temporary withdrawal of manufacturing or import authority
  • Typically issued for serious but potentially remediable non-compliance
  • Suspension may be lifted once manufacturer demonstrates corrective actions and passes reinspection
  • Duration varies; common timeframes are 6–12 months

License Cancellation:

  • Permanent withdrawal of manufacturing or import authority
  • Issued for repeated violations, fraud, or irreversible non-compliance
  • Manufacturer must reapply for new license after cancellation

Appeal Rights:

  • Applicants may appeal suspension or cancellation orders to the Central Licensing Authority
  • Further appeal to Courts is available if CLB decision is unfavorable