Seizure Prosecution

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

Seizure & Prosecution Overview

Legal grounds for seizure: CDSCO may seize medical devices under Section 21 of the D&C Act 1940 when:

Devices are adulterated, misbranded, or sub-standard
Manufacturing or storage conditions violate GMP requirements
Devices lack required approvals or licenses
Devices pose a safety or public health risk

Seizure process:

Inspector documents non-compliance and issues seizure notice
Seized devices are held pending investigation
Manufacturer may request release upon demonstration of compliance
If non-compliance confirmed, devices are destroyed or forfeited

Criminal prosecution: CDSCO may prosecute manufacturers, importers, or distributors under Sections 22–27B of the D&C Act for:

Manufacture or sale of adulterated/misbranded devices
Violation of GMP or licensing requirements
Failure to comply with enforcement orders

Penalties: Criminal sanctions include fines (up to ₹5 lakhs for first offense; ₹10 lakhs+ for subsequent offenses) and imprisonment (up to 3 years).

Official source: D&C Act 1940, Sections 21–27B; MDR 2017, Chapter VIII

Seizure & Prosecution Overview

CDSCO has authority to seize non-compliant devices under Section 21 of the Drugs and Cosmetics Act 1940. Seizure may be followed by prosecution under Sections 27–27B of the D&C Act 1940, which provides for:

Criminal penalties including fines and imprisonment
Confiscation of devices and manufacturing equipment
Disqualification of manufacturers or importers

Prosecution is typically pursued for serious violations such as:

Manufacturing without valid license
Distributing counterfeit or substandard devices
Misrepresentation of device specifications or clinical data
Violation of recall orders