CDSCO Inspection Types & Authority
Legal authority
CDSCO inspectors derive their authority from Section 21 of the Drugs and Cosmetics Act 1940, which empowers them to:
- Enter and inspect any premises where devices are manufactured, stored, or sold;
- Inspect, test, or examine any device;
- Seize or detain devices where non-compliance is suspected.
Types of inspections
| Type | Purpose | Who conducts |
|---|---|---|
| Pre-licence inspection | GMP verification before granting manufacturing licence | CDSCO (Class C/D) or SLA (Class A/B) |
| Surveillance inspection | Periodic check on licence compliance | CDSCO or SLA |
| Complaint-based inspection | Triggered by adverse event, complaint, or tip-off | CDSCO or SLA |
| Import alert inspection | Inspection at port of entry | CDSCO port officers |
Inspection process
- CDSCO typically issues advance notice 5–7 days prior to inspection (except for unannounced surveillance or complaint-based inspections);
- Inspection team reviews documents, GMP facilities, and records;
- Non-conformities are documented in the inspection report;
- Manufacturer must respond to observations within the specified timeframe (typically 10–15 days from receipt of inspection report), providing evidence of corrective actions and root cause analysis;
- CDSCO may issue a show-cause notice, demand corrective action, or initiate enforcement action.
Official source: D&C Act 1940, Section 21; MDR 2017, Chapter VIII