CDSCO — the Central Drugs Standard Control Organisation, India's National Regulatory Authority — has moved from periodic, scheduled inspections to a sustained, active enforcement posture under revised Schedule M. State and UT drug controllers now report compliance-inspection findings to CDSCO on a monthly cadence, and manufacturers who didn't file for a compliance-extension by the deadline became subject to immediate inspection as of January 1, 2026.
The enforcement trend is real, not theoretical
CDSCO classified 1,879 drug batches as Not-of-Standard-Quality (NSQ) in 2025 — more than double the 877 classified in 2024. This isn't a projection; it's the actual 2024-to-2025 shift.
What CDSCO actually checks
- Pharmaceutical Quality System (PQS) implementation — not whether a PQS policy document exists, but whether it's operating: is CAPA, change control, and deviation management actually running as one connected system?
- Quality Risk Management (QRM) application — documented, structured risk assessments applied to real decisions, not a one-off exercise buried in a validation report.
- Product Quality Review (PQR) completion — periodic review of product quality trends across batches, complaints, and deviations.
- Equipment qualification and validation status — IQ/OQ/PQ evidence, traceable and current.
- Computerised (electronic) record-keeping — revised Schedule M explicitly requires this for drug product records.
- ALCOA+-aligned data integrity discipline — attributable, contemporaneous, accurate records throughout, not reconstructed under deadline pressure.
The philosophical shift most checklists miss
Revised Schedule M isn't just a longer version of the old checklist — it's a different question entirely. The pre-2023 standard effectively asked, "do you have an SOP for this?" The revised standard asks, "can you demonstrate systemic control?" An SOP that exists but isn't actually followed, or a CAPA process that closes items without effectiveness checks, satisfies the old question but fails the new one.
Practical preparation, not just documentation
Because CDSCO inspections now check whether systems are operating, not just documented, the most useful preparation is ensuring your PQS, QRM, and PQR processes run continuously — not assembled the week before an anticipated visit. A system that produces a clean CAPA status report, a current validation matrix, and an intact audit trail on any random Tuesday is inspection-ready by definition.
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