The Central Drugs Standard Control Organization (CDSCO) has directed state and Union Territory drug controllers to initiate immediate inspections of pharmaceutical manufacturing facilities to ensure compliance with the revised Schedule M standards under Good Manufacturing Practices (GMP).
In a directive to state authorities, the Drugs Controller General of India (DCGI) instructed that inspections and enforcement action must begin without delay for units that have not sought extensions. Drug regulators have also been told to submit monthly reports highlighting inspection findings, compliance gaps, and corrective measures undertaken.
For manufacturers that submitted their upgradation plans by May and were granted extensions, inspections will commence from January, according to the order.
Industry sources indicate that nearly 80 per cent of India’s 10,500 drug manufacturing units are classified as micro, small and medium enterprises (MSMEs), but only a limited number have made significant progress on the required upgrades.
The directive comes amid heightened scrutiny of drug quality standards following a recent tragedy in which at least 24 children died after consuming contaminated Coldrif syrup. The incident has intensified regulatory focus on manufacturing practices and the implementation of stricter quality controls across the pharmaceutical sector.