(MENAFN- KNN India) New Delhi, Nov 8 (KNN) The Central Drugs Standard Control Organization (CDSCO) has instructed state and Union Territory drug controllers to begin immediate inspections of pharmaceutical manufacturing facilities to assess compliance with the revised Schedule M standards for Good Manufacturing Practices (GMP).

In a directive to state authorities, the Drugs Controller General of India (DCGI) said that inspections and enforcement action must commence without delay for units that have not sought extensions.

“Immediate inspection and action shall be initiated right now for those units who have not applied for the extension, as the revised Schedule M is already applicable for such units,” the order stated.

It further warned,“In case any manufacturing unit is found non-complying to the requirements of revised schedule M during inspections, strict action shall be initiated against such units,” ET reported.

Authorities have also been asked to submit monthly reports detailing inspections, compliance gaps, and corrective steps undertaken.

For manufacturers that submitted upgradation plans by May and were granted an extension, inspections are scheduled to begin from January.

Industry sources note that while around 80 percent of India's 10,500 drug manufacturing units fall under the MSME category, only a limited number have progressed on their mandated upgrade plans.

The move follows heightened scrutiny of drug quality standards after a cough syrup-linked tragedy last month in which at least 24 children died after consuming contaminated Coldrif syrup.

Subsequent inspections found Sresan Pharma's facility to be severely non-compliant with Schedule M norms, with regulators issuing more than 300 observations.

Separately, a state drug laboratory in Chhattisgarh identified a spurious sample of another cough syrup, Besto-Cof, during routine checks in September.

Currently, the revised Schedule M standards apply to larger firms, while smaller manufacturers with an annual turnover up to Rs 250 crore remain exempt.

The latest directive signals a more assertive push to tighten manufacturing oversight across the sector amid growing concerns over quality lapses.

(KNN Bureau)

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