Ministry of Health Proposes Amendments to Schedule M to Align Grade A Microbial Monitoring Requirements with WHO Guidelines

Ministry of Health proposes amendments to Schedule M to align Grade A microbial monitoring requirements with WHO guidelines

The Union Ministry of Health and Family Welfare has proposed amendments to Schedule M of the Drugs Rules, 1945, vide GSR No. 953(E) dated 28 October, 2026, to revise the prescribed limits for microbial contamination in Grade A clean areas in accordance with the World Health Organisation (WHO) Technical Report Series (TRS) No. 1044, Annexure 2, on Good Manufacturing Practices (GMP) for Sterile Pharmaceutical Products.

India Drugs and Cosmetics Rules draft proposes stricter cleanroom monitoring for pharmaceutical firms

India's Ministry of Health is revising the Drugs and Cosmetics Rules of 1945 to tighten microbiological control standards in pharmaceutical manufacturing, specifically targeting Class A clean zones where open product, sterile components, and containers are processed. The technical shift replaces a quantitative threshold with a zero-tolerance mandate. Under current Good Manufacturing Practice (GMP) guidelines in "Schedule M," Class A zones allowe…

Health Ministry proposes changes to microbial contamination limits for sterile drug manufacturing

Union Health Ministry proposes stricter microbial contamination limits for sterile drug manufacturing, aligning Schedule M with WHO guidelines and inviting public objections.

Health Ministry proposes amendments to schedule M to align Grade A microbial monitoring requirements with WHO guidelines

New Delhi, Nov 4: Union Ministry of Health and Family Welfare has proposed amendments to Schedule M of the Drugs Rules, 1945, vide G.S.R. No. 953(E) dated 28 October, 2026, to revise the prescribed limits for microbial contamination in Grade A clean areas in accordance with the World Health Organization (WHO) Technical Report Series (TRS) No. 1044, Annexure 2, on Good Manufacturing Practices (GMP) for Sterile Pharmaceutical Products.   Grade A a…

Health Ministry proposes WHO-aligned microbial monitoring norms for drug manufacturing

Stay updated with ThePrint: Preferred Source Google Discover New Delhi, Nov 4 (PTI) The Union Health Ministry has proposed amendments to Schedule M of the Drugs Rules, 1945, to align microbial contamination limits in Grade A clean areas of sterile pharmaceutical manufacturing facilities with World Health Organization (WHO) guidelines. The proposed amendment, notified vide gazette […]

Health Ministry Proposes Schedule M Amendments to Align Microbial Monitoring with WHO Guidelines

New Delhi: The Union Ministry of Health and Family Welfare has proposed amendments to Schedule M of the Drugs Rules, 1945, vide GSR No. 953(E) dated 28 October, 2026, to revise the prescribed limits for microbial contamination in Grade A clean areas in accordance with the World Health Organisation (WHO) Technical Report Series (TRS) No. […]