Health Ministry Proposes Schedule M Amendment to Bring Grade A Microbial Limits in Line with WHO Standards

Key facts

• The 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 prescribed limits for microbial contamination in Grade A clean areas.
• The revision aligns 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 areas are critical zones in sterile pharmaceutical manufacturing where exposed products, containers and sterilised components are handled.
• The amendment provides for treating any microbial growth detected in Grade A areas as a trigger for investigation, in accordance with WHO guidance.
• Stakeholders and the public may submit objections and suggestions to the Under Secretary (Drugs Regulation), Ministry of Health and Family Welfare, New Delhi, or via email at drugsdiv-mohfw[at]gov[dot]in.