Union 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 proposed amendments to Schedule M of the Drugs Rules, 1945, to align Grade A microbial monitoring requirements with WHO guidelines.

• The amendment was proposed via G.S.R. No. 953(E) dated 28 October, 2026.
• The revision references WHO Technical Report Series (TRS) No. 1044, Annexure 2.
• It mandates treating detected microbial growth in Grade A areas as a trigger for investigation.
• Stakeholders can submit objections to the Under Secretary (Drugs Regulation), Ministry of Health and Family Welfare, New Delhi.
• The Official Gazette can be accessed through the link: https://egazette.gov.in/.