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. According to the Ministry, the revision updates the prescribed limits for microbial contamination in Grade A clean areas in accordance with World Health Organization guidelines.
The Ministry stated that the changes aim to remove differences between Schedule M and WHO requirements for Grade A areas, which are critical zones in sterile pharmaceutical manufacturing where exposed products, containers and sterilised components are handled. The proposal also treats any microbial growth detected in Grade A areas as a trigger for investigation.
Stakeholders and the public can 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.
What it means
- Stakeholders and members of the public can submit objections and suggestions on the proposed amendment to the Ministry.
Source
Press Information Bureau, Government of India, “Union Ministry of Health Proposes Amendments to Schedule M to Align Grade A Microbial Monitoring Requirements with WHO Guidelines”. Read the original release.
Summary of an official release for general information only. Not investment advice. Read the original source before acting on any information.
Official RBI, SEBI, Government and Defence updates as they happen.
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