The Health Ministry has proposed amending Schedule M of the Drugs Rules, 1945, to align microbial limits in Grade A sterile-manufacturing areas with WHO guidelines. Any microbial growth would trigger an investigation. Stakeholders and the public may submit objections and suggestions.
Union Ministry of Health Proposes Amendments to Schedule M to Align Grade A Microbial Monitoring Requirements with WHO Guidelines
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Ministry of Health and Family Welfare (India)