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NewsOnAir 2026-11-04
Health Ministry Proposes Amendments for Microbial Monitoring in Drug Manufacturing to Align with WHO Guidelines The Health and Family Welfare Ministry has proposed amendments to the Drugs Rules 1945 to align microbial monitoring in Grade A clean areas with World Health Organization guidelines. This notification, issued on October 28, aims to harmonize India's regulatory standards with WHO's Good Manufacturing Practices for Sterile Pharmaceutical Products. The amendments will require any detected microbial growth in Grade A areas to trigger an investigation, enhancing microbial control in critical manufacturing zones. The Ministry is currently seeking feedback from stakeholders and the public on these proposed changes.
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