The government on Wednesday (November 4) said it has proposed amendments to Schedule M of the Drugs Rules, 1945, to revise the prescribed limits for microbial contamination in Grade A clean areas in accordance with World Health Organization (WHO) guidelines, IANS reported, citing the Health Ministry.

Source: IANS

G.S.R. 953(E)Gazette notification dated October 28, 2026
WHO TRS 1044, Annex 2The WHO good-manufacturing-practice standard being aligned with
Grade AThe most critical sterile-manufacturing clean area covered

The amendment, issued vide G.S.R. No. 953(E) dated October 28, 2026, seeks to align the limits with WHO Technical Report Series No. 1044, Annexure 2, on Good Manufacturing Practices for sterile pharmaceutical products, the Press Information Bureau said. Grade A areas are critical zones where exposed products, containers and sterilised components are handled, so stringent microbial control there is essential to the quality and safety of sterile medicines.

Source: Press Information Bureau (via India Education Diary)

Any growth means an investigation

The proposed revision will harmonise the revised Schedule M with WHO guidelines and strengthen the framework for sterile pharmaceutical manufacturing, the ministry said. It also provides for treating any microbial growth detected in Grade A areas as a trigger for investigation, in accordance with WHO guidance.

Consultation open

Stakeholders and members of the public are invited to submit objections and suggestions to the Under Secretary (Drugs Regulation), Ministry of Health and Family Welfare, at Kartavya Bhawan-1, New Delhi, or by email, the ministry said. The proposal follows a separate November 3 proposal to amend the Drugs Rules to mandate authorised personnel for batch release of drugs, aimed at accountability and traceability in manufacturing, IANS reported.