Health Ministry proposes tighter germ limits in sterile drug-making areas to match WHO

The Union Health Ministry has proposed tighter rules on microbial contamination in the cleanest zones of sterile drug factories, to bring Indian standards in line with the World Health Organization (WHO).

The draft amendment to Schedule M of the Drugs Rules, 1945, was notified as G.S.R. 953(E) on 28 October 2026. It revises the permitted limits for microbial contamination in "Grade A" clean areas, following WHO Technical Report Series No. 1044, Annexure 2, on good manufacturing practices for sterile pharmaceutical products.

Why Grade A matters

Grade A areas are the critical zones where exposed products, containers and sterilised components are handled. The ministry says strict microbial control there is essential to the quality and safety of sterile medicines.

What would change

• Differences between Schedule M limits and the WHO's Grade A requirements would be removed.
• Any microbial growth detected in a Grade A area would be treated as a trigger for investigation, as WHO guidance advises.

Have your say

The proposal is open for comment. Stakeholders and members of the public can send objections and suggestions to the Under Secretary (Drugs Regulation), Ministry of Health and Family Welfare, Kartavya Bhawan-1, New Delhi 110001, or by email at drugsdiv-mohfw[at]gov[dot]in. The release does not state a deadline or give the numerical limits proposed.

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Source: official release by the Ministry of Health and Family Welfare, issued through the Press Information Bureau, Government of India (04 NOV 2026 2:15PM by PIB Delhi). Read the full official text: Union Ministry of Health Proposes Amendments to Schedule M to Align Grade A Microbial Monitoring Requirements with WHO Guidelines.