The Union Ministry of Health and Family Welfare has proposed amending Schedule M of the Drugs Rules, 1945, so that Grade A clean areas in sterile drug plants must show no microbial growth at all. The draft, notified as G.S.R. 953(E) on 28 October 2026, aligns India’s sterile manufacturing norms with WHO Technical Report Series No. 1044 and is open for comments for 30 days.

What the Schedule M sterile amendment changes

Grade A zones are the most critical spaces in a sterile plant, where exposed product, containers and sterilised components are handled, such as aseptic filling of injectables and eye drops. Under the current Schedule M table, these areas were allowed less than 1 colony-forming unit (CFU) in environmental monitoring samples. The draft replaces that with a flat “no growth” standard across air samples, settle plates, contact plates and glove prints.

According to the Press Information Bureau release, any microbial growth detected in a Grade A area will be treated as a trigger for investigation, in line with WHO guidance. The ministry said the revision will harmonise the Revised Schedule M with WHO guidelines and strengthen oversight of sterile pharmaceutical manufacturing.

Proposed microbial limits by cleanroom grade

The substituted table in Part II of Schedule M, which covers small-volume injectables, large-volume parenterals and sterile ophthalmic preparations, sets these limits:

• Grade A: no growth in any monitoring method
• Grade B: 10 CFU/m³ in air, 5 CFU on settle plates, contact plates and glove prints
• Grade C: 100 CFU/m³ in air, 50 CFU on settle plates and 25 CFU on contact plates
• Grade D: 200 CFU/m³ in air, 100 CFU on settle plates and 50 CFU on contact plates

The figures mirror the maximum contamination levels in WHO TRS 1044 Annex 2 on good manufacturing practices for sterile products.

How the proposal came about

The Drugs Consultative Committee had flagged a mismatch between Schedule M limits and the WHO standard during a review last year. The Drugs Technical Advisory Board (DTAB) took up the issue at its 93rd meeting in February 2026 and agreed to revise the limits. The draft rules will come into force on a date the government sets when it publishes the final notification.

The step is part of a wider tightening of drug quality rules this autumn. The ministry has separately proposed instant licence suspension for drugs that fail critical quality tests, and CDSCO has asked states to enforce batch testing of raw materials, excipients and finished drugs.

Why it matters for sterile drug makers

Sterile products such as injections, vaccines, IV fluids and eye drops go directly into the body, so contamination can cause serious adverse events. The proposal follows regulatory action at eye-drop facilities, including the CDSCO halt on Sun Pharma eye-drop production at its Assam plant.

Cleanroom monitoring gaps are also a frequent theme in US FDA inspections of Indian plants. A recent analysis found that 17% of USFDA inspections at Indian drug plants flagged serious lapses. Industry voices have said that aligning domestic limits with WHO benchmarks could ease export acceptance, though companies will need tighter environmental monitoring, investigation procedures and training to comply.

Key takeaways

• The draft G.S.R. 953(E), dated 28 October 2026, sets “no growth” as the microbial limit for Grade A sterile manufacturing areas.
• Any growth in a Grade A area becomes a trigger for investigation, as WHO TRS 1044 requires.
• Stakeholders have 30 days from publication to comment before the rules are finalised.

FAQ

What is a Grade A area in drug manufacturing?

It is the highest-cleanliness zone in a sterile plant, used for high-risk operations such as aseptic filling where the product is exposed to the environment.

When will the new Schedule M limits apply?

The rules are in draft form. They will take effect from a date the Centre specifies when it publishes the final notification after the 30-day comment period.

Featured image: A microbiologist working inside a biosafety cabinet (representative image). Photo: U.S. Food and Drug Administration, via Wikimedia Commons (public domain)

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