India to Align Pharma Cleanroom Standards with WHO Guidelines

India is going to change the microbial contamination limits as per Schedule M in the Drugs and Cosmetics Rules to the global WHO limits in a major initiative to improve pharmaceutical manufacturing standards.

The decision was taken at the Drugs Consultative Committee (DCC) meeting on June 17, 2025, and is part of a larger agenda to have quality practices that are internationally harmonized.

The prescribed limits for Grade A cleanroom environments in Schedule M, Table II, Paragraph B of the Part XIID do not align with the rigorous contamination limits that the WHO TRS 1044, Annex 2 provides. Due to this misalignment cleanroom validation, monitoring and regulatory requirements have not been similar in various areas and created obstacles for Indian pharmaceutical manufacturers, especially those selling to regulated markets.

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With the incorporation of this modification, India will now utilize microbial limits that are internationally accepted according to WHO guidelines, allowing consistency in environmental monitoring, simplicity in global regulatory approvals, and an overall enhancement in product safety and efficacy. It is reflective of India's commitment to improving quality and readiness to meet the increasing demands of the global pharmaceutical supply chain.

Experts in the industry view this change as a positive advancement, enhancing compliance, international competitiveness, and alleviating ambiguity for manufacturers who are regulated by multiple authorities. The modification also encourages a more efficient auditing process, batch release process, and ultimately better patient safety.

This proactive regulatory alignment signals India’s ongoing evolution as a global pharma hub committed to world-class manufacturing excellence.