India to Align Microbial Contamination Limits in Cleanrooms with WHO Standards

India’s drug regulators are working to revise Schedule M of the Drugs and Cosmetics Act, 1940 to align microbial contamination limits in Grade A cleanroom environments with those outlined in the WHO’s Technical Report Series (TRS) 1044, Annexure II. During its June 17 meeting, the Drugs Consultative Committee (DCC) acknowledged a mismatch between India’s existing microbial limits and WHO’s guidelines. After detailed deliberation, the DCC recommended amending Table II of Para B under Part XIID of Schedule M to reflect WHO’s updated contamination thresholds. Currently, Schedule M outlines microbial limits in terms of Colony-Forming Units (CFU) to monitor cleanroom environments. Harmonising these values will streamline regulatory approvals, reduce industry ambiguity, and align Indian manufacturing practices with global standards. This move is expected to improve the quality, safety, and global acceptance of Indian-manufactured drugs, supporting their expansion into international markets through better compliance and credibility.

27-07-2025