New Delhi, Nov. 4 -- The Union Ministry of Health and Family Welfare has proposed amendments to Schedule M of the Drugs Rules, 1945, vide GSR No. 953(E) dated 28 October, 2026, to revise the prescribed limits for microbial contamination in Grade A clean areas in accordance with the World Health Organisation (WHO) Technical Report Series (TRS) No. 1044, Annexure 2, on Good Manufacturing Practices (GMP) for Sterile Pharmaceutical Products.

According to the Ministry of Health and Family Welfare, the proposed amendment aims to address the existing differences between the microbial contamination limits prescribed under Schedule M and the corresponding WHO requirements for Grade A areas, thereby bringing India's regulatory provisions in line w...