India, Nov. 4 -- The Government of India has issued a release:
Union Ministry of Health and Family Welfare has proposed amendments to Schedule M of the Drugs Rules, 1945, vide G.S.R. 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 Organization (WHO) Technical Report Series (TRS) No. 1044, Annexure 2, on Good Manufacturing Practices (GMP) for Sterile Pharmaceutical Products.
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 with internationa...