The Union Ministry of Health and Family Welfare has announced proposed amendments to the Drugs Rules, 1945, aiming to bring India's regulatory provisions for sterile pharmaceutical manufacturing in line with World Health Organization (WHO) guidelines.
On 04 NOV 2026, the Union Ministry of Health and Family Welfare announced proposed amendments to Schedule M of the Drugs Rules, 1945, as per G.S.R. No. 953(E) dated 28 October, 2026. The amendments aim to revise the prescribed limits for microbial contamination in Grade A clean areas in accordance with WHO Technical Report Series (TRS) No. 1044, Annexure 2, on Good Manufacturing Practices (GMP) for Sterile Pharmaceutical Products.
The proposed changes are designed to address existing differences between the microbial contamination limits prescribed under Schedule M and WHO requirements for Grade A areas. This move will harmonize the Revised Schedule M with WHO guidelines, thereby strengthening the regulatory framework governing sterile pharmaceutical manufacturing in the country.
Grade A areas are critical zones in sterile pharmaceutical manufacturing, where exposed products, containers, and sterilized components are handled. Maintaining stringent microbial control in these areas is essential to ensuring the quality and safety of sterile pharmaceutical products. The proposed amendment will treat any microbial growth detected in Grade A areas as a trigger for investigation, in accordance with WHO guidance.
The proposed amendment reflects the Government's commitment to strengthening quality standards in pharmaceutical manufacturing, aligning domestic regulatory requirements with international benchmarks and ensuring the quality and safety of pharmaceutical products.
Source:
Press Information Bureau
