New Delhi, Nov 4 (PTI) The Union Health Ministry has proposed amendments to Schedule M of the Drugs Rules, 1945, to align microbial contamination limits in Grade A clean areas of sterile pharmaceutical manufacturing facilities with World Health Organization (WHO) guidelines.
The proposed amendment, notified vide gazette notification dated October 28, seeks to address differences between India’s existing regulatory requirements and WHO’s Technical Report Series No. 1044, Annexure 2, on Good Manufacturing Practices (GMP) for Sterile Pharmaceutical Products.
“It 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 internationally recognised standards,” a health ministry statement said.
Grade A areas are critical zones in sterile pharmaceutical manufacturing, where exposed products, containers and sterilised components are handled.
Maintaining stringent microbial control in these areas is essential to ensuring the quality and safety of sterile pharmaceutical products.
The proposed revision will harmonise the Revised Schedule M with WHO guidelines and further strengthen the regulatory framework governing sterile pharmaceutical manufacturing in the country, the statement said.
It also provides for treating 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. PTI PLB
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