NEW DELHI: The centre has proposed to revise the prescribed limits for microbial contamination in Grade A clean areas in accordance with the World Health Organization (WHO) guidelines.
The proposed amendment aims to address the existing differences between the microbial contamination limits prescribed under Schedule M of the Drugs Rule, 1945, and the corresponding WHO requirements for Grade A areas.
The proposal will help in bringing India's regulatory provisions in line with internationally recognised standards.
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 Union Health Ministry officials said.
The proposed amendment is in accordance with the WHO Technical Report Series (TRS) No. 1044, Annexure 2, on Good Manufacturing Practices (GMP) for 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,” a statement from the Union Health Ministry said.
“It also provides for treating any microbial growth detected in Grade A areas as a trigger for investigation, in accordance with WHO guidance,” it added.
“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,” the statement further said.
The ministry invited stakeholders and members of the public to submit their objections and suggestions, if any, on the proposed amendment.
