New Delhi: The government on Wednesday said it has proposed amendments to ‘Schedule M’ of the Drugs Rules 1945, to revise the prescribed limits for microbial contamination in Grade A clean areas in accordance with the World Health Organisation (WHO) guidelines.
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.
According to Health Ministry, 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 internationally recognised standards”.
“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. It also provides for treating any microbial growth detected in Grade A areas as a trigger for investigation, in accordance with WHO guidance,” the ministry said in a statement.
Stakeholders and members of the public are invited to submit their objections and suggestions, if any, on the proposed amendment to the Under Secretary (Drugs Regulation), Ministry of Health and Family Welfare, or via email.
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.
On Tuesday, the Health Ministry proposed changes to the Drugs Rules, 1945, aimed at enhancing accountability and traceability in pharmaceutical manufacturing by mandating the appointment of authorised personnel for batch release of drugs.
Under the proposed amendments, drug manufacturers seeking licences under the relevant provisions of the Drugs Rules, 1945, will be required to nominate a suitably qualified and experienced individual to undertake batch-release functions.
Manufacturers will also have to maintain prescribed records related to the release of each batch and issue batch-release certificates in a specified format. The ministry said the move seeks to address a regulatory gap in the existing framework.
(IANS)
