The Ministry of Health and Family Welfare has announced a proposed extension for small and medium drug manufacturers to comply with the revised Schedule M of the Drugs Rules, 1945. This draft notification was issued on January 4, 2025.
It may be recalled that the Drugs Rules, 1945, were amended in December 2023. A new set of guidelines titled “GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS” were introduced in Schedule M. The guidelines outline several key principles to be adhered to by pharmaceutical manufacturers, focusing on pharmaceutical quality systems, quality risk management, sanitation and hygiene, qualification and validation, complaints and adverse reactions, product recalls, and change control.
However, small and medium manufacturers expressed concerns about meeting the initial implementation deadline due to resource constraints.
Following industry representations, the government has decided to extend the compliance deadline for manufacturers with a turnover of ₹250 crore or less. These companies can now apply for an extension until December 31, 2025.
Application Process
To avail of the extension, manufacturers must submit an application to the Central Licensing Approving Authority (CLAA) by April 4, 2025. This application should be accompanied by a detailed plan outlining their strategy for upgrading their facilities and processes to meet the revised Schedule M requirements.
Public Consultation
The draft notification for this extension will be available for public comment until January 11, 2025. The government encourages interested parties to submit their feedback during this period.
