Risk-based audits of drug units to begin from July 1

The revised Schedule M, which is considered more stringent than the World Health Organization’s (WHO) good manufacturing practices (GMP) in certain areas, was notified on December 28, 2023. Companies with turnover of over ₹250 crore will have to comply with the upgraded version of Schedule M, starting July 1, and the remaining others, which are largely micro, small, and medium enterprises (MSMEs), have been given a year’s time to comply. Inspections on those firms will begin from January 1, 2025.