The Ministry of Health and Family Welfare (MoH&FW) on January 04, 2025, issued a notification regarding the extension of the compliance timeline for Small and Medium Manufacturers with the revised Drugs Rules, 1945.
The following has been stated: -
•The Drugs Rules, 1945, were amended in December 2023, providing a 12-month timeline for small and medium manufacturers with a turnover of ₹250 crores or less to comply with revised Schedule M.
•Due to representations from associations, the Central Government proposes to extend the compliance deadline until December 31, 2025, for eligible manufacturers, provided they apply for an extension within three months along with an upgradation plan.
The detailed notification is given in the document below.
[Notification No.G.S.R.10(E)]
