The Ministry of Health and Family Welfare (MoH&FW) on February 11, 2025, issued the Drugs Amendment Rules, 2025, to further amend the Drugs Rules, 1945.
This shall come into force from February 11, 2025.
The following has been amended namely: -
In rule 6, in the Table, in the entry against ‘Small and Medium manufacturers’, under column (2) after the words “Twelve months from the date of publication of these rules”, a new proviso shall be inserted, namely:-
“Provided that the small and medium manufacturers with turnover less than two hundred and fifty crores may seek extension of the timeline for implementation and for that purpose shall make an application to the Central Licence Approving Authority in Form ‘A’ annexed to this notification, within a period of three months from the date of publication of this notification, along with a plan of upgradation and for such manufacturers, the timeline for implementation shall be extended till 31st day of December, 2025”.
[Notification no. G.S.R. 127(E)]
