The Ministry of Health and Family Welfare (MoH&FW) on July 12, 2024, issued draft Drugs (Amendment) Rules, 2024 further to amend the Drugs Rules, 1945.
The following has been stated: -
•In rule 96, in sub-rule (7):
i.In particular no (vii) the words “date of expiry; and” shall be substituted with the words “date of expiry;”.
ii. In particular no (viii) the words “manufacturing license number.” Shall be substituted with the words “manufacturing license number; and”.
iii.After particular no (viii) the words “(ix) details of excipients.” shall be inserted.
•Objections and suggestions shall be taken into consideration on or after the expiry of a period of thirty days.
The detailed notification is given in the document below.
[Notification No. G.S.R. 391(E).]