The Ministry of Health and Family Welfare (MoH&FW) on June 22, 2026, issued the Draft Drugs (...... Amendment) Rules, 2026, further to amend the Drugs Rules, 1945.
The following has been stated:-
•In the Drugs Rules, 1945, in Rule 31, the second proviso shall be substituted as follows:- “Provided further that the licensing authority shall not allow the import of any drug having less than one year residual shelf-life period as on the date of import. However, in the case of Biological drugs and Radiopharmaceuticals, 60% of the labelled shelf-life may be allowed.”
Objections and suggestions may be given within 30 days from June 26, 2026.
The detailed notification is given in the document below.
[Notification No.: G.S.R. 505(E)]
