Section 109(1) in The Drugs and Cosmetics Rules, 1945
(1)The following particulars and such further particulars, if any, as are specified in Schedule F or Schedule F(I), as the case may be, shall be printed or written in indelible ink on the label of every phial, ampoule or other container of a substance specified in Schedule C and on every other covering in which such phial, ampoule or container is packed-(a)Where a drug is imported, the number of license under which it is imported, preceded by the words "Import License":Provided that no reference shall be made to any other import license number granted by any authority outside India on any label or container or in any covering in which the container is packed or in any other matter of advertisement enclosed therein.(b)Where a test for potency in units is required by these rules, a statement of the potency in units defined in terms of relating to the standard preparation specified in Schedule F or F(I), as the case may be:Provided that this clause shall not apply in the case of vaccine lymph.(c)Where a test for potency of maximum toxicity is required the date upto which the substance if kept under suitable conditions may be expected to retain a potency not less than that stated on the label of the container or not to acquire a toxicity greater than that permitted by the test, as the case may be. The date of expiry shall be in terms of month and year and it shall mean that the drug is recommended for use till the last day of the month. The date of expiry shall be preceded by the words "Expiry date":Provided that nothing in these rules shall be deemed to require the labelling of any transparent cover or any wrapper, case or other covering used solely for the purpose of packing, transport or delivery.
