Section 96(7) in The Drugs and Cosmetics Rules, 1945
(7)In the case of medicinal gases produced by a continuous process of operation a week's production from one tank load shall be considered as a Batch.(vi)Every drug manufactured in India shall bear on its label the number of the license under which the drug is manufactured, the figure representing the manufacturing license number being preceded by the words "Manufacturing License Number" or "Mfg. Lic. No." or "M.L.".(vii)Drugs specified in Schedule P and their preparations including combinations with other drugs shall bear on their labels the date of manufacture and the date of expiry of potency, and the period between the date of manufacture and the date of expiry shall not exceed that laid down in the said Schedule [under the conditions of storage's specified therein. [Drugs and their preparations not included in Schedule P,] [shall bear or their labels the date of their manufacture and also the date of their expiry which shall not exceed sixty months from the date of manufacture:] [Substituted by G.S.R. 17(E), dated 7.1.1986 (w.e.f. 7.1.1986).][Provided that this period may be extended by the licensing authority specified in clause (b) of rule 21 in respect of any specified drug if satisfactory evidence is produced by the manufacturer to justify such an extension.(viii)[ drugs specified in Schedule C(l) and their preparations including combinations in other drugs shall bear on their labels (a) the date of manufacture, and (b) date of expiry of potency fixed by the manufacturer:][Provided that drugs in bulk form included in Schedule C(1) which are not ready for use and not included in Schedule P need not bear on the label the date of expiry of potency:] [Substituted by G.S.R. 813(E), dated 27.7.1988 (w.e.f. 27.7.1988).][Provided further that no reference shall be made to any other 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 or advertisement enclosed therewith.(ix)Every drug intended for distribution to the medical profession as a free sample shall, while complying with the labelling provisions under clauses (i) to (viii), further bear on the label of the container the words "Physician's" sample-"Not to be sold" which shall be overprinted.(x)[ If any preparation contains not less than 3 per cent. by volume of alcohol the quantity of alcohol shall be stated in terms of the average percentage by volume of absolute alcohol in the finished products.](xi)[ In addition to the other particulars which are required to be printed or written under these rules, the label of innermost container of the following categories of drugs and every other covering in which the container is packed shall bear a conspicuous red vertical line on the left side running throughout the body of the label which should not be less than 1 mm in width and without disturbing the other conditions printed on the label under these rules, namely:- [Inserted by G.S.R. 597(E), dated 17.6.1992 (w.e.f. 17.12.1997).]Narcotic analgesic, hypnotics, sedatives, tranquillisers, corticosteroids, hormones, hypoglycemics, anti-microbials, anti-epileptics, anti-depressants, anti-coagulants, anti-cancer drugs and all other drugs falling under Schedules G, H and X whether covered or not in the above list:Provided that the provisions of this clause shall not apply to-(a)preparations intended for animal treatment;(b)preparations intended for external use;(c)ophthalmic preparations and ear drops; and(d)sterile preparations such as sutures, surgical dressings and preparations intended for parenteral use.](xii)[ Drugs and their preparations including combinations with other drugs imported into the country shall bear on the label, the license number under which the drug is imported, preceded by the words "Import License" and the name and address of the importer.] [Inserted by G.S.R. 592(E), dated 13.8.2008 (w.e.f. 13.8.2008).]
