Section 96(1) in The Drugs and Cosmetics Rules, 1945
(1)Subject to the other provisions of these rules, the following particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any drug and on every other covering in which the container is packed, namely:-(i)The name of the drug;(A)[ For this purpose,] [the proper name of the drug shall be printed or written in a more conspicuous manner than the trade name, if any which shall be shown immediately after or under the proper name and shall be] [Substituted by G.S.R. 27(E), dated 17.1.1981 (w.e.f. 1.8.1981).]-(a)[ for drugs included in Schedule F or Schedule F(I), the name given therein; [Substituted by G.S.R. 19, dated 15.12.1977 (w.e.f. 7.1.1978).](b)for drugs included in the Indian Pharmacopoeia or the official Pharmacopoeias and official compendia of drug standards prescribed in rule 124, the name or synonym specified in the respective official pharmacopoeias and official compendia of drug standards followed by the letters "I.P." or, as the case may be, by the recognized abbreviations of the respective official pharmacopoeia and official compendia of drug standards;(c)for drugs included in the National Formulary of India, the name or synonym specified therein followed by the letters "N. F. I.";(d)for other drugs, the international non-proprietary name, if any, published by the World Health Organisation or where an international non-proprietary name is not published, the name descriptive of the true nature or origin of the substance;[* * *](ii)[ A correct statement of the net contents in terms of weight, measure, volume, number of units of contents, number of units of activity, as the case may be, and the weight, measure and volume shall be expressed in Metric system. [Substituted by G.S.R. 19, dated 15.12.1977 (w.e.f. 7.1.1978).](iii)The content of active ingredients-This shall be expressed-(a)for oral liquid preparations in terms of the content per single dose, the dose being indicated in 5 millilitres [* * *]:[Provided that where the dose is below 5 millilitres the contents of active ingredients may be expressed in terms of one millilitre [or fraction thereof] [Substituted by G.S.R. 19, dated 15.12.1977 (w.e.f. 7.1.1978).]:[Provided further that where the single dose is more than 5 millilitres, the content of active ingredients shall be expressed in terms of minimum single dose as approved by the licensing authority;] [Inserted by G.S.R. 285(E), dated 16.7.1996 (w.e.f. 16.7.1996).](b)[ for liquid parenteral preparations ready for administration, in terms of 1 millilitre or percentage by volume or per dose in the case of a single dose container: [Substituted by G.S.R. 19, dated 15.12.1977 (w.e.f. 7.1.1978).]Provided that if the preparation is contained in an ampoule it will be enough if the composition is shown on the label or wrapper affixed to any package in which such ampoule is issued for sale;(c)for drugs in solid form intended for parenteral administration in terms of units or weight per milligramme or gramme;(d)for tablets, capsules, pills and the like, in terms of the content in each tablet, capsule, pill or other unit, as the case may be;(e)for other preparations, in terms of percentage by weight or volume or in terms of unitage per gram or millilitre as the case may be:Provided that clause (iii) shall not apply to a pharmacopoeial preparation where the composition of such preparation is specified in the respective pharmacopoeia and to a preparation included in the National Formulary of India.(iv)[The name of the manufacturer and the address of the premises of the manufacturer where the drug has been manufactured:][Provided that if the drug is contained in an ampoule or a similar small container, it shall be enough if only the name of the [manufacturer] [Substituted by G.S.R. 19, dated 15.12.1977 (w.e.f. 7.1.1978).] and his principal place of manufacture is shown.(v)[ A distinctive batch number, that is to say, the number by reference to which details of manufacture of the particular batch from which the substance in the container is taken are recorded and are available for inspection, the figure representing the batch number being preceded by the words "Batch No." or "B. No.", or "Batch" or "Lot No." or "Lot". [Substituted by G.S.R. 19, dated 15.12.1977 (w.e.f. 7.1.1978).]Notes. - (1) In the case of drugs manufactured by a continuous process, like manufacture of magnesium sulphate, pharmaceutical chemicals, etc., the production resulting in one homogeneous mix of the finished products shall be considered as one "Batch";
