Section 106A in The Drugs and Cosmetics Rules, 1945
106A. Manner of labelling of Homeopathic medicines.
- (A) 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 Homeopathic medicine and on every other covering in which the container is packed:-(i)The words "Homeopathic medicine".(ii)The name of the medicine-(a)[ For drugs included in the Homeopathic Pharmacopoeia of India or the United States of America or the United Kingdom, or the German Homeopathic Pharmacopoeia, the name specified in that Pharmacopoeia.] [Substituted by G.S.R. 680(E), dated 5.12.1980 (w.e.f. 5.12.1980).](b)For other drugs, the name descriptive of the true nature of the drug.(iii)The potency of the Homeopathic medicine-For this purpose the potency shall be expressed either in decimal, centesimal or millisimal systems.[(iii-A) In case of a Homeopathic medicine containing two or more ingredients, the name of each ingredient together with its potency and proportion expressed in metric system shall be stated on the label.] [Substituted by G.S.R. 466(E), dated 17.5.1994 (w.e.f. 17.5.1994).](iv)[ Name and address of the manufacturer when sold in original containers of the manufacturer. In case a Homeopathic medicine is sold in a container other than that of the manufacturer-the name and address of the seller: [Substituted by Notification No. F. 1-59/68-D, dated 19.11.1969.][Provided that where such medicines are imported, the name and address of the importer shall also be mentioned on the label.](v)[ In case the Homeopathic medicine contains alcohol, the alcohol content in percentage by volume in terms of ethyl alcohol shall be stated on the label:] [Substituted by Notification No. F. 1-59/68-D, dated 19.11.1969.][Provided that in case that the total quantity of the pharmacopoeial Homeopathic medicine in the container is 30 millilitres or less, it will not be necessary to state the content of alcohol in the label.] [Substituted by G.S.R. 108(E), dated 22.2.1994 (w.e.f. 22.6.1994).](B)In addition to the above particulars the label of a Homeopathic mother tincture shall display the following particulars:-(i)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 figures representing the batch number being preceded by the words "Batch No". or "Batch" or "Lot Number" or "Lot No." or "Lot" or any distinguishing prefix;(ii)manufacturing license number, the number being preceded by the words "Manufacturing License Number" or "Mfg. Lic No." or "M.L.".[ Explanation. - This clause shall not apply to a Homeopathic mother tincture manufactured outside India.(C)No Homeopathic medicine containing a single ingredient shall bear a proprietary name on its label.] [Inserted by S.O. 2139, dated 5.6.1972 (w.e.f. 12.8.1972).]
