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Union of India - Section

Section 161 in The Drugs and Cosmetics Rules, 1945

161. [Labelling, packing and limit of alcohol ] [Substituted by G.S.R. 904(E), dated 2.11.1992 (w.e.f. 2.11.1992).]

.-(1) There shall be conspicuously displayed on the label of the container or package of an Ayurvedic (including Siddha) or Unani drug, the true list of all the ingredients [with the botanical names of plant based ingredients along with plant part(s) and form of ingredients, in which, these are] [Inserted by Notification No. G.S.R. 844 (E) dated 26.11.2012 (w.e.f. 21.12.1945)] used in the manufacture of the preparation together with the quantity of each of the ingredients incorporated therein and a reference to the method of preparation thereof as detailed in the standard text and Adikarana, as are prescribed in the authoritative books specified in the First Schedule of the Act [and in respect of Patent or Proprietary Ayurveda, Siddha or Unani drugs, the true list of all the ingredients with the botanical names of plant based ingredients along with plant part(s) and form of ingredients, in which, these are used in the formulation, with their quantity:PROVIDED that if needed, standardized abbreviations prescribed for parties) and form of Ingredient(s) in the official Ayurveda, Siddha and Unani Pharmacopoeias and Formularies, may be used on the label] [Inserted by Notification No. G.S.R. 844 (E) dated 26.11.2012 (w.e.f. 21.12.1945)];Provided that if the list of ingredients contained in the medicine is large and cannot be accommodated on the label, the same may be printed separately and enclosed with the packing and reference be made to this effect on the label.
(2)The container of a medicine for internal use made up ready for the treatment of human ailments shall, if it is made up from a substance specified in Schedule E(1), be labelled conspicuously with the words "Caution: to be taken under medical supervision" both in English and Hindi languages.
(3)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 Ayurvedic (including Siddha) or Unani drug [and Patent or Proprietary Ayurveda, Siddha or Unani drugs] [Inserted by Notification No. G.S.R. 844 (E) dated 26.11.2012 (w.e.f. 21.12.1945)] and on any other covering in which the container is packed, namely:-
(i)The name of the drug. [For Ayurveda, Siddha or Unani Drug] [Substituted for the words "For this" by Notification No. G.S.R. 844 (E) dated 26.11.2012 (w.e.f. 21.12.1945)] purpose the name shall be the same as mentioned in the authoritative books included in the First Schedule of the Act.
(ii)A correct statement of the net content in terms of weight, measure or number as the case may be. The weight and volume shall be expressed in metric system.
(iii)The name and address of the manufacturer.
(iv)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.".
(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 "Batch" or "Lot Number" or "Lot No." or "Lot" or any distinguishing prefix.
(vi)The date of manufacture. For this purpose the date of manufacture shall be the date of completion of the final products, or the date of bottling or packing for issue.
(vii)The words "Ayurvedic medicine" or "Siddha medicine" or "Unani medicine" as the case may be.
(viii)The words "For external use only" if the medicine is for external application.
(ix)Every drug intended for distribution to the medical profession as a free sample shall, while complying with the labelling provisions under clause (i) or (viii), further bear on the label of the container the words "Physician's sample. Not to be sold" which shall be overprinted.
[((x)) (a) Preparation (Asavas) with high content of alcohol as base. [Inserted by G.S.R. 904(E), dated 2.11.1992 (w.e.f. 2.11.1992).]
  Name of the drug Maximum size of packing
(i) Karpur Asava 15 ml
(ii) Aphiphenasava 15 ml
(iii) Margamadasava 15 ml
(b)Preparations containing self-generated alcohol.
  Name of the drug Maximum content of alcohol (Ethyl-alcohol v/v) Maximum size of packing
(i) Mritsanjivani Sura 16 per cent 30ml.
(ii) Mahadrakshava 16 per cent 120 ml.
(4)Nothing in these rules shall be deemed to require the labelling of any transparent cover or of any wrapper-case or other covering used solely for the purpose of packing, transport or delivery.]