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[Cites 0, Cited by 0] [Section 161] [Entire Act]

Union of India - Subsection

Section 161(3) in The Drugs and Cosmetics Rules, 1945

(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.