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Union of India - Section

Section 97 in The Drugs and Cosmetics Rules, 1945

97. Labelling of medicines.

- [(1) The container of a medicine for internal use shall-(a)if it contains a substance specified in Schedule G, be labelled with the words Caution "it is dangerous to take this preparation except under medical supervision"-conspicuously printed and surrounded by a line within which there shall be no other words;(b)if it contains a substance specified in Schedule H be labelled with the symbol Rx and conspicuously displayed on the left top corner of the label and be also labelled with the following words:-"Schedule H drug-Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only";(c)if it contains a substance specified in Schedule H and comes within the purview of the [Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985)] [be labelled with the symbol NRx which shall be in red and conspicuously displayed on the left top corner of the label, and be also labelled with the following words:- [Substituted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).]"Schedule H drug-Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only";(d)if it contains a substance specified in Schedule X, be labelled with the symbol XRx which shall be in red conspicuously displayed on the left top corner of the label, and be also labelled with the following words:-"Schedule X drug-Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only";(e)[ if it contains a drug substance specified in Schedule H1, the drug formulation shall be labelled with the symbol Rx which shall be in red and conspicuously displayed on the left top corner of the label, and shall also be labelled with the following words)n a box with a red border:
SCHEDULE H1 DRUG – WARNING;-It is dangerous to take thispreparation except in accordance with the medical advice.-Not to be sold by retail without the prescription of aRegistered Medical Practitioner.;
]
(2)The container of an embrocation, liniment, lotion, [ointment, antiseptic cream,] [Inserted by G.S.R. 850(E), dated 7.12.1994 (w.e.f. 7.12.1994).][liquid antiseptic or other liquid medicine for external application shall be labelled with the words in capital "For External use only".] [Substituted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).] [Substituted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).]
(3)[ The container of a medicine made up ready only for treatment of an animal shall be labelled conspicuously with the words "Not for human use; for animal treatment only", and shall bear a symbol depicting the head of a domestic animal.] [Substituted by S.O. 2898, dated 2.7.1969 (w.e.f. 19.7.1969).]
(3A)[ The container of a medicine for treatment of food producing animals shall be labelled with the withdrawal period of the drug for the species on which it is intended to be usedProvided that if the specific withdrawal period has not been validated, the withdrawal period shall not be less than seven days for eggs or trulk, twenty eight days for meat from poultry and mammals including fat and offal, five hundred degree days for fish mealExplanation - For the purpose of this rule, the withdrawal period is the period of material between the last administration of a vetennary medtcme to arumals under the normal conditions of use and the producl1on of food stuff from such animals to ensure that food stuffs do not contain residues in quantities in excess of the maximum residue limits laid down.] [Inserted by Notification No. G.S.R. 28(E) dated 17.1.2012 (w.e.f. 21.12.1945)]
(4)[] [Sub-Rule (4) omitted and sub-Rule (5) renumbered as sub-rule (4) by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).] The container of a medicine prepared for treatment of human ailments shall if the medicine contains industrial methylated spirit, indicate this fact on the label and be labelled with the words-"For external use only".
(5)[ Substances specified in Schedule X in bulk form shall bear a label wherein the symbol as specified in sub-rule (1) shall be given conspicuously in red letters.] [Inserted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).]