Labeling of drugs and cosmetics

  • Act/Rule/Legislation

  • Online Link to Act/Rule/Legislation

  • Initial Setup or Ongoing Maintenance

    Ongoing compliance requirement

  • Filing and Maintenance Requirements

    To comply with the labeling and packing requirements in respect of drugs and cosmetics manufactured as specified in the Rules . Medicines are to be labelled in accordance with specifications prescribed in Rule 96.

  • Penalty

    Imprisonment for a minimum term of one year and fine.

  • Application Guidelines / Responsible Persons / Comments

    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 2
    [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:
    ‘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’.

    For more guidelines kindly look at http://www.indianmedicine.nic.in/writereaddata/mainlinkFile/File222.pdf