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Rule 96, Sub rule 1, Clause (i)
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(i) The name of the drug :
[(A) For this purpose the
proper name of the drug shall be printed or written in a more conspicuous
manner than the trade name, if any which shall be shown immediately after or
under the proper name and shall be]-
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GSR 222 E, 13th March 2018
[(A) For this purpose, the
proper name of the drug or fixed dose combination
drug other than fixed combinations of vitamin and other fixed dose
combinations containing three or more drugs, shall be printed or
written in a conspicuous manner which shall be in the
same font but at least two font size larger than the brand name or the
trade name, if any, and in other cases the brand name
or the trade name, if any shall be written in brackets below or after the
proper name and shall be]-
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1. Proper name of the drug or
FDC should be in more conspicuous manner and 2 fonts larger than trade name
2. Trade Name to be written in
Brackets below proper name
3. Not applicable for FDCs of
vitamins or FDCs containing 3 or more drugs.
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Rule 96, Sub rule 1, Clause
(xi)
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[(xi) In addition to the other
particulars which are required to be printed or written under these Rules,
the label of innermost container of the following categories of drugs and
every other covering in which the container is packed shall bear a
conspicuous red vertical line on the left side running throughout the body of
the label which should not
be less than 1mm in width and without disturbing
the other conditions printed on the label under these rules, namely: —
Narcotic analgestics,
hypnotics, sedatives, tranquillisers, corticosteroids, hormones,
hypoglycemics, antimicrobials, antiepileptics, antidepressants,
anticoagulants, anti-cancer drugs and all other drugs falling under Schedules
‘G’, ‘H’, and ‘X’ whether covered or not in the above list
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GSR 408 (E) 26th April 2018
[(xi) In addition to the other
particulars which are required to be printed or written under these rules,
the label of inner most container of the following categories of drugs and
every other covering in which the container
is packed shall bear a caution or warning, as applicable, depending on
whether the drug is covered under Schedule G or Schedule H or Schedule H1 or
Schedule X, as
specified in rule 97, in legible black coloured font size in a completely red
rectangular box without
disturbing other conditions printed on the label under these rules,
namely:—
Narcotic analgesics, hypnotics,
sedatives, tranquillisers, corticosteroids, hormones, hypoglycemic,
antimicrobials, antiepileptics, antidepressants, anticoagulants, anti-cancer
drugs and all other drugs falling under Schedules G, H, H1 and Schedule X
whether covered or not in the above list:
Provided that if any of the
drug referred above category is not covered under any of the Schedule, namely, Schedule G, Schedule H,
Schedule H1 and Schedule X, the label of inner most container of drugs and
every other covering in which the container is packed shall bear caution or
warning, as the case may be, applicable for that drugs covered under Schedule
H as
specified in rule 97.”;
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Red vertical line to be removed
from the packs and replaced with Caution / Warning, as applicable
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Rule 97, Sub rule 1
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(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;
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“(a) if it contains a drug
substance specified in Schedule G, be labelled with following words in legible black coloured font size in completely red rectangular
box: SCHEDULE G PRESCRIPTION DRUG – CAUTION It is dangerous to take this
preparation except under medical supervision.
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SCHEDULE G PRESCRIPTION
DRUG – CAUTION
It is dangerous to take this preparation
except under medical supervision.
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Schedule G
warning should be in black font in completely
red box
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"(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”
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(b) if it contains a drug
substance specified in Schedule H, be labelled with symbol Rx and
conspicuously displayed on the left top corner of the label and shall also be
labelled with the following words in legible black
coloured font size in completely red rectangular box: SCHEDULE H PRESCRIPTION
DRUG – CAUTION Not to be sold by retail without the prescription of a
Registered Medical Practitioner.
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SCHEDULE H PRESCRIPTION
DRUG – CAUTION
Not to be sold by retail
without the prescription of a Registered Medical Practitioner
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Schedule H
warning should be in black font in completely red box and Rx symbol on left corner
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"(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:
‘Schedule H drug -Warning: To be sold by retail on the prescription of
a Registered Medical Practitioner only’;
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(c) if it contains a drug
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 symbol NRx, which shall be
in red and conspicuously displayed on the left top corner of the label and shall also be labeled with the
following words in legible black coloured font size
in completely red rectangular box: SCHEDULE H PRESCRIPTION DRUG – WARNING To
be sold by retail on the prescription of a Registered Medical Practitioner
only.
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Schedule H drugs falling under
Psychotropic / Narcotic substances category should have Schedule H warning in
black font in completely red box, with red NRx symbol
on the left corner.
SCHEDULE H PRESCRIPTION
DRUG – WARNING
To be sold by retail on the
prescription of a Registered Medical Practitioner Only
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"(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’.
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(d) if it contains a drug
substance specified in Schedule X, be labelled with symbol XRx, 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 in
legible black coloured font size in completely red rectangular box: SCHEDULE
X PRESCRIPTION DRUG – WARNING To be sold by retail on the prescription of a
Registered Medical Practitioner only.
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SCHEDULE X PRESCRIPTION
DRUG – WARNING
To be sold by retail on the
prescription of a Registered Medical Practitioner Only
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Schedule X
drugs should have Schedule X warning
in black font in completely red box, with red XRx
symbol on the left corner
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(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 labeled with the following words
in a box with a red border : SCHEDULE H1 DRUG - WARNING - It is dangerous to
take this preparation except in accordance with the medical advice. - Not to
be sold by retail without the prescription of a Registered Medical
Practitioner
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(e) if
it contains a drug substance specified in Schedule H1, be labelled with
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 in legible black
coloured font size in completely red rectangular box: SCHEDULE H1 PRESCRIPTION DRUG – CAUTION − It is dangerous to take this
preparation except in accordance with the medical advice. − Not to be sold by
retail without the prescription of a Registered Medical Practitioner.
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SCHEDULE H1 PRESCRIPTION
DRUG – CAUTION
- It is dangerous to take
this preparation except in accordance with the medical advice.
- Not to be sold by retail
without the prescription of a Registered Medical Practitioner.
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Schedule H1
drugs should have Schedule H1 warning
in black font in completely red rectangular box, with red Rx symbol on the left corner
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