GOVT.

NOTIFICATION ON GENERIC AND BRAND NAME AND SCHEDULE H

IMPLEMENTATIO

CHECKLIST FOR PREPARATION OF ARTWORKS AS PER GOVT.

NOTIFICATION ON GENERIC AND BRAND NAME AND SCHEDULE H

IMPLEMENTATION
 

A)  FOR PRODUCTS WITH BRAND NAME AND GENERIC NAME

 Fonts for the Generic name should be 2 points bigger than the font used for the
Brand name.
For Eg. Brand Name: 10 points
Generic Name: 12 points
 The Type of font for Generic and Brand Name should be the
 Italic, Underline for fonts of Generic name /Brand name should not be used.
 The generic name for the carton/mono cartons /: Can be 70 % of Black Or in
any other color which is used for a generic name in existing
 Generic Name on the foil: 100% black
 Text Matter should be in Calibri/Arial/Myriad Pro
 No changes in existing color schemes and carton
 Text matter in existing artworks to be as per the guidelines.
 Complete red box for schedule H as per new guidelines
 Storage conditions in bold
 All the text of brand and generic to be in Upper Lower Case
For Eg. Brand Name: Vibcacetam
Generic name: Piracetam
 B)  FOR PRODUCTS HAVING 3 OR MORE INGREDIENTS
 For products having 3 or more ingredients, Round Bracket will be put for the
Brand name in the same color of a brand name. NO other change in font size of
Brand and generic is required.
 Complete red box for schedule H, H1 as per new guidelines
 Storage conditions in bold
 Text matter in existing artworks to be as per the guidelines
 All designs to remain same
 

C)  FOR PRODUCTS WITH GENERIC NAME ONLY

  Complete red box for schedule H, H1 as per new guidelines
 Storage conditions in bold
 Text matter in existing artworks to be as per the guidelines
 All the text of generic to be in Upper Lower Case
 

IMPORTANT:

1) DO NOT BREAK THE SENTENCE IN THE SCHEDULE BOX.

2) MAINTAIN THE FONT SIZE AND FONT OF THIS BOX AS PER THE
REMAINING TEXT ON ARTWORK
 

Existing Proposed

If it contains a substance specified If it contains a drug substance

in Schedule G, be labeled 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
If it contains a substance specified
in Schedule H, be labeled with the
symbol Rx and conspicuously
displayed on the left top comer of
the label and be also labeled with
the following words:
specified in Schedule G, be
labeled with following words in
legible black colored font size in a
completely Red rectangular box:
SCHEDULE G PRESCRIPTION
DRUG-CAUTION
It is dangerous to take this
preparation except under medical
supervision.
If it contains a drug substance
specified in Schedule H, be
labeled with symbol Rx and
conspicuously displayed on the left
top corner of the label and shall
also be labeled with the following
words in legible black colored font

Schedule H Drug-Warning
To be sold by retail on the
prescription of a Registered
Medical Practitioner only
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)]2 be labeled with the
symbol NRx which shall be
in red and conspicuously
displayed on the left top comer 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
If it contains a substance specified
in Schedule X, be labeled with the
symbol XRx which shall be
in red conspicuously displayed on
the left top comer of the label, and
be also labeled with the following
words:
Schedule X Drug-Warning
To be sold by retail on the
prescription of a Registered
size in a completely Red
rectangular box:
SCHEDULE H PRESCRIPTION
DRUG-CAUTION
Not to be sold by retail without the
prescription of a Registered
Medical Practitioner.
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 labeled 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.
If it contains a drug substance
specified in Schedule X, be labeled
with symbol XRx 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 colored font size in a
completely Red rectangular box:
SCHEDULE X PRESCRIPTION
DRUG-WARNING

Medical Practitioner only
If it contains a substance specified
in Schedule H1, the drug
formulation shall be labeled with
the symbol Rx which shall be
in red and conspicuously
displayed on the left top comer of
the label, and shall also be labeled
with the following words in a box
with a red
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 it Registered
Medical Practitioner
To be sold by retail on the
prescription of a Registered
Medical Practitioner only.
If it contains a drug substance
specified in Schedule H1, be
labeled with 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 legible
black colored font size in a
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 prescption of a Registered
Medical Practitioner.
If it contains a drug substance
specified in
Schedule H1 and comes within the
purview of the Narcotic Drugs and
Psychotropic Substances Act,
1985 (61 of 1985) be labeled 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 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 prescption of a Registered
Medical Practitioner.