Govt. Notification on generic and brand name implementation

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

For Eg. Brand Name: 10 points

Generic Name: 12 points

For Eg. Brand Name: Vibcacetam

Generic name: Piracetam

Guideline for Generic Name, Brand Name, and Schedule H implementation

b)  For products having 3 or more ingredients

 

c)  For products with Generic name only

 

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 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 drug substance 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 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:

Schedule H 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 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 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 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 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 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 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
To be sold by retail on the prescription of a Registered 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

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.