CDSCO Releases Artwork Guidelines For Compliance With Label Change Norms

Mumbai, 24 July 2018: The Central Drugs Standard Control Organization (CDSCO) has released checklist for preparation of artworks for drug pack labels as per notification on generic and brand name and schedule H implementation. 

The artwork guidance will help drug companies comply with the health ministry's notification mandating a label change for bigger font size of generic names from September 13 this year. This is also a guide to effective compliance with new labelling norms for Schedule H, H1, G and X drugs with effect from November 1 this year. 

The artwork document contains checklist for products with brand name and generic name, products having 3 or more ingredients, products with generic name only, etc.

The artwork guidance document on products with brand name and generic name says fonts for the generic name should be 2 points bigger than the font used for brand name. The type of font for generic and brand name should be the same. Italic, Underline for fonts of generic name /brand name should not be used. Generic name for the carton/mono cartons can be 70 per cent of black or in any other color which is used for generic name in existing artwork. Generic name on the foil should be 100 per cent black. Text matter should be in Calibri/Arial/Myriad Pro. There are no changes in existing color schemes and carton designs. Text matter in existing artworks should be as per the guidelines. There should be complete red box for Schedule H as per new guidelines and storage conditions be mentioned in bold. All the text of brand and generic to be in upper lower case.

For products having 3 or more ingredients, round bracket will be put for the brand name in same color of brand name. No other change in font size of brand and generic is required. There should be complete red box for Schedule H, H1 as per new guidelines and storage conditions be mentioned in bold. Text matter in existing artworks to be as per the guidelines. All designs shall remain same.

The artwork for products with generic name only will remain same as above.

For the compliance of new labelling norms for Schedule H, H1, G and X drugs, the pharma companies need to introduce following changes on drug packs. They need to maintain the font size and font of schedule box as per the remaining text on artwork. The sentence in the this box should remain intact.

For Schedule G drugs, the packs shall mention following warning in legible black coloured font size in red rectangular box: “Schedule G Prescription Drug- Caution: It is dangerous to take this preparation except under medical supervision.”

For Schedule H drugs, the label shall display symbol Rx on the left top corner with a warning written in black coloured font in red box, “Schedule H Prescription Drug- Caution: To be sold by retail on the prescription of a Registered Medical Practitioner only.” 

Schedule H drugs falling under Narcotic Drugs and Psychotropic Substances Act, 1985 be labeled with symbol NRx in red on the left top corner of pack and shall display above warning. 

Schedule X drugs be labeled with symbol XRx in red on the left top corner of the label and the warning remains the same.

Schedule H1 be labeled with symbol Rx in red on the left top corner of the label and shall also be labeled with the warning in black coloured font size in red 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 it Registered Medical Practitioner.” 

Schedule H1 coming under NDPS Act be labeled with symbol NRx in red on the left top corner of the pack and shall also be labeled with above warning.  Pharmabiz