GSR 222 E, 13th March 2018 and GSR 408 (E) 26th April 2018

	Existing Labelling Guidelines	Revised Labelling Guidelines	Interpretation
Rule 96, Sub rule 1, Clause (i)	(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]-	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]-	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.
Rule 96, Sub rule 1, Clause (xi)	[(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	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.”;	Red vertical line to be removed from the packs and replaced with Caution / Warning, as applicable
Rule 97, Sub rule 1	(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;	“(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.	SCHEDULE G PRESCRIPTION DRUG – CAUTION  It is dangerous to take this preparation except under medical supervision.   Schedule G warning should be in black font in completely red box
	"(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”	(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.	SCHEDULE H PRESCRIPTION DRUG – CAUTION Not to be sold by retail without the prescription of a Registered Medical Practitioner   Schedule H warning should be in black font in completely red box and Rx symbol on left corner
	"(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’;	(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.	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
	"(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’.	(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.	SCHEDULE X PRESCRIPTION DRUG – WARNING To be sold by retail on the prescription of a Registered Medical Practitioner Only   Schedule X drugs should have Schedule X warning  in black font in completely red box, with red XRx symbol on the left corner
	(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	(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.	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.   Schedule H1 drugs should have Schedule H1 warning  in black font in completely red rectangular box, with red Rx symbol on the left corner
		(f) 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 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 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.	Schedule H1 drugs falling under Psychotropic / Narcotic substances category should have Schedule H1 warning in black font in completely red box, with red NRx symbol on the left corner. 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.