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Union of India - Section

Section 127 in The Drugs and Cosmetics Rules, 1945

127. [ List of colours permitted to be used in drugs. [Substituted by S.O. 289, dated 20.12.1972 (w.e.f. 3.2.1973).]

(1)No drug shall contain a colour other than that specified below:
(1)Natural ColoursAnnattoCaroteneChlorophyCochinealCurcuminRed Oxide of ironYellow Oxide of iron[Titanium Dioxide] [Inserted by G.S.R. 1074, dated 19.8.1978 (w.e.f. 2.9.1978).][Black Oxide of iron] [Inserted by G.S.R. 370(E), dated 7.4.1994 (w.e.f. 7.4.1994).][Titanium dioxide coated mica pearlescent pigments] [Inserted by Notification No. G.S.R. 76 (E) dated 8.2.2012 (w.e.f. 21.12.1945)]
(2)Artificial ColoursCaramel[Riboflavine] [Inserted by G.S.R. 681(E), dated 6.6.1988 (w.e.f. 6.6.1988).]
(3)Coal Tar Colours
Common name of the colour Colour Index Number Chemical Name
1 2 3
GREEN    
Quinazarine Green SS 61565 1, 4-bis (p-Toluino)-anthraquinone.
Alizarin Cyanine Green F 61570 Disodium salt of 1, 4-bis (O-sulfo-p-toluino) anthraquinone.
[Fast Green FCF[Inserted by G.S.R. 1074, dated 19.8.1978 (w.e.f. 2.9.1978).]| [42053 [Inserted by G.S.R. 1074, dated 19.8.1978 (w.e.f. 2.9.1978).] [Disodium salt of 4-{[4-(N-ethyl-p-sulfobenzylamino(-phenyl-]-(4-hydroxy-2-sulfoniumphenyl)-methylene}[1-N-ethyl-N-p-sulfobenzyl-1-A 2,5-cyclohexadienimine] [Inserted by G.S.R. 1074, dated 19.8.1978 (w.e.f. 2.9.1978).]
[***] [Entries omitted by G.S.R. 753(E), dated 4.11.1999 (w.e.f. 4.11.1999).]YELLOW    
Tartrazine 19140 Trisodium salt of3-carboxy-5-hydroxy-1-p-sulfogpheny 1-4-psulfophenyl asopyrazole.
Sunset Yellow FCF 15985 Discodium salt of 1-p-sulfophenyl-azo-2-naphthol-6-sulfonic acid.
[Quinoline Yellow WS[Substituted by G.S.R. 11(E), dated 7.1.1991 (w.e.f. 7.1.1991).]| [47005 [Substituted by G.S.R. 11(E), dated 7.1.1991 (w.e.f. 7.1.1991).] [Discodium salt of disulfonic acid of 12-(2-quinolyl)-1,3-indandione.] [Substituted by G.S.R. 11(E), dated 7.1.1991 (w.e.f. 7.1.1991).]
RED[***] [Entries omitted by G.S.R. 753(E), dated 4.11.1999 (w.e.f. 4.11.1999).]    
Erythrosine 45430 Disodium salt of9-0-carboxphenyl-6-hydroxy 2,4,5,7-tetraiod-3-isoxanthone.
Eosin YS or Eosine G 45380 Disodium salt of 2,4,5,7-Tetrabrome-9-p-carboxphenyl-6-hydroxy-3-isoxanthone.
Toney Red or Sudan III 26100 1-p-phenylazophenylazo-2-naphthol.
Ponceau 4 R 16255 Trisodium salt of 1-(4-sulpho-1-1naphthyazo)-2-napthol-6:8-disulphonic acid.
Carmoisine 14720 Disodium salt of 2-(4-sulpho-1-naph-thylazo)-1-naphthol-4-sulphonic acid.
***BLUE    
Indigo Carmine 73015 Disodium salt of indigotin-5:-5'Disulphonic acid.
[Brillium Blue FCF[Inserted by G.S.R. 1074, dated 19.8.1978 (w.e.f. 2.9.1978).]| [42090 [Inserted by G.S.R. 1074, dated 19.8.1978 (w.e.f. 2.9.1978).] [Disodium salt of 4-{[4-(N-ethyl-p-sulphobenzylamino-phenyl-(2-sulphoniumphenyl)-methylene]-1-(N-ethyl-N-p-sulphobenzyl)-∆2,5-cycolhexa-dienomine.] [Inserted by G.S.R. 1074, dated 19.8.1978 (w.e.f. 2.9.1978).]
***ORANGE    
Orange G 16230 Disodium salt on 1-phenylazo-2-naphthol 6,8-disulfonic acid.
BROWN    
Resorcin Brown 20170 Monosodium salt of 4-p-sulfophenylazo 2-(2,4-xylozo)-1,3-resorcinol.
BLACK    
Naphthol Blue Black 20470 Disodium salt of 8-amino-7-p-nitrophenylazo-2-phenylazo-naphthol-3,6-disulfonic acid.
(4)LakesThe aluminium or calcium salts (lakeh) of any of the water-soluble colours listed above.
(2)The label on the container of a drug containing a permitted colour shall indicate the common name of the colour">(2) The label on the container of a drug containing a permitted colour shall indicate the common name of the colour.][Provided that disinfectants may also contain colours specified nuder Schedule Q, which are non-staining.] [Inserted by Notification No. G.S.R. 76 (E) dated 8.2.2012 (w.e.f. 21.12.1945)]