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70 Colors including Tartrazine, Erythrosine added into Drug Rule for disinfectants
New Delhi: Amending the Drugs Rules, 1945, through a recent gazette notification, the Ministry of Health and Family Welfare has inserted 70 colors, which are non-staining, into the list of colours permitted to be used in the case of disinfectants.
The government has specified 70 colours together with their corresponding colour index number and chemical name.
The list of 70 colors which are permitted to be used in disinfectant includes Guinea Green B, Light Green SF Yellowish, Tartrazine, Sunset yellow FCF, Ponceau 3R, Amarnath, Erythrosine and others.
This came as a result of draft of certain rules further to amend the Drugs Rules, 1945, which was published as required under sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare) number G.S.R. 227(E), dated the 29th March, 2022, in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), inviting objections and suggestions from persons likely to be affected thereby, before the expiry of a period of thirty days from the date on which the copies of the Official Gazette containing the said notification were made available to the public.
Furthermore, the copies of the said Official Gazette were made available to the public on March 30th, 2022.
Accordingly, objections and suggestions received from the public on the said draft rules have been considered by the Central Government.
In light of the abovementioned, the notice read,
" In exercise of the powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs Rules, 1945, namely:-A. (1) These rules may be called the Drugs (Sixth Amendment) Rules, 2022.(2) They shall come into force on the date of their publication in the Official Gazette.B. In the Drugs Rules, 1945, in rule 127, in sub-rule (1), for the proviso, the following proviso shall be substituted, namely:—"Provided that in case of disinfectants, in addition to the above said colours, the colours referred in IS 4707 (Part I) as amended by Bureau of Indian Standards from time to time or any of the colours listed in the table below, which is non-staining shall be permissible to use."
Serial Number | Common name of colour | Colour Index Number | Chemical name of colour |
(1) | (2) | (3) | (4) |
1 | Guinea Green B | 42085 | Monosodium salt of 4-(N-ethyl-psulfobenzylamino)–diphenyl -methylone-(1- (N-ethyl-N-p-sulfonium -benzyl)∆2,5- cyclohexadien- imine) |
2 | Light Green SF Yellowish | 42095 | Disodium salt of 4-[4-(N-ethyl-psulfobenzylamine)-phenyl)-4-sulphonium- - phenyl)methylene]-2(-(N-ethyl-Nsulfobenzyl)∆2,5-Cyclohexadienimine |
3 | Tartrazine | 19140 | Trisodium salt of 3-carboxy-5-hydroxy-1-psulfophenyl-4-p- sulfophenylazo -pyrazole |
4 | Sunset yellow FCF | 15985 | Disodium salt of 1-p-sulfophenylazo-2- naphthol-6-sulfonic acid |
5 | Ponceau 3R | 16155 | Disodium salts of a mixture of 1-alkylphenylazo-2-napthol 3, 6-disulfonic acids |
6 | Amarnath | 16185 | Trisodium salt of 1-(4-sulfo-1- napthyl - -azo ) 2-naphthol 3, 6- disulfonic acid |
7 | Erythrosine | 45430 | Disodium salt of 9-0-carboxyphenyl-6- hydroxy 2,4,5, 7- tetraiodo-3- isoxanthone |
8 | Ponceau SX | 14700 | Disodium salt of 2-(5 sulfo-2, 4-xylyl- azo)-1- naphthol-4- sulfonic acid |
9 | Brilliant Blue FCF | 42090 | Disodium salt of 4-(9-4-(N-ethyl-psulfobenzylamino)-phenyl)- 2-sulfonium phenyl)- methylene)-(1-(N-ethyl-N-psulfobenzyl)-∆ 2, 5- cyclohexadienimine) |
10 | Indigocarmine | 73015 | Disodium salt of 5,5'-indigotindisulfonic acid |
11 | Wool Violet 5 BN (Acidviolet 6B) | 42640 | Monosodium salt of 4-(N-ethyl-psulfobenzylamino)-phenyl)-(4- (N-ethyl-p- (sulfonium-benzylamine)-phenyl) methylene)- (N, N- dimethyl-∆ 2,5-cyclohexadienimine) |
12 | Light Green SF Yellowish | 42095 | Calcium salt of 4-(4-(N-ethyl-p-sulfobenzyl ) (minophenyl)(4- sulfonium-phenyl) methylene), (1-(N-ethyl-N-p-sulfobenzyl)-∆2,5- cyclohexadienimine) |
13 | Alizarin Cyanine Green F | 61570 | Disodium salt of 1,4-bis (O-sulfo-p-toluino) anthraquinone |
14 | Quinazarine Green SS | 61565 | 1,4-bis-(p-Toluino)-anthraquinone |
15 | Fast Green FCF | 42053 | Disodium salt of 4-(4-(ethyl-psulfobenzylamino)-phenyl) (4- hydroxy-2 sulphoniumphenyl) methylene)-(1-N-ethyl-Np- sulfobenzyl) ∆ 2, 5, cyclohexa -dienimine) |
16 | Acid Fast Green | 42100 | Monosodium salt of 4-(4-N-ethyl-psulfobenzylomino) phenyl)- (o-chlorophenyl)- methylene)- 1-(N-ethyl-N-p-sulfonium benzyl- ∆ 2,5, cyclohexa - -dienimine) |
17 | Pyranine Concentrated | 59040 | Trisodium salt of 10-hydroxy-3,5,8-pyrenetrisulfonic Acid |
18 | Quinoline Yellow WS | 47005 | Disodium indandione |
19 | Quinoline Yellow SS | 47000 | 2-(2-quinolyl)-1, 3 indandiene |
20 | Poneceau 2 R | 16150 | Disodium salt of 1-xylylazo-2-naphthol-3, 6- disulfonic acid |
21 | Lithol Rubin B | 15850 | Monosodium salt of 4-(o-sulfo-p-tolylazo ) 3 hydroxy-2-naphthoic acid |
22 | Lithol Rubin BCA | 15850 | Calcium salt of 4-(o-sulfo-p-tolylazo)-3- hydroxy-2-naphthoic acid |
23 | Lake Red D | 15500 | Monosodium salt of 1-0-carboxyphenyl-azo-2- naphthol |
24 | Lake Red DBA | 15500 | Barium salt of 1-o-carboxyphenylazo-2- naphthol |
25 | Lake Red DCA | 15500 | Calcium salt of 1-o-carboxyphenylazo-2- naphthol |
26 | Toney Red | 26100 | I-p-phenylazophenylazo-2-naphthol |
27 | Oil Red OS | 26125 | I-Xylylazoxylylazo-2-napththol |
28 | Tetrabromofluorescein | 45380 | 2,4,5,7-Tetrabromo-3, 6-flurandiol |
29 | Eosin TS | 45380 | Disodium salt of 2,4,5,7-tetrabromo-9-0 carboxyphenyl-6- hyroxy-3-isoxanthone |
30 | Eosin YSK | 45380 | Dipotassium salt of 2,4,5,7-tetrabromo-9-0 carboxyphenyl-6-hyroxy-3-isoxanthone |
31 | Tetrachlorofluorescein NA | 45366 | 2,4,5,7- tetrachloro-S, 6-Fluorandiol |
32 | Tetrachlorofluorescein K | 45366 | Disodium salt of 9-0-carboxyphenyl-2,4,5,7- tetrachloro-6- hydroxyl-3-isoxanthone |
33 | Tetrachloro Tetrabromo fluorescein | 45410 | 2,4,5,7-Tetrabromo-12,13,14,15-tetrachloro-3, 6-fluorandiol |
34 | Phloxine B | 45410 | Disodium salt of 2,4,5,7-tetrabromo-9 (3,4,5,6- tetra chloro- o-carboxyphenyl)-6-hydroxy-3- isoxanthone |
35 | Bluish Orange T.R. | 45457 | 1,4,5,8, 15-Pentabromo-2, 7-dicarboxy-3, 6- fluoran diol |
36 | Helindone Pink CN | 73360 | 5, 5-Dichloro-3, 3' dimethyl-thioindigo |
37 | Deep Maroon (Fanchon Maroon) | 15880 | Calcium salt of 4-(I-sulfo-2-naphthylazo 3- hydroxy-2- naphthoic acid |
38 | Toluidine Red | 12120 | 1-(o-Nitro-p-tolylazo)-2-naphthol |
39 | Flaming Red | 12085 | I- (o-Chloro-p-nitrophenylazo)-2-naphthol |
40 | Deep Red (Maroon) | 12350 | 3-Hydroxy-N- (m-nitrophenyl)-4-(o-nitro-ptolylazo)-2- naphthamide |
41 | Alba Red | 13058 | o-(p,β,β-Dihydroxy-diethylamino)-phenylazo)- benzoic acid |
42 | Orange G | 16230 | Disodium salt of 1-phenylazo-2-naphthol-6-8- disulfonic acid |
43 | Orange II | 15510 | Monosodium salt of 1-p-sulfophenylazo-2- naphthol |
44 | Dichlorofluorescein | 45365 | 4,5-Dichloro-3, 6-fluorandiol |
45 | Dichlorofluorescein NA | 45365 | Disodium salt of 9-o-carboxyphenyl-1-4,5- dichloro-6- hydroxy-3-isoxanthone |
46 | Diiodofluorescein | 45425 | 4,5 –Diiodo-3, 6-fluorandiol |
47 | Erythrosine Yellowish NA | 45425 | Disodium salt of 9-o-carboxypheny l-6- hydroxy-4, 5- diiodo-3-isoxanthone |
48 | Erythrosine Yellowish K | 45425 | Dipotassium salt of 9-o-carboxyphenyl-6- hydroxy-4, 5- diiodo-3-isoxanthone |
49 | Erythrosine Yellowish NH | 45425 | Dipotassium salt of 9-o-carboxyphenyl -6- hydroxy-4, 5- diiodo-3-isoxanthone |
50 | Orange TR | 45456 | 4,5, 15-Tribromo 2, 7-dicarboxy-3, 6- fluorandiol |
51 | Alizarin | 58000 | 1,2- Anthraquinonediol |
52 | Dibromodiiodofluorescein | 45371 | 4,5- Dibromo-2, 7-diiodo-3, 6-fluorandiol |
53 | Alphazurine FG | 42090 | Diammonium salt of 4-(N-ethyl-p- sulfobenzyl amino)- phenyl)-(2-sulfoniumphenyl)- Methytlene)-(-(1 (N-ethyl-N- p-sulfobenzyl) ∆ 2 ,5-cyclohexadienimine) |
54 | Allarin Astrol B | 61530 | Monosodium salt of 1-methylamino-4-(o-sulfop-toluino)- anthroquinone |
55 | Indigo | 73000 | Indigotin |
56 | Patent Blue NA | 42052 | Monosodium salt of 4-(4- (N-ethyl- benzylamino)-phenyl – (5-hydroxy-4-sulfo-2- sulfoniumphenyl-methylene) (N-ethyl- Benzyl- ∆ 2, 5-cyclohexadienimine ) |
57 | Patent Blue CA | 42052 | Calcium salt of 4-(4- (N-ethyl- benzyl-amino)- phenyl)-(5 hydroxy-4-sulfo-2-sulfoniumphenyl, methylene)- (N-ethylN-benzyl- ∆ 2- 5-cyclohexadienimine) |
58 | Carbrantherene Blue | 69825 | 3, 3- Dichloroindanthrene |
59 | Napthol Blue Black | 20470 | Disodium salt of 8-amino-7-p- nitrophenyl- azo 3- phenylazo-1- naphthol-3, 6-disulfonic acid |
60 | Alizurol purple SS | 60725 | I-hydroxy-4-p-toluino-anthraquinone |
61 | Acid Red 89 | 23910 | -------------------------------------------------- |
62 | Acid Red 97 | 22890 | -------------------------------------------------- |
63 | Acid Blue 1 | 42045 | -------------------------------------------------- |
64 | Food Blue 3 | 42045 | -------------------------------------------------- |
65 | Natural Orange | 75480 | -------------------------------------------------- |
66 | Solvent Blues 4 | 44045 | -------------------------------------------------- |
67 | Solvent Yellow 18 | 12740 | -------------------------------------------------- |
68 | Food Yellow 12 | 12740 | -------------------------------------------------- |
69 | Solvent Yellow 32 | 48045 | -------------------------------------------------- |
70 | Fanchon Yellow (Hansa Yellow G) | 11680 | (α)-(O-Nitro-p-tolylazo) accetoacetanilide." |
Doctor of Pharmacy
Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.