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  • 70 Colors including...

70 Colors including Tartrazine, Erythrosine added into Drug Rule for disinfectants

Dr. Divya ColinWritten by Dr. Divya Colin Published On 2022-08-16T18:00:29+05:30  |  Updated On 16 Aug 2022 6:00 PM IST
70 Colors including Tartrazine, Erythrosine added into Drug Rule for disinfectants
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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."

To review the official notice,click the link below:

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODg3OQ==

Also Read: Govt amends Drug Rules to include liquid antiseptic under Schedule K


disinfectantministry of health and family walfareDrug Rules 1945disinfectant colorstartrazineerythrosineMOHFW
Dr. Divya Colin
Dr. Divya Colin

    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.

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