Drugs and Cosmetics Rules 1945

1 2 3

Alizarin Cyanine Green F 61570 Disodium salt of 1,4-bis (O-sulfo-p-toluino) anthraquinone

Quinazarine Green SS 61565 1,4-bis-(p-Toluino)-anthraquinone

Fast Green FCF 42053 Disodium salt of 4-(4-(ethyl-p-sulfobenzylamino)-phenyl) (4-

hydroxy-2 sulphoniumphenyl) methylene)-(1-N-ethyl-N-p-
sulfobenzyl) ∆ 2, 5, cyclohexadienimine).
Acid Fast Green 42100 Monosodium salt of 4-(4-N-ethyl-p-sulfobenzylomino) phenyl)-
(o-chlorophenyl)-methylene)- 1-(N-ethyl-N- p-sulfonium-
benzyl- ∆ 2,5, cyclohexadienimine).

Pyranine Concentrated 59040 Trisodium salt of acid.

Quinoline Yellow WS 47005 Disodium salt of disulfonic acid of 2-(2-Quinolyl)-1, 3-
indandione.
Quinoline Yellow SS 47000 2-(2-quinolyl)-1, 3 indandiene.
Poneceau 2 R 16150 Disodium salt of 1-xylylazo-2-naphthol-3, 6-disulfonic acid.

Lithol Rubin B. 15850 Monosodium salt of 4-(o-sulfo-p-tolylazo)3 hydroxy-2-naphthoic

acid.
Lithol Rubin BCA 15850 Calcium salt of 4-(o-sulfo-p-tolylazo)-3-hydroxy-2-naphthoic
acid

Lake Red D. 15500 Monosodium salt of 1-0-carboxyphenylazo-2-naphthol.

Lake Red DBA 15500 Barium salt of 1-o-carboxyphenylazo-2-naphthol.

Lake Red DCA. 15500 Calcium salt of 1-o-carboxyphenylazo-2-naphthol.

Toney Red. 26100 I-p-phenylazophenylazo-2-naphthol.

Oil Red OS. 26125 I-Xylylazoxylylazo-2-napththol
Tetrabromofluorescein 45380 2,4,5,7-Tetrabromo-3, 6-flurandiol.
Eosin TS 45380 Disodium salt of 2,4,5,7-tetrabromo-9-0 carboxyphenyl-6-
hyroxy-3-isoxanthone.
Eosin YSK. . 45380 Dipotassium salt of 2,4,5,7-tetrabromo-9-0 carboxyphenyl-
6-hyroxy-3-isoxanthone
Tetrachlorofluorescein NA 45366 2,4,5,7- tetrachloro-S, 6-Fluorandiol
Tetrachlorofluorescein K. 45366 Disodium salt of 9-0-carboxyphenyl-2,4,5,7-tetrachloro-6-
hydroxy-3-isoxanthone.
Tetrachloro Tetrabromo 45410 2,4,5,7-Tetrabromo-12,13,14,15-tetrachloro-3,
fluorescein 6-fluorandiol.
Phloxine B 45410 Disodium salt of 2,4,5,7-tetrabromo-9 (3,4,5,6-tetra chloro-
o-carboxyphenyl)-6-hydroxy-3-isoxanthone
Bluish Orange T.R. 45457 1,4,5,8, 15-Pentabromo-2, 7-dicarboxy-3, 6-fluoran diol.

Helindone Pink CN. 73360 5, 5-Dichloro-3, 3‘ dimethyl-thioindigo

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Deep Maroon (Fanchon Maroon) 15880 Calcium salt of 4-(I-sulfo-2-naphthylazo 3- hydroxy-2-

naphthoic acid.
Toluidine Red. . 12120 1-(o-Nitro-p-tolylazo)-2-naphthol.

Flaming Red. 12085 I- (o-Chloro-p-nitrophenylazo)-2-naphthol

Deep Red (Maroon). 12350 3-Hydroxy-N- (m-nitrophenyl)-4-(o-nitro-p-tolylazo)-2-
naphthamide.
Alba Red. 13058 o-(p,β,β-Dihydroxy-diethylamino)- phenylazo)-benzoic
acid.
Orange G. 16230 Disodium salt of 1-phenylazo-2-naphthol-6-8-disulfonic
acid.
Orange II 15510 Monosodium salt of 1-p-sulfophenylazo-2-naphthol.
Dichlorofluorescein 45365 4,5-Dichloro-3, 6-fluorandiol.
Dichlorofluorescein. NA 45365 Disodium salt of 9-o-carboxyphenyl-1-4,5- dichloro-6-
hydroxy-3-isoxanthone
Diiodofluorescein. 45425 4,5 –Diiodo-3, 6-fluorandiol
Erythrosine Yellowish NA. 45425 Disodium salt of 9-o-carboxyphenyl-6- hydroxy-4, 5-
diiodo-3-isoxanthone.
Erythrosine Yellowish K. 45425 Dipotassium salt of 9-o-carboxyphenyl-6-hydroxy-4, 5-
diiodo-3-isoxanthone.
Erythrosine Yellowish NH 45425 Dipotassium salt of 9-o-carboxyphenyl-6-hydroxy-4, 5-
diiodo-3-isoxanthone
Orange TR 45456 4,5, 15-Tribromo 2, 7-dicarboxy-3, 6- fluorandiol.
Alizarin. 58000 1,2- Anthraquinonediol.
Dibromodiiodofluorescein. 45371 4 ,5- Dibromo-2, 7-diiodo-3, 6-fluorandiol.
1
[***]

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).
Allarin Astrol B. 61530 Monosodium salt of 1-methylamino-4-(o-sulfo-p-toluino)-
anthroquinone.
Indigo. 73000 Indigotin.
Patent Blue NA. . 42052 Monosodium salt of 4-(4- (N-ethyl- benzyl-amino)-phenyl –
(5-hydroxy-4-sulfo-2-sulfoniumphenyl-methylene)(N-ethyl-
Benzyl- ∆ 2, 5-cyclohexadienimine).

Patent Blue CA. 42052 Calcium salt of 4-(4- (N-ethyl- benzyl-amino)-phenyl)-(5

hydroxy-4-sulfo-2-sulfoniumphenyl, methylene)- (N-ethyl-
N-benzyl- ∆ 2- 5-cyclohexadienimine).

Carbrantherene Blue 69825 3, 3- Dichloroindanthrene.

1. Omitted by G.S.R. 203(E), dated 18-03-2015.

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 Drugs and Cosmetics Rules 1945

1 2 3

Napthol Blue 20470 Disodium salt of 8-amino-7-p- nitrophenylazo 3-

Black phenylazo-1- naphthol-3, 6-disulfonic acid

Alizurol purple SS 60725 I-hydroxy-4-p-toluino-anthraquinone.

Acid Red 89 23910 ----

Acid Red 97 22890 ----

Acid Blue 1 42045 ----
Food Blue 3 42045 ----
Natural Orange 75480 ----
Solvent Blues 4 44045 ----
Solvent Yellow 18 12740 ----
Food Yellow 12. 12740 ----
1
[***] ----
Solvent Yellow 32. 48045 ----
Fanchon Yellow 11680 (α) -(O-Nitro-p-tolylazo)
(Hansa Yellow G). accetoacetanilide
2
[Part II
LIST OF COLOURS PERMITTED TO BE USED IN SOAPS.

Common name of the Colour Index Chemical name of the colour

Colour No.

Phthalocyanine Blue 74160 (phthalocyninate (2--) copper.

Iragalite Red CVPB 12075 1-(2,4-dinithro phenylazo)-2-Naphthalenol.
Paste or Pigment
Orange 5
Citrus Red No.2. 12156 1-2(2,5-dimethoxy phenylazo) 2-naphthol.
Rhodamine B 500 45170 3-ethochloride of 9-0 carboxy-ethenyl-6-diethylamino-
3-ethylamine-3-isoxanthene.
Aqueous Green Paste 74260 Polychloro copper Phthalocyanine.
Pigment Yellow 3 11710 2-(4-Chloro-2-nitrophenyl)-azo-N-(-2-Chloro-
phenyl)-3- Oxobutamide.
Irgalite Carmine F-P Powder 12490 N-(5-Chloro-2, 4-dimethoxy-phenyl)-4-(CS-
or Pigments Red 5. diathylamine) Sulfonyl-2-methoxyphenyl)azo-
3-hydroxy-2-naphthalene carboxamide.
Monolite Red 4R HV Paste 12420 N-(4-Chloro-2-methylphenyl-4-(-4-Chloro-2-methylphenyl)
or Pigment Red 7. Azo 3-hydroxy-2-naphthalenol Carboxamide.
Oil Red No.1 or Solvent 26105 4-0-Tolylazo-Toluidine azo 2-naphthalenol.]
Red 24 or Oil Red 3R.

*This list of colour for use in soaps is in addition to those colours already given in Schedule Q and are used
for soaps.]

1. Omitted by G.S.R. 203(E) dated 18-03-2015

2. Ins. by G.S.R. 11(E) , dt. 7.1.1991.

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 Drugs and Cosmetics Rules 1945

1
[SCHEDULE R
[See Rule 125]

STANDARDS FOR CONDOMS MADE OF RUBBER LATEX INTENDED FOR SINGLE USE
AND OTHER MECHANICAL CONTRACEPTIVES

I-Condoms

1. Description - Condoms consist of cylindrical rubber sheaths with one end open. The
open end shall terminate with an integral rim. The closed end may have a receptacle. They
may be supplied rolled and shall be free from tackiness and shall be capable of being unrolled
readily.

2. Materials - (1) Condoms shall be manufactured from good quality rubber latex and
shall be free from embedded grit and shall be opaque or translucent prior to the application of
dusting materials or lubricants.

(2) The rubber latex, colours used and any dusting materials or lubricants applied to the
condoms shall neither contain nor liberate substances which are known to have toxic or other
harmful effects under normal conditions of use. Any dusting material or lubricant or colour
used shall not have deleterious effect on the condoms or be harmful to the users.

3. Procedure for sampling during production − (1) Specimens constituting the test
samples shall be taken at random successively from each quantum of production that is, from
the quantity produced from the same finished rubber latex and under the same processing
and finishing conditions of manufacture and samples from each quantum shall be tested
separately to ascertain conformity of quantum with the specified requirements in accordance
with the tests described in this Schedule.

(2) (a) The number of samples drawn from each quantum shall be not less than 0.5 per
cent of the number.

(b) The number of samples drawn from each quantum shall be tested for Burst
Volume and Pressure Test and Water Leakage Test in accordance with the method prescribed
in paras 9 and 10 of this Schedule. 75 per cent of the samples drawn will be tested for Water
Leakage Test and 25 per cent will be tested for Burst Volume and Pressure Test.

(c) The number of test samples ‗N‘ and the number of rejected samples ‗R‘ from a
sequence of production quanta shall be recorded in a register. The cumulative total of test
samples ‗N‘ and the cumulative total of rejects ‗R‘ from the test shall be recorded and the
condoms shall be deemed to comply with the requirements if the cumulative total of rejects
‗R‘ is not more than 2[0.0025N+3 x √0.0025N] for Water Leakage Test, and 2[0.015N+3 x
√0.015N] for Burst Volume and Pressure Test.

(3) Each unit of 100 test samples shall be distributed for the various tests as follows: -
25 for Burst Volume Pressure Test, and;
75 for Water Leakage Test.

1 Subs. by G.S.R. 495(E) , dt. 9.6.1995.

2. Subs. by G.S.R. 353(E), dt. 26.4.2000.

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 Drugs and Cosmetics Rules 1945

(4) Where the number of test samples is a multiple of 100 the distribution scale
mentioned above shall be prorated.

(5) If the cumulative total sample rejected exceeds the number of allowables at any
point in the sequence of quanta, the quantum at which this occurs shall be liable to rejection.
The assessment of quality of further production quanta shall include all previous test results
starting from quantum number 1 and approval of production shall be in suspense until the
condition required by the scheme is again fulfilled.

(6) At least one sample shall be taken at random from each production quantum not
exceeding 10,000 condoms and shall satisfy all requirements regarding dimensions as
specified in paragraph 8 of this Schedule.

4. Procedure for sampling and testing of finished products by a manufacturer –

A. Water Leakage Test.- (1) Statistical sampling for quality control assessment of the finished
product in respect of Water Leakage Test shall be done in accordance with the plan set out in
Annexure 1 to this Schedule.

(2) A test sample failing in the above test is to be considered as defective. If the
cumulative total of rejects ‗R‘ is found to be equal to or greater than the number shown against
‗R‘ in Annexure-I, the batch or lot shall be declared as not of standard quality.

B. Bursting Volume and Pressure Test.- (1) Sample condoms shall be tested for
Bursting Volume and Pressure Test. Statistical sampling for this test shall be done in
accordance with the plan set out in Annexure III to this Schedule.

Condoms shall not leak or burst at a volume of less than that specified or at a
pressure less than 1.0 kpa (gauge), when tested as per paragraph 9, both before and after oven
conditioning as specified in Annexure V. Bursting Volume minimum limit in litres shall be
equal to [mean condom width (mm)2] rounded to the nearest 0.5 litre.
151.8

(2) A test sample failing in the above test is to be considered defective. If the
cumulative total of rejects ‗R‘ is found to be equal or greater than the number shown against
‗R‘ in Annexure III, the batch or lot shall be declared as not of standard quality.

C. Dimensions. - At least 2 samples drawn from the lot or batch shall satisfy the requirements
regarding dimensions as specified in paragraph 8 of this Schedule.

5. Procedure for sampling and testing of condoms by a purchaser -

A. Water Leakage Test- (1) Statistical sampling of condoms by a purchaser for Water Leakage
Test shall be done in accordance with the plan set out in Annexure II to this Schedule;

(2) A test sample failing in the above test is to be considered as defective. If the
cumulative total of rejects ‗R‘ is found to be equal to or greater than the number shown
against ‗R‘ in the Annexure-II, the batch or lot shall be declared as not of standard quality.

B. Bursting Volume and Pressure Test - Sample condoms shall be tested for Bursting
Volume and Pressure Test. Statistical sampling for this test shall be done in accordance with
the plan set out in Annexure III to this Schedule. If the cumulative total of rejects ‗R‘ is found
545