Extracts from the Drugs and Cosmetics Act, 1940
Misbranded cosmetics
Spurious cosmetics
Prohibition of import of certain drugs or cosmetics
Power of Central Government to prohibit import of drugs and Cosmetics in public interest
Cosmetic means any article intended to be
rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise
applied to, the human body or any part thereof for cleansing, beautifying,
promoting attractiveness, or altering the appearance, and includes any article
intended for use as a component of cosmetic;
(9C)
Misbranded cosmetics- For
the purposes of this Chapter, a cosmetic shall be deemed to be misbranded-
(a) if it contains
a colour which is not prescribed.
or
.
(b) if it is not labelled in the prescribed manner; or
(c) if the label or
container or anything accompanying the cosmetic bears any statement which is
false or misleading in any particular.
(9D)
Spurious cosmetics- For the
purposes of this Chapter, a cosmetic shall be deemed to be spurious,-
(a) if it is
imported under a name which belongs to another cosmetic; or
(b) if it is an imitation of, or is a
substitute for, another cosmetic or resembles another cosmetic in a manner
likely to deceive or bears upon it or upon its label or container the name of
another cosmetic, unless it is plainly and conspicuously marked so as to reveal
its true character and its lack of identity with such other cosmetic; or
(c) if the label or container bears the name
of an individual or a company purporting to be the manufacturer of the cosmetic
which individual or company is fictitious or does not exist; or
(d) if it purports
to be the product of a manufacturer of whom it is not truly a product.
(10)
Prohibition of import of certain drugs or cosmetics - From such date as may be fixed by the
Central Government by notification in the Official Gazette in this behalf, no
person shall import-
(a) any drug or
cosmetic which is not of standard quality;
(b) any misbranded
drug or misbranded or spurious cosmetic;
(bb) any
adulterated or spurious drug;
(c) any drug or cosmetic for the import of
which a licence is prescribed, otherwise than under, and in accordance with,
such licence;
(d) any patent or
proprietary medicine, unless there is displayed in the prescribed manner on the
label or container thereof the true formula or list of active ingredients contained in it together
with the quantities thereof;
(e) any drug which
by means of any statement, design or device
Accompanying it or by any other means,
purports or claims to cure or mitigate any such disease or ailment, or to have
any such other effect, as may be prescribed;
(ee)
any cosmetic containing any ingredient which may render it unsafe or harmful
for use under the directions indicated or recommended;
(f) any drug or
cosmetic the import of which is prohibited by rule made under this Chapter.
Provided that nothing in the section shall
apply to the import, subject to prescribed conditions, of small quantities of
any drug for the purpose of examination, test or analysis or for personal use
Provided further that the Central Government
may, after consultation with the Board, by notification in the Official
Gazette, permit, subject to any conditions specified in the notification, the
import of any drug or class of drugs not being of standard quality
(10A)
Power of Central Government to prohibit import of drugs and Cosmetics in public
interest - Without
prejudice to any other provision contained in this Chapter, if the Central
Government is satisfied that the use of any drug or cosmetic is likely to
involve any risk to human beings or animals or that any drug does not have the
therapeutic value claimed for it or contains ingredients and in such quantity
for which there is no therapeutic justification and that in the public interest
it is necessary or expedient so to do then, that Government may, by
notification in the Official Gazette, prohibit the import of such drug or
cosmetic
(11)
Application of law relating to sea customs and powers of Customs Officers- (1) The law for the time being in force
relating to sea customs and to goods, the import of which is prohibited by
section 18 of the Sea Customs Act, 1878 (18 of 1978) shall, subject to the
provisions of Section 13 of this Act, apply in respect of drugs and cosmetics
the import of which is prohibited under this Chapter, and officers of Customs
and officers empowered under this Act to perform the duties imposed thereby on
a Commissioner of Customs and other officers of Customs, shall have the same
powers in respect of such drugs and cosmetics as they have for the time being
in respect of such goods as aforesaid.
(2) Without prejudice to the provisions of
sub-section (1), the Commissioner of Customs or any officer of the Government
authorised by the Central Government in this behalf, may detain any imported
package which he suspects to contain any drug or cosmetic the import of which
is prohibited under this Chapter and shall forthwith report such detention to
the Drugs Controller, India, and if necessary, forward the package or sample of
any suspected drug or cosmetic found therein to the Central Drugs Laboratory
IMPORT OF
COSMETICS
(129)
Statement to accompany imported cosmetics- All consignments of cosmetics sought to be imported shall be
accompanied by an invoice or statement showing the name and quantities of each
article of cosmetic included in the consignment and the name and address of the
manufacturer.
(130)
Documents to be supplied to the Collector of Customs - Before any cosmetics are imported, a
declaration signed by or on behalf of the manufacturer or by or on behalf of
the importer that the cosmetics comply with the provisions of Chapter III of
the Act, and the rules made thereunder, shall be supplied to the Collector of
Customs.
(131)
Procedure for the import of cosmetics
- (1) If the officer appointed at the post of entry by Central Government has
reason to believe that any cosmetic contravenes any of the provisions of the
Act or the rules made thereunder he may take sample of the cosmetic from the
consignment for inspection. If on examination of the sample defects are noticed
the officer shall advice the Commissioner of Customs for further action to be
taken.
If the suspected contravention of the
provisions of the Act or the rules is such as may have to be determined by
test, the officer shall send the sample to the laboratory established for the
purpose for performing such tests. The consignment of the said cosmetic shall
be detained till such time that the test report on such sample is received from
the Director of the said laboratory or any other officer of the laboratory
empowered by him in this behalf with the approval of the Central Government.
Provided that if the importer gives an
undertaking in writing not to dispose of the cosmetic without the consent of
the Commissioner of Customs and to return the consignment or such portion
thereof as may be required, the Commissioner of Customs shall make over the
consignment to the importer.
(2) If the importer who has given an
undertaking under the proviso to sub- rule (1) is
required by the Collector of Customs to return the consignment or portion
thereof within ten days, of receipt of the notice.
(3) If the Director of the laboratory
established for the purpose by the Central Government or any other officer of
the laboratory empowered by him in this behalf with the approval of. the
Central Government, reports to the Commissioner of Customs or to the officer
mentioned in sub-rule (1) above that the sample of any cosmetic in a
consignment contravenes the provisions of Chapter III of the Act or the rules
made thereunder and that the contravention is such that it cannot be remedied
by the importer, the Commissioner of Customs shall communicate the report forth
with to the importer who shall within two months of receiving such a
communication either send back all the cosmetic of that description in the
consignment to the country in which it was manufactured or to the country from
which it was imported or hand it over to the Central Government which shall
cause it to be destroyed.
Provided that the importer may within thirty
days of receipt of the report make a representation against the report to the
Commissioner of Customs who shall forward the representation with a fresh
sample of the cosmetic to the Drugs Controller, India, who after obtaining, if
necessary, the report of the Director of the Central Drugs Laboratory shall
pass orders thereon which shall be final.
(4) If the Drugs Controller or any other
officer empowered by him in this behalf with the approval of Central Government
reports to the Commissioner of Customs after inspection of the sample of
cosmetic and if necessary, after obtaining a test report thereon that the
sample of the said cosmetic contravenes in any respect the provisions of
Chapter III of the Act or the rules made thereunder but that the contravention
is such that it can be remedied by the importer the Commissioner of Customs
shall communicate the report fortl1with to the importer and permit him to
import the cosmetic on his giving an undertaking in writing not to dispose of
the cosmetic without the permission of the officer authorised in this behalf by
the Central Government.
(132)
Exemption of cosmetics -
Cosmetics as may be specified in Schedule D shall be exempted from the
provisions of Chapter III of the Act and the rules made thereunder to the
extent and subject to the conditions specified in that Schedule.
(133)
Import through points of entry
- No cosmetic shall be imported into
(134)
Cosmetic to contain Dyes, Colours and Pigments - No Cosmetic shall contain Dyes, Colours
and Pigments other than those specified by the Bureau Indian Standards (IS:
4707 Part I as amended) and Schedule Q.
The permitted Synthetic Organic Colours and
Natural Organic colours used in the Cosmetic shall not contain more than-
(i) 2 parts per million of Arsenic
calculated as Arsenic Trioxide.
(ii) 20 parts per million of Lead calculated
as Lead.
(iii) 100 parts per million of Heavy Metals
other than Lead calculated as the total of the respective metals.
(134A)
Prohibition of import of cosmetic containing hexachlorophene -
No cosmetic containing hexachlorophene shall
be imported.
(135)
Import of cosmetics containing lead or arsenic compound Prohibited - No cosmetic shall be imported in which a
lead or arsenic compound has been used for purposes of colouring.
(135A)
Import of cosmetics containing mercury compounds prohibited-
No cosmetic shall be Imported which contains
mercury compounds.
(136)
Import of cosmetics for personal use
-
Small quantities of cosmetics the import of which is otherwise prohibited under
Section 10 of the Act, may be imported for personal use subject to the
following conditions-
(i) The cosmetics shall form part of a
passengers baggage and shall be the property of, and be intended for, the bona
fide use of the passenger; and
(ii) The cosmetics shall be declared to the
Customs authorities if they so direct.
SCHEDULE Q
(See Rules 134 and
144)
Part I list of dyes, colours and pigments
permitted to be used in cosmetics and soaps as given under is: 4707 (Part
I)-1988 as amended by the Bureau of Indian Standards.
|
Common Name of the
Colour |
Colour Index Number |
Chemical Name of the
Colour |
|
1 |
2 |
3 |
|
|
42085 |
Monosodium salt of
4-N-ethyl-p-sulfo-benzylamino)-disphenylmethylone-(1-(N-ethyl-Np-sulfoniumbenzyl)
2, 5-cyclohexadienimine) |
|
Light Green SF Yellowish |
42095 |
Disodium salt of 4-[4-N-ethyl-p-sulfobenzylamino)-phenyl)
4-sulfoniumphenyl) methylenel]-(-N-ethyl-N-sulfobenzyl)
2, 5-Cyclohexadienimine |
|
Tartrazine |
19140 |
Trisodium salt of
3-carboxy-5-hydroxy-1-p-sulfophenyl 4-p-sulfophenylazo-pyrazole |
|
Sunset Yellow FCF |
15985 |
Disodium salt of 1-p-sulfophenylazo-2-naphthol-6-sulfonic
acid |
|
Ponceau 3R |
16155 |
Disodium salt of a mixture of
1-alkylphenylazo-2-naphthol-3, 6-disulfonic acids |
|
Amaranth |
16185 |
Trisodium salt of
1-(4-sulfo-1-napthylazo)-2-naphthol 3, 6-disulfonic acid |
|
Erythrosine |
45430 |
Disodium salt of 9-0-carboxyphenyl-6 hydroxy 2,4,5,7-tetraiodo-3-isoxanthone |
|
Ponceau SX |
17400 |
Disodium salt of
2-(5-sulfo-2,4-xylyl-azo)-1-naphthol-4-sulfonic acid |
|
Brilliant Blue FCF |
42090 |
Disodium salt of 4-(9-4-(N-ethyl-p-sulfobenzylamino-phenyl)-(2-sulfonium-phenyl)-methylene)-(1-(N-ethyl-N-p-sulfobenzyl)-2, 5-cyclohexadienimine) |
|
Indigocarmine |
73015 |
Disodium salt of 5, 5'-indigotindisulfonic acid |
|
Wool Violet 5 BN (Acid violet 6B) |
42640 |
Monosodium salt of 4-(N-ethyl-p-sulfobenzylamino)-phenyl)-(4-(N-ethyl-p-(sulfonium-benzylamine)-phenyl) methylene)-(N,N-dimethyl-2,5-cyclohexadienimine) |
|
Light Green SF |
42095 |
Calcium salt of 4-(4-N-ethyl-p-sulfobenzyl) (minophennyl) |
|
Yellowish |
|
(4-sulfonium-phenyl)-methylene),
(1(N-ethyl-N-p-sulfobenzyl-)2,5-cyclohexadienimine) |
|
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 sulphonium-phenyl) methylene)(1-N-ethyl-N-p-sulfobenzyl)-2, 5,-cyclohexadienimine) |
|
Acid Fast Green |
42100 |
Monosodium salt of 4-(4-(ethyl-p-sulfobenzylamino)-phenyl)-(O-chlorophenyl)-methylene)-1-(N-ethyl-N-p-sulfonium-benzyl-2,5-cyclohexadienimine) |
|
Pyranine Concentrated |
59040 |
Trisodium salt of
10-hydroxy-3,5,8-pyrenetrisulfonic 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
indandione |
|
Poneceau 2 R |
16150 |
Disodium salt of 1-xylylazo-2-naphthol-3,6-disulfonic
acid |
|
Lithol Rubin B |
15850 |
Monosodium salt of 4-(0-sulfo-p-tolylazo)
3-hydroxy-2-naphthoic acid |
|
Lithol Rubin BCA |
15850 |
Calcium salt of 4-(0-sulfo-p-tolylazo)
3-hydroxy-2-naphthoic acid |
|
|
15500 |
Monosodium salt of 1-0-carboxyphenylazo-2-naphthol |
|
|
15500 |
Barium salt of
1-0-carboxyphenylazo-2-naphthol |
|
|
15500 |
Calcium salt of
1-0-carboxyphenylazo-2-naphthol |
|
Toney Red |
26100 |
1-p-phenylazophenylazo-2-naphthol |
|
Oil Red OS |
26125 |
1-Xylylazoxylylazo-2-naphthol |
|
Tetrabromofluorescein |
45380 |
2,4,5,7, Tetrabromo-3,6
fluorandiol |
|
Eosin TS |
45380 |
Disodium salt of
2,4,5,7,-tetrabromo-9-0-carboxyphenyl-6-hydroxy-3-isoxanthone |
|
Eosin YSK |
45380 |
Dipotassium salt of
2,4,5,7,-tetrabromo-9-0-carboxyphenyl-6-hydroxy-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
Tetrabromofluorescien |
45410 |
2,4,5,7,-Tetrabromo-12,13,14,15-tetrachloro-3,
6-fluorandiol |
|
Phloxine B |
45410 |
Disodium salt of
2,4,5,7,-tetrabromo-9-(3,4,5,6,-tetrachloroo-carboxyphenyl)-6-hydroxy-3-isoxanthone |
|
Bluish
|
45457 |
1,4,5,8,15-Pentabromo-2-7-dicarboxy-3,6-fluorandiol |
|
Helindone Pink CN |
73360 |
5,5-Dichloro-3,3-dimethyl-thioindigo |
|
|
15800 |
Calcium salt of
3-hydroxy-4-phenylazo-2-naphthoic acid |
|
Deep Maroon (Fanchon
Maroon) |
15880 |
Calcium salt of
4-(1-sulfo-2-napthylazo)-3-hydroxy-2-naphthoic acid |
|
Toluidine Red |
12120 |
1-(o-Nitro-p-tolylazo)-2-naphthol |
|
Flaming Red |
12085 |
1-(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-b,b'-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-carboxypheny-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-carboxypheny-6-hydroxy-4,5-diiodo-3-isoxanthone |
|
Orange TR |
45456 |
4,5,15-Tribromo-2,7-dicarboxzy-3,6-fluorandiol |
|
Alizarin |
58000 |
1,2-Anthraquinonediol |
|
Dibromodiiodofluorescein |
45371 |
4,5-Dibromo-2,7-diiodo-3,6-fluorandiol |
|
Resorcin Brown |
20170 |
Monosodium salt of
4-p-sulfophenylazo-2-(2,4,xylylazo)-1,3-rescorcinol |
|
Alphazurine FG |
42090 |
Diammonium salt of 4-(N-ethyl-p-sulfobenzylamino)-phenyl)-(2-sulfoniumphenyl)-methylene)(1-(N-ethyl-N-p-sulfobenzyl)-2,5-cyclohexadienimine |
|
Alizarin 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-sulfoniumphenyl -methylene) (N-ethyl-N-Benzyl
2,5-cyclohexadienimine) |
|
Patent Blue CA |
42052 |
Calcium salt of
4-(4(N-ethyl-benzyl-amino)-phenyl)-(5-hydroxy-4-sulfo-2-sulfonium-phenyl-methylene)-(N-ethyl-N-Benzyl
2,-5-cyclohexadienimine) |
|
Carbanthrene Blue |
69825 |
3,3-Dichloroindanthrene |
|
Naphthol Blue Black |
20470 |
Disodium salt of 8-amino-7-p-nitrophenylazo
3-phenylazo-1-naphthol 3,6-disulfonic acid |
|
Alizurol purple SS |
60725 |
1-hydroxy-4-p-toluino-anthraquinone |
|
Acid Red 89 |
23910 |
|
|
Acid Red 97 |
22890 |
|
|
Acid Blue 1 |
42045 |
|
|
Food Blue 3 |
42045 |
|
|
Natural |
75480 |
|
|
Solvent Blue 4 |
44045 |
|
|
Solvent Yellow 18 |
12740 |
|
|
Food Yellow 12 |
12740 |
|
|
Solvent Red 1 |
12150 |
|
|
Solvent Yellow 32 |
48045 |
|
|
Fanchon Yellow (Hansa
Yellow G) |
11680 |
(a)-(O-Nitro-p-tolylazo)
acetoacetanilide |
PART II-LIST OF COLOURS
PERMITTED TO BE USED IN SOAPS
|
Common Name of the
Colour |
Colour Index No. |
Chemical Name of the
Colour |
|
Phthalocyanine Blue |
74160 |
(phthalocyaninate (2-) copper |
|
Iragalite Rod CVPB Paste or Pigment Orange 5 |
12075 |
1-(2,4-dinithro phenylazo)-2-Naphthalenol |
|
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 |
Polychlor copper
Phthalocyanine |
|
Pigment Yellow 3 |
11710 |
2-(4-Chloro-2-nitrophenyl)-azo-N-(-2-Chlorophenyl)-3-Oxobutamide |
|
Irgalite Cermine F-P
Powder or Pigments Red 5 |
12490 |
N-(5-Chloro-2,4-Dimethoxy-phenyl)4-(CS-diathylamine)
Sulfonyl-2-methoxyphenyl)azo-3-hydroxy-2-naphthalene
carboxamide |
|
Monolite Red 4R HV Paste or Pigment Red 7 |
12420 |
N-(4-Chloro-2-methylphenyl-4-(4-Chloro-2-methylphenyl) azo 3-hydroxy-2-naphthalenol
Carboxamide |
|
Oil Red No.1 or Solvent Red 24 or Oil Red 3R |
26105 |
4-0-Tolylazo-Toluidine azo 2-naphthalenol |
This list of
colours for use in soaps is in addition to those colours already given in
Schedule Q and are used for soaps.
SCHEDULE S
See Rule 150-A
STANDARDS FOR COSMETICS
Standards for cosmetics in
finished form
The
following cosmetics in finished form shall conform to the Bureau of Indian
Standards (BIS) specifications laid down form time to time by the Bureau of
Indian Standards (BIS).
|
1. |
Skin Powders |
2. |
Skin Powder for infants |
|
3. |
Tooth Powder |
4. |
Tooth Paste |
|
5. |
Skin Creams |
6. |
Hair Oils |
|
7. |
Shampoo, Soap-based |
8. |
Shampoo, Synthetic-Detergent based |
|
9. |
Hair Creams |
10. |
Oxidation hair dyes, Liquid |
|
11. |
|
12. |
Nail Polish (Nail Enamel) |
|
13. |
After shave Lotion |
14. |
Pomades and
Brilliantines |
|
15. |
Depliatories Chemicals |
16. |
Shaving Creams |
|
17. |
Cosmetic Pencils |
18. |
Lipstick |
|
19. |
Toilet Soap |
20. |
Liquid Toilet Soap |
|
21. |
Baby Toilet Soap |
22. |
Shaving Soap |
|
23. |
Transparent Toilet Soap |
24. |
Lipsalve, IS:10284 |
|
25. |
Powder Hair Dye, IS:10350 |
26. |
Bindi (Liquid), IS:10998 |
|
27. |
Kum Kum Powder, IS: 10999 |
28. |
Henna Powder, IS: 11142 |