cosmetics, definition, export-import and other regulation of cosmetics as per D & C act

1. COSMETICS AND ITS
REGULATIONS
IN INDIA
Bindu Kshtriya
khanchibindu95@gmail.com

2. CONTENTS-
➢ DEFINITION
➢ DRUG AND COSMETICS ACT 1940 & RULE 1945 LABELLING
REQUIREMENTS FOR COSMETICS
➢ DECLARATION OF INGREDIENTS
➢ IMPORT OF COSMETICS
➢ COMPARE REGULATORY REQUIREMENT OF
INDIA WITH USA & E.U
➢ REFERENCES

3. COSMETICS
Drug and Cosmetic Act1940&rule1945:
Section 3(aaa)
(1) articles intended to be rubbed, poured, sprinkled,
or sprayed on, introduced into, or otherwise applied
to the human body or any part thereof for
cleansing, beautifying, promoting attractiveness, or
altering the appearance, and includes
(2) articles intended for use as a component of any
such articles.

4. MISBRANDED COSMETICS
Section – 9C &17c
a) Contains colour which is not prescribed or
b) Not labelled in prescribed manner or
c) Label or container accompanying cosmetic
bears an statement which is false or
misleading.

5. SPURIOUS COSMETICS
Section-9D & 17 D
a) Manufacturing under a name which belong to another
cosmetics
b) Imitation of or substitute(copy)
c) Label or container bears name of individual or company
purporting to be mfg of cosmetics which is fictitious or
doesn’t exist
d) Purports to be product of manufacturing of whom its not
truly a product.

6. ADULTRATED COSMETICS
Section-17 E
(a) If it consists in whole or in part, of any filthy, putrid or decomposed substance; or
(b) If it has been prepared, packed or stored under unsanitary conditions whereby it
may have been contaminated with filth or whereby it may have been rendered
injurious to health; or
(c) If its container is composed, in whole or in part, of any poisonous or deleterious
substance which may render the contents injurious to health; or
(d) If it bears or contains, for purposes of colouring only, a colour other than one
which is prescribed; or
(e) If it contains any harmful or toxic substance which may render it injurious to
health; or
(f) If any substance has been mixed therewith so as to reduce its quality or strength.

7. DRUG & COSMETICS
ACT1940 & RULE 1945
• ACT consist of 5 CHAPTER
• ->CHAPTER 3-import of drug & cosmetics
->CHAPTER 4- manufacturing ,sale ,
distribution drugs & cosmetics
. RULE of the ACT divided in different parts
->part13-import of cosmetics
->part14-manufacturing of cosmetics
->part15-labeling, packaging , standard
of cosmetics
->part15-A-approval of institute for
analysis of drug ,cosmetics &
raw material

8. Schedule to the rules
• Schedule M2- GMPs
requirements , factory -
-premises , plant, equipment
for manufacturing of cosmetics
• Schedule Q-list of coal tar colours permit
in cosmetics &soaps
• Schedule S -standard for cosmetics
• Schedule U1-particulars to be shown in
manufacturing records of
cosmetics.
Cont....
DRUG & COSMETICS
ACT1940 & RULE 1945

9. 1.Schedule M-2-
- Form 31-to obtain license for mfg. of
cosmetics
2.Schedule Q- -rule 134&144
condition no.1- a. no coal tar colour (i.e other than prescribed in sch.Q) b.2ppm arsenic oxide
20ppm of lead
100ppm heavy metals
condition no. 2- no cosmetics import that contain coal tar dye colour , coal tar base , coal tar intermediate for eyebrow ,
eyelash , around the eye.
Cont...
.
DRUG & COSMETICS ACT1940
& RULE 1945

10. .
3. Schedule S- (standard for cosmetics in finished form)BIS--classified raw material for cosmetics in 2 categories
part 1 (GRAS)generally recognised as safe
part 2 (GNRAS) generally not recognised as safe
4.Schedule u(1) --
rule 142 & 142 B
Offences & penalties -related to import ,
manufacturing ,
sales ,distribution
mention in
SECTION 3,18,27A
DRUG & COSMETICS ACT1940
& RULE 1945

11. DECLARATION OF
INGREDIENTS
->Rule 148(7) of D&C rule 1945 makes provision for
listing of ingredients
• present in concentration of >1% listed in descending
order of weight or volume
• Concentration<1%- any order & preceded by word
ingredients
• (need not appear for packs <60ml for liquid or 30grm , For solid &semisolid)

12. LABELLING
REQUIREMENTS
Labelling declaration
i) Name and address of the importer;
ii) Generic or common name of the commodity packed;
iii) Net quantity in terms of standard unit of weights and measures;
iv) Month and year of packing in which the commodity is
manufactured or packed or imported; and
v) Maximum retail sales price (MRP) at which the commodity in
packaged form may be sold to the end consumer.

13. LABELLING
REQUIREMENTS
On both the inner & outer labels:-
a). Name of the cosmetic.
b). Name of the manufacturer and
complete address of the premises of the
manufacturer where the cosmetic has
been manufactured .

14. LABELLING
REQUIREMENTSOn the outer label
a). A declaration of the net contents expressed in terms of
weight for solids/ semi solids, fluid measure for liquids.
(Note: In the case of package of perfume, toilet water or
the like, the net content which does not exceed 60 ml or
any package of solid or semi solid cosmetic where the
net content doesn’t exceed 30 gms, the statement of net
content need not appear).
b). The names of ingredients in the order of percentage of
content.

15. LABELLING
REQUIREMENTS
On the inner label
a) Where a hazard exists, adequate directions for safe use,
warning, caution or special direction required to be observed by
the consumer, statement of the names and quantities of the
ingredients that are hazardous or poisonous.
b) The names of ingredients in the order of percentage of
content.
-Batch number preceded by the letter “B”
-Manufacturing license number preceded by the letter “M.”

16. IMPORT OF COSMETICS
• Require compulsory registration certificate for importing from DCGI
(CDSCO). ( April 1st , 2013
• Registration procedure—
Application for registration on form-42, along with requisite documents
submitted to DCGI,CDSCO, FDA OFFICE in NEW DELHI
List of documents:
-Particulars of the manufacturer & manufacturing premisis
-Proof of payment of the requested registration> FEES —
USD- $250
-particulars of the cosmetics to be registered
cont...

17. IMPORT OF COSMETICS
• Time lines for processing of application—
Issuance of registration certificate-- with in 6 months from date of submission of
application and the required documents.
• Registration certificate validity—
3 years from date of its issuance
• Import of cosmetics only through specified ports of entry:
Sea ports =Chennai, Kolkata, Mumbai,
and Cochin
Airports=Delhi, Mumbai, Chennai, Kolkata, and Ahmedabad.

18. THANK YOU
BINDU KSHTRIYA