Regulatory provisions relating to import of cosmetics., Misbranded and spurious cosmetics.

1. REGULATORY PROVISIONS
RELATING
TO IMPORT OF COSMETICS
DEV JAIN
M.PHARM

2. COSMETICS
• Cosmetics are regulated under The Drug and Cosmetic Act (D
& C Act)1940 and The Rule in 1945 and the labeling
Declarations by Bureau of Indian Standards (BIS). BIS sets the
standards for cosmetics for the products listed under
Schedule 'S' of the Drugs and cosmetics Rules 1945s.
• According to D & C Act Cosmetic is define as the 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.

3. • Chapter III of Drug and Cosmetic Act deals with import of
Drug and Cosmetic. Now import of certain cosmetic is
prohibited under section 10 of the Act and rules 134A, 135,
135A of Drug and Cosmetic Rules 1945 they are:
• Any cosmetic which is not of standard quality,
• Any misbranded or spurious cosmetic,
• Any cosmetic containing any ingredient which may render
it unsafe or harmful for use under the directions indicated
or recommended,
• Any cosmetic the import of which is prohibited by rule,
• Any cosmetic containing hexachlorophene,
• Any cosmetic in which lead and arsenic compound has
been used for coloring purpose,
• Any cosmetic which contains mercury compound.

4. Registration Guidelines

5. • As defined under Rule 21 of Drugs & Cosmetics Rules, 1945,
all cosmetic products imported for sale in India need to be
registered with licensing authority.
• Application for registration (Form-42) with required
documents, are submitted to Drugs Controller General (I),
CDSCO, FDA Bhavan, Kotla Road, New Delhi.
• This application will be accompanied by the fee specified
along with information and undertaking in Schedule D-III.
• Single application in Form 42 for any number of brands
manufactured at one or more locations by a single
manufacturer.
• Single registration certificate in Form 43 issued to a particular
applicant in respect of import of any number of brands
manufactured at one or more locations by a single
manufacturer.

6. • Skin powder
• Skin powder for infants
• Powder hair dye
• Tooth powder
• tooth paste
• Bindi
• Skin creams
• Hair oils
• Kumkum powder
• Shampoos, soap based
• Shampoos, synthetic detergent based
• hair creams
• Oxidation hair dyes, liquid
• Henna powder
• Cologne
• Nail polish
• Aftershave lotions
• Pomades & brilliantine
• Depilatories, chemical
• Shaving creams
• Cosmetic pencils
• Lipsticks
• Toilet soap
• Liquid toilet soap
• Baby toilet soap
• Transparent toilet soap
• Saving soap
• Lip salve
 28 cosmetics have been placed under schedule “S” (standards for
cosmetics) to the rules and are required to comply with Indian
standards and these are:

7. • Misbranded and Spurious cosmetics have
been define in section 17-C and 17-D as
under:
Misbranded cosmetic:
• If it contain a color which is not prescribed,
• If it not labeled in the prescribed manner,
• if the label or container bears any statement
which is false or misleading in any particular.

8. Spurious Cosmetic:
• A cosmetic shall be deemed to be spurious when:
• If it imported under a name which belongs to
another cosmetic,
• 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
• If it purport to be the product of a manufacturer
of whom it is not truly a product.

9. • Rule 134 of D&C Act stipulates that no
cosmetic shall be imported which
• contains a coal tar color other than the one
prescribed in schedule ’Q’.
• Coal tar color used in cosmetics shall not
contain more than:
• 2ppm of arsenic calculated as arsenic trioxide,
• 20ppm of lead calculated as lead,
• 100ppm of heavy metals other than lead
calculated as the total of the respective
metals.

10. OFFENCES AND PENALTIES
Contravention in brief Penalty
Import of spurious cosmetic or cosmetic
containing any ingredient which harmful for
use.
Imprisonment for term of 3 years which may
extends to 5 years with fine of five thousand
rupees.
Import of cosmetic whose import is prohibited
under section 10-A
Imprisonment for term of 3 years which may
extends to 5 years with fine of five thousand
rupees.
Repeated offence of above two. Imprisonment for term of 5 years and fine
which
may extend to 10 thousand rupees.
Sale/manufacture of cosmetic which is not of
standard or misbranded cosmetic
Imprisonment for term of 3 years which may
extends to 5 years with fine of five thousand
rupees.