The document discusses regulations for cosmetics in India according to the Drugs and Cosmetics Act of 1940 and Rules of 1945. It outlines the objectives of cosmetic regulations, definitions, requirements for importing and manufacturing cosmetics including licensing and labeling. Penalties are specified for offenses like importing spurious cosmetics or those containing harmful ingredients or misbranded products. Overall the document provides an overview of the regulatory framework and compliance requirements for the cosmetics industry in India.

1. 1
PRESENTED BY :
PRAVIN DHAS
M.PHARM [ II SEM ]
PHARMACEUTICS
GUIDED BY :
DR. S. G. GATTANI
HOD OF PHARMACEDUTICS

2. Content :
 Aim
 Rational
 Objective
 Definitions
 CDSCO
 Import Of Cosmetic
 Manufacture Of Cosmetics.
 Requirements pertaining to
labelling of products:
 Offences and penalties
 Conclusion
 References
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3. AIM
The present contribution gives insight into the important cosmetic regulations in
areas of premarket approval, ingredient control, and labeling and warnings, with a
special focus on the cosmetic regulatory environments in the INDIA
RATIONAL
The regulatory framework, compliance requirement, efficacy, safety, and
marketing of cosmetic products are considered the most important factors for
growth of the cosmetic industry.
Therefore one should regulate the requirement, Quality, efficacy, safety, and
marketing of cosmetic products for their safe application. 3

4. OBJECTIVE
There are different regulatory bodies across the globe that
have their own insights for regulation; moreover,
governments such as the United States, European Union, and
Japan follow a stringent regulatory framework, whereas
cosmetics are not so much strictly regulated in countries
such as India, Brazil, and China
We are Nationals of INDIA that’s why we should know
about our country regulations and their efforts to control
such a grooming market of cosmetics
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5. COSMETIC &
COSMECEUTICALS
MANUFACTURER
OR
IMPORTER
STANDARDS
&
GRANTS
MRP OF PRODUT
EFFICACY & USE
APPLICATION
SAFETY &
TOXIOCITY
PROFILE
COMPOSITION
OF COSMETIC
PRODUCT
BEFORE USE OF COSMETIC USER MUST BE LITERATE ABOUT
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6. DEFINATIONS:
As per Drugs and Cosmetics Act, 1940
Cosmetics:
“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”
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7. Misbranded cosmetics:
For the purposes , 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 a 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
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8. Spurious cosmetics:For the purposes of this Chapter, a drug
shall be deemed to be spurious,—
(a) if it is imported under the name which belongs to another
cosmetic; or
(b) if the label or the container bears the name of an
individual or company purporting to be the
manufacturer of the cosmetic, which individual or
company is fictitious or does not exist; or
(c) if it purports to be the product of a manufacturer of
whom it is not truly a product.
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9. Adulterated cosmetics:
For the purposes of this Chapter, a cosmetic shall be deemed to be
adulterated,-
(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 insanitary
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 9

10. (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.
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11. CDSCO :
Under the provisions of Drugs and Cosmetics Act, 1940 and Rules made thereunder,
the manufacture of cosmetics is regulated under a system of inspection and
licensing by the State Licensing Authorities appointed by the respective State
Governments while the import of cosmetics is regulated under a system of registration
by the Central Licensing Authorities appointed by Central Government.
The office of Drugs Controller General (India) i.e Central Drugs Standard
Control Organization [CDSCO]functions as the Central Licensing Authority grants
the registration certificate and regulates the import of cosmetics in India vide Gazette
notification G.S.R 426(E) under the provisions of Drugs and Cosmetics Act 1940 and
Rules made there under.
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13. FUNCTIONALITIES
• Scrutiny of applications relating to registration of cosmetic products for Import
into the country as per the requirements of Drugs and Cosmetics Act 1940 and
Rules, 1945 thereunder.
• Scrutiny of various applications for NOC /Clarification relating to cosmetic
products import.
• Preparation of draft replies to RTI, court cases, VIP references and Parliament
Question related to cosmetics.
• Replying to Government correspondences/ BIS as and when required.
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14. • Handling of public enquiries/hearings relating to cosmetic import registration
process and providing guidance thereto.
• Handling of public/NGOs/Consumer forums complaints/grievances regarding
standards of cosmetics products.
• Amendment of Drugs & Cosmetic Rules, 1945 with respect to registration of
import of Cosmetic products.
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15. 15

16. Import of Cosmetic:
A: PURPOSE:
1. The Government of India has issued a Gazette Notification G.S.R 426(E) dated 19th May 2010 for
amending the Drugs & Cosmetics Rules, 1945 providing for registration of import of cosmetics
into the Country.
2. The above provision was to come into effect from the 1st April, 2011. But in view of the various
possible difficulties apprehended by the stakeholders, its implementation has been deferred till the
31st March, 2013.
3. With a view to implementing the provisions of the aforesaid notification and facilitate the
registration process for import of cosmetics, the following guidelines / clarifications, including
general requirements for grant of Registration Certificate, are being provided hereunder.
4. These guidelines are not exhaustive and may be augmented / modified further through additional
guidelines or amendments of these rules, if considered necessary.
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17. Documents are required to be submitted for grant of registration certificate to import:
i. Covering letter by the applicant
ii. Form 42
iii. Treasury Challan
iv. Power of Attorney
v. Schedule D III
vi. Original or a copy of the Label.
vii. Free Sale Certificate (FSC)/Marketing Authorization letter/Manufacturing
License, if any
viii. Product specification and testing protocol.
ix. List of countries where Market Authorization or import permission or
registration was granted.
x. Pack insert, if any
xi. Soft copies of the information about the brands, products and manufacturer
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18. Who can apply for Registration of Import of
Cosmetics / who can be an importer:
(i) The Manufacturer himself having
registered office in India.
(ii) The Authorised Agent of the Manufacturer
(iii) The Subsidiary of the Manufacturer
(iv) Any other importer
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19. Regulatory Provisions on Sale & import of Cosmetics :
Central Government [CDSCO] by notification in the Official Gazette in this behalf
give a notice , no person shall import or sale
i. Any cosmetic this is not of Standard Quality.
ii. Any cosmetic this is misbranded or spurious.
iii. A cosmetic containing ingredient which render it injurious or harmful or
unsafeto use.
iv. A cosmetic whose import is prohibited by rule.
v. Any cosmetic accept toilet soap containing hexachlorophene.
vi. Any cosmetic in which lead or arsenic compound used for coloring purpose.
Vii. Any cosmetic which contains mercury compounds.
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20. Manufacture Of Cosmetics: Regulatory Provision Relating To
1. How to obtain License
 The procedure to be followed in order to manufacture cosmetics in India has
been laid down under the Drugs and Cosmetics Rules, 1945.Schedule M-II
classifies cosmetics into 11 broad product categories as:
1)Powders,
2) Creams, lotions, emulsions,
pastes, cleansing milks, shampoos,
pomade,brilliantine, shaving creams,
hair oils etc.,
3) Nail Polishes and Nail Lacquers,
4) Lipsticks & Lip Gloss etc.,
5) Depilatories,
6) Preparations used for eyes,
7) Aerosol,
8) Alcoholic Fragrance Solutions
(Cologne),
9) Hair Dyes,
10)Tooth Powders and Tooth Pastes
11) Toilet Soaps.
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21.  To manufacture any of these products, a license has to be obtained from a
Licensing Authority appointed by The State Government.
 The application has to be submitted in form (Form-31) along with a license
fee of Rs. 2500 and an inspection fee of Rs. 1000
 The manufacturer has to ensure that the production is done in the presence of a
competent and qualified technical staff and at least one of the staff persons
should possess the following educational requirements:
 Holds a Diploma in Pharmacy approved by the Pharmacy Council of India
under the Pharmacy Act, 1948; or
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22.  Is registered under the Pharmacy Act, 1948; or
Has passed the intermediate examination with Chemistry as one of the
subjects or any other examination as recognized by the Licensing Authority as
equivalent to it.
 Before granting or refusing the license, the Licensing Authority is required to
order inspection of the whole premises where the operations are to be carried
out.
 The inspectors are appointed under the Act. They are then required to submit a
detailed report to the Licensing Authority which can then decide whether to
grant the license or not.
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23. 2.Conditions of License
a) Manufacturer shall have to continue to provide and maintain the
premises, equipment and staff as at the time of grant of license.
b) Manufacturer should test each batch of raw material before its
use in the manufacture of cosmetic.
c) Manufacturer should have to test each batch of finished
cosmetics.
d) Manufacturer should have to maintain records of raw materials,
manufacturer of each batch of cosmetic and their testing.
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24. 3.Requirements of factory premises for manufacture
of cosmetics:
as per Schedule M (II) of Drug and Cosmetic rule 1945
 GENERAL REQUIREMENTS:
1. Location and Surroundings.
2. Buildings.
3. Water supply.
4. Disposal of water.
5. Health clothing and sanitary requirements of the staff
6. Medical devices.
7. Working benches for the operation of cosmetics.
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25.  REQUIREMENT OF PLANT AND EQUIPMENT
A. POWDER: (face powder, cake make-up, compacts, face packs, rouges etc.)
a. Powder mixer of suitable type provided with a dust collector
b. Perfume and color blender.
c. Ball mill or suitable grinder.
d. Filling and Sealing equipment
e. Weighing and measuring devices.
f. Storage tanks.
g. An area of 15 square meters is recommended.
B. CREAMS, LOTIONS, SHAMPOOS, HAIR OILS:
a. Mixing and storage tanks of suitable materials.
b. Suitable agitator.
c. Heating kettle steam gas or electrically heated.
d. Filling and Sealing equipment
e. weighing and measuring devices.
f. An area of 25 square meters is recommended
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26. C. NAIL POLISHES AND NAIL LACQUERS:
1. Equipment:
a. A suitable mixer.
b. Storage tanks.
c. Filling and sealing machine.
d. Weighing and measuring devices.
2. Premises:
a. It shall be suitable in an industrial area.
b. It shall be separate from other cosmetic manufacturing areas.
c. Floors, walls, and doors shall be proof.
3. Storage:All explosive solvent and ingredients shall be stored
in metal cupboards.
4. Manufacture:
Workers shall be asked to wear shoes in the section.
8
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27. D. LIPSTICKS:
a. Vertical mixer.
b. Mixing vessel.
c. Triple roller mill/ball mill.
d. Weighing and measuring devices.
e. An area of 15 square meters is recommended.
E. HAIR DYES:
a. Stainless steel tanks.
b. Mixer.
c. Filing and sealing unit.
d. Weighing and measuring devices
e. Gloves, masks.
f. An area of 15 square meter is recommended.
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28. F. TOOTH POWDER:
a. Weighing and measuring devices.
b. Dry mixer.
c. Stainless steel sieves.
d. Powder filling and sealing unit.
e. An area of 15 square meter is recommended.
G. TOOTH PASTES:
a. Weighing and measuring devices.
b. Kettle-steam, gas or electrically heated.
c. Planetary mixer
d. Tube filling equipment.
e. Crimping machine.
f. An area of 15 square meters is recommended.
10
H. AREOSOL:
a. Air compressor.
b. Mixing tanks
c. Filtering. Filling and cramping equipment.
d. Liquid filing unit
e. Leak test equipment.
f. fire extinguisher
g. An area of 15 square meters recommended.
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29. I. EYE BROWS, EYE LASHES, EYE
LINERS:
a. Mixing tanks
b. A suitable mixer.
c. Homogenizer.
d. Weighing and measuring devices.
e. Filling and sealing equipment.
f. An area of 15 square meters is recommended.
J. ALCOHOLIC FRAGRANCE SOLUTIONS:
a. Mixing tanks.
b. Filtering, filling and sealing equipment.
c. Weighing and measuring devices.
d. An area of 15 square meters is recommended.
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30. The requirements pertaining to labelling of products:
 Name of the product along with the manufacturing address must be mentioned on both
the inner and the outer labels. If the container is small in size then the principal place of
manufacturing and the pin code are enough.
 The outer label should clearly specify the net contents of the ingredients used in the
manufacture of the product.
 The inner label should contain the ‘directions for use’ along with any warning or caution
that may be necessary. It should also contain names and quantities of ingredients which
are hazardous in nature.
 A distinctive batch number preceded by letter ‘B’ along with manufacturing license
number preceded by letter ‘M’ must be mentioned on the label.
 Quality standards in case of the aforementioned categories of products must conform to
the Indian standards laid down and revised by the Bureau of Indian Standards (BIS)
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31. PARTICULARS TO BE SHOWN IN THE
MANUFACTURING RECORDS: (schedule ‘U’)
1. Serial number.
2. Name of the product.
3. Batch size.
4. Batch number.
5. Name of all ingredients and quantities used.
6. Actual production and packaging particulars
indicating the size and quantity of finished
packings.
7. Signature of the expert staff responsible for the
manufacture.
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34. 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.
OFFENCES AND PENALTIES
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35. CONCLUSION
All the cosmetics which are
manufactured and imported must be
within the regulatory provisions of
D&C Act.1940 & rules thereunder.
If not then product will be BANNED
for its sale in INDIAN Market
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36. REFERANCES
1. THE DRUGS AND COSMETICS ACT, 1940 (23 OF 1940) (As amended
up to the 31st December, 2016) and THE DRUGS AND COSMETICS
RULES, 1945 (As amended up to the 31st December, 2016)
2. https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/
Sharma P.P; Cosmetic formulation manufacturing and quality control; 3rd
Edition; Nirali Prakashan; chapter-1; P.13-33
3. http://www.cdsco.nic.in/forms/contentpage1.aspx?lid=1888
4. http://www.pharmatutor.org/articles/review-regulatory-provisions-
regarding-cosmetics-in India
5. http://blog.ipleaders.in/cosmetics-regulation-in-india-the-law-you-need-
to-know-before getting-into-cosmetics-manufacturing-business/
6. URL:http://www.cdsco.nic.in/writereaddata/G_S_R_%20 69(E).pdf.
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