2. 2
Content:
Aim
Rational
Objective
Definitions
CDSCO
Import Of Cosmetic
Manufacture Of Cosmetics.
Requirements pertaining to labelling of products:
Offences and penalties
Conclusion
References
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
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.
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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 4
6. DEFINATION:
As per Drugs and CosmeticsAct, 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:
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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
8. Spurious cosmetics: For the purposes of this Chapter, a drug
shall be deemed to be spurious,—
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(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.
9. Adulterated cosmetics:
For the purposes of this Chapter, a cosmetic shall be deemed to be adulterated,-
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(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
10. (d) if it bears or contains, for purposes of colouring only, a colour other
than one which is prescribed; or
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(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.
11. CDSCO :
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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 LicensingAuthorities 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
CosmeticsAct 1940 and Rules made there under.
13. FUNCTIONALITIES
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• 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.
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. Import of Cosmetic:
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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.
16. Documents are required to be submitted for grant of registration certificate to
import:
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• Covering letter by the applicant Form 42
• Treasury Challan Power of Attorney
Schedule D III
• Original or a copy of the Label.
• Free Sale Certificate (FSC)/MarketingAuthorization letter/Manufacturing License,
• if anyProduct specification and testing protocol.
• List of countries where Market Authorization or import permission or registration was
granted.
• Pack insert,
• if any Soft copies of the information about the brands, products and manufacturer
17. Who can apply for Registration of Import of
Cosmetics / who can be an importer:
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(i) The Manufacturer himself having registered
office in India.
(ii) TheAuthorisedAgent of the Manufacturer
(iii) The Subsidiary of the Manufacturer
(iv) Any other importer
18. Regulatory Provisions on Sale & import of Cosmetics :
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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. Acosmetic containing ingredient which render it injurious or harmful or
unsafeto use.
iv. Acosmetic 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.
19. Manufacture Of Cosmetics: Regulatory Provision Relating To
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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.
20. To manufacture any of these products, a license has to be obtained from a
LicensingAuthority 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 PharmacyAct, 1948; or
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21. 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 LicensingAuthority 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 theAct. They are then required to submit a
detailed report to the LicensingAuthority which can then decide whether to
grant the license or not.
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22. 2.Conditions of License
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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.
23. 3.Requirements of factory premises for manufacture of
cosmetics:
7. Working benches for the operation of cosmetics.
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as per Schedule M (II) of Drug and Cosmetic rule 1945
GENERALREQUIREMENTS:
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.
24. REQUIREMENT OF PLANTAND 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 7 25
25. C. NAIL POLISHES AND NAIL LACQUERS:
1.Equipment:
a.Asuitable 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.
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26. 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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27. 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.
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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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28. I.EYE BROWS, EYE LASHES, EYE
LINERS:
a. Mixing tanks
b. Asuitable mixer.
c. Homogenizer.
d. Weighing and measuring devices.
e. Filling and sealing equipment.
f. An area of 15 square meters is recommende
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 recommende
d.
d.
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29. The requirements pertaining to labelling of products:
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🠶 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)
30. PARTICULARS TO BE SHOWN IN THE MANUFACTURING RECORDS:
(schedule ‘U’)
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0
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.
32. CONCLUSION
All the cosmetics which are
manufactured and imported must be
within the regulatory provisions of
D&CAct.1940 & rules thereunder.
If not then product will be BANNED
for its sale in INDIAN Market
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![1
PRESENTED BY :
Sathish Kumar.P
M.Pharm [ II Sem ]
Department Of Pharmaceutics](https://image.slidesharecdn.com/cosmeticregulation-190217191719-231029144000-f547bc18/85/cosmeticregulation-190217191719-pptx-1-320.jpg)
