Definition of cosmetics. Regulation provision relating to manufacture of cosmetics a. How to obtain license b. Conditions of license c. Regulatory provision on sale of cosmetics d. Loan license Offences and Penalties

1. REGULATORY PROVISIONS RELATING TO
MANUFACTURING OF COSMETICS
Subject Name: Cosmetics and Cosmeceuticals
Subject Code:MPH204T.
Prepared By: Patel Snehal.
M Pharm
Sem II
Enrollment No: 192650820006.
Department of Pharmaceutics.
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2.  Contents:
 Definition of cosmetics.
 Regulation provision relating to manufacture of cosmetics
a. How to obtain license
b. Conditions of license
c. Regulatory provision on sale of cosmetics
d. Loan license
 Offences and Penalties.
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3.  Cosmetics
 According to D&C Act cosmetics 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 cleaning, beautifying
promoting attractiveness or altering the appearance and includes any article
intended for use as a component of cosmetic.
Regulatory Provision Relating to Manufacture of
Cosmetics.
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.
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4.  Schedule M-II classifies cosmetics into 11 broad product categories: 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 , 9) Hair Dyes, 10)
Tooth Powders and Tooth Pastes etc., 11) Toilet Soaps.
 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
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5. 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;
■ Is registered under the Pharmacy Act, 1948;
■ 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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6. 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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7.  REQUIREMENT OF PLANT AND EQUIPMENT
Depending on manufacturing of different formulation equipment, area and other
requirements are been taken into considerations.
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.
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8. 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.
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.
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9. 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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10. 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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11. 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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12. H. AEROSOL:
a. Air compressor.
b. Mixing tanks.
c. Filtering, filling and cramping equipment.
d. Liquid filling unit.
e. Leak test equipment.
f. Fire extinguisher.
g. An area of 15 square meters recommended.
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13. I. EYE BROWS, EYE LASHES, EYE LINERS:
a. Mixing tanks.
b. A suitable mixer.
c. Weighing and measuring devices.
d. Filling and sealing equipment.
e. 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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14. 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 cosmetics and their testing.
 PARTICULARS TO BE SHOWN IN THE MANUFACTURING RECORDS
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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15. The requirements pertaining to labelling of
products.
Following are some of the labelling requirements as laid down under the Drugs
and Cosmetics Rules, 1945:
 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.
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16.  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.
3. Regulatory Provisions on sale of Cosmetics
■ Sale of certain cosmetics is prohibited under the act these are:
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 of harmful or
unsafe to use.
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17. 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 colouring purpose.
vii. Any cosmetic which contains mercury compounds.
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18. 4.Loan license
 A person not having his own manufacturing facilities can get cosmetics
manufactured from licensed cosmetic manufacturer under license system.
Application for loan license in prescribed form (Form-31-A) along with a fee
Rs.3500.00(at present it may be revised) together with other requisite
documents should be submitted to the State Regulatory Authorities.
 The Licensing Authority of the state, after examining that the licensed
manufacturer has spare capacity and has agrees to manufacture cosmetics
for applicant, will grant loan license.
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19. REGULATORY PROVISIONS RELATING TO IMPORT
OF COSMETICS
 Import of certain cosmetic is prohibited under D&C Act rules 134A,135,135A
 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.
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20. OFFENCES AND PENALTIES
Here are some offences and penalties which are important aspect of regulatory
provision for cosmetics in India.
Contravention in brief. Penalty.
Import of spurious cosmetic or cosmetic
containing any ingredient which is
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.
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21. Questions:
1. What are regulatory provisions for manufacturing
of cosmetics?
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22. References:
■ http://www.pharmatutor.org/articles/review-regulatory-provisions-regarding-
cosmetics-in-India.
■ http://www.authorstream.com/Presentation/shashi4883-906961-regulatory-
provisions-related-cosmetics/
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23. THANK YOU
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