DEFINITION INDIAN REGULATION FOR LABELLING ,IMPORT, REGISTRSTIONGUIDELINESS SPURIOUS, MISBRANDED DRUGS

1. COSMETICS -
REGULATIONS
PRESENTED BY
SUJITHA MARY
M PHARM
ST JOSEPH COLLEGE OF PHARMACY
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2. CONTENTS
 Definition
 Indian Regulatory Requirement For Labelling Of Cosmetics
 Regulatory Provisions Relating To Import Of Cosmetics
 Registration Guidelines
 Misbranded Cosmetic
 Spurious Cosmetic
 Regulatory Provision Relating To Manufacture Of Cosmetics
 Requirements Of The Factory Premises For Manufacturing Of Cosmetics
 Loan Liciense
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3. DEFINITION
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.
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4.  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.
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5. INDIAN REGULATORY REQUIREMENTS FOR
LABELING OF COSMETICS
Following are the labeling requirements under D&C Rules 1945
 Name of the product along with manufacturing address must be mentioned on
both inner and outer labels. If the container is small in size then place of
manufacturing and pin code are enough.
 The outer label should clearly specify the net contents of the ingredients used in
manufacturing of the product.
 The inner label should contain directions of use along with necessary warnings
and precautions.
 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 of the product must be conform to Indian Standards laid down
and revised by BIS.
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6. REGULATORY PROVISIONS RELATING TO
IMPORT OF COSMETICS
 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/or
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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7. REGISTRATION GUIDELINES
 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.
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8. 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
 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
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9.  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
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10. MISBRANDED COSMETIC:
 Misbranded and Spurious cosmetics have been define in section 17-C and
17-D as under: 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.
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11. 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.
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12.  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.
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13. OFFENCES AND PENALTIES
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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

14. REGULATORY PROVISION RELATING TO
MANUFACTURE OF COSMETICS
 A Licensed Is Required Under The Drugs And Cosmetics Rules For The
Manufacturing Of Cosmetics For Sale/Distribution .This License By State
Regulatory Authorities
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15. HOW TO OBTAIN LICENSE
An application should be accompanied with the following documents
(Form No 31)
 Layout plan of the factory premises.
 A list of equipment and Machinery installed .
 A document about the constitution of the firm.
 A document showing the possession of the applicant of the proposed
premises for the factory.
 The factory premises are inspected by the officers of the state regulatory
agency.
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16. The officer find out whether :
 The applicant has provided adequate space for the manufacturing
operations , quality control & storage of the raw material , packaging material
and finished products .
 The applicant has provided adequate equipment and machinery for the
manufacture of the cosmetics which he intends to manufacture.
 The applicant has provided adequate Testing facilities for the raw material
and after finished form of the cosmetics.
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17. REQUIREMENTS OF THE FACTORY PREMISES
FOR MANUFACTURING OF COSMETICS
1. GENERAL REQUIREMENTS
A. LOCATION & SURROUNDINGS
 The factory premises shall be located in a sanitary place and hygienic
conditions shall be maintained in the premises .
 Well ventilated and clean .
B. BUILDINGS
 The walls of the room in which manufacturing operations are carried out
shall up to a height of the 6 feet from the floor , it should be water proof and
the capable of being kept clean.
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18. C. WATER SUPPLY
 The Water used in manufacture shall be of the potable quality.
D. DISPOSAL OF WATER
 Suitable arrangements shall be made for the disposal of the waste water .
E. HEALTH , CLOTHING & SANITARY REQUIREMENTS OF THE STAFF •
 All the workers shall be free from contagious or the infectious diseases. They
shall be provided with the clean uniforms and gloves wherever required .
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19. 2, REQUIREMENT FOR PLANT AND EQUIPMENT
A. POWDERS
EQUIPMENTS
a.Powder mixer of the suitable provided with the dust collector.
b.Perfume and color blender.
c. Ball mill or suitable grinder.
d.Filling and sealing equipment.
e.Weighing and measuring
. f. Storage tanks .
g.An area of 15 m2 is recommended.
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20. B. CREAMS , LOTIONS , SHAMPOOS , HAIR OILS
EQUIPMENTS
a.Mixing and storage of the suitable materials.
b.Suitable agitator.
c. Heating mantle.
d.Filling and sealing equipment , weighing and measuring devices .
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21. C . NAIL POLISH AND NAIL LACQUER
1. EQUIPMENTS
A. suitable mixer
B. Storage tanks
C. Filling machines
D. Weighing and measuring devices
2. PREMISES
A. It shall be situated in an industrial area.
B. . It shall be separate from other cosmetics manufacturing areas.
C. Floors, walls and doors shall be fire proof.
3. STORAGE
All the explosive solvents and ingredients shall be a storage in metal cupboard. 21

22. D. LIPSTICKS
1. EQUIPMENTS
a. Vertical mixer.
b. Mixing vessels.
c. Triple roller mill / ball mill.
d. . Weighing and measuring devices.
e. An area of 15m2 is re commended.
E. HAIR DYES EQUIPMENTS
a,Stainless steel tanks.
b. Mixer.
c. Filling unit.
d. Weighing and measuring devices.
e. Gloves and masks. 22

23. PARTICULARS TO BE SHOWN IN THE
MANUFACTURING PROCESS
1.Serial number
2.Name of the product
3.Batch size
4.Batch number
5.Name of the all ingredients and quantities used
6.Actual production and packaging particular size and quantity of the finished
products
Signature of the expert staff responsible for the manufacture.
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24. MANUFACTURE OF DRUGS OTHER THAN IN
SCHEDULE C/C1
Conditions ;
 Premises should comply with schedule M.
 Adequate facility for testing , separate from manufacturing.
 Adequate storage facility.
 Records maintained for at least 2 years from from date of expiry.
 Should provide sample to authority.
 Furnish data of stability.
 Maintain the inspection book.
 Maintain references samples from each batch.
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25. MANUFACTURE OF DRUGS WHICH ARE IN
SCHEDULE C/C1
Conditions ;
 Drugs must be issued in previously sterilized sealed glass or suitable
container.
 Containers should comply with the Schedule F.
 Some classes tested for the aerobic and anaerobic. microorganism e.g..
Sera , Insulin , Pituitary hormones.
 Serum tested for abnormal toxicity.
 Parenteral in dose of 10ml or more should be tested for freedom from
pyrogen .
 Test for sterility should be carried out.
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26. PROHIBITION OF MANUFACTURE
 Drugs not of the standard quality or misbranded, adulterated or spurious.
 Patent or proprietary medicine.
 Drugs in schedule J.
 Risky to human beings or animals .
 Drugs without therapeutic value.
 Preparation containing cyclamates.
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27. PROHIBITION OF FOLLOWING CLASSES OF
THE DRUGS
 Misbranded or spurious cosmetics and of substandard quality
 Cosmetics containing hexachlorophene or mercury compounds
 Cosmetics containing color which contain more than –
- 2ppm of arsenic
- 20 ppm of lead
- 100 ppm of heavy metals
 Eye preparations containing coal –tar color
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28. CLASS OC DRUG PROHIBITED TO SALE
 Misbranded , spurious , adulterated , drugs not of standard quality
 Patent / propriety drugs with undisclosed formula.
 Schedule J drugs.
 Expired drugs.
 Drugs used for consumption by government schemes such as , Armed
forces.
 Physician’s samples .
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29. LOAN LICENSE
Definition
 A person (applicant) who does not have his own arrangements (factory) for
the manufacturing but who wish to manufacturing facilities owned by another
licensee. Such licenses are called as Loan licenses.
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30. Loan license is issued for ;
1)Drugs other than specified in Schedule C/C1 & X
2)Drugs specified in schedule C/C1
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31. OFFENCES AND PENALITIES
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OFFENCES PENALTIES
Manufacturing of any spurious drugs A) 1-3 Years imprisonment & Rs. 5000
fine
B) B) 2-6 years imprisonment & Rs.
10000 fine on the subsequent
conviction
Manufacturing of adulterated drugs A) 1 year imprisonment & Rs. 2000 fine
B) B) 2 years imprisonment & Rs.2000
fine on the subsequent conviction
Manufacturing of drugs in contravention
of the provisions
A) Imprisonment up to 3 months & Rs
500 fine
B) B) Imprisonment up to 6 months &
Rs.1000 fine .