Regulated provison of cosmetics

1. SUBMITTED TO
DR. YASMIN SULTANA
DEPARTMENT OF PHARMACEUTICS
SPER ,
JAMIA HAMDRAD

2. • Regulatory provision relating to manufacturing of cosmetics
• Requirement of factory premise to manufacturing the cosmetics
• Prohibition of manufacturing & the Sale of the certain cosmetics
• Loan license
• Offences and Penalties

3. Drug and Cosmetics Act , 1940 , defines “cosmetics” as -
“any article intended to be rubbed , poured sprinkled or
sprayed on or intended into or applied to any part of the
human body for cleansing , beautifying , promoting
attractiveness & altering appearance, and includes any article
intended for use as a component of cosmetics”

4. A license is required under the Drug and Cosmetic Rules
for the manufacture of cosmetics for sale / Distribution .
This license is issued by state regulatory authorities.

5. 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.

6. 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.

7. 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.

8. 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 .

9. 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.

10. 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 .

11. C . NAIL POLISH AND NAIL LACQUER
1. EQUIPMENTS
A. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. • 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.

17. • 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

18. • 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 .

19. 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.

20. Loan license is issued for ;
1)Drugs other than specified in Schedule C/C1 & X
2)Drugs specified in schedule C/C1

21. OFFENCES PENALTIES
Manufacturing of any spurious drugs A) 1-3 Years imprisonment & Rs. 5000 fine
B) 2-6 years imprisonment & Rs. 10000 fine
on the subsequent conviction
Manufacturing of adulterated drugs A) 1 year imprisonment & Rs. 2000 fine
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) Imprisonment up to 6 months & Rs.1000
fine .