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Regulatory of Cosmetic in India

SEMINAR BY: PATEL JANKI

ID NO: 15MPHRA008

M.PHARM 1ST YR (DRA)

UNDER THE GUIDENCE OF

Dr. GAYATRI PATEL M.Pharm, PHD

ASST. PROFESSOR

DEPT: PHARMACEUTICS

RAMANBHAI PATEL COLLEGE OF PHARMACY,CHARUSAT,CHANGA

2 Contents

1. Terminology of cosmetics

2. 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

3. Offences and penalties

3. List of Amending Act and Adaptation orders

4. Conclusion

3 Terminology of 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.

4 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.

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 (Cologne), 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

5Cont..

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

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.

6Schedule M (II) of Drug and Cosmetic rule 1945 Deals with Requirements for the factory premises for manufacture of cosmetics.

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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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 collectorb. Perfume and color blender.c. Ball mill or suitable grinder.d. Filling and Sealing equipmente. 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 equipmente. weighing and measuring devices.f. An area of 25 square meters is recommended

8C. 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.

9 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:

f. Stainless steel tanks.

g. Mixer.

h. Filing and sealing unit.

i. Weighing and measuring devices

j. Gloves, masks.

k. An area of 15 square meter is recommended.

10F. TOOTH POWDER: H. AREOSOL:

a. Weighing and measuring devices. a. Air compressor.

b. Dry mixer. b. Mixing tanks

c. Stainless steel sieves. c. Filtering. Filling and cramping equipment.

d. Powder filling and sealing unit. d. Liquid filing unit

e. An area of 15 square meter is recommended. e. Leak test equipment.

G. TOOTH PASTES: f. fire extinguisher

f. Weighing and measuring devices. g. An area of 15 square meters recommended.

g. Kettle-steam, gas or electrically heated.

h. Planetary mixer

i. Tube filling equipment.

j. Crimping machine.

k. An area of 15 square meters is recommended.

11I. 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:

g. Mixing tanks.

h. Filtering, filling and sealing equipment.

i. Weighing and measuring devices.

j. An area of 15 square meters is recommended.

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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.

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.

13 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.

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) from time to time.

14 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 or harmful or unsafe to 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.

15 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.

16 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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In eighties, the standard framed by Indian Standards institution were adopted for certain cosmetics. 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:

1. Skin powder 2. Skin powder for infants 25. Powder hair dye

3. Tooth powder 4. tooth paste 26. Bindi

5. Skin creams 6. Hair oils27. Kumkum powder

7. Shampoos, soap based 8. Shampoos, synthetic detergent based 9. hair creams 10. Oxidation hair dyes, liquid 28. Henna powder 11. Cologne 12. Nail polish 13. Aftershave lotions 14. Pomades & brilliantines 15. Depilatories, chemical 16. Shaving creams 17. Cosmetic pencils 18. Lipsticks 19. Toilet soap 20. Liquid toilet soap 21 Baby toilet soap 22. Transparent toilet soap 23 Saving soap 24. Lipsalve

18Misbranded and spurious cosmetics have been define in section 17-C and 17-D as under:

Misbranded cosmetic: If it contain a color which is not prescribed, If it not labelled in the prescribed manner, if the label or container bears any statement which is false or misleading in any particular.

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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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.

20 OFFENCES AND PENALTIES

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.

Here are some offences and penalties which are important aspect of regulatory provision for cosmetic in India.

21 List of Amending Act And Adaptation Orders

The Drug Amendment Act 11 of 1955, The Drug Amendment Act 35 of 1960, The Drug Amendment Act 21 of 1962, The Drug and Cosmetic Amendment Act 13 of 1964, The Drug and Cosmetic Amendment Act 19 of 1972, The Drug and Cosmetic Amendment Act 68 of 1982, The Drug and Cosmetic Amendment Act 71 of 1995, The Drug and Cosmetic Amendment Act 26 of 2008 and The Drugs & Cosmetic Rules 1945 as amended from time to time Regulate the import, manufacture and sale or distribution of drugs and cosmetics through Licenses

and permits etc.

22 CONCLUSION

All the cosmetics which are manufactured and imported must be within the provisions of D&C Act.

23 REFERANCE

Sharma P.P; Cosmetic formulation manufacturing and quality control; 3rd Edition; Nirali Prakashan; chapter-1; P.13-33

http://www.cdsco.nic.in/forms/contentpage1.aspx?lid=1888 http://

www.pharmatutor.org/articles/review-regulatory-provisions-regarding-cosmetics-in-india http://blog.ipleaders.in/cosmetics-regulation-in-india-the-law-you-need-to-know-before-get

ting-into-cosmetics-manufacturing-business/

URL:http://www.cdsco.nic.in/writereaddata/G_S_R_%20 69(E).pdf. http://www.authorstream.com/Presentation/shashi4883-906961-regulatory-provisions-relat

ed-cosmetics/

24 ACKNOWLEDGEMENT

This is an opportunity to express my sincere thanks to our:

H.O.DGUIDECLASS INCHARGESTAFF AND CLASSMATES.