COSMETICS &

COSMECEUTICALS

M.PHARM 2nd SEMESTER

 CONTENT
 DEFINITION
 INDIAN REGULATORY REQUIREMENTS FOR LABELING OF COSMETIC
PRODUCTS.
 REGULATORY PROVISIONS RELATING TO THE IMPORT OF COSMETICS
 MISBRANDED AND SPURIOUS COSMETIC
 REGULATION PROVISIONS RELATING TO THE MANUFACTURE OF
COSMETICS.
 CONDITIONS FOR OBTAINING LICENSE.
 CONDITIONS OF LICENSE.
 PROHIBITION OF MANUFACTURING AND SALE OF COSMETICS.
 LOAN LICENSE
 OFFENCES AND PENALTIES
GLOBAL COSMETICS MARKET SIZE
INDIAN COSMETICS MARKET SIZE
GLOBAL TOP TEN COSMETICS INDUSTRY
1. L’Oréal – €27.99bn ($33.93bn)
2. Unilever – €21.1bn ($25.38bn)
3. P&G – $19.41bn
4. Estée Lauder – $14.29bn
5. Shiseido – JPY920.88bn ($8.73bn)
6. Beiersdorf – €5.7bn ($6.91bn)
7. LVMH – €5.24bn ($6.36bn)
8. Kao – JPY543bn ($5.17bn)
9. Coty – $4.71bn
10.Johnson & Johnson – $4.45bn
INDIAN TOP TEN COSMETICS INDUSTRY
1. LAKME - Over INR 500 cr
2. LOTUS HERBALS PVT LTD - Over INR 500 cr
3. UNILEVER INDIA LIMITED - Over INR 500cr
4. L’OREAL INDIA PRIVATE LIMITED-Over INR 500 cr
5. COLORBAR- INR 100 cr – 500 cr
6. BIOTECH-Under INR 1 cr
7. MAMAEARTH-Over INR 500 cr
8. COLOR ESSENCE- 1800 crores
9. HIMALAYA- 1,800 crore
10.REVLON-200 crore
DEFINITION OF COSMETIC PRODUCT AS PER INDIAN
REGULATION

 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.

“As per the Drug and Cosmetic Act 1940, “cosmetic” means any article
intended to be rubbed, poured, sprinkled or sprayed on, or introduced
into, or otherwise applicated to, the human body or any part of it for
cleansing, beautifying, promoting attractiveness, or altering the
appearance, and includes any article intended for use as a component of
cosmetic.”
 COSMECEUTICALS
“Cosmeceuticals are the ingredient with medicinal
properties, which manifests beneficial topical actions and
provides protection against degenerative skin conditions.”

Cosmetics Pharmaceuticals

Cosmeceuticals
DIFFERENCE BETWEEN COSMETICS &
COSMECEUTICALS

 A cosmetic product is applied to the

outer surface of the human body and
cannot pass through the dermal-
epidermal junction, which is the area
between the epidermis and dermis.

 In a cosmeceutical product, the active

principles are able to pass through the
epidermis and act deep within the
dermis.
REGULATORY BODY OF DIFFERENT COUNTRY
Sl. Country Regulation Body Act
No Name
1 European EU Scientific Committee on Consumer Regulation (EC) No 1223/2009 (the
Union Safety (SCCS) “Cosmetic Products Regulation”),
2 United Food and Drug Administration (FDA) Food, Drug, and Cosmetic Act
State regulate cosmetic products
3 China Cosmetics Supervision and Regulations concerning the hygiene
Administration Regulations (CSAR) supervision over cosmetics (1990)
China Food & Drug Administration
(CFDA)
4 Japan Ministry of Health, Labour, and Welfare The Pharmaceutical and Medical
(MHLW) Devices (PMD) Act.
5 Canada Health Canada Cosmetic Regulations and the Food
and Drugs Act
6 Australia National Industrial Chemicals Therapeutic Goods Act 1989
Notification and Assessment Scheme
(NICNAS)

7 South South African Health Products Medicines and Related Substances

Africa Regulatory Authority (SAHPRA) Act, 1965 (Act 101 of 1965)
 INDIAN REGULATORY REQUIREMENTS FOR
LABELING OF COSMETIC PRODUCTS.

1.Product Information:
 The label should contain the name of the cosmetic product.
 Ingredients, including the International Nomenclature of Cosmetic Ingredients (INCI)
names, should be listed in descending order of their quantity.
2.Manufacturer Information:
 The name and address of the manufacturer should be provided on the label.
 The manufacturing license number should be mentioned.
3.Batch Number and Manufacturing Date:
 Each product should have a batch number and manufacturing date for traceability.
4.Use Instructions:
 Clear use instructions, including precautions, should be provided.
5. Net Quantity:
 The quantity of the product should be mentioned in metric units.
6. Country of Origin:
 The country of origin should be specified.
7. Expiry Date:
 An expiration date, if applicable, should be mentioned.
8. Precautions and Warnings:
 Any necessary precautions or warnings for safe use should be clearly stated.
9. Colorants and Perfumes:
 If the product contains colorants or perfumes, they should be specified.
10.Retail Sale Price:
 Some cosmetic products may require an ISI mark if they fall under the purview of
the Bureau of Indian Standards (BIS).
11. Storage Conditions
12. Barcode
 REGULATORY PROVISIONS RELATING TO THE
IMPORT OF COSMETICS
 Chapter III of the Drug and Cosmetic Act deals with the import of Drugs and cosmetics.
 Now import of specific cosmetic is prohibited under section 10 of the Act and rules
134A, 135, 135A, 135B, 136 of Drug and Cosmetic Rules 1945 they are:
1. Any cosmetic that is not of Standard Quality.
2. Any cosmetic that is misbranded or spurious.
3. A cosmetic containing an ingredient that renders it injurious, harmful, or unsafe to
use.
4. A cosmetic whose import is prohibited by the rule.
5. Any cosmetic containing hexachlorophene.
6. Any cosmetic in which lead or arsenic compound is used for coloring purposes.
7. Any cosmetic that contains mercury compounds.
 REGISTRATION GUIDELINES
 As defined under Rule 21 of the Drugs & Cosmetics Rules, 1945, all
cosmetic products imported for sale in India must be registered with a
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 regarding the import of any number of brands manufactured
at one or more locations by a single manufacturer.
 Cosmetic can be imported in India only through
following ports as per the rule 43A.

1. Firozpur Cantonment and Amritsar Railway Stations:In respect of drugs imported by rail
across the frontier with Pakistan.
2. Ranaghat, Bongaon and Mohiassan Railways Stations: In respect of drugs imported by rail
across the frontier with Bangladesh.
3. Chennai, Kolkata, Mumbai, Cochin, Nhava Sheva, Kandla, and Inland Container Depots at
Tuglakabad and Patparganj in Delhi and Tuticorin in Tamil Nadu and Marmugao port in Goa
and Visakhapatnam in Andhra Pradesh by seaways.
4. Chennai, Kolkata, Mumbai, Delhi, Ahmedabad, Hyderabad, Goa, Bengaluru and
Visakhapatnam by air ways.
5. Raxaul: In respect of drugs imported by road and railway lines connecting Raxaul in India and
Birganj in Nepal.
6. Petrapole Road in West Bengal, Sutarkandi in Assam, Old Raghna Bazar and Agartala in
Tripura : In respect of drugs imported by Road from Bangladesh
Schedule S lists 36 cosmetics and toiletries, and directs the manufacturers of cosmetics
to conform to the Bureau of Indian Standards requirements.

List of products in Schedule S:

1. Skin Powders. 14. Pomades and Brilliantines. 28. Henna Powder IS: 11142.]
2. Skin Powder for infants. 15. Depliatories Chemical. 29. Bathing Bars IS: 13498: 1997
3. Tooth Powder. 16. Shaving Creams. 30. Sindoor IS: 14649: 1999
4. Toothpaste. 17. Cosmetic Pencils. 31. Liquid Foundation makeup IS
5. Skin Creams. 18. Lipstick 14318
6. Hair Oils. 19. Toilet Soap. 32. Cold Wax Hair remover IS
15152
7. Shampoo, Soap-based. 20. Liquid Toilet Soap.
33. Face pack IS 15153
8. Shampoo, Synthetic-Detergent 21. Baby Toilet Soap.
based. 34. Kajal IS 15154
22. Shaving Soap.
9. Hair Creams. 35. Oxidation Hair Dyes (Emulson
23. Transparent Toilet Soap.
Type) IS 15205
10. Oxidation hair dyes, Liquid. 24. Lipsalve IS:10284.
36. Cream Bleach IS 15608
11. Cologne 25. Powder Hair Dye IS: 10350.
12. Nail Polish (Nail Enamel). 26. Bindi (Liquid) IS: 10998.
13. After Shave Lotion. 27. Kum Kum Powder IS: 10999.
Any Questions