This document discusses herbal cosmetics, including their definition, classification, economic aspects, regulations, and industries involved in production. Herbal cosmetics are defined as beauty products containing herbal ingredients that have physiological effects like skin healing. They are classified by dosage form (e.g. creams, oils) and body part (e.g. products for skin, hair, nails). The global herbal cosmetics market is valued at $1500 billion and growing. Major producers include China, India, Germany and France. Key Indian companies in this sector are Dabur, Emami, Patanjali, Himalaya and VLCC. The document also outlines licensing requirements, good manufacturing practices, and

1. HERBAL COSMETICS
M PHARM - PHARMACOGNOSY SEM 2 UNIT 1
S. PRITHIVIRAJAN., M. Pharm
Dept. of Pharmacognosy, COP,
Madurai Medical College,
Madurai-20

2. CONTENTS
 Introduction to Herbal Cosmetics
 Classification
 Economic aspects
 Regulatory Provisions relation to manufacture of cosmetics
i. License
ii. GMP
iii. Offences & penalities
iv. Import & Export of Herbal cosmetics
v. Industies involved in production of Herbal cosmetics

3. HERBAL COSMETICS
• Herbal cosmetics is defined as the beauty products, which has desirable
physiological activities, such as Skin healing, Smoothening, Conditioning, and
Enhancing the appearance with the help of Herbal ingredients/ Natural products.
• According to Drugs and Cosmetics act 1940, Any type of substance indended to be
rubbed, poured, sprinkled or sprayed or introduced to or applied oto any part of
human body for cleansing, beautifying, promoting, attractiveness or altering the
appearance by herbal ingredients is known as Herbal Cosmetics

4. CLASSIFICATION OF HERBAL COSMETICS:
Herbal cosmetics can be classified on the basis of
I. Dosage form
II. Part of the body to be applied for
I. Dosage form
1. Emulsion
2. Powders
3. Cakes
4. Oils
5. Mucilage
6. Jellies
7. Paste
8. Soaps
9. Suspensions
10. Creams
11. Solutions

5. II. Part (or) Organ of the body to be applied for
1. Herbal Cosmetics for Skin
• Powders
• Creams
• Lotions
• Deodorants
• Bath & cleansing products
• Make up preparations
• Sun care preparations
2. Herbal Cosmetics for Hairs
• Shampoo
• Tonics
• Hair Dressing
• Beard softners
• Hair waving preparations
• Shaving media
• Depilatories (Hair removers)

6. 4. Herbal cosmetics for Nails
• Nail polishes
• Manicure preparations
3. Herbal cosmetics for Teeth and Mouth
• Tooth powders
• Deutifrices
• Mouthwashes
• Herbal Toothpastes

7. Economic aspects of Herbal cosmetics
• According to market experts, the herbal cosmetics industry is heading towards a
new phase of its expansion.
• At present global market for herbal cosmetics is $ 1500 billion and is estimated to
grow at the rate of 25% per annum.
• In European countries the natural skin care products have the maximum market
share of all product categories. The German and the French herbal cosmetics
markets are the most upcoming markets among the European countries.
• China is the largest exporters of herbal cosmetics in the world whereas India
stands second in the global market share.

8. • Both the countries have a rich bio diversity which helps in evolution of various
species of plants and herbs and leading exporters of herbal cosmetics.
• Indian ayurvedic products market is estimated to be Rs. 2500 crore per annum
out which Rs. 450 crore is the market of natural herbal cosmetics.
• The Indian personal care market is estimated to be worth USS 4 Billion (approx.
Rs. 20,000 crore) this includes bath and shower products, hair care, skin care,
cosmetics, fragrances and deodorants.
• Soaps market has grown at a rate of 5% per annum over the last 5 years and
stands at market size of USS 1.5 billion (approx Rs. 7500 crores).

9. REGULATORY PROVISIONS RELATING TO MANUFACTURE OF
COSMETICS
A licence is required under the Drugs & Cosmetics Rules for manufacture of
cosmetics for sale/distribution. This licence is issued by the state regulatory
authorities (State Drugs Control Department or State Food and Drug Administration)
How to Obtain Licence
• Application form has been prescribed under the rules.Application is required to be
made in Form 31.
• The application should be accompanied by a licence fee of Rs.2500.00 and
inspection fee of Rs.1000.00.
• Additional fee will be required to be deposited, if number of items in any category
exceeds ten.
• The categories of cosmetics have been specified under Schedule M-II to the rules.

10. The application should be accompanied by the following documents
• Layout plan of the factory premises
• A list of equipment and machinery installed
• A document about the constitution of the firm.
i.e, an proof of ownership;
in case of sole-ownership (combined ownership) - a copy of partnership deed;
in case of partnership firm -a copy of memorandum and articles of association;
in case of a private limited or public limited company - a document showing
possession of the applicant on the proposed premises for factory;
e.g. rent agreement/rent receipt etc.
• Usually the application forms are got printed by the State Drugs Control Dept./FDA
and are available from their office. Before grant of licence (which is issued in Form
32) the factory premisesare inspected by the officer(s) of the State regulatory agency.

11. Conditions of Licence
• Manufacturer should continue to provide and maintain the premises, equipment
and staff as at the time of grant of licence.
• Manufacturer should test each batch or lot of raw materials before its use in the
manufacture of cosmetics.
• Manufacturer should test each batch of finished cosmetics.
• Manufacturer should maintain records of raw materials, manufacture of each
batch of cosmetic(s) and their testing.
• In the raw material and manufacturing records, at least the particulars those given
under Schedule U(I) to the Drugs and Cosmetics Rules.

12. Good Manufacturing Practices
A basic principle of GMP is that quality cannot be tested into a batch of product
but must be built into each batch of product during all stages of the manufacturing
process.
It is designed to minimize the risks involved in any pharmaceutical production
that cannot be eliminated through testing the final product.
Principles of GMP
 Design and construct the facilities and equipments properly
 Follow written procedures and Instructions
 Document work & Validate work
 Monitor facilities and equipment
Write step by step operating procedures and work on instructions
Design, develop and demonstrate job competence

13. Protect against contamination
Control components and product related processes
Conduct planned and periodic audits
GMP Categories
1. GMP Categories
2. Sale
3. Premises
4. Equipment
5. Personnel
6. Sanitation
7. Raw Material Testing
8. Testing of Finished products
9. Testing of Packaging
10. Quality control department
11. Records
12. Samples
13. Stability
14. Sterile products

14. REQUIREMENTS OF FACTORY PREMISES FOR MANUFACTURE OF
COSMETICS
1. Location and surroundings: The factory shall be located in a sanitary place and
hygienic conditions shall be maintained in the premises. . It shall be well
ventilated and clean.
2. Buildings: The walls of the room in which manufacturing operations are carried
out, shall be up to a height of six feet from the floor, be smooth, water-proof and
capable of being kept clean.
3. Water supply: The water used in manufacture shall be of potable quality.
4. Disposal of waste: Suitable arrangements shall be made for disposal of wastes.
5. Personnel: All workers shall be free from contagious or infectious diseases. They
shall be provided with clean uniforms, masks, headgears and gloves wherever
required.
6. Storage: Adequate proper storage area should be maintained for both raw
materials and finished products

15. OFFENCES PENALITIES
Manufacture for sale/distribution or
stock/exhibit for sale/distribution or sale of a
cosmetic not of standard quality or
misbranded.
Imprisonment for a term which may extend to
1 year or fine which may extend to 1000
rupees or with both.
Manufacture for sale/distribution or
stock/exhibit for sale/distribution or sale of a
cosmetic containing any ingredient which may
render it unsafe/harmful for use under
indicated direction.
Imprisonment for a term which may extend to
1 year or fine which may extend to 1000
rupees or with both.
Manufacture for sale/distribution or stock/
exhibit for sale/distribution or sale of a
cosmetic in contravention with provisions of
Chapter IV of the Drug & Cosmetics Act
Imprisonment for a term which may extend to
1 year or fine which may extend to 1000
rupees or with both.

16. OFFENCES PENALITIES
Sale or stock/exhibit for sale/distribution of a
cosmetic imported or manufactured in
contravention with provisions of the Act or any
rule made thereunder.
Imprisonment for a term which may extend to
1 year or fine which may extend to 1000
rupees or with both.
Manufacture for sale/distribution of a cosmetic
except under, and in accordance with a license
issued for the purpose.
Imprisonment for a term which may extend to
1 year or fine which may extend to 1000
rupees or with both.
Manufacture for sale/distribution or stock/
exhibit for sale/distribution or sale of a
spurious cosmetic
Imprisonment for a term which may extend to
3 years and fine.

17. IMPORT AND EXPORT OF HERBAL/ NATURAL COSMETICS
Effective, April 1, 2013, India introduced a compulsory registration system for
imported cosmetics products.
The importer will still however need to take necessary permission from the
office of the CDSCO and provide a written undertaking that the imported products
will not be released for domestic sales in India.
The same applies for import of cosmetics for research purposes such as
packaging trials, and consumer and other shelf life or transport studies.
Bulk imports of cosmetics into India for re-packaging and sale in the Indian
market arenot exempted and would need to be registered.
Banned items: India prohibits the manufacture and import of any cosmetic products
containing hexachlorophene, lead, arsenic or mercury compounds.

18. In India, the permitted synthetic organic colors and natural organic colors
used in the cosmetics shall not contain more than,
 2 parts per million of arsenic calculated as arsenic trioxide
20 parts per million of lead calculated as lead
100 parts per million of heavy metals other than lead calculated as the total of the
respective metals.
India allows import of cosmetics into the country only through specified ports
of entry, which includes: Chennai, Kolkata, Mumbai, and Cochin sea ports; and
Delhi, Mumbai, Chennai, Kolkata, and Ahmedabad airports.

19. Industries involved in production of Herbal Cosmetics
The demand in the herbal beauty products market is anticipated to grow at
approximately 6.3% CAGR between 2023 and 2033. The market for herbal beauty
products may reach US$ 73.0 billion in 2023.
The target market nearly holds a 5.9% share in the overall beauty products
industry.Increasing focus on healthy skin and hair and surging demand for natural
remedies have positioned the herbal beauty products market to surpass US$ 134.0
Billion in 2033.
As growth continues, competition within the market is poised to augment. FMI
herbal beauty products market assessment has projected the major players of herbal
beauty products to account for barely 2% to 5% of sales of herbal beauty products.

20. Some of major production of Herbal cosmetics industries in India are,
 Dabur
 Emami
 Patanjali
 Himalaya
 VLCC
Biotique
 Lotus
 Revlon India
Mama earth