HERBAL COSMETICS UNIT 1, PCG SEM 2.pptx

M Pharm Pharmacognosy Semester 2, HERBAL COSMETICS UNIT 1, Herbal/natural cosmetics, Classification &
Economic aspects. Regulatory Provisions relation to manufacture of cosmetics: -
License, GMP, offences & Penalties, Import & Export of
Herbal/natural cosmetics, Industries involved in the production of
Herbal/natural cosmetics.

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 License GMP Offences & penalities Import & Export of Herbal cosmetics 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, S moothening, 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 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 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 S chedule M-II to the rules.

10. The application should be accompanied by the following documents L ayout 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 GMP Categories Sale Premises Equipment Personnel Sanitation Raw Material Testing Testing of F inished 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 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. 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. Water supply : The water used in manufacture shall be of potable quality. Disposal of waste : Suitable arrangements shall be made for disposal of wastes. Personnel: All workers shall be free from contagious or infectious diseases. They shall be provided with clean uniforms, masks, headgears and gloves wherever required . 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