Cosmetic regulatory

cosmetic regulatory

1. SEMINAR ON COSMETICS - REGULATORY B.K.MODY GOVERNMENT PHARMACY COLLEGE RAJKOT . GUIDED BY: JAYDEEP M. PATEL Senior lecturer Dept. of pharmaceutics PRESENTED BY: CHINTAN MAVANI M. Pharm SEM-II (Pharmaceutics) Enroll. 172120820008

2. CONTENT DEFINITION INDIAN REGULATORY REQUIREMENTS Labeling of Cosmetic product Regulatory provisions relating to import of Cosmetics MISBRANDED AND SPURIOUS COSMETICS REGULATION PROVISIONS RELATING TO MANUFACTURE OF COSMETICS How to obtain license Conditions of license Regulatory provision on sale of cosmetics Loan licens e OFFENCES AND PENALTIES 2

3. Definition of cosmetic product as per Indian regulation 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. 3

4. Indian regulatory requirement for cosmetic product 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. 4

5. 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. 5

6. 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 mention by letter ‘ B ’ along with manufacturing license number mention by letter ‘ M ’ must be present 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) 6

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8. 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 containing hexachlorophene , Any cosmetic in which lead and arsenic compound has been used for colouring purpose, Any cosmetic which contains mercury compound 8

9. In eighties, the standard framed by Indian Standards institution were adopted for certain cosmetics. 27 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 oils 27. Kumkum powder 7. Shampoos, soap based 8. Shampoos, synthetic detergent based 9. hair creams 10 . Oxidation hair dyes, liquid 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 9

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11. Major Minor Actions Taken by CDSCO against the applicants Manufacturer Importers Cancellation of cosmetics Registration Certificate No. 154/13 of M/s G.S Pharmbutor  (Private) Uttarakhand -March 2016 Cancellation of cosmetics Registration Certificate No. COS-84/13 of M/s Stiefel India (Private) Limited Mumbai   November-2015 Cancellation of cosmetics Registration Certificate No. COS-85/13 of M/s Stiefel India (Private) Limited Mumbai  October-2015 Cancellation of cosmetics Registration Certificate No. COS-304/14 of M/s Jeevanseva Enterprises India Privated Limited Hyderabad Cancellation of Cosmetics Registration Certificate No. COS-520/14 of M/s Modi Revlon Pvt. Ltd 1400 Modi Tower, 98 Nehru Place, New Delhi 11

12. List of ingredient which are banned by FDA Bithionol: The use of bithionol is prohibited because it may cause photocontact sensitization (21 CFR 700.11 ). Chlorofluorocarbon propellants . The use of chlorofluorocarbon propellants in cosmetic aerosol products intended for domestic consumption is prohibited (21 CFR 700.23). Chloroform. The use of chloroform in cosmetic products is prohibited because it causes cancer in animals and is likely to be harmful to human health, too .( 21 CFR 700.18). Halogenated salicylanilides (di-, tri-, metabromsalan and tetrachlorosalicylanilide). These are prohibited in cosmetic products because they may cause serious skin disorders (21 CFR 700.15 ). 12

13. Cont.. Hexachlorophene . Because of its toxic effect and ability to penetrate human skin, hexachlorophene (HCP) may be used only when no other preservative has been shown to be as effective . The HCP concentration in a cosmetic may not exceed 0.1 percent, and it may not be used in cosmetics that are applied to mucous membranes, such as the lips Vinyl chloride . The use of vinyl chloride is prohibited as an ingredient of aerosol products, because it causes cancer and other health problems (21 CFR 700.14). Zirconium-containing complexes. The use of zirconium-containing complexes in aerosol cosmetic products is prohibited because of their toxic effect on lungs of animals, as well as the formation of granulomas in human skin (21 CFR 700.16). 13

14. Misbranded and spurious cosmetics have been define in section 17-C and 17-D as under : Misbranded cosmetic: If it contain a colour which is not prescribed , If it not labelled in the prescribed manner , I f the label or container bears any statement which is false or misleading in any particular. 14

15. 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 15

16. 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 . 16 Regulatory Provision Relating To Manufacture Of Cosmetics.

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18. 18 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 . 6000 and an inspection fee of Rs . 1500

19. Cont.. 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 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. 19

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21. 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. 21

22. 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 injuriou s or harmful or unsafe to use. iv. Any cosmetic accept toilet soap containing hexachlorophene . v. Any cosmetic in which lead or arsenic compound used for colouring purpose. vi. Any cosmetic which contains mercury compounds 22

23. 23 “ 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.6000 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 4. Loan license

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25. OFFENCES AND PENALTIES Here are some offences and penalties which are important aspect of regulatory provision for cosmetic in India . 25 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.

26. Reference http:// www.cdsco.nic.in https:// www.fda.gov/Cosmetics/default.htm http://www.bis.gov.in / https:// cliniexperts.com Pharmaceutical jurisprudence., D r. G.K. J ani 26

27. T h a n k y o u . . .