Cosmetics regulations in India.pptx

This presentation will give General overview about Indian Regulatory Requirements for cosmetics.
This ppt contains information about latest cosmetics rules 2020 and D& C Act 1940

1. 1 SVKM’s Institute of Pharmacy , Dhule F.Y. Pharm. , Branch Pharmaceutics Mr. Saurabhasing J. Rajput PRN No: 2254482817012 Indian Regulatory Requirements For Cosmetics Presented by : Dr. Babasaheb Ambedkar Technological University Lonere-402103 Tal. - Mangaon, Dist. - Raigad (M.S.) India (MPH204T) COSMETICS & COSMECEUTICALS Guided by : Dr. Aarti Belgamwar

2. 2 Points to be discussed : Definition of cosmetics Cosmetics regulation in INDIA & Chapters List of Categories of Cosmetics Types of License for cosmetics Regulatory requirements for mfg. of Cosmetics Regulatory requirements for Labelling of Cosmetics New Schedules & Forms Reference

3. Cosmetic Products (as per Indian regulation) Cosmetic is defined under section 3( aaa ) of the Drugs and Cosmetics Act, 1940 as, 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 3

4. Cosmetics Regulation In INDIA • Cosmetic Legislation is driven in IN D IA through Drugs and Cosmetics Act 1940 & rules 1945, and the legislative body is CDSCO headed by DCGI • Import of cosmetics is regulated under a system of registration by CDSCO who is the main authority to regulate activities relating to cosmetics. • Manufacturing of cosmetics in India is regulated under a system of inspection and licensing by the State Drug Control Department . 4

5. New Cosmetics Rule , 2020 The Ministry of Health and Family Welfare notified the Cosmetics Rules,2020, on December 15, 2020 :- with an aim to separately codify and update the rules relating to import, manufacture, labelling, sale and distribution of cosmetics in India, which were earlier set out under the Drugs and Cosmetics Rules, 1945 Cosmetic Rules 2020 have been modified vide notification No. G.S,R. 763 (E) Dated 15- 12-2020 and the same have come into force from the date of its notification i.e. 15-12- 2020. 5

6. New Cosmetics Rule,2020 Chapters : 6

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8. 8 List of Categories of Cosmetics for sale in Country: (A) Powders (B) Skin Powder for Infants (C) Creams, lotions, emulsions, pastes, cleansing milks, shampoos, pomade, brilliantine, shaving-creams and hair-oils, etc. (D) Nail Polishes and Nail Lacquers. (E) Lipsticks and Lip-gloss. (F) Depilatories (G) Preparations used for Eyes 1. Eyebrows, Eyelashes, Eyeliners. 2. Kajal and Surma. (H) Aerosol (I) Alcoholic Fragrance solutions ( J) Hair Dyes (K) Tooth-powders and toothpastes, etc. 1. Tooth-powder in General. 2. Tooth pastes. 3. Tooth — Powder (Black). (L) Toilet Soaps

9. Central Licensing Authority Import of cosmetics is regulated under a system of registrationby the CDSCO State Licenscing Authority The State Government appoints a Licensing Authority State Drug Control Department ,who inspect and provide license for manufacturing of the products. IMPORT LICENSE MANUFACTURING LICENSE Types of Cosmetics License in INDIA : 9

10. As per D&C Act & Rules 1945 certain cosmetics are prohibited to Import in India: 01 02 03 04 05 06 07 Cosemetics containing Mercury Cosmetics containing lead Cosmetics containing hexachlorophene . Cosmetics containing harmful ingredient Misbranded Cosmetics Spurious & Adultrated cosmetics Not of standard quality 10

11. Regulatory requirements to Import of Cosmetics The import of cosmetics is regulated under a system of registration by central licensing authority appointed by central Government Require compulsory registration certificate for importing from DCGI (CDSCO) Cos 1 Application of a product to be imported made through online portal on SUGAM Portal by Importer 11

12. Regulatory requirements for manufacturing of Cosmetics : Loan License : A person(applicant) who does not have his own arrangements(factory) for manufacture but who wish to avail the manufacturing facilities owned by another licensee. Such licenses are called Loan licenses. Labelling Conditions For Loan License : Manufactured By Marketed By 12

13. Application for grant of loan license & Manufacturing License to manufacture cosmetics for sale or for distribution : 13 Any person who intends to mfg. cosmetics . For Distribution Loan license Online Application on SUGAM Portal Form COS– 5&6 Fee 3 rd. Schedule 45 Days State Licensing Authority Site inspection by officer License granted in form COS 8 & 9 who Issue How

14. Conditions of license : Manufacturing of Cosmetics : Manufacture of cosmetics shall be conducted under the direction and personal supervision of at least one person who is a whole-time employee and who possesses any one of the following qualifications. ( i ) Holds a Diploma in Pharmacy approved by the Pharmacy Council of India under the Pharmacy Act, 1948 (8 of 1948), or (ii) Must beregistered under the Pharmacy Act, 1948 (8 of 1948), or (iii) Has passed the Intermediate Examination with Chemistry as one of the subjects or an examination recognized by the Licensing Authority as equivalent to it. (iv) Holds a bachelor degree in Cosmetic Technology from recognized university. Factory Premises : comply with the requirements and conditions specified in the 7 th Schedule. The manufacturer shall either : ( i ) Provide and maintain adequate staff. (ii) Laboratory equipment approved by the Central Licensing Authority ( i ) Documents in respect of the ownership or occupation on rental or other basis of the (ii) constitution of the firm. The applicant shall maintain documentary evidence of : 14

15. Grant & Validity of license : If the Licensing Authority, is satisfied then shall grant a license in Form COS-8 or Form COS-9 . 2) If the Licensing Authority is not so satisfied, he shall reject the application with Reason. 3) within a period of 6 months from the rejection of an application for a license is granted if rejected requirements are fulfilled 4) A license or loan license issued in Form COS- 8 or Form COS- 9 shall remain valid from 5 years from the date of its issue, unless, it is suspended or cancelled by the State Licensing Authority. 15

16. Requirements of plant and equipment : Creams, lotions, emulsions, pastes, cleansing milks, shampoos, pomade, brilliantine, shaving-creams and hair-oils, etc.- Equipment’s: (a) Mixing and storage tanks of suitable materials. (b) Heating kettle — steam, gas or electrically heated. (c) Suitable agitator. (d) Colloidal mill or homogenizer (wherever necessary). (e) Triple roller mill (wherever necessary). (f) Filling and sealing equipment. (g) Weighing and measuring devices. An area of 25 square metres is recommended. 16

17. Regulatory Requirements for Labelling of Cosmetics : Generic or common name of the commodity packed. (Brand Name) Name and address of the importer if imported . Net quantity in terms of standard unit of weights and measures. (gm/ml) Month and year of packing & Expiry Date Maximum retail sales price (MRP) in INR Adequate direction for safe use Full ingredients listing . Any warning, caution or special direction required to be observed by the consumer A statement of the names and quantities of the ingredients that are hazardous or poisonous Batch number starting with “ B ” Manufacturing license number starting with suffix “ M ” Import Registration No. (in case of Imports) QR Code & Bar Code . Name of the manufacturer with complete address of the premises of the manufacturing place 17

18. New Schedules Introduced in Cosmetics Rules 2020 : 18

19. New Schedules Introduced in Cosmetics Rules 2020 : 19

20. Forms comes under New Cosmetics Rules 2020 : 20

21. Forms comes under New Cosmetics Rules 2020 : 21

22. Forms comes under New Cosmetics Rules 2020 : 22

23. SUGAM Portal : 23

24. CDSCO Official Website : 24

25. References : https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/ https://cdscoonline.gov.in/CDSCO/UserRegistration MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 15th December, 2020 , Cosmetics Rules, 2020 . 25

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