This article shows an Overview of the current Cosmetics Registration in India.
Introduction:
Imports of cosmetics products are regulated in India under the provisions of the Drugs & Cosmetics Act 1940 & Rules 1945 vide Gazette notification G.S.R 426(E). Manufacturers can leverage their approvals in the US, Canada, Europe, Australia or Japan for Registration of cosmetics in India. For Medical Devices and IVDs registration in India, please visit Registration of Medical Devices and Registration of In Vitro Diagnostics respectively.
Background:
The Government of India has issued a Gazette Notification G.S.R 426(E) dated 19th May 2010 for amending the Drugs & Cosmetics Rules, 1945 providing for registration of import of cosmetics into the Country. The above provision was to come into effect from the 1st April, 2011. But in view of the various possible difficulties apprehended by the stakeholders, its implementation has been deferred till the 31st March, 2013.
All cosmetics products that are imported for sale in India need to be registered with the licensing authority as defined under Rule 21 of Drugs & Cosmetics Rules, 1945. For the import of Cosmetics in India, the imported cosmetics products are required to be registered with Central Drugs Standards Control Organization (CDSCO) by giving application in Form 42 to obtain Registration Certificate in Form 43.
Important Terminologies:
Brand
- A “Brand” for the purpose of these rules will mean each category of cosmetics product as mentioned in Column 3 of the list enclosed at Annexure 1.
- A “Brand” will include all variants of a product e.g. colour, shades, pack sizes, etc.
- A “Brand” will not mean the trade name of any product of a manufacturer or the manufacturer himself / itself.
Manufacturer
- “Manufacturer” means a person or entity in a Country other than India who owns the trade name of the brand of the cosmetics product for which registration has been applied for and who / which manufactures such product at his / its own manufacturing site or at a site owned by another manufacturer in the trade name of his / its brand.
Authorized Agent:
An “Authorized Agent” means a person or entity in India authorized by the manufacturer. The Indian Authorized Agent will be responsible for the business activities of the manufacturer in India including compliance to the provisions of the Act in all respects.
Time Line:
Time period for Grant of Registration Certificate in Form 43
As per Rule 129C provided that if the application is complete in all respects and the information specified in Schedule (D III) is in order, the licensing authority shall, within six months from the date of receipt of an application, issue such Registration certificate, and in exceptional circumstances and for reasons to be recorded in writing, the Registration Certificate may be issued within such extended period, not exceeding three months, as the licensing authority may deem fit. However CDSCO targeted timeline for processing of application is 90 days as per circular dated 30.05.2014. Check this table – The Timelines of CDSCO for further understanding the CDSCO timelines for different categories.
Duration/Validity of “Registration certificate” in Form-43 for Cosmetics in India:
A Registration Certificate, unless, it is sooner suspended or cancelled, shall be valid for a period of three years from the date of its issue.
Cosmetics Product List:
| Brands of Cosmetic Products | ||
| Column-1 | Column-2 | Column-3 |
| Skin Products | 1 Skin care products | 1. Face care products other than face mask |
| 2. Face mask | ||
| 3. Eye contour products | ||
| 4. Lip care products | ||
| 5. Hand care products | ||
| 6. Foot care products | ||
| 7. Body care products | ||
| 8. External intimate care products | ||
| 9. Chemcal exfoliation products | ||
| 10. Mechanical exfoliation products | ||
| 11. Skin lightening products | ||
| 12. Other skin care products | ||
| 2 Skin cleansing products | 1. Soap products | |
| 2. Bath / shower products | ||
| 3. Make-up remover products | ||
| 4. External Intimate hygiene products | ||
| 5. Other skin cleansing products | ||
| 3. Body hair removal products | 1. Chemical epilatories | |
| 2. Physical epilation products | ||
| 3. Other body hair removal products | ||
| 4. Bleach for body hair products | 1. Bleach for body hair | |
| 5. Correction of body odour and/or perspiration | 1. Products with anti perspirant activity | |
| 2. Products without anti perspirant activity | ||
| 6. Shaving and pre after shaving products | 1. Shaving products | |
| 2. Pre- / after-shaving products | ||
| 3. Other shaving and Pre- / after-shaving products | ||
| 7. Make-up products | 1. Foundation | |
| 2. Concealer | ||
| 3. Other face ma ke-up products | ||
| 4. Mascara | ||
| 5. Eye shadow | ||
| 6. Eye pencil | ||
| 7. Eye liner | ||
| 8. Other eye make-up products | ||
| 9. Lipstick | ||
| 10. Lipstick sealer | ||
| 11. Other lip make-up products | ||
| 12. Body or face paint , including “carnival makeup” | ||
| 13. Other make-up products | ||
| 8. Perfumes | 1. Hydro alcoholic perfumes | |
| 2. Non hydroalcoholic perfumes | ||
| 9. Sun and self tanning products | 1. Before and after sun products, sun protection products | |
| 2. Selft tanning products | ||
| 3. Other sun and self tanning products | ||
| 10. Other skin products | 1. Other skin products | |
| 2. Hair and Scalp Products | 11. Hair and scalp care and cleansing products | 1. Hair conditioner |
| 2. Scalp and hair root care products | ||
| 3. Anti hair-loss products | ||
| 4. Other hair and scalp care and cleansing products | ||
| 5. Anti dandruff products | ||
| 12. Hair coloring products | 1. Oxidative hair color products | |
| 2. Non-Oxidative hair color products | ||
| 3. Hair bleaching and dye remover products | ||
| 4. Other hair colouring products | ||
| 13. Hair styling products | 1. Products for temporary hair | |
| 2. Styling permanent wave products | ||
| 3. Hair relaxer and straightner products | ||
| 4. Other hair styling products | ||
| 14. Other hair and scalp products | 1. Hair sun protection products | |
| 2. Other hair and scalp products | ||
| 3. Nail and Cuticle Products | 15. Nail varnish and remover products | 1. Nail varnish/ nail make-up |
| 2. Nail varnish remover | ||
| 3. Nail varnish thinner | ||
| 4. Nail bleach | ||
| 5. Other nail varnish and remover products | ||
| 16. Nailcare/ nail hardner products | 1. Nail care products | |
| 2. Nail hardener | ||
| 3. Other nail care / nail hardener products | ||
| 17. Nail glue remover products | 1. Nail glue remover | |
| 18. Other nail andcuticle products | 1. Cuticle remover / softener | |
| 2. Nail sculpting products | ||
| 3. Other nail and cuticle products | ||
| 4. Oral Hygiene Products | 19. Tooth care products | 1. Toothpaste |
| 2. Tooth cleansing powder / salt | ||
| 3. Other tooth care products | ||
| 20. Mouth wash / breath spray | 1. Mouth wash | |
| 2. Breath spray | ||
| 3. Other mouth wash / breath spray products | ||
| 21. Tooth whiteners | 1. Tooth whiteners | |
| 22. Other oral hygiene products | 1. Other oral hygiene products |