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Cosmetics Registration in India – An Overview

Cosmetics Registration in India – An Overview

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 Products1  Skin care products1.    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 products1.    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 products1.    Chemical epilatories
2.    Physical epilation products
3.    Other body hair removal products
4.    Bleach for body hair products1.    Bleach for body hair
5.    Correction of body odour and/or perspiration1.    Products with anti perspirant activity
2.    Products without anti perspirant activity
6.    Shaving and pre after shaving products1.    Shaving products
2.    Pre- / after-shaving products
3.    Other shaving and  Pre- / after-shaving products
7.    Make-up products1.    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.    Perfumes1.    Hydro alcoholic perfumes
2.    Non hydroalcoholic perfumes
9.    Sun and self tanning products1.    Before and after sun products, sun protection products
2.    Selft tanning products
3.    Other sun and self tanning products
10.  Other skin products1.    Other skin products
2.    Hair and Scalp Products11.  Hair and scalp care and cleansing products1.    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 products1.    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 products1.    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 products1.    Hair sun protection products
2.    Other hair and scalp products
3.  Nail and Cuticle Products15.  Nail varnish and remover products1.   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 products1.    Nail care products
2.    Nail hardener
3.    Other nail care / nail hardener products
17.  Nail glue remover products1.    Nail glue remover
18.  Other nail andcuticle products1.    Cuticle remover / softener
2.    Nail  sculpting products
3.    Other nail and cuticle products
4.    Oral Hygiene Products19.  Tooth care products1.    Toothpaste
2.    Tooth cleansing powder / salt
3.    Other tooth care products
20.  Mouth wash / breath spray1.    Mouth wash
2.    Breath spray
3.    Other mouth wash / breath spray products
21.  Tooth whiteners1.    Tooth whiteners
22.  Other oral hygiene products1.  Other oral hygiene products

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