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India Cosmetics Regulation

In India, cosmetics are regulated by Central Drug Standard Control Organization (CDSCO) under the overarching regulation Drug and Cosemtic Act 1940 & Rules 1945 (amended up to Dec.31st 2016). The Bureau of Indian Standards (BIS) issued standards for ingredient usage in cosmetics.

Under the provisions of Drugs and Cosmetics Act, 1940 and Rules made thereunder, the manufacture of cosmetics in India is regulated under a system of inspection and licensing by the State Drug Control Department while the import of cosmetics is regulated under a system of registration by the Central Drugs Standard Control Organization (CDSCO).

The application for a license of manufacture is submitted though the website of each state in India. Specific procedures vary from state to state. The required documents in Maharashtra State are as follows, for example:

  • Application in form 31 (for cosmetics)
  • Challan of fees paid to be upload in MFW module
  • Specific power of attorney in favor authorized signatory for submitting application on behalf of the company
  • List of competent technical staff, with their qualification, registration, experience, previous FDA approvals, etc.
  • Appointment/acceptance letter of competent technical staff of manufacturing section
  • Appointment/acceptance letter of competent technical staff of testing section
  • Section wise list of plant and machineries
  • Plan layout of the premises approved by the licensing authority
  • Consent to establish & consent to operate from Maharashtra State Pollution Control Board
  • Noc of department of industrial safety & health
  • Details of manufacturing process, process flow chart (for bulk drug)
  • AHU installation and validation certificate (wherever necessary)
  • Water system installation and validation certificate (wherever necessary)

For registration of imported cosmetics, India adopts the concept of "brand" which refers to products in "product" column in above classification list. 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 mean the manufacturer himself/itself.

A single application may be made for any number of brands manufactured at one or more locations by a single manufacturer. If the applicant seeks to import the same brand belonging to different manufacturers, he needs to submit separate application for each manufacturer and has to pay separate fees. In any existing valid registration certificate, if the applicant wants to add any further brand of already registered category as mentioned in the above "product" list for the same manufacturer, separate application will need to be submitted by the importer. But no fee will be charged. In such cases additional product permission will be endorsed to the already approved category in a given registration certificate.

  • India Notifies the Draft Cosmetics Rules 2018 to the WTO

      Official Release   2 Jul 2019   Winnie Xu

    On June 21, 2019, the Draft Cosmetics Rules 2018 (G/TBT/N/IND/101) was notified to the Technical Barriers to Trade (TBT) Committee of WTO...
  • India Consults on the Draft Cosmetics Rules 2018

      Official Release   25 Dec 2018   Winnie Xu

    On Nov. 29, India Ministry of Health and Family Welfare issued a draft cosmetics regulation—Cosmetics Rules 2018 which consists of 71 rules, 13 schedules and 24 appended forms for public consultation until Jan. 13, 2019...
  • China and India Cut Tariffs on Imported Cosmetics amid Trade War with US

      Official Release   27 Jul 2018   Winnie Xu

    Since July 1st, China has lowered import tariffs on 19 cosmetic products and India has lowered import tariffs on 26 cosmetic items. The tariffs concessions were made as part of the Asia-Pacific Trade Agreement (APTA)...
  • India Amended Cosmetic Manufacture and Sale License Validity and Verification

      Official Release   6 Dec 2017   Jo Zhou

    India has amended the "Drugs and Cosmetics Rules 1945" that stipulated the validity provisions for drugs and cosmetics manufacturing license and relevant manufacturing premises inspection measures. Ministry of Health and Family Welfare of India amended the...
  • India Encourages Use of Non-animal Alternative Tests

      Official Release   27 Dec 2016   Angelita Hu

    Recently India Ministry of Health & Family Welfare published the notice regarding partial amendment to “Drugs and Cosmetics Rules, 1945”. The amendments are relating to animal toxicity studies and encourage...
  • Cosmetic Registration in India Goes Online

      Official Release   2 Jun 2016   Melody Shen

    From 6 June 2016 cosmetic registration in India must be submitted online. On 30 May India Central Drug Standard Control Organization (CDACO) announced that from 06 June the registration for cosmetics have to be...

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  • China Cruelty Free Cosmetics: An Interview With Cruelty Free International

      ChemLinked Exclusive   17 Jul 2018   Paul O Brien

    Cruelty free is a both a hugely contentious and polarizing issue for the global cosmetics industry. Despite global trends towards cruelty free best exemplified by the blanket bans on animal testing of cosmetics imposed in Europe and India, China has...
  • India Lowers Tax Rate to 18% on 7 Types of Cosmetics

      ChemLinked Exclusive   12 Dec 2017   Jo Zhou

    In India, 178 kinds of products will now be subject to a reduced GTS tax rate (28% to 18%). 7 types of cosmetics are included...  
  • Significant Events in India’s Ban on Animal Testing

      ChemLinked Exclusive   28 May 2014   Daisy Suo

    India is celebrating an epoch in its legislative and regulatory history. After years of debate the final implementation of the amendment to the “Drugs and Cosmetics Rules” completely bans the use of domestic animal...
  • Giacomo Cirillo

    Overview on Regulations on Animal testing for Cosmetics

      10 Aug 2017  Regulation  1470

    In this article we will talk about animal testing for cosmetic products in general, its legal status in various countries and how can companies with a "cruelty free" profile export their products to China avoiding this practice. Animal testing, that is to say the...
  • Ashwini Kumar

    Registration of Imported Cosmetics in India

      28 May 2015  Regulation  2975

    A Gazette Notification G.S.R 426(E) dated 19th May 2010 has been issued by the Government of India for amending the Drugs & Cosmetics Rules, 1945 providing for registration of import of cosmetics into the Country. This provision was to come into effect from the 1st...

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