India Cosmetic Legislation

  •   5 Apr 2017
  •    Jo Zhou

     India Cosmetics Legislation

    Overarching Regulation
    Drug and Cosmetic Act 1940& Rules 1945 (amended 2016)
    Competent Authority
    Central Drugs Standard Control Organization
    Bureau of India Standards
    Main Supporting Rules 
    31 Mar 2013Guidelines on Registration of Import of Cosmetics
    15 May 2013Classification of Cosmetic Raw Materials and Adjuncts Part1
    15 May 2013Classification of Cosmetic Raw Materials and Adjuncts Par2

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

    Before March 2013, there were no requirements to register imported cosmetics, but from April 1st 2013, all cosmetics imported for sale in India require mandatory registration with the Central Drugs General (India) (DCGI).

    Domestic cosmetics in India don’t require registration, but 11 categories of cosmetics (cosmetics require auditing of factory premises, space, plant and machinery and other requisites) must obtain a loan license before manufacturing.

    Cosmetics that have been tested on animals are prohibited from import into India. Besides, cosmetics with Hexachlorophene, Lead or Arsenic compounds and mercury compounds are prohibited to be manufactured and imported.

    Contents

    Part 1 Regulatory Framework and Competent Authority

    1. Existing Main Cosmetic Regulations in India

    Regulations

    Functions

    Effective Date

    Status

    Drug and Cosmetic Act 1940& Rules 1945

    (amended up to  Dec. 31st 2016)

    Overarching Regulations on manufacturing and importing, distribution and sale of cosmetics

    2016-12-21

    In Force

    Guidelines on Registration of Import of Cosmetics

    Guidance to instruct registration for cosmetics imported for sale

    2013-3-31

    In Force

    Classification of Cosmetic Raw Materials and Adjuncts Part1 & Part 2

    Lists of ingredients which are prohibited and restricted in cosmetics

    2015-5-15

    In Force

    2. Competent Authority

    The Central Drugs Standard Control Organization (CDSCO) is the main authority to regulate activities relating to cosmetics and promulgate corresponding regulations. Under CDSCO, the Central Drugs General (India) (DCGI) is established as the executive sector to deal with operations such as application for registration or license.

    Exact functions of CDSCO include:

    i. Pre-screening of applications received by the applicant with respect to registration of the import of the cosmetic.

    ii. Scrutiny of applications relating to registration of cosmetic products for Import into the country as per the requirements of Drugs and Cosmetics Act 1940 and Rules, 1945 thereunder.

    iii. Scrutiny of various applications for NOC /Clarification relating to cosmetic products import.

    iv. Preparation of draft replies to RTI, VIP references and Parliament Question related to cosmetics.

    v. Replying to Government correspondences/ BIS as and when required.

    vi. Handling of public enquiries/hearings relating to cosmetic import registration process and providing guidance thereto.

    vii. Handling of public/NGOs/Consumer forums complaints/grievances regarding standards of cosmetics products.

    viii. Amendment of pre-screening checklist and preparation of SOP as per the present working procedures on evaluation of applications for import and registration of cosmetics.

    ix. Amendment of Drugs & Cosmetic Rules, 1945 with respect to registration of import of cosmetic products.

    Besides, the Bureau of Indian Standards (BIS) provides specifications of certain cosmetics, and issued lists for prohibited/allowed ingredients used in cosmetics.

    Any question?

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    Comments

    FREQUENTLY USE OF HAND SANITIZER ALCOHOL CONTAIN HARMFUL TO HANDS
    Hi, If I want to introduce a new sunscreen product in India which have a novel ingredient, do I need to get approval for that novel ingredient?