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India Cosmetic Legislation

  •   5 Apr 2017
  •    Jo Zhou
  •  115510
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     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

    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), who is the main authority to regulate activities relating to cosmetics and promulgate corresponding regulations.

    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

    RegulationsFunctionsEffective DateStatus
    Drug and Cosmetic Act 1940& Rules 1945
    (amended up to  Dec. 31st 2016)
    Overarching Regulations on manufacturing and importing, distribution and sale of cosmetics2016-12-21In Force
    Guidelines on Registration of Import of CosmeticsGuidance to instruct registration for cosmetics imported for sale2013-3-31In Force
    Clarification for Import and Registration of CosmeticsExplain details that are not clarified in "Guidelines"2015-10-15In Force
    Classification of Cosmetic Raw Materials and Adjuncts Part1 & Part 2Lists of ingredients which are prohibited and restricted in cosmetics2017-3-1In Force

    2. Competent Authority

    The organizations for Drugs Control exist at two levels: Central and State Government level.

    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:

    1. Amendment of Drugs & Cosmetic Rules, 1945 with respect to registration of import of Cosmetic products.
    2. 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 made thereunder.
    3. Scrutiny of various applications for NOC /Clarification relating to import of cosmetic products.
    4. Preparation of draft replies to RTI, court cases, VIP references and Parliament Question related to cosmetics.
    5. Replying to Government correspondences/ BIS as and when required.
    6. Handling of PMOPGs/public enquiries/hearings related to cosmetic import registration process and providing guidance thereto.
    7. Handling of public/NGOs/Consumer forums complaints/grievances regarding standards of cosmetic products.
    The State Drug Control Department deals with licensing of both manufacturing and sales premises of cosmetics. Its most important mandate is to ensure the supply of quality drugs at the price fixed by GOI (NPPA) to the people of the State.
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    Comments


    FREQUENTLY USE OF HAND SANITIZER ALCOHOL CONTAIN HARMFUL TO HANDS
    Saturday, 3 June 2017
    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?
    Tuesday, 12 September 2017