Cosmeceutical Regulation.docx

ASSIGNMENT: MARKETING OF COSMECUTICALS.  Regulation for cosmeceuticals in India:

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Cosmeceuticals bridge the gap between pharmaceuticals and cosmetics. They contain biologically active ingredients which have or claim to have medical benefits.

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In India, Drugs and Cosmetics Act, 1945, defines regulation with respect to manufacturing, sales, distribution, storage and import of drugs as well as cosmetics, with Labelling declaration by Bureau of Indian Standards (BIS).

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BIS sets standards for cosmetics for the products listed under the ‘Schedule S’ of the Drug & Cosmetics Rules, 1945. It has also provided specifications for skin creams and lipsticks in Indian Standards.

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The legal difference between cosmetics and drugs is defined by the intended use of the product. As per the current concept, the boundary at which a cosmetic becomes a drug is not clear. And for each drug and cosmetics we have laws governing both of them.

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The ‘Rule 134‘ of Drug & Cosmetics Rules has laid down restriction on the use of cosmetics containing dyes, colours and pigments other than those specified by the BIS.

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The ‘Rule 135’ prohibits import of cosmetics which comprised the amount or traces of Lead or Arsenic compounds which might be used in the colouring agents.

 Registration of Import of Cosmetics:

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A Gazette notification ‘GSR 426(E) valid from 19th May, 2010 has been issued by the Government of India for amending the Drug & Cosmetics Rules, 1945, providing for registration of import of cosmetics into the country.

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The provision was come into effect from 1st April, 2011. But in view of the various possible difficulties apprehended by the stakeholders, its implementation was defended till 31st March, 2013.

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Imported cosmetics for sale in India are needed to be registered by CDSCO, which has been appointed as the licensing authority for the purpose of these rules.

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The new registration requirement is primarily to regulate indiscriminate import of beauty and personal care products by traders with no accountability.