GoI’s implements new COSMETIC RULES 2018

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The Indian Government (GoI) has made a final regulation to govern various clause and rules pertaining to import and manufacture of cosmetics.

The final regulation was circulated Vide Notification No.GSR 1153(E) dated 29th November 2018. The new law governing will be called ‘COSMETIC RULES 2018.’ Listed below are the key changes in the regulation regarding ‘IMPORT OF COSMETICS in INDIA’.

  • The application shall be submitted in Form named COS-1 instead of Form 42 and Application shall be approved in Form named COS-2 instead of Form 43.
  • New Cosmetics: The permission should be issued in Form COS-3. Any person who intends to import or manufacture a new cosmetic shall apply to the central licensing authority in Form COS-12 along with the data on safety and effectiveness of cosmetic. Methods of test or analysis to be employed for safety evaluation of new cosmetic shall be compiled by the manufacturer as specified in the IS 4011 : 1997 methods of test for safety evaluation of cosmetics, published by the Bureau of Indian Standards as amended from time to time.
  • No cosmetics shall be imported unless the ‘Use before or use by’ date shown on the label, wrapper or container of the cosmetic is later than six months from the date of import.
  • No cosmetic containing hexachlorophene shall be imported. Provided that in case of soaps, hexachlorophene may be used in concentrations not exceeding one percent weight by weight: Provided further that the following cautionary note shall be printed and shall appear in a conspicuous manner on the wrapper of a package of each soap, namely ‘Contains hexachlorophene – not to be used on babies’.
  • A distinctive batch number, that is to say, the number by reference to which details of manufacture of the particular batch from which the substance in the container is taken are recorded and are available for inspection, the figures representing the batch number being preceded by the letter ‘B’ or the words ‘Batch No.’ or ‘B. No.’ or ‘Batch’ or ‘Lot No.’ or ‘Lot’ shall carry on both the inner and outer labels; Provided that this clause shall not apply to any cosmetic containing 10 grams or less if the cosmetic is in solid or semi-solid state and 25 milliliters or less if the cosmetic is in a liquid state: Provided further that in the case of soaps, instead of the batch number, the month and year of manufacture of soap shall be given on the label.
  • In the case of imported cosmetics to be marketed in India, import registration certificate number shall be mentioned on the label preceded by the letter ‘RC’ or ‘RC No’ or ‘Reg. Cert. No’ along with name and address of the importer.
  • Where a package of a cosmetic has only one label, such label shall contain all the information required to be shown on both the inner and the outer labels, under these rules.
  • The prohibition against false or misleading claims. No cosmetic may purport or claim to purport or convey an idea, which is false or misleading to the intending user.
  • No cosmetic shall be imported or manufactured unless it complies with the specifications prescribed under the Schedule and the Tenth Schedule or any other standards of quality and safety, applicable to it, and other provisions under the rules. In case, the cosmetic is not included under the Ninth Schedule and the Tenth Schedule, it shall meet the requirements under these rules and specifications and standards applicable to it in the country of origin.
  • Raw materials generally not recognised as safe for use in cosmetics as specified by the Bureau of Indian Standards (IS: 4707 Part II (as amended)) shall not be added in the cosmetics.
  • No Cosmetic shall be imported or manufactured which contains Dyes, Colours and Pigments other than the one specified by the Bureau of Indian Standards (IS : 4707 Part I as amended) and included the Tenth Schedule.
  • Category fees are proposed as USD 1000 instead of USD 250 earlier.
  • Fee for each variant of cosmetic for the grant of registration certificate USD 50.
  • Fee for each manufacturing site for the grant of registration certificate USD 500.
  • Fee for grant of permission for new cosmetics USD 500
  • The registration period is increased from 3 years to 5 years
  • Fee for grant of license in Form COS- 24 for test and analysis of cosmetics USD 1000.
  • Ninth Schedule at Page No.104 refers Standards for cosmetics in finished form: The following cosmetics in finished form shall conform to the Indian Standards specifications laid down from time to time by the Bureau of Indian Standards (BIS).
  • Tenth Schedule at Page 105 refers List of dyes, colours and pigments permitted to be used in cosmetics and soaps as given under IS: 4707 (CHAPTER I) – 1988 as amended by the Bureau of Indian Standards.

It is also very important to note that Indian government has given a period of 45 days from the date of notification of the attached draft rules during which period any foreign manufacturer/ person/entity/manufacturer is free to communicate their Objections/suggestions to email id drugsdiv-mohfw@gov.in. Upon completion of 45 days, it is most likely that Government of India will implement the New Rules.

The above information has been provided by NK Consultants. They stated, “We are in the process of preparing the templates/formats which will become applicable for the purpose of Registration under new Laws. We also wish to mention that the government will also initiate urgent actions for making a provision in the CDSCO electronic portal to enable the companies/agents for submitting applications online. In the interim period, applications would have to be submitted in hard copy.”

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