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Health ministry notifies Cosmetics Rules, 2020 for effective regulation and compliance
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Shardul Nautiyal, Mumbai
December 18 , 2020
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In order to separately codify rules relating to cosmetics for effective compliance, the Union health ministry, through a gazette notification, has notified the Cosmetics Rules, 2020.
The ministry issued the notification in exercise of the powers conferred by section 12 and section 33 of the Drugs and Cosmetics (D&C) Act, 1940 (23 of 1940). These rules shall be applicable to the cosmetic as defined in clause (aaa) of Section 3 of the D&C Act, 1940 (23 of 1940).
In these rules, unless the context otherwise requires, Act means the Drugs and Cosmetics Act, 1940 (23 of 1940);(b)?Actual manufacturer in relation to import of cosmetics, means a person who manufactures cosmetics at his own manufacturing site in a country other than India approved by National Regulatory Authority or any authorised competent authority in that country for that purpose, by whatever name called for the purpose of this clause, person includes a company or a unit or a body corporate or any other establishment.
As per the notified rules, authorised agent means a person in India authorised by the manufacturer. The authorised agent shall be responsible for the business activities of the manufacturer in India including compliance to the provisions of the Act and rules made thereunder for the purpose of this clause, person includes a company or a unit or a body corporate or any other establishment.
Bureau of Indian Standards (BIS)means the Bureau of Indian Standards established under Section 3 of the Bureau of Indian Standards Act, 2016 (11 of 2016).
No cosmetic shall be imported into India unless the product has been registered in accordance with these rules by the Central Licensing Authority or by any officer to whom such powers may be delegated under sub-rule (1) of rule 5.
An application for registration of a cosmetic product intended to be imported into India shall be made through the online portal of the Central Government in Form COS-1 either by the manufacturer himself or by his authorised agent or the importer in India or by the subsidiary in India authorised by the manufacturer.
An authorisation by the manufacturer to his agent in India shall be duly authenticated either in India before a first class Magistrate or in the country of origin before the authority competent under the laws of that country or by an authority specified in the First Schedule.
The applicant referred to sub-rule (2) above shall furnish along with the application such other information and documents as specified in Part I of the Second Schedule provided also that in the event of application for import of bulk finished formulation ready to fill, the following additional documents shall also required to be furnished.
A registration certificate granted under rule 13 shall remain valid in perpetuity, subject to payment of registration certificate retention fee as specified in the Third Schedule before completion of the period of five years from the date of its issue, unless, it is suspended or cancelled by the licensing authority.
If the licensee fails to pay the required registration certificate retention fee on or before the due date as referred to in sub-rule (1), the registration certificate holder shall, in addition to the registration certificate retention fee, be liable to pay a late fee calculated at the rate of two percent of the registration certificate retention fee for every month or part thereof within one hundred and eighty days and in the event of non-payment of such fee during that period, the registration certificate shall be deemed to have been cancelled.
In case of change in constitution of a registration holder or overseas manufacturer, after grant of registration under sub-rule (1) of rule 13, an application shall be made under sub-rule (2) of rule 12 for grant of fresh registration within a period of one hundred and eighty days from the date of such change in constitution provided that the existing registration shall be deemed to be valid till such time, fresh registration is issued or application is rejected by the Central Licensing Authority.
In case of any change in respect of labelling or composition or testing of registered product or its specifications, the Central Licensing Authority shall be informed by manufacturer or by the authorised agent or the importer or the subsidiary in India authorised by the manufacturer within fifteen days along with an undertaking that products comply with standards laid down by the Bureau of Indian Standards as referred in the Ninth Schedule.
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