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CDSCO issues guidance document on license for import or manufacture of cosmetics in India
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Shardul Nautiyal, Mumbai
January 22 , 2021
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In order to streamline the process of import registration of cosmetics, the Central Drugs Standard Control Organisation (CDSCO) has issued frequently asked questions (FAQs) and guidance document for grant or retention of registration certificate (RC) or license for import or manufacture of cosmetics in India under the new Cosmetics Rules 2020.
The Cosmetics Rules 2020 have been recently published through a gazette notification dated December 15, 2020 and is in effective from December 15, 2020.
“Aimed at ease of doing business, FAQs and guidance document have been prepared in light of the Cosmetics Rules 2020 and uploaded on CDSCO website. The approvals/licenses/permissions/certificate issued under the provisions of the Drugs and Cosmetics Act, 1940 and D&C Rules, 1945 in respect of cosmetics prior to commencement of these rules shall be deemed to be valid for all purposes till its expiry or for a period of eighteen months from the date of notification of these rules whichever is later under the compounding provisions of the said Rules,” as per the DCGI notice.
The Union health ministry, through a gazette notification, has notified the Cosmetics Rules, 2020 to separately codify rules relating to cosmetics for effective compliance.
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.
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.
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.
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