Regulatory Framework for Import of Cosmetics from Korea, Japan, other countries

India offers a large and diverse market for the import and sale of cosmetics and has recently witnessed a rise in demand for Korean and Japanese skin-care and cosmetic imported products. These products have created a niche for themselves and are capturing a significant portion of the cosmetics market share in India. The Central Government notified on 15.12.2020, the Cosmetics Rules, 2020 (“Rules”), with a view to updating and streamlining the process of import registration of cosmetics and to address the various concerns and challenges faced by the stakeholders regarding the application for grant of import registration. The Rules regulate the import of cosmetics in India to ensure safety, quality and performance of the cosmetics being imported into India.

As per the Drugs and Cosmetics Act, 1940 (“Act”), cosmetics are defined to mean any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic.

The import of cosmetics in India, is regulated through a system of registration by the CDSCO under the provisions of the Act and the Rules. Any product falling under the ambit of the definition of cosmetic (as detailed above) is required to be registered along with pack size, variants and manufacturing premises, before import into the country. It is prescribed under the Rules that no cosmetic can be imported into India unless with the product has been registered in accordance with the Rules (Rule 12). Under the Fourth Schedule of the Rules, cosmetics have been categorised and classified into different variants and the category/ variant needs to be specified when moving an application for Import Registration Certificate for import of cosmetics products into India and fees is payable accordingly as per the Third Schedule.

The application for registration of a cosmetic product intended to be imported into India can be made through the online portal of the Central Government. The application for grant of Import Registration Certificate for import of cosmetics products into India may be filed by the manufacturer himself or his authorised agent or the importer in India or the subsidiary in India authorised by the manufacturer.

The applicants must also be cognizant of the labelling requirements set forth in the Rules and note that no cosmetic product may be imported into India unless it is packed and labelled in conformity with the Rules (specifically Rule 34 read with Chapter VI of the Rules) and the label of imported cosmetics bears the registration certificate number of the product and the name and address of the registration certificate holder for marketing the said products in India.

Further, imported cosmetics are also required to comply with applicable BIS standards and the specifications prescribed under the Rules or any other standards of quality and safety, applicable to it, and other provisions under the Rules. Cosmetics not under the Ninth Schedule are required to meet the requirements under these Rules and specifications and standards applicable to it in the country of origin. It is important to note that no cosmetic, the manufacture, sale or distribution of which is prohibited in the country of origin, shall be imported under the same name or under any other name except for the purpose of examination, test or analysis.

Moreover, applicants must be aware that cosmetic products having any drug claim on the label/ literature would not come under the definition of cosmetics as per the Act and therefore cannot be considered for registration as a cosmetic. Also the applicant must ensure that the cosmetic imported does not purport or claim to purport or convey any idea which is false or misleading to the intending user.

In case of a ‘New Cosmetic’ permission for import of such new cosmetic is required to be specially sought under the Rules. Further, a separate procedure in respect of import of cosmetics already registered for import has also been detailed under the Rules.

In view of the regulatory framework under the Act and Rules, manufacturers, its authorised agent/ importer must furnish the necessary forms, information, documentation and certifications to the CDSCO (in the form and manner provided in the Rules) and ensure that their cosmetic products comply with the standards and prescriptions detailed in the Rules to seek registration for import of their respective cosmetic products into India.

Manufacturers of cosmetics are required to comply with another set of compliances for undertaking manufacture of cosmetics for sale and distribution including applying for license to manufacture cosmetics for sale and distribution in India. Similarly there are separate compliances for sale and distribution of cosmetics in India.

The import of cosmetics in India is subject to the regulatory framework set forth in the Act and Rules and it is essential for manufacturers, their agents, importers, distributors to comply with the necessary standards and specifications and seek the appropriate registrations and licenses so that they are able to operate in the Indian market and access its diverse and burgeoning consumer base.

(This Article is solely for information purposes, does not constitute legal or professional advisory and should not be relied upon or used as a substitute for legal advice from attorney.)

About the Authors:

Jayshree Navin Chandra, Senior Partner at ZEUS Law, has been a practicing lawyer since 2001 with extensive corporate and transactional advisory experience. She manages and oversees the Corporate & Commercial, M&A, Infrastructure & Real Estate and Technology practice at the firm and advises and represents clients ranging from Fortune 500 companies to start-ups as well as Central and State Government departments and public bodies in a wide range of domestic and cross border transactions, across industries. Nitika Bakshi, is an Associate at ZEUS Law and works in the Corporate, Commercial & Technology practice vertical.

ZEUS Law Associates is an ISO certified full service corporate commercial law firm with a team of dedicated and experienced lawyers well versed in handling domestic and cross border transactions across sectors, jurisdictions and regulatory landscapes. The firm’s practice areas include Corporate & Commercial Law, M & A, Infrastructure & Real Estate, Litigation, Alternate Dispute Resolution, Indirect Tax, Technology & E-commerce and NRI Services.