Author: Shreya (Foreign attorney: India )

Introduction

In the current scenario, the cosmetics industry has been growing significantly in India, especially increasing their presence on the social media platform. More and more international cosmetic brands are importing their products into India to keep up with the high demands for skin care and health care products by the urban population.

Cosmetic Regulations in India

Cosmetics that are imported into India are primarily regulated by ‘The Central Drugs Standard Control Organization (CDSCO)’, Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, the Central Licensing Authority under the provisions of the Drugs and Cosmetic Act 1940 and the relatively new Cosmetic Rules, 2020, which governs rules pertaining to registration and licensing, inspection, and all other compliance requirements of the imported cosmetics.

According to the Drugs & Cosmetics Act, 1940, a ‘Cosmetic’ refers to “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 appearance and includes any article intended for use as a component of cosmetic”.

The new Cosmetic Rules, 2020 also introduced the concept of “New Cosmetics”, which refers to a cosmetic which contain novel ingredient which has not been used anywhere in the world or is not recognized for use in cosmetics in any national or international literature.

No cosmetics shall be imported to India unless the importers ensure that all mandatory specifications, guidelines and declarations prescribed under the Drugs & Cosmetics Act, 1940 and the Cosmetic Rules, 2020 are complied with.

Registration and Licensing of Cosmetics in India

Any company intending to import cosmetics in India is required to obtain registration certificate and license from the CDSCO either through the Manufacturer having registered office in India or by his authorized agent, or an importer in India or by the subsidiary in India authorized by the manufacturer.

As per Rule 13 of the Cosmetic Rules, 2020, any such application regarding the issuance of the Import Registration Certificate (Form COS-2) must be made by filing Form COS-1 through an online Portal named ‘SUGAM’, specifying detailed report of the imported products including testing methods and safety evaluation, along with the requisite fees and documentations, listed in detail on the website of CDSCO [https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/].

In cases where an importer is seeking approval for and issuance of registration of the ‘New Cosmetic’ (Form COS-3) shall do so by filing the form COS-12, also on the SUGAM Portal along with the necessary fees and documents.

The licensing authority, thereafter shall grant the license after being satisfied with the documentation, or may reject so within a period of six months from the date of submission of the application. The Registration Certificate granted to the importer shall remain valid for a period of five years from the date of its issuance, unless suspended or cancelled by the authority.

Cosmetic Products prohibited from importation

The Cosmetic Rules, 2020 has prohibited import of cosmetic to India, in the cases where:

1. The manufacture or sale of the cosmetic is prohibited in the country of origin;
2. The ‘Use Before or Use by date’ is less than six months from the date of import;
3. The cosmetic which contains ‘hexachlorophene’ (considered harmful on humans); and
4. The cosmetic has been tested on animals.

Labelling Requirement under Cosmetic Rules, 2020

The 2020 Rules mandates importers to ensure that the Cosmetic products to be sold in India would comply with the specifications listed thereunder and would have both inner and outer box labelling along with the mandatory declarations on it.

The declarations to be made are stated in brief as follows:

1. The name of the cosmetic, name of legal manufacturer, complete address of the manufacturing site and date of expiry must be stated on both the inner and outer labels;
2. A declaration on the outer label specifying the net content in terms of weight, fluid measures, and numerical count being used in manufacturing the product;
3. A distinctive Batch number, Lot number, Manufacturing license number and Registration Certificate number in a proper manner required under the 2020 Rules;
4. Name of ingredients, present in concentration of more than one present must be listed in descending order of weight or volume at the time they are added, followed by those in concentration of less than or equal to one percent, in any order, and preceded by the word “INGREDIENTS”
5. In case of cosmetic products containing hazardous ingredients, the label for ‘Direction for safe use’ or any such caution or warning must be specified in the inner label of the product;
6. Details of the importer must also be stated, along with any other information necessary to be disclosed under the 2020 Rules and rules stipulated by the Bureau of Indian Standards (BIS) for a few specific categories of cosmetic products.

Conclusion

The new Cosmetic Rules brought in by the Government of India in 2020 has much more clarity on the rules and regulations regarding the cosmetic business and streamlined the application process for registration of cosmetics to be imported in India by digitalizing the whole regulatory process, making it less time consuming for the importers. These relaxed rules and regulations seem to provide efficient measures towards making it easier for foreign brands to operate and work with multiple importers in India.