In an era of constant innovation, the cosmetics industry is witnessing a surge in novel product development, driven by advancements in technology and evolving consumer preferences. As manufacturers introduce cutting-edge formulations and groundbreaking ingredients, navigating the regulatory landscape becomes increasingly crucial. In this blog, we delve into the regulatory framework governing novel cosmetic products in India and how businesses can ensure compliance while fostering innovation.
What is considered as a New Cosmetic in India?
As per the CDSCO Cosmetic Rules 2020, New cosmetic is a cosmetic which contains a novel ingredient which has not been used anywhere in the world or is not recognised for use in cosmetics in any National or International literature.
CDSCO Regulation of New Cosmetics in India
In India, while there exist distinct registration pathways for domestically manufactured cosmetics and those imported from overseas, the process for registering new cosmetics—regardless of their origin, whether manufactured domestically or abroad—remains uniform. The Indian Authorized Agent or the domestic manufacturer must obtain prior permission from CDSCO before proceeding with the application for either an Import Registration Certificate or a Manufacturing License.
Unlike the manufacturing license for domestic cosmetic products, which is issued by the State Licensing Authority, the process for obtaining approval for new cosmetics developed in India lies within the jurisdiction of the Central Licensing Authority. In the case of a new cosmetic, the applicant is required to seek prior permission from the Central Licensing Authority, as stipulated in Chapter V of the Cosmetic Rules, 2020. This permission is obtained through Form COS-3 before initiating the manufacturing license process for manufacturing a new cosmetic in India. Additionally, no manufacturing license for any cosmetic can be granted by the State Licensing Authority without prior permission from the Central Licensing Authority for new cosmetics.
The application for registration of a new cosmetic is submitted using Form COS-12, and the approval is issued by the Central Licensing Authority after thorough assessment, typically in the form of Form COS-03. This meticulous process ensures that new cosmetics entering the Indian market comply with regulatory standards and prioritize consumer safety and product quality.
Documents to be submitted for New Cosmetic Registration with CDSCO –
Checklist for grant of permission for New Cosmetics in Form COS-12 under the provisions of Cosmetics Rules 2020
Covering Letter- Purpose should be clearly mentioned with page number and Index.
Particulars of New Cosmetics: -
o Name of the cosmetics
o Category of cosmetic/intended use
o Composition of product.
o Test Protocol/Test method of the raw materials and finished product.
o Specification of the raw materials and finished product along with Certificate of Analysis.
Assessment of the safety for human health of the finished product, its ingredients, their chemical structure and level of exposure.
Existing data on undesirable effects on human health resulting from use of the cosmetic product.
Supporting data for the claimed benefits of cosmetic product should be made available to justify the nature of its effect.
Specimen copy of the product label and carton.
o Package insert and Promotional literature etc.
Whether the preparation of the proposed cosmetic is approved and marketed in other major countries if yes details of the same
Any other data generated on safety, effectiveness and quality parameters.
Other documents
o Undertaking that the cosmetic products to be imported in to the country have not been tested on animals as per the Cosmetics Rules, 2020.
o Undertaking from the manufacturer stating compliance of all raw materials or pigments used, heavy metals and hexachlorophene contents in products with Bureau of Indian Standards and the Cosmetics Rules, 2020.
o Any other (if any)
o Details of IEC and GSTIN of the firm (enclose copy of documents)
Fee Bharatkosh e-receipt and challan 11. Application (Form COS - 12)
The manufacturer is required to adhere to the methods of test or analysis specified in IS 4011:2018, titled "Methods of Test for Safety Evaluation of Cosmetics," published by the Bureau of Indian Standards. These methods should be followed as amended from time to time to ensure the safety evaluation of new cosmetics.
CDSCO Fees for obtaining Permission for New Cosmetic Registration with CDSCO
Conditions for granting permission to import or manufacture new cosmetics include ensuring conformity to specifications approved by the Central Licensing Authority. Additionally, the cosmetic's name must be clearly printed or written in indelible ink and prominently displayed. Any special instructions permitted must be included on the label, and claims beyond those permitted require prior approval from the Central Licensing Authority.
An application for import, as outlined in Chapter III, and for manufacture, as outlined in Chapter IV, of the Cosmetics Rules, 2020, must be submitted to the appropriate authority, either the Central Licensing Authority or the State Licensing Authority. This submission should include the prior permission obtained in Form COS-3 from the Central Licensing Authority.
As India's cosmetics market continues to flourish, navigating the regulatory landscape is paramount for manufacturers seeking to introduce new products. By understanding and adhering to regulatory requirements, businesses can ensure product safety, build consumer trust, and unlock growth opportunities in this dynamic industry. With Artixio as your regulatory partner, you can navigate the complexities of new cosmetics regulation in India with confidence and success.
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