New Cosmetic in India? When and Why, You Need Form COS-3 and COS-12

The Pathway Most Brands Don’t Know Exists

Many global Cosmetic brands first become aware of India’s novel ingredient approval requirements only after submitting their import registration application in Form COS-1 and receiving a query from the Central Drugs Standard Control Organisation (CDSCO). The reason is often straightforward: one or more ingredients in the formulation may qualify as a “novel ingredient” under the Cosmetics Rules, 2020.

At that stage, brands face a difficult decision: reformulate the product—potentially requiring significant time, cost, and product redevelopment—or pursue the New Cosmetic approval pathway by obtaining prior permission from the Central Licensing Authority (CLA).Both options can delay market entry. Early identification of ingredients that may trigger the New Cosmetic pathway is the most effective way to avoid costly surprises. 

This article explains what makes a Cosmetic ‘New’ under Indian regulations, walks through the COS-3 and COS-12 process, and provides practical guidance for global brands whose formulations include newer actives not yet established in the Indian market.

What is a “New Cosmetic” Under the Cosmetics Rules 2020?

Rule 3(r) of the Cosmetics Rules, 2020 defines “New Cosmetic” means 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. This definition focuses on the ingredient — not the product format, brand, or delivery mechanism.

In practical terms, if an ingredient:

• Has not been previously permitted in Indian Cosmetics through the BIS Ninth Schedule permitted lists
• Has not been used commercially in cosmetic products previously imported or manufactured in India
• Is a novel synthetic molecule, a novel biotechnology-derived active, or a novel natural extract with no prior India-market history

…then the product containing it is likely to be classified as a ‘new cosmetic’ and will require Prior permission in COS-3 from central licensing Authoritybefore the standard COS-2 application can be processed.

Ingredients That Commonly Trigger the New Cosmetic Pathway

Based on CliniExperts’ experience with Import Registration application applications and CDSCO queries, the following types of ingredients most frequently trigger the novel ingredient classification:

• Novel peptides and biomimetic actives: Copper peptides, palmitoyl tripeptides, acetyl hexapeptides, and other synthetic peptide complexes with limited history of use in India. Fermentation-derived actives: galactomyces, lactobacillus ferment filtrates, and post-biotic Cosmetic actives that have emerged from K-beauty and J-beauty formulation trends
• Novel botanical extracts: plant-derived extracts standardised to specific actives (e.g., bakuchiol, turmeric extract standardised to curcuminoids) where the extract form differs from traditional botanical usage
• Newer UV filters: UV filter molecules that are approved in the EU under the more progressive EC review process but not yet incorporated into India’s permitted UV filter schedule
• Novel preservative blends: ingredient combinations that have been developed to replace parabens or formaldehyde releasers but have not been individually evaluated in the Indian framework

Form COS-12: Permission to Import a New Cosmetic for Testing or Trial

Under Rule 32 of the Cosmetics Rules, 2020, any person intending to import or manufacture a new Cosmetic containing a novel ingredient must obtain prior permission from the Central Licensing Authority (CLA) by submitting an application in Form COS-12 through CDSCO, along with the prescribed fee.

The application may be submitted by the manufacturer, importer, or the manufacturer’s authorised agent in India. The dossier should include complete formulation details, INCI names, CAS numbers, ingredient specifications, manufacturing information, proposed labels, international Regulatory status, and available safety and toxicological data.

As per Rule 32(4), all safety evaluations must comply with IS 4011:2018 – Methods of Test for Safety Evaluation of Cosmetics. Depending on the ingredient and intended use, supporting data may include studies on skin and eye irritation, sensitisation, phototoxicity, genotoxicity, repeated-dose toxicity, dermal absorption, and human safety assessments.

Form COS-3: Permission to Import or Manufacture a New Cosmetic for Marketing

Upon satisfactory review of the application and supporting data, the Central Licensing Authority may grant prior permission in Form COS-3.

Form COS-3 is not an application form—it is the approval issued by CDSCO authorising the import or manufacture of a New Cosmetic in India.

Information Evaluated by CDSCO

CDSCO may evaluate:

• Complete formulation details;
• Compliance of ingredients with IS 4707;
• Toxicological profile of the novel ingredient;
• Safety evaluation data generated in accordance with IS 4011:2018;
• Exposure assessment and justification of use concentrations;
• International regulatory status and history of cosmetic use;
• Finished product safety information;
• Product specifications and quality controls;
• Proposed labelling in accordance with the Cosmetics Rules, 2020.

Additional information may be requested during the review process.

Relationship Between COS-3 and COS-2

• The New Cosmetic approval process is a prerequisite to the standard import registration process.
• A Cosmetic containing a novel ingredient cannot obtain an import registration certificate in Form COS-2 unless prior permission has been granted in Form COS-3.
• The practical sequence is:
• Assess the formulation for potential novel ingredients.
• Verify ingredient compliance with IS 4707 and applicable provisions of the Cosmetics Rules, 2020.
• Prepare the safety dossier in accordance with IS 4011:2018.
• Submit an application in Form COS-12.
• Obtain prior permission in Form COS-3.
• Submit the import registration application in Form COS-1, enclosing the approved Form COS-3.
• Obtain the registration certificate in Form COS-2.

Timeline Realities

The Novel Cosmetic approval pathway adds significant time to the India market entry timeline. While a standard COS-2 application carries a 180-working-day statutory timeline, the COS-3 pathway does not have a fixed statutory deadline in the same way, and review timelines can extend considerably for novel ingredients where CDSCO requires additional data.

For brands planning India launches for products with potentially novel ingredients, CliniExperts recommends initiating the regulatory feasibility assessment at least 18 to 24 months before the desired commercial launch date.

Key Takeaways

• Under the Cosmetics Rules, 2020, a “New Cosmetic” is a product containing a novel ingredient that is not recognised for cosmetic use in national or international literature. The regulatory trigger is the ingredient, not the finished product.
• Ingredient categories that frequently require additional scrutiny include novel peptides, fermentation-derived actives, innovative botanical extracts, new-generation UV filters, and alternative preservative systems.
• Form COS-12 is the application submitted to the Central Licensing Authority (CLA) for prior permission to import or manufacture a new cosmetic, while Form COS-3 is the approval granted by the CLA.
• Approval under the new cosmetic pathway is a prerequisite to import registration in Form COS-2; products containing novel ingredients cannot obtain a COS-2 registration certificate without prior approval in Form COS-3.
• Since no statutory review timeline is prescribed for new cosmetic approvals under Rule 32, brands should conduct an early regulatory assessment and plan for additional lead time when introducing products containing potentially novel ingredients.

How CliniExperts Can Help

CliniExperts conducts pre-filing ingredient novelty assessments to identify whether any components of your formulation require the COS-3/COS-12 pathway before you invest in a full COS-2 application. This is one of the most valuable upstream services we provide — it prevents a complete application restart mid-process. Contact us at contact@cliniexperts.com.