Cosmetic Labelling in India: CDSCO, , and Legal Metrology — Three Bodies, One Label

Three Regulatory Bodies, One Physical Label

A Cosmetic label entering India is reviewed — directly or through market surveillance — against the requirements of three separate regulatory frameworks: CDSCO’s Cosmetics Rules 2020 (governing Cosmetic-specific content and claims), BIS (informing ingredient and specification details), and the Legal Metrology (Packaged Commodities) Rules 2011 (governing trade and packaging information).

The vast majority of EU- or US-approved Cosmetic labels will require modifications before they are compliant for India. The modifications are predictable, but they require specific knowledge of each framework’s requirements. This article provides a comprehensive guide to Indian Cosmetic label compliance — addressing each Regulatory body’s requirements and explaining the most common label errors seen in import applications.

Part 1: CDSCO Labelling Requirements under Rule 34, Cosmetics Rules 2020

Rule 34 of the Cosmetics Rules 2020 sets out the mandatory information that must appear on the inner and outer labels of every Cosmetic product imported into or manufactured for sale in India.

Mandatory Inner and Outer Label Declarations

• Name of the Cosmetic
• Name and address of the manufacturer
• Name and address of the importer in India (or authorised agent/registration holder)
• Net contents — by weight or volume, in metric units
• Batch number 
• Manufacturing date
• Expiry date (Month and Year)
• List of ingredients in Decreasing Order (INGREDIENTS) (If product is below 30gm or 60ml, then not applicable)
• Directions for use (where relevant for safety)
• Precautions and warnings applicable to the product category
• Mfg. Lic. No. / RC. No in case of Import

Prohibited Label Content

The Cosmetics Rules 2020 explicitly prohibit certain types of claims and content on Cosmetic labels:

• Non-Cosmetic claims: any therapeutic, medicinal, or disease-treatment claim (‘cures acne’, ‘treats eczema’, ‘reduces inflammation’) takes the product out of Cosmetics regulation and into drug regulation
• Claims that imply permanent structural change to the body (‘permanently reverses ageing’, ‘restructures collagen at a cellular level’)
• Misleading claims about composition (‘contains 100% natural ingredients’ when synthetic preservatives are present)

Part 2: INCI Ingredient Listing — The Specific Requirements

The INCI (International Nomenclature of Cosmetic Ingredients) listing requirement in India aligns with global practice — ingredients above 1% must be listed in descending order, using INCI nomenclature. However, there are India-specific nuances:

• Colouring agents may be listed at the end of the ingredient list. For products marketed in multiple shades or colour variants, the applicable Colour Index (CI) numbers may be declared using the “+/-“ notation, where appropriate
•  Fragrance or Parfum consistent with internationally accepted INCI terminology.
• The full ingredient list must appear on the outer label; where outer label space is constrained, it may appear on an attached leaflet or folded label — but the label must indicate where the full list can be found

Part 3: BIS Specifications and Label Declarations

The Bureau of Indian Standards (BIS) specifications of the Cosmetics Rules, 2020 primarily establish quality, safety, and performance requirements for Cosmetic products. These standards govern product formulation, testing, and compliance rather than prescribing additional mandatory label declarations for most Cosmetic categories.

Key regulatory considerations include:

• Heavy Metals: Cosmetic products must comply with the permissible limits for heavy metals specified in the applicable BIS standards. Compliance should be demonstrated through appropriate test reports, which should be maintained as part of the product’s technical documentation. There is no requirement to declare heavy metal compliance on the product label.
• Preservatives: Preservatives must comply with the restrictions and permissible limits prescribed under the Cosmetics Rules, 2020 and BIS. They should be declared as part of the mandatory INCI ingredient list. 
• Sunscreen Products: Products making SPF, UVA, UVB, broad-spectrum, or water-resistant claims should be supported by scientifically valid test reports generated using recognised national or international test methods. Any performance claim appearing on the label should be accurate, substantiated, and consistent with the supporting technical documentation maintained by the manufacturer or importer.

Part 4: Legal Metrology (Packaged Commodities) Rules 2011

The Legal Metrology (Packaged Commodities) Rules 2011, administered by the Ministry of Consumer Affairs, govern packaging and labelling requirements for all pre-packaged commodities sold in India — including Cosmetics. Key requirements:

MRP Declaration

Every pre-packaged Cosmetic sold in India must carry a Maximum Retail Price (MRP) declaration in the format: ‘MRP ₹ [amount] (inclusive of all taxes)’. The MRP must be printed or stickered on the label before the product enters retail distribution. MRP is set by the importer/brand owner and declared to customs at the time of import.

Net Quantity

Net quantity must be declared in metric units (grams or millilitres). The declaration must be accurate and meet Legal Metrology tolerance limits for packaged commodity accuracy.

Country of Origin

‘Country of Origin: [Country]’ must appear on every imported Cosmetic. This declaration is mandatory and must be accurate — it is checked at Customs.

Importer Details

The name and address of the Indian importer, authorised agent, or registered entity must appear on the label — consistent with the CDSCO COS-2 certificate details.

Customer Care Details

A customer care address and/or phone number for the Indian market must appear on the label — this is a Legal Metrology requirement, not a CDSCO requirement.

Part 5: Language Requirements

Cosmetic labels in India must carry all mandatory information in English and/or Hindi. Most global brands include all mandatory content in English (which is widely accepted) and include Hindi text for specific declarations where required by the SLA or Customs authorities.

There is no requirement for the full INCI list to be in Hindi — the INCI names are internationally standardised in Latin/English. However, directions for use and warning statements are expected to be comprehensible to the Indian consumer, and including Hindi text for these elements is considered best practice.

Common Label Errors in COS-2 Applications

• Non-Cosmetic claims on the label submitted with the COS-1 application — this is the single most common reason for CDSCO queries on label content
• Missing importer/authorised agent name and address — particularly common when the label was prepared before the India regulatory partner was appointed
• Absent or incorrectly formatted INCI list — using trade names instead of INCI nomenclature, or listing ingredients alphabetically rather than in descending order of concentration
• No shelf life or ‘best before’ date format — or use of ‘expiry date’ when the product does not have a fixed expiry (should be stated as ‘Best before X months of manufacture’)
• MRP not declared — MRP is a pre-distribution Legal Metrology requirement, but its absence on the label submitted with the COS-2 application can trigger queries about whether the label is India-market-ready

Key Takeaways

• Three regulatory frameworks govern Cosmetic labels in India: CDSCO (Rule 34), BIS, and Legal Metrology (Packaged Commodities) Rules
• Mandatory CDSCO label elements include: product name, manufacturer and importer details, net contents, batch number, manufacturing date, Expiry Date, Ingredient list, and RC No.
• Prohibited label claims include therapeutic or medicinal claims — these take the product out of Cosmetics regulation
• Legal Metrology requires MRP declaration (inclusive of taxes), country of origin, and metric net quantity on every pre-packaged Cosmetic
• All mandatory information must be in English; Hindi is accepted and recommended for special case directions of use and warnings

How CliniExperts Can Help

CliniExperts’ label compliance service covers all three regulatory frameworks — CDSCO, BIS, and Legal Metrology — in one consolidated label review. We identify every non-compliant element before you submit your COS-2 application or before product launch. Contact us at contact@cliniexperts.com or visit cliniexperts.com/india-regulatory-services/Cosmetic/assistance-on-Cosmetics-labelling/.