Rule 36 of the Cosmetics Rules 2020 prohibits false or misleading cosmetic claims. Section 3(aaa) of the Drugs and Cosmetics Act 1940 sets the boundary between cosmetic and drug claims. Products exceeding that boundary lose cosmetic registration.
Every claim on a cosmetic label or promotional material in India is evaluated against a single legal threshold: does it push the product across the boundary from cosmetic into drug? That boundary is set by Section 3(aaa) of the Drugs and Cosmetics Act 1940 and enforced through Rule 36 of the Cosmetics Rules 2020. A product that exceeds it loses its cosmetic registration and requires drug approval — a fundamentally different and more demanding regulatory pathway.
This page explains the legal framework, identifies the categories most frequently flagged during CDSCO review, and sets out the compliance steps for manufacturers and importers bringing cosmetics into India.
Section 3(aaa) of the Drugs and Cosmetics Act 1940 defines cosmetic as:
"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."
Section 3(b) defines drug to include all substances intended for use in "the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings."
The operative distinction is intended purpose and mode of action. A cosmetic acts on appearance — it cleans, colours, covers, or alters the surface presentation of the body. A drug acts on a physiological or biochemical process — it treats, prevents, or modifies a disease or body function. CDSCO FAQ 54 states the position directly: "Products having drug claim do not come under the definition of cosmetic as per the Act and therefore cannot be considered for registration as cosmetic."
The consequence of crossing this boundary is not a labelling correction — it is full reclassification. The product must be withdrawn from the cosmetics registration pathway and submitted for drug approval under the applicable provisions of the Act.
Rule 36 of the Cosmetics Rules 2020 states:
"No cosmetic may purport or claim to purport or convey any idea which is false or misleading to the intending user."
This rule applies to labels, outer packaging, inserts, and — as the QR678 Neo enforcement action in December 2025 demonstrated — to online promotional materials and product websites. CDSCO assessed the totality of claims made for the product, not only those on the physical label. The import registration was cancelled because the website carried therapeutic claims that were absent from the approved label but nonetheless attributed to the registered cosmetic.
Rule 36 does not enumerate specific prohibited phrases. Its application is determined by whether the claim, read by the intending user, conveys a therapeutic or medicinal idea. CDSCO's General Non-compliances Observed checklist — used at the application review stage — flags labels containing phrases that "may appear to attract the definition of the drug," with examples including: "affects the structure or any function of the human body," "Treatment of any disease/disorder," "Drug Facts," and "Dermatologist recommended."
Rule 34 of the Cosmetics Rules 2020 governs the manner of labelling. It mandates informational declarations: brand name, net contents, manufacturer and importer details, batch number, date of manufacture, expiry or use-before date, ingredients list, and applicable hazard warnings. Rule 34 does not contain any provision restricting the type of claims that appear on a label. The claims restriction operates separately through Rule 36 and Section 3(aaa).
For labels submitted as part of a COS-1 or COS-2 import registration application, CDSCO reviewers apply the Rule 36 standard at the point of document review. Labels carrying prohibited claim language are rejected and require revision before registration proceeds. The most efficient point of compliance intervention is therefore pre-submission label review, not post-rejection correction.
India does not publish a statutory list of permitted or prohibited cosmetic claims equivalent to EU Regulation 655/2013. The following categories are identified as high-risk based on CDSCO enforcement actions and reviewer guidance.
Anti-hair-loss and hair regrowth claims. Entry 48 of the Fourth Schedule recognises "anti hair loss products" as a registered cosmetic category. A claim that the product reduces hair fall by a stated percentage may be acceptable as a cosmetic claim. A claim that it treats androgenetic alopecia, post-chemotherapy hair loss, or seborrhoeic dermatitis is a drug claim. The QR678 Neo cancellation turned on exactly this distinction.
Sun protection and SPF claims. Entry 42 of the Fourth Schedule recognises "sun protection products" as a cosmetic category. SPF values and broad-spectrum UVA/UVB protection are established cosmetic descriptor conventions in the industry. Claims that the product "repairs UV-induced DNA damage" or "prevents skin cancer" are therapeutic claims and reclassify the product.
Skin-lightening claims. Entry 11 of the Fourth Schedule recognises "skin lightening products" as a cosmetic category. Claims that a product provides coverage or reduces the visible appearance of dark spots are cosmetic claims. Claims that it inhibits melanin synthesis at a cellular level, or treats melasma as a medical condition, move into drug territory.
Anti-acne claims. Claims that a product controls excess sebum or reduces the visible appearance of blemishes are borderline but defensible as cosmetic claims. Claims that it "heals acne," "treats bacterial infection," or addresses any named dermatological condition are drug claims.
Anti-ageing claims. Claims that a product makes skin look smoother, reduces the visible appearance of fine lines, or improves skin tone are cosmetic claims. Claims that it "repairs the skin barrier," "reverses cellular ageing," or affects collagen synthesis at a structural level carry drug-claim risk.
"Medicated" and clinical descriptor language. The word "medicated" on a cosmetic label has no defined regulatory status under the Cosmetics Rules 2020 but consistently draws CDSCO scrutiny because it implies a therapeutic mode of action. "Dermatologist tested," "clinically proven," and "clinical strength" are similarly flagged in CDSCO reviewer guidance as phrases that may attract drug classification.
India does not incorporate EU Cosmetics Regulation Article 20, EU Regulation 655/2013 (the Common Criteria for claims), ASEAN Cosmetic Claims Guidelines, or ISO 22716 as a claims framework into domestic regulation. ISO 22716 is referenced in the Cosmetics Rules 2020 in the context of Good Manufacturing Practices (GMP), not claims substantiation.
Claims substantiation in India is not a formal pre-market requirement for standard cosmetics — there is no submission of efficacy data to CDSCO as a condition of registration under the standard COS-1 pathway. The obligation is negative: do not make a claim that is false, misleading, or therapeutic. For novel cosmetic ingredients under Rule 12(4) and Chapter V, supporting data justifying claimed benefits must be held on file, and no claims beyond those permitted may be made without prior CDSCO approval.
CDSCO and State Drug Controllers enforce claims compliance through the following mechanisms.
Pre-registration label rejection. CDSCO application reviewers reject labels containing prohibited claim language. The applicant receives a query requiring label revision before registration is granted. This is the most common enforcement point for imported cosmetics.
Show-cause notice and registration cancellation. Under Rule 16, the Central Licensing Authority may, after issuing a show-cause notice, suspend or cancel a registration certificate where the holder is found non-compliant with registration conditions. The QR678 Neo cancellation was executed under this provision.
Confiscation on conviction. Rule 53 of the Cosmetics Rules 2020 provides that where a person is convicted of manufacturing a misbranded cosmetic under Section 17C of the Act, all implements, machinery, receptacles, packaging, and conveyances used in connection with that cosmetic are liable to confiscation.
Prosecution under the Drugs and Cosmetics Act 1940. Section 27A of the Act provides penalties for manufacture, sale, or distribution of cosmetics in contravention of the chapter. Specific penalties for misbranding — including false or misleading claims — are governed by Sections 17C and subsequent penalty clauses of the parent Act.
Seizure by Drug Inspectors. Chapter VII of the Cosmetics Rules 2020 provides Drug Inspectors with authority to take samples and seize stocks of cosmetics suspected of contravening the Act or Rules.
1. Audit every claim on the label, outer carton, and any included insert against Section 3(aaa). For each claim, confirm it describes an effect on appearance, not a physiological or therapeutic effect.
2. Remove or rephrase any claim that uses the following language categories: disease or condition names, treatment or cure language, structural or functional body modification, clinical or medicated descriptors.
3. Audit the product's online presence — website, product pages, e-commerce listings. CDSCO has demonstrated it reviews digital promotional materials, not only the physical label submitted at registration.
4. For hair loss, SPF, skin-lightening, and anti-acne categories, map each claim explicitly to the cosmetic category definition in the Fourth Schedule. Claims that fall outside the scope of the Fourth Schedule entry for that category carry elevated risk.
5. Confirm the label meets all mandatory Rule 34 requirements: batch number, date of manufacture, expiry or use-before date, net contents, manufacturer name and address, importer name and address, Import RC number, country of origin, and ingredients list in Second Schedule format.
6. Submit for pre-registration review. Revised labels require CDSCO approval before being printed and affixed to product stocks entering India.
Pre-submission label review: Internal audit and claim revision — 3–5 working days.
CDSCO application review: Query raised on label claims — 30–90 days from submission.
Label query response: Revised label submission to CDSCO — 30 days from query date.
Registration grant: COS-1 / COS-2 issued with approved label — varies by product category.
No separate government fee applies specifically to label claim review. Label compliance is assessed as part of the standard COS-1 or COS-2 application process.
Claims compliance for cosmetics in India is a definitional exercise, not a disclosure exercise — the question is whether each claim keeps the product within Section 3(aaa) or pushes it into Section 3(b). Cosmetics Consultants India conducts pre-submission label audits against Rule 36 and CDSCO reviewer standards, covering both physical labels and digital promotional materials, before any application is filed.
Pre-submission label audit against Rule 34, IS 4707, and CDSCO non-compliance requirements. Every defect identified before your application reaches the portal.
Learn more →Rule 34 of the Cosmetics Rules, 2020 governs every mandatory label declaration for imported cosmetics in India — from RC number and INCI ingredients list to expiry date format and net contents. Full compliance reference with inner vs. outer label obligations.
Learn more →Rule 34(7) of the Cosmetics Rules 2020 mandates descending-order ingredient listing on Indian cosmetics labels. INCI nomenclature is required at the dossier level under Second Schedule Part-I, Clause 3(a). This page covers the full compliance standard: listing order, fragrance declaration thresholds, colour additive identification, pack-size exemptions, and CDSCO rejection triggers.
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