1. Introduction: Why Borderline Classification Matters The fine line between cosmetics and drugs is, in fact, getting blurrier in India. With the development in formulation science and marketing strategies, anti-dandruff shampoos, anti-aging serums, and sunscreens generally lie between beauty and treatment. This raises a regulatory question: is the product merely altering aesthetics, or is it rendering a cure for a specific ailment?

India’s CDSCO Guidelines for Borderline Products (Cosmetic vs Drug): Navigating the Regulatory Landscape – 2025 Update

Regulation, Latest News . May 14, 2025

1. Introduction: Why Borderline Classification Matters

The fine line between cosmetics and drugs is, in fact, getting blurrier in India. With the development in formulation science and marketing strategies, anti-dandruff shampoos, anti-aging serums, and sunscreens generally lie between beauty and treatment. This raises a regulatory question: is the product merely altering aesthetics, or is it rendering a cure for a specific ailment?

If improperly classified, there can be serious implications for brands and consumers – including regulatory violations, recalls, and/or fines. So, to navigate the maze, you need to comprehend the criteria of classification as established by Drugs and Cosmetics Act, 1940, and subsequent amendments that have been announced by the Central Drugs Standard Control Organization (CDSCO) effective from 2025. [1]

2. What Is a ‘Borderline Product’ in India?

A borderline product is a formulation, the use, claims or composition straddles the definitions of both cosmetic and drug under Indian law. These products require serious regulatory oversight to understand how to comply with the Drugs and Cosmetics Act. [2]

Examples of Borderline Products:

Product Type	Possible Claims	Classification Impact
Anti-dandruff shampoo	“Treats scalp infection”	Likely a Drug
Skin-lightening cream	“Treats hyperpigmentation”	Likely a Drug
Sunscreen SPF 50	“12-hour UV protection”	Likely a Drug
Acne gel	“Reduces pimples & controls bacteria”	Depends on ingredients/claim
Anti-aging serum	“Reduces wrinkles & restores collagen”	Likely a Drug

3. Regulatory Bodies in India: Who Regulates What?

There are different regulatory bodies in India tasked with the responsibility for classifying, licensing and marketing cosmetics and drugs.

Regulatory Authority	Responsibility
CDSCO	Central licensing, and regulating new drugs and significant cosmetics
State Licensing Authorities (SLAs)	Grant licenses to manufacturers and distributors in states
DCGI	Drug Controller General of India; apex authority for drug approval.

Cosmetics: Governed under Rules 129 to 142 of the Drugs and Cosmetics Rules, 1945; Cosmetics Rules, 2020
Drugs: Governed under Schedule Y, Rule 21, Section 3(b) of the Drugs and Cosmetics Act, 1940 [1]

4. How CDSCO Defines Cosmetics vs. Drugs

4.1 Cosmetic Definition (Rule 129): Any article intended to be rubbed, poured, sprinkled, or sprayed on the human body for purposes of cleansing, beautifying, promoting attractiveness, or altering appearances is considered as a cosmetic. It is not supposed to have any therapeutic or physiological effect. [1]

4.2 Drug Definition (Section 3(b)): Any substance used in the diagnosis, treatment, mitigation, or prevention of a disease. Articles intended to affect the structure or function of the human body are also included within the meaning of the term “Drug”. [3]

5. CDSCO 2025 Guidelines:

Recent Updates for Borderline Products In 2025, a new set of updated guidelines were presented by CDSCO to converge Indian regulation to internationally accepted protocols, the intent of use, marketing claims, concentration of the ingredients.

Key Highlights:

Functional or therapeutic claims (e.g. “Heals acne”, “Repairs skin barrier”) reclassifies the product as a drug
SPF Claims above 30 or makes extended claim claims (e.g. UV shield for 10 hours) falls under a drug classification
scheduled ingredients (e.g. clindamycin, hydroquinone, minoxidil) would require drug licensing Only beautifying and non-therapeutic claims remain cosmetic [4]

6. Decision Criteria – Cosmetic or Drug?

Criteria	Cosmetic	Drug
Function	Beautification, cleansing	Diagnosis, treatment, prevention
Claims	Enhances appearance	Treats, prevents disease
Ingredients	Moisturizers, perfumes, botanical oils	Retinoids, antibiotics, steroids
Dose	No pharmacological dose	Requires therapeutic dosage
Regulation	Cosmetics Rules 2020	Drugs Rules 1945, Schedule Y
Approval Required	Self-declaration	CDSCO drug license + CTD dossier

7. Case Examples (2023–2025)

7.1 Anti-Pigmentation Cream with Kojic Acid (2%)

Cosmetic: Any claims to “even skin tone” or “promote radiance” qualify a product as a cosmetic.
Drug: When it claims to “treat melasma” or “reduce hyper-pigmentation,” such a product would require a drug license along with clinical data for efficacy and safety.

7.2 Sunscreen SPF 50 with “UV Protection for 10 Hours”

Cosmetic: Sunscreens that claim to “protect against sunburn” or “shield skin from UV damage” are categorized as cosmetics. [5]
Drug: The sunscreens with SPF >30 claiming extended protection, such as “UV protection for 10 hours,” are considered drugs; therefore, they require clinical validation and provision of drug license.

7.3 Hair Serum with Minoxidil (5%)

Cosmetic: Hair serum claims like “nourishes hair,” “adds shine,” and “promotes healthy-looking hair” classify it as cosmetic.
Drug: Any product with an active agent like minoxidil, which needs a drug license with clinical data since minoxidil is recognized in treating androgenic alopecia. [6]

7.4 Acne Gel: Tea Tree Oil vs. Clindamycin

Ingredient	Claims	Classification
Tea Tree Oil	“Gently controls unwanted pimples”	Cosmetic
Clindamycin	“Treats bacterial acne”	Drug

8. For Labelling, Licensing & Marketing Claims – what is permissible?

8.1. For Cosmetics

Prohibited Claims: Cosmetic products must not claim to cure, treat, or prevent any disease or medical condition.
Mandatory Labelling Requirements:
- Product Information: Name of the cosmetic product, variant (if any), and pack size.
- Manufacturer Details: Name and complete address of the manufacturer or the country of origin if imported.
- Registration Certificate Number: For imported cosmetics, the label must bear the registration certificate number (e.g., “RC No.”) and the name and address of the registration certificate holder.
- Batch Number: A distinctive batch or lot number.
- Manufacturing License Number: Preceded by “M” or “M.L. No.”
- Expiry Details: Use before or expiry date (month and year).
- Net Contents: Declared in terms of weight for solids, fluid measure for liquids, or both for semi-solids.
- Ingredient List: Ingredients present in concentrations of more than one percent listed in descending order by weight or volume, followed by those in concentrations of one percent or less, preceded by the word “INGREDIENTS.”
- Warnings and Directions: Adequate directions for safe use, any warnings, cautions, or special directions required to be observed by the consumer. [7]
Registration Process: Importers must obtain a Registration Certificate by submitting Form COS-1 through the SUGAM portal, along with necessary documents and fees, as per the Cosmetics Rules, 2020.

8.2 For Drugs:

Licensing Requirements:

Manufacturing License: Obtain a manufacturing license in Form 25 or 28 for domestic production.
Import License: For imported drugs, acquire an import license in Form 10, along with a Registration Certificate in Form 41 [8]

Common Technical Document (CTD) Submission:

Module 1: Administrative and Product Information.
Module 2: Summaries of Quality, Non-clinical, and Clinical Information.
Module 3: Quality (Pharmaceutical Documentation).
Module 4: Non-clinical Study Reports.

Module 5: Clinical Study Reports. [9]

Clinical Data Requirements: Submit data supporting pharmacopoeial compliance, clinical safety, and efficacy studies.

9. International Comparisons: Approaches from EU & US

Region	Definition	Regulatory Highlights
US FDA	Monograph vs NDA system	Certain OTC products (e.g., sunscreens) categorized as monographs; others need NDAs if claims are therapeutic
EU	No legal category for “cosmeceuticals”	Products are evaluated on basis of claims, compositions, and mode of action
India	CDSCO defines borderline via 2025 guidelines	Like EU/US with specific context India in licensing & regulatory pathways

At the end of the day, both the FDA and the EU are generally evaluating the intent of the product (and the claim), rather than just the formulation.

10. Advice for Consumers & Formulators

Carefully Evaluate Claims: Always review both the ingredient list and the marketing claim to understand the definition of the product.

Avoid Imprecise Claims: Avoid using claims that incorporate therapeutic terminology (e.g., “treats psoriasis”).
Use Regulated Terminology: For the cosmetic category, phrasing such as “reduces the appearance of blemishes” is acceptable; however, where it states, “treats acne vulgaris,” this would classify it as a drug.
Consult with Experts: If you’re in the range of borderline products, consult with regulatory experts prior to launching the product.
Seek Collaboration: Work with regulators or consultants, like Food Research Lab, to prepare your dossier, ascertain claims, and seek licensing support. [10]

Conclusion: Transparency & Scientific Rigor Are Key

The CDSCO 2025 guidance on cosmetics to drug classification provides a great deal of clarity in the cosmetic regulations landscape within India. By placing the intent of the product, the claims, the composition of the item into context, the CDSCO 2025 guidance will ensure that intended items are classified correctly and should hopefully assist with future regulatory complications. When you consider the formulation, intended claims along with expert consultation, brands can ensure every item is regulatory compliant and, on the path, to market success.

CTA for Food Research Lab:

Confused if your product is a cosmetic or drug under Indian regulations?

Partner with Food Research Lab for:

Regulatory classification and strategy
Dossier compilation and CTD organisation
Claims validation and scientific substantiation
Licensing support with CDSCO and State Authorities

[email protected]

www.foodresearchlab.com

India’s CDSCO Guidelines for Borderline Products (Cosmetic vs Drug): Navigating the Regulatory Landscape – 2025 Update

1. Introduction: Why Borderline Classification Matters

2. What Is a ‘Borderline Product’ in India?