WHO Herbal Labeling Guidelines 2025: Global Compliance
                     INDIA’S CDSCO GUIDELINES FOR 
BORDERLINE PRODUCTS: 
COSMETIC VS DRUG (2025 
UPDATE)
NAVIGATING THE REGULATORY LANDSCAPE
INTRODUCTION
WHY CLASSIFICATION MATTERS
The line between cosmetics and drugs 
is increasingly blurred in India.
Products like anti-dandruff shampoos
and sunscreens lie in a  gray area. 
Misclassification can  lead to fines, 
recalls, or violations.
CDSCO has  issued updated 2025 
guidelines for clarity.
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WHAT IS A 
BORDERLINE PRODUCT?
Products whose use, claims, or composition may  fall under both drug and 
cosmetic definitions.
Requires careful regulatory consideration under the Drugs and Cosmetics Act. 
Examples:
Anti-dandruff shampoo claiming to treat infection → Drug. 
SPF 50 sunscreen with long protection → Drug.
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REGULATORY 
AUTHORITIES IN INDIA
CDSCO : Central authority for licensing and
regulating.
State Licensing Authorities (SLAs): 
Issue manufacturing and distribution 
licenses. DCGI: Apex authority for drug 
approvals. Rules Governing:
Cosmetics: Cosmetics Rules, 2020 
Drugs: Schedule Y, Drugs & Cosmetics 
Act, 1940
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CDSCO DEFINITIONS –  
COSMETIC VS DRUG
Cosmetic (Rule 129):
For beautifying, cleansing, or altering appearance. 
No therapeutic or physiological effect.
Drug (Section 3(b)):
Used to diagnose, treat, or prevent 
diseases.
Affects the structure/function of the 
body.
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CDSCO 2025 GUIDELINES 
–  KEY HIGHLIGHTS
Functional/therapeutic claims (e.g., "Heals acne") =  Drug. 
SPF claims above 30 with long-duration protection =  Drug.
Products with scheduled ingredients (e.g., hydroquinone) =  Drug license needed. 
Only beautifying, non-therapeutic claims =  Cosmetic.
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DECISION CRITERIA –  
COSMETIC VS DRUG
Criteria Cosmetic Drug
Function Beautification,  cleansing Treatment, diagnosis, prevention 
Claims Enhances appearance Prevents/treats disease 
Ingredients Oils, botanicals, perfumes Antibiotics, steroids, retinoids 
Regulation Cosmetics Rules 2020 Drugs Rules 1945, Schedule Y 
Approval Self-declaration CDSCO License +  CTD dossier
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CASE STUDY 1 –  KOJIC 
ACID CREAM
Cosmetic: "Promotes radiance" or "evens skin tone" 
Drug: "Treats melasma" or "reduces hyperpigmentation" 
Drug classification requires licensing and efficacy data.
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CASE STUDY 2 –  
SUNSCREEN SPF 50
Cosmetic: Claims to “protect against sunburn” 
Drug: Claims “UV protection for 10 hours” 
Requires drug licensing and clinical studies.
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CASE STUDY 3 & 4 –  
HAIR SERUM & ACNE 
GEL Acne Gel: 
Cosmetic : With Tea Tree 
Oil
Drug (requires regulatory approval) : 
With Clindamycin
Hair Serum with Minoxidil: 
Cosmetic: "Adds shine"
Drug: Contains Minoxidil (5%) → needs drug 
license
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LABELING & LICENSING –  
COSMETICS
Prohibited Claims: No therapeutic or 
disease-curing language.
Mandatory Labeling:
Product name, Mfg. details, batch 
number
Ingredient list (with %), expiry, RC 
Number.
Importers: Must submit Form COS -1 
on SUGAM portal.
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LICENSING FOR DRUGS & 
CTD SUBMISSION
Manufacturing License: Form 25/28 
(domestic)
Import License: Form 10 +  RC (Form 
41)
CTD Modules:
Module 1: Administrative info
Module 3–5: Quality, non-clinical, and 
clinical data
Requires pharmacopoeial, safety & 
efficacy data
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FINAL TAKEAWAYS & 
BEST PRACTICES
Carefully evaluate claims and ingredients to determine classification. 
Use acceptable language (e.g., “reduces appearance of blemishes”). 
Avoid unregulated claims (e.g., “treats psoriasis”).
Collaborate with regulatory consultants and use CDSCO resources. 
Transparency and scientific rigor are crucial for market success.
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CONTACT US
+91 95662 
99022
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