FDA-Approved Cosmetic Ingredients in India – What’s Allowed?
While the U.S. FDA regulates cosmetics in the United States, in India, the approval and regulation of cosmetic ingredients are handled by:
CDSCO – Central Drugs Standard Control Organization
BIS – Bureau of Indian Standards
🧴 Who Regulates Cosmetic Ingredients in India?
1. CDSCO (Central Drugs Standard Control Organization)
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India’s national regulatory authority for cosmetics, drugs, and medical devices.
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Enforces the Drugs and Cosmetics Act, 1940 and the Cosmetic Rules, 2020.
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All imported cosmetic products must be registered with CDSCO before being sold in India.
2. BIS (Bureau of Indian Standards)
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Sets safety and quality standards for cosmetic ingredients.
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IS 4707 (Part 1 & 2) defines the approved colorants, preservatives, UV filters, and their limits and restrictions.
🌍 Use of Internationally Approved Ingredients
Certain ingredients approved by global regulators like the U.S. FDA, European Union, or Japan may be used in India — but only if they meet CDSCO and BIS standards.
Example:
Ethyl Lauroyl Arginate (LAE) is approved in the US, EU, Canada, and Asia-Pacific countries as a cosmetic preservative. However, its use in India must still follow BIS/CDSCO guidelines.
❌ Important Note
India does not maintain or follow a list of FDA-approved ingredients. Instead:
India has its own approval framework.
Ingredients must meet Indian regulations, not just international ones.
✅ Summary Table
| Aspect | United States (FDA) | India (CDSCO & BIS) |
|---|---|---|
| Main Regulator | FDA | CDSCO (Regulator), BIS (Standards Body) |
| Ingredient Approval | Based on FDA safety guidelines | Based on Indian BIS IS 4707 Standards |
| Requirement for Sale | No need for CDSCO registration | Mandatory CDSCO registration for imports |
| Global Ingredients | Can be used if proven safe | Must be listed/approved by CDSCO or BIS |