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)
India’s national regulatory authority for cosmetics, drugs, and medical devices.
Enforces the Drugs and Cosmetics Act, 1940 and the Cosmetic Rules, 2020.
All imported cosmetic products must be registered with CDSCO before being sold in India.
2. BIS (Bureau of Indian Standards)
Sets safety and quality standards for cosmetic ingredients.
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 |