Article · 15 min read

Nutraceuticals in India: FSSAI vs CDSCO, Complete Regulatory Guide

PharmaNow editorial team · PharmaNow Free Intermediate India

Supplements and wellness founders get burned by the same trap: assuming a product sits under FSSAI when a dosage or a claim quietly pushes it into drug territory under CDSCO. This guide draws that exact line, listing the triggers (Vitamin D3 above 1000 IU, therapeutic claims like treats or cures, sales through practitioners) that reclassify your product and demand drug licensing (Form 25/28) and clinical data instead of a simple FSSAI registration.

  • Most nutraceuticals and health supplements are FSSAI-regulated under the FSS (Health Supplements, Nutraceuticals) Regulations 2022, which allow structure/function claims but not disease claims.
  • High-potency ingredients beyond FSSAI limits, pharmaceutical delivery systems, or therapeutic claims flip a product to CDSCO, requiring drug licensing and clinical trials.
  • Confirm your classification before you manufacture, because a wrong call means relabeling, a fresh license, or a recall rather than a quick fix.
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The question it answers

  1. I'm selling a physical D2C product (cosmetics, supplements, wellness). What product approvals do I need before I list?

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