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Why we picked it 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.
Nutraceuticals in India: FSSAI vs CDSCO, Complete Regulatory Guide
From PharmaNow by PharmaNow editorial team 15 min read
- 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.