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Nutraceutical Clinical Studies India | FSSAI & CDSCO Tracks

We will tell you which track your product needs in the first conversation.

If your nutraceutical product makes a nutritional efficacy claim — "improves muscle strength", "supports immune function", "enhances bioavailability" — you may only need an Ethics Committee approval and an Auriga study under FSSAI Nutraceutical Regulations 2022.

If you want to make a Disease Risk Reduction (DRR) claim — "reduces risk of Type 2 diabetes", "lowers cholesterol", "prevents osteoporosis" — CDSCO requires a full clinical trial under the New Drugs and Clinical Trials Rules 2019. Auriga handles both tracks.

Documented experience spans 5 nutraceutical clinical studies across sports nutrition, vitamin bioavailability, and functional-food efficacy — including a 120-subject, 3-site muscle-strength study. Every study is supported by our own NABL- and USFDA-inspected bioanalytical laboratory — vitamins, minerals, and amino acids quantified in-house.

Request a Study Proposal Call +91-7428116100

Two Regulatory Tracks. One CRO.

The single most important decision for a nutraceutical sponsor is which regulatory track applies. Picking the wrong one wastes 6-12 months and a large budget. Here is the framework.

Non-Regulated (FSSAI)

Governance
FSSAI Nutraceutical Regulations 2022
Approvals
Independent Ethics Committee approval (ICMR ethical guidelines)
Claim Types
Nutritional efficacy · Bioavailability · Ingredient performance · Sensory and consumer-acceptance
Example Claims
"Improves muscle strength" · "Supports immune function" · "Enhances bioavailability" · "Helps maintain energy levels"
Typical Timeline
3–9 months from protocol to final report

Regulated (CDSCO)

Governance
New Drugs and Clinical Trials Rules 2019
Approvals
CDSCO Clinical Trial Application (Form CT-04) · Ethics Committee · CTRI registration
Claim Types
Disease Risk Reduction (DRR) · Therapeutic equivalence · Products at the food–drug boundary
Example Claims
"Reduces risk of Type 2 diabetes" · "Lowers cholesterol" · "Prevents osteoporosis"
Typical Timeline
12–24 months from CTA filing to final CSR

Documented Nutraceutical Study Experience

Five documented clinical studies across sports nutrition, vitamin bioavailability, and hangover symptom relief. Full study references are available under NDA during proposal scoping.

Hangover / Alcohol Recovery

Study Design Subjects Sites
A-Hango Symptom-relief study 76 —

Vitamin Bioavailability

Study Design Subjects Sites
Vitamin D — Shiitake Mushroom-derived Bioavailability study 60 —

Sports Nutrition / Protein

Study Design Subjects Sites
Whey Protein Bioavailability study 24 —
Protein Supplements — Essential Amino Acids (EAA) Bioavailability study 24 —
Protein Supplement + Lifestyle Counselling — Muscle Strength Multi-site efficacy study 120 3

Nutraceutical Study Capabilities

From bioavailability and efficacy through long-term safety and real-world evidence — both FSSAI and CDSCO tracks supported on one integrated platform.

Bioavailability & PK Studies

Absorption profiles, peak plasma concentration, and dose-response measurement for vitamins, minerals, amino acids, and bioactive ingredients — supported by Auriga's NABL- and USFDA-inspected analytical lab.

Nutritional Efficacy Studies (FSSAI Track)

Randomised controlled trials for nutritional and function claims under FSSAI Nutraceutical Regulations 2022 — muscle strength, immune support, gut health, cognitive performance, energy claims.

Disease Risk Reduction Studies (CDSCO Track)

Full clinical trials under NDCT Rules 2019 for products making Disease Risk Reduction (DRR) claims or operating at the food–drug boundary. Requires CDSCO CTA and CTRI registration.

Safety & Long-Term Tolerance

Long-term supplementation safety, gastrointestinal tolerance, liver and kidney function monitoring, and vital-sign surveillance — for both consumer reassurance and regulatory dossiers.

Consumer & Sensory Studies

Acceptability, palatability, compliance, and adherence studies — flavour, texture, and dosage-form preference research that informs formulation decisions and marketing positioning.

Real World Evidence (RWE)

Post-launch effectiveness, real-world tolerability, and label-claim verification studies in routine use — feeding into both FSSAI compliance and continued payer/retailer evidence.

Mind to Market — One Group, One Relationship

Auriga can take your nutraceutical product from ingredient testing → formulation development → clinical study → contract manufacturing — all under one Arbro Group relationship. No vendor sprawl, no chain-of-custody hand-offs, faster timelines.

Step 1
Ingredient & Product Testing
NABL · FSSAI · AYUSH testing
Step 2
Formulation Development
R&D · Scale-up · Tech transfer
Step 3
Clinical Study
Bioavailability · Efficacy · Safety
Step 4
Contract Manufacturing
WHO GMP · Private label

Related Services

CRO Services Overview Full CRO capabilities Phase II–IV Clinical Trials CDSCO regulated track Cosmetics Clinical Studies Safety & claim substantiation Nutraceutical Testing FSSAI · AYUSH · Stability Nutraceutical CDMO Formulation · Manufacturing Nutraceutical Industry Hub End-to-end services

Frequently Asked Questions

Does my nutraceutical product need CDSCO approval or only FSSAI / Ethics Committee?
It depends on the claim. If your product makes a nutritional efficacy claim ("improves muscle strength", "supports immune function", "enhances bioavailability"), you typically need only Independent Ethics Committee approval and an Auriga clinical study under FSSAI Nutraceutical Regulations 2022. If you want to make a Disease Risk Reduction (DRR) claim ("reduces risk of Type 2 diabetes", "lowers cholesterol"), CDSCO requires a full clinical trial under the New Drugs and Clinical Trials Rules 2019. Auriga handles both tracks — we will tell you which track your product needs in the first conversation.
What nutraceutical study experience does Auriga have?
Five documented nutraceutical clinical studies: A-Hango (76 subjects) for hangover symptom relief; Vitamin D bioavailability from Shiitake Mushroom (60 subjects); Whey Protein bioavailability (24 subjects); Protein Supplements EAA bioavailability (24 subjects); and Protein Supplement + Lifestyle Counselling for Muscle Strength (120 subjects across 3 sites). Studies cover sports nutrition, vitamin bioavailability, and functional-food efficacy.
What does FSSAI Nutraceutical Regulations 2022 require for health claims?
FSSAI requires substantiation evidence for nutritional and function claims on nutraceutical products — typically randomised controlled studies, dose-response data, or systematic reviews of published evidence. Function claims must be specific, measurable, and not imply Disease Risk Reduction unless the product is filed as a drug. Auriga designs claim-specific studies that produce the evidence FSSAI expects.
What is a Disease Risk Reduction (DRR) claim and why does it need CDSCO?
A Disease Risk Reduction claim states that a product reduces the risk of a disease ("reduces risk of cardiovascular disease", "prevents osteoporosis"). Such claims position the product at the food–drug boundary and trigger CDSCO oversight under the New Drugs and Clinical Trials Rules 2019. A full clinical trial (typically Phase II/III) with CDSCO Clinical Trial Application, Ethics Committee approval, and CTRI registration is required.
Can Auriga handle bioavailability studies for vitamins and amino acids?
Yes. Auriga's integrated bioanalytical laboratory is NABL- and USFDA-inspected and runs validated LC-MS/MS, HPLC, and immunoassay methods for vitamins (A, D, E, K, B-complex), minerals, amino acids, peptides, and bioactive ingredients. Bioavailability studies follow PK study design with Cmax, Tmax, AUC, and t½ measurements — same analytical rigour as pharmaceutical PK studies.
What is the Mind to Market advantage?
Auriga can take a nutraceutical product from ingredient testing → formulation development → clinical study → contract manufacturing — all under one Arbro Group relationship. Sponsors avoid coordinating across separate analytical labs, R&D vendors, clinical CROs, and contract manufacturers. One commercial relationship, one chain of custody, faster timelines from ideation to launch.
How long does a nutraceutical clinical study take?
Bioavailability studies typically run 1-3 months from protocol approval to final report. Single-arm efficacy studies (e.g., for ingredient performance) take 3-6 months. Multi-site randomised efficacy studies (muscle strength, immune function, gut health) typically take 6-12 months. DRR clinical trials under CDSCO take 12-24 months. Detailed timelines are provided at the proposal stage.

Plan Your Nutraceutical Study

FSSAI Nutraceutical Regulations 2022 · CDSCO NDCT Rules 2019 · Bioavailability, efficacy, and safety studies · Integrated with Arbro Group testing and CDMO.

+91-7428116100 Request a Study Proposal

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