Regulyze
Immune Support Capsule — Sample Product
Overall: Conditionally Compliant — 3 items need attention
6
Compliant
3
Review Needed
1
Non-Compliant
2
Not Applicable
Ingredient-by-Ingredient Analysis
6 of 10 ingredients fully compliant with FSSAI Schedule III-A permitted list and dosage limits.
Vitamin C at 200 mg exceeds the Schedule III-A maximum single-dose limit of 160 mg. Consider splitting into two servings or reformulating.
| Ingredient | Declared Dose | Permitted Limit | Schedule / Source | Status |
|---|---|---|---|---|
|
Ashwagandha Root Extract
Standardised to 5% Withanolides (KSM-66)
|
500 mg | 500 mg/day | Schedule III-A · Botanicals | Compliant |
|
Vitamin C (Ascorbic Acid)
Dosage 25% above maximum permitted single dose
|
200 mg | 160 mg/dose | Schedule III-A · Vitamins | Review Needed |
|
Zinc (as Zinc Bisglycinate)
Elemental zinc verified via conversion factor
|
10 mg elemental | 15 mg/day | Schedule III-A · Minerals | Compliant |
|
Vitamin D3 (Cholecalciferol)
600 IU = 15 mcg; within Schedule III-A range
|
600 IU | 1000 IU/day | Schedule III-A · Vitamins | Compliant |
|
Elderberry Extract
Not listed in Schedule III-A botanical approved list
|
150 mg | Not specified | Novel Ingredient / Schedule II check needed | Verify Listing |
| Turmeric Extract (95% Curcuminoids) | 250 mg | 400 mg/day | Schedule III-A · Botanicals | Compliant |
|
Piperine
Used as absorption enhancer
|
5 mg | 10 mg/day | Schedule III-A · Botanicals | Compliant |
|
Selenium (as Sodium Selenate)
Conversion: Sodium Selenate → elemental Se factor 0.415
|
55 mcg elemental | 55 mcg/day | Schedule III-A · Minerals | Compliant |
|
Colloidal Silicon Dioxide
Processing aid / anti-caking agent
|
3 mg | GMP as required | GMP Additive — Codex List | Compliant |
|
Magnesium Stearate
Lubricant; GMP permitted in capsule formulations
|
10 mg | GMP as required | GMP Additive — FSSR List | Compliant |
Schedule & Regulatory Cross-Check
Schedule I — General Requirements for Nutraceuticals
Product category classified as Health Supplement. Manufacturing in a GMP-certified facility required. Shelf life and stability testing mandatory. ✓ All general requirements met.
Schedule III-A — Vitamins & Minerals (Permitted)
Vitamin C, D3, Zinc, and Selenium all appear in the Schedule III-A approved vitamins and minerals list. Forms used (Ascorbic Acid, Cholecalciferol, Zinc Bisglycinate, Sodium Selenate) are permitted salt forms.
Schedule III-A — Dose Limit Verification
Vitamin C (200 mg) exceeds the single-dose maximum of 160 mg permitted under Schedule III-A. The daily intake limit is 500 mg. Reformulate to ≤160 mg/serving or document multi-serving label claim.
Schedule III-A — Botanical Ingredients
Ashwagandha, Turmeric Extract, and Piperine are confirmed in Schedule III-A botanical list. Elderberry Extract is not listed — requires verification with latest FSSAI notifications for botanical inclusion or separate Novel Food approval under Schedule II.
GMP Additives — Codex & FSSR Permitted List
Colloidal Silicon Dioxide (anti-caking agent) and Magnesium Stearate (lubricant) both appear in the GMP-permitted additives list. Usage at declared quantities is within GMP compliance.
NSF Closure List — No Prohibited Substances
None of the 10 declared ingredients appear in the NSF Rejected / FSSAI Prohibited Substances list. All ingredients cleared for nutraceutical use.
% RDA Analysis (ICMR 2020 Reference)
| Nutrient | Dose | RDA (Adult Male) | RDA (Adult Female) | % RDA (M) | % RDA (F) |
|---|---|---|---|---|---|
| Vitamin C | 200 mg | 65 mg | 65 mg | 308% | 308% |
| Vitamin D3 | 600 IU (15 mcg) | 15 mcg | 15 mcg | 100% | 100% |
| Zinc | 10 mg | 17 mg | 10 mg | 59% | 100% |
| Selenium | 55 mcg | 40 mcg | 40 mcg | 138% | 138% |
RDA values sourced from ICMR-NIN Recommended Dietary Allowances for Indians (2020). Vitamin C at 308% RDA is above the 1× RDA threshold; this is permitted for supplements but must be declared on label.
Mandatory Label Checklist — Health Supplement
Per FSS (Labelling and Display) Regulations 2020 and FSSAI Nutraceuticals Order. All items below are mandatory for Health Supplements sold in India.
Product name and nature of food
e.g. "Immune Support Capsule — Health Supplement"
Complete list of ingredients with quantities
All 10 declared ingredients must be listed in descending order by weight
Net quantity per serving and per pack
Nutrition information panel
Must declare % RDA for all vitamins/minerals. Vitamin C at 308% RDA must be explicitly declared.
FSSAI license number of manufacturer
Batch number, manufacturing date, best before date
Directions for use
Recommended serving size and frequency
Advisory / warning statements
Must include: "Not a substitute for a varied diet." "Keep out of reach of children." "Consult a physician before use if pregnant/lactating."
"Food Safety Statement" — for health supplements
"This product is not intended to diagnose, treat, cure or prevent any disease."
Allergen declaration
Piperine (black pepper) must be declared as potential allergen for sensitive individuals. Gelatin capsule shell (if bovine) must be declared.
Storage instructions
e.g. "Store in a cool, dry place below 30°C. Protect from light."
Country of origin
Regulatory References Used
FSSR 2011 — Food Safety and Standards (Food Products Standards and Food Additives) Regulations
FSS (Nutraceuticals) Rules 2022 — Schedule I through IV permitted ingredients and dosage limits
ICMR-NIN RDA 2020 — Recommended Dietary Allowances for Indians, National Institute of Nutrition
GMP Codex / FSSR Additives — Permitted processing aids, excipients and additives list
NSF / FSSAI Closure List — Prohibited and restricted substances in nutraceuticals
FSS (Labelling & Display) Regs 2020 — Mandatory label declarations for health supplements
Disclaimer: This is a sample report for demonstration purposes only. The formulation, ingredient names, dosages, and compliance outcomes shown here are illustrative and do not constitute actual regulatory advice. Regulyze is an automated compliance screening tool — results are indicative and should be verified by a qualified FSSAI regulatory consultant before use in product development, manufacturing, or labelling decisions. TPS Xperts Group accepts no liability for reliance on automated report outputs. Always refer to the current official FSSAI notifications and applicable regulations.