FSSAI I–IV · CDSCO G/H/H1/X · Rules 96–97 · Schedule E(1)
Is this legal to make in India?
Answered from the schedules themselves — ingredient by ingredient, dose by dose, each line carrying the gazette entry and the source page it came from. A deterministic engine decides. The language model only narrates.
A pre-screening tool. It decides nothing, and is not legal advice.
Sleep & Recovery · capsule
data 2026.08.11-r5-PROVISIONAL
Magnesium glycinate
Sch I (B.7) · elemental Mg 60 mg · max 370 mg/day
300 mg
CompliantMelatonin
Sch III Part A · 25 · 2–10 mg/day
12 mg
Over limitTUDCA
Absent from Schedules I–IV
250 mg
Not permitted
Not permitted as formulated — one line has no schedule entry
Worst-of across three ingredients: TUDCA governs. Clamp melatonin to 10 mg and that line resolves; TUDCA needs one of two documented routes before the formulation can.
Worked example
One formulation. Three verdicts. Every line shows its citation.
This is the actual shape of the output — an ingredient comfortably inside its permitted range, one over its per-day limit with the fix stated, and one that is not a permitted ingredient at any dose.
Recovery Blend v3
Checked against FSS (Health Supplements, Nutraceuticals, FSDU, FSMP and Prebiotic and Probiotic Food) Regulations, 2022
- Format
- powder
- Serving
- 5 g
- Servings / day
- 1
- Population
- adults
One ingredient not permitted, one above its per-day limit, one flagged across modules. Strictest line governs the formulation. The full report also carries Schedule II Note 2 for the two botanicals, and a boundary-gap disclosure: no verified dose corridor covers these ingredients, so the point at which any of them becomes a drug was not checked.
Tinospora cardifolia Miers
entered as “giloy” · resolved via synonym map
500 mg / dayCompliantWithin the permitted range. Schedule II sets a maximum of 10,000 mg per day for this botanical.
Schedule II, entry 417 (source PDF p. 56)FSS (Health Supplements, Nutraceuticals, FSDU, FSMP and Prebiotic and Probiotic Food) Regulations, 2022
Curcuma longa L
typed in full — “haldi” matches two entries and returns a prompt
4,000 mg / dayConditionalAbove the permitted maximum. Schedule II caps this botanical at 3,000 mg per day for adults.
Fix — Reduce to 3,000 mg per day, then re-run. One click applies every fix at once.
Schedule II, entry 147 (source PDF p. 36)FSS (Health Supplements, Nutraceuticals, FSDU, FSMP and Prebiotic and Probiotic Food) Regulations, 2022
TUDCA
tauroursodeoxycholic acid
250 mg / dayNot permittedAbsent from Schedules I–IV. Not a permitted nutraceutical ingredient in India at any dose.
Never a dead end — The check returns permitted substitutes matched on documented therapeutic purpose, each with its own schedule entry, plus the novel-ingredient and export-only NOC routes and the authority to contact.
Absent from Schedules I–IV — not a permitted nutraceutical ingredientFSS (Health Supplements, Nutraceuticals, FSDU, FSMP and Prebiotic and Probiotic Food) Regulations, 2022
Cross-module flag — also listed in a drug schedule
L-Carnitine · 500 mg / day · no numeric limit stated
Permitted as a Schedule I nutrient and listed in the Drugs Rules, 1945. Working from the FSSAI schedules alone would never surface this. Schedule I sets no numeric maximum here, so the 500 mg was not compared against one — that is the schedule declining to set a limit, not a finding that any amount is acceptable. Confirm the intended product category before you commit to a run.
The Drugs Rules, 1945 (as amended to 17-11-2022) — Schedule H (H:p507)
Worked example, produced by the same deterministic rules engine that runs a live check. Entries, limits and page numbers are read from the digitized gazette text — not generated.
How it works
Spec sheet in, cited verdict out.
- 01
Enter the formulation
Ingredients and doses as they appear on your spec sheet. Vernacular and trade names resolve against 1,045 mapped synonyms — ashwagandha becomes Withania somnifera. Where a name is genuinely ambiguous the resolver proposes candidates and waits, rather than picking one for you.
- 02
Get a cited verdict
A traffic-light result per ingredient and for the formulation as a whole, in seconds. Every non-grey line carries the exact schedule entry and source page it came from. No citation, no verdict — that rule is enforced in the engine, not in the copy.
- 03
Act on it
Over a limit? Apply the cited fix and re-run in one click. Not permitted? See permitted substitutes matched on documented therapeutic purpose, the novel-ingredient and export-only routes, and the state authority to contact. Save the report; get alerted when the regulation behind it changes.
Why not just ask a chatbot?
Because a production run is not the place to find out the answer was plausible rather than correct.
A general chat model
- A fluent answer with nothing you can check
- A training cutoff you cannot see, on rules that were amended in 2022
- A different answer when you ask again tomorrow
- Nothing you could put in front of an auditor
Dolly Intelligence
- Every non-grey line cites a schedule entry and a source page
- Each verdict pinned to a data version and an engine version
- Same input, same versions — a byte-identical verdict, checked in CI
- A printable report carrying its citations with it
What is behind it
Digitized from the gazette PDFs, and page-cited row by row.
Invent — start from the formulation, not the rulebook
A researcher does not think "is this a nutraceutical or a drug"; they think about a target and the actives that might reach it. Which regulator owns the result is a CONSEQUENCE of what goes in. Enter any combination — botanicals, nutrients, drug actives — and the engine reports which regime the whole product lands in, why, and what would move it. One Schedule H active takes the entire preparation with it; there is no such category as a nutraceutical with a drug in it.
FSSAI — nutraceuticals
829 ingredients digitized from the official 2022 Nutraceutical Regulations across Schedules I–IV, with per-day ranges, ICMR-NIN RDA caps on Schedule I nutrients, and Schedule II Notes 1–5 applied at the formulation level, including child dose scaling.
CDSCO — drug schedules
646 actives from the Drugs Rules, 1945 as amended to 17-11-2022, across Schedules G, H, H1 and X, each mapped to its label, sale, register and licence-form obligations. Schedule H Note 2 extends the schedule to salts and esters the gazette never prints by name, and entry 31 covers the anabolic and oestrogenic classes — both cited to the provision that does the work, not to a neighbouring entry.
Artwork — before it goes to print
Upload the carton and every mandatory particular is checked against the instrument that governs it: the FSS Labelling Regulations 2020 for a food pack, Rules 96 and 97 of the Drugs Rules for a drug pack. The two rulebooks never mix. Anything geometric — type sizes, the red caution box, the Rx symbol — is reported as needing measurement and never as met.
The boundary between them
The question neither rulebook answers alone: is this a food or a drug. L-Carnitine is a permitted Schedule I nutrient and a Schedule H drug at once. Every check states how much of that boundary it actually consulted, because a screen with no flags on it must not read as an all-clear — the cross-links are exact-name only and the overlap we can prove is small.
Kept current, by a person
Six official gazette sources swept daily for changes. Detections land in a review queue; nothing reaches the live data until a person signs it off, which bumps the data version and flags every past verdict computed under the old one.
Provisional data — read this before you rely on it
The live dataset is auto-extracted from the official gazette PDFs and machine-validated: every row’s name and dose match the source page it cites, at 100%. A human expert review pass is still under way, so treat the data as provisional. 45 uncertain parses are held back as restricted rather than shown as permitted, and 17 Schedule I nutrients with no published RDA in the source answer amber — verify manually — rather than green. Every screen and every report says so.
Run your next formulation through it.
A few minutes now, against the schedules as written, instead of a recall conversation later.
Disclaimer
Dolly Intelligence is a pre-screening aid and is not legal or regulatory advice. It does not grant, replace or predict any decision by FSSAI, CDSCO, or a state licensing authority; those decisions rest with them alone. Confirm every result against the current gazette text and with your regulatory consultant before you print a label, file an application, or commit to a production run.