INDIA — FSSAI NUTRACEUTICAL REGULATIONS
The FSSAI nutraceutical regulations define separate categories — health supplements, nutraceuticals, foods for special dietary use, and more — each with its own permitted ingredient schedules and limits. Category selection determines what you may add, how much, and what the label may say.
CATEGORY BEFORE FORMULA
Get the category wrong and the schedule works against you.
A health supplement in India is bounded by the vitamin, mineral, amino acid, and botanical schedules, with maximum daily amounts set against recommended intakes. A nutraceutical draws on a different list and allows a different type of positioning. Ingredients outside every schedule require a formal approval before use, and no amount of overseas precedent shortens that route. We place the product in the correct category first, then reconcile the formula to the schedule that governs it.
LICENSING & IMPORT
An importer licence, then every consignment.
Imported product requires a central FSSAI licence held by an Indian entity, with product details registered against it. Consignments are cleared through the food import clearance system, sampled, and tested against Indian limits for contaminants and declared actives. Shelf-life rules on arrival are strict, so production scheduling and shipping windows belong in the regulatory plan rather than the logistics plan.
THE INDIAN CHECKLIST
Three requirements that decide clearance.
Schedule compliance
Each active mapped to its schedule entry and daily limit, with out-of-schedule ingredients flagged for approval or removal.
Mandatory label set
Category declaration, vegetarian or non-vegetarian mark, cautionary wording, FSSAI licence number, and importer particulars.
Consignment testing
Heavy metals, microbiology, and active assay run against Indian methods, with specifications written so results agree.
BOTANICALS & AYUSH
Two regulators, two different products.
Traditional Indian botanicals can sit under FSSAI as a nutraceutical or under AYUSH as a traditional medicine, and the two regimes ask for different evidence, different manufacturing, and different claim language. Brands built on ashwagandha, turmeric, or shilajit often assume the AYUSH route is automatic; it is not, and moving between the two after launch means relabelling and relicensing. We set that boundary at the design stage.
Find your schedule before you find a distributor.
We review your formula against the FSSAI schedules, identify what must change, and set out the licensing and testing sequence for a first consignment.