Omega-3 fish oil is a food in India, not a drug, and it is regulated by the Food Safety and Standards Authority of India under the health supplement and nutraceutical framework. That determines the licence a marketer needs, the standard the oil must meet, and what the label may say. This guide is written for a brand or contract manufacturer sourcing bulk fish oil, and for exporters who need to know how the Indian position compares with the destination’s.
Which Regulation Applies
Finished omega-3 supplements sit under the FSSAI regulations governing health supplements, nutraceuticals, foods for special dietary use and related categories, which were consolidated in a 2022 revision of the earlier 2016 regulations. Those regulations define what a health supplement and a nutraceutical are, set the framework for permitted ingredients and their levels, and lay down labelling rules specific to the category. Fish oil as a raw material also falls under the general product standards and the contaminant, toxin and residue limits in the food product standards regulations. A marketer must read both sets: the category rules for the finished product and the commodity and contaminant rules for the oil.
Licensing
Anyone manufacturing, importing, distributing or selling omega-3 supplements in India needs an FSSAI licence or registration appropriate to their scale and activity, and manufacturers of nutraceuticals are licensed under the category that covers health supplements and nutraceuticals rather than under a general food category. The 14-digit licence number must appear on the label with the FSSAI logo. Importers additionally clear each consignment through the FSSAI import process at the port, where sampling and testing against the applicable standards can occur.
What to Specify in the Oil
| Parameter | Why it matters | Typical specification line |
|---|---|---|
| EPA and DHA content | The label claim is built on it; concentrates (30/20, 40/20, 60/30 and higher) are graded on it | EPA and DHA as mg/g or % by GC, as triglyceride or ethyl ester form stated |
| Oxidation: peroxide value, anisidine value, TOTOX | Rancid oil fails organoleptically and is the main quality complaint | PV NMT 5 meq/kg, AV NMT 20, TOTOX NMT 26 are the widely used industry ceilings |
| Acid value and free fatty acids | Refining quality | Stated per grade |
| Heavy metals | Mercury, lead, cadmium, arsenic limits under the contaminant regulations | By ICP-MS, reported as numbers |
| Dioxins, PCBs and other organic contaminants | Required by most buyers and by several destination markets | Reported on a reference lot at minimum |
| Antioxidant | Mixed tocopherols or rosemary extract are usual; must be declared | Named with level |
| Species and origin | Sustainability and allergen declarations depend on it | Anchovy, sardine, mackerel; fishing area |
Internationally, the GOED voluntary monograph is the reference most buyers use for oxidation and contaminant limits, and pharmacopoeial monographs (USP, European Pharmacopoeia) set the standards for pharmaceutical-grade concentrates. An Indian marketer specifying to those limits will meet the domestic contaminant rules comfortably.
Labelling and Claims
- Category name as the regulations require (for example “health supplement”), with the statement that the product is not for medicinal use and the “not to exceed the recommended daily usage” line.
- Nutritional information including EPA and DHA per serving, expressed against the reference daily requirements the regulations point to.
- Fish as an allergen, and the species where a consumer claim depends on it.
- Claims limited to those the regulations permit; disease-treatment claims move the product into the drug regime and are not available.
The Exporter’s Angle
Bulk fish oil exported from India for manufacture abroad is not labelled for the Indian consumer, but the exporter still needs an FSSAI licence covering export, a batch COA against the buyer’s specification, and a health certificate where the destination asks for one. The destination’s rules govern the finished product: the EU sets contaminant limits and novel-food status for some oil forms, and the US treats fish oil supplements under its dietary supplement framework with its own labelling. SV Botanica supplies omega-3 fish oil as a bulk ingredient against specification, with EPA/DHA by GC and the oxidation and contaminant panel on the COA; see the omega-3 fish oil product page.
This guide describes the regulatory framework as understood at the date of publication; the regulations and their schedules are amended periodically and the FSSAI website is the authoritative source.
Omega-3 Fish Oil, specified to GOED and pharmacopoeial limits
EPA and DHA by GC, oxidation indices and contaminant panel on every batch COA, documentation for FSSAI import or export.