Food & Nutraceuticals
Nutraceutical and health supplement manufacturing, licensed properly
Ingredient screening, category selection, Schedule IV GMP readiness and the FSSAI licence, handled as one project rather than five disconnected filings.
- Authority
- FSSAI, through a Central or State Licence with nutraceutical categories endorsed
- Governing rules
- FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose and Prebiotic and Probiotic Food) Regulations, 2016 and Schedule IV of the Licensing Regulations
- Typical timeline
- 45 to 90 days from formulation review to licence grant
Nutraceutical & Health Supplement Manufacturing Licence: what it involves
Nutraceuticals, health supplements, foods for special dietary use, foods for special medical purpose, and prebiotic and probiotic foods are governed by a dedicated set of FSSAI regulations notified in 2016 and amended since. They are food products, not drugs, so they are licensed by FSSAI rather than CDSCO, but the compliance bar is noticeably higher than for ordinary food.
Two things decide whether a supplement project succeeds. The first is ingredient eligibility: every vitamin, mineral, amino acid, botanical, enzyme and probiotic strain has to be traceable to the schedules of the 2016 regulations, at permitted levels, and any ingredient outside those schedules needs a separate approval route. The second is Schedule IV good manufacturing practice, which governs everything from air handling and personnel flow to in-process records. We work on both in parallel with the licence application.
This is the area the founding team has spent most of its career in, having supported more than a hundred health supplement and nutraceutical manufacturing projects.
Who needs this
- Manufacturers of tablets, capsules, softgels, powders, gummies and shots
- Sports nutrition and protein supplement brands setting up their own plant
- Ayurvedic and botanical brands moving into the nutraceutical category
- Probiotic and prebiotic food manufacturers
- Contract manufacturers taking on supplement lines
- Brands moving from third-party manufacturing to an owned facility
Documentation
Documents required
Arrange these and the file moves. We tell you exactly which format each one has to be in, and we draft the technical annexures ourselves.
- Complete formulation with quantities per unit dose for every product
- Ingredient justification mapped to the schedules of the 2016 regulations
- Specification and certificate of analysis for each raw material
- Finished product specification and shelf life or stability data
- Draft labels including nutritional information, claims and mandatory warnings
- CAD layout showing clean areas, air locks, personnel and material flow
- List of manufacturing and testing equipment with capacity
- In-house or outsourced laboratory arrangement with scope of testing
- Water and environment monitoring reports
- Schedule IV documentation set including SOPs, formats and records
- Technical staff qualification records
- Standard FSSAI licence documents such as Form B, premises proof and constitution documents
How we work
The process, stage by stage
Indicative durations for a file where documents arrive on time. We tell you at the outset which stage is most likely to slip in your case.
- 1
Formulation and ingredient screening
5 to 10 daysEvery ingredient in every SKU is checked against the permitted lists and maximum levels in the 2016 regulations. We flag ingredients that need an alternative source, a reduced level, or a separate approval before you commit to a recipe.
- 2
Category and claim positioning
3 to 5 daysWe place each product in the correct regulatory category, because a health supplement, a nutraceutical and a food for special medical purpose carry different labelling, dosage and claim rules. Claims are vetted against the Advertising and Claims Regulations at this stage, not after printing.
- 3
Schedule IV and layout readiness
10 to 20 daysWe review or design the plant layout for the clean area classification your dosage forms require, and prepare the GMP documentation set covering SOPs, batch records, cleaning validation formats and personnel hygiene.
- 4
Licence application on FoSCoS
1 to 2 daysThe licence application is filed with nutraceutical categories endorsed and the full technical annexure set attached.
- 5
Inspection support and grant
20 to 45 daysWe prepare your team for the inspection, attend where required, close observations and follow the file through to grant.
Questions
Frequently asked questions
Do nutraceuticals need a drug licence from CDSCO?
No. Health supplements and nutraceuticals are regulated as food by FSSAI under the 2016 regulations. A CDSCO drug licence is only needed if a product is genuinely a drug by composition or claim. Products that sit close to the boundary need careful positioning, because a therapeutic claim can pull a food product into drug regulation.
Can I use any botanical extract in a supplement?
Only those listed in the schedules to the 2016 regulations, and only within the specified limits. Ingredients outside the lists require a separate approval route, which takes considerably longer. This is why we screen formulations before anything else.
What clean area standard does a supplement plant need?
It depends on the dosage form. Dry powders, tablets and capsules, liquids and softgels each imply different air handling, pressure differentials and segregation. We size the requirement against your product mix rather than applying a single template.
Can I get a licence before the plant is built?
The licence is granted against a specific premises and usually follows an inspection, so the facility needs to be substantially ready. What we can do is run the licensing workstream in parallel with construction so the two finish together instead of one waiting on the other.
Do I need my own laboratory?
You need access to testing that covers your finished product specification. Many small plants start with a basic in-house laboratory for routine parameters plus an arrangement with an NABL accredited laboratory for the rest. We help structure the split and document it for the file.
Related services
Often taken together with this
FSSAI Central Licence
For turnover above Rs 50 crore, importers, exporters, e-commerce sellers and businesses operating in more than one state.
Typical timeline · 30 to 60 working days in a clean file
Read morePlant Setup Consultancy
Site selection to first commercial batch, with licensing running in parallel rather than as an afterthought.
Typical timeline · 6 to 15 months from concept to first commercial batch
Read moreFood Factory Layout Design
CAD drawings designed around flow, segregation and clean area classification, drawn to be approved.
Typical timeline · 2 to 6 weeks for a complete drawing set
Read moreTell us what you are manufacturing. We will tell you what you need.
Share your product category, premises and turnover. You will get a written scope covering the exact licences that apply, the documents to arrange, and a realistic timeline.