Category • Food & Ayush

Food & Ayush Compliance

FSSAI licensing, nutraceutical and health-supplement compliance, product approval and cGMP plant setup, plus AYUSH licensing — the full route for anyone making or importing food, supplements or Ayurvedic products.

Overview

Food, supplements and traditional medicine sit under different regulators but share one reality: the rules are detailed, the labelling is scrutinised, and a small formulation or claim error can hold up a whole product. Packaged foods and nutraceuticals fall under FSSAI; Ayurvedic, Siddha, Unani and Homeopathic products fall under the Ministry of AYUSH.

This category brings both together — FSSAI licensing and product approval, nutraceutical and health-supplement compliance, cGMP plant setup for a compliant facility, and AYUSH licensing. Whether you are launching a supplement, importing a specialty food or building a manufacturing unit, the relevant service is below.

FSSAI licensing is tiered by scale, and getting the tier right matters. A very small business turning over under ₹12 lakh a year needs only a Basic Registration; a mid-sized manufacturer or trader takes a State Licence; and large manufacturers, importers, and businesses operating across several states need a Central Licence. Every importer, regardless of size, needs a Central Licence. All of it runs through the FSSAI's online FoSCoS portal, and the licence must match the exact food categories and manufacturing processes you actually run — a mismatch between what you make and what your licence covers is a common inspection finding.

Nutraceuticals and health supplements are the fastest-growing and most tightly scrutinised part of this space. Under the FSSAI's Health Supplements and Nutraceuticals Regulations, every vitamin, mineral, botanical and amino acid in a formulation must sit within the permitted lists and stay inside the Recommended Daily Allowance limits. An ingredient outside those lists, or a formulation above RDA, cannot simply be sold — it needs a separate approval backed by safety data. We vet formulations against the permitted lists before a product is finalised, so a launch is not stopped at the last step by an ingredient that was never going to clear.

Some foods do not fit any existing standard at all. A novel ingredient, a proprietary formulation or a health claim that needs evidence triggers a Non-Specified Food or product-approval dossier assessed by the FSSAI's scientific panels — a slower, evidence-heavy route that is best identified early rather than discovered after the rest of the licence is in place. Labelling is the other frequent stumbling block: the mandatory FSSAI logo and licence number, the Veg/Non-Veg mark, the nutrition panel, allergen declarations and claim rules are all enforced, and non-compliant labels are a leading cause of consignments being held.

On the AYUSH side, Ayurvedic, Siddha, Unani and Homeopathic manufacturing is licensed by the state AYUSH authorities and must meet the Good Manufacturing Practices set out in Schedule T of the Drugs and Cosmetics Rules — covering premises, equipment, qualified staff and quality control. For companies building a new facility, our cGMP plant-setup service gets the layout, documentation and systems right before the inspection rather than retrofitting them under pressure. Handled together, a food or supplement business can move from formulation and facility to licence and label as one coordinated project instead of a series of disconnected filings.

A licence is not the end of the obligation. FSSAI licences and registrations are issued for one to five years and must be renewed before expiry — an expired licence stops you trading and can trigger penalties. Central and larger State licence holders are also expected to run a Food Safety Management System, submit annual returns, and keep their food-handlers trained, and licensees are subject to inspection and periodic product sampling. We build renewal tracking, FSMS documentation and annual-return support into the engagement so compliance is continuous rather than a scramble at inspection time.

Getting the sequence right saves the most time and money. We assess the product and business model first — the food categories, the ingredients, the claims and the scale — so the correct licence tier is chosen and any product-approval or non-specified-food route is identified before packaging and labels are finalised. Formulation vetting, label design and, where needed, plant setup then proceed in parallel with the licence application rather than after it, so a launch is not held up at the final step by an ingredient, a claim or a label declaration that could have been caught at the start.

From our base in Dadri, Gautam Buddha Nagar (Delhi NCR), we work with food and supplement manufacturers, importers and Ayurvedic units across India — from first-time FSSAI registrations to Central licences, nutraceutical launches and full cGMP plant setups. Because the same team handles both the FSSAI and AYUSH sides, a business that sits across both worlds gets one coordinated plan instead of two disconnected ones. If you are launching a food, supplement or Ayurvedic product, a short conversation before you finalise the formulation and label is the cheapest insurance you can buy — the services below cover each step, and our consultants can map exactly what your product needs to reach the shelf.

Key Takeaways

  • Packaged foods and nutraceuticals are regulated by FSSAI; AYUSH products by the Ministry of AYUSH.
  • Nutraceutical ingredients must sit within permitted lists and RDA limits, or need separate approval.
  • A non-standardised food or novel ingredient triggers a product-approval dossier.
  • FSSAI licences are tiered — Basic Registration, State, or Central — and every importer needs a Central licence.
  • AYUSH manufacturing must meet Schedule T GMP, verified by a state AYUSH inspection.

Frequently Asked Questions

It depends on the product. Foods, beverages, nutraceuticals and health supplements are licensed by FSSAI. Ayurvedic, Siddha, Unani and Homeopathic medicines are licensed under AYUSH. Some businesses need both.
When a food or ingredient is not already covered by an existing FSSAI standard — for example a novel ingredient or a functional claim needing evidence.
Basic Registration for turnover under ₹12 lakh, a State Licence for mid-sized single-state operations, and a Central Licence for large manufacturers, multi-state operators and all importers. It is filed on the FoSCoS portal.
Ingredients must appear on the FSSAI permitted lists and stay within Recommended Daily Allowance limits. Anything outside those lists or above RDA needs a separate safety-backed approval before it can be sold.
Schedule T of the Drugs and Cosmetics Rules, covering premises, equipment, qualified personnel and quality control. A state AYUSH inspection verifies compliance before the manufacturing licence is granted.
FSSAI licences and registrations are issued for one to five years and must be renewed before expiry. An expired licence stops you from trading legally and can attract penalties, so renewals should be tracked well ahead of the due date.

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