Quick answer. An FSSAI licence applies to products sold as food (including health supplements and nutraceuticals) and comes from the Food Safety and Standards Authority of India under the Food Safety and Standards Act, 2006. An AYUSH licence applies to products sold as Ayurvedic (ASU) medicines and is granted under the Drugs and Cosmetics Act, 1940. Which one a product needs depends on how it is positioned: a herbal "health supplement" is food and needs FSSAI; a classical Ayurvedic medicine needs an AYUSH manufacturing licence. Some products legitimately carry both. This is general information, not legal advice.
Pick up almost any Ayurvedic supplement in India and turn it over: somewhere on the back you will find an FSSAI number, an AYUSH licence number, or sometimes both, and very little explanation of what either one means.
This guide answers what most product pages skip: the difference between FSSAI and AYUSH licences, which one a given Ayurvedic product needs, and whether a product carrying "only FSSAI" is somehow lesser. You will leave able to read the regulatory block with confidence — and understanding the principle that does most of the work: the law treats a product as food or as medicine, and that decision, not the herb inside, decides which regulator and licence apply.
What is an FSSAI licence?
An FSSAI licence is the food licence. The Food Safety and Standards Authority of India (FSSAI) is the statutory food regulator constituted under the Food Safety and Standards Act, 2006, which sits under the Ministry of Health and Family Welfare. The Act's own long title describes it as legislation "to consolidate the laws relating to food and to establish the Food Safety and Standards Authority of India" [1].
If a product is sold as food, FSSAI is the regulator. That includes the categories most relevant to wellness brands: health supplements and nutraceuticals. These are governed by FSSAI's nutraceutical framework — the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016, which were later revised through a 2022 direction [4][5].
The practical point for a reader: an FSSAI number on a pack tells you the product is regulated as food. A food product may make general structure/function statements ("supports energy and well-being") but may not claim to treat, cure, or prevent disease.
What is an AYUSH licence?
An AYUSH licence is the medicine licence for traditional systems. Ayurvedic, Siddha and Unani (ASU) medicines are regulated not under food law but under the Drugs and Cosmetics Act, 1940, with policy oversight from the Ministry of AYUSH.
The law is specific about what counts. Section 3(a) of the Drugs and Cosmetics Act defines an "Ayurvedic, Siddha or Unani drug" as a medicine intended for the diagnosis, treatment, mitigation or prevention of disease, "manufactured exclusively in accordance with the formulae described in, the authoritative books of Ayurvedic, Siddha and Unani Tibb systems of medicine, specified in the First Schedule" to the Act [2]. The manufacture, labelling and sale of ASU drugs is governed by Chapter IVA of the same Act.
One nuance worth knowing: an Ayurvedic manufacturing licence is issued by the State Licensing Authority (in Delhi, the relevant office is at Mandi House), not a single central body. The Ministry of AYUSH sets the policy framework; the licence is granted at state level.
Keep two ideas separate here. The traditional idea of what makes something "Ayurvedic" (its grounding in classical texts and concepts like dosha and rasayana) is a knowledge system. The legal definition of an Ayurvedic drug is the precise one in Section 3(a): a formulation made per a recognised authoritative text and intended as medicine. A herb being "Ayurvedic" in spirit does not, on its own, make a product a licensed Ayurvedic drug.
FSSAI vs AYUSH: a side-by-side
| Property | FSSAI licence | AYUSH licence |
|---|---|---|
| Governing law | Food Safety and Standards Act, 2006 | Drugs and Cosmetics Act, 1940 |
| Regulator / ministry | FSSAI (Ministry of Health & Family Welfare) | Ministry of AYUSH; manufacturing licence issued by the State Licensing Authority |
| What it covers | Products sold as food, including health supplements & nutraceuticals | Products sold as Ayurvedic, Siddha or Unani (ASU) medicines |
| Typical product | A herbal "health supplement," juice, gummy, or nutraceutical capsule | A classical or proprietary Ayurvedic medicine (e.g. a churna or asava per an authoritative text) |
| Claims allowed | General structure/function statements; no disease treatment/cure/prevention claims | May carry therapeutic indications drawn from the authoritative texts, within legal limits |
| Where the number appears | FSSAI licence number (and the FSSAI logo) in the label's regulatory block | AYUSH manufacturing / loan licence number in the label's regulatory block |
The table makes the core contrast visible: two Acts, two regulators, two sets of permitted claims. Everything else in this article is detail hanging off that one distinction.
Which licence does an Ayurvedic product need?
There is a simple test, and it is not about the ingredient. It is about how the product is positioned and what it claims.
- If the product is sold as a health supplement or nutraceutical (general wellness positioning, structure/function language, no disease claims), then it is food, and it needs an FSSAI licence.
- If the product is sold as an Ayurvedic medicine (a formulation per an authoritative text, carrying therapeutic indications), then it is a drug under the 1940 Act, and it needs an AYUSH manufacturing licence.
The same herb can sit in either bucket. Ashwagandha sold as an energy-and-vitality supplement is food (FSSAI). The same herb formulated and labelled as a classical Ayurvedic medicine with therapeutic indications is a drug (AYUSH). The composition and the claim decide the pathway — not the plant.
This is also why a product carrying "only FSSAI" is not lesser or unsafe. It simply means the brand has chosen to sell that product as a food supplement, with the claim restrictions that come with food law. It is a different legal lane, not a lower-quality one.
The "Ayurveda Aahara" category — where food and Ayurveda meet
For years the awkward question was: what about a food made to a traditional Ayurvedic recipe, is it food, or medicine? In 2022, FSSAI answered it by creating a dedicated category.
FSSAI notified the Food Safety and Standards (Ayurveda Aahara) Regulations, 2022, formulated in consultation with the Ministry of AYUSH, through a Gazette of India notification dated 5 May 2022 (gazette reference CG-DL-E-07052022-235642) [3]. The regulation defines "Ayurveda Aahara" as food prepared per the recipes, ingredients and processes described in the authoritative books of Ayurveda listed under its Schedule A.
Crucially, the category excludes Ayurvedic drugs and proprietary Ayurvedic medicines, cosmetics, and narcotic or psychotropic substances, keeping the food lane and the medicine lane clearly apart. It is also not meant for infants up to 24 months.
A dedicated "Ayurveda Aahar" logo was launched on 7 June 2022 and must be displayed close to the product and brand name, so shoppers can recognise the category on shelf. FSSAI has since slotted Ayurveda Aahara into the food-category system as FC 102 (with sub-categories), and a definitive Category A list of Ayurveda Aahara products has been rolled out [Source: FSSAI Ayurveda Aahara category framework]. (Regulatory rollouts move; verify the current Category A status with FSSAI before relying on it commercially.)
The short version: Ayurveda Aahara is the formal home for a traditional Ayurvedic food — a third lane that is firmly food, regulated by FSSAI, but built on Ayurvedic recipes.
Can one factory make both?
A common assumption is that AYUSH-medicine manufacturing and FSSAI-food manufacturing must happen in separate facilities. They do not have to.
On 31 August 2023, the Ministry of AYUSH clarified that there is no specific prohibition on using a combined setup of manufacturing line and equipment for products licensed under Ayurveda, Siddha and Unani and products licensed under FSSAI. The clarification stated that ASU facilities can be used to manufacture FSSAI-licensed food products, provided the company takes due precautions to avoid cross-contamination as per Schedule T of the Drugs and Cosmetics Act, 1940 [6].
So the answer is yes — with the explicit condition that good-manufacturing-practice and cross-contamination safeguards (Schedule T) are followed. The shared facility is permitted; the hygiene and separation discipline is not optional.
The Patanjali case — what it was really about
A lot of online writing frames a famous Patanjali matter as an "FSSAI vs AYUSH classification dispute," a fight over whether herbal products are food or medicine. On the evidence, that framing is inaccurate, and it is worth correcting because it teaches the wrong lesson.
There is no clean primary court ruling of a Patanjali "food supplement vs Ayurvedic medicine classification" dispute. The well-documented Patanjali case before the Supreme Court was about advertising, not classification. In Indian Medical Association v. Union of India, 2024 INSC 605 (judgment dated 13 August 2024), the issue was that advertisements claimed Ayurvedic products could cure diseases, including conditions whose cure-advertising is barred by the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954. After an undertaking was given and the advertisements continued, the company faced contempt proceedings, and the Court restrained advertisements making such disease-cure claims [7].
(A separate Patanjali matter, a GST penalty case before the Allahabad High Court, is sometimes confused with this; it concerns tax penalties, not product classification [Source: M/s Patanjali Ayurved Ltd v. Union of India, Allahabad High Court, WRIT-TAX No. 1603 of 2024].)
Why this matters for our topic: the case is the cleanest real-world illustration of the article's whole point. The regulatory bucket a product sits in decides what it may legally claim. A product positioned and licensed as a food supplement cannot advertise disease cures. The Patanjali matter was about claims crossing that line — which is exactly why understanding food-versus-medicine licensing is worth your time.
How to read these codes as a buyer
When you turn a pack over, the regulatory block is doing useful work for you. An FSSAI number tells you the product is sold and regulated as food, with food-law claim limits. An AYUSH licence number tells you the product is licensed as an Ayurvedic medicine under drug law. Seeing both is not a contradiction. It usually means the brand operates across both lanes, or the product genuinely sits in a category that warrants both.
A few things to look for, calmly rather than anxiously: a visible licence number rather than a vague "Ayurvedic" badge; claim language that matches the lane (a food supplement should "support" things, not "cure" them); and, on a traditional food, the Ayurveda Aahar logo. Once you know what the codes mean, the rest of the label tells a fuller story — see our guide on how to read an Ayurvedic supplement label.
As we prepare to launch, this is exactly how we think about our own range: deciding, product by product, whether something is honestly a food supplement or an Ayurvedic medicine, and following the licence and claim rules that go with that choice. That discipline is the same one behind how we source our herbs, and it sits alongside the bigger question of whether Ayurvedic medicine is safe long-term. For products we sell as supplements, our aim is simple, supportive positioning, for example an everyday wellness formula like KayaSuddhi Ashwagandha Tablets, kept squarely inside food-law claim limits.
When this approach does NOT apply — cautions
- This is general information, not legal or regulatory advice. Licensing decisions for your own product should be verified directly with FSSAI or your state AYUSH authority, or with a qualified licensing consultant.
- The right licence depends on the specific product. Composition, claims and intended use change the answer; do not assume one product's licence applies to another.
- Regulatory status moves. The nutraceutical regulations (2016, revised via a 2022 direction), the Ayurveda Aahara Category A rollout, and advertising rules under the Drugs and Cosmetics Rules are all live areas — re-verify the current position before relying on it.
- A licence is not a health claim. Holding an FSSAI or AYUSH licence does not mean a product treats, cures or prevents any disease; it means the product is permitted to be sold within a defined legal lane.
Frequently asked questions
Do Ayurvedic / herbal products need FSSAI registration?
If the Ayurvedic or herbal product is sold as food (for example a health supplement, nutraceutical, juice or gummy), then yes, it falls under the Food Safety and Standards Act, 2006, and needs FSSAI licensing or registration. If instead the product is sold as a classical Ayurvedic medicine under the Drugs and Cosmetics Act, 1940, it follows the AYUSH route rather than FSSAI. The deciding factor is whether the product is positioned as food or as medicine.
Is an AYUSH license mandatory for Ayurvedic supplements?
Not necessarily. A product sold as an Ayurvedic medicine needs an AYUSH manufacturing licence under the Drugs and Cosmetics Act, 1940. But many "Ayurvedic supplements" are positioned as health supplements or nutraceuticals, which are food, and those need an FSSAI licence, not an AYUSH one. So whether AYUSH is mandatory depends entirely on whether the supplement is sold as food or as medicine.
Which license is needed for an Ayurvedic health supplement vs an Ayurvedic medicine?
An Ayurvedic health supplement is regulated as food and needs an FSSAI licence under the Food Safety and Standards Act, 2006. An Ayurvedic medicine (a formulation made per an authoritative text and carrying therapeutic indications) is a drug and needs an AYUSH manufacturing licence under the Drugs and Cosmetics Act, 1940. Same herb, different bucket: the claim and composition, not the ingredient, decide the pathway.
Can FSSAI-licensed products be made in an AYUSH-approved facility?
Yes. On 31 August 2023 the Ministry of AYUSH clarified that there is no specific prohibition on a combined manufacturing setup for AYUSH-licensed and FSSAI-licensed products. ASU facilities may be used to make FSSAI-licensed food products, provided the company takes due precautions to avoid cross-contamination as per Schedule T of the Drugs and Cosmetics Act, 1940. The shared facility is allowed; the contamination safeguards are required.
Are Ayurvedic products exempt from the FSSAI 2022 regulations?
No general exemption exists. If an Ayurvedic product is sold as food, FSSAI's rules apply — including the nutraceutical framework (the 2016 regulations, revised via a 2022 direction) and, for traditional foods, the Ayurveda Aahara Regulations, 2022. What sits outside FSSAI is a product sold as an Ayurvedic medicine, which is governed by the Drugs and Cosmetics Act, 1940 instead. So it is not an exemption — it is a different law for a different category.
What is an "Ayurveda Aahara" product under FSSAI?
"Ayurveda Aahara" is a dedicated FSSAI food category, notified via the FSS (Ayurveda Aahara) Regulations, 2022 (gazette dated 5 May 2022) in consultation with the Ministry of AYUSH. It covers food prepared per recipes and processes in the authoritative books of Ayurveda, and it excludes Ayurvedic drugs and proprietary medicines. These products carry a dedicated "Ayurveda Aahar" logo near the brand name.
Why did Patanjali get into an FSSAI vs AYUSH classification dispute?
It is a common misconception. The famous Patanjali Supreme Court matter was not a food-versus-medicine classification dispute but an advertising case. In Indian Medical Association v. Union of India, 2024 INSC 605, advertisements claimed Ayurvedic products could cure diseases, including ones barred by the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, leading to contempt proceedings and a restraint on such ads. It illustrates a real principle: a product's regulatory bucket decides what it may legally claim.
Related reading
- How to Read an Ayurvedic Supplement Label
- Is Ayurvedic Medicine Safe Long-Term?
- How We Source Our Herbs — the KayaSuddhi Process
Sources
- Food Safety and Standards Act, 2006 — official text, India Code.
- Drugs and Cosmetics Act, 1940 (Section 3(a), First Schedule, Chapter IVA) — official text, India Code.
- Food Safety and Standards (Ayurveda Aahara) Regulations, 2022 — Gazette of India notification dated 5 May 2022 (ref CG-DL-E-07052022-235642), FSSAI.
- FSSAI — Health Supplements & Nutraceuticals product-standards page (FSS Health Supplements, Nutraceuticals… Regulations, 2016).
- FSSAI — Direction dated 30 March 2022 revising the nutraceutical regime.
- Ministry of AYUSH clarification dated 31 August 2023 on combined AYUSH + FSSAI manufacturing (Schedule T) — NutraIngredients, 13 September 2023.
-
Indian Medical Association v. Union of India, 2024 INSC 605, Supreme Court of India (judgment dated 13 August 2024).
Educational use only — not medical advice. These statements have not been evaluated by AYUSH or FSSAI as treatment claims. KayaSuddhi products are purely herbal and not intended to diagnose, treat, cure, or prevent any disease. Results may vary. Please consult your physician or a qualified BAMS-certified Ayurvedic practitioner before starting any new supplement — especially if you are pregnant, breastfeeding, on prescription medication, or managing a chronic condition.
Written & researched by
The KayaSuddhi Team
We are a small team of Ayurveda writers, researchers and reviewers in Delhi NCR. We track the health questions real people are asking, read the latest studies, and turn them into honest, practical guides — so you can make informed choices, not follow hype.
