AYUSH Licence vs FSSAI: Choosing the Right Route for a Herbal Product in India (2026)

AYUSH licence vs FSSAI: is your product a medicine or a food?

India has two separate legal homes for a herbal product. Ayurveda, Siddha and Unani (ASU) medicines are drugs under the Drugs and Cosmetics Act, 1940 and its 1945 Rules, licensed by state licensing authorities.^[2] Health supplements and nutraceuticals are foods under the Food Safety and Standards Act, 2006, regulated by FSSAI, and they are not meant to treat or cure a disease.^[1] The Ministry of Ayush has said the two categories are regulated by different laws, and that Ayurvedic and related products should not claim nutraceutical value, according to a 2024 NutraIngredients report of its notice.^[1]

So the first decision is not which form to fill in. It is what the product is for and what it will say. A 2026 review of Indian nutraceutical regulation notes that a product claiming to treat, cure, prevent or mitigate a disease is treated as a drug, and that unclear boundaries between food and drug are a recurring problem for manufacturers.^[7] Fix the intended use and the claim first, and the licence follows from them (Figure 1).

This guide is about that choice. For the quality and GMP requirements once you are on the AYUSH route, see our AYUSH guidelines for herbal products; for category rules, dose limits and labels on the food route, see our FSSAI nutraceutical regulations explainer.

The AYUSH licence route for ASU medicines

Who grants an AYUSH licence

What brands call an “AYUSH licence” is, in law, a state licence to manufacture ASU drugs for sale. Under Rule 152 of the Drugs and Cosmetics Rules, each state government appoints the licensing authorities for its area.^[2] The application is made in Form 24-D (Rule 153), and the licence is issued in Form 25-D (Rule 154) after the authority consults an expert in the relevant system of medicine.^[2] The Ministry of Ayush does not itself grant manufacturing licences or product approvals, and it has warned that claims such as “approved by the Ministry of Ayush” on labels or advertisements are incorrect.^[1]

State procedures, portals, checklists and fees differ. The Delhi Directorate of AYUSH, for example, publishes its own forms and checklists for Form 25-D and loan licences.^[3] Confirm the current requirements with the authority in the state where the product will be made.

Own factory or contract manufacturer

A brand that has no manufacturing facility of its own can apply for a loan licence under Rule 153A, which lets it use the facilities of a manufacturer that already holds a Form 25-D licence.^[2] This is the usual route for a brand launching an ASU product through a contract manufacturer.

GMP and labelling on the AYUSH route

Manufacture must take place in premises and under the hygienic conditions set out in Schedule T. The licensing authority checks those requirements and issues the GMP certificate in Form 26 E-I together with the licence (Rule 157).^[2] Rule 161 requires the label to list every ingredient with its botanical name, the plant part and the form used, with quantities, and to carry the words “Ayurvedic medicine”, “Siddha medicine” or “Unani medicine” as applicable.^[2] Advertising falls under the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954.^[1][7] Homoeopathic medicines are licensed under separate provisions of the same Rules and are outside this comparison.

The FSSAI nutraceutical route for herbal supplements

What the route covers

The notified text is 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.^[4] Since 1 April 2022 FSSAI has also applied a revised 2022 draft by direction, pending final notification. It covers five categories: health supplements, nutraceuticals, food for special dietary use, food for special medical purpose, and prebiotic and probiotic food.^[5] Our FSSAI nutraceutical regulations explainer sets out which text applies where they differ.

Licence, claims and labels

Manufacturers of products under the nutraceutical regulations are licensed by FSSAI’s Central Licensing Authority, whatever their turnover.^[6][7] Claims are governed mainly by the Advertising and Claims Regulations, 2018 and labels by the Labelling and Display Regulations, 2020, alongside the category rules.^[7] The category rules also require the statement “NOT FOR MEDICINAL USE” on the label.^[4] A treatment or cure claim is not available on this route, because it would make the product a drug.^[7]

Botanicals: the plant and the plant part

For herbal products the ingredient list matters as much as the claim. Schedule IV of the 2016 Regulations lists the plants and botanicals permitted in these categories, and FSSAI reads that list by plant part: for ashwagandha, only the roots and their extracts are permitted.^[9] A botanical or part that is not listed needs a different route, such as FSSAI product approval for non-specified foods.

A third route: Ayurveda Aahara

Some products are neither ASU medicines nor nutraceuticals. The Food Safety and Standards (Ayurveda Aahara) Regulations, 2022, notified in the official gazette on 5 May 2022, cover foods prepared to recipes, ingredients or processes described in the authoritative Ayurveda books listed in Schedule A.^[8] They exclude Ayurvedic drugs and proprietary Ayurvedic medicines, herbs listed in Schedule E-1 of the Drugs and Cosmetics Rules, and metal-based preparations such as bhasma or pishti.^[8]

Every Ayurveda Aahara product must carry the words “AYURVEDA AAHARA” close to the product name, the specified logo on the front of the pack and the statement “ONLY FOR DIETARY USE”.^[8] This route suits a classical food such as a traditional preparation sold as a food. It is not a way to sell a medicine without a drug licence.

How to decide which route applies

Start with the claim, then check that the ingredients, the plant parts and the format support it. A therapeutic indication points to the ASU drug route. A general well-being or nutritional claim on a product whose botanicals are listed for food use points to FSSAI. A classical food made to a Schedule A text points to Ayurveda Aahara.

Table 1. The three Indian routes for a herbal product compared

Where the routes overlap

The overlap is where products are challenged. The Ministry of Ayush has said Ayush products should not claim nutraceutical value,^[1] and the 2026 review notes that state drug inspectors may step in where it is unclear whether a product is a nutraceutical or a drug.^[7] Each product should sit under one route. A company that makes both medicines and foods can hold both kinds of licence, but for different products, each with its own label and claims.

Worked example: a 240 mg ashwagandha root-extract capsule

Take a single-ingredient capsule containing 240 mg of ashwagandha (Withania somnifera) root extract, taken once daily. Ashwagandha root is a classical Ayurvedic herb, so the same capsule could in principle be made as an ASU proprietary medicine under a state licence, or as an FSSAI nutraceutical with general well-being wording under a central licence. The intended use and the claim decide which. Three checks are specific to this product.

• Plant part. On 15 April 2026 the Ministry of Ayush directed Ayush drug manufacturers to use only ashwagandha roots, in any form, and to declare the plant parts on the label under Rule 161. On 16 April 2026 FSSAI issued an advisory that only the roots and their extracts are permitted under Schedule IV of the 2016 Regulations, and that leaves in crude, extract or any other form are not.^[9] The Ministry’s letter cites studies reporting possible safety concerns with the leaves, linked to higher levels of reactive withanolides such as withaferin A.^[9] Declaring “root extract” on a nutraceutical label is also the simplest way to show compliance.
• Court status. In May 2026 the Karnataka High Court stayed both the FSSAI advisory and the Ayush directive in an interim order, but only for the petitioners in W.P. No. 14990/2026 and W.P. No. 15010/2026, and listed the matter for 8 June.^[10] We could not verify any later order. The stay does not apply to other businesses, and it does not matter for a root-only product; check the current position before relying on it.
• Claim. Wording such as “treats anxiety” is a therapeutic claim and would take the capsule out of the food route.^[7] Evidence on a branded root extract, such as the trial in our Lopresti 2019 ashwagandha study explainer, does not by itself allow a treatment claim on a food. Keep to wording permitted for the category and have it reviewed.

Our ashwagandha capsule development worked example follows the same product through specification, testing and stability.

Compliance checklist for herbal brands

Table 2. Route and licence checklist for a herbal product in India

Conclusion

The choice between an AYUSH licence and FSSAI follows the product’s intended use. A therapeutic indication means an ASU drug licence from the state; a well-being or nutritional claim on a product with food-permitted botanicals means the FSSAI nutraceutical route and a central licence; a classical Ayurvedic food can use Ayurveda Aahara. Most problems arise in the overlap, so settle the classification, the plant parts and the claim wording before formulation is locked, and record the decision. For more on specification, testing and stability, see our herbal product development Q&A.

For brands & formulators

Food Research Lab’s regulatory and scientific research team can review a herbal product’s intended use, ingredients, plant parts and draft claims against the ASU, FSSAI nutraceutical and Ayurveda Aahara routes, and set out the licence and label requirements for the route you choose.

Our herbal formulation development team can then build the product to fit that route, from extract selection to pilot batches. See also our herbal product development sector page, or contact us with your brief.

In this series

• Herbal product development process: the pillar guide: seven stages from claim to launch.
• AYUSH licence vs FSSAI (this page): You are here.
• Standardised extract, HPLC and DNA testing: how to prove identity and strength.
• The ashwagandha stress study (Lopresti 2019) explained: what one trial does and does not support.
• Ashwagandha capsule development: a worked example: one product from brief to stability-ready specification.
• Private-label herbal supplements in India: stock formulas versus your own.
• Herbal product development in India: 10 questions: short answers on extracts, testing, stability and regulation.
• Herbal formulation development service: work with our team on your product.

1. Koe, T. (2024, May 1). AYUSH products should not claim nutraceutical value – Indian authorities. NutraIngredients. https://www.nutraingredients.com/Article/2024/05/01/ayush-products-should-not-claim-nutraceutical-value-says-indian-regulator (cited for the Ministry of Ayush notice of 18 April 2024: Ayush products and nutraceuticals regulated by different laws, no nutraceutical-value claims, the Ministry does not grant manufacturing licences or approvals, “approved by the Ministry” claims incorrect, Drugs and Magic Remedies Act for advertising).
2. Ministry of Health and Family Welfare, Central Drugs Standard Control Organisation. (2016). The Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945 [as amended up to 2016]. https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf (cited for Rules 152 (state licensing authorities), 153 (Form 24-D), 153A (loan licence), 154 (Form 25-D, expert consultation), 157 (Schedule T, GMP certificate in Form 26 E-I) and 161 (labelling with botanical names and plant parts)).
3. Directorate of AYUSH, Government of NCT of Delhi. (n.d.). Requirements for issuing a new license/renewal of license. https://ayush.delhi.gov.in/ayush/requirements-issuing-new-license-renewal-license (cited as an example of a state authority’s forms and checklists for ASU manufacturing and loan licences).
4. Food Safety and Standards Authority of India. (2021). Compendium: Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016 (Version I, 29 September 2021). https://fssai.gov.in/upload/uploadfiles/files/Compendium_Nutra_29_09_2021.pdf (cited for the notified 2016 text and the “NOT FOR MEDICINAL USE” statement).
5. Food Safety and Standards Authority of India. (2022). Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, and Prebiotic and Probiotic Food) Regulations, 2022 [Draft text operationalised by direction]. https://fssai.gov.in/upload/uploadfiles/files/Direction_New_compressed.pdf (cited for the five categories and application by direction from 1 April 2022).
6. Food Safety and Standards Authority of India. (2022, March 31). SOP for mandatory modification of old methodology licence or migration of state licence for manufacturing of nutraceuticals and related products w.e.f. 01.04.2022 (encloses the September 2020 order on central licensing). https://fssai.gov.in/upload/advisories/2022/03/624561f927c4aSOP_License_Nutra_31_03_2022.pdf (cited for central licensing of nutraceutical manufacturers regardless of turnover).
7. Takle, S. P., & Mahajan, U. (2026). Regulatory landscape of nutraceuticals in India: Current status, challenges, and a roadmap for harmonization. International Journal of Pharmaceutical Sciences, 4(5), 4880–4890. https://doi.org/10.5281/zenodo.20284587 (cited for therapeutic claims reclassifying a product as a drug, unclear food–drug boundaries, the 2018 Advertising and Claims and 2020 Labelling and Display Regulations, central licensing, the Drugs and Magic Remedies Act, and state drug inspectors in borderline cases).
8. Press Information Bureau, Government of India. (2022, July 29). Ayurvedic Aahar products [Press release, Ministry of Ayush]. https://pib.gov.in/PressReleasePage.aspx?PRID=1846185 (cited for the Ayurveda Aahara Regulations, 2022: notification on 5 May 2022, Schedule A scope, exclusions, “AYURVEDA AAHARA”, logo and “ONLY FOR DIETARY USE”).
9. Food Safety and Standards Authority of India. (2026, April 16). Advisory regarding non-use of Ashwagandha (Withania somnifera) leaves in crude or extract or any other form in food products (F. No. RCD-15001/11/2021-Regulatory-FSSAI; encloses Ministry of Ayush letter T-13020/4/2022-DCC-Part(2) of 15 April 2026). https://fssai.gov.in/upload/advisories/2026/04/69e0d84fcac2fAdvisory%20on%20non%20use%20of%20ashwagandha%20leaves%20in%20crude%20or%20extract%20or%20any%20other%20form%20in%20food%20products-%20reg.pdf (cited for Schedule IV permitting only ashwagandha roots and their extracts, leaves not permitted, and the Ayush letter: roots only in Ayush products, Rule 161 plant-part labelling, stated safety concerns about leaves).
10. LiveLaw. (2026, May 19). Karnataka High Court stays FSSAI advisory restricting use of ashwagandha leaves in health supplements. https://www.livelaw.in/high-court/karnataka-high-court/karnataka-high-court-stays-centre-advisory-ashwagandha-leaves-nutraceuticals-534813 (cited for the interim stay limited to the petitioners in W.P. Nos. 14990/2026 and 15010/2026 and the next hearing on 8 June 2026).