India Playbook

Ayurvedic Products Online: Three Licences, One Call

An Ayurvedic brand is not an FSSAI brand. Ayurvedic, Siddha and Unani medicines are licensed by state licensing authorities under their own chapter of the Drugs and Cosmetics Act, and the licence you hold decides the label you print.

Key takeaways
  • Ayurvedic, Siddha and Unani medicines are licensed by state licensing authorities under Chapter IVA of the Drugs and Cosmetics Act, 1940. FSSAI does not license them, and homoeopathy runs on separate rules again.
  • Section 3(a) and section 3(h)(i) split the category into classical book formulations and proprietary medicines. One ingredient outside the First Schedule books takes the product out of the definition entirely.
  • Ayurveda Aahara is a genuine food route with a live FSSAI licensing window since September 2025, but it expressly excludes Ayurvedic drugs and proprietary Ayurvedic medicines.
  • Pick the door before artwork sign-off, because the manufacturing licence number printed on the pack ties the product to one named licence and one named site.

A brand with an ashwagandha capsule, a chyawanprash and a pain balm is often selling three products under three different laws. Nothing on the shelf says so.

Where a product sits on the food side of that line is handled separately, in nutraceutical versus food supplement classification. This post starts on the far side, where the answer came back Ayurvedic and the regulator is no longer FSSAI.

A different statute, and a different desk

Ayurvedic, Siddha and Unani medicines are licensed under the Drugs and Cosmetics Act, 1940, which gives them a chapter of their own. Chapter IVA, sections 33B to 33-O, is headed Provisions relating to Ayurvedic, Siddha and Unani drugs. Section 33EEC(c) says no person shall manufacture for sale or for distribution any such drug except under, and in accordance with the conditions of, a licence issued under that chapter by the prescribed authority. That authority is a state licensing authority, not FSSAI.

Homoeopathy is spoken of in the same breath as AYUSH, and for licensing it is not in the same place. Chapter IVA covers Ayurvedic, Siddha and Unani only. Homoeopathic medicines run on their own rules, with the application in Form 24-C and the licence in Form 25-C. A portfolio spanning both is two files.

Classical formula or proprietary medicine

Section 3(a) defines an Ayurvedic, Siddha or Unani drug as one manufactured exclusively in accordance with the formulae described in the authoritative books of those systems specified in the First Schedule to the Act. Section 3(h)(i) defines a patent or proprietary medicine for the same systems as a formulation containing only ingredients mentioned in those book formulae, but which is not itself one of the book formulations.

That is the classification, in two clauses. Make a classical preparation to the text and you are making a book drug. Build your own combination from ingredients the texts name and you are making a proprietary medicine. Both are drugs. Rule 158-B of the Drugs and Cosmetics Rules, 1945 provides for proof of safety and effectiveness for certain categories, and a proprietary formulation is where that lands hardest.

Bring in one ingredient the First Schedule books do not name and you have stepped outside the definition entirely.

Own licence or loan licence

The manufacturing route sits in rules 153 to 157. The application is made in Form 24-D, the licence issues in Form 25-D, and rule 154 gives the authority three months from the date the application is received. Rule 157 sets the conditions: manufacture in premises and hygienic conditions specified in Schedule T, the Good Manufacturing Practices standard for these medicines, under the direction of at least one whole-time technical staff member holding a degree in Ayurveda, Ayurvedic Pharmacy, Siddha or Unani.

With no plant of your own, rule 153-A gives you a loan licence, issued in Form 25-E, for an applicant who has no manufacturing arrangements but intends to use the facilities of a Form 25-D licensee. The authority must first satisfy itself the host unit has adequate equipment, staff, capacity and testing facilities.

The commercial consequence is easy to miss. A loan licence is tied to a named site, and the pack carries a manufacturing licence number belonging to that arrangement. Moving production is a licence event and an artwork event at once, which is heavier than changing a co-packer on a food product.

Ayurveda Aahara is a real food door

Not every Ayurvedic recipe has to be a drug. FSSAI notified the Food Safety and Standards (Ayurveda Aahara) Regulations, 2022, covering food prepared in accordance with recipes, ingredients or processes described in the authoritative books of Ayurveda listed in Schedule A to those regulations. The Ministry of Ayush was explicit about the exclusions: Ayurveda Aahara does not include Ayurvedic drugs or proprietary Ayurvedic medicines and medicinal products, cosmetics, narcotic or psychotropic substances, or herbs.

The route stopped being theoretical in 2025. FSSAI issued an order dated 25 July 2025, in consultation with the Ministry of Ayush, listing the Ayurveda Aahara covered under category A. On 25 September 2025 the government announced a dedicated Kind of Business for Ayurveda Aahara on the FoSCoS portal, referring to 91 approved recipes in that July order. If the product is a food in substance, there is now a window to apply at.

A herbal cream sold to cleanse or beautify is a third thing again, a cosmetic, under the Cosmetics Rules, 2020 which commenced on 15 December 2020. The application goes to the state licensing authority in Form COS-5, with Form COS-6 for a loan licence, and the licence issues in Form COS-8 or Form COS-9. Three doors, three files, three label regimes. The composition and the claim pick the door.

What a catalogue reviewer can see

Rule 161 sets out what has to appear on the innermost container of an Ayurvedic, Siddha or Unani drug: the name of the drug as it appears in the First Schedule books, a correct statement of net content, the name and address of the manufacturer, the manufacturing licence number preceded by the words Manufacturing Licence Number or Mfg. Lic. No. or M.L., a distinctive batch number, the date of manufacture, the words Ayurvedic medicine or Siddha medicine or Unani medicine as the case may be, and FOR EXTERNAL USE ONLY where that applies. Rule 161(1) separately requires the true list of all ingredients with the quantity of each.

That licence number is the one field a reviewer can check against the licence copy you upload, so the two must agree before artwork goes to print. The platform has a sharper interest than document hygiene, because section 33EEC(b) prohibits selling, stocking, exhibiting or offering for sale any such drug manufactured in contravention of the Act or its rules. The seller sits inside the offence, not beside it. How listings get gated and pulled is covered in selling supplements on marketplaces.

The wellness trap

The trap is a product sold as a wellness item that is in substance an Ayurvedic medicine. It happens by drift. The formulation follows a classical text because that is what the founder knows, the licence taken is the easier one, and then the marketing describes what the formulation does. That description is a therapeutic claim.

At that point the brand is manufacturing an Ayurvedic drug without an Ayurvedic drug licence, and the pack is missing every particular rule 161 requires. The fix costs a conversation while the formula is still soft and a production run once it is not. Decide the door before artwork sign-off.

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FAQ

Quick answers.

Only if the product is a food. FSSAI licenses food, including the Ayurveda Aahara category created by the Food Safety and Standards (Ayurveda Aahara) Regulations, 2022. It does not license Ayurvedic, Siddha or Unani drugs, which are licensed by state licensing authorities under Chapter IVA of the Drugs and Cosmetics Act, 1940. A product carrying only an FSSAI licence while making therapeutic claims is not covered by that licence.
Yes, through a loan licence under rule 153-A of the Drugs and Cosmetics Rules, 1945, issued in Form 25-E. It is meant for an applicant who has no manufacturing arrangements of his own and intends to use the facilities of a Form 25-D licensee. The licensing authority has to satisfy itself first that the host unit has adequate equipment, staff, capacity and testing facilities.
The licensing route is the same chapter and the same rules. The differences show up in which First Schedule book the formula comes from and in the wording rule 161 requires on the label, which is Ayurvedic medicine, Siddha medicine or Unani medicine as the case may be.
Outside Chapter IVA. Homoeopathic medicines are licensed under their own set of rules, with the application in Form 24-C and the licence in Form 25-C. Treating AYUSH as a single licensing track is a common filing mistake in a mixed portfolio.

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