Ayush explained: this guide covers what it means, who it applies to, the step-by-step process, documents required, fees, due dates and penalties in India — so you can stay compliant with confidence and avoid costly mistakes.
Principles 4 to 6 of the Ayush Guidelines cover three situations: claims to a specific range of known ingredients, claims that pick one ingredient out of a known multi-ingredient formulation, and claims to a device for a known Ayush procedure. The Guidelines then annex a note on synergism, with three illustrations of how data shows it, and list the databases examiners use. This article explains each in plain terms; principles 1 to 3 are in the previous article.
The Guidelines are the Patent Office's guidance and do not have the force of law; the Patents Act, 1970 and the Patents Rules, 2003 as now in force prevail. The Office revises its guidelines, so check the current version on ipindia.gov.in.
Selecting an optimum range of known ingredients is generally treated as within the skilled person's expectation, so it is inventive only if not obvious. Picking one ingredient from a known multi-ingredient formulation for the same activity is not inventive. A device for a known Ayush procedure may be patentable if it meets the ordinary criteria. Synergy is proved with comparative data on each ingredient alone and in combination.
Principle 4: optimum or workable range
The Guidelines say that finding the optimum or workable range of traditionally known ingredients by routine experimentation is inventive only if it is not obvious to the person skilled in the art, and that choosing a particular range is generally well within that person's expectation. In the Guidelines' illustration, a formulation of several plant extracts in stated percentage ranges, for ulcers and wounds, is objected to as obvious over a traditional text that taught a composition of two of the plants as a topical oil. Although the text did not give the claimed percentages, the amount of an ingredient is described as a result-affecting variable that a skilled person would routinely optimise.
For applicants the lesson is that a range claim needs more than a range. Show why the particular range matters, for example a threshold at which the effect changes in a way the prior art would not predict, and put the comparative data in the specification.
If your formulation claims depend on percentages or ratios, our patent objection reply service can help build the evidence and the amended claim set.
Principle 5: selecting one ingredient from a known formulation
Where a multi-ingredient formulation is known to have a specific therapeutic activity, the Guidelines say that merely selecting one or more of its ingredients for the same activity is not inventive. In the illustration, a claim to an extract of a single ginger species for inflammation and asthma is objected to because a traditional formulation containing that plant, with a few others, was already used for the same conditions. It is obvious, the Guidelines reason, that one component taken out of the formulation has the same activity, so the skilled person would be motivated to arrive at the claim.
The answer lies in showing something the formulation did not teach: a new activity, a materially better result than the formulation or a technical effect of isolation that could not be expected. Without it, the selection is treated as obvious.
Principle 6: devices for known Ayush procedures
The Guidelines say that an invention in equipment or a device used for a known procedure in Ayush systems or related fields may be patentable if its claims satisfy the criteria of the Act. In the illustration, an automated device for a classical therapeutic emesis procedure, with sensors for acidity, temperature, weight and volume, a display and a collection bag, together with its method of making, is treated as patentable. The procedure itself is documented in Ayurveda, but a sensor-equipped automated device for carrying it out was not known.
This is the clearest route for Ayush innovation that is not a formulation: the procedure is old, but the engineering is new. The specification should describe the technical problem, the sensing and control features and what they achieve, in the language of an ordinary engineering claim.
The annexed note on synergism
The Guidelines annex a brief on synergism. It links the idea to section 3(e): to decide whether a composition is a mere admixture, the examiner asks whether the composition has an effect greater than the combined effect of each component used alone. It quotes the 2014 Pharmaceutical Guidelines for the idea that a combined technical effect greater than the sum of the individual effects shows more than a mere aggregation.
Three illustrations follow, each built on a comparison table in the specification, which we describe without the figures. In the first, a polysaccharide with a plant extract stimulated an antimicrobial peptide response far beyond the sum of the two used alone. In the second, two plant extracts used together produced healing of ulcers many times higher than the sum of their separate effects. In the third, two extracts for a neurodegenerative condition gave a milder clinical course together than either did alone, which the Guidelines read as synergy. A common feature is the design: a control, each ingredient alone, and the combination, with statistical significance given.
The databases examiners search
An annexure lists databases and legal texts for Ayush and traditional knowledge searches. They include the Ayush research portal, the database of Ayurvedic, Unani, Siddha and Sowa-Rigpa formulations, a medicinal plants database from FRLHT, the e-Charak portal, and a tribal digital document repository, along with the Biological Diversity (Amendment) Act, 2023, the Patents Act and the Patents Rules. A drafter should search the same sources before filing. The Guidelines close with a disclaimer that they are not exhaustive, each application is decided on merit, and they may be revised in the light of court rulings and amendments. The pages that follow show granted patents, and a brief on a poly-herbal drug developed by the Central Council for Research in Ayurvedic Sciences, as examples of Ayush innovation.
What the examiner checks, what you show
| What the examiner asks | What the applicant shows | Principle |
|---|---|---|
| Is the range just routine optimisation? | A critical range with data and a surprising effect | 4 |
| Is one ingredient simply lifted from a known formulation? | A new use, a better result or an unexpected effect | 5 |
| Is the device only the old procedure in a new form? | Technical features and a technical problem solved | 6 |
| Is the composition a mere admixture? | Control, single-ingredient and combination data | Annexure on synergism |
| Have the Ayush databases been searched? | Distinction over what they disclose | Databases list |
A worked example
Prakriti Devices Pvt Ltd files two applications. The first claims an automated herbal steam therapy cabinet with temperature and humidity sensing, tied to a known Ayush steam procedure; the examiner accepts it as device-based and moves to the usual tests. The second claims a three-extract paste in a stated percentage range. The examiner objects on optimisation, since a text discloses two of the extracts. Prakriti's reply adds data at several percentages showing the effect changes sharply above a threshold, and files a control, single extract and combination table.
Common lapses
- Filing a range claim without evidence for why that range matters.
- Taking one ingredient from a known formulation and claiming it as new.
- Describing a device by the traditional procedure it performs, not by its technical features.
- Claiming synergy without a control and each ingredient alone.
- Skipping the Ayush databases in the pre-filing search.
Need help with a herbal composition or Ayush device?
Replies in this area rely on well-designed data and precise claims. If you are preparing or answering an Ayush application, see our patent objection reply service for support on the evidence and the amended claims.
Key takeaways
- Range claims need proof that the range is not routine optimisation.
- Selecting one ingredient from a known formulation is not inventive on its own.
- Devices for known Ayush procedures can be patentable on ordinary criteria.
- Synergy is shown by control, single-ingredient and combination data.
- Search the Ayush and traditional knowledge databases before filing.
Read next
- Ayush Guidelines 2025: scope, provisions and filing
- Ayush Guidelines 2025: guiding principles 1 to 3
- TK Guidelines 2012: novelty and inventive step, the six principles
- Section 3 exclusions: what cannot be patented
Disclaimer: Based on the manuals and guidelines published by the Office of the Controller General of Patents, Designs and Trade Marks that are named in the article, as consulted on 4 October 2026. They are guidance and do not have the force of law; the Patents Act, 1970 and the Patents Rules, 2003 as amended (including the 2024 amendment rules) prevail, and the current versions on ipindia.gov.in should be checked. This article is general information, not legal advice; check the official text before acting.