# What the formulary fixes, and what it leaves to the manufacturer

> Classical Ayurvedic preparations have an official composition in the Ayurvedic Formulary of India, whose Part I is in the First Schedule of the Drugs and Cosmetics Act. It binds the ingredients, their plant parts and their proportions, and fixes the dosage form. It sets no assays and no marker or heavy-metal limits, so two products that both follow it can still differ in strength and purity.

A classical preparation is not a brand's recipe. It is a formula from a classical text, and
in India the [Ayurvedic Formulary of India](https://archive.org/details/b32232184) selects
those formulas and states each one officially. It is not merely a reference book: its Part I
was included in the First Schedule of the Drugs and Cosmetics Act, 1940, which gives it legal
standing.

Where this site publishes a composition, it is that official one, transcribed and checked
row by row against the book. Where the scan is too damaged to read a cell, that cell says illegible
rather than being guessed at: of 1,452 published rows, 176 have at least one such cell.

## What the formulary binds

**The ingredients, their parts and their proportions.**
[Triphala Curna](/nighantu/formulation/triphala-churna/), entry 7:15, is three drugs and no
others: Pathya (haritaki), Bibhita (bibhitaka) and Dhatri (amalaki), each one part, each the
pericarp, the fruit wall rather than the seed.
[Trikatu Curna](/nighantu/formulation/trikatu-churna/), entry 7:14, is Pippali and Marica
fruits with Sunthi rhizome, equal parts. Others are not equal: Abhayarista, entry 1:1, takes
Abhaya at 4.800 kg against Svadamstra and nine other drugs at 96 g.

**The dosage form.** Each group opens with a definition. A curna is "a fine powder of drug
or drugs", passed through at least an 80 mesh sieve and kept in airtight containers. A
product selling a concentrated extract under a curna name has departed from the entry
rather than used a latitude it grants.

The *method* is a different matter, and the formulary says so itself: each group gives a
general method, but "irrespective of the method of preparation, the resulting substances
must comply with Formulary requirements". A manufacturer may use another method and often
does; what it may not do is change what the preparation is.

**Deviation, where the entry is claimed.** The formulary's Legal Notice is explicit: a
manufacturer may prepare medicines on the basis of other formulae, but "should the medicines
be prepared according to the reference mentioned in the formulary, deviation in the details
of the ingredients or their quantities is not permissible". Substitutes are allowed only
where the texts or the formulary name them.

**Botanical identity.** The second edition added authentic botanical names for the single
drugs, including the cases where more than one species is accepted, which is a subject of
its own: see [why one herb has several botanical names](/nighantu/choosing/one-herb-several-names/).

Each entry also states a dose and its therapeutic indications, and many add an anupana.
This site publishes the composition and not those, deliberately.

## What it leaves to the manufacturer

- **Assay and standardisation.** There are no marker limits, no assay methods and no
  heavy-metal limits in the formulary. The 1978 preface says so plainly: the committee was
  not able to recommend standards.
- **Sourcing.** The formulary's own introduction notes that the same plant has varying
  properties depending on region and climate. Which permitted species a batch used, and
  where it was grown, the label need not say.
- **Testing.** The formulary requires crude drugs to be free of foreign matter and
  deterioration, and puts the duty on the pharmacy to satisfy itself of identity and
  purity. Whether anything was analytically tested, and for what, is the manufacturer's to
  publish or not.

## How to read a label against it

1. **Find the entry.** Each composition page here gives the part and entry number, and the
   classical text the formulary cites for it.
2. **Compare the ingredient list.** Extra or missing actives mean the product is not that
   entry, whatever the name says.
3. **Check the parts** for the plant drugs. "Amla" is not specific; entry 7:15 asks for the
   pericarp.
4. **Compare quantities for the dry forms.** Churnas, kwatha curnas, vatis and gugguls are
   weighed and mixed, so the entry's proportions are the product's. For tailas, ghritas,
   avalehas and asavas the formulary's figures are what goes into the pan rather than what
   is in the bottle: Abhayarista's 49.152 litres of decoction water are reduced to 12.288
   during manufacture, and a taila's juices and milks evaporate off entirely. Note that a
   ready-made liquid kashayam is a different product from the formulary's kvatha curna,
   which is a coarse powder.
5. **Ask about testing separately.** Nothing in the formulary answers it.

## What this site can and cannot tell you

It can tell you what the official composition is, which classical text the formulary cites,
and where the botanical identity of an ingredient is disputed. It cannot tell you whether a
particular product matches its label, because that is a question about a batch, answerable
only by testing it.

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Canonical version of this page: https://nighantu.ageayurveda.com/choosing/reading-a-formulation-label/

Published by Age Ayurveda in the Nighantu. Educational reference only, not medical advice.
Incorporates material from the Amidha Ayurveda Herb Database under CC BY 4.0.