The Homeopathic Pharmacopeia of India
By Eric L. Foxman
A quick look at its structure and contents, as well as the potential for adulteration and misbranding in the U.S. market.
Structure
The Homeopathic Pharmacopeia of India (HPI) is published by the Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy (AYUSH). The Ministry is responsible for developing education and research in these fields of alternative medicines. The Ministry’s work in homeopathy is the most established branch as it goes back to the precursor agency, the Department of Indian System of Medicine and Homeopathy, founded in 1995.
The Ministry is active in creating Memorandums of Understanding (MOU) with various international organizations and other national regulatory bodies. Of the 30 MOUs signed with other countries and organizations, the MOU with the HPCUS is the most significant and advanced in terms of actual work, accomplishments, tangible benefits, and potential future collaborative work.
The HPI has been published in a series of 10 volumes from 1971 to 2013. An 11th volume is in preparation and is expected to be published soon.
Year of Publication | No. of Monographs | |
Volume I | 1971 | 180 |
Volume II | 1974 (Rev1982) | 100 |
Volume III | 1978 | 105 |
Volume IV | 1984 | 107 |
Volume V | 1987 | 114 |
Year of Publication | No. of Monographs | |
Volume VI | 1990 | 104 |
Volume VII | 1999 | 105 |
Volume VIII | 2000 | 101 |
Volume IX | 2006 | 100 |
Volume X | 2013 | 101 |
Volumes I–V were “revised and augmented” in a combined edition, as were Volumes VI–IX. Both combined editions were published in 2016. Each volume contains a subset of the HPIs approved monographs; some monographs are revisions of those in earlier volumes. Because of these revisions, there are 940 different monographed substances out of the 1,117 monographs.
Contents
The early volumes’ monographs look very similar to those that appeared in the HPUS Seventh Edition (1964) and Eighth Edition (1978):
- These monographs include synonyms, descriptions (often including extensive microscopic details), habitat information, and the part of plant used. Almost every monograph includes a short list of selected references in which the substance’s homeopathic therapeutic information appears.
- Botanical monographs include a “recipe” for preparing the tincture; these “recipes” are duplicates of the older HPUS formulae. Many are based upon a stated quantity of dried, pulverized botanical material. When fresh plants are specified, the formula is based upon an ‘ideal” composition: the stated weight of plant matter contains exactly 100 grams of plant solids (see below for a caution in this regard).
- Some of the chemical monographs include identification tests, assays, and a few limit tests.
- Use of the “combined editions” is extremely important as there are cross-references to revised monographs that correct critical errors in the original monographs.
Later volumes have the same general monograph format. Increasingly, botanical monographs have “wet chemistry” or thin layer chromatography tests and results; these tend to be simplistic and are often performed in the absence of a reference substance.
However, chapters at the end of Volumes VI and VIII have QC tests for many substances that appeared in earlier volumes. Unless one has familiarity with the entire HPI, it is easy to miss this additional essential information. Later volumes also include test method descriptions that might be helpful to companies looking for a starting place to create inhouse quality control tests for substances that do not have that information in any of the pharmacopeias reviewed to date. [1] A partial list of test methods described in the HPI follows the text below; be aware that some of these methods were developed 30 to 40 years ago and might be considered obsolete in a contemporary laboratory setting.
The HPI does not include information on first safe attenuation for marketing or dispensing. The permissible alcohol content of botanical tinctures in the HPI may be different than that allowed in the HPUS; users of the HPI need to cross check what is permitted in the HPUS for use of HPI tinctures in the United States or any other country that uses the HPUS as its legal reference.
[1] The Homeopathic Pharmacopeia of the United States, The German Homeopathic Pharmacopeia, The French Pharmacopeia, The European Pharmacopeia, the British Homeopathic Pharmacopeia. Links accessible by Members only.
Crucial Issues for U.S. Companies
As noted above, numerous early monographs have critical errors and must be read carefully to ascertain the validity of the information presented. Use of the combined editions is somewhat helpful, as the combined editions note monographs that have been revised. However, to date, not all revisions and corrections have been completed and published.
Many monographs in the HPUS and the HPI are the same but have somewhat different names. It is important to search the HPI carefully for possible synonyms if one cannot locate an HPUS monographed substance in the HPI.
More critically, there are monographs in the HPUS and the HPI that have the same name, but a careful reading of the descriptions reveals the monographs are for different substances (different part of plant or different chemical salts). These differences are not identified in the name of the monographs. It is crucial to check with a vendor that uses the HPI as their legal reference compendium in order to determine what has been used and to compare that information with the HPUS. If a foreign supplier uses a different plant part than specified in the HPUS, the product will be considered adulterated and misbranded when sold in the United States. This is the first of two critical issues that may require access to, or understanding of, the HPI.
A more complex issue: the HPI ratios (plant/water/ethanol) for making botanical tinctures are based on ratios the HPUS abandoned more than 30 years ago. The HPUS now requires the moisture content of fresh botanical material to be accurately measured, and that percentage is factored into the calculation of water and ethanol to be utilized.
The HPI assumes an unvarying amount of plant moisture irrespective of growth and harvest circumstances. Those who work with botanical substances are aware that the HPI method is unreliable in its dictation of set and predetermined plant moisture content. The two methods are similar, but not necessarily interchangeable. Any botanical tincture prepared according to an HPI monograph needs to be individually evaluated for compliance with the HPUS as it might be adulterated and misbranded when sold in the United States.
Availability
Because the Homeopathic Pharmacopeia of India is a government publication of the Ministry of AYUSH, most of it is currently available via free download. Volumes I through IX, as the combined Editions noted above, can be download at this webpage. Volume X is only available in hard copy and can be obtained here or here. The official language of the HPI is English, so no translation is necessary.
Partial List of Test Methods Described in Various Volumes of the Homeopathic Pharmacopeia of India
Determination of Melting Range or Boiling Range
Determination of Refractive Index
Determination of Specific Gravity
Qualitative Reactions of Some Common Substances and Radicals
Determination of Ash, Sulphated Ash, Ignition Residue, or Water-Soluble Ash
Moisture-Content determination for chemicals or vegetable products
Determination of Saponification Value, Iodine Value, Acid Value, Esters or Ester Value
Test for the Absence of certain adulterant oils in other Oils
Identification tests for specific ions based on chemical reactions.
Determination of Optical Rotation, Specific Rotation, or Light Absorption
Qualitative Reactions of Some Common Substances and Radicals
Determination of Viscosity
Test for Pyrogens
Chromatography