The Ayurvedic Pharmacopoeia of India (Volume VI, Part I)

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The first and second part of the Ayurvedic Formulary of India comprising of 444 and 191 formulations respectively cover more than 351 single drugs of plant origin. This is part of nearly 500 priority single drugs of plant origin to come with in the ambit of the Ayurvedic Pharmacopoeia of India. The Ayurvedic Pharmacopoeia of India, Part-I, Vol-I, Vol-II, Vol III, Vol IV and V comprises 80, 78, 100, 68 and 72 monographs of Ayurvedic single drugs of plant origin which go into one or more formulations included in the Ayurvedic Formulary of India, Part-I and Part-Il. As a continuing activity monographs on 96 single drugs of plant origin and four monographs each on Guda (Jaggery), Goghrta (Clarified Cow's Butter), Jala (Potable water), Madhu (Honey) and Sarkara (Sugar) used as Vehicle or adjuvant, making compilation of Vol VI of the Ayurvedic Pharmacopoeia of India Part-I comprising of these 101 monographs. In compiling the monograph, each monograph bears the title of the drug in Sanskrit as given in Ayurvedic Formulary of India. This is followed by definition of the drug giving botanical identity by using scientific binomial nomenclature with authority and very brief information about its source, occurrence, distribution and precautions to be taken during collection, if any. List of synonyms in Sanskrit and also in other Indian regional languages. The monograph further records macroscopic and microscopic description of the drug highlighting diagnostic features for identification and authentication even if the drug is in powdered state. The monograph further gives under Identity, Purity and Strength, certain physico chemical parameters such as limits of foreign matter, moisture content, total ash, acid insoluble ash, alcohol soluble extractive, water soluble extractive, volatile content (if any) followed by thin layer chromatographic fingerprint profile. Wherever feasible, an Assay of active/marker chemical constituent or a group of chemical constituents such as total alkaloids or volatile oil etc have been given. There is always range of variations in data on chemical constituents and certain physico chemical parameters due to geographical, climatic and ontogenetic variability. Therefore, variations in results of such data pose difficulty in fixing narrow range. The data has been given on the basis of average results of 3 samples from different laboratories. Under the constituents major chemical constituents as reported in the literature have been given.

Under each monograph, classical attributes of each drug according to the doctrine of Rasa, Guna, Virya, Vipaka and Karma have been kept intact. These are considered a reasonable basis and convenient reference point for a clinical classification. Such parameters are not possible to measures by modern scientific methods thus not mandatory.

The legal notices and general notices have been provided for pharmaceutical and regulatory purposes. The Appendices include details of the apparatus, reagents, chemicals, and solution tests, methods of preparation of samples for microscopic or chromatographic examination.

The committee hopes that the publication of Ayurvedic Pharmacopoeia of India, Part- I Vol-VI containing 101 monographs would add to the requirements under the Drugs and Cosmetic Act. The regular monitoring of the manufactured and marketed Ayurvedic drugs, on the basis of the standards prescribed here in would bear evidence of the usefulness of these volumes and help ensure their quality and status revision for the future.

The Committee urges the Government of India to recommend the adoption of these monographs for the purposes of identity, purity and strength of drugs for use in their Government, Semi-Government and Government aided institutions and voluntary public organizations. The Ayurvedic Pharmacopoeia of India, Part-I, Vol. VI, 2008 would be added to Rule 168 of the Drugs and Cosmetics Act and be notified by Government as standards to be complied with by the manufacturers for sale or distribution of Ayurvedic drugs. Ayurvedic Pharmacopoeia of India, Part-I, Vol. I, 11, Ill, IV and V are already included in the First Schedule of Drugs & Cosmetics act 1940.

The Ayurvedic system of medicine has been prevalent in India since the Vedic period, and still remains the mainstay of medical relief to over 60 per cent of the population of the nation. In earlier times the practitioners of Ayurveda (Vaidya) were themselves collecting herbs and other ingredients and preparing medicines. For the purpose of acquiring raw materials Vaidyas now depend on commercial organizations trading in crude herbal drugs. Likewise, with passage of time a number of Ayurvedic Pharmaceutical units have come up for the manufacture of Ayurvedic drugs and formulations on commercial scale.

Under the circumstances and responding to opinions of the scientific community after independence, the Govt. of India began a series of measures to introduce a quality control system, from 1964 onwards similar to that existing already under the Drugs and Cosmetics Act, 1940, for western medicine. The Government of India introduced an amendment in 196 to the Drug and Cosmetics Act 1940, to control to a limited measure the Ayurvedic, Siddha and Unani drugs.

The Act was accordingly amended in 1964, to ensure only a limited control over the production and sale of Ayurvedic medicines namely:-

i. The manufacture should be carried out under prescribed hygienic conditions, under the supervision of a person having prescribed qualifications;

ii. The raw materials used in the preparation of drugs should be genuine and properly identified; and

iii. The formula or the true list of all the ingredients contained in the drugs should be displayed on the label of every container.

To start with, development of standards for the identity, purity and strength of single drugs and those of formulations at a later stage, assumed importance for the effective enforcement of the provision of the Act. If the raw materials to be used in a medicine and stage-by-stage processes of manufacturers are standardised, the final product namely, the compound formulation could be expected to conform to uniform standards. The requirement that the list of ingredients be displayed on the label will enable analysts to verify label claims. It will also ensure that the manufacture do not make false claim. Arrangements to evolve and lay down physical, chemical and biological standards, wherever even necessary, to identify the drugs and ascertain their quality and to detect adulterations are an urgent necessity of the profession. Setting up of Drug Standardisation Units, Research Centres, Drug resting Institutes and Central Drug Laboratories for Ayurvedic Medicines both at national and regional level for this purpose are therefore, essential. The several Committees appointed by the Government of India to assess and evaluate the status and practice of Ayurvedic Medicine have stressed the importance of preparing an Ayurvedic Pharmacopoeia, which is precisely a book of standards.