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

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Awareness on Quality Standards of Ayurvedic Medicine is increasing with the demand for these products. The growth and acceptability of these medicines depend upon the compliance with the quality standards and in process quality assurance in the manufacture of these medicines. Therefore, it is essential to have scientific standards for identity, purity and strength of these medicines. Government of India appreciated the need for developing Pharmacopoeial Standards of Ayurveda, Siddha & Unani medicines and established the Pharmacopoeial Laboratory of Indian Medicines (PLIM) at Ghaziabad in the year 1970 to undertake pharmacopoeial work on Ayurvedic, Siddha & Unani medicines. The scientific work of PLIM is guided and monitored by the Ayurvedic Pharmacopoeia Committee (APC). The APC comprises of experts in Ayurveda, Pharmacognosy, Phyto-Chemistry, Pharmaceuticals Sciences and Ayurvedic Pharmacy who constantly scrutinize the scientific data generated by PLIM and other Laboratories on Pharmacopoeial work. Quality standardization of natural products is a complex task, therefore, 20 other laboratories of the Council of Scientific & Industrial (CCRAS) and other eminent Laboratories & Universities have been associated with the work of development of the Pharmacopoeial Standards under the APC Scheme of the Department of Ayush. The scientific work of various laboratories is regularly monitored by subject experts of the Ayurvedic Pharmacopoeia Committee.

This Sixth volume of the Ayurvedic Pharmacopoeia of India containing 101 monographs of single drugs is a result of hard work of experts of Pharmacopoeia Committee, scientists working in PLIM, CCRAS and other laboratories associated with the APC Scheme. I place on record my appreciation for the dedication and hard work put by the officers of the dedication and hard work put by the officers of the Department of Ayush, PLIM, CCRAS and experts associated with the APC in the publication of this Volume. I hope that the Drug Testing Laboratories, in-house Quality Control Labs of Manufacturing units, teaching and R&D institutions will be highly benefited with this publication and their suggestions and feedback will be welcome for updation of APC Volumes.

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-II. As a continuing activity monographs on 96 single drugs of plant origin and four monographs each on Gupta (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 the 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/maker 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, 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 evidences 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 the manufacturers for sale or distribution of Ayurvedic drugs Ayurvedic Pharmacopoeia of India, Part-I, Vol. I, II, III, IV and V are already included in the First Schedule of Drugs & Cosmetics act 1940.