The Ayurvedic Pharmacopoeia of India: Formulations First Edition (Part-2, Volume-4)

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Owing to diverse method of manufacturing described for the Ayurvedic formulations in different classical text of Ayurveda and inadequate adherence to quality parameters and in-house Standard Operating Procedures (SOPs) the variability in the quality of the same classical Ayurvedic formulation produced by different manufacturers is frequently observed. An effort has been made now to optimize and develop SOP's in order to ensure that such differences in quality of the same product produced by different manufacturers are as per permissible limits.
The three volumes of the Ayurvedic Pharmacopoeia of India, Part-Il published in 2007, 2008 and 2010, respectively comprise official standards for 152 compound formulations, selected from Ayurvedic Formulary of India, Part-1, Part-11 and Part-III.
In continuation of the work on the quality standards of classical Ayurvedic compound formulations, the present Vol-IV of the Ayurvedic Pharmacopoeia of India, Part-11 comprises of official standards for compound formulations included in the Ayurvedic Formulary of India, Part-1, Part-II and Part-III.
The title of the monograph for each compound formulation is classical name of formulation at mentioned in the Ayurvedic Formulary of India. This is followed by the Definition, Formulation Composition, Method of Preparation, a brief Description of the Formulation, Standards for Identity and Purity in so far as these are reflected by microscopy, chromatography (thin layer chromatography) and physicochemical parameters. Other requirements include limits for microbial load, heavy metals and aflatoxins.
Information on therapeutic uses, dose, mode of administration and storage is included. Each ingredient of the compound formulations complies with the standards prescribed for it in the Ayurvedic Pharmacopoeia of India Part-1. Monographs on Compound Formulations provide Assay methods and range of limits for any one chemical constituent or group of chemical constituents, wherever possible.
I hope that the publication of Ayurvedic Pharmacopoeia of India, Part-Il (Formulations) Vol-IV, stating quality standards and method of preparation of the Compound Formulations would help implementation of the Drugs and Cosmetics Act and Rules thereunder. It is also expected that such implementation would generate a feedback, which is necessary for updating the prescribed standards.

The outreach and acceptability of Ayurvedic systems of medicine both nationally as well as internationally are dependent on the quality of medicines. For ensuring the quality of drugs, and implementation of the Drugs & Cosmetics Act and Rules thereunder, it is necessary to work out standards of Ayurvedic drugs. India is one of the few countries which has taken major strides towards establishing Pharmacopoeial standards on medicines used in its different system of medicines viz. Ayurveda, Siddha, Unani and Homoeopathy Ministry of AYUSH has already published 645 pharmacopoeial monographs on single drugs and extracts as well as 152 pharmacopoeial monographs on classical compound formulations of Ayurveda Updating the existing monographs and adding new monographs are the ongoing activities of the Ayurvedic Pharmacopoeia Committee (APC) under the aegis of Pharmacopoeia Commission for Indian Medicine and Homoeopathy (PCIM&H).
2. The 4 volume of the Ayurvedic Pharmacopoeia of India, Part-II comprises of 50 monographs on widely used classical compound formulations. The pharmacognostic, physic-chemical standards and Thin Layer Chromatograms of these formulations will provide guidelines for the stakeholders in the preparation and standardization of these compound formulations.
3. I appreciate efforts of the contributing institutions, Prof. S.S. Handa, Chairman, Scientific Body, PCIM&H, Prof. V.K. Joshi, Chairman and member of the Ayurvedic Pharmacopoeia Committee, Prof. K.S. Dhiman, Director General CCRAS, Dr. MM. Padhi, Deputy Director General and Former Director l/c PCIM and dr. Rajeev Kumar Sharma, Director, PCIM&H and the entire team to bring out this volume of Ayurvedic Pharmacopoeia of India.
4. It is expected that the bringing out of this volume of the Ayurvedic Pharmacopoeia of India will be of great utility to all the stakeholders and the regulatory standards set in these monographs will be widely used by the Ayurvedic pharmaceutical industry.