The Ayurvedic Pharmacopoeia of India, Pt. II (formulations) Vol. I is a legal document of standards for the quality of Ayurvedic formulations included therein (under the Drug and Cosmetic Act, 1940). This volume comprises 50 monographs on compound formulations. Each monograph contains the definition, formulation composition, indicating the official Ayurvedic name equivalent Botanical name, part used, and their proportion in the formulation. This also includes method of preparation and description of the product. The identification of product includes microscopy of the ingredients, thin Layer Chromatographic (TLC) and chemical tests. The physico-chemical parameter contains loss of drying, total ash value, acid insoluble ash, alcohol soluble extractives, water soluble extractives, pH etc. the indications, therapeutic uses and daily dose along with Anupan is also indicated in the monograph.

This volume is first publication of its kind, wherein the pharmacopoeial standards of multiple ingredients formulations have been scientifically described. The standards have been consciously kept modest so that the implementation by the manufacturing companies becomes easily acceptable in order to maintain quality control and batch to batch Ayurveda uniformity. However, the efforts of the manufacturer should be to maintain higher standards of quality than described in this book.

The appendix of this volume contains the details of protocol used in the determination of various scientific standards as well as methods of testing. References of the Ayurvedic literature in its original form are also added in order to authenticate the Ayurvedic standards referred in each monograph. In the appendix, Ayurvedic definition and method of Sodhana etc. are also given. This book in general is more user friendly for the manufactures, scientists and students, teachers involved in the standardization of Ayurvedic formulations.

This book is included in the first schedule of Drugs and Cosmetics Act, 1940. Manufacturers are required to follow pharmacopoeial standards and these are mandatory requirements under the Act. Users are welcome to give their suggestions on these monographs so that these suggestions are evaluated and followed in the forthcoming volumes of Ayurvedic Pharmacopoeia of India Part II (formulations).

Foreword

The Drugs & Cosmetics Act, 1940 was amended in 1964 to bring within its purview the drugs of Indian Systems of Medicine (Ayurveda, Unani and Siddha). For the implementation of the Act and Rules framed there under it was considered necessary to work out the standards for the drugs of these systems.

Ayurvedic material medica contains a large number of formulations, most of which are compound formulations. Accordingly, the Department of AYUSH, Ministry of Health & Family Welfare, realized the need for developing pharmacopoeial standards for the Ayurvedic formulations and initiated a project on the "Development of standards of method of preparation, pharmacopoeial standards and shelf life studies of Ayurvedic classical compound formulations". The Standardisation of Method of Preparation (SMP) of compound formulations involves many basic sciences like Ayurvedic pharmacy, Pharmaceutics, Pharmacognosy and Phytochemistry. Considering the depth of scientific knowledge and skills involved, the expertise of many reputed laboratories of the CSIR, PLIM, CCRAS and other laboratories of Universities and ASU manufacturing units were roped in for this effort in 2003. Publication of this Volume-I of the Ayurvedic Pharmacopoeia of India, Part-II (Formulations) is in a sense culmination of the process which was started in 2003. The work of these laboratories was closely monitored by a group of experts of Ayurvedic Pharmacopoeia Committee at regular intervals.

This volume is a result of untiring effort and hardwork of scientists from different laboratories and members of Ayurvedic Pharmacopoeia Committee and I place on record the appreciation of Department of AYUSH for their efforts. The First volume of the pharmacopoeial standards of compound Ayurvedic formulations has provided lot of learning to all the collaborating scientists and I am sure they will utilize the expertise gained for completing the work of laying down pharmacopoeial standards for most widely used classical Ayurvedic formulations in the next two years. I am confident that coromatographic fingerprints of Ayurvedic compound formulations would be made more precise.

I am certain that Ayurvedic Pharmacopoeia of India, Part-II, Volume-II will be welcomed by scientists and researchers, regulatory authorities and Ayurvedic manufacturing units alike and their suggestions for improvement in the subsequent editions would prove very valuable.