The Ayurvedic Pharmacopoeia of India (Part II, Volume - III, Formulations )

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The Ayurvedic Pharmacopoeia of India, Pt. II (Formulations) Vol. III is a legal document of standards for the quality of Ayurvedic formulations included therein (under the Drug and Cosmetic Act, 1940). This volume comprises 51 monographs on compound formulations. Each monograph contains the definition, formulation composition, indicating the official Ayurvedic name of the ingredient, equivalent Scientific name, part/form 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 Chromatography (TLC) and Chemical tests. The Physicochemical parameters contain loss of drying, total ash, acid insoluble ash, alcohol soluble extractive, water soluble extractive, pH etc. The indications, therapeutic uses and daily dose along with Anupana is also indicated in the monograph.

This volume is third publication in this series, wherein the pharmacopoeial standards of multiple ingredient 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 uniformity. However, the efforts of the manufacturer should be to maintain higher standards of quality than described in this book.

The appendices of this volume contain the details of protocols used in the determination of various 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 manufacturers, 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).

Standardization of drugs and pharmaceuticals by setting Pharmacopoeial standards of Ayurveda, Siddha & Unani (ASU) medicines is a priority area identified by the Department of AYUSH. The Ayurvedic Pharmacopoeia Committee (APC) is continuously working towards this goal in collaboration with eminent research and Ayurvedic institutions in the country. After publishing the Pharmacopoeial standards of 549 single drugs going in various formulations, the APC has also published two volumes API (Part-II) containing 101 formulations. In this series, the third volume of Ayurvedic Pharmacopoia of India Part-II containing 51 formulations is being published by Department of AYUSH. This volume contains Pharmacopoeial standards of commonly used Ayurvedic formulations in various Ayurvedic hospitals, dispensaries and also by the practitioners of the system.

Bringing out the Pharmacopoeial standards of multiple ingredients of Ayurvedic formulations requires expertise in various disciplines like Ayurvedic Pharmacognosy, Pharmacy, Phytochemistry and Pharmaceutical Chemistry. The present volume contains standard manufacturing procedures including in-process standardization procedures, final product standardization with pharmacognostic, physicochemical and chromatographic techniques. It is needless to say that the present volume is the result of the untiring efforts of scientists from various laboratories as well as by the members of the Pharmacopoeia Committee.

There is no doubt that this publication on multiple ingredient Compound Formulations will provide the required technical knowledge to manufacturers, regulators, scientists, teachers, researchers and students in this field. I place on record my appreciation for the continuous efforts made by the members of the Ayurvedic Pharmacopoeia Committee (APC). Scientists working in various Laboratories, Prof. S.S. Handa, Chairman, APC, Dr. S.K. Sharma, Adviser (Ayurveda), Department of AYUSH, Dr. Ramesh Bobu. Director General, Central Council for Research in Ayurveda and Siddha (CCRAS) and his team. Director, Pharmacopoeial Laboratory of Indian Medicine (PUM), Ghaziabad and his team in particular for helping to bring out this volume.

In the Ayurvedic Formulary of India Part I and Part II there are 636 Formulations. Out of these nearly 65 per cent are solid dosage forms (Curna, Vati, Gutika etc.), about 20 per cent are liquid preparations (Asava, Arista, Taila etc.) and about 15 per cent are semisolids (Avaleha, Ghrta, Lepa etc.). Each of the Formulations contains a number of ingredients, a few even going upto 75. It is observed that nearly 70 per cent each of the liquid and semisolid preparations contain over ten ingredients. Since the spectrum of tests which can be applied to liquids and semisolids for pharmacopoeial monographs are more limited than that available for solids, these preparations are particularly difficult to deal with. Considering the total of 636 Formulations about 50 per cent contain over 10 ingredients. This means that in 318 monographs of solids, semisolids and liquids, standards and tests would involve an average of 25 ingredients in each. This is really a complex and formidable task to achieve. In addition to sheer volume, the unique processing methods used for manufacture, turn a simple mixture of single drugs into a very complex material from which separation and identification, let alone estimation, of components is no longer an easy and routine affair. It calls for complete knowledge of manufacturing complexities for a pharmaceutical/analytical chemist, for proper appreciation and interpretation of test results. At present, only a few generalized quality parameters are adopted. Not all Ayurvedic drug manufacturers may be having in-house standard methods of preparation (SOPs) and their own quality parameters for finished Compound Formulations. Therefore there is no consistency in the SOPs and quality parameters among them. This results in a lot of variability in the quality of the same classical Ayurvedic formulation produced by the same recommended classical procedures, but by different manufacturers even among their different batches. An effort has been made now to optimize and develop uniform SOPs in order to ensure that such differences in quality of the same product produced by different manufacturers are 110t beyond permissible limits.

Under Part I of Ayurvedic Pharmacopoeia of India (on single drugs) so far six volumes have been published viz. Vol I (80 monographs), Vol II (78 monographs), Vol III (100 Monographs), Vol IV (68 monographs), Vol V (92 monographs) and Vol VI (101 monographs) for single drugs of plant origin, and Vol VII (21 monographs) for Minerals and Metals, which go into one or more compound formulations included in the Ayurvedic Formulary of India, Part-I and Part-II. The two volumes of the Ayurvedic Pharmacopoeia of India, Part-II published in 2007 and 2008 respectively contain official standards for 101 compound formulations, selected from Ayurvedic Formulary of India, Part-I and Part-II.

In continuation of the work 011 the quality standards of classical Ayurvedic compound formulations, the present Vol-III of the Ayurvedic Pharmacopoeia of India, Part-II contains official standards for compound formulations included in the Ayurvedic Formulary of India, Part-I, Part-II and Part-III (under preparation).

The title of the monograph for each Compound Formulation is given in Samskrta as 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 or gas liquid chromatography) and physicochemical parameters. Other requirements include limits for heavy metals and microbial load. 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. In a few cases, where pharmacopoeial standards for individual ingredient were not available, collaborating institutes developed standards for such an ingredient before using it in the Formulation. Monographs of the Compound Formulations provide Assay methods for and range of limits of, anyone chemical constituent or group of chemical constituents, wherever possible.

The General Notices provide guidance for the Ayurvedic drug manufacturers and analysts. Appendices given in the Pharmacopoeia include details of the apparatus/equipment, reagents, solutions used methods of tests employed and preparations of sample for microscopic examination.

The Ayurvedic Pharmacopoeia Committee hopes that the publication of Ayurvedic Pharmacopoeia of India, Part-II (Formulations) Vol-III, containing quality standards and method of preparation of the Compound Formulations would serve to assist in the implementation of the Drugs and Cosmetic Act and Rules there under. It is also expected that such implementation would generate a feedback, which is necessary for updating the prescribed standards.

The Ayurvedic Pharmacopoeia Committee urges the Government of India to recommend the adoption of these monographs published in the Ayurvedic Pharmacopoeia of India, Part-II (formulations) - Vol III for the purpose of methods of preparations and quality standards of Ayurvedic compound formulation for use in their Government, Semi government, Government aided institutions and Voluntary public organizations. Ayurvedic Pharmacopoeia of India, Part-II (Formulations) Vol-III may also be notified by the Government of India as a book of standards for implementation of Drugs and Cosmetic Act 1940 and Rules there under (as amended from time to time) all over India, just as the Ayurvedic Pharmacopoeia of India Part-I Vol-I, II, III, IV, V, VI, VII and the Ayurvedic Pharmacopoeia of India, Part-II (formulations), Vol-I, II have been included in the First Schedule of the Drugs and Cosmetic 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 1964 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 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 manufacturers 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 Testing 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.