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

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UNSUB STARCHAT TO155223 The Ayurvedic Pharmacopoeia of India, Pt. II (Formulations) Vol. II 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 Physico-chemical 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 second 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-Il (Formulations).

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 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 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.

With the growing popularity and demand of Ayurvedic Medicines in the country and abroad, availability of quality standards of Ayurvedic formulations has become a top priority for maintaining uniform, safe and quality medicines for the consumption of patients. Evolving Pharmacopoeial standards for Ayurveda, Siddha and Unani Medicine is essential for implementing the relevant provisions under the Drugs and Cosmetic Act, and Rules thereunder. The Ayurvedic Pharmacopoea Committee has been assigned the task of evolving Pharmacopoeial standards of the commonly used formulations in the country.

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

I have no doubt that this publication on Compound. Formulations will provide required technical assistance for manufacturers, regulators, scientists, teachers, researchers and students. I place on record my appreciation for the members for Ayurvedic Pharmacopoeia Committee, Scientists working in various laboratories, Dr. S.K. Sharma, Adviser (Ayurveda), Department of Ayush, Dr. D.R. Lohar, Director, Pharmacopoeia Laboratory for Indian Medicine (PLIM) and his team and Dr. G.S. Lavekar, Director, Central Council for Research in Ayurveda & Siddha (CCRAS) and his team for bringing out this volume. My congratulations to Shri Shiv Basant, Joint Secretary, Department of Ayush whose overall coordination has made this enormous work possible.

In Ayurvedic Formulary of India Part I and Part II there are 636 formulations, out of these nearly 65 percent are solid dosage forms (Curna, Vati, Gutika etc.) about 20 percent are liquid preparations (Asva, Arista, Taila) and about 15 percent are semisolid (Avaleha, Ghrta, Lepa). Each of the formulations contains a number of ingredients, a few even going upto 75. It is observed that nearly 70 percent each of the liquid and semisolid preparations contain over ten ingredients. Since the spectrum of the tests which can be applied to liquids and semisolids for pharmacopoeial monographs are more limited than those available for solids, these preparation are particularly difficult to deal with. Considering the total 636 formulations about 50 percent 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 accomplish. 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, very few generalized quality parameters are adopted. Only a few Ayurvedic drug manufacturers may be having in house standard methods of preparations (SOPs) and quality parameters for finished compound formulations. But there exists no uniformity in the SOPs and quality parameters in the country. This results in lot of variability in quality of the same classical Ayurvedic formulation produced by different manufacturers. An effort has been made now to optimize and to develop uniform SOPs in order to ensure that such differences in quality of the same product produced by different manufacturers are not beyond permissible limits.

Under part I of Ayurvedic Pharmacopoeia of India (on single drug) so far six volumes have been published viz. Vol 1(80 monographs), Vol 11(78 monograph), Vol III (100 Monographs), Vol IV (68 monographs) and Vol V (92 monographs) and Vol VI (101 monographs) for Ayurvedic single drugs of plant origin, which go into one or more compound formulations included in the Ayurvedic Formulary of India, Part-I and Part-TI. The first volume of the Ayurvedic Pharmacopoeia of India, Part-TI published in 2007 contains official standards for 50 compound formulations selected from Ayurvedic Formulary of India, Part-I and Part-Il.

In continuation of the work of the quality standards of classical Ayurvedic compound formulations, the present Vol-IT of the Ayurvedic Pharmacopoeia of India, Part-IT contain official standards for compound formulations included in the Ayurvedic Formulary of India, Part-I and Part-Il.

The title of the monograph for each compound formulation is given in Sanskrit 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), Physicochemical parameters. Others 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 in the Ayurvedic Pharmacopoeia of India. In a few cases, where pharmacopoeial standards for individual ingredient are not available, the collaborating institute develops standards for such an ingredient before using it in the formulation. The monograph for majority of the compound formulations provides Assay method for and range of limits of any one chemical constituent or group of chemical constituents.

The general notice 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 Pharmacopoeial Committee hopes that the publication of Ayurvedic Pharmacopoeia of India, Part-Il (formulations) Vol-IT containing quality standards and method of preparation of compound formulation 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 feedback information which is necessary compound formulations given in this Vol-IT of the Ayurvedic Pharmacopoeia of India, Part-Il.

The Ayurvedic Pharmacopoeial committee urges the Government of India to recommend the adoption of these monographs published in the Ayurvedic Pharmacopoeia of India, Part-II (formulations) — Vol II 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-II 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 and the Ayurvedic Pharmacopoeia of India, Part-TI (formulations), Vol-I have been included in the First Schedule of the Drugs and Cosmetic Act 1940.