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

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The Ayurvedic Pharmacopoeia of India, Pt. 11 (formulations) Vol. 1 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 arc 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).

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 the reunder it was considered necessary to work out the standards for the drugs of these systems.

Ayurvedic materia medica contains a large number of formulations, most & which are compound formulations. Accordingly, the Department of AYUSH, Ministry of Health & Family Welfare, realised 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-Il (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 hard work of scientists from different laboratories and members of Ayurvedic Pharmacopoeia Committee and I place on record me appreciation of Department of AYUSH for their efforts. The First volume of the pharmacopoeial standards of compound Ayurvedic formulations has provided lot of learning t a the collaborating scientists and tam sure they will utilise 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 chromatographic ‘fingerprints of Ayurvedic compound formulations would be made more precise.

I am certain that Ayurvedic Pharmacopoeia of India, Part-Il, 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.

Introduction 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 came 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.

1. Ayurveda is the most ancient science of life having a holistic health approach. The preparation of medicines i.e. pharmacy is an integral part of this science, and evolved from a very rudimentary form. In ancient times, the preparation of medicine was part of the practising physician’s functions. The preparation of medicine was limited, selective and at personal level only. Hence the methodology of preparation and quality parameters more or less differed from Vaidya to Vaidya. In Vedic times the practice of medicine was a personal mission without any monetary motive, and exclusively for the recovery of ailing people. Later on, this attitude changed and the profession was followed with a profit motive. The manufacture of Ayurvedic medicines also began on a larger scale. Since the last 40 years Ayurvedic practice has assumed business proportions and the manufacture of Ayurvedic drugs are on a commercial scale.

2. Ayurvedic science is dynamic and progressive. It gives importance to therapeutic strategy. The four pillars of treatment are said to be the Physician, the Medicine, the Auxiliary Staff and the Patient. In the classics, it is clearly explained that an ideal medicine should have multiple actions, should be available in different dosage forms, should possess all the required attributes suited to a patient to rid him of the disease and be devoid of any adverse effects.

3. In ancient texts the quality parameters for raw drugs and finished products including compound formulations are well described and moreover this is in practices. It is mentioned how to collect the plant material, auspicious day and specific time with offering prayer to the plant that the material to be procured will be used for the welfare of the humanity.

Procurement of plant material in a particular time has a strong scientific base, like for collection of latex; it is advised to collect latex before sunrise to get good quality and quantity of material. Similarly after procurement of the material, use of plant material after a specific period of storage is described. For example Vidanga (Embilia ribes, seeds) are advise are to be used after one year of its procurement as the percentage of embelin (active phyto-constituents ) will be stable and quantity will be more compared to freshly procured sample. This reflects the quality assurance parameters.

4. The Ayurvedic pharmaceutical preparations were evolved gradually from a simpler form to more complex forms based on plants and plant—mineral combinations. During early period, particularly in Charakacharya’s time, the pharmaceutical preparations were primarily in five simple forms, which were collectively termed as “Pancavidha Kasaya Kalpanas”. Apart from this, a number of other dosage forms were described in Caraka Samhita such as Asava, Arista, Curna, Avaleha, Ksirapaka, Vataka, Varti, Taila, Ghrta, Lepa, Mantha, Ayaskriti etc. for various purposes.

5. During the period of Susruta also, a few new pharmaceutical preparations and aids were introduced, as for example Ksara, Ksarodaka, Ksarasutra, Masi, Vikesika etc. In Astanga Sangraha and Hrdaya more or less similar pharmaceutical preparations were mentioned as described in the earlier texts like Caraka and Susruta Samhita. During the time of 11th AD, Cakradatta added a few more preparations like Khanda, Parpati etc. The significant contribution of Cakradatta is an elaborate description of Ksarasutra.

6. Sarngadhara Samhita, which was written during l4 AD, gave new dimensions to Ayurvedic pharmacy. This book is considered as an authoritative text for Ayurvedic pharmacy. Many new pharmaceutical preparations like Malahara, Sukta, Phala Varti etc were defined with explanations. The concept of Phala Varti, though available in Caraka Samhita, its use was extended to urethral and vaginal disorders by Adhamalla.

7. Later, Yoga Ratnakara introduced a few innovative drug delivery systems and pharmaceutical preparations like Sucikabharana Rasa, which were to be administered in micro quantities into the blood through scratch made by the tip of a needle. A detailed description of Satva, extraction with reference to Guduci Satva was explained, which is a reductionist approach to dosage forms.

8. During 18th A.D., Bhaisajya Ratnavali listed a few more pharmaceutical preparations like Murchita Taila. Such concepts can also be observed in the commentaries on Aarngadhara Samhita, but the purpose of both the Murchana processes is different. Commentators on Sarngadhara Samhita advised the process of Murchana for removing excess water content and other unwanted residues if any from the formulated oil, while in Bhaisajya Ratnavali the process was advised to be followed in the expressed oil prior to use in the formulation.

9. The numbers of compound formulations are very huge, even more than 75,000, and of varied nature, using plant, mineral and animal sources. Another important characteristic feature of Ayurvedic compound formulations is that of their availability in different dosage forms such as curna, guti, vati, taila, ghrta, kvatha, asava, avaleha, bhasma, parpati, pottali malahara, lepa, panaka etc.

10. In recent times, even encapsulating an Ayurvedic drug in capsules is prevalent, in harmony with advancement of science and technology. Though this seems to be new to Ayurvedic sciences, the concept of encapsulating has been in tradition since centuries. For example, metallic preparations were embedded in Jaggery or banana, and such other palatable materials.

11. Ayurvedic Compound Formulations are complex in nature. The pharmaceutical processes involve any one or more of the following steps:

1. Ansuobhedana- Fine cutting
2. Apakarsapa- Elimination
3. Abhisavana- Fermentation
4. Avasincana- Sprinkling
5. Adityapaka- Sun-cooking
6. Alodana- Mixing a liquid
7. Upakodana- Baking of Cakrikas
8. Kledana- Moistening
9. Ksodana/Curnana- Pulverization
10. Khandasah chedana- Cutting into pieces
11. Jarjarikarna- Disintegration
12. Tapana- Heating
13. Dahana- Burning
14. Dhupana- Fumigation
15. Nirvapapa- Dipping in liquid
16. Niskulikarana- Elimination of seeds
17. Niskvathana- Boiling
18. Nispavana- Winnowing
19. Paripavana/Galana- Filtration
20. Paripana- Soaking
21. Parisravana- Decantation
22. Pidana- Compression
23. Pesana- Grinding
24. Putapaka- Heating in a closed vessel
25. Praksalana- Washing
26. Prativapana- Addition
27. Bharjana- Roasting
28. Bhavana- Impregnation
29. Manthana- Churning
30. Rasagrahana- Extraction
31. Vipacana- Cooking
32. Sodhana- Purification
33. Sosapa- Desiccation
34. Atapasosapa- Sun-drying
35. Chayasosapa- Drying in shade
36. Sadhana- Preparation and
37. Svedana- Steaming etc.

12. Any one or more of the above said processes will be integral part of Ayurvedic drug manufacturing. It is a challenging exercise to define and standardize the above processes, and establish quality parameters for different ingredients before and during the manufacturing process as well as for the final product.

13. At present in the industry, very few generalized quality parameters are adopted. Some pharmaceutical firms may be having their in-house standard method of operations, and quality parameters for finished compound formulations. But there is no uniformity in the operating procedures i.e. in the method of preparations. This is sometimes responsible for one and the same formulation by name having different qualities in the finished products, and not having reproducibility. An effort has been made now to optimize the method of preparation, so that such differences between manufacturer’s products in the market are not beyond reasonable limits.

14. It was again during the last 100 years of colonial rule that economic conditions in India changed, a process of urbanization began and it was during this period that the Ayurvedic physicians took to cities and lost their contact with forests and drug sources.

It was during this period that as a consequence of better transport facilities, the crude drug supplying agencies came up and commercial manufacture of Ayurvedic Medicines on mass scale in factories started. These were the inevitable consequences of the socioeconomic changes in the county. The new economic set up was such that the Ayurvedic practitioner could no longer process and prepare his own medicines but had to depend on commercial sources for supply of crude drugs to whatever extent he needed them. There was, in a way, a forced division of professional responsibilities where the vaidya had no choice but to purchase his drugs. Nor had he any means to ascertain the authenticity of the medicines and formulations supplied to him. There was no Governmental control on manufacturers to ensure the quality of the marketed medicines prescribed by vaidyas and administered to their patients.

15. The conditions prevailing in India prior to Independence were quite discouraging for indigenous medicines to make any progress. But, during the post-independence era, many scientists took active interest in preserving the legacy of Ayurveda and other indigenous systems.

16. As an outcome of the first Health Minister’s Conference of 1946, a Committee under the Chairmanship of Lt. Col. R. N. Chopra was appointed in 1946 by the Government of India. It was the Chopra Committee that had first gone into the question of need for proper identification of Ayurvedic medicinal plants as available in the bazaar, control over collection and distribution of crude drugs and made positive recommendations for compilation of an Ayurvedic Pharmacopoeia. Thereafter, the Dave’ Committee [1955] reiterated the recommendations for compilation of an Ayurvedic Pharmacopoeia.

17. The Government of Bombay was especially interested in the survey of resources of Ayurvedic Drugs, their collection, cultivation, farming, distribution and standardization. They, therefore had appointed a Committee for Standard and Genuine Ayurvedic Herbs and Drugs in 1955 and subsequently after receiving its report, appointed a second committee with fresh set of terms of reference, called the Committee for Standard Ayurvedic Herbs and Drugs in 1957 both under the Chairmanship of Vaidya Bapalal Shah, of which Professor A. N. Namjoshi was the Member Secretary. The Bapalal Committee had very elaborately recommended the compilation Of the Ayurvedic Pharmacopoeia as an urgent prerequisite for effective control of Ayurvedic Drugs to ensure quality assurance: Finally Government of India appointed the “Ayurvedic Research Evaluation Committee”, under the Chairmanship of Dr. K. N. Udupa (1958) which had strongly highlighted the urgency of the compilation of an Ayurvedic Pharmacopoeia.

18. In compliance with some of these recommendations, the Union Government as also some of the State Governments had started taking positive steps. The Government of Bombay State established its Board of Research in Ayurveda, Bombay in 1951, which was subsequently reconstituted in 1955 and 1958. The Government of India established CCRJMH in 1969 for research in all aspects including drug standardization in Indian Medicine & Homeopathy. This Council was divided into 4 research councils in 1978 and the research work in Ayurveda & Siddha was entrusted to the Central Council for Research in Ayurveda & Siddha. The PLIM at Ghaziabad was established in 1970 for testing and standardization of single drugs and compound formulations. Under the auspices of the Central Council for Research in Ayurveda and Siddha, several survey units in different States were established and work of standardization of single drugs and compound medicines as also composite research work was initiated. The first Ayurvedic Pharmacopoeia Committee was constituted in 1962 under the Chairmanship of Col. Sir Ram Nath Chopra. The Committee was reconstituted in 1972 under the Chairmanship of Prof. A.N.Namjoshi to continue the work of compilation of the Ayurvedic Formulary of India as a pre-requisite for undertaking the work of Ayurvedic Pharmacopoeia of India. The first part of the Ayurvedic Formulary was published in 1978 and the second part in 2000. A revised edition of the first part also brought out in 2003.

19. After publication of the First and the Second part of the Ayurvedic Formulary of India Part-Ill of the Formulary is under preparation.

20. The First and Second Part of the Ayurvedic Formulary of India comprising of some 444 and 191 formulations respectively cover more than 351 single drugs of plant origin. This covers about 500 priority drugs of plant origin for which monographs have been evolved and included in several volumes of Ayurvedic Pharmacopoeia of India.

21. As a fallout of the growing interest in the renaissance of Ayurveda and the systematic efforts to investigate into the merits of this ancient science during the post-independence period, it is of significance that the western or modern system of medicine, with its formidable armoury of synthetic drugs, chemo-therapeutic agents and antibiotics, has slowly come to terms with the adverse side effects and toxicity of synthetic drugs. The western world has now turned its attention to traditional medicines based on drugs of natural origin. An appreciation of the basic tenets of Ayurvedic therapeutics, which initially appeared to be rather abstract and difficult to interpret in terms of modern medical sciences, has now emerged, resulting in new branches of pharmacology such as pharmacogenomics.

22. With the introduction of a uniform system of Ayurvedic education all over the country, a process initiated some 50 years ago, there would be some uniformity in the education in pharmacy, pharmaceutical technology, pharmaceutical chemistry, pharmacognosy and research. With the physician and the patient needing to be assured of the quality of the medicine through research, such an advance in Ayurvedic education would have a positive effect.

23. In the absence of official standards published by Government for statutory purposes, Ayurvedic Pharmaceutical Industry in particular has been experiencing several handicaps in implementing in house standards, as in any case, they need to comply with official standards.

24. The publication of the Ayurvedic Formulary of India and the Ayurvedic Pharmacopoeia of India would now enable the Government to implement the Drugs and Cosmetic Act, 1940 in respect of quality control for the Ayurvedic, Siddha, Unani drug manufacturers, distributed and sold in India, under a license granted by it.

25. The Ayurvedic Pharmacopoeia Committee has laid down standards for single drugs based on experimental data worked out at the PLIM, Ghaziabad and in some of the units of the Central Council for Research in Ayurveda and Siddha. Published scientific literature on the subject, although scanty, has also been collected and included after due verification.

26. The western countries did pass through the same phase over 150 years ago for their medicines, their characteristics, methods of preparation and identity, purity and strength. Research towards this end was vigorous and out of the scientific data contributed by the scientists in research institutes and, industry, the pharmacopoeial monographs of drugs were drafted. As a result pharmacopeiae of the western world show considerable uniformity in principles, approach and information. Thus, while for compilation of the British Pharmacopoeia, information and scientific data was available, for the compilation of the Ayurvedic Pharmacopoeia little information and published data existed and the Ayurvedic Pharmacopoeia Committee had to do a lot of spade work.

27. The Part I of Ayurvedic pharmacopoeia of India consists of Vol-I, II, III, IV and V comprising respectively 80, 78, 100, 68 and 92 monographs prescribing standards for Ayurvedic single drugs of plant origin, which go into one or more formulations admitted to the Ayurvedic Formularies of India, Part-I and Part-Il. The Part-Il of the Ayurvedic Pharmacopoeia consists of official standards for 50 compound formulations present in the Ayurvedic Formulary of India Part-I and Part-II.

28. The title of the monograph for each compound formulation is given in Samskrit, as in the Ayurvedic Formulary of India. This is followed by the Definition, Formulation Composition, Method of Preparation, a brief Description of the compound formulation, standards for Identity and Purity in so far as they are reflected by microscopy and physico chemical parameters. Other requirements such as tests for heavy metals, microbial content have also been prescribed. Information on therapeutic uses, dose, administration and storage is included. The raw material which complies with the standards of API were selected for developing standards for compound formulations. In a few cases, where such standards were not available, the collaborator developed them and used them as standards for that raw material.

29. The monograph gives limits under Assay, for any one constituent or group of constituents like total alkaloids or total volatile oils. In the case of water soluble or alcohol soluble extractives a minimum lower limit has been given. For impurities like Ash, Acid insoluble Ash etc, a maximum upper limit has been given. It is a well known fact that there is wide variation in such values for crude drugs of plant origin in respect of their chemical contents. Therefore, such variations had to be taken into consideration in laying down minimum and maximum standards for the compound formulations.

30. The General Notices provide guidance for the manufacturers and analysts. Official details of Apparatus, Reagents and solutions, Methods of tests, preparation of sample for microscopical examination have all been given the Appendices.

31. The Committee hopes that with the publication of Ayurvedic Pharmacopoeia of India Part-Il (Formulations) Vol.-I, comprising of 50 compound formulations, would serve to exercise quality control and help in the implementation of the Drugs and Cosmetics Act.

It is also expected that such implementation would create a feedback data, which is essential for improving the standards given in the pharmacopoeia.

32. The Committee urges the Government of India to recommend the adoption of these monographs for the purpose of defining Method of Preparation, Developing Standards for compound formulations for use in their Government, Semi-Government and Government aided institutions and voluntary public organizations. The Ayurvedic Pharmacopoeia of India, 2007, Part-II (Formulations), Vol.-l may also be notified by Government as a book of standards for implementation of the Drugs and Cosmetics Act, 1940 all over India, just as the Ayurvedic Pharmacopoeia of India part I, Vol. I, II, III, IV and V have been included in the First Schedule of Drugs & Cosmetics Act 1940.

33. The Ayurvedic Pharmacopoeia Committee records with deep appreciation the contributions made by the Directors, Officer In-charges, Project Officers and scientific staff of all the collaborating laboratories and Institutions who were associated with the project work on developing Pharmacopoeial Standards for formulations allotted to them.

34. I am indebted to secretary Department of AYUSI-1, Ms. Anita Das for her constant inspiration and motivation for this unique work. My sincere thanks and credit to Joint Secretary, Department of AYUSH, Sh. Shiv Basant for providing constant support and strategic plan for completion of this first phase of task and momentum to on going work.

35. It is my duty to place on records our sincere thanks and appreciation to Dept. of AYUSH, Ministry of Health & Family Welfare, Govt. of India; State Governments, Institutions, Councils, Scientists and Ayurvedic Scholars, for their whole hearted cooperation in preparing the monographs on compound formulations. I sincerely thank all members of Ayurvedic Pharmacopoeia Committee for their dedicated efforts and hard work in finalizing the monographs. My thanks to Prof. S.S. Handa, Chairman; Dr. S.K. Sharma, Vice-Chairman; Miss. S. S Satakopan, Member; Prof. S.K. Dixit, Member; Prof Ved Vrat Sharma, Member; Prof. V.K. Kapoor, Member; Dr.(Ms.) Shanta Mehrotra, Member; Dr. P.D. Sethi, Member; Dr. D.R. Lohar, Member; Prof. M.A. Iyengar, Member; Sh. J. K. Dhing, Member; Dr. J. Mohansundaram, Member; Dr. B. L. Gaur, Member; Prof Siddhinandan Mishra, Member; Dr. P. K. Prajapati, Member; Dr. Narendra Bhatt, Member; Sh. Ranjit Puranik, Member; Prof. V. K. Joshi, Member; Prof. K.C. Chunekar, Member; Vd. Devender Triguna, Member; Dr: M.R. Uniyal, Member; Prof. V.V. Prasad, Member and Dr. Karan Vashisth, Expert member for their constant efforts in bringing out this volume. My thanks are also to Dr. MM Padhi, Deputy Director [Tech.]; Shri. Vasantha Kumar, Asst. Director [Chem.] Dr. Pramila Pant, Research Officer [Chem.], Dr. Rajiv Sharma, Senior Scientific Officer [Pharmacognosy), Sri. Ravinder Singh, Research Officer [Chem.], Dr. Jai Prakash, Research Officer [Chem.], Dr. Chhote Lal, Dr. AKS Bhadoria and Dr. MN Rangne, Dr. Bishnu Priya Dhar, Research Officer [Phar], Dr. Galib, Research Officer [Awl, Dr. K. Sandhya Rani, S.R.F. [Ayu.] and other associated officers, who contributed a lot in finalizing the volume. I am also thankful to Mr. Sandeep Kumar, D.E.O., who took pains in typing and arranging all the technical data into a final shape.