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

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The Ayurvedic Pharmacopoeia of India is a legal document of standards for the quality of Ayurvedic drugs and substances included therein (under Drugs and Cosmetics Act, 1940). This Vth Volume consists of 92 monographs on single drugs of plant origin. Pharma-cognostical, chemical and Ayurvedic standards of the parts of the plants used in Ayurveda are described in detail in each monograph.

Each monograph describes macroscopic, microscopic characters along with their chemical standards of identity, permissible limit of foreign matter, purity & strength and have been developed on the protocol developed and approved by the Ayurvedic Pharmacopoeia Committee, It also prescribes about total ash value, acid insoluble ash, alcohol soluble extractive, water soluble extractive and thin layer chromatographic description (TLC). All this work was carried out by different scientific laboratories of CSIR, CCRAS, universities, academic institutions, Drug Testing Laboratory and Pharmacopoeial Laboratory of Indian Medicine (PLIM). The data has been finalised after confirmation of various samples obtained from different agro-climatic zones by the cross-section of experienced scientists in Ayurvedic Pharmacopoeia Committee and after careful scientific scrutiny. The standards have been consciously kept modest so that its implementation by the manufacturing companies becomes easily acceptable in order to maintain quality control and batch to batch uniformity. However, efforts of the manufacturers should be to maintain higher standards of quality.

Ayurvedic pharmacological properties like Rasa, Guna, Virya, Vipaka, Karma, etc. are also mentioned in each monograph along with their therapeutic uses, some of the important classical formulations and therapeutic dose.

Appendix of this volume contains the details of the protocols used in determination of various scientific standards. References of ancient Ayurvedic literature in its original form are added, in order to authenticate the Ayurvedic statements made in each monograph.

In the end, English equivalents of each Ayurvedic term have been given to make the volume user friendly for all people who work in the area of Ayurveda drugs and who are not conversant with Sanskrit/Ayurvedic terminology.

In general, this book is more user friendly for scientists, manufacturers, students involved in quality testing’s of Ayurvedic medicines, teachers of Dravyaguna, research scholars, physicians of Ayurveda and many others who have interest in the quality standards of Ayurvedic medicines.

This book is included in the 1st schedule of Drugs and Cosmetic Act, 1940. Manufacturers are required to follow pharmacopoeial standards as these are mandatory requirement under the Act.

The demand for Ayurvedic medicines as well as other natural products for healthcare is increasing globally. Their acceptability and future prospects are associated with the quality standards of these products. Therefore, it is essential to have scientific standards for identity, purity and strength of these medicines. Government of India appreciated the need for developing Pharmacopoeial Standards of Ayurveda, Siddha Unani medicines and established the Pharmacopoeial Laboratory of Indian Medicines (PLIM) at Ghaziabad in the year 1970 to undertake pharmacopoeial work on Ayurvedic, Siddha & Unani medicines. The Ayurvedic Pharmacopoeia Committee (APC) comprising of experts in Pharmacognosy, Chemistry, Pharmaceuticals and Ayurvedic Pharmacy have been constantly advising PLIM and other Laboratories on Pharmacopoeial work. Quality standardization of natural products is a complex task and so 15 other laboratories of the Council of Scientific & Industrial Research (CSIR), Central Council for Research in Ayurveda c& Siddha (CCRAS) and other eminent institutions have been associated to develop the Pharmacopoeial Standards under the APC Scheme of the Department of AVUSH. The scientific work of various laboratories has been regularly monitored by experts of the Ayurvedic Pharmacopoeia Committee and ultimately 93 monographs on Ayurvedic medicines have been prepared which constitute Volume V of the Ayurvedic Pharmacopoeia of India.

This volume is a result of hard work of various scientists working in various laboratories under the APC Scheme, PLIM, office bearers and members representing Ayurveda on the Pharmacopoeia Committee. I want to place on record my appreciation for their work resulting in the publication of this Volume. I hope that all those associated with the Ayurvedic Pharmacopoeia Committee will redouble their efforts and expedite the work of finalizing Pharmacopoeial standards for all the classical poly-herbal/ herbo-metallic preparations and simultaneously also develop chromatographic fingerprints for inclusion in the Ayurvedic Pharmacopoeia.

Science & Technology are developing very rapidly and so new scientific parameters of assessment of quality, purity and strength of natural drugs are also being developed. These scientific parameters needs to be adopted for Ayurvedic drugs as well. The department of Ayush would welcome suggestions of experts-user-industries to improve the quality standards of future editions.

I hope the fifth Volume of the Ayurvedic Pharmacopoeia of India will meet the needs of the industry and regulatory authorities and will help to improve the quality of Ayurvedic products.

India, due to its unique variety of geographical and climatic factors, has had a rich and varied flora of medicinal plants since the Vedic period. No wonder that out of a total number of over 15,000 plant species in India about 2000 are known to have medicinal properties and some of them are even used as home-remedies in the rural and remotest parts of the country.

2. The vastness of the country with its inadequate means of communication and facilities for transport of drugs coupled with diverse regional languages, resulted into a multitude of synonyms (the names in regional languages). Further, Ayurveda being a science put into professional practice on umpteen occasions to try newer drugs locally available, led to the successful use of several other drugs with therapeutic values similar to those of he drugs which were originally equated with the classical Ayurvedic drug, but later assumed the name of the very same classical drug and continued to be locally collected, sold and used in that name since the main classical drug was famous yet locally unavailable and substitution was a necessity. Later, in the first half of the century, while scientifically identifying the drugs in vogue in different regions, the scientists found that there were more than one species, belonging even to different families of plants, claiming the same classical name of the Ayurvedic drug. ‘Brahmi’ could be cited as a good example. This created a sensation that there existed a great controversy about the identity of Ayurvedic drugs and that there were more than one independent drug’ claiming the classical name of drug and one drug therefore, having different scientific identities. This innocent impression of scientists was further exaggerated during the alien rule to run down the claim of Ayurveda as a cultural heritage of India out of patriotism. All such drugs with a multiple claim on the classical name in different provinces were stamped as controversial drugs without going into their genesis basically as therapeutic equivalents.

3. Ayurveda had never been static. Its practitioners had been innovative and dynamic in the therapeutic practice and carried on clinical trials out of the local flora and discovered newer medicine with same therapeutic values as the classical drugs which might have been then either locally un-available or perhaps demanding heavy prices. These newer drugs have been accepted by the then practicing profession as substitutes. In fact on study of Ayurvedic literature, one comes across several references of permitting the use of a substitute drug when the classical drug is not available. This is based on its therapeutic equivalence and clinical efficacy.

4. Then there were certain classical drugs of Himalayan origin whose supply was limited and seasonal. They were not, or perhaps could not be, grown on plains and hence their use was restricted to the traders. By the time efforts were made to identify these drugs, their supply had dwindled and commercial substitution started These few drugs were rightly stamped as “Sandigdha Dravyas” (or drugs of doubtful identity) of which ‘Ashta Varga’ could be cited as a glaring example.

5. It was again during the last 100 years of the alien rule, that the social and economic conditions in India changed, that the process of urbanisation began and growth of forests neglected. 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 socio-economic changes in the country. 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 the big pharmaceutical houses run commercially and on the suppliers of crude drugs to whatever extent he needed them. There was, in a way, a forced division of labour where he had no choice but to purchase his drugs and no means to ascertain the authenticity of the medicines and formulations offered to him by the pharmaceutical houses, nor was there any Governmental control on the manufacture to ensure the quality of the medicines marketed, prescribed and administered to his patient.

6. The conditions prevailing in India for compilation of Ayurvedic Formulary and the Ayurvedic Pharmacopoeia were quite discouraging under the alien rule. Not only no efforts were made to investigate the efficacy and potency of Ayurvedic drugs, but there was also a systematic policy to discourage such moves and project Ayurveda as an out-dated and unscientific native system of treatment. Its drugs were poblicised to be crude, poisonous and detrimental to health. The influence of this canard unfortunately still continues to lurk in some quarters. It was under these circumstances that some of the rationalist Indian Scientists and Scholars of Ayurveda dedicated themselves to the renaissance of Ayurveda. It was a part, of the overall movement of independence of the country. But it gave the necessary momentum and after independence, not only Ayurvedic education but Ayurvedic drugs and their marketing were looked into.

7. As an outcome of the first Health Minister’s Conference of 1946, a Committee under the Chairmanship of Lt. Col. RN. 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, control over collection and distribution of crude drugs and made positive recommendation for compilation of an Ayurvedic Pharmacopoeia. Thereafter, the Dave Committee (1955) reiterated the recommendations for compilation of an Ayurvedic Pharmacopoeia.

8. The Government of Bombay, was specially 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 with fresh set of terms of reference, appointed a second committee called the Committee for Standard Ayurvedic Herbs and Drugs in 1957 both under the Chairmanship of Vaidya Bapalal Shah, of which I had the privilege to be the Member Secretary. The Bapalal Committee has 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.

9. 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 CCRIMH in 1969 for research in all aspects including drug standardisation in Indian Medicine & l4omoeopathy. This Council was divided into 4 research councils in 1978 and the research work in Ayurveda and Siddha was entrusted to the Central Council for Research in Ayurveda & Siddha. The PLIM, at Ghaziabad was established in 1970 for testing and standardisation of single drugs and compound formulations. Under the auspices of the Central Council for Research in Ayurveda and Siddha. several survey units in different Slates were established and work of standardisation 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 which took over the work of compilation of the Ayurvedic Formulary of India as a pre-requisite for under taking the work of Ayurvedic Pharmacopoeia of India.

10. Alter publication of the First and the Second part of the Ayurvedic Formulary of India, Part III of the Formulary is under preparation. A list of single drugs which enter into the formulations has been prepared and the Committee could now apply its mind to the task of collection of data from published material and to entrust experimental work to produce data necessary to supplement the information already available as well as to vei-i1’ experimentally some of the information previously gathered.

11. 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 takes up about 500 priority drugs of plant origin to come within the ambit of the Ayurvedic Pharmacopoeia of India.

12. As against the above land-marks of growing interest in the renaissance of Ayurveda and systematic efforts to investigate into the merits of this ancient science during the post-independence period it is interesting to note that the western or modem system of medicine with a formidable armoury of mostly synthetic drugs, chemo-therapeutic agents and later antibiotics, slowly realised that they also had adverse side effects and toxicity which would damage human systems. The western world slowly started appreciating the value of herbal medicines, and understanding the basic comprehensive philosophy of Ayurveda, which initially appeared to be rather abstract and difficult to interpret in terms of modern medical sciences.

13. 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 Ayurvedic medicines marketed, in so far as their identity, purity and strength are concerned, with the physician and the patient needing to be assured of the quality of the medicine through proper drug control measures. The efforts to publish an Ayurvedic Formulary of India and to compile the Ayurvedic Pharmacopoeia of India have been well scheduled as to serve the profession and the public through proper quality assurance.

14. the Union Government have brought the Ayurvedic Drugs under the preview of the Drugs and Cosmetic Act 1940 from 15-9-1964. The publication of the Ayurvedic Formulary of India and the Ayurvedic Pharmacopoeia of India would give Government a base for fuller enforcement of the Act in respect of standards.

15. In the absence of technical information officially published by Government for statutory purposes, the Indian Pharmaceutical Industry in general and the Ayurvedic Pharmaceutical Industry in particular have been experiencing a great handicap in imposing standards as a part of their own internal discipline, as whatever standards they would lay down would be only arbitrary and subjective.

16. To meet the acute need of the hour felt by the academic institutions, the Ayurvedic Pharmacists and Pharmaceutical Industry and the authorities, implementing Drugs and Cosmetics Act, the Ayurvedic Pharmacopoeia Committee has made a modest effort to lay down earlier some norms of single drugs based on experimental data worked out at the PLIM, Ghaziabad and some of the units of the Central Council for Research in Ayurveda and Siddha, supplemented by the published scientific literature on the subject after due verification wherever found necessary and additions wherever possible.

17. The Western countries did pass through this phase years ago and had to codil5’ their medicine and their characteristics, methods of preparation and determining criteria of their identity, purity and strength. Endeavors to determining the above were made by researchers all over the world and out of this common pool of scientific data the pharmacopoeial monographs of single drugs and formulations were drafted. And the result of these efforts are the several pharmacopoeias of the modem world with considerable commonness of approach and information. Thus, while for compilation of the modern pharmacopoeia universal need of 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 begin from scratch.

18. While incorporating the experimental data like macroscopic and microscopic pharmacognostic descriptions and chemical norms, one must admit that modern pharmacognosy had its genesis in Texts of Ayurvedic Nighantus where entire drug and drug plant have been minutely studied and eloquent Sanskrit terms used to describe the parts of plant so that it projects a convincing picture of the drug and the drug plant before the reader. The description of the Castor oil plant — (Ricinus communis Linn.) given by Bhavprakash and of Guduchi (Tinospora cordifolia (Wild). Miers.) are typical examples. Thus when we insist on the pharmacognostic study of each drug, we are really extending and expanding Ayurvedic Pharmacognosy.

19. The Ayurvedic Pharmacopoeia of India Part—I, Vol—I comprises of 80 monographs of Ayurvedic single drugs of plant origin, which go into one or more formulations enlisted in the Ayurvedic Formulary of India Part I. In compiling the monographs, the title of each drug had been given in Sanskrit as already obtained in the Ayurvedic Formulary of India. Then comes the definition of the drug giving its identify in scientific nomenclature and very brief information about its source, occurrence, distribution and precautions in collection if any, etc.

20. This is followed by a list of synonyms in Sanskrit and also the other Indian regional languages. The monographs then record the detailed gross or Microscopic description of the drug and its Microscopic tissue structures, the individual elements, deposition of crystals, starch grains, hairy out growths etc, each having a pharmacognostic value in identification, especially when the drug is in powder form.

21. The monograph then gives norms and limits under “Identity, Purity and Strength” like tolerance of foreign matter, total ash, acid insoluble ash, alcohol soluble extractive, water soluble extractive volatile oil contents etc. Some of them have a direct bearing on the purity and strength, while others enable to detect substitution or adulteration, if any. Where possible, Assay of one constituent or group of constituents like total alkaloids or total volatile oils has been given. However, under the heading ‘Constituents’ one or more constituents or group of constituents like oleoresins, essential oils, alkaloids have been mentioned which only have an informative value based on published research work in phytochemistry. In the case of water soluble or alcohol soluble extractives specification of lower limit has an added relevance to the maturity of the drug in addition to its authenticity. It will however, be worth mentioning that there is always a wide variation in crude drugs (raw materials) of plant origin in respect of their chemical contents, due to varied climatic conditions, geographical distribution, source and season of collection and lack of scientific methods of storage and preservation. Therefore, the variation in the chemical data created a great difficulty in fixing the standards for single drugs. However, the data has been fixed up by working out as many samples as possible procured from different sources.

22. Since the effort is to compile pharmaeopoeial monographs of Ayurvedic drugs, the accent of the classical attributes of respective drugs according to the doctrine of Rasa, Guna, Virya, Vipaka and Karma has not been lost sight of, though some of them appear to be abstract and subjective in the absence of an established experimental methods to quantify them.

23. The Legal Notices and General Notices have been given for guidance of the analysts, the Pharmaceutical suppliers and manufactures and the research workers engaged in this field Details about the apparatus, reagents and solutions, tests, methods of preparation of speciments for microscopical examinations have been given in the Appendices.

24. The Committee hopes that with the publication of Ayurvedic Pharmacopoeia of India Part I, Vol.11 comprising of 78 single drugs of vegetables origin, as per the format and procedure laid don the different research units under Deptt. of ISM & H under the Ministry of Health and Family Welfare would plan their research enquiries such that the output of work would be accelerated. At the same time, these 78 drugs would provide basic information and norms about these drugs to those research institutions which would be interested in an in-depth study of these drugs, the outcome of which might provide further data for incorporation to the extent it would be relevant to the second edition of the pharmacopoeia.

25. The Committee urges the Government of India to recommend the adoption of these monographs for the purposes of identity, purity and strength of drugs for use in their Government, Semi- Government and Government aided institutions and voluntary public organisations. The Ayurvedic Pharmacopoeia of India, 1998, Part-I, Vol 11 may also be notified by Government as a book of reference for implementation of the drugs and Cosmetics Act, 1944) all over India as Ayurvedic Pharmacopoeia of India Vol. I is already included in the First Schedule of Drugs & Cosmitis Act 1940.

26. The Ayurvedic Pharmacopoeia Committee records the appreciation for the Directors, Officer In-charges, Project Officers and scientific staff of all the contributing laboratories and institutions those were associated with the project work on developing Pharmacopoeial Standards. The present volume of Ayurvedic Pharmacopoeia of Inida comprises the technical work contributed by these laboratories and institutions.

27. On behalf of the Ayurvedic Pharmacopoeia Committee, I feel it my duty to place on records our sincere thanks and appreciation to the Government of India, State Governments, Institutions, Councils, Scientists and Ayurvedic. Scholars for their whole hearted co-operation in preparing the monographs on Single Drugs. I thank all members of the Ayurvedic Pharmacopoeia Committee without whose co-operation this volume would not have seen the light of day. My thanks are also due to Km. Savita Satakopan, Dr. D.R. Lohar, Director, I/c, PLM, Ghaziabad and his colleagues viz. Dr. P.C. Srivastava, Sr. Principal Scientific Officer (Chen), Dr. Rajeev Kr Sharma, Senior Scientific Officer (Pharmacognosy), search Assistant (Chem.), Shri B.B. Prasad, R.A (Botany), Shri S.K. Gaur, R.A. (Chen.), Shri C.Arunachalam, R.A. (Botany), Shri R.K. Pawar, R.A. (Chem), Shri Hari Om Shankar Gupta, Lab. Asstt. (Chem.), Shri Rajendra Singh, Lab. Asstt. (Chem.), and Shri Sanjeev Gupta, Lab. Asstt. (Botany) who deserve my special thanks for this endeavour. The technical officers of Ayurvedic Pharmacopoeia Committee for preparing the Ayurvedic portion of the Pharmacopoeia viz; Dr. Chhote Lal, Dr. A.K.S. Bhadoria, Dr. M.N. Ragne, Mr. Padam Kumar, Mr. Ashok Kumar and Section Officer (APC) and also other officers who have done a wonderful job in convening the meeting of the committee and completion of this work also deserve my sincere thanks.