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The Ayurvedic Pharmacopoeia of India (Volume III, Part I)
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The Ayurvedic Pharmacopoeia of India (Volume III, Part I)
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Preface

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 the 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 publicised 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. 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, 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 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 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 contro 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 & Homoeopathy. 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 PUM, 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 States 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 Pr of. 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. After 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 verify 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.

Introduction

The Ayurvedic system of medicine is prevalent in India since the Vedic period and as early as the dawn of human civilization. Though Ayurveda has under gone many changes in the course of its long history, it still remains the mainstay of medical relief to a large section of population of the nation. Due to urbanisation and dwindling of forests, the Vaidya by and large is no longer a self contained unit collecting and preparing his own medicines as before. He has now to depend on the newly developed agencies like one collecting and supplying the crude drugs and the other undertaking mass production of medicines in the Ayurvedic Pharmaceutical units run on commercial scale.

2. In view of the new trend in Ayurvedic Pharmaceutical field, Government of India considered it expedient to utilise the existing Drug and Cosmetics Act 1940, to also control to a limited measure the Ayurvedic, Siddha and Unani drugs by amending the Act.

3. The Act was accordingly amended in 1964, to ensure only a limited control over the production and sale of these medicines namely:-

The manufacture should be carried under prescribed hygienic conditions, under supervision of a person having a prescribed qualification;

ii. The raw materials used in the preparation of durgs 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.

4. To start with, development of standards for the identity, purity and strength of single drugs and 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 manufacturer standardised, the final product namely, the compound formulation could be expected to conform to uniform standards. The requirements-that the list of ingredients be displayed on the label will enable analysts in important cases to verify label claims and to that extent will bind the manufacture to a true claim. Arrangements to evolve and lay down physical, chemical and biological tests, where necessary, to identify the drugs and ascertain their quality and to detect aduiterations, 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 the All-India and Regional levels 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.





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The Ayurvedic Pharmacopoeia of India (Volume III, Part I)

Item Code:
NAM501
Cover:
Hardcover
Edition:
2001
ISBN:
819011512X
Language:
English
Size:
11.0 inch X 8.5 inch
Pages:
495
Other Details:
Weight of the Book: 1.6 kg
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$40.00   Shipping Free
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Preface

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 the 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 publicised 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. 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, 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 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 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 contro 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 & Homoeopathy. 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 PUM, 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 States 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 Pr of. 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. After 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 verify 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.

Introduction

The Ayurvedic system of medicine is prevalent in India since the Vedic period and as early as the dawn of human civilization. Though Ayurveda has under gone many changes in the course of its long history, it still remains the mainstay of medical relief to a large section of population of the nation. Due to urbanisation and dwindling of forests, the Vaidya by and large is no longer a self contained unit collecting and preparing his own medicines as before. He has now to depend on the newly developed agencies like one collecting and supplying the crude drugs and the other undertaking mass production of medicines in the Ayurvedic Pharmaceutical units run on commercial scale.

2. In view of the new trend in Ayurvedic Pharmaceutical field, Government of India considered it expedient to utilise the existing Drug and Cosmetics Act 1940, to also control to a limited measure the Ayurvedic, Siddha and Unani drugs by amending the Act.

3. The Act was accordingly amended in 1964, to ensure only a limited control over the production and sale of these medicines namely:-

The manufacture should be carried under prescribed hygienic conditions, under supervision of a person having a prescribed qualification;

ii. The raw materials used in the preparation of durgs 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.

4. To start with, development of standards for the identity, purity and strength of single drugs and 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 manufacturer standardised, the final product namely, the compound formulation could be expected to conform to uniform standards. The requirements-that the list of ingredients be displayed on the label will enable analysts in important cases to verify label claims and to that extent will bind the manufacture to a true claim. Arrangements to evolve and lay down physical, chemical and biological tests, where necessary, to identify the drugs and ascertain their quality and to detect aduiterations, 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 the All-India and Regional levels 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.





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