Welcome to my blog :)

rss

Friday, June 14, 2013

Scientific Basis for Ayurvedic Therapies -2























Scientific Basis for
Ayurvedic Therapies 


edited by
Brahmasree Lakshmi Chandra Mishra





1
of the act
contains a list of poisonous substances under the Ayurvedic and Unani system. In
addition to the above, other acts that are relevant to the manufacturing of Ayurvedic
drugs are the (1) Medicine and Toiletry Preparation Act, (2) Magic Remedies and Objectionable
Advertisement Act, (3) Poisons Act, (4) Weights and Measurement Act, (5) Shops
and Establishment Act, (6) Dangerous Drugs (Psychotropic and Narcotic Substances)
Act, (7) Patents Act, and, in the future, the (8) Biodiversity Act (which is in the offing).
Three types of agencies are involved in the administration of the acts and rules mentioned
above: the Drug Technical Advisory Board and Drug Consultative Committee,
which act as advisory bodies;

drug testing laboratories, which provide support by shouldering
the analytical responsibilities; and licensing and controlling authorities, which
function as the executive wing. The Technical Advisory Board and the Drug Consultative
Committee have been set up to advise the government on matters relating to ISM drugs.
The Drug Technical Advisory Board (Ayurveda, Siddha, and Unani Technical Advisory
Board) has been functioning regularly. The Drug Controller General of India is in charge
of licensing and enforcing the above acts and rules. At the state level are drug controllers
or Food and Drug Administration Commissioners who shoulder this responsibility. The
drugs manufactured in the Ayurvedic sector are also under their controlling authority. In
some states, like Kerala, there are officers trained in Ayurveda who provide technical
assistance to the enforcing authorities.
Manufacturing of Ayurvedic drugs, except in accordance with the prescribed standards,
is prohibited. It is essential to obtain a license from the licensing authority to manufacture
Ayurvedic drugs. Separate licensing is required for each of the manufacturing premises
maintained by the manufacturer. Manufacturing activity can also be undertaken through
a loan license. For drug manufacturing, it is necessary to maintain a certain level of hygiene
and optimum manufacturing conditions. These conditions are specified in Schedule T of
the act (mentioned under the schedule to the rules). On 23rd June 2000 an amendment
was made in the above act to specify GMP for Ayurveda, Siddha, and Unani drugs. Notice
was made to ensure that (1) raw materials used in the manufacture of drugs are authentic,
of prescribed quality, and are free from contamination; (2) drugs are manufactured according
to standard conditions; (3) adequate quality control measures are adopted; and (4) the
manufactured preparations released to the marketplace are of acceptable quality.

The ISM drug-manufacturing industry is in the process of technical upgrading to comply
with GMP norms prescribed by the government of India. To achieve the objectives listed
above, each licensee is expected to evolve methodology and procedures for following the
prescribed process of manufacture of drugs, which should be documented as a manual
and kept for reference and inspection. However, teaching institutions and registered,
qualified
Vaidyas
,
Siddhas
, and
Hakeems
who prepare medicines on their own to dispense
to their patients and not to sell such drugs in the market are exempt from the purview of
this practice. Part I of two parts contains specification regarding the maintenance of factory
premises; Part II contains the list of machinery, equipment, and minimum manufacturing
premises required.
For the implementation of drug testing provisions under the Drugs and Cosmetics Act
(1940) and Rules (1945), it is necessary to evolve pharmacopoeial standards. At present,
pharmacopoeial standards are available for 258 drugs, and 654 formulations have been
published in the
Ayurvedic Formulary of India
. The Department of ISM is developing
pharmacopoeial standards through pharmacopoeial committees. Three volumes of Part I
of the pharmacopoeia, called
Ayurvedic Pharmacopoeia
, have been published containing 258
monographs. The target is to cover 600 single drugs.
At present, there are more than 8000 licensed pharmacies in the country manufacturing
Ayurvedic drugs. There is the Mumbai-based Ayurvedic Drug Manufacturer’s Association
which can be contacted for further details about issues related to Ayurvedic drug manufacturing.
A drug-control cell in the Department of ISM deals with various issues pertaining to
quality control, import, export, classification of drugs under the Drugs and Cosmetics Act,
patents, and the establishment of a TKDL. It monitors and coordinates implementation
of legislation relating to drugs of ISM & H. The agency may be a good source for information
on matters related to regulations.
1.9 Globalization of Ayurveda
Globalization of Ayurveda has gained momentum. Many active groups have been formed
in many parts of the world, including developed countries, to spread the concept and
practice of Ayurveda. This is due primarily to the following three reasons: (1) the holistic
approach advocated by Ayurveda in therapeutic practice, (2) it has one of the most
extensive and profound conceptual bases among the TMSs of the world, and (3) its survival
for more than 2 millennium as a vibrant medical system. It is believed that Ayurveda has
the potential to develop into a global health-care system.
The first requirement is to undertake globalization of Ayurvedic education to generate
high-quality, competent manpower with the requisite communication skills to teach the
principles and practice of the system. There is a requirement to start introductory, short
and long-term courses as per the local requirement and situation in different parts of the
world. It is also necessary to start similar types of courses in the premier Ayurvedic
institutes in India. Some universities have already taken a step in this direction by starting
short- and long-term courses under its International Center for Ayurvedic Studies. Another
important requirement is to translate important Ayurvedic literature to major international
languages.
The second requirement is to globalize Ayurvedic practice and marketing of Ayurvedic
drugs. There are many obstacles to achieve this, especially in the developed countries.
The laws regulating these aspects are quite rigid and a lot of time, effort, and finance will

be required to comply with them. They do not take into consideration the conceptual
uniqueness of Ayurveda. A two-pronged strategy is required to overcome this problem.
The first one is to undertake multicenter collaborative studies on internationally acceptable
guidelines to prove therapeutic utility and safety of Ayurvedic drugs and practices. The
second one is to establish Ayurvedic clinics and hospitals in countries where there is no
such barrier. Standardization of Ayurvedic drugs and formulations should be given top
priority — without this it would not be possible to promote the utilization of Ayurvedic
drugs at the global level. Another aspect needs to be taken into consideration is the
possibility of existence of constitutional differences among different races and communities
as per the concepts of Ayurveda. Also, it would be necessary to explore the possibility
of utilization and integration of locally available flora into Ayurvedic practice of the
particular country or region.
Facilities have been established in many countries to impart short- and long-term training
in Ayurveda. Such facilities are available in the U.S., Argentina, Australia, Brazil, New
Zealand, South Africa, Czech Republic, Greece, Italy, Hungary, the Netherlands, Russia,
U.K., Israel, Japan, Nepal, and Sri Lanka.
1.10 Research at the International Level
At present, there are no international collaborative studies to validate the therapeutic
claims of Ayurvedic preparations except for some studies carried out on medicinal plants
used in Ayurveda. A recent review

points out that more than 13,000 plants have been
investigated during the past 5 years. A number of medicinal plants have been shown to
possess important pharmacological activities in preclinical testing; however, the generated
leads have not been adequately followed up with double-blind, placebo-controlled clinical
trails. The following drugs are identified for such studies based on existing biological and
clinical data:
Curcuma longa, Boswellia serrata, Picrorhiza kurroa, Terminalia chebula, Emblica
officinalis
,
Bacopa monnieri, Boerhaavia diffusa, Phyllanthus niruri, Celastrus paniculatus, Ocimum
sanctum, Gymnema sylvestre, Momordica charantia, Commiphora mukul, Withania somnifera,
Pterocarpus marsupium, Tinospora cordifolia, Trichopus zeylanicum,
and
Terminalia
arjuna.





One of the main lacunae that becomes apparent for any reviewer of this sector is
that most of the studies are undertaken on an individual pharmacologic-effect basis. These
studies need to be organized and reviewed. Such a review of these studies is likely to
provide scientific basis to the traditional usage of Ayurvedic therapies. It is also of utmost
importance that sufficient attention be paid to the conceptual basis that underlies selection
of a drug or group of drugs to treat a particular disease condition. Furthermore, many
more studies are required to be undertaken on multicomponent formulations and assessment
of possible drug interactions when a person who is already on modern drugs takes
herbal preparations. If the recent trends are any indications, interest in medicinal plantbased
preparations and traditional medical systems is bound to increase.
List 1: Postgraduate Study Centers
1. Central Drug Research Institute, Chattar Manzil Palace, Lucknow 226 001

2. Dabur Research Foundation, 22, Site IV, Sahibabad, Ghaziabad 201 010
3. Himalaya Drug Company, Research and Development Centre, Makali, Bangalore
563 123
4. Institute of Medical Sciences, Faculty of Ayurveda, Banaras Hindu University,
Varanasi 226 004
5. Institute of Postgraduate Teaching and Research in Ayurveda, Gujarat Ayurved
University, Post Box no. 4, Jamnagar 361 008
6. National Institute of Ayurveda, Madhav Vilas Palace, Ajmer Road, Jaipur 302 002
7. National Institute of Pharmaceutical Education and Research (NIPER), Sector 67,
SAS Nagar, Mohali, Punjab
8. National Botanical Research Institute (NBRI, Lucknow), Rana Pratap Marg Lucknow
226 001
9. R.A. Podar Medical College, Dr. Annie, Bessant Road, Worli, Mumbai 400 018
10. Regional Research Laboratory, Canal Road, Jammu, Jammu and Kashmir 181 001
11. State Ayurvedic College, Tulsidas Marg, Turia Ganj, Lucknow 226 004
12. Swami Prakashananda Ayurveda Research Centre (SPARC), 13th N A S Road,
Mittal Nagar, JBPD-Scheme, Juhu, Mumbai 400 049
13. Tropical Botanical Garden and Research Institute (TBGRI), Pacha, Palode Trivandrum
695 562
14. Zandu Research Foundation attached to Zandu Pharmaceutical Works Ltd., 70,
Gokhale Road South (Dadar), Mumbai 400 025
List 2: Regional Research Institutes (RRIs)
RRIs under Central Council for Research in Ayurveda and Siddha (CCRAS), 61-65,
Institutional Area, Opp. D-Block, New Delhi 110058, Ph: 011-5528748/5536520/5624457
(O), 5614971 (R).
Addresses
1. Road No. 66, Punjabi Bagh, New Delhi 110026, Ph: 011-5919128/5411059, Fax:
5464546
2. R.A. Podar College, Worli, Mumbai 400 018, Ph: 022-4947822, Fax: 4947833 (O)
0250-462991 (R)
3. 4, CN Block, Sector V, Bidhan Nagar, Calcutta 700 091, Ph/Fax: 033-3673808
4. RCRI, AA Govt. Hospital Campus, Arumbakkam, Chennai 600 106, Ph: 044-
6214809(O), 6214925 (G), 6265857 (R)
5. Cheruthuruthy, Via. Shoranur, Trichur, Kerala 679 531, Ph/Fax: 0488-462366,
462543 (O), 462544 (H), 622175 (R)
6. No. 1, Bhubaneswar 751 009, Ph/Fax: 0674-530125, 531941 (H), 570650/570705 (R)
7. Moti Bagh Road, Patiala 147 001, Ph/Fax: 0175-212393, 228361(H), 212348 (R)
© 2004 by CRC Press LLC
Ayurveda — A Potential Global Medical System
13
8. Govt. Ayurvedic Hospital, Amhho, Gwalior 474 009, Ph/Fax: 0751-323307, 430317
(Fax), 327959 (R).
9. 474/6, Sitapur Road, Lucknow 206 020, Ph/Fax: 0522-369156, 362341/732238(R)
10. Indira Colony, Jhotwara, Bani Park, Jaipur 320 016, Ph/Fax: 0141-200812/206063,
392174/399646 (R)
11. 1044 Jagnada Chowk, KDK College Rd., Nandanwan, Nagpur 440 009, Ph/Fax:
0712-714230, 242310 (R)
12. Govt. Central Pharmacy Annexe, Ashoka Pillar, Jayanagar, Bangalore 560 011, Ph/
Fax: 080-6562030, 2272208 (R)
13. Poojapura, Trivandrum 695 012, Ph/Fax: 0471-340628, 342070 (R)
14. Indira Gandhi Municipal Stadium Complex A, First Floor, North Wing, Vijayawada
520 010, Ph/Fax: 0866-472535, 481512 (R)
15. Govt. Pharmacy (Upstairs), Indira Nagar, Gorimedu, Pondicherry 605 5006, Ph:
0413-272420 (O), 202097 (R)
16. D Block, Rajindra Memorial Res. Institute Bldg., Agam Kuan, Patna – 800 007,
Ph/fax: 0612-631678, 345775 (R).
17. Borsojai (Bhetapara), Beltola, Guwahati 781 028, Assam, Ph: 0361-303714
18. Tadung, Gangtok, Sikkim 737 102, Ph/Fax: 03592-31494, 81649/81662 (R)
19. New Itanagar 791 111 (Arunachal Pradesh), Ph/Fax: 0361-212284, 211498 (O),
212520 (R)
20. 20, Rewari Chowk, Jammu 180 005, Ph/Fax: 0191-546475
21. Gandhi Bhawan, Mandi 175 001 (HP), Ph/Fax: 01905-35236
22. Tarikhet 263 663 (Uttaranchal), Ph/Fax: 05966-64227, 64222(R)
23. Gwalior Road, Jhansi 284 003 (UP), Ph/Fax: 05174-442132
24. Tajmanzil, Sardar Bagh, Junagadh 362 001, Ph/Fax: 0285-631631
25. Nehru Garden, Kothrud, Pune 411 029, Ph: 020-5383138, Fax: 5386715, 5442338 (R)
26. Indian Institute of History of Medicine, Osmania Medical College Buildings, Putlibowli,
Hyderabad 500 095, Ph/Fax: 040-4657388, 3511259 (R)
27. CSMDRIA, A.A. Govt. Hospital Campus, Arumbakkam, Chennai 600 106, Ph: 044-
6214823/6207566 (O), 6282487 (R)
Chennai 600 113, Ph: 044-2541537
95123380338 (R)
30. CCRAS Main Office, #61-65, Institutional Area, Opp. D. Block, New Delhi 110 058,
Ph: 5528748/5624457
Address: Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan,
Ph: 91-011-5614970/71/72, Fax: 91-011-5528748
No. 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi 110 058 (India)
Further details can be obtained from the Council’s headquarters:
29. Regional Research Institute (Ay), Hastinapur 250 404, Ph/Fax: 95123380176,
28. Dr. A. Laksmipati Research Centre for Ayurveda, VHS Medical Centre, Adyar,

 







Om Tat Sat
                                                        
(Continued...) 


(My humble salutations to H H Maharshi ji,  Brahmasri Sreeman Lakshmi Chandra Mishra ji and other eminent medical scholars and doctors   for the collection)



0 comments:

Post a Comment