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)