AMERICAN ASSOCIATION OF PRACTITIONERS AND RESEARCHERS OF AYURVEDA (AAPRA)

13505 Cleveland Drive, Rockville, Maryland  20850

301-762-8262      mishra13505@yahoo.com

 

3 10 06

 

TITLE:  PETITION FOR LICENSING OF QUALIFIED AYURVEDIC PHYSICIANS IN MARYLAND, USA

TO:  PETER A. HAMMEN, CHAIR, HOUSE HEALTH AND GOVERNEMENTAL OPERATIONS COMMITTEE, MARYLAND GENERAL ASSEMBLY

 

FROM: LAKSHMI C. MISHRA, M. PHARM, PH.D., B. I. M. S.

               PRESIDENT AND AAPRA MEMBERS

Supported by:

1.Medical Professional Societies Supporting Regulation of AMI in Maryland:  

(1) Am Assoc. of Physicians of Indian Origin (AAPI) (MDs and AMI  degree holders: >45000 members) V. Koli, MD, President, H. Sharma, MD Chair of Integrative medicine committee AAPI 

(2) Assoc. of Ayurvedic Professionals of North America.

(3) Am. Assoc. of Practitioners, Researchers of Ayurveda

(4)  Florida Vedic College

2. Support from Citizens of Maryland

1.      Over 300 signatures of registered voters of MD

2.      Support letter from India House of Worship

3.      Support letter from Asian Americans for Community Service, Inc.

I. PURPOSE OF THE PETITION 

The purpose of the petition is to regulate Traditional Ayurvedic Medical System of India through licensure of qualified ayurvedic physicians to practice Ayurvedic Medicine of India (AMI) in order to protect citizens from unqualified Ayurvedic practitioners and to provide quality ayurvedic health care.  Minimum qualification required for licensing AMI practitioners in India (the home country of AMI) is a Bachelor of Ayurvedic Medicine and Surgery (BAMS) degree or its equivalent degree.  The degree consists of 4 ½ years of training from an accredited institution and one year of internship in an Ayurvedic hospital (Appendix 1).  American citizens deserve a guarantee of protection from unqualified practitioners of AMI as the citizens of India are protected.  The petition is asking for the state of Maryland to regulate AMI and license BAMS or equivalent degree holders with experience to use Ayurvedic procedures and therapies to diagnose, prevent, and treat diseases.  Since the license does not include allopathic treatments, there is no direct conflict with conventional medicine practitioners.  We are asking for license parameters relevant to traditional practice in the same manner that Acupuncture and Oriental Medicine is regulated. 

 

II. PARAMETERS OF AMI PRACTICES TO BE REGULATED

 

The AMI practice to be regulated will include diagnose, prevention , treatment  and cure of  diseases using standard Ayurvedic disease management procedures, dietary and life style interventions,  therapeutic use of herbs, minerals, herbo-mineral dietary supplements, personal, family and environmental hygiene, spiritual practices, yoga, yogic exercises, breathing exercise, meditation, and spiritual counseling. 

 

III. JUSTIFICATION FOR LICENSING QUALIFIED AYURVEDIC PHYSICIANS (BAMS, BIMS, AMS AND EQUIVALENT FROM ACCREDITED INSTITUTIONS)

 

  1. Regulation of Medical Systems the US:  Many medical systems, e.g., chiropractic, acupuncture and oriental medicine, naturopathy, osteopathy are currently regulated in most states.  AMI which is a very useful therapeutic modality is not regulated in any State. Even massage therapy that does not require diagnosis of diseases and treatment with herbal drugs is regulated in many states.  But AMI, which includes diagnosis, prevention, treatment of diseases by use of herbals, dietary interventions, minerals and Panchkarma procedures such as, strong purgatives, enemas and emetics, requiring significant training and close supervision of patients by a physician, is not.  Even a massage therapy license requires 500 to 1000 hours of training, passage of National Board Exams, and other regulatory steps before being allowed to practice in most states.

Potential Public Health Hazard from unqualified AMI practitioners in the US:  Currently there are over 20 educational facilities in the US (Appendix 2) offering AMI training limited to a total of about 500 hours (less than 300 hours of lectures) and covers primarily health maintenance and life style choices (National Ayurvedic Medical Association web site).  The admission criteria is only a High School Diploma.  None of the schools are accredited by regional accreditation boards such as WASC.  A certificate, such as Clinical Ayurvedic Specialist” given by California College of Ayurveda, implies that a student has mastered and can practice AMI.  The fact is that in order to be a clinical specialist of AMI to be able to diagnose, prevent, treat and cure diseases, the minimum required course work in India is 2860 lecture hours and 700 practicum hours (full time 4 ½ years) and one year of internship. American citizens deserve to be treated by equally qualified physicians as the citizens of India. AMI practitioners with 500 total training hours without a previous medical degree are not qualified to treat diseases as Ayurvedic clinical specialist. However, students are often lead to believe that they can practice AMI as long as they do not use words like “diagnose, prevent, treat and cure” in their communication with patients.  AMI practitioners whose training is limited to 500 total lecture hour and do not hold a separate medical degree are not qualified to treat diseases, however, they are often advised by AMI schools that they can practice AMI as long as they do not use the words like “diagnose, prevent, treat and cure’ in their practice, obtain a signed contract from the patient and operate under a limited liability company (The Law and Ayurveda: Practical Guidelines for Licensed and Non-licensed Health care Providers by Jeff Turner, Light on Ayurveda Vol. IV, Issue 3, page 8). 

 

 

2.   Status of AMI in the UK:  The UK government has recognized the potential hazard and acknowledged BAMS degree (Bachelors of Ayurvedic Medicine and Surgery) in AMI for licensing ((2002-09-27 – NPI center News).  Herbal Medicine Regulatory Working Group (HMRWG) of UK is responsible for working out the details for regulating herbal practitioners including AMI.  “Based on the current timetable, it is anticipated that the U.K. acupuncture and herbal professions could be registered as early as 2006” (HerbalGram. 2004;62:66-67 © American Botanical Council.  By Michael McIntyre).

3.   India to teach AMI in the US:  Thursday , Jan 12, 2006, IST PTI
NEW DELHI: In a major step towards promoting Ayurvedic studies in the US and tapping its $40 billion herbal market, India has cleared the proposal to send experts to teach AMI in 10 American medical colleges.
"Prime Minister Manmohan Singh has extended his full support for the proposal and we are in touch with officials of the AMI Department in this regard,'' said Navin C Shah, a senior medical representative of Indian doctors in the US. For details call Dr. Navin Shah, 301 699 3192 ; Dr. K.K. Dwivedi, Embassy of India,
202-939-9803.

4. Scope of AMI Training: The subjects included in the BAMS training program are listed in Appendix 1.  The major subjects are: (1) Sharir Rachana (Anatomy), (2) Sharir Kriya (Physiology), (3) Padarth Vigyan (Ayu. Physics), (4) Bhasajya Kalpana (Ayu. Pharmacy), (5) Rasa Shastra (Ayu. Drugs of Metals and Mineral origin), (6) Dravya Guna (Ayu. Pharmacology), (7) Kaya Chikitsa (Medicine, Charak and Ashtanghradaya Samhitas), (8). Shalya Chikitsa (Minor surgery, Susruta Samhita), (10) Shalakya Chikitsa, (Eye, Ear, Nose and Throat), (11) Kaumarbhratya (Pediatrics), (12) Prasuti Tantra (Obstetrics), (13) Stri Roga (Gynecology), (14) Bhutavidya (Psychiatry), (15) Swasthyavrat (Hygiene, mediation, Yoga, life style changes, dietary choices), (16) Agadtantra (Toxicology and Forensic Medicine)  (17) Rasayan Tantra (Science of Health and Longevity), (18) Vajeekarantantra (Ayu. Procreative Activity and Rejuvenation). http://www.ccimindia.org/curriculum_ayurveda_1_7.htm  The training covers conventional medical subjects as an integral content of the AMI courses.  Students are also familiarized with the conventional drugs and interactions with Ayurvedic drugs. The program is designed to allow for smooth cross referral between conventional and AMI practitioners. 

5. No Conflict with Conventional Medicine:  A license will include only the right to  use ayurvedic diagnostic methods, diagnosis, prevention, treatment recommendations and treatment protocol; the license would NOT allow the use of conventional medicine treatments.

6.  Validity and Scientific Basis of Ayurvedic Therapies: Indian government   agencies      and universities have studied AMI and published findings in conventional medical journals included in the National Library of Medicine and indexed in Index Medicus. Additionally, the NIH, private foundations and ayurvedic herbal products manufacturers have expended millions of dollars in funds to underpin the safety and effectiveness of AMI therapies.  Many of these findings from the pharmacological, biochemical and clinical studies have been summarized in (www.redwingbooks.com/products/books/SciBasAyuThe.cfm) Scientific Basis of Ayurvedic Therapies, CRC Press Florida, 2003.    

7.Popularity of AMI: “Even in such major cities as New Delhi, which boasts several world-class medical facilities, AMI is widely embraced.  Pharmacies stock AMI remedies alongside conventional medical products such as antibiotics” (Washington Post, 1/8/06).

8.Ayurvedic Pharmacopoeia and Formulary of India:  Briefly, AMI has over 1000 therapeutic herbs of which over 326 have been included in the Ayurvedic Pharmacopoeia of India.  In addition, the Ayurvedic Formulary of India has over 780 Text formulas of animal, mineral and plant origin. These books provide specific standards for formulations and testing Ayurvedic herbs and Text formulas.  The Government of India has set up the following permissible limit for heavy metals in Ayurvedic products containing only herbal ingredients for oral administration:  lead, 10 ppm, Cadmium, 0.30 ppm, arsenic 10 ppm, and mercury, 1 ppm.  

9.Usefulness of AMI:  Ayurvedic Text formulas and single herbs are known to be useful in the management of chronic diseases, psychiatric disorders, neurological disorders and maintenance of good health, particularly when patients become resistant to conventional drugs or are unable to utilize conventional drugs due to co-morbidities which put them at risk for side effects from conventional treatment.  Volumes of effectiveness/ efficacy, and safety data have been published both in India as well as the West.

10.  Education:  Education in AMI at the college level, equivalent to BAMS, will be more easily facilitated in states where it is regulated.  

11.  Growth of AMI: Maryland could be on the forefront of the growing interest in Ayurvedic medicine with co-operation among practitioners, users of the medical practice and the government. 

12.  Supply of AMI Products: With regulation, Ayurvedic suppliers will be encouraged to open outlets in Maryland increasing the tax base while providing local access to high quality Ayurvedic products.

13.  Third part payment:  Although, Complimentary Alternative Medicine health services are often not covered by third party payers in the way conventional health services are.  However, many CAM therapies (e.g., Acupuncture and Oriental Medicine, Chiropractic) are given a % discount by third party payers.  AMI services are not given such discounts.

14.  Health Care cost:  AMI may bring down the health care cost by providing an alternative therapeutic system.  

1) AMI is known to produces desirable therapeutic effect without causing adverse health effects, thus may save health care costs from the treatment of side effects known to result from treatment with conventional dugs. (Appendix 3)

(2) AMI is not known to cause delayed adverse health effects or co-morbid conditions which sometimes develop years after the use of a conventional drug, again saving the cost of treating the secondary disorders. (Appendix 3)

(3) Based on available data AMI formulas are proven useful dietary supplements to improve health, strengthen the cardiovascular system, immune system, improve memory, and relieve depression.  The formulas are also cited in Texts to reduce the frequency of illnesses. Through the emphasis on prevention, health care cost may be reduced. 

(4) AMI therapies and Text formulas are herbal or herbo-mineral, thus, can not be patented.  The use of the formulas should be less expensive.

 

It is apparent from the scope and extent of AMI that there is a great need for the regulation of AMI in the US so that a minimum standard of education and experience necessary to practice AMI can be enforced to protect the public and establish it as a reliable and safe medicine in the US.

 

IV. AVAILABLITY OF QUALIFIED AMI PHYSICIANS

 

There are over 200 accredited AMI colleges and over 367,528 registered qualified ayurvedic physicians in India (Dep. Ayush India web site).  There are many AMI graduates in the UK.  There is no formal registry to provide any proof of the exact number of AMI graduates in the US because there is no licensing.  We believe there are a few hundred BAMS degree holders in the US.

 

In Maryland and other states such as California, there are many persons with degrees in Ayurvedic medicine, trained in India, who because of lack of regulation see patients in their homes for moderate fees and have to refer patients to Indian grocery stores or have their relatives ship the herbals to them from Indian outlets which may or may not have followed the GMP standard.  Additionally, there are those persons trained in mail order courses or in short courses of 200-600 hours who wish to stay off the radar screen of any regulatory body.   This is how AMI is being practiced in the USA.  As a result, it is currently impossible to determine how many persons are practicing AMI in Maryland or any other state and how many patients treated.  Size of  the membership in Ayurvedic organizations is a poor measure of numbers of professionals in the same way that membership in the American Medical Association is not an accurate measure of physicians in this country—a fact that has been demonstrated in the past.

Additionally, there will be those who will not practice, in spite of having the BAMS degree, due to fear of malpractice issues as the medical discipline is not regulated and therefore generally uninsurable. As soon as BAMS and equivalent degrees in AMI are recognized, licenses are given, the number of qualified degree holders will increase considerably similar to Indian MDs. 

V. IS THERE A PUBLIC OUTCRY FOR THIS MEDICAL SYSTEM?

 Yes. The public has complained about wrong diagnosis of disease, useless treatment and overcharging for a long time from conventional medicine practitioners.  Subsequently, patients can go to regulated AOM practitioners but do not know where to turn for Ayurvedic treatment. Many of the community members have been highly verbal in their desire for regulation. 

VI. WHY ARE THERE SO FEW COMPLAINTS REPORTED AGAINST PRACTITIONERS?

The public does not know where to file complaints; with no system in place for regulation,   patients merely go to another health care practice for treatment if unhappy with the practitioner. Absence of complaints in official files does not necessarily mean absence of health risk.

VII. HAVE OTHER STATES IN THE US REGULATED THIS PROFESSION?

No.  Although AMI has been practiced in India for over 5000 years, it is new to US.  People have been using the non-drug therapy portions of AMI e.g. Yoga, meditation, spiritual counseling for over 50 years in the US but herbal treatments and other measures of the health care system have not been used until the 1980’s.  The Government of India has moved forward in advocating global usefulness of AMI as contemporary scenario of health care through global net works. (Appendix 4)

VII. ARE WIDELY ACCEPTED TESTNG STANDARDS AVAILABLE?

Yes.  Widely accepted testing standards are available.  Ayurvedic Pharmacopoeia of India (four volumes and over 1000 pages) has been established by the Ministry of Health and Family Planning, Department of Ayurveda, Yoga, Naturopathy Unani, Sidha, and Homeopathy (Ayush), Government of India New Delhi India, Controller of Publications, Civil Lines, New Delhi India.  The Pharmacopoeia lists all standards for each Ayurvedic herb similar to drugs listed in US Pharmacopoeia. The standards for herbs include macroscopic and microscopic description, foreign matter, total ash, acid insoluble ash, alcohol soluble extractives, and water soluble extractives. It also gives methods to test for total heavy metals, lead, mercury, and arsenic and active ingredient if known.   In addition, the Ayurvedic Formulary of India published by Ayush contains the constituent herbs of each formula with the amounts of each herb and other ingredients along with therapeutic indications. These books are described in detail in article XIV.  These books can be made available on request.

VIII. DOES AYURVEDIC MEDICINE MANUFACTURED BY LICENSED PHARMACEUTICAL COMPANIES CONTAIN UNSAFE LEVELS OF LEAD?

Although the permissible levels of heavy metals have not been formally set by US FDA, the Government of India, Department of AYUSH has set following permissible limit of heavy metals in Ayurvedic products with only herbal ingredients:  lead, 10 ppm, cadmium, 0.30 ppm, arsenic 10 ppm, and mercury, 1 ppm.  It is important that qualified physicians knowledgeable about the available safe drugs are licensed.

IX. INSURANCE COVERAGE:

Ayurvedic practitioners are advised to prepare a waver form and have patients sign it.  They are also advised to search for city ordinances concerning the scope of practice limitations and the presence of a registered nurse while performing invasive procedures or refer patients to a qualified MD physician.  After the AMI practice is regulated then practitioners will be required to carry insurance coverage.  Without a license to practice it is very difficult to get insurance coverage.  At this time Ayurvedic practitioners without an MD degree are legally  not allowed to “diagnose, prevent, treat and cure” diseases and limit their practice to health maintenance by life style changes and Yoga exercises.  

In more conventional clinics in California, persons practicing AMI had to work under the umbrella of a practitioner whose discipline was government regulated.  This situation was the case even if the licensed practitioner knew nothing about AMI.  This scenario is not the solution.

 

X.  PROPOSED LICENSE CRDENTIALS 

Persons with a BAMS or an equivalent degree, one year of clinical experience and passing a National AMI Board Examination will be considered qualified for a license to practice AMI which includes diagnosis, prevention, treatment and cure of diseases using ayurvedic methods and therapies.  The minimum Ayurvedic Program course work required consists of 2860 lecture hours and 700 practicum hours, a total of 3,560 hours, as required for BAMS degree by CCIM in India (Appendix 1.).  After AMI is regulated in Maryland, US trained practitioners with 500 hours of course work and 100 hours of practicum in Yoga, meditation, spiritual counseling, herbals and dietary intervention will not be eligible for a license to practice AMI. They may be eligible to be a Lifestyle Coach based on their training after they pass a board examination for the life style choice subject content. They will not be allowed to call themselves Ayurvedic Practitioners or Physicians. 

 

XI. FOLLOWING APPENDICES ARE AVIALBALE ON REQUEST

 

1.      CCIM curriculum for BAMS degree program in AMI

2.      AMI Educational facilities in the US

3.      Conventional drugs banned for serious adverse health effects

4.      Government of India initiative to globalize AMI

5.      Frequently asked questions about AMI

6.      Brief history and principles of AMI

7.      Sources of theoretical and scientific knowledge of AMI

8.      Ayurvedic research

9.      AMI Education in the US and in India

10.  AMI drug regulations

11.  Manufacturing of AMI drugs

12.  Regional Research Centers of AMI

13.  Post Graduate Study Centers

14.  Effectiveness of AMI confirmed by CCRAS clinical trials     

15.  List of AMI drugs with confirmed therapeutic activity