1. MYTHS AND FACTS ON SAFETY OF AYURVEDIC BHASMAS AND RASA KALPAS: A PRODUCER, PRESCRIBER AND ENDUSER ORIENTED PRAGMATIC APPROACH
N.SRIKANTH
ASSISTANT DIRECTOR
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
Department of AYUSH
Ministry of Health & Family Welfare
Govt. of India

2. BACKGROUND
Ayurveda and other TM have been in vogue in India from the earliest times and serving the medical needs of most of our people.
In recent times the use of Ayurveda and other TM has expanded globally and has gained popularity .
They have not only continued to be used for primary health care of the poor in developing countries, but has also been used in countries where conventional medicine is predominant in the national health care system.

3. BACKGROUND
About 65% of population in India is reported to use Ayurveda and medicinal plants to help meet their primary health care needs (WHO traditional medicine Strategy 2002 – 2005, Document/ WHO/ EDM/ TRM/ 2002)
The safety of this vibrant tradition is attributed
Time-tested use
Textual references and
Supported by scientific studies

4. BACKGROUND
Rasa Shastra is one among the sub-specialties of Ayurvedic Pharmaceuticals that deal with preparation and therapeutic use of Metal and Mineral based Bhasmas and Rasakalpas.
Even though these practices are in vogue since Vedic period, much emphasis has been made during medieval period.
The Ayurvedic classics have specified different methods of preparation and operational procedures since from the collection of raw drugs their purification, processing, method of use, dosage forms etc.

5. SIGNIFICANCE
The significance of Rasa sastra may be attributable to added advantages and patient compliance factors viz.
Required in lesser doses
Causes no distaste unlike herbal drugs
Faster in action
These practices became popular and widely accepted and safely used since long.

6. NEED OF THE HOUR
With the tremendous expansion in the use of Ayurveda worldwide…………….
Safety
Efficacy
Quality Control
of ASU medicines and traditional procedure-based therapies have become important concerns for both
Health authorities and
Public
This has drawn the scientific presentation of facts in universal language. 1 2 3

7. GLOBAL PERSPECTIVE
Some recent articles (An article appeared in JAMA, Dec.15, 2004, Vol.292, No.23) mentioned about the
Toxicity
Presence of heavy metal contents
of certain Ayurvedic Classical/Proprietary preparations .
This has created misconceptions among scientific communities regarding the safety of Ayurvedic Rasa Kalpas and Bhasmas.

8. FACTS
It is true that all Ayurvedic drugs including Rasakalpas and Bhasmas are safe, If they are……..
Prepared and
Used
as per the specifications mentioned in the literature.

9. PIVOTAL FACTORS
The issues may be discussed with the following elucidations…..
Non-observance of classical trends and practices
Drug Design
Inherent phyto -constituents
Export policy

10. NON-OBSERVANCE OF CLASSICAL TRENDS AND PRACTICES
Ayurvedic Pharmaceutical practices strongly recommend various aspects like
GAP,
GFCP and
GMPs
This has relevance in the preparation of quality assured drugs
The issues like place, season, soil from where the drugs are collected and cultivated play a pivotal role in the purity of drug.

11. NON-OBSERVANCE OF CLASSICAL TRENDS AND PRACTICES Contd……
The heavy metal contaminants may be acquired by
The drugs collected from contaminated soils and places
The raw drugs and finished products
If not processed and preserved as per the classical literature, they may result in to unacceptable finished product with contaminants and may lead to toxic symptoms.
Numerous illustrations of adverse effects of improper purification and processing have been narrated in the literature

12. DRUG DESIGN
Bhasmas and Rasa Kalpas are prepared with metals as basic ingredients and they naturally possess certain amount of original ingredients in native form.
These components forms legends with herbal drugs and other substances used in purification and processing .
This unique combination may possibly attributable to safety and efficacy

13. INHERENT PHYTO -CONSTITUENTS
Certain plants used for processing these preparations also possess metals in natural biological form
Vitis Vinifera L. (Draksha) ppm lead
Glycyrrhiza glabra (Liconci/Yastimadhu)-24 ppm Tin
Reference: (http.//
These factors may sometimes appear in the finished products if not properly observed, the manufacturing procedure.

14. EXPORT POLICY
Exporting these products as food supplements and are being exempted from many formalities as required for a drug.
This may some times miss the quality check for certain important components of quality process.

15. SUGGESTED APPROACHES FOR SUSTAINABILITY OF QUALITY AND SAFETY
Observance of classical methods
Limited preclinical Safety studies
Pharmaco- vigilance mechanism
Export policy for ASU drug.
Developing consumer guidelines on appropriate use of ASU drugs

16. OBSERVANCE OF CLASSICAL METHODS
Observance of classical methods of
Purification and SOPs along with
Adoption of all necessary formalities of drug development at par ICH, GCP guidelines, GMP, GLP, GACP guidelines
Integrating them with principles and philosophies of Ayurveda and Siddha.

17. LIMITED PRECLINICAL SAFETY STUDIES
Limited preclinical Safety studies for
Propriety metal based formulations
Reproductive toxicity of RCH ASU products
before their marketing.

18. PHARMACO- VIGILANCE MECHANISMS
Putting the Pharmaco- vigilance mechanisms of classical and propriety pharmaceutical products in to force by ASU Pharmaceutical industry.
Reporting of unusual episodes SAE,AE,ADR
Rechecking the quality based on reported episodes of product oriented SAE,AE,ADR.

19. EXPORT POLICY FOR ASU DRUGS
A separate export policy may be put into force for ASU drugs .
This will ensure the quality check for certain important components of quality process.

20. DEVELOPING CONSUMER GUIDELINES
Developing consumer guidelines on appropriate use of ASU drugs for the benefit of end-user.
It is the need of hour to create awareness among scientific community on suitable use of Ayurvedic medicines for better clarity on their rational uses.
Awareness creation among consumer for rational use of Ayurveda and Siddha medicines and providing clarifications on wrong notions prevailing on the safety of these medications.

21. DEVELOPING CONSUMER GUIDELINES
The ideal component of guidelines comprise …………
Method of preparation
Quality control mechanism and regulations
Selection of prescription by a physician
Diet and practices
Co-medications
Purchase of product
Possible adverse effects on improper use
Reporting mechanism of side effects, etc.
is pivotal for a user for promotion of Ayurveda and Siddha practices.

22. THANKYOU