Evidence Based Safety of Ayurvedic Herbo-Mineral Formulations

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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.

Ayurvedic has specified different methods of preparation and operational procedures since from the collection of raw drugs their purification, processing, method of use, dosage forms etc. As these drugs required in lesser doses, causes no distaste unlike herbal drugs and faster in action, these practices became popular and widely accepted and safely used since long. With the tremendous expansion in the use of Ayurveda worldwide, safety and efficacy as well as quality control of herbal medicines and traditional procedure-based therapies have become important concerns for both health authorities and the public which draw the scientific presentation of facts in universal language.

Some recent articles published in some journals have mentioned about the toxicity, presence of heavy metal contents of certain Ayurvedic Classical/Proprietary preparations which is creating misconceptions among scientific communities regarding the safety of Ayurvedic Rasa Kalpas and Bhasmas.

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 . Ayurvedic Pharmaceutical practices strongly recommend various aspects like GAP, GFCP and GMPs which has relevance in the preparation of quality assured drugs The issues like place, season, soil from where the drugs are collected and cultivated playa pivotal role in the purity of drug. 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.

The pharmacovigilance of metallic and mineral preparations are well documented and the possible remedial measures of adverse effects on improper use have been advocated in Ayurvedic literatures and are to be prepared and prescribed rationally following the textual advocacy. Further more certain Scientific experimental studies conducted by CCRAS and other institutions on safety profile of metal based Ayurvedic drugs revealed the safety of these formulations at therapeutic dose level.

The information from published sources such as books, monographs, journals, and web based search engines etc. has been compiled, systematically arranged and edited by experts in concerned fields to make the document as an authentic source of reference.

I would like to place in record of appreciation; the efforts put in by Scientists of CCRAS in bringing out this document. The technical support extended by Senior Research fellows of this Council is duly acknowledged. I am convinced that this compendium would certainly help the Scientists and Scholars pursuing research, Academicians, physicians, Pharmaceutical Industries, policy makers etc. as a resource document.

**Contents and Sample Pages**