History of safe use of herbs - Approaches for documenting evidence.

Approval by regulatory authorities for commerce of herbs to different nations is lengthy process involving quality, safety, and efficacy data submission for the herbs under different category. Submission of documented history of use of herbs in such steps has gained momentum in the last decade globally. EU Directives and Food Regulations, India, specifically describes this requirement.

Ayurveda: (W)here is the evidence.

It is common to hear a general statement that Ayurveda lacks scientific evidence. By scientific evidence, it is commonly referred to results of human clinical trials undertaken adoring those applied to pharmaceuticals, involving randomized controlled trials (RCT), either a placebo or active controlled. This paper explores the actual situation related to practice of Ayurveda, use of medicines, application of therapies, and the individual dravyas (ingredients).

A Perspective on Additional Approaches Beyond Organic Marker Compounds While Developing Analytical Monographs for Botanicals.

Most of the Pharmacopoeia and other monographs that provide the quality specifications for botanicals typically contain identification and physicochemical tests, assays, and limits for contaminants. The assay methods generally involve quantitative determination of known organic compounds, commonly known as markers. The authors explore and propose that there is a need for additional approaches beyond markers, especially for botanicals derived from traditional knowledge and use.

Chyawanprash: A review of therapeutic benefits as in authoritative texts and documented clinical literature.

Ethnopharmacological Relevance: Chyawanprash (CP), a traditional immune booster recipe, has a long history of ethnic origin, development, household preparation and usage. There are even mythological stories about the origin of this recipe including its nomenclature. In the last six decades, CP, because of entrepreneurial actions of some research Vaidyas (traditional doctors) has grown to industrial production and marketing in packed forms to a large number of consumers/patients like any food or health care product.

Approaches to pre-formulation R and D for phytopharmaceuticals emanating from herb based traditional Ayurvedic processes.

Botanicals constitute a large part of the drugs from the traditional medicine (TM) and ethno medicine (EM) known for their history of safe use (HOSU). Phytopharmaceuticals having a base of such origin offer high advantages as they come with safety profiles, and often allow extrapolation of the HOSU data, under certain circumstances. However, while current pharmaceutical technologies are being adopted by the industry to make phytopharmaceuticals with such origin, there is a need for preformulation research and development (R and D) during formulation.