Looking at the mounting healthcare costs in the West and Japan and realizing the potential contribution that natural products can make to reduce national healthcare bills, most Governments have woken up to the need to either provide better access to proven & safe nutraceuticals or give concessions to multi-active partially characterized phyto products to shorten approval time and costs.

The FDA and European regulators have recently provided this concession and have significantly lowered the bar for approvals botanicals vis-à-vis chemicals and biologicals in these regions. These guidance documents have allowed fast track and low risk development of botanicals to be approved as regular pharmaceuticals. Botanical drug products (or Herbal Medicinal Products as they are known in Europe) will ultimately compete alongside conventional in the $ 500 billion global pharma market.

Exotic Naturals, having realized this business opportunity, plans to embark on a Botanical drug Development program in 2009. Our business model involves first getting useful history of safe usage in the US markets via the dietary supplement route and then fast track into Phase IIb under an IND application with FDA.