?Standardization of clinically validated polyherbal formulation?.

Since both EU & US now have mandatory GMPs in place for all the products coming onto the market, there is significant recognition by the herbal drug industry for the absolute standardization to ensure batch to batch consistency. The concept of phyto equivalence is also in practice in order to ensure consistency in efficacy of herbal products. According to this concept, a chemical fingerprint profile of efficacy proven herbal product should be constructed which will serve as the reference for the quality control at commercial scale. An exercise was carried out to establish the phyto equivalence by generating the fingerprint profile of the clinically validated product and simultaneously standardizing the two antidiarrheal herbs Acacia catechu & Berberis aristata with their respective bioactive markers to ensure quality and efficacy of the product Diaroak, a proprietary polyherbal formulation of AYURVET.