Speaking at a press conference, Dr Christoph von Keudell, chief scientific officer of Centers for Medical Innovation, said the guidelines pertain to cultivation, processing and manufacturing of plant-based medicines. The guidelines will also stipulate norms for toxicology studies and evidence-based research. The move to formulate guidelines for plant-based therapeutics indicates a major shift in the US FDA's attitude towards alternative systems of medicine. Until now, the US FDA considered drugs as formulations containing single active ingredients. A plant-based formulation usually contain multiple ingredients along with the active ingredient.
Active ingredients are the ones that demonstrate therapeutic efficacy for a given ailment.
This myopic view of the US FDA towards alternative systems was largely a response to unsubstantiated claims and safety issues related to quality, drug interactions, and the effect of multiple ingredients on human body. The demand for inclusion of alternative therapies as first line treatment is now becoming stronger in developed countries. This is forcing more and more people in the US, Europe, and Japan to go back to their roots. Separate guidelines on botanicals will expand the market for plant-based therapies, feels Dr von Keudell. This market is highly crowded and competitive and is known for its high and multiple unsubstantiated claims.