Indena illustrates guidelines for
biologically complex materials

New Delhi, 3rd February 2005 – On the occasion of the 2nd International Nutraceutical Summit in New Delhi, Ezio Bombardelli, President of the Scientific Board of Indena, gave a talk on the approaches to establishing the quality of biologically complex materials.

Indena is committed to guaranteeing quality in this field, and is tireless in suggesting ways forward both to regulatory authorities and throughout the industry itself.

“During the last fifteen years – said Dr Bombardelli – we have witnessed a proliferation of formulations containing botanical derivatives, marketed around the world mainly as food and dietary supplements.This rapid, yet unpredictable, development has led to changes in the ways in which botanical products are managed.Legislators are now faced with the task of writing down new rules to protect consumers from malpractice as well as dangerous side effects.”

The tendency around the world is to harmonize the basic concepts concerning in the first place safety and, secondly, the efficacy of a plethora of products.Due to the confusion created partly by the growing demand and partly by speculation, poor quality products found their way into the marketplace, systematically eroding the credibility of many botanical preparations.Safety is the chief concern.The use of untested products, prepared from any kind of plant material without proper GMP preparation and biological controls, has resulted in a disturbing number of side effects.

“To win over consumer confidence, continued Dr Bombardelli, we have to return to basics in the preparation of botanical extracts.We have to follow the concepts of standardization rigorously and scientifically assess both tolerability and efficacy.It is very important to bear in mind that by changing the preparation method of a given extract, the biological profile of the final product may also be dramatically changed.The presence of unknown substances may well have a significant role to play, which is why NMR and NIR spectroscopy has been introduced in the characterization of the extracts”. Bombardelli cited as an example the preparation of Ginkgo biloba, Hypericum perforatum or Serenoa repens extracts, very popular products which are marketed in several countries both as a prescription drug and as a health food product.

The New Delhi international symposium bestows particular relevance on the nutraceutical market, one of the world’s fastest growing segments today.

The occasion provides an important meeting ground for experts and researchers from all over the world to discuss the latest advances in dietary supplements.The Indian Government was well represented at the three-day event, which opened in New Delhi on February 3rd.

2nd Nutraceutical Summit:

http://www.nutraceuticalsummit.com

Press contacts:

Sylvia Moy, Lorenzo Petracco, Elena Silva – Cohn & Wolfe

Tel. +39.02.202391 – Sylvia_Moy@it.cohnwolfe.com

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