The European Union "has relaxed its norms of 15-year usage criteria under the Herbal Medicinal Product Directive that posed technical barriers to Indian exporters of herbal products", according to a recent communication by the Asia-Pacific Traditional Medicine and Herbal Technology Network.

The move follows a challenge to the new European herbal medicine rules by Indian authorities in August 2005:

"In a letter to EU trade commissioner Peter Mandelson India’s commerce and industry minister Kamal Nath said that this directive would become a barrier to trade since it straightaway removes ayurvedic medicines from consideration, which have been in use in India for centuries but which may not have found a place in Europe 15 years ago." (Reported in India's Financial Express)

After recent detailed discussions between a European Union delegation and Indian health authorities, Dr Konstantin Keller, chairman of the committee on Herbal Medicinal Products of the European Medicines Agency (EMEA) made it clear that producers of Ayurvedic herbal medicines could apply for registration of their products in Europe, even if they had not been in use for 15 years in the European Union.

The European Directive on Herbal Medicines was passed in 2004, as part of a campaign to tighten rules on both nutrients and herbs used for prevention and maintenance of good health. Although no particular problem existed with either herbs or nutrients, the new rules added red tape such as a new registration process for herbs as medicines, and lists of "allowed ingredients" greatly restricting sources for the vitamins and minerals in supplements. The impetus behind these new rules seems to have been a pharmaceutically inspired campaign denigrating the use of and raising doubts about the safety of both nutrients and herbs.

The campaign, which has been going for decades, has made life difficult for both producers of natural health products and practitioners of the healing arts who are not following the pharmaceutical paradigm dear to contemporary western medicine. So the success achieved by India and its Ayurvedic community in getting the restrictive rules relaxed is a welcome break from a string of previous negative news.

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EU relaxes 15-year usage norm for Indian herbal exports
23/01/2007
(see original here)

The European Union has relaxed its norms of 15-year usage criteria under the Herbal Medicinal Product Directive that posed technical barriers to the Indian exporters of herbal products.

With this relaxation of its rules, any manufacturing unit can file a dossier of their products having less than 15 years of documented usage in any of the European Union countries and such a product can be considered for market authorization, Department of Ayush clarified.