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.

Dr Konstantin Keller, chairman of the committee on Herbal Medicinal Products (HMPC), European Medicines Agency (EMEA) and Department for International Pharmaceutical Affairs, Federal Ministry of Health, Germany, made this point clear in his talks with AYUSH secretary Anita Das. He is, currently, leading an expert delegation of the European Commission on pharma and biotechnology.

Both the sides held detailed discussions on various issues relating to regulation of teaching practice and quality control of Ayurvedic products in the country. The Indian side expressed its concerns arising out of the Herbal Medicinal Product Directive of the European Union.

The Indian side while appreciating European Union's public health concerns on safety and quality control of herbal medicinal products impressed upon the European Union expert team that the condition of 15 year usage in Europe and quantitative determination of all the ingredients in any herbal formulation pose technical barriers to the trade of Ayurveda products in European Union.

The European team would be presenting their report to the India-EU Joint Working Group on Pharma and Biotechnology, which is scheduled to meet in New Delhi in the first quarter of 2007 for further steps.

European Commission also invited Indian scientists and experts in Ayurvedic drugs to participate in the process of development of monographs on medicinal plants being prepared by EMEA.

Other members of the delegation are Rul Santos Ivo, Policy Officer-Administrator, Pharmaceuticals Unit, European Commission and Anthony Humphreys, head of the regulatory affairs and organisational support sector, EMEA.

The Indian side emphasized that Ayurveda is a holistic health science and its teaching, practice and products are properly regulated in India and EU's concerns relating to safety and quality control are being addressed by mandatory testing for heavy metals/microbial load/pesticide residue and institution of export inspection mechanism.

Earlier the members of the commission visited Maharishi Ayurved manufacturing unit in Noida, regional research laboratory, CSIR, Jammu and Arya Vaidyasala, Kottakal to get first hand experience of standardization and quality control work being done on Ayurveda products and authentic Ayurvedic treatment for chronic disease conditions.