EU relaxes 15-year usage norm for Indian herbal exports
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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.