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Compendium of Drug Registration Formats of Selected Countries : Volume - 1

By: Central Council for Research in Ayurveda and SiddhaContributor(s): Lavekar, G. S | Padhi, M. MMaterial type: TextTextPublication details: New Delhi Central Council for Research in Ayurveda and Siddha 2009Description: x, 383pDDC classification: 615.32(08)(4/9)
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India is one of the richest Biodiversity Country in the World having more than 2000 medicinal plant species. Many medicinal plants are being exported to various countries mainly in the form of : Crude drugs, Herbal extracts/concentrates, Herbal medicines, Ayurvedic medicines, Neutraceuticals/ Cosmoceuticals, Dietary supplements, Health/Functional foods etc. The regulation pertaining to registration of herbal preparations varies from Country to Country. In some Countries, phytomedicines are well established where as in many others they are regarded as food supplements and not considered as drugs even to the extent of Ayurvedic classical preparations also. In view of the complex situation regarding the export of Herbs/Herbal products, the CCRAS has initiated the efforts to consolidate the information on requirement of Drug registration in various Countries. During the continuous interactions with large number of Pharma Companies especially Herbal Drug industry, it is felt that most of the Herbal companies are in need of basic regulatory requirements for export. Towards this a small beginning is made to help herbal Industry. Present compilations consists of drug registration formats of 60 Countries and we have provided 31 Countries drug registration formats, many more are in the process. out of the selected Countries wherever there is no separate registration form, we have provided common drug registration format/food supplement registration formats are provided.

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