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Efficacy and safety validation of traditional products——current regulatory status in India

作者:Dinesh; Kumar; BHARATRAJ

摘要:The traditional medicine differs from country to country and region to region and is dependent on indigenous cultural practices.Since one decade there is a growing demand of natural products as potential preventive and therapeutic agents all over the world.Many international agencies especially WHO recognized Ayurveda,Unani,siddha as a part of integrated system of medicine to achieve health for all.Despite WHO recognition acceptance of Ayurveda has been limited mainly due to:i) Lack of scientific validation in current acceptable terms;ii) A general inadequacy of Good Manufacturing Practices;iii) Non availability of safety profile at pre-clinical and clinical levels;iv) In-adequate documentation of true extent of toxicity;iv) Contamination of herbal products.Therefore,validating therapeutic claims of traditional preparation and evaluation of safety profile has become important not only for global acceptance but for compliance to National and International regulatory guidelines.

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