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Regulatory guidelines for nutraceuticals in India: an overview


Mar 02, 2021

Nutraceuticals are the bioactive substances and constituents of herbs and minerals or those dietary supplements which have therapeutic activity. They are supplied as dosage formulations, in addition to the basic nutritional value found in foodstuffs, and have emerged as an essential component of the diet for the common consumer. Vitamins, minerals, fatty acids, pre- and probiotics, herbal supplements, etc. are now widely consumed globally for prophylactic and therapeutic purposes, and this has made the maintenance of safety and quality standards extremely important. The rapidly expanding global nutraceutical industry has further emphasized the need for development of such regulatory guidelines. Though regulations in the United States, United Kingdom, and Europe are streamlined and have become conducive to the development of nutraceutical products, the Indian industry and regulatory scenario are relatively nascent and has great potential to develop to compete with the other international agencies. This is a rapidly growing industry in India and several initiatives have been taken in this direction to make India one of the key players in the area of nutraceuticals in the years to come.

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