Current Regulatory requirements for Registration of Nutraceuticals in India and USA

  • Pooja Nemichand Jain no
  • Meera H. Rathod
  • Vineet C. Jain
  • Vijayendraswamy S. M.


There is growing recognition of the potential role for nutraceuticals and dietary supplements in helping to reduce health risks and improve health quality. Pharmaceutical and nutritional companies are aware of the monetary success taking advantage of the nutraceuticals and dietary supplements. Nutraceuticals has proven health benefits and their Consumption will keep disease at bay and allow humans to maintain an overall good health. Functional foods and internationally products represent a value added growth opportunity both domestically and internationally. Development of better characterized and research proven products will help enhance consumer confidence in nutraceutical and functional food products in the world. Regulatory aspects of such products were in a state of confusion in 20th century. Till date the regulations are not harmonized for the globe and change from country to country. But now it is clearly understood that the regulations for clinical evidence and safety of such products cannot be less stringent than rules for modern medicines and thus the science of nutraceutical is progressing. The global nutraceutical market will reach $285.0 billion by 2021 from $198.7 billion in 2016 at CAGR of 7.5% from 2016-2021. The present research has been devoted towards better understanding of the nutraceuticals and its regulation in India and USA.

Keywords: Nutraceuticals, dietary supplements, Regulations, Market scenario


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How to Cite
Jain, P., M. Rathod, V. Jain, and V. S. M. “Current Regulatory Requirements for Registration of Nutraceuticals in India and USA”. International Journal of Drug Regulatory Affairs, Vol. 6, no. 2, June 2018, pp. 22-29, doi: