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A Study on Nutraceutical Products in India: Need of Harmonization in Global Scenario

Shashi Kiran



During the study of regulatory guidelines for nutraceuticals and functional foods in India, it was noted that introduction of FSS act in 2006 was a major milestone in integrating of different food laws in India. The FSS act, replaced diverse local laws (such as PFA act. Essential commodity act etc.), post which the Indian regulatory structure of food products has meaningfully progressed. During this journey, the functional food and nutraceutical terminology came into being in 2016. With the introduction of FSSAI and implementation of regulations of functional food and nutraceuticals, a strong framework was established for nutraceuticals in India. Under these regulations, stringent guidelines have been laid down in the context of providing evidences to support health claims of nutraceutical products and to ensure the quality and safety of these products. Moreover, being elected as the regional coordinator for Codex in Asia, India has recognized itself at the international platform. For the registration of nutraceuticals in India, the product should comply with the quality requirements laid down in Indian Pharmacopoeia. Although the approval of existing nutraceutical ingredient can be granted based on usage history (minimum 15 years in India) in India; a requirement for adequate scientific evidence has been specified for a new ingredient approval which should include controlled clinical trials, nutra-epidemiological data and published scientific literature. Due to multiple different terminologies of health foods in India such as health supplement, nutraceuticals, food for special dietary use, FSMP; there are scenarios that applicants were submitting their applications under incorrect categories. FSSAI has tried to explain the difference between these categories along with the examples in 2020 gazette release to avoid any further confusion. Furthermore, the Indian regulatory system is also moving towards having a regulated system of collection and reporting of adverse events related nutraceutical/herbal products with AYUSH introducing a central sector scheme for post marketing adverse event reporting and collection of Ayurveda, Unani, Siddha and Homoeopathy drugs.


Keywords: FSSAI, HCP, IOM, NDI

Citation: Shashi Kiran. A Study on Nutraceutical Products in India: Need of Harmonization in Global Scenario. Research & Reviews: A Journal of Pharmacognosy. 2022; 9(3): 1–9p

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