ABSTRACT: The nutraceuticals industry in India has witnessed strong growth, expanding at a CAGR of ~12%-15% in recent years (2020-2023), driven by rising health awareness, increasing disposable incomes, and demand for preventive healthcare. The market, valued at 8-10 billion in 2023, is expected to reach 18-20 billion by 2027, fueled by trends like immunity-boosting supplements, functional foods, and e-commerce penetration. However, the regulatory framework governing this sector remains complex. Nutraceuticals, which fall between food and pharmaceuticals, pose unique challenges regarding their quality, safety and effectiveness. In India, nutraceutical products are categorized as foods and are regulated by the Food Safety and Standards (FSS) Act, 2006. The FSS Authority of India is the primary regulatory body responsible for monitoring the manufacturing and marketing of nutraceuticals in India. Regardless of these efforts, there exists an uncertainty regarding the categorization of nutraceuticals. The main reason is with respect to their therapeutic effect and the form in which they are sold in the market. It closely resembles pharmaceutical products. With the global expansion of these products, it is imperative to ensure their quality and safety. This article critically analyses the current regulatory framework for nutraceuticals in India and also makes a comparative analysis of the regulation of nutraceuticals in various countries. The article also emphasizes the necessity for more rigorous regulation for the manufacturing and marketing of nutraceuticals to ensure the quality and safety of the products, thereby protecting public health.
Haripriya et al. (2026) studied this question.