Ministry of Health and Family Welfare A panel has been set up to monitor the Regulation of nutraceutical ProductsWhich aims to transfer its supervision from the Food Safety and Standards Authority of India.FSSAI) Central Drugs Standard Control Organisation (CDSCO,

This proposed change is aimed at enhancing quality control nutraceuticalsThe proposal has been passed to address concerns over the prevalence of fake and counterfeit products in the market. If the proposal is approved, nutraceuticals could be placed under the purview of the National Pharmaceutical Pricing Authority (NPPA), subjecting them to stricter scrutiny, restricted access, and potentially higher prices under certain conditions.

Although the government’s concerns are justified given the significant growth in nutraceutical consumption in India, a more nuanced and in-depth examination of the products, their regulation, and their alignment with existing laws and regulations is required.

Currently, the Food Safety and Standards Authority of India (FSSAI) regulates the quality of nutraceutical products, while their use and market control remains with the consumer. Such a move could significantly increase regulatory requirements, expenses, and scrutiny. While the industry facilitates easy and affordable access to important health and food SupplementsIronically, a government panel is aiming to restrict access to these products and increase scrutiny of them.

Pharmaceuticals and nutraceuticals are two distinct categories of drugs that provide health-enhancing benefits, which often appear separate from one another. Pharmaceuticals are generally approved drug compounds designed to treat diseases and provide immediate relief. In contrast, nutraceuticals are nutrient-rich dietary substances derived from whole foods or parts of food sources, which provide health benefits beyond essential nutrition. The latter are formulated using whole foods or their parts, making them more akin to food than medicine. As a result, their mode of action is typically slow, positioning them as affordable and accessible products to improve health. Furthermore, global examples have set a clear trend for these supplements to be regulated under the food authority rather than drugs. Leading countries such as Japan, Australia, Canada, Europe and the United States collectively hold 90 per cent of the global share and regulate nutraceuticals as food products. They recognize the fundamental differences between nutraceuticals and drugs and the implications thereof. It is important to maintain separate regulatory frameworks for nutraceuticals and drugs to ensure proper monitoring.

The International Alliance of Dietary Supplement Associations (IADSA) has recognized the need for a shared understanding of food supplements and their global implementation. To this end, they have introduced CODEX, a comprehensive guide that establishes standards for supplement marketing. These standards can serve as an excellent basis for a comprehensive understanding of nutraceuticals, the degree of variation in global laws and regulations, and how these supplements differ from drugs and their use cases.

Health supplements are currently regulated under Section 22 of the FSSA, which stipulates their relevance and familiarity with food products. However, with the aid of digital technology and the proliferation of direct-to-consumer (D2C) and e-commerce channels, nutraceutical brands have the potential to provide better access to high-quality nutrition and supplements tailored to individual needs. Ayurveda and India’s rich history in Ayurveda Homeopathy It enjoys a unique advantage in the nutraceutical industry, resulting in lower manufacturing costs and a competitive edge in pricing. This is further enhanced by official website reports on food processing, claiming its vital importance in India’s economy and export potential.

The country’s nutraceutical market is estimated to be worth US$4-5 billion at a CAGR of 21 percent, making it the global leader in the sector. Interestingly, about 71 percent of Indian households regularly consume nutraceuticals such as vitamins, minerals and herbal supplements, indicating the wide acceptance of these products. As preventive healthcare takes center stage, this will result in rapid growth in the nutraceutical market, reflecting the huge potential of the Indian market in manufacturing and consumption.

However, the recent establishment of the panel represents a regressive step rather than a proactive measure, as it undermines the growth of the industry, which is the opposite of its intended purpose. Given the important role of nutraceuticals in our lives, it is pertinent to understand their differences from medicines and their functioning and adopt a more comprehensive and nuanced approach towards their regulation. With promising growth indicators, consumer safeguards must be in place to ensure informed access to these supplements.

This article is written by Dr. Fauzia Khan, Member of Parliament, Rajya Sabha.

(Disclaimer: The views expressed are solely of the author and ETHealthworld.com does not necessarily agree with it. ETHealthworld.com will not be responsible for any damage caused directly or indirectly to any person/organisation)