Industry opposes move to bring nutraceuticals under ambit of drug regulations

The Union Government is considering the inclusion of nutraceuticals within the purview of drug regulations, potentially granting regulatory authority to the Central Drugs Standard Control Organisation (CDSCO) over these products. Currently, nutraceuticals are governed by the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, and Prebiotic and Probiotic Food) Regulations, 2022, under the jurisdiction of the Food Safety and Standards Authority of India (FSSAI).

Given that nutraceuticals serve dual purposes as health supplements and pharmaceutical products, a Committee has been formed under the Secretary of Health to address challenges related to uniform enforcement, interchangeable usage of the same nutrient/ingredient at different doses for pharmaceutical and nutraceutical purposes, and concerns about overlapping prophylactic and therapeutic usage, along with claims related to disease risk reduction.

However, the nutraceuticals industry strongly opposes any move to subject them to drug regulations. Industry experts argue that India’s food regulations have evolved to prioritize public health and safety through unified legislation under a single food regulatory authority, namely the FSSAI. They emphasize that the regulation of nutraceuticals and functional foods has received significant attention over the years to address emerging challenges and ensure consumer welfare.

Internationally, nutraceuticals are primarily regulated as food or dietary supplements, aligning with their preventive health focus. Despite superficial similarities with drugs, the industry argues that their distinct functional and usage differences necessitate separate regulatory pathways to maintain consumer safety and confidence.

Industry representatives caution against the potential economic repercussions of reclassifying nutraceuticals as drugs, citing potential impacts on exports, the entire supply chain, and negative consequences for food science, technology, and innovation.

They urge a cautious approach, considering the unique characteristics of nutraceuticals and the broader implications for industry development and consumer welfare before any attempt to shift their classification under drug regulations.