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Govt Panel to Assess Inclusion of Nutraceuticals under CDSCO Review

The government has established a committee to evaluate the potential transfer of nutraceuticals oversight from the Food Safety and Standards Authority of India (FSSAI) to the Central Drugs Standard Control Organisation (CDSCO), aiming to address regulatory complexities and enhance consumer safety. Currently, the FSSAI regulates health supplements and nutraceuticals under 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, covering food items designed for specific nutritional or dietary purposes.

Nutraceuticals, derived from food sources and believed to offer additional health benefits beyond basic nutrition, have prompted discussions regarding uniform implementation challenges, interchangeable usage of ingredients, and overlaps in therapeutic claims. A high-level committee, chaired by the Secretary of the Ministry of Health, has been formed to assess these regulatory issues and ensure consumer safety. Comprising members from various ministries and regulatory bodies, the committee aims to review the evolving landscape of nutraceuticals, given projections that the Indian nutraceutical market will reach USD 18 billion by 2025.

Among its objectives, the committee will explore the feasibility of regulating probiotic and prebiotic formats in both food and drug categories, assess the need for CDSCO oversight of nutraceuticals and health supplements, and examine options for price control and Good Manufacturing Practice (GMP) certification alignment with drug manufacturing standards. Concerns over unsupervised supplement consumption, potential interactions with medications, and antagonistic nutrient effects highlight the importance of clarifying regulatory boundaries and ensuring safe usage practices.


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