Gov to review if nutraceuticals can shift to CDSCO from FSSAI

India’s health ministry has formed a committee to explore shifting nutraceuticals from food regulation under Food Safety and Standards Authority of India (FSSAI) to drug regulation under Central Drugs Standard Control Organisation (CDSCO). This move seeks to address challenges in managing the rapidly growing nutraceutical market and prioritize consumer safety.

Currently, FSSAI oversees health supplements and nutraceuticals, which are food-based products claiming additional health benefits. However, concerns exist about inconsistent enforcement, interchangeable use of ingredients in drugs and nutraceuticals, and potential misuse for disease management.

Officials highlighted issues like unclear demarcation between therapeutic and nutritional usage, leading companies to seek FSSAI approval for drug-like ingredients. Additionally, unsupervised use and potential interactions with medications raise safety concerns.

The committee will assess the feasibility of regulating probiotics and prebiotics in both food and drug formats. It will also explore bringing nutraceuticals under CDSCO’s stricter purview, considering price control, Good Manufacturing Practices (GMP), and certification.

With the nutraceutical market projected to reach $18 billion by 2025, ensuring safety and clarity in regulations becomes crucial. This review could lead to significant changes in how nutraceuticals are regulated in India, impacting industry players and consumers alike.