A government panel has been convened to assess whether nutraceuticals should fall under the purview of the Central Drugs Standard Control Organization (CDSCO) instead of the Food Safety and Standards Authority of India (FSSAI), with the aim of addressing regulatory challenges and enhancing consumer safety. Currently, the FSSAI oversees the regulation of 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 specifically formulated for nutritional or dietary purposes.
Nutraceuticals derived from food sources and believed to offer additional health benefits beyond basic nutrition, pose challenges in consistent implementation and enforcement, as well as in distinguishing between their usage for pharmaceutical and nutraceutical purposes. To tackle these issues and ensure consumer safety, a high-level committee chaired by the Secretary of the Ministry of Health has been established.
The committee comprises members from various relevant ministries and organizations, including the Ministry of Ayush, the Ministry of Food Processing Industries, the Department of Pharmaceuticals, FSSAI, the Drugs Controller General of India, the Indian Council of Medical Research, and the Director General of Health Services. With the nutraceutical market in India projected to grow significantly, officials highlighted concerns regarding the therapeutic usage of many health supplements and the ambiguous distinction between nutraceuticals and drugs.
Besides, the committee will explore the feasibility of regulating probiotics/prebiotics in both food and drug formats, assess the need to bring nutraceuticals and health supplements under CDSCO jurisdiction, and consider implementing price controls for regulated categories. Additionally, it will evaluate the feasibility of implementing Good Manufacturing Practices (GMP) provisions and certification for nutraceuticals in alignment with drug manufacturing standards. These measures aim to mitigate potential risks associated with the unsupervised consumption of supplements and ensure the safety of consumers.