Are Nutraceuticals DRUGS? Examining a Needless Regulatory Tussle

The news has been around for a while which has put a big question mark ahead of the Indian nutraceuticals industry.

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The news is about changing rules, it is about switching regulations and even about reimagining the entire identity of nutraceuticals. The talk is about moving nutraceuticals from one existing regulatory body to another. Very recently, government has formed a panel to examine the possibility of bringing nutraceuticals under the ambit of the apex drug regulator, Central Drugs Standard Control Organisation (CDSCO) instead of the food regulator Food Safety and Standards Authority of India (FSSAI) to address regulatory challenges and promote consumer safety. This step taken by the centre towards nutraceuticals products has been receiving mixed reactions from the industry players and associations. According to our research, along with nutraceuticals producers, pharma players also have their own say on this particular development. Based on this, it can be said that bringing nutraceuticals under the jurisdiction of the CDSCO rather than the FSSAI could have significant implications, both positive and negative. Let's explore the numerous implications for the nutraceutical industry and the stakeholders involved.

The committee formed by the government has Secretary, Ministry of Ayush; Secretary, Ministry of Food Processing Industries; Secretary, Department of Pharmaceuticals; Chief Executive Officer (CEO), FSSAI; Drugs Controller General of India (DCGI); Director General (DG), Indian Council of Medical Research (ICMR) and Director General of Health Services (DGHS) as members. Presently, the FSSAI regulates the usage 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. This regulation covers food items that are specially processed or formulated for specific nutritional or dietary purposes.

Why this step and why now?