The government has formed a panel to examine the possibility of bringing nutraceuticals under the ambit of the apex drug regulator
The news has been around for a while, putting a big question mark ahead of the Indian nutraceuticals industry. 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, the 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. The centre’s approach towards nutraceutical products has been receiving mixed reactions from industry players and associations. According to our research, along with nutraceuticals producers, pharma players also have their say in 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 a 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 specially processed or formulated for specific nutritional or dietary purposes.
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