The government has formed a panel to examine the possibility of bringing nutraceuticals under the ambit of the apex drug regulator CDSCO instead of the food regulator FSSAI to address regulatory challenges and promote consumer safety Presently, the Food Safety and Standards Authority of India (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.
According to official sources, this regulation includes food items that undergo special processing or formulation for specific nutritional or dietary purposes.
Nutraceuticals are products derived from food sources that are believed to provide extra health benefits besides the basic nutritional value found in foods
Continue Exploring: HyugaLife unveils Vito, a revolutionary health supplement brand for time-strapped consumers
The sources indicated that during a recent meeting with officials from the Central Drugs Standard Control Organisation (CDSCO), challenges related to uniform implementation and enforcement, interchangeable usage of the same nutrient/ingredient at varying doses for pharmaceutical and nutraceutical purposes, as well as overlapping prophylactic and therapeutic uses, alongside claims of reducing disease risk, were discussed.
“Several issues were discussed following which a high-level committee under the chairmanship of Secretary, Ministry of Health has been constituted to review the regulatory challenges in nutraceutical and drugs to ensure consumer safety,” a source said.
The committee comprises the Secretary of the Ministry of Ayush, the Secretary of the Ministry of Food Processing Industries, the Secretary of the Department of Pharmaceuticals, the Chief Executive Officer (CEO) of FSSAI, the Drugs Controller General of India, the Director General of the Indian Council of Medical Research, and the Director General of Health Services (DGHS).
Continue Exploring: Trimacare receives patent for revolutionary multi-micronutrient prenatal supplement, paving the way for enhanced prenatal care in India
According to industry data, the nutraceutical market in India is projected to reach USD 18 billion by the end of 2025, compared to USD 4 billion in 2020.
During the meeting some officials noted that many health supplements like probiotics, vitamins, minerals and botanicals also have therapeutic usage and due to unclear demarcation, many companies are shifting from CDSCO to FSSAI for approval of ingredients which are akin to drugs such as melatonin and zinc carnosine.
According to the sources, some officials mentioned that numerous supplements are being marketed with claims of managing diseases or reducing disease risk. This is because the same ingredients are permitted in both drug and nutraceutical regulations.
“Besides, there is no mandatory medical supervision for products covered under nutra regulations as a result people might consume it for longer duration and/or in higher doses which might prove harmful,” the sources said.
Officials said due to unsupervised usage of supplements, people at the same time consume supplements along with drugs which might interact with each other and may cause adverse effects on the health of the consumer.
Continue Exploring: Dietary supplement innovator Setu Nutrition secures funding from notable HNIs and celebrities
Due to availability of health supplements over the counter there are chances of consuming multiple nutrients whose action might be antagonistic to each other like calcium from a multi-mineral supplement might affect the absorption of iron.
“The committee will identify the feasibility of regulating probiotic/prebiotic in food formats and drug formats. It will also examine if there is a need and possibility of bringing nutraceuticals and health supplements under the ambit of the CDSCO,” another official source said.
The panel will also explore the feasibility of price control for categories covered under nutraceutical regulations, besides, examining the feasibility of GMP provisions and certification for nutraceuticals and similar products in alignment with schedule M of drugs.
