NEW DELHI : Concerned with unsupervised consumption and overpricing of nutraceuticals/probiotics/ food for special medical purpose/food for special dietary use, the health ministry is planning to bring them under the Central Drugs Standard Control Organization (CDSCO), highly-placed sources told TNIE. These items currently come under the purview of Foods Safety and Standards Authority of India (FSSAI).
As per sources, the Ministry has also proposed forming a committee chaired by the Secretary of Health to address overlapping concerns between Nutraceuticals and Drugs. The committee would have representatives from various key entities such as FSSAI, CDSCO, Indian Council of Medical Research (ICMR), Ministry of Ayush, and the Department of Pharmaceuticals.
Health Ministry has flagged the dual licensing of probiotics as both drugs and probiotic foods under the purview of the Food Safety and Standards Authority of India (FSSAI). Of particular concern are the health claims associated with probiotic products, such as women’s health gummies, which purport to address recurrent UTIs, reduce bacterial growth, and support urinary tract health.
According to health ministry officials, there are risks associated with prolonged and high-dosage usage of such products, given the absence of mandatory medical supervision under Nutra Regulations. Also absence of price controls for nutraceuticals is also a major concern.
A top source also said that no price controls are currently in place for nutraceuticals. “This regulatory gap has led to instances where certain products have been shifted from the medicine to the dietary supplement category, resulting in significant price differentials,” a top source told TNIE.
The National Pharmaceutical Pricing Authority (NPPA), which operates under the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, is responsible for regulating the prices of pharmaceutical drugs and ensuring that they are affordable and accessible to the general public.
The sources also highlighted the alarming trend of disease management claims made for supplements, leading to potential unsupervised consumption and health risks. Renochlor, a health supplement, has been singled out for its promises to arrest kidney decline in the early stages of Chronic Kidney Disease (CKD) progression, alongside claims of reducing microalbuminuria, oxidative stress, and enhancing eGH levels.