The Department of Pharmaceuticals and the National Pharmaceutical Pricing Authority (“NPPA”) have approached the Drug Controller of India (“DCI”) and the Food Safety and Standards Authority of India (“FSSAI”) for clarity on the parameters for classification of health/nutritional supplements as food products or as drugs. Various products, claiming to contain higher amounts of vitamins and minerals, are being sold in the Indian market as health/nutritional supplements. At the same time, multivitamin tablets and products containing other nutrients are being sold as drugs, with requisite licensing from the Drug authorities.
It, therefore, largely remains the choice of the manufacturer to sell its multivitamin/mineral products as a “food product” or as a “drug”. Food supplements are sold at considerably higher prices as compared to their drug counterparts, and are also subjected to lesser regulatory monitoring and restrictions. Regulators believe that various pharmaceutical companies accordingly sell drugs and medicines camouflaged as food/health supplements.