With the increasing healthcare costs, fast changing lifestyle, ageing population and rising interest in attaining wellness through diet, nutraceuticals has emerged as one of the fastest growing industry segments in the country. Both the pharmaceutical and food processing industries are increasingly looking at the potential of this new sector for their future growth. The market size for nutraceutical and health ingredients market is currently estimated at around Rs. 3,000 crore in India. The sector registers an annual growth rate of 25 per cent. Huge growth of this segment has lured several leading pharma companies including GSK, Piramal, Abbott, Sun Pharma among others. Some of the other leading players in the country are Herbalife, British Biologicals, Amway, Nestle Nutrition, Sami Labs, Biogen Phytotec Extracts, Green Chem, Parrys and DSM Nutrition. Another trend is the opening of wellness stores in major cities in the country creating awareness among the customers about ‘wholesome’ products. It is possible that this trend may continue to gain momentum in the years to come. As launching of these products has increased in the recent past by both pharma and food companies with tall claims of curative and preventive properties of these products, the government has been contemplating to bring some regulatory control on their manufacturing and marketing in interest of public health.  

For the regulatory authorities in the country, classifying products as nutraceuticals or as a drug has been a challenging task in the context of conflicting claims made by the companies through the labels and advertisements. The need for defining what is a drug or food supplement surfaced in 2009 when the National Pharmaceutical Pricing Authority found some pharmaceutical firms marketing drugs as food supplements to escape the price control. As such marketing of food supplements with drug ingredients not only violates provisions of the Drug Price Control Order but also can cause health problems, the government appointed an expert committee under DTAB to distinguish between vitamins as health supplements or drugs. The proposals of the panel was accepted by DTAB in its 68th meeting in June 2015. As per the recommendations, all vitamins included in a product having a quantity as mentioned in Schedule V (prophylaxis or therapeutic) under Drugs & Cosmetics Act, will imply that the formulation concerned is a drug. Now, most of the food and health supplements contain vitamins A, B1, B2, C and E, which are drugs covered under DPCO and their prices are fixed by the NPPA. At the same time vitamins need to be allowed both in health and nutritional supplements if they are within the recommended dietary allowance (RDA) stipulated by Indian Council of Medical Research. And if vitamins are removed from health supplements, it will have far reaching effects on the health of the consumers. Therefore, the government should allow vitamins both in food as well as drug on the basis of recommended dosages and clear label claims. Probably appointment of some new experts to study and modify DTAB panel recommendations may help the DCGI and Food Safety and Standards Authority of India to arrive at a system to effectively regulate nutraceuticals market in the country.