Nutraceuticals

Nutraceuticals represent one of the fastest growing markets in the developed world. The term Nutraceuticals was coined to cover a group of products and claims that were seen to fall between ordinary foods and the highly-regulated pharmaceuticals. But companies marketing these products invariably make curative or functional claims on their labels. These claims, currently, are not subjected to any scrutiny by the authorities before they are allowed to be marketed. With increasing number of products entering the market with claims to cure even serious ailments like diabetes, hypertension, arthritis, osteoporosis, etc. adequate regulatory control on their manufacture and marketing is conspicuous by its absence. If at all any key ingredient in a Nutraceuticals product has a claimed curative value for a disease, that claim needs to be examined and approved before the marketing permission is given. Such a product has to be then classified as a drug and not as a dietary supplement.

Currently, the sector is governed by three separate laws namely Prevention of Food Adulteration Act, Food Products order and Drugs and Cosmetics Act. Unlike the US, where the Dietary Supplement Health and Education Act (DSHEA) is in place to regulate these products, in India the Government is in the process of drafting a law to regulate manufacturing, importing and marketing of health foods, dietary supplements and other Nutraceuticals. The Central Drug Control Department has put some structures in place for dietary supplements, but not all States have fallen in line.

Recently, United States Pharmacopeial Convention (USP) have decided to have a separate advisory panel on Nutraceuticals  and will be joining hands with Indian scientific community for developing   safety standards for the entire range of dietary supplements and Nutraceuticals that are currently not under the strict regulatory classification of either drugs or foods. Central Food Technological Research Institute (CFTRI), Mysore is to be the major agency to associate with USP in this regard.

The responsibility of framing and regulating standards for Nutraceuticals is to rest with the Food Safety and Standards Authority of India (FSAI) as outlined in the Food Safety Act, 2006. The authority will be in charge of categories like functional foods, Nutraceuticals, dietetic products and other similar products.