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The Indian Food Safety and Standards Bill 2005, which stands to revitalize India’s dietary supplement industry and increase foreign trade, was recently signed into law.1 The bill essentially creates a new regulatory category in India for dietary supplements, nutraceuticals, functional foods, and foods for special dietary applications.
The new rule establishes what kind of health/nutritional claims can be made for these products and encourages manufacturers to perform testing and clinical studies and form structure-function claims based on the results.2 According to a release posted on the NPIcenter website, Bhushan Karnik, PhD, president of the nutraceutical ingredient supply company GCI Nutrients-India, said the bill will have as significant an impact on the Indian dietary supplement industry as the Dietary Supplement Health and Education Act of 1994 (DSHEA) had on the US dietary supplement industry.3 He added that it should also provide increased opportunities to dietary supplement companies across the world that want to sell to the Indian market.
According to reports released in October, it has not yet been decided whether the new act will be governed by India’s Ministry of Health or Ministry of Food Processing Industry.2,3 Manufacturers in India will be able to apply for fresh licenses under the new rule, although these companies will not be under the threat of revoking their current licenses issued under the Prevention of Food Adulteration Act.2
Dietary supplement trade associations in the United States have expressed their approval of the bill. “India has such a rich tradition in Complementary and Alternative Medicine (CAM) and Modalities, it is great progress to see such a bill expand the use of such products as dietary supplements similar to the availability DSHEA afforded the US market,” said Daniel Fabricant, PhD, vice president of scientific affairs of the Natural Products Association (NPA), a US-based trade association, in an article published by NutraIngredients.com.2
John Hathcock, PhD, vice president of scientific and international affairs for the US-based trade association the Council of Responsible Nutrition (CRN), echoed such sentiments about the new law. “It clearly recognizes that supplements can be effectively related under food law and it requires that be done,” he told NutraIngredients.com.2 “This should effectively preclude arbitrary and uneven declaration as attempted recently by some Indian States that supplements are drugs merely because of the physical form, e.g., capsules and tablets. The list of permitted ingredients is similar to that in the US in that vitamins, minerals, amino acids, plant materials and even animal products are permitted.” He added that the law’s administrative authorities should ensure that sections of the new law do not conflict with the Codex Alimentarius’ Vitamin and Mineral Food Supplements Guideline.
“For the first time dietary supplements now have a clear status in Indian law,” said Simon Pettman, executive director of the International Alliance of Dietary Supplement Associations (IADSA). “This should be the first step to removing them from the continual push and pull of regulatory authorities with different views and interpretation of the existing regulations across India and the beginning of the first stage of creating a world-class regulatory system” (e-mail, December 17, 2006).
The original bill as introduced to the Indian Parliament may be accessed at: http://mofpi.nic.in/foodsfty.pdf. 1
-Courtney Cavaliere
References
1. The Food Safety and Standards Bill, 2005 [bill]. Bill 123 of 2005. August 25, 2005. Available at: http://mofpi.nic.in/foodsfty.pdf. Accessed December 11, 2006.
2. Indian food bill with supplements category becomes law. NutraIngredients.com. October 16, 2006. Available at: http://www.nutraingredients-usa.com/news-by-product/news.asp?id=71292&idCat=53&k=indian-food-bill. Accessed December 6, 2006.
3. Indian food safety and standards bill 2005 signed into law. NPIcenter. October 12, 2006. Available at: http://www.npicenter.com/anm/templates/newsATemp.aspx?articleid=16796&zoneid=18. Accessed December 6, 2006.
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