The bill was proposed in 2005 and essentially creates a third category in India for "Dietary Supplements / Nutraceuticals / Functional Foods / Foods for special dietary application." It has not been established yet however which government ministry - the Ministry of Health or the Ministry of Food Processing Industry - will be responsible for governing the act.
Although the Ministry of Health is expected to have some involvement in governing the new regulation, it appears likely that the Ministry of Food Processing Industry will stake a claim to regulate it.
The Ministry of Health is set to issue official notification regarding the new rule so that all those manufacturers who are currently manufacturing these products under food licenses under the Prevention of Food Adulteration Act, will be able to apply for fresh licenses under the new rule. The companies will not be under the threat of revoking their current license.
Although foreign companies can already export products to India, there will be greater opportunities for marketing tie-ups with Indian companies, said the trade association INHADSA, and a greater array of products available for Indian consumers.
What is more, the new rule should boost the level of science behind products, with manufacturers encouraged to do product R&D/new product development, develop reliable testing protocols, carry out clinical studies and establish structure-function claims based on these studies.
Dr. Bhushan Karnik, president of GCI Nutrients-India, said that 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) has had for the United States dietary supplement industry.
"The Indian bill will open up tremendous opportunities for dietary supplement companies throughout the world that want to sell to the Indian market," said GCI Nutrients-India in a statement.
The Bill has been welcomed by supplement industry associations, especially in the US.
Dr. Daniel Fabricant, VP of scientific affairs at the Natural Products Association (NPA), a US dietary supplements trade association, told NutraIngredients.com that the bill does appear to have DSHEA-like elements, and that the NPA was highly supportive of this.
"From an economic standpoint, India is a growing market that has wonderful people and a wonderful potential for growth," said Dr. Fabricant.
"It (the bill) will put forth guidelines and a framework where supplements and their benefits (through label claims) can be promoted. This is somewhat of a departure of the previous framework that was somewhat prohibitive (via the regulators/regulatory agencies).
"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," he said.
John Hathcock, Ph.D., vice president scientific and international affairs for the Council for Responsible Nutrition (CRN), told NutraIngredients.com that the CRN are pleased with the law, and said it was a "major step in the right direction".
"It clearly recognizes that supplements can be effectively related under food law and it requires that be done. 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."
Dr. Hathcock pointed out that, based on history, the Indian industry may urge the assignment of the regulatory burden to the Ministry of Food Processing Industries.
"Once the administrative home for the law is established, the responsible authorities should carefully scrutinize the law to determine what sections directly conflict with the Codex Vitamin and Mineral Food Supplements Guideline, and urge the modifications necessary to importation of products under regulations that would keep India in agreement with Codex and thus not in violation of WTO obligations," said Dr. Hathcock.
"Specifically, the RDA-based maximum limits for vitamin and minerals seem to be in direct conflict with Codex. Secondly, the reference in another section to "possibility" when "scientific uncertainty persists" also seems to exceed any authority in Codex. Certainly, all regulations any where should recognize that some scientific uncertainty always persists," he said.
According to Frost and Sullivan, the Indian food-processing sector was worth US$65.5bn (c €51.2bn) in 2005, $20.6bn (€16bn) of which was value-added products. It is expected to grow by around 9 per cent per annum over the next five years.
Aparna Singh, program manager of Frost's Indian chemical, material and food practice, said in a recent paper giving an overview of the country's food industry that nutritional supplements have yet to be embraced by consumers, partly because the lack of a regulatory framework means they are perceived as a "grey area", sitting somewhere between foods and pharmaceuticals.
The new law may therefore have an impact on consumer perception, and have a knock-on effect for the supplements sector at large.