Firms such as Amway, Daehsan Trading and Elken International, which are entering the dietary supplement market of India, however, need to tweak the original composition of their vitamin formulations specially for the Indian market. The reformulation is to ensure that these products do not fall under the definition of drugs, which will entail more stringent regulatory requirements. While drugs are regulated under the Drugs and Cosmetics Act, food supplements fall under the Prevention of Food Adulteration Act.
If these products are marketed as drugs, the firms will have to furnish clinical evidence of the therapeutic claims they make, meet the stringent licensing norms of the Drug Controller General of India and may even have to reduce prices, if the drug falls under the Drug Price Control Order.
Sandip Misra, CEO, Elken International, told FE: We have altered the composition of some of our products. For instance, Calrich, which is a calcium supplement, has undergone some compositional changes to be in line with the Indian food standards.
According to Amway, highly regulated markets such as the US, EU and even some Southeast Asian markets permit much higher vitamin levels in the composition of food supplements. These markets follow the Codex Alimentarius guidelines of upper safety limits of vitamins and minerals as the higher permissible limits in composition for food supplements, an Amway spokesperson said.
The purpose of supplements are different from drugs, he noted. Supplements are being marketed for specific anti-oxidant or nutrient properties and not for any curatory purpose.
These firms also say that the regulation of nutraceuticals is a grey area which calls for an exclusive set of guidelines, for which they are in touch with the Food Safety and Standards Authority of India.
Amarnath Sen Gupta, country manager, Daehsan Trading, narrates an anecdote: Our product Morinzhi, a juice of Morinda and Roselle was detained in India for not being sweet enough. These fruits, even under ripe conditions, are not sweet. Under the Indian standards, a minimum sweetness is prescribed for every fruit juice measured by the Total Soluble Solid (TSS). For Morinzhi, we had to actually alter the global standard to add more sweetness to meet Indian regulatory requirement.
This was because the authorities here could not be convinced that the TSS requirements are not valid for Morinda and any shortfall in TSS standard has no bearing on the product quality and utility, said Gupta.
However, government officials told FE that the nutraceutical firms should have no reason to complain as Recommended Dietary Allowances (RDA) here have just been revised late last year. This revision came 22 years after the previous one in 1988.
In contrast, the US revisits its RDA guidelines every five years.
A member of the ICMR expert group told FE: For instance, on calcium supplements, a committee had held in 1988 that population groups in many developing countries subsist on a much lower calcium intake than in developed countries without any ill effects.
However, last year, a committee after examining evidence for calcium nutrition status of the Indian population suggested an upward revision of calcium RDA.
The blurred line between drug and food supplement surfaced prominently in 2009 when the drug price regulator stated that pharma firms are marketing drugs as food supplement to escape the price ceiling net. In a letter to the health ministry, it cited the example of food supplements such as Ranbaxy's Revital and Germany-based Merck KgaA's vitamin E product Evion which it said were earlier being marketed as drugs. A Bihar High Court order of 2009, however, held that health supplements marketed by various drug companies such as Feradol manufactured by Pfizer, Revital (Ranbaxy), A to Z (Alkem), Beneficial, CSN and DSN capsules (Shreya Life Sciences) need to be marketed as health supplements as the manufacturers have made no therapeutic claims on the label to suggest that can cure. The Indian nutraceutical market Rs 4,400 crore in 2009 is expected to more than double to Rs 9500 crore by 2013. The Codex Alimentarius Commission was created in 1963 by UN's Food and Agricultural Organization and World Health Organization to develop international food standards and guidelines.