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Probiotic foods likely to come under clinical trial norms like drugs


The probiotic food industry in the country may have to establish the safety and efficacy of their products through clinical trials just like drugs, if they wish to use the word “probiotic” on their label, according to Indian Council of Medical Research (ICMR) draft guidelines. Even imported products, which may have already undergone requisite trials in their countries, would have to be tested on Indian population before they are granted marketing approval, according to a report in The Financial Express.

The ICMR recommendations, if implemented, could go a long way in reducing exaggerated, false and broad generalized claims that accompany probiotic food products sold in the country. The market size of probiotic products in the country was estimated to be around Rs 120 crore in 2007, growing at the rate of 40% annually.

The global probiotic industry is pegged at $14 billion with a compound annual growth rate (CAGR) of 13.7%, according to a Frost & Sullivan estimate.

There is lack of regulations in this area and it is important that guidelines for probiotic products are established in India to ensure product safety, quality, reliability for all companies introducing and producing probiotic food. “Once the draft is finalized after a public debate, we will send it to the Drug Controller General of India, Department of Biotechnology and the Food Safety & Standards Authority of India. We have tried to harmonise the standards with international norms as a large section of probiotic products produced in the country is also exported,” said N K Ganguly, former director-general, ICMR. Although the guidelines would be voluntary initially, ICMR expects them to become part of a statute eventually and see it becoming the guiding document to determine standards for the industry.

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