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New Delhi: The standards for the probiotic product market in the country would be laid down by the Indian Council of Medical Research (ICMR) by early 2010. Although the guidelines would be voluntary initially, ICMR expects them to become part of statute eventually and see it becoming the guiding document to determine standards for the probiotic industry in the country. "These guidelines would have a provision for assessment of efficacy, safety and health claims made by the probiotic products that are being launched and would define a set of parameters required for a product to be classified as probiotic," said VM Katoch, director general, ICMR. He further said stringent labeling of the probiotic product with strain specification, viable numbers at the end of shelf life, storage conditions would prevent misleading the consumer.
The market size of probiotic product in the country was estimated to be around Rs120 crore in 2007, growing at the rate of 40% annually. The global probiotics industry is pegged at $14billion with a compound annual growth rate of 13.7%, according to a Frost and Sullivan estimate.
"We have a zero plus draft ready. After the draft is finalized, we would send it to the Drug Controller General of India, Department of Biotechnology, Food Authority of India. We have tried to harmonize the standards with international norms, as a large section of probiotic products produced in the country is also exported," said NK Ganguly, former DG, ICMR. Asia and Europe are the largest producers of probiotics. Since 2005, the Drug Controller General of India has made it mandatory to get a license from the drug controller for manufacturing and marketing all probiotic products in the country, with a view to address the rampant practice of selling such products as functional foods.
According to the definition adopted by WHO, probiotics are live microorganisms which when administered in adequate amounts confer a health benefit on the host. Gregor Reid, former president, International Scientific Association for Probiotics and Prebiotics insisted that any health claim made in a probiotic product must be supported through human clinical trials.
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