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 other geographies, would have to be tested on Indian population before they are granted marketing approval, ICMR recommends.
?The commercial probiotic cultures currently used in India are of foreign origin. Inherent differences in gut flora of Indian population are known to occur, hence it is imperative to carry out efficacy studies in Indian population prior to their use in the country. Further, there is an urgent need for development of indigenous probiotic strains for expressing optimal functionality,? the guidelines say. ICMR further advocates surveillance system containing multiple check-points, including trace-back and post-marketing surveillance so that adverse events associated with probiotics food can be recorded.
The recommendation if implemented, could go a long way in reducing exaggerated, false and broad generalised claims that accompany probiotic food products in the country. 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 $14 billion with a compound annual growth rate of 13.7%, according to a Frost and Sullivan estimate.
?After a public debate, once the draft is finalised, we would send it to the Drug Controller General of India, department of biotechnology, Food Authority of India. We have tried to harmonise the standards with international norms as large section of probiotic products produced in the country is also exported,? said NK Ganguly, former director-general, ICMR. 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 industry. Gregor Reid, former president, International Scientific Association for Probiotics and Prebiotics, who was recently in India, had insisted that any health claim made in a probiotic product must be supported through human clinical trials. The ICMR guidelines also advocate stringent labeling to prevent misleading the consumers. Warning against indiscriminate use of the term ?probiotic?, it says that the term should only be used on the labels of the products if physiological (health) benefit in humans is well established.
?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. The draft guidelines have a provision for assessment of efficacy, safety and health claims made by the probiotic foods that are being launched in India and defined parametres required for a strain/product to be classified as a probiotic,? said Neerja Hajela, head-science at Yakult Danone India Private Ltd, a 50:50 joint venture between Yakult Honsha of Japan and Groupe Danone of France. Yakult Honsha is a leading global player in probiotics while Groupe Danone is a leading player in dairy products. She added that stringent labeling of the probiotic products mentioned in the draft would help consumers make informed choices.
Monitoring necessary
* This will help in reducing exaggerated, false and broad generalised claims that accompany probiotic food products
* 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 $14 billion with a compound annual growth rate of 13.7%