With India fast emerging as a potential market for probiotics in food, the Indian Council of Medical Research (ICMR) in collaboration with Department of Biotechnology (DBT) is in the process of framing guidelines for evaluation of probiotics in food. The ICMR has issued a draft guidelines on probiotics and has asked for comments and suggestions from scientists, industries, NGOs, individuals and institutes before finalising the guidelines.
These guidelines aim to have a provision for assessment of efficacy, safety and health claims about the probiotic foods that are being launched in India and would define a set of parameters required for a product to be classified as probiotic. Probiotics are live microorganisms which, when ingested in adequate amounts as a single strain or as a combination of strains, confer one or more specified health benefits to the consumers.
Probiotics, particularly 'Lactobacillus' and 'Bifidobacterium' have been associated with alleviation of lactose intolerance; prevention and cure of viral, bacterial and antibiotic-or radiotherapy-induced diarrhoeas; immunomodulation; antimutagenic and anticarcinogenic effects; and even blood cholesterol reduction. The optimism associated with probiotics is counter-balanced by skepticism as many 'probiotic' products are unreliable in content and unproven clinically. There are no established or validated testing criteria and methodology to determine the safety and to assess the efficacy of a probiotic product. The regulatory mechanism differs from country to country and within a country from the way the product is labelled.
In India there are no regulatory guidelines for probiotic foods. In absence of any regulatory standards and guidelines, there would always be a possibility of spurious and ineffective products with false claims. Hence, it becomes imperative that these products are standardized and fulfil the prerequisite conditions before being labelled as a ‘probiotic product’. Holistic approach is needed for formulating guidelines and regulations for evaluating the efficacy of Indian probiotics in harmony with international standards.
The draft guidelines define on genus, species and strain identification; in vitro tests to screen potential probiotic strains; evaluation of safety of probiotics for human use; in vivo studies in animals for safety; in vivo studies in animal models and humans; labelling requirements; and manufacturing and handling procedures.
Surveillance systems containing multiple check-points, including trace-back and post-marketing surveillance, should be in place to record and analyse any
adverse events associated with probiotics in food. Such systems could also be used to monitor the long-term health benefits of probiotics. Safety in elderly and young children also needs to be evaluated. Use in infants (especially in 0-6 month’s infants) is another area of concern, as per the draft guidelines.