The Indian Council of Medical Research (ICMR) in collaboration with Department of Biotechnology (DBT) has issued guidelines for evaluation of probiotics in food. The guideline is significant in the wake of India emerging as a potential market for probiotics in food.
The ICMR-DBT guidelines comprehensively address various concerns regarding safety, efficacy and reliability as well as labelling of probiotic products being sold in India.
The 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.
The 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.
In India, so far there has been no regulatory guidelines for probiotic foods. In the absence of any regulatory standards and guidelines, there would always be a possibility of spurious and ineffective products with false claims. Hence, it became imperative that these products are standardized and fulfill the prerequisite conditions before being labelled as a ‘probiotic product’. Holistic approach was needed for formulating guidelines and regulations for evaluating the efficacy of Indian probiotics in harmony with international standards.
Probiotics are bacteria that help maintain the natural balance of microflora in the intestines. The normal human digestive tract contains about 400 types of probiotic bacteria that reduce the growth of harmful bacteria and promote a healthy digestive system. Experiments into the benefits of probiotic therapies suggest a range of potentially beneficial medicinal uses for probiotics. Recent research on the molecular biology and genomics of Lactobacillus has focused on the interaction with the immune system, anti-cancer potential, and potential as a biotherapeutic agent in cases of antibiotic-associated diarrhoea, travellers’ diarrhoea, paediatric diarrhoea, inflammatory bowel disease and irritable bowel syndrome.
“The increasing globalization of food trade has resulted in India being a fast emerging market for probiotic products. With the availability of these products increasing exponentially and the multiple claims made regarding the beneficial health effects, there is the need to put in place sufficient safeguards to protect the consumers from any adverse effects, ensure standardization of commercial products and their efficacy”, said MK Bhan, secretary, DBT.