Indian J Med Res. 2011 Jul;134(1):22-5.
There has been an increased influx of probiotic products in the Indian market during the last decade. However, there has been no systematic approach for evaluation of probiotics in food to ensure their safety and efficacy. An initiative was, therefore, taken by the Indian Council of Medical Research (ICMR) along with the Department of Biotechnology (DBT) to formulate guidelines for regulation of probiotic products in the country. These guidelines define a set of parameters required for a product/strain to be termed as 'probiotic'. These include identification of the strain, in vitro screening for probiotic characteristics, animal studies to establish safety and in vivo animal and human studies to establish efficacy. The guidelines also include requirements for labeling of the probiotic products with strain specification, viable numbers at the end of shelf life, storage conditions, etc., which would be helpful to the consumers to safeguard their own interest.
在过去的十年中，益生菌产品在印度市场的涌入量有所增加。然而，对于食品中的益生菌评估，一直没有系统的方法来确保其安全性和有效性。因此，印度医学研究理事会（ICMR）与生物技术部（DBT）共同采取了一项举措，制定了在该国监管益生菌产品的指导方针。这些指南定义了产品/菌株被称为“益生菌”所需的一组参数。这些参数包括菌株的鉴定、益生菌特性的体外筛选、安全性的动物研究以及体内动物和人体研究以建立功效。该指南还包括对益生菌产品进行标签规定的要求，包括菌株规格、保质期结束时的活菌数、储存条件等，这将有助于消费者维护自身利益。
