Alkem Laboratories Introduces DSS Probiotic in India
Filing Summary
Alkem Laboratories Ltd. has launched the probiotic “DSS,” the original De Simone formulation, in India, targeting gut health management. The DSS probiotic, developed by Prof. Claudio De Simone, combines eight bacterial strains and is backed by over 80 clinical trials. It is available in four strengths, with Alkem holding exclusive marketing rights for two of these strengths in India. The probiotic addresses conditions such as IBS and Ulcerative Colitis. The Indian prescription probiotic market is valued at INR 2,071 crore, with a five-year CAGR of approximately 14%.
Alkem Laboratories Ltd. has announced the launch of the probiotic “DSS,” the original De Simone formulation, in India. This product is designed for gut health management and aims to restore gut microbiota balance. The DSS formulation, developed by Prof. Claudio De Simone, includes eight bacterial strains selected for their biochemical and enzymatic profiles. The formulation is supported by over 80 clinical trials and 200 publications, and it is endorsed by leading gastroenterology associations in the US and Europe.
The DSS probiotic is available in four different strengths: 225 billion CFU sachet, 112.5 billion CFU capsule, 45 billion CFU capsule, and 10 billion CFU capsule. Alkem Laboratories holds exclusive marketing rights for the 225 billion CFU and 10 billion CFU strengths in India. The product is in-licensed from Next Gen Pharma India Pvt. Ltd. and is the first in India to offer all four strengths. The DSS probiotic contains a combination of Lactobacillus, Bifidobacterium, and Streptococcus strains, which are freeze-dried and live, aimed at restoring gut microbiota balance.
The DSS probiotic is indicated for managing various gastrointestinal disorders, including Irritable Bowel Syndrome (IBS), Ulcerative Colitis (UC), Pouchitis, Hepatic Encephalopathy (HE), Non-Alcoholic Fatty Liver Disease (NAFLD), Cirrhosis, Bacterial Vaginosis (BV), and Antibiotic-Associated Diarrhea (AAD). It is also recommended for supplementation during pregnancy and lactation. The launch of DSS is part of Alkem’s strategy to expand its product portfolio in the gastrointestinal segment.
According to IQVIA data as of October 2025, the prescription probiotic market in India is valued at approximately INR 2,071 crore, with a compound annual growth rate (CAGR) of about 14% over the past five years. The increasing consumer awareness and prevalence of lifestyle-related digestive issues are driving demand for probiotics in the region.
Alkem Laboratories Ltd. is a leading pharmaceutical company in India, known for its extensive range of high-quality medicines. The company holds a significant position in the therapy areas of anti-infectives, gastrointestinal, and pain management drugs. Alkem is also expanding its presence in chronic therapies such as diabetes, neurology, and cardiology. The company operates 19 manufacturing facilities and research and development centers across India and the US, focusing on generic formulations, active pharmaceutical ingredients (APIs), and biosimilars.