Dr Reddy's Laboratories Gets CDSCO Panel Nod To Import, Market Saccharomyces Boulardii CNCM-I 745 Powder in Sachet
New Delhi: Granting the bioequivalence study waiver and clinical trial study waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has given its nod to the drug major Dr Reddy's Laboratories to import and market Saccharomyces boulardii CNCM-I 745 500 mg powder in Sachet (for oral suspension).
However, this approval is subject to the condition that the firm should conduct a Phase IV clinical trial study.
In addition, the committee recommended the firm submit the Phase IV clinical trial study protocol to CDSCO within 3 months from the date of approval of the drug product for further review by the committee.
This came after Dr Reddy's Laboratories presented the proposal for import and market of Saccharomyces Boulardii CNCM-I 745 500mg Powder in Sachet (For Oral Suspension) for the
- Treatment of acute infectious diarrhea in adults and children.
- Prevention and treatment of antibiotic-associated colitis and diarrhea.
- In addition to vancomycin/metronidazole treatment to prevent the recurrence of Clostridium difficile disease (CDD).
- Supportive in the treatment of diarrhea occurring in irritable bowel syndrome (IBS).
The firm also presented the justification for the bioequivalence (BE) waiver and clinical trial (CT) waiver before the committee.
The yeast Saccharomyces boulardii CNCM I-745 is a unique, non-bacterial microorganism classified as a probiotic agent.
Saccharomyces boulardii CNCM-I 745 500 mg Powder in Sachet (for Oral Suspension) is a probiotic that is used to improve digestion and restore normal flora.
The action of S. boulardii CNCM I-745 is based on several mechanisms, such as immunological and anti-toxin effects, pathogen-binding, as well as effects on digestive enzymes. The interaction with enteropathogenic microorganisms and the effect on the intestinal mucosa are the main targets and potential mechanisms of S. boulardii ‘s CNCM I-745 action
At the recent SEC meeting for gastroenterology and hepatology held on February 27, 2025, the expert panel reviewed the proposal for import and market of Saccharomyces boulardii CNCM-I 745 500 mg.
The committee noted that the applied drug product was approved in the USA, Europe, and Canada.
After detailed deliberation, the committee recommended the grant of import and market of Saccharomyces boulardii CNCM-I 745 500 mg powder in Sachet (for oral suspension) with a bioequivalence study waiver and clinical trial study waiver with the condition to conduct a Phase IV clinical trial study.
Accordingly, the expert panel suggested that the firm should submit the Phase IV clinical trial study protocol to CDSCO within 3 months from the date of approval of the drug product for further review by the committee.
