Dr Reddy's Gets CDSCO Panel Nod To Import, Market Saccharomyces Boulardii, BE, CT Waived

This came firm presented the proposal for import and market of Saccharomyces Boulardii CNCM I-745, 250 mg/ 8 ml powder and solvent for oral suspension for the

-Treatment of acute infectious diarrhoea in adults and children.

- Prevention and treatment of antibiotic associated colitis and diarrhoea.

- In addition to vancomycin/ metronidazole treatment to prevent recurrence of Clostridium difficile disease (CDD).

- Supportive in the treatment of diarrhea occurring in irritable bowel syndrome (IBS).

Along with justification for BE waiver and CT waiver before the committee.

The committee noted that Saccharomyces Boulardii 250 mg Sachets/ Capsules were already approved in India since 1997 and the applied product Saccharomyces Boulardii CNCM I-745, 250 mg/ 8 ml powder and solvent for oral suspension was approved in France, Hungary, Sweden and Bulgaria.

Saccharomyces boulardii for treating and preventing diarrhea, including rotaviral diarrhea in children. It's also used for other types of diarrhea, acne, a digestive tract infection that can lead to ulcers, and many other conditions, but there is no good scientific evidence to support many of its other uses.

At the recent SEC meeting for Gastroenterology and Hepatology held on 23rd May 2025, the expert panel reviewed the proposal for import and market of Saccharomyces Boulardii CNCM I-745, 250 mg/ 8 ml powder and solvent for oral suspension.

After detailed deliberation, the committee recommended for grant of permission for import and market of Saccharomyces Boulardii CNCM I-745, 250 mg/ 8 ml powder and solvent for oral suspension with bioequivalence study waiver and clinical trial study waiver.

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