CDSCO Panel Asks Unique Biotech to Submit Approval Status of Bacillus coagulans Unique IS-2 2 Billion CFU

New Delhi: In line with the proposal regarding the combination of an osmotic laxative and a probiotic, which is Lactulose 10 gm plus Bacillus coagulans (Unique IS-2) 2 billion CFU per 15 mL oral suspension, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has opined that Unique Biotech submit the approval status of Bacillus coagulans Unique IS-2 2 billion CFU (Colony Forming Units) by CDSCO.

In addition, the expert panel suggested that the firm should submit published scientific literature in peer-reviewed journals in support of the essentiality and desirability of the proposed FDC and for the safety and efficacy of individual ingredients compared to the FDC (finished product).

Furthermore, the committee added that the firm should submit international approval status, including post-marketing surveillance (PMS) study data in ICH countries.

This came after the firm presented the proposal before the committee regarding the combination of an osmotic laxative and a probiotic, which is Lactulose 10 g plus Bacillus coagulans (Unique IS-2) 2 billion CFU per 15 mL oral suspension.

Lactulose 10 gm plus Bacillus coagulans (Unique IS-2) 2 billion CFU per 15 mL oral suspension is a combination of an osmotic laxative and a probiotic.

This suspension is mainly used in constipation management (especially chronic or functional constipation) and to improve gut health through probiotic action.

At the recent SEC meeting for Gastroenterology and Hepatology, the expert panel reviewed the proposal.

After detailed deliberation, the committee opined that:

1. The firm should submit the approval status of Bacillus coagulans Unique IS-2 2 billion CFU by CDSCO.

2. The firm should submit published scientific literature in peer-reviewed journals in support of the essentiality and desirability of the proposed FDC.

3. The firm should submit literature in peer-reviewed journals for the safety and efficacy of individual ingredients compared to FDC (finished product).

4. The firm should submit international approval status, including PMS study data in ICH countries.

Accordingly, the expert panel suggested that the firm should submit the above data/documents for further review by the committee.