CDSCO Panel Defers Biosphere's Colloidal Nano Silver Gel Trial, Seeks Full Data

Additionally, the Committee directed Biosphere to submit the complete clinical trial protocol, detailed report, and toxicity data for review before any further decision could be taken.

The company had appeared before the committee to present findings from a Phase I clinical trial (Protocol No. BCR-VIR-003, dated May 12, 2025) that sought to evaluate the safety and pharmacokinetics of Colloidal Nano Silver Gel in healthy adult female subjects. The application was linked to an earlier recommendation dated July 25, 2024.

However, after deliberation, the SEC observed that the pharmacokinetic study details were not adequately reflected in the PowerPoint presentation submitted by the firm. The panel observed:

"Complete details with respect to the pharmacokinetics study are not reflected in PowerPoint presentation presented by firm."

The committee also emphasized that Colloidal Nano Silver vaginal gel is not yet approved in India or in any other country. In view of this, it decided that a comprehensive review of the full study protocol, detailed report, and toxicity data would be required before taking any further decision on the clinical trial.

"Colloidal Nano Silver vaginal gel is not yet approved in India and other countries and opined that committee needs to review complete protocol, report and toxicity data for further necessary action," the Expert Committee said.

Colloidal silver products have historically been promoted for their antimicrobial properties. However, global regulatory authorities, including the U.S. Food and Drug Administration (FDA), have repeatedly raised safety concerns due to lack of robust clinical evidence. The FDA had issued warning letters to companies marketing colloidal silver products with unapproved health claims, underscoring that such products require rigorous clinical validation before being considered safe for medical use