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

"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