The Department of Drug Administration in Nepal has suspended the sales and distribution of the antibiotic injection Biotax 1gm, manufactured by Zydus Healthcare Ltd., India, following rigorous testing that revealed serious deviations from production specifications.
The affected batch, F300460, failed to meet safety standards in Nepali laboratories, prompting regulatory intervention.
Spokesperson for the Department of Drug Administration, emphasized the gravity of the findings, citing potential risks to patients' lives posed by the non-compliant antibiotic, The Wire reported.
While specific details of the issues detected were not disclosed pending further investigation, the spokesperson assured the public that alternative medications of similar composition, from different manufacturers, remain available in the market without disruption to patient treatment.
The Department has instructed Zydus Healthcare Ltd., along with importers and distributors, to cease all sales, imports, and distributions of Biotax 1gm until further notice. Further actions against the manufacturer will be determined upon completion of the investigation into the batch's quality and safety concerns.