Nepal Halts Indian Antibiotic Sales Amid Quality Concerns

Zydus Lifesciences, an Indian pharmaceutical company, has refuted claims regarding quality problems with their antibiotic injection Biotax 1 gm. Previously, Nepal's Department of Drug Administration (DDA) halted the sale of this drug after batch F300460 did not pass laboratory tests. The DDA labeled this batch as unsafe, citing non-adherence to manufacturing standards and potential health risks

Responding to inquiries from Business Standard, Zydus Lifesciences described the reports as "misleading and inaccurate." They maintain that their product complies with all quality standards, and the DDA's issue is limited to the quantity of sterile water for injection provided with the drug.

Biotax 1gm is employed in treating bacterial infections and preventing post-surgical infections. The suspension's discontinuation won't significantly impact treatment options due to the availability of alternative medications. Zydus Lifesciences assures that their product adheres to all quality standards. According to a company representative, the DDA's concern stems from a misunderstanding regarding the amount of sterile water for injection provided with the medication.

Biotax 1gm includes 5 ml of sterile water and can be administered either intramuscularly (with 3 ml) or intravenously (with 10 ml). Zydus asserts that this does not compromise safety, as users can acquire additional sterile water for intravenous administration if needed. The company also emphasizes that Biotax 1gm has maintained a spotless safety record in Nepal since its introduction in 2018.

Nepal's Department of Drug Administration (DDA) regularly conducts tests on medications available in the market to verify their quality. Although they recognize that limited staffing hampers their ability to consistently monitor recalls, they have posted a notice on their website calling on companies to start recalling any substandard drugs.