Nepal Halts Indian Antibiotic Sales Amid Quality Concerns
Zydus Lifesciences refutes claims of quality issues with Biotax 1 gm, assures compliance with standards.
Breaking News
Jun 20, 2024
Mrudula Kulkarni
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.