Regulatory Concerns Over Biotax 1gm Injection's Compliance with Standards
In Short:
- Nepal halts sale and distribution of Biotax 1gm injection.
- Manufactured by Indian company Zydus Lifesciences.
- Issues found with production standards during lab tests.
- Alternative medications are available in the market.
- Zydus Lifesciences disputes the findings, claiming compliance with quality standards.
Nepal has recently suspended the sale and distribution of the Biotax 1gm injection, a product of the Indian pharmaceutical company Zydus Lifesciences. This decision, announced by Nepal’s Department of Drug Administration (DDA), was taken due to significant health risks associated with the antibiotic injection.
Laboratory tests conducted on the Biotax 1gm batch F300460 revealed discrepancies with production standards, prompting the DDA to take action. The department is now conducting a thorough investigation to decide on future steps.
Pramod KC, the spokesperson for the Department of Drug Administration, confirmed that the order to halt sales, import, and distribution of the medicine is effective immediately and will remain in place until further notice.
“We found serious issues with the Biotax 1gm injections and have initiated a probe. Further actions will depend on the investigation results,” Pramod said.
The DDA emphasized that suspending the import and sale of substandard drugs is a routine part of their risk reduction strategy. This suspension aligns with previous actions taken against other medicines failing to meet production standards.
Officials assured that this suspension would not impact treatment options, as there are alternative medications with similar compositions readily available in the market.
In response to the suspension, Zydus Lifesciences told Business Standard that the reports from Nepal's DDA are “misleading and erroneous.” They asserted that their product meets all the quality standards set by the DDA and clarified that the concern was merely about the volume of sterile water provided with the injection.
Biotax 1gm includes 5 ml of sterile water, whereas the department’s guidelines specify 3 ml for intramuscular and 10 ml for intravenous administration. Zydus Lifesciences pointed out that this discrepancy does not pose any health risks and noted that additional sterile water can be used for intravenous applications.
Since its launch in Nepal in 2018, Biotax 1gm has maintained a clean safety record, according to Zydus Lifesciences. The company remains confident in the quality and safety of its product.