‘BIOTAX 1GM:’ – Nepal Suspends Sale of Indian Antibiotic Injection Biotax 1gm Due to Health Risks-2024!
Overview
Nepal’s Department of Drug Administration (DDA) has halted the sale and distribution of Biotax 1gm, an antibiotic injection made by the Indian company Zydus Healthcare Limited. This decision follows significant health concerns and laboratory test results showing the drug does not meet production standards.
Reason for Suspension
Test Results and Health Risks
- Non-Compliance with Standards: Laboratory tests on batch F300460 of Biotax 1gm found that it did not comply with production standards.
- Health Concerns: The injection poses potential risks to patients’ health and safety .
Official Statement
- Immediate Suspension: The DDA has directed Zydus Healthcare, importers, and distributors to stop the sales and distribution of the affected batch immediately.
- Further Investigation: According to Pramod KC, the DDA spokesperson, the department is investigating the issues further to determine additional actions .
About Biotax 1gm
Usage
Biotax 1gm is commonly used to treat various bacterial infections, including:
- Brain
- Lungs
- Ears
- Urinary Tract
- Skin and Soft Tissues
- Bones and Joints
- Blood
- Heart
It is also used to prevent infections during surgeries .
Impact on Treatment
Availability of Alternatives
- Alternative Medications: The suspension of Biotax 1gm will not disrupt patient care because there are other medications with the same composition available on the market.
- Routine Actions: The recall of substandard drugs is a common practice to ensure patient safety and is part of the department’s regular risk mitigation measures .
Regulatory Procedures
Drug Monitoring and Testing
- Random Sampling: The DDA collects drug samples from pharmacies across Nepal and tests them in its own laboratory to ensure they meet quality standards.
- Recall Notices: When a drug is found to be substandard, the DDA issues notices to companies for immediate recall.
Challenges
- Staff Shortages: The department faces challenges in promptly monitoring the recall status of substandard drugs due to limited staffing. This often results in delays, with many substandard drugs being sold before a recall can be effectively implemented.
Conclusion
The suspension of Biotax 1gm highlights the importance of stringent drug quality control to protect public health. With alternative antibiotics available, patient treatment will continue without significant disruption. The ongoing investigation will help determine the next steps to address the safety concerns associated with this antibiotic injection.
References
- The Kathmandu Post
- Department of Drug Administration, Nepal
For more details, please visit The Kathmandu Post or the Department of Drug Administration, Nepal.
This restructured article provides a detailed yet simple explanation of the suspension of Biotax 1gm, ensuring clarity on the reasons, impact, and procedures followed by the regulatory authority.
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