Nepal Blocks Indian Antibiotic After Failing Quality Tests
Nepal’s Department of Drug Administration has halted the sale and distribution of Biotax 1gm, an antibiotic injection produced by the Indian company Zydus Healthcare Ltd, citing significant health concerns. Laboratory tests on batch F300460 of Biotax 1gm revealed non-compliance with production standards, prompting this decisive action.
The drug regulatory authority emphasized that the particular batch poses potential risks to patients’ lives. Pramod KC, spokesperson for the department, stated that they have instructed the manufacturer, importers, and distributors to suspend all sales, imports, and distribution of the affected medication until further notice. He also noted that serious issues had been identified with the antibiotic, and further actions would depend on the outcome of ongoing investigations.
Biotax 1gm is commonly prescribed to treat various bacterial infections affecting the brain, lungs, ears, urinary tract, skin, soft tissues, bones and joints, blood, and heart. It is also used as a preventive measure against infections during surgical procedures. Despite the suspension, treatment options will not be affected, as alternative medications with the same composition are available in the market, according to the drug regulator.
The suspension and recall of substandard drugs are regular tasks for the department, forming a crucial part of its risk mitigation strategy. Officials have suspended or recalled numerous medications identified as substandard in the past. The department routinely collects drug samples from pharmacies nationwide and tests them in its laboratory to ensure compliance with quality standards.
However, officials admitted that due to inadequate staffing, they struggle to monitor the recall status of all substandard drugs consistently. Notices are published on the department’s website, instructing companies to recall these drugs as soon as possible. Unfortunately, by the time these notices are issued, many substandard drugs have already been sold, as the laboratory testing process can take several months due to staffing shortages.
Q&A
Q: Why has Nepal suspended the sale and distribution of Biotax 1gm?
A: Nepal’s Department of Drug Administration suspended the sale and distribution of Biotax 1gm due to significant health concerns. Laboratory tests on batch F300460, manufactured by Zydus Healthcare Ltd, revealed non-compliance with production standards, posing potential risks to patients’ lives.
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Q: Who manufactures Biotax 1gm?
A: Biotax 1gm is manufactured by Zydus Healthcare Ltd, an Indian pharmaceutical company based in Ahmedabad.
Q: What are the specific issues with Biotax 1gm?
A: The specific issues with Biotax 1gm include non-compliance with production standards and serious health concerns identified during laboratory testing. The exact nature of these issues is still under investigation.
Q: How will the suspension of Biotax 1gm impact patients?
A: The suspension of Biotax 1gm is not expected to impact patients significantly because alternative medications with identical compositions are available in the market, according to the drug regulator’s spokesperson.
Q: What steps have been taken by the Department of Drug Administration in Nepal?
A: The Department of Drug Administration has directed the manufacturer, importers, and distributors to immediately suspend the sales, import, and distribution of the affected batch of Biotax 1gm. They have also initiated further investigations into the issues identified.
Q: What types of infections is Biotax 1gm used to treat?
A: Biotax 1gm is an antibiotic used to treat bacterial infections affecting the brain, lungs, ears, urinary tract, skin, soft tissues, bones and joints, blood, and heart. It is also used as a preventive measure against infections during surgical procedures.
Q: How common are drug suspensions and recalls in Nepal?
A: Suspending and recalling substandard drugs is a regular task for Nepal’s Department of Drug Administration. This process is part of the department’s measures to mitigate risks and ensure the quality of medications available in the market.
Q: What challenges does the Department of Drug Administration face in monitoring drug quality?
A: The department faces challenges such as inadequate staffing, which makes it difficult to consistently monitor the recall status of all substandard drugs. The process of testing drugs in their laboratory and issuing recall notices can take several months, during which time many substandard drugs may already be sold.
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Q: What is the impact of staffing shortages on the recall process?
A: Staffing shortages delay the laboratory testing and issuance of recall notices, leading to situations where substandard drugs are sold before the recall notices are published. This makes it challenging for the department to ensure timely recalls of unsafe medications.
