 "Injections, Injection syringe")
Nepal’s Department of Drug Administration has suspended the sale and distribution of Biotax 1gm, an antibiotic injection produced by an Indian company, due to ‘significant health concerns’, according to a report by Nepal’s national daily The Kathmandu Post.
Nepal’s drug regulatory authority mentions laboratory tests on batch F300460 of ‘Biotax 1gm’, manufactured by Ahmedabad-based Zydus Healthcare Limited, indicating non-compliance with production standards.
The department said Biotax 1 gm batch F300460 has been deemed unsafe for use and poses a potential risk to patients’ lives.
The report quoted Pramod KC, spokesperson at the department, as saying, “We have directed the manufacturing company, importers and distributors to immediately suspend sales, import and distribution of the said medicine, until further notice.”
Serious health issues detected in Biotax 1 gm
Pramod KC said some serious issues have been identified with the antibiotic, and further actions will be determined upon completion of the investigation.
Biotax 1gm injection is an antibiotic medication prescribed for treating bacterial infections affecting various parts of the body such as the brain, lungs, ears, urinary tract, skin, soft tissues, bones and joints, blood, and heart. Additionally, it is used as a preventive measure against infections during surgical procedures.
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No impact on treatment
The suspension of injection sales will not impact treatment options, as alternative medications with identical composition are available in the market, the drug regulator’s spokesperson said, as quoted by the report.
Suspending and recalling substandard drugs from the market is a regular task and forms an integral part of the department’s measures to mitigate risks. The report quoted officials as saying that numerous medications identified as ‘substandard’ have previously been suspended from sale and distribution or recalled.
The regulatory agency routinely gathers drugs from pharmacies nationwide using random sampling methods and tests them in its own laboratory to verify compliance with quality standards, the report said.
The officials from the regulatory authority said that due to inadequate staffing, they are unable to consistently monitor the recall status of all these drugs. The department issued a notice on its website instructing respective companies to initiate the recall of these drugs as soon as possible, the report further added.
However, in most cases, these substandard drugs have already been sold by the time the notices are published, primarily because it takes several months, largely due to staffing shortages, for the department to conduct laboratory tests, the report said.
