KATHMANDU: The Department of Drug Administration (DDA) has halted the sales and distribution of Biotax 1gm, an antibiotic injection manufactured by an Indian company, due to significant health concerns. The decision follows laboratory tests conducted on batch F300460 of the antibiotic, produced by Zydus Healthcare Ltd, which revealed deviations from production specifications. Pramod KC, a spokesperson for the department, emphasized the gravity of the situation, stating that immediate action was necessary to safeguard public health.
Biotax 1gm injection is commonly prescribed for various bacterial infections, ranging from those affecting the brain, lungs, and urinary tract to skin and soft tissue infections. However, the DDA's testing revealed that batch F300460 of the drug posed serious risks to patients and was deemed unsafe for use. Consequently, the department instructed the manufacturing company, importers, and distributors to suspend all sales, imports, and distribution of the affected medicine until further notice.
KC assured the public that the suspension of Biotax 1gm would not disrupt patient treatment, as alternative medications with the same composition are readily available in the market. The DDA routinely takes such measures to mitigate risks associated with substandard drugs, often suspending sales and recalling products found to be non-compliant with quality standards. However, challenges arise in ensuring the timely recall of all substandard medicines, as the department faces constraints such as understaffing and limited capacity.
Despite efforts to monitor drug recalls and disseminate notices through its website, the DDA acknowledges limitations in enforcing timely recalls for all substandard drugs. The regulatory agency relies on random sampling methods to collect drugs from pharmacies nationwide and tests them in its laboratory to assess compliance with quality standards. Nonetheless, the process of conducting tests and issuing recall notices can be lengthy, allowing some substandard drugs to potentially remain on the market before appropriate action can be taken.
