Nepal's drug regulator bans sale of Indian antibiotic over quality issues

Indian pharmaceutical company Zydus Lifesciences denies allegations of quality issues in their antibiotic injection Biotax 1 gm. Earlier, it was reported that Nepal's Department of Drug Administration (DDA) suspended sales of the drug citing failing lab tests on batch F300460. The DDA deemed the batch unsafe due to non-compliance with production standards, potentially posing a health risk.

In response to queries sent by Business Standard, Zydus Lifesciences said the reports were "misleading and erroneous." They claim their product meets all quality specifications and the DDA's objection is only related to the amount of sterile water for injection provided with the medication.

Biotax 1 gm is used to treat bacterial infections and prevent infections during surgery. The suspension is unlikely to disrupt treatment as alternative medications exist.

Zydus Lifesciences maintains their product meets all quality specifications. In a statement, a company spokesperson claimed the DDA's objection is a misunderstanding related to the volume of sterile water for injection included with the medication.

Biotax 1 gm comes with 5 ml of sterile water, while the instructions allow for both intramuscular (3 ml) and intravenous (10 ml) administration. Zydus argues this doesn't impact safety and users can obtain additional sterile water separately for intravenous use. The company also highlights a clean safety record for Biotax 1 gm in Nepal since its launch in 2018.

Nepal's DDA routinely tests medications sold in the country to ensure quality. They acknowledge staffing limitations that hinder consistent recall monitoring. However, they have issued a notice on their website urging companies to initiate recalls of substandard drugs.