The laboratory testing of the Biotax 1gm batch F300460 revealed that the products do not match the production standards, the regulator said. The department has started further investigation into the injection to determine future action.
Pramod KC, spokesperson of the Department of Drug Administration said that they ordered the manufacturing company, importers and distributors to stop the sales, import and distribution of the mentioned medicine with immediate effect, until further notice.
“We have detected some serious issues in the Biotax 1gm injections. We have started a probe and further actions will be taken based on the investigation report,” Pramod said.
Officials said that suspending the import and sales of substandard drugs is routine work and is part of the department’s risk reduction measures. The import and sale of several other medicines that failed to meet production standards were also suspended.
The suspension of the sales of the injection will not affect treatment options as alternative medications with similar compositions are available in the market, they said.
Meanwhile, responding to the suspension in Nepal, Zydus Lifesciences told Business Standard that the reports sent by the Department of Drug Administration of Nepal are “misleading and erroneous.”
The officials stated that their product met all quality standards listed by the department and their only objection was related to the amount of sterile wanted for injection that is provided with the medication.
Biotax 1gm comes with 5 ml of sterile water while the department allows both intramuscular (3 ml) and intravenous (10 ml) administration.
Zydus Lifesciences stated that this difference does not pose health risks, adding they can use additional sterile water separately for intravenous use.
Zydus Lifesciences has held a clean safety record for the injection in Nepal since its launch in 2018.
