The regulator said laboratory testing of Biotax 1 gram batch F300460 showed that the products did not match production standards. The department has initiated further investigation of the injections to determine future action.
Drug Administration Department spokesperson Pramod K.C. said that he has ordered the manufacturing company, importers and distributors to stop the sale, import and distribution of the said drug with immediate effect until further orders.
Pramod said, “We have found some serious problems in Biotax 1 gm injection. We have started an investigation and further action will be taken based on the investigation report.”
Officials said suspending the import and sale of substandard drugs is routine and part of the department's risk mitigation measures. The import and sale of several other drugs that did not meet production standards were also suspended.
He said that banning the sale of the injection will not affect the treatment options as alternative medicines with similar composition are available in the market.
Meanwhile, reacting to the suspension in Nepal, Zydus Lifesciences told Business Standard that the reports sent by Nepal’s Department of Drug Administration were “misleading and incorrect”.
Officials said their product met all the quality standards listed by the department and their only objection was to the amount of sterile injection required along with the drug.
Biotax 1 gram comes with 5 ml sterile water, while the department allows both intramuscular (3 ml) and intravenous (10 ml) administration.
Zydus Lifesciences said there is no health risk from this difference, and they may use additional sterile water separately for intravenous use.
Zydus Lifesciences has maintained a clean safety record for injectables in Nepal since its launch in 2018.