Zydus to make Biotax 1 gram injection available with 10 ml sterile water

Zydus group on Wednesday said it will make its antibiotic injection Biotax 1g with 10ml sterile water available in Nepal after the Department of Drug Administration of that country raised objection for not providing the solvent.

The Indian pharmaceuticals group refuted a media report that the Department of Drug Administration, Nepal has suspended sales and distribution of Biotax 1 gram due to "serious health risks" stating these were "misleading and erroneous" as it complies with all quality parameters as per approved specification.

Zydus has supplied 5ml sterile water for injection along with the product but the direction for use states "use 3ml for intramuscular injection and 10ml for intravenous injection".

For intramuscular injection, the product can be constituted with 3 ml sterile water provided with the product. 

For intravenous injection, the product should be reconstituted by using 10 ml sterile water for injection separately, it added.

Zydus group asserted that no product complaint or any adverse event because of the usage of the product has been received from Nepal since the product commercialisation in 2018. The product Biotax 1g injection has been renewed every year as per DDA, Nepal regulation.