Zydus to make Biotax 1 gram injection available with 10 ml sterile water post Nepal regulator's objection

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.

"The letter received from the Department of Drug Administration, Nepal, refers to the quantity of sterile water for injection made available with the product," Zydus Group said in a statement.

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".

"The objection raised by the agency is only with reference to the non-supply of 10 ml sterile water for injection along with the product," the statement said, adding that this does not have any impact on product quality nor does it pose any risk to patient safety as stated in the article.

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.

Further, it said, "Based on the letter received from DDA Nepal, we are amending as per the agency's requirement, the product will be made available with 10ml sterile water for injection instead of 5 ml so that the product can be administered for intramuscular as well as intravenous as per the patient's requirement." 

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."