New Delhi: Zydus Group on Wednesday said it will make its antibiotic injection Biotax 1G available in Nepal with 10 ml of sterile water after that country's drug administration department objected to it not providing the solvent.
Indian Pharmaceuticals Group refuted a media report that Nepal's Department of Drug Administration had suspended the sale and distribution of Biotax 1 gram due to "serious health risks", stating that these were "misleading and inaccurate" as it Complies with all quality standards as per approved specification. ,
"The letter received from the Drug Administration Department of Nepal mentions the quantity of sterile water for injection to be provided with the product," Zydus Group said in a statement.
Zydus supplies 5 ml of sterile water for injection with the product, but the instructions for use state, "use 3 ml for intramuscular injection and 10 ml for intravenous injection".
“The objection raised by the agency is only in the context of not supplying 10 ml of sterile water for injection along with the product,” the statement said.''The statement said that this does not affect the quality of the product nor does it pose any threat. Patient safety, as mentioned in the article.
For intramuscular injection, the product can be prepared with 3 ml of sterile water provided with the product. It states that for intravenous injection, the product should be reconstituted using 10 ml of sterile water for injection separately.
Further, it added, “Based on the letter received from DDA Nepal, we are making amendment as per the requirement of the agency, the product will be made available in 10 ml Sterile Water for Injection instead of 5 ml so that the product can be administered intramuscularly. Can also be administered for.Intravenously as per the patient's need."
Zydus Group claimed that "No product complaints or any adverse events due to the use of the product have been received from Nepal since the product commercialization in 2018. The product Biotax 1G Injection has been renewed every year as per the DDA, Nepal regulation ."
Indian Pharmaceuticals Group refuted a media report that Nepal's Department of Drug Administration had suspended the sale and distribution of Biotax 1 gram due to "serious health risks", stating that these were "misleading and inaccurate" as it Complies with all quality standards as per approved specification. ,
"The letter received from the Drug Administration Department of Nepal mentions the quantity of sterile water for injection to be provided with the product," Zydus Group said in a statement.
Zydus supplies 5 ml of sterile water for injection with the product, but the instructions for use state, "use 3 ml for intramuscular injection and 10 ml for intravenous injection".
“The objection raised by the agency is only in the context of not supplying 10 ml of sterile water for injection along with the product,” the statement said.''The statement said that this does not affect the quality of the product nor does it pose any threat. Patient safety, as mentioned in the article.
For intramuscular injection, the product can be prepared with 3 ml of sterile water provided with the product. It states that for intravenous injection, the product should be reconstituted using 10 ml of sterile water for injection separately.
Further, it added, “Based on the letter received from DDA Nepal, we are making amendment as per the requirement of the agency, the product will be made available in 10 ml Sterile Water for Injection instead of 5 ml so that the product can be administered intramuscularly. Can also be administered for.Intravenously as per the patient's need."
Zydus Group claimed that "No product complaints or any adverse events due to the use of the product have been received from Nepal since the product commercialization in 2018. The product Biotax 1G Injection has been renewed every year as per the DDA, Nepal regulation ."
