Nepal suspends sale of injection made by Indian company citing ‘serious health risks’
The Nepali drug regulator said that Biotax 1gm, an antibiotic medicine produced by Zydus Healthcare Limited, was not up to production standards.
Nepal on Tuesday suspended the sale and distribution of Biotax 1gm, an antibiotic injection manufactured by the Indian firm Zydus Healthcare Limited, citing “serious health risks”, reported The Kathmandu Post.
This came after laboratory tests by Nepal’s drug regulatory body found that the antibiotic medicine was not in compliance with its production specifications, reported the newspaper.
Biotax 1gm is used to treat bacterial infections, particularly those of the brain, lungs, ear, urinary tract, skin, soft tissues, bones and joints, blood and heart. It is also used to prevent infections during surgery.
“We have directed the manufacturing company, importers and distributors to immediately suspend sales, import and distribution of the said medicine, until further notice,” The Kathmandu Post quoted Pramod KC, a spokesperson for the Nepali drug regulatory body, as saying. “Some serious issues have been detected in the said antibiotic. Decisions about further actions will be taken once the investigation is completed.”
The Zydus Group on Wednesday denied reports that its product posed “serious health risks”. The pharmaceutical company said that these were “misleading and erroneous” claims and maintained that Biotax 1mg is compliant with all quality specifications.
“The letter received from the Department of Drug Administration, Nepal, refers to the quantity of sterile water for injection made available with the product,” the Zydus Group said in a statement.
The company said that it would provide the antibiotic injection in Nepal with 10 ml of sterile water, based on the Department of Drug Administration’s complaint, reported PTI.
Sterile water is used to dissolve or dilute medicines that are administered intravenously.