Nepal’s drug administration suspends Indian-made Biotax 1gm

The Department of Drug Administration (DDA) in Nepal has ordered an immediate suspension of the sales and distribution of the Biotax 1gm antibiotic injection, following serious health risk concerns.

The drug, manufactured by Indian pharmaceutical company Zydus Healthcare Ltd, was found to be non-compliant with production specifications after laboratory tests conducted by Nepal’s national drug regulatory body.

Pramod KC, spokesperson for the DDA, was quoted by a report by The Wire, "We have directed the manufacturing company, importers, and distributors to immediately suspend sales, import, and distribution of the said medicine, until further notice."

He further mentioned, "Some serious issues have been detected in the said antibiotic. Decisions about further actions will be taken once the investigation is completed," according to The Kathmandu Post.

In response to the suspension, Zydus Group stated on Wednesday clarifying that it will provide Biotax 1g with 10ml sterile water in Nepal. The Indian pharmaceuticals group refuted claims of health risks, labelling such reports as “misleading and erroneous.”

According to Business Standard, Zydus maintained that the product complies with all quality parameters as per the approved specifications.

Media reports said that the investigation revealed that the specific batch F300460 of Biotax 1gm injection, which is used to treat bacterial infections such as those affecting the brain, lungs, ear, urinary tract, skin, soft tissues, blood, bones, and joints, did not meet the necessary safety standards.

The DDA said that the batch tested poses a significant risk to patient safety.

Despite the suspension, the DDA assured that the availability of alternative treatments would not be affected, as similar antibiotic injections from other manufacturers are still accessible in the market.

Zydus Group in a statement said, “The letter received from the Department of Drug Administration, Nepal, refers to the quantity of sterile water for injection made available with the product.” They explained that they had supplied 5ml sterile water for injection with the product, while the direction for use indicates “use 3ml for intramuscular injection and 10ml for intravenous injection.”

“The objection raised by the agency is only concerning the non-supply of 10ml sterile water for injection along with the product,” the statement continued, claiming that the discrepancy does not impact product quality nor pose any risk to patient safety.