Indian pharma firm says reports of Nepal banning its injection 'misleading, erroneous'

Indian pharma company Zydus Healthcare Ltd on Wednesday (June 19) responded to reports that Nepal has suspended sale and distribution of one of its injections 'over serious health risks'.

The Kathmandu Post had reported on Tuesday that Department of Drug Administration (DDA), Nepal's national medicines regulatory authority, suspended the sales and distribution of Biotax 1gm.

Biotax 1gm is an antibiotic injection manufactured by Zydus Healthcare Ltd. The news report claimed that the laboratory testing of the Biotax 1gm batch F300460 revealed that the drug was not in compliance with the production specifications.

It also claimed that it is not safe for use and could risk patients' lives.

The Biotax 1gm injection is an antibiotic medicine, which is often used to treat bacterial infections, including those of the brain, lungs, ear, urinary tract, skin, soft tissues, bones and joints, blood and heart.

Zydus issues response to reports

Responding to questions by WION on the report, a Zydus spokesperson said, "The news reported is misleading and erroneous as our product batch of Biotax 1g Injection complies with the product specification for product description and all other 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," the spokesperson added.

The spokesperson also said that Zydus has supplied "5ml of Sterile Water for Injection along with the product" and "the direction for use states, 'Use 3ml for Intra Muscular Injection and 10ml for Intra Venous injection'".

The objection raised by the agency is only with reference to the non-supply of 10ml Sterile water for injection along with the product, the spokesperson said.

"This does not have any impact on product quality nor does it pose any risk to patient safety as stated in the article. For intra muscular injection, the product can be constituted with 3ml of sterile water provided with the product. For Intra Venous Injection, the product should be reconstituted by using 10ml sterile water for injection separately," the spokesperson explained.

"No product complaint or any adverse event because of the usage of the product has been received from Nepal since the product commercialization in 2018. The product Biotax 1g Injection has been renewed every year as per DDA, Nepal regulations," the spokesperson said.

What did Nepal's medicines regulatory authority say?

As quoted in the Kathmandu Post report, Pramod KC, who is the spokesperson at the department, said, "We have directed the manufacturing company, importers and distributors to immediately suspend sales, import and distribution of the said medicine, until further notice."

"Some serious issues have been detected in the said antibiotic. Decisions about further actions will be taken once the investigation is completed," he added.

"Injections of the same composition manufactured by other companies are available in the market. The suspension of sales will not affect the treatment of patients," said KC.

Zydus spokesperson told WION that "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 5ml so that the product can be administered for Intra Muscular as well as Intra Venous as per the patient's requirement".

(With inputs from agencies)