Imported Dialysis Solution Fails Endotoxin Test, Ingredient, Labelling Issues Flagged
New Delhi: A government laboratory in Himachal Pradesh has classified two batches of an imported peritoneal dialysis solution as Not of Standard Quality after samples failed the bacterial endotoxin test specified in the Indian Pharmacopoeia 2022.
The samples were collected from the paediatric intensive care unit and nephrology department of AIIMS-Bilaspur.
According to the media reports, the solution was manufactured in Thailand and imported by Baxter India. ET said it had reviewed the Drug Testing Laboratory, Baddi, report dated September 3 and a September 7 letter from the state health department to the Drugs Controller General of India.
Apart from the endotoxin test failure, the laboratory report identified nine concerns relating to the product’s ingredients and labelling. It said sodium chloride, calcium chloride and magnesium chloride were identified as meeting US Pharmacopeia specifications rather than Indian Pharmacopoeia specifications. Sodium lactate appeared on the label without a pharmacopoeial specification. The report classified the product as misbranded.
The report also questioned the prominence given to the Vantive brand name on the label. It said the brand name appeared above the generic name in a larger, bold font, contrary to the Indian labelling requirement cited in the report that the generic name be at least two font sizes larger and appear before or above the brand name.
Several instructions concerning the solution’s handling and use were also absent from the label, according to the report. These included identifying it as a “Single Dose Container”, specifying a lower storage-temperature limit, and carrying the warnings “Do not Freeze” and not to use a solution containing visible particles. The report noted that exposure below 4°C could cause crystallisation and separation of solid particles.
The label further omitted the importer’s name and address and the import licence number, the report said.
Baxter told ET that its renal division had been spun off in 2024. Vantive, which operates as an independent kidney-care company, did not respond to ET’s request for comment. The laboratory’s findings covered both the failed endotoxin test and nine concerns about compliance with Indian requirements for ingredients, labelling and safety information.
