Imported dialysis solution fails endotoxin test in Himachal; lab flags nine regulatory violations

New Delhi: A government drug testing laboratory in Himachal Pradesh has declared two batches of an imported peritoneal dialysis solution, a critical medicine used in kidney failure patients, as "Not of Standard Quality" after they failed bacterial endotoxin tests conducted under local regulations.

The solution was manufactured in Thailand and imported by Baxter India, as per a report by the health and family welfare department in Himachal Pradesh. The test at the Drug Testing Laboratory, Baddi, found that the samples drawn from the paediatric intensive care unit and nephrology department of AIIMS-Bilaspur in Himachal did not conform to the standards prescribed in Indian Pharmacopoeia 2022 on bacterial endotoxins, the report said.

ET has seen a copy of the laboratory's report dated September 3 and the state department's September 7 letter flagging the findings to the Drugs Controller General of India.


Baxter told ET that it spun off its renal division in 2024. Vantive, the kidney-care business which is now an independent standalone company, did not respond to a request for comment.

The violations cited in the report range from the use of wrong pharmacopoeia standards for key ingredients to missing critical safety warnings.

According to the documents assessed by ET, the most fundamental concern is that the product contained sodium chloride, calcium chloride and magnesium chloride that conform to the US Pharmacopeia rather than the Indian standards. "Since the product is intended for sale in India, all ingredients must conform to Indian Pharmacopoeia standards," said a person in the know.

The report flagged this as a violation and classified the product as "misbranded".

The ingredient sodium lactate was mentioned on the label without any pharmacopoeial specification, attracting the misbranded classification, it said.

Indian drug labelling rules are explicit that the generic name of a drug must be displayed in a font size at least two sizes larger than the brand name, and the brand name must appear below or after the generic name, not above it.

The Vantive label does the opposite, according to the report. "The brand name Vantive is displayed in bold, in a larger font size than the generic name, and is positioned above it," violating the rule, said the person cited earlier.

"The rule exists to ensure that healthcare professionals and patients can immediately identify what drug they are dealing with, and not be led by brand identity," the person said.

Another issue was the missing safety information that the Indian Pharmacopoeia specifically requires on the label of peritoneal dialysis solutions.

The label does not state that the product is a "Single Dose Container", a mandatory requirement under the report said. It does not mention the lower limit of storage temperature, despite the Indian Pharmacopoeia explicitly warning that exposure to temperatures below 4 degrees C may cause crystallisation and separation of solid particles, rendering the preparation unsuitable for use.

The warning "Do not Freeze" is also absent, the report said. And the caution that "the solution containing visible particles should not be used", a critical patient safety instruction, is nowhere on the label, it said.

"Together, they represent a significant failure to provide patients and healthcare professionals with information that could directly affect patient safety," the report said.

The label also does not mention the name and address of the importer or the import licence number, the report said. For a regulated imported drug product, the import licence number is a basic traceability requirement.

"Taken together, the nine violations paint a picture of a product that was brought to market in India without adequate attention to Indian regulatory requirements on standards, labelling and safety communications," a second person said.

He said for a product like peritoneal dialysis solution, which was administered to critically ill kidney failure patients in a hospital setting, these were gross violations and carry the potential to cause direct patient harm.