Dialysis fluid contained chemicals linked to infertility liver damage:Kit flagged as fatal by US-FDA; supplied from Indore

Dialysis kits imported from Thailand and supplied to government hospitals in Madhya Pradesh have been flagged by the US-FDA as potentially fatal for patients. The supplying companies, Vantiv and Baxter, have admitted the kits contain hazardous chemicals that may cause infertility and liver damage. Following Bhaskar’s investigation, a team from the MP Food and Drug Department and Central Drugs Standard Control Organization (CDSCO) inspected the drug supplier MK Brothers in Lasudia Mori on Thursday and collected samples of several medicines. Officials also found that two companies were operating under the same import license. Orders for recall issued The fluid from the same company, Baxter of Thailand, whose products were ordered to be recalled by the US FDA (Food and Drug Administration), considering them a ‘Class-1’ (most serious category) threat, was supplied from Indore across the entire state. Baxter had admitted in a ‘Correction Notice’ on February 20, 2025, that dangerous chemicals were found in their ‘dialysis kits’. This chemical can cause disturbances in the endocrine system. Vantiv does not have an import license
The Drug Inspector had investigated MK Brothers on August 21, 2025. At that time, serious irregularities were found in the labeling and packaging of dialysis fluid. The investigation report of MP Drug Inspector Lokesh Gupta specifically mentions Dynal PD-2 (Peritoneal Dialysis Solution 2). However, the department had not seized any samples at that time. In response to the notice, MK Brothers had submitted documents on August 25, admitting that Vantiv India did not have an import license. No notice received Bharat Jain, Head, MK Brothers, says, The Drug Department had also inspected on August 21, 2025. At that time, clarification was sought regarding labeling and misbranding on dialysis fluid. A response was given on August 25 itself. The status of Baxter and Vantiv’s import licenses was clarified. No samples were taken from our firm at that time. No notice was received regarding product recall. Investigation started, samples taken Gaurav Kumar, Deputy Drug Controller, CDSCO, says, A complaint has been received regarding MK Brothers importing dialysis kits and fluids from a Thailand-based company without a valid import license. The Drug Department and CDSCO team started a joint inspection on Thursday. Samples have been collected. Documents related to the import license are also being investigated. Provision for punishment up to 5 years
Narendra Ahuja, Former State Drug Controller, Haryana, says that this case, related to rejected or recalled medicines from other countries being dumped in our country, is very serious. Earlier, too, Indian patients suffered great harm due to faulty hip implants. Later, the foreign company had to pay compensation. Importing and selling medicines from abroad without a valid import license is a violation of Section 18-C of the Drugs and Cosmetics Act. This can lead to a punishment of up to 5 years. The Act does not permit the sale of misbranded medicines.