Karnataka Government Urges Centre to Investigate Discrepancies in IV Fluid Test Results Following Lactating Women Deaths, ET HealthWorld
Bengaluru: Probing the mysterious deaths of lactating women at Ballari district hospital a few days ago, the state govt expressed its concern over the discrepancies in lab results of the controversial IV fluid — Ringer’s Lactate IP — administered to the deceased.
Flagging the mismatch in the test results between the state and central laboratories, the state govt has written to the Drugs Controller General (India) in New Delhi, seeking to investigate the matter further and initiate action against the pharma company and others concerned on a priority basis.
In the letter, the state’s health and family welfare principal secretary, Harsh Gupta, apprised the Centre about the varying results. While the state drug-testing lab found 22 batches of the Compound Sodium Lactate Injection IP (Ringer’s Lactate IP) as ‘not of standard quality (NSQ)’, a few of these 22 batches were found to be of ‘standard quality (SQ)’ at the Central Drugs Laboratory (CDL), Kolkata. Similarly, a few of the samples were also certified SQ by National Accreditation Board for Testing and Calibration Laboratories-empanelled labs.
“Out of the 22 batches of said drug that were drawn for testing and analysis by drugs controller officers across Karnataka, all 22 failed in various parameters, including tests for sterility and tests for bacterial endotoxin particulate matter. Similarly, a few of these NSQ samples were also found to be SQ by the CDL later,” Gupta highlighted in his letter to the Centre. Health minister Dinesh Gundu Rao also reiterated that the Centre must strengthen the existing drug regulatory framework.
“We’re only reporting the discrepancies in test results conducted by both the state laboratory and CDL. While 22 batches failed the tests in our state laboratory, four batches out of these 22 were cleared by CDL. Yet, as a precautionary measure, we (Karnataka) haven’t supplied the drug belonging to these 22 batches to any hospitals. The Centre must probe this as CDL is under its jurisdiction… and ensure that the Centre’s drug regulatory framework is strengthened to tighten the noose around pharma companies,” Rao said.
Report sought on discrepancy in results
Noticing the discrepancies in test results, the health and family welfare services commissionerate has sought a detailed report on the methodology adopted for testing the presence of endotoxins in IV fluids. The health commissioner has requested the medical education department to conduct an inquiry and submit a report.
Visit: Valley Vision News
