In the aftermath of four maternal deaths reported at the Ballari District Hospital between November 9 and 11, Karnataka’s Health Department has sought an investigation into the quality of Ringer’s Lactate (RL) solution supplied by Paschim Banga Pharmaceuticals, a West Bengal-based manufacturer.
Harsh Gupta, Principal Secretary of Health and Family Welfare, has written to the Drugs Controller General of India (DCGI), highlighting concerns over the IV fluid batches used during the period when the deaths occurred. He urged the DCGI to probe the manufacturer and collaborate with the Drugs Controller of West Bengal to investigate the production unit.
Manufacturer Under Scrutiny
RL solution is widely used to restore hydration and electrolyte balance. However, batches supplied by Paschim Banga Pharmaceuticals have come under suspicion following the deaths. Of 34 cesarean sections conducted during the affected days, seven patients experienced severe complications, including acute kidney injury and multi-organ dysfunction, resulting in four fatalities.
A confidential review by specialists from the Rajiv Gandhi University of Health Sciences found no negligence by the hospital’s medical staff, asserting that patient care protocols were followed.
History of Quality Concerns
The Karnataka State Medical Supplies Corporation Limited (KSMSCL) had previously flagged RL batches supplied by the manufacturer. In March 2023, two batches were declared “Not of Standard Quality” (NSQ) by the Karnataka Government Analyst. However, upon being challenged, the Central Drugs Laboratory (CDL) in Kolkata certified the same batches as “Standard Quality” (SQ). Subsequent testing of 22 batches across Karnataka revealed failures in critical parameters, including sterility and bacterial endotoxin levels.
Despite some batches being declared SQ by NABL-accredited laboratories, concerns about quality control persist. KSMSCL had frozen certain batches, but they were later released after clearance by NABL labs.
Government Action and Accountability
Karnataka Chief Minister Siddaramaiah has ordered stringent measures, including blacklisting the manufacturer, suspending the state drugs controller, and initiating legal proceedings. IAS officer K. Srinivas has been appointed as the administrative head of the Drugs Control Department to oversee the investigation.
The Karnataka Janarogya Chaluvali (KJC), a public health advocacy group, has called for a high-level fact-finding committee to examine the deaths, emphasizing systemic failures in public healthcare and lax quality control of medical supplies.
In its statement, KJC noted that “preventable maternal deaths underscore a glaring lack of accountability,” demanding reforms in quality control, training, and healthcare infrastructure.
Next Steps
The Health Department has assured transparency in the ongoing investigation. A detailed report on the IV fluid batches and patient complications will be made public once the inquiry concludes. Karnataka has also requested cooperation from West Bengal authorities to ensure thorough scrutiny of the manufacturing process at the supplier’s unit.
The state government’s actions reflect its commitment to ensuring accountability and preventing similar tragedies in the future.