Deaths of Pregnant Women After Administration of Contaminated Ringer's Lactate Solution: CDSCO Under Scanner
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) is under scrutiny as the Karnataka government seeks clarification regarding reports linking the deaths of pregnant women at Ballari District Hospital to bacterial and fungal contamination in the Ringer's Lactate solution administered to them.
Health Department Principal Secretary Harsha Gupta has formally addressed the issue in a letter to the Drugs Controller General of India, Rajeev Singh Raghuvanshi.
The controversy has raised serious concerns about drug safety and regulatory oversight. The key point of contention lies in the conflicting reports from the state drug control department and the Central Drug Laboratory (CDL) in Kolkata. While the state department flagged several batches of the Ringer Lactate solution as substandard, the CDL cleared them, leading to questions about regulatory oversight and the reliability of quality assurance processes.
The fatalities occurred between November 9 and 11, 2024 post-caesarean operations at the Ballari District Hospital, with initial investigations linking the tragedies to a suspected substandard batch of Ringer Lactate solution—a commonly used intravenous fluid for hydration and electrolyte balance.
The implicated solution, manufactured by Paschim Banga Pharmaceutical Ltd and supplied through the Karnataka State Medical Supplies Corporation Limited (KSMSCL), has raised serious concerns about drug quality control and regulatory oversight. Acting swiftly, the Karnataka government has suspended the state's drugs controller and blacklisted the supplier. Additionally, Chief Minister Siddaramaiah announced an ex-gratia payment of Rs 2 lakh to each bereaved family, promising stringent action against those responsible.
Also Read: Maternal Deaths at Ballary District Hospital: Karnataka Drug Controller Suspended for Negligence
Health department officials revealed that, out of 34 caesarean operations performed over three days, seven patients developed complications, including acute kidney injury and multi-organ dysfunction, leading to four deaths. One patient is still undergoing treatment at Vijayanagar Institute of Medical Sciences (VIMS), while two have recovered and been discharged.
A confidential investigation into the maternal deaths, led by specialist doctors under the guidance of the Rajiv Gandhi University of Health Sciences and Karnataka’s Health and Family Welfare Department, found no evidence of negligence by the hospital staff. According to the review, protocols for patient care, caesarean procedures, and post-operative management were appropriately followed. Despite these efforts, complications in the ICU and dialysis unit proved fatal for four patients.
The complications were traced to the Ringer Lactate solution administered at the hospital.
"The onset of complications following caesarean operations is being suspected to the ringer lactate solution supplied by Paschim Banga Pharmaceutical Ltd to Karnataka State Medical Supplies Corporation Ltd (KSMSCL). Earlier, all 192 batches supplied by the said company were temporarily frozen by KSMSCL, even though two batches were declared not of standard quality on March 18, 2024, by the Drugs Control Department," read a statement by the Karnataka Health Department as quoted by PTI.
"Later, following the certificate of standard quality by Central Drug Laboratories, the usage of ringer lactate of 84 batches was permitted by KSMSCL on August 13, 2024," it said.
Also Read: Karnataka BJP Calls for Resignations After 5 Women Die Post-Delivery in 2 Govt Hospitals
Discrepancies in Drug Quality Certification
This tragedy has underlined inconsistencies in drug quality control. Karnataka’s Drugs Testing Laboratory had previously declared some batches of the Ringer Lactate solution as "not of standard quality" (NSQ). However, upon review by the Central Drug Laboratory (CDL) in Kolkata, the same batches were certified as "standard quality" (SQ). According to a recent media report in The Indian Express, despite these clearances, later testing revealed sterility and bacterial endotoxin failures in 22 batches, prompting a statewide recall of the implicated IV fluids.
A letter from Harsha Gupta, Karnataka's Principal Secretary for Health, has urged the Drugs Controller General of India (DCGI) to investigate the CDL's quality certification process. Gupta also requested assistance from West Bengal's drugs controller to scrutinize the manufacturing facilities of Paschim Banga Pharmaceutical Ltd.
Political and Regulatory Fallout
Opposition leaders, including former Chief Minister Basavaraj Bommai, have criticized the state government for lapses in oversight. Bommai has called for Health Minister Dinesh Gundu Rao's resignation, alleging negligence. Meanwhile, health experts have underscored the systemic vulnerabilities in India’s pharmaceutical supply chain, particularly in public healthcare settings.
The CDSCO, under increasing pressure, has been directed to provide an explanation for the lapses. Simultaneously, the DCGI has initiated its own probe to assess the accountability of manufacturers, regulatory bodies, and procurement agencies.
Precautionary Measures and Future Actions
As a preventive measure, the state has blacklisted all implicated batches of Ringer Lactate and halted their usage across hospitals. Samples of the IV fluid have been sent for further testing, with results expected by December 9. The government has promised corrective reforms to ensure such tragedies are not repeated.
