Substandard lactate solution, a fluid administered intravenously for hydration and fluid balance, is suspected to be the cause of the deaths of four women.
Published Dec 01, 2024 | 9:00 AM ⚊ Updated Dec 02, 2024 | 3:07 PM
The use of the suspected IV fluid Ringer Lactate solution has been suspended in all hospitals in the Ballari district. (Wikimedia Commons)
Four families in the Ballari district awaiting the joy of welcoming newborns are instead grieving the death of new mothers at government hospitals.
Substandard lactate solution, a fluid administered intravenously for hydration and fluid balance, is suspected to be the cause of the deaths.
Of 34 caesarian procedures conducted, seven patients suffered severe complications, including acute kidney injury and multi-organ dysfunction. Among these, four turned fatal.
The deaths of the young women who just delivered babies unleashed a political slugfest.
The use of the suspected IV fluid Ringer Lactate solution has been suspended in all hospitals in the Ballari district. The drug controller has been placed on suspension and the manufacturer of the Ringer Lactate solution was blacklisted.
Between 9-11 November, Ballari District Hospital saw an unexpected rise in maternal deaths during caesarean operations.
Of 34 procedures conducted, seven patients suffered severe complications and four died.
It was suspected that the women deteriorated after they were given Ringer Lactate solution IV fluid supplied by the government.
While the link to Ringer Lactate is unconfirmed, the solution, sourced from Paschim Banga Pharmaceutical Ltd in West Bengal, has been suspended and is undergoing rigorous testing.
With previous tests showing no abnormalities, state Health Minister Gundu Rao, after a meeting with the chief minister, informed the media about ongoing efforts to ensure the product’s safety.
“We suspect the IV Ringer’s Lactate solution to be the cause, but we are awaiting the lab testing reports. Anaerobic testing has already been initiated,” said the minister.
Karnataka Chief Minister Siddaramaiah ordered the suspension of Drug Controller Umesh S, citing negligence of responsibility.
Addressing the media following a high-level meeting on the tragedy, the Chief Minister announced that the West Bengal-based company responsible for supplying the Ringer’s Lactate solution has been blacklisted.
He also directed authorities to file a criminal case against the company.
The government has already declared compensation of ₹2 lakh for each victim’s family.
Additionally, Siddaramaiah instructed officials to recover damages from the drug supplier and distribute the amount to the families of the deceased.
To prevent similar incidents in the future, an expert committee led by the state Development Secretary will investigate reported cases across hospitals statewide, he said.
ಬಳ್ಳಾರಿ ಜಿಲ್ಲಾಸ್ಪತ್ರೆಯಲ್ಲಿ ಸಂಭವಿಸಿದ ನಾಲ್ವರು ಬಾಣಂತಿಯರ ಸಾವು ಪ್ರಕರಣಕ್ಕೆ ಸಂಬಂಧಿಸಿದಂತೆ ಮೃತ ಬಾಣಂತಿಯರ ಕುಟುಂಬಕ್ಕೆ ರಾಜ್ಯ ಸರ್ಕಾರ ₹ 2 ಲಕ್ಷ ಪರಿಹಾರ ಘೋಷಿಸಿದೆ. ಅಲ್ಲದೇ, ಸಾವಿಗೆ ಕಾರಣವಾದ ಔಷಧ ಪೂರೈಸಿದ ಕಂಪನಿಯಿಂದಲೂ ಪರಿಹಾರ ವಸೂಲಿ ಮಾಡಿ, ಮೃತರ ಕುಟುಂಬಕ್ಕೆ ನೀಡಲು ಅಧಿಕಾರಿಗಳಿಗೆ ಸೂಚನೆ ನೀಡಿದ್ದೇನೆ ಎಂದು… pic.twitter.com/JOjexmkJZx
— DIPR Karnataka (@KarnatakaVarthe) December 2, 2024
The state health minister said a total of 2,600 surgeries, including numerous cesarean deliveries, have been conducted at the Ballari district hospital without any fatalities.
“For the first time, the deaths of four postpartum women have raised suspicions about the IV solution,” he explained.
The solution has been sent for quality testing, and the report may take 8-9 days to arrive. “We will take appropriate action based on the findings,” he said.
The company was earlier blacklisted, but it approached the High Court and presented a certification from the Central Drug Laboratory stating that the IV solution could be used.
The minister said the Drug Control Department had tested 92 batches, of which 22 were found to lack standard quality.
“Despite the CDL’s certification, the 22 substandard batches identified by the Drug Control Department were not supplied to hospitals. Only those batches deemed of standard quality were provided to hospitals by the Karnataka Drugs Logistics and Warehousing Society,” he said,
The state health minister said the committee of experts who examined the fatalities concluded that the doctors performed their duties properly and were not at fault.
Previously, IV solutions used in Davangere and Pavagada were tested, and the reports indicated no issues.
However, subsequent tests conducted by the Drug Control Department revealed that 22 batches fell short of the required standard. “Based on this, we may prosecute the company,” the minister said.
The government has announced compensation for the families. Among the four deceased postpartum women, two were in good health and had no other medical conditions.
“Their deaths during cesarean deliveries, despite being in excellent health, have deeply pained us,” the health minister said
The minister also ordered a thorough review of similar incidents in hospitals across Karnataka.
Chief Minister Siddaramaiah stressed the urgent need to revamp Karnataka’s drug regulation framework, pointing out critical gaps exposed by the recent maternal deaths at Ballari District Hospital.
“Our current drug regulation laws need a comprehensive review to ensure the highest standards of safety and quality in medical supplies,” the CM stated.
He directed a re-organisation of the Drug Control Department and procurement process, modeled on Tamil Nadu’s system, known for its robust checks and balances.
A proposal to strengthen drug regulation laws will be presented at the next cabinet meeting, signaling the government’s commitment to systemic reform.
The CM also highlighted the pressing issue of curbing the “medicine mafia” and emphasised accountability within the healthcare system.
“We cannot allow the unchecked influence of rogue entities in our drug supply chain. Strict laws and vigilant enforcement are essential to restore public trust,” he remarked.
Officials were instructed to ensure that such incidents are not repeated and to identify those responsible once laboratory reports are available. The government will also seek stricter regulations from the central government to safeguard public health.
Several BJP leaders in the state slammed the Congress government and its health department for negligence and demanded the resignation of the health minister and the medical education minister.
On Saturday, Union Minister of State Shobha Karandlaje told the media, “Around 110 children and around 30 women have lost their lives in the last six to seven months. Four women died in Ballari district hospital in just a week. In Bellary Medical College, one woman lost her life. The glucose was fake. The Siddaramaiah government is hiding everything. This government isn’t doing anything for the health of the public,” she said
Meanwhile, R Ashoka, a social media user, on Friday took to X alleging that the government has hidden the report submitted by the expert committee probing the recent deaths and said,
“Neither Chief Minister Siddaramaiah nor Deputy Chief Minister DK Shivakumar expressed their condolences. Ballari district in-charge Minister Zameer Ahmed Khan has not yet visited the hospital. Taking moral responsibility for the deaths, Health Minister Dinesh Gundu Rao and Medical Education Minister Sharan Prakash Patil should resign. I appeal to Chief Minster Siddaramaiah to get an impartial probe done and take stringent legal action against the offenders,” Ashoka said in the post.
(Edited by Rosamma Thomas).
