IV fluid
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Ringer’s Lactate Solution is typically used to maintain the body's water, sugar and electrolyte balance during dehydration. Paschim Banga Pharma's IV fluid had been flagged over quality issues. Representational image: iStock

Karnataka maternal deaths: Lab tests confirm fungi, bacteria in IV fluid

Lokayukta findings trigger suspicion that IV glucose supplied by blacklisted pharma co may have been used in several other government hospitals, too


The deaths of four women post-delivery at a Karnataka government hospital within a fortnight, after being administered a banned drug, has caused public outrage, forcing the Siddaramaiah government on the backfoot.

The widespread anger has refused to subside even as the government has blacklisted the pharmaceutical company responsible for the contaminated intravenous (IV) fluids that caused the deaths, and suspended the state’s Drugs Controller K Umesh.

Of the four deaths, two occurred at the Ballari Government District Hospital, while two more deaths occurred at VIMS (Ballari), after the patients were shifted there from the former. A preliminary report by an experts’ committee suggests that the use of Ringer’s Lactate Solution — an IV fluid banned in Karnataka— during caesarean sections caused the deaths.

A report on IV fluid samples supplied by the West Bengal-based Paschim Banga Pharmaceutical Co revealed the presence of fungi and multiple bacteria in the fluids, sources in the Karnataka Health Ministry told The Federal.

How it unfolded

Between November 9 and 11, 34 cesarean sections were performed at the Ballari District Hospital. Among these, seven women experienced health complications. On the night of November 11, one woman passed away, followed by another in the early hours of November 12.

The remaining five women were referred to the Ballari Institute of Medical Sciences and Research (formerly VIMS) for advanced treatment. All the affected women exhibited symptoms of organ failure.

A three-member medical committee visited Ballari on November 14, conducted an investigation, and submitted a report to the government the same day. The very same day, another woman died at VIMS. On November 25, yet another woman died, bringing the total to four.

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Revelations from tests conducted by the state laboratory came to light, and the investigation team concluded that the suspect IV fluids caused all the deaths.

Fifth death?

Mahalakshmi, a resident of Kudligi taluk's Gudekote Primary Health Centre, was admitted to VIMS on November 24 and passed away on November 26 despite treatment after she underwent a cesarean section.

Health officials have submitted a report on this. Investigations are underway to determine if this incident is related to the four recent cases and whether there is any link between the fifth dead woman and the IV fluid administered.

The fact that she also passed away at VIMS has raised suspicions about the incident.

Systemic lapses

The tragedy has highlighted systemic lapses, with allegations of negligence by hospital authorities and failures in drug quality monitoring.

Ringer’s Lactate Solution is typically used to maintain the body's water, sugar and electrolyte balance during dehydration. It contains water, glucose, potassium, sodium and chloride. Paschim Banga Pharma's IV fluid had been banned in Karnataka due to known quality issues.

The pharmaceutical company had supplied 192 batches of Ringer's Lactate IV fluids, out of which 22 were flagged for quality concerns. The state government then told all hospitals not to use these 22 batches. It is suspected that one of these batches went to Ballari district, triggering multi-organ failure in the victims.

Informed sources allege the government has withheld the probe team's report from the public, sparking allegations of a cover-up.

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Tests confirm contaminants

Karnataka Health Ministry sources told The Federal that a report on the IV fluid samples supplied by Paschim Banga Pharma revealed the presence of fungi and multiple bacteria. State laboratory tests have confirmed this.

Harsha Gupta, Principal Secretary of the state Health and Family Welfare Department, wrote to the Central Drug Control Department, as a central drug laboratory report suggested that 22 suspect batches of the IV fluids could have been used.

The samples have now been sent to the Central Drugs Laboratory in Kolkata, and the state government is expected to receive the report on December 9. "We will get more accurate details about the incident from there," a state Health Ministry official told The Federal.

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Damage control

The Karnataka government has now blacklisted Paschim Banga Pharma, and suspended Drugs Controller K Umesh.

IAS officer K Srinivas, the Food Department Commissioner, has been named the new head of the Drug Control Department.

The use of all batches of Ringer’s Lactate Solution has been suspended across Karnataka.

In a related development, a team led by Lokayukta SP Hanumantharay found boxes of IV glucose supplied by the same company at the Belagavi District Hospital's warehouse.

Investigation revealed that this IV fluid had been distributed across hospitals in Belagavi since April, raising concerns about its broader impact.

Opposition attacks government

The deaths at the Ballari hospitals have triggered a war of words between the government and opposition parties. BJP leader R Ashok has accused the Congress government in the state of negligence, stating that the withheld report indicates an intent to deflect responsibility.

He alleged that health department officials’ apathy caused the deaths.

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Public outrage has been directed at the district administrators, health department officials and the district in-charge minister Zameer Ahmed Khan, who has allegedly avoided visiting the site.

Concealment charges

Union Minister Shobha Karandlaje has accused the Siddaramaiah government of concealing maternal deaths in Ballari and demanded action against state Health Minister Dinesh Gundu Rao, who promised a thorough investigation into the lapses

Chief Minister Siddaramaiah held a meeting on November 30 with health officials to address expert findings and allegations of negligence. The government announced Rs 2 lakh as compensation to the victims' families, initiated a state-wide probe and directed additional recovery from the pharmaceutical company.

The government's critics, however, point out that such vigilance and stern action could have saved four young mothers' deaths.

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