Twenty-five-year-old Raja HG hadn’t held his son even once, nearly four months after the baby was born. He was still grieving the loss of his wife, Rojamma, when TNM met him in February 2025. She was one of the six women who died between November and December 2024, following a C-Section surgery at the Ballari District Hospital in Karnataka.
The entire episode has exposed the bizarre ways in which India’s drug regulation functions.
The Karnataka state government has attributed the deaths of the six women to a substandard batch of Ringer’s Lactate (RL), an intravenous fluid commonly used to hydrate patients during surgery. The RL in question was procured from Paschim Banga Pharmaceuticals, a company based in West Bengal. But the story is far from straightforward.
While a clinical investigation by the state points to RL as the likely cause, lab tests conducted on the specific batch administered to the women showed it met quality standards. However, nearly half of Karnataka’s overall RL supply from Paschim Banga Pharmaceuticals was found to be substandard.
What makes this more puzzling is that earlier in 2024, the same RL batches that failed quality checks in Karnataka’s state-run labs had passed tests at the Central Drugs Laboratory in Kolkata.
All this demonstrates how India’s apathetic drug regulatory system—across both state and Union government levels—has consistently failed the public, placing patients at risk of illness and even death.
Rojamma (22), Sumaiya (23), Muskan (21), Kammari Lalitha (28), T Mahalakshmi (20), and Hoogar Nandini (27) underwent C-Section or Caesarean delivery at the Ballari District Hospital between November 9-11. They barely saw their babies before their condition deteriorated dramatically and led to their deaths.
The deaths sparked anger across the state, with the families of the deceased women alleging medical negligence and activists demanding an inquiry to ascertain the cause of death and to investigate whether such deaths had occurred elsewhere in the state.
A panel of doctors from Bengaluru’s Rajiv Gandhi University of Health Sciences (RGUHS) exonerated the doctors and blamed the deaths on RL. The Karnataka State Medical Supplies Corporation Limited (KSMSCL) had procured 196 batches of RL from Paschim Banga Pharmaceuticals, located near Siliguri in West Bengal.
Health and Family Welfare Minister Dinesh Gundu Rao has since been waging a zealous battle with the Union government, claiming that states are helpless in penalising manufacturers of substandard drugs that are located outside the state. He has written opinion pieces in newspapers and shot off letters to the Union government calling for a centralised database of information on substandard drugs.
The families of the deceased women are struggling to cope. Not only are they grieving, they’re also battling disbelief—how could a woman who had no complications during pregnancy suddenly die?
Families struggle to cope
Raja, a Dalit man, met Rojamma, a Kuruba woman, while working as a driver. They fell in love and got married in 2020. Their families were initially against their inter-caste marriage, but that was resolved by the intervention of a local Congress MLA, Raja told TNM.
All of Rojamma’s routine examinations had been carried out at private clinics, Raja said. When they went to the Ballari District Hospital on November 9, 2024, for the delivery, doctors said Rojamma needed to undergo C-Section surgery. At 9.25 that night, Raja and Rojamma had a son. “Everything was fine,” Raja said.
In a few hours when hospital staff came in to check on Rojamma, they saw her arms, legs, and stomach had swollen up. She was moved to the Intensive Care Unit (ICU). When her condition worsened, she was shifted to the Ballari Medical College and Research Centre (BMCRC). She died on November 14.
“For four days, she did not pass urine. Something happened during the C-Section,” Raja said. Two days after she died, he attempted to take his own life. “For five days, it was not clear whether I would survive. I am a little weak but I’m fine. We had a good relationship,” Raja said.
Asked about the name he had given his son, Raja said, “I haven’t held him yet.” His mother and other relatives are looking after the baby.
Thirty-seven-year-old Manjunath Achari, Lalitha’s husband, is also struggling with grief. When Lalitha was admitted to the District Hospital on the night of November 9, doctors said she would have to undergo a Caesarean surgery but did not give a reason.
After the couple insisted on a normal delivery, the doctors allowed it. However, when Lalitha could not push the baby out even after several hours, doctors took her to surgery. At 6 am the next day, their son was born.
“She saw the baby, she spoke to us. My mother was there when they gave her another bottle (of IV fluid). The doctors came and told us she would be fine,” Manjunath said.
He was picking up medical reports when he got a call from one of his relatives saying that Lalitha was getting fits. He rushed back to the ward. “They took her to the ICU and said she would recover,” Manjunath said.
Lalitha was in the ICU the whole day and even put on a ventilator. “The next morning, they told us her kidney and liver had failed. At 7 am, they told us she had died,” Manjunath said. It was November 11.
Manjunath has an eight-year-old daughter too. “Her classmates sometimes pick on her telling her that her mother has died. She comes home crying and we have to console her. I’m unable to sleep at night,” Manjunath said.
‘I have never seen anything like this in 25 years’
According to District Surgeon Basa Reddy, Ballari District Hospital delivered 6,397 babies in 2022-23 and 6,929 in 2023-24, with only one death each in both years. On average, 30 deliveries are done each day, half of which are C-Sections.
Basa Reddy told TNM that the hospital got a particular batch of RL on November 8 and doctors started using it the next day—November 9.
Between November 9 and 11, the District Hospital performed C-Sections for 36 women, among whom nine developed complications. Four of these women recovered and five died.
Within 10-12 hours of the surgery, some of the women started showing signs of inflammation and infection in the body, indicated by a rise in parameters such as total count, CRP, and D-Dimer. They also had decreased urine and abnormal blood clotting, Basa Reddy said.
“We did not know why it was happening. On all three days the doctors were different, the post-graduate students were different. There was nothing common. We did panic, but we had to keep the hospital running,” Basa Reddy said.
Doctors at BMCRC say they were taken aback by how fast the six women’s condition deteriorated. Four of the six women who died had been referred to BMCRC when they developed complications.
“I have never seen anything like this in 25 years,” Dr Veerendra Kumar, head of the department of obstetrics and gynaecology at BMCRC, told TNM. The hospital sees around 30 deliveries a day, of which around 10 are often high-risk cases. The hospital recorded 56 deaths in 2022, 26 in 2023, and 32 in 2024.
Normally, Dr Veerendra said, complications would develop between three and five days of a C-Section surgery. “But these women deteriorated drastically to multi-organ failure within 24 hours of surgery.” He said that the patients’ kidneys failed and several of them had high blood pressure.
Initially, they did not know what was causing such a sudden decline. “Women aged 22-25 were dying. Nothing we knew caused such sudden deterioration. Even though I’ve been a doctor for 25 years, I could not explain what happened.”
It was the government appointed medical panel that inquired into the deaths that zeroed in on Ringers’ Lactate as a possible cause and ruled out medical negligence.
Asked how medical negligence was ruled out, Dr Savitha C, Medical Superintendent at Vani Vilas Hospital in Bengaluru and one of the panel members, told TNM that they suspected medicines after they found no “procedural error”.
“Doctors cannot cause bleeding inside the abdomen, or complete renal shutdown. Doctors cannot bring urine output to zero. We found no procedural errors from the records,” she said.
After examining the case documents and the OT records, the panel found that the staff who performed the surgery and all other materials used during surgery such as antibiotics were the same as previously used. “The only change we could point out was the RL,” Dr Savitha said.
She said that IV fluids could contain remnants of bacterial endotoxins that can produce adverse effects in patients. A similar situation with RL had been found in Brazil, she said.
Quality control and cause of death
Tests of RL batches procured by the state show a strange and somewhat alarming picture.
The preliminary report of the Lokayukta inquiry, of which TNM has a copy, found that five of the women who died had been given batch number 03BF2338 of the RL. It was unclear what was administered to the sixth woman.
Bottles from the batch were tested by four labs, three private and one government, and passed quality parameters for sterility, particulate contamination, and bacterial endotoxins. These include Devansh Testing Lab, which tested a sample from the batch in February 2024, Vimta, which tested a sample in December 2024, and Standard Analytical, which tested it in August 2024. The government lab tested the sample in December 2024.
Even as the batch administered to five women who died turned out to be free of contaminants, over 60% of Karnataka’s supply of 196 batches of RL is substandard.
TNM went through the website of the Karnataka Drugs Control Department and found that 121 batches from all 31 districts in the state had failed one or more quality parameters. However, according to a Health Department press release dated April 8, 113 batches were found to be Not of Standard Quality (NSQ).
Karnataka’s Drugs Control Department has been raising red flags about the RL supplied by Paschim Banga since at least January 8, 2024, when a batch flagged in Chamarajanagar district turned up NSQ.
Samples of the IV fluid kept getting flagged in 15 other districts in Karnataka—in some cases up to three samples from the same district—until the tragedy in Ballari raised an alarm.
In June last year, the Central Drugs Standard Control Organisation (CDSCO) found that a batch of RL manufactured by Vision Parenteral had failed the test for bacterial endotoxins and another batch manufactured by Higgs Healthcare had failed the potassium assay test. An assay test measures whether a drug contains the exact quantities of ingredients that it is supposed to have.
KSMSCL halted the use of RL across the public health system and blacklisted RL manufactured by Paschim Banga in March 2024 after two or more batches of RL were found to be not of standard quality. However, the company petitioned the Karnataka High Court, which stayed the blacklisting in April last year.
Some months later, in August, the Technical Advisory Committee of KSMSCL allowed the usage of 86 batches, but according to the Lokayukta inquiry the three batches of RL supplied to the Ballari District Hospital in October and November were not among these, indicating lapses on the part of KSMSCL.
All batches of RL were frozen again on November 16, 2024, after the deaths occurred.
Contradictory results, complicated laws, and lack of transparency
The six deaths in Ballari have exposed how the dubious workings of quality testing, poor policy, and the division of regulatory powers between the states and Union governments can pose a risk to patient safety.
In December, the Karnataka Health Department wrote to the Drugs Controller General of India (DCGI) seeking an investigation into the test results from the Central Drugs Laboratory, Kolkata. Principal Secretary to the Health Department Harsh Gupta wrote that several batches of RL tested by the state lab were found to be NSQ. However, some of these batches were certified as of standard quality by the CDL, Kolkata.
“How is this possible? How did these batches pass testing at CDL? What was the process used to test? No one is asking these questions,” said Dinesh Thakur, co-author of The Truth Pill, a book that details India’s shockingly inadequate and apathetic drug regulatory system.
Dinesh also drew attention to the lack of a centralised data sharing mechanism where information about substandard drugs in any part of the country was publicly available.
While the CDSCO issues alerts on drugs that fail quality testing, these simply do not provide the full picture. For instance, the state alert for January 2025 only mentions four samples—three from Karnataka and one from Jammu and Kashmir. The DCD website for Karnataka, however, listed 50 samples of various drugs, including 46 samples of RL, found to be NSQ in January.
Dinesh welcomed the Health Department’s move to formulate a drug recall policy as announced in the Karnataka Legislative Council.
“Such a body should have public health experts who have no vested interest in the pharmaceutical industry and make a collective decision. This is the only way in which we can ensure objectivity,” he added.
However, he described as “nonsensical” the idea that the government should test procured drugs before distributing them in the public health system. This is a demand made by many activists, including DAF-K, and is already in practice in Tamil Nadu. “Regulation exists to ensure that the quality of a product is good before it is sold to the public. You buy food every day. Do you test everything you buy for quality before you eat?”
Drug manufacturing plants are regulated under Schedule M of the Drugs and Cosmetics Rules but that system only exists on paper, says Dr Anant Phadke, a member of the All India Drug Action Network (AIDAN).
Dr Anant is also a trustee of Low Cost Standard Therapeutics, a non-profit that manufactures low cost essential drugs. “Drug inspectors are supposed to visit the plants, and some of them do a good job, but compliance with Schedule M is largely non-existent.”
But he says that quality control is achievable if manufacturers maintain proper records about raw materials, manufacturing processes, and internal quality testing in real-time. “The government can monitor this and quality can be ensured.”
Dr Anant said that according to the National Drug Survey 2014-16, about 3% of drugs in the country were not of standard quality. “It used to be about 8%, but it has improved. Of course, we should aim for 0.”
The Mashelkar Committee had recommended one drug inspector for 50 factories and one for 200 pharmacies. “But no state follows this,” Dr Anant said. Karnataka has only eight drug inspectors for the whole state.
Under the Drugs and Cosmetics Act 1940, a state has regulatory control only over facilities that are located within its jurisdiction. When something goes wrong and a manufacturer from another state is involved, states rarely cooperate with requests for records of manufacturers or with regard to inspections, owing to competition between states for pharmaceutical investments, according to the authors of The Truth Pill.
This lack of jurisdiction over manufacturers in other states is a point that Karnataka’s Health Minister has repeatedly made in the wake of the deaths. Recently, Dinesh Gundu Rao wrote to Union Health Minister JP Nadda drawing attention to the state’s helplessness in tackling substandard drugs from other states.
According to a recent press release, 78 cases had been filed against the manufacturer Paschim Banga. TNM went through the websites of courts across the state and found that the state government had filed 30 cases against Paschim Banga in courts in 13 districts since December 2024.
Most of these cases have been filed against the company under Sections 25(4) (reports of government analysts), 18 (a)(1) (prohibition of manufacture and sale of certain drugs and cosmetics), and 27 (d) (penalty for manufacture, sale, of drugs in contravention of law) of the Drugs and Cosmetics Act.
However, even the cases that have been filed are unlikely to have an impact if precedent is anything to go by. The authors of The Truth Pill analysed 285 cases in Karnataka for NSQ drugs between 2015 and 2021 that ended in convictions.
In a whopping 248 cases, the accused were sentenced to “simple imprisonment till the rising of the court”—which means that the convicts could walk free once the judge rose from their seat for the day. In the remaining cases, fines were imposed in 23 cases and prison terms were awarded only in 14 cases.
“Such lenient sentencing, combined with a statutory cap on monetary fines at a mere Rs 20,000 means that pharmaceutical companies found guilty of manufacturing NSQ drugs seldom face any material punishment for a crime that could seriously hurt or kill people, especially the most vulnerable patients,” Dinesh Thakur and Prashant Reddy T wrote in The Truth Pill.
The authors aptly summarise the impact of all these lapses and failures: “The consequences of an inadequate scheme of drug regulation are much like climate change—not everybody can see the linkages in real time; its consequences cannot be easily measured, but it is most definitely causing harm to public health.”
Whether or not substandard Ringers’ Lactate was responsible for the deaths of the six women in Ballari district, the deaths did erode trust in the public health system. From 15-20 a day, the number of deliveries at the Ballari District Hospital fell to about 4-5 in the weeks after the deaths. When TNM visited the hospital in February, it had not yet climbed back to normal levels.
For people like Gulzar Begum, the fracas between the government departments doesn’t matter. Her daughter Muskan is never going to come back. “My daughter was tough. She studied till Class 12. On the day of her labour, she said she could ride the two-wheeler and take herself to the hospital,” Gulzar said.
Muskan had a C-Section at the District Hospital at 4 pm on November 11. “After the surgery, they took her for an injection. Then she started turning yellow. In a few hours, she was as yellow as her salwar,” Gulzar recalled, showing TNM a picture of Muskan.
The next day, they took her to a private hospital. “They put a tube in her neck, then into her mouth,” recalled Saif, Muskan’s older brother.
Muskan spent nearly two weeks in the hospital, most of the time unconscious. “One day, she spoke a little. She asked for her daughter and her husband,” Gulzar recalled.
On the morning of November 25, Muskan’s uncle was in her room. “I saw them remove all the machines, so I went inside,” Saif said. The doctors had informed his uncle that she was no more, and his uncle then told the rest of the family.
Although Muskan’s husband has been loving towards his daughter Inaya, Gulzar and her family will raise Inaya. Gulzar said that the maternal grandmother has the right to raise the child if the mother dies. “Her husband will marry again. I lost one daughter, now I have another,” Gulzar said.
Meanwhile, the government has given compensation of Rs 5 lakh to the families of the deceased women. “What will I do with the money? I will give them Rs 50 lakh. Will they bring my wife back? I could have gone to a private hospital (if they couldn’t treat my wife),” Raja said angrily.
(With inputs from R Venkatesh)