In Karnataka, a worrying mismatch in drug test results

Karnataka Health Minister Dinesh Gundu Rao on December 7, 2024 interacts with the family of a woman who died recently at the district hospital in Ballari.
| Photo Credit: The Hindu

The recent deaths of five women following caesarean section deliveries at the district hospital in Ballari have raised concerns about not just the quality of maternal care in the north Karnataka district, but also public healthcare in general.

Of the 34 women who delivered through C-section between November 9 and November 11 at the Ballari hospital, seven developed complications such as acute kidney injury and multi-organ dysfunction. Five of them are dead, though none of them had high-risk pregnancies. An expert committee from the Rajiv Gandhi University of Health Sciences, set up by the government to probe the deaths, concluded that the women had developed complications after they were administered a substandard Compound Sodium lactate Injection IP (Ringer’s Lactate solution), an intravenous fluid that doctors use to restore hydration and fluid balance.

These fatalities occurred despite the significant improvement in maternal mortality over the years in Karnataka. The Sample Registration System 2018-20 bulletin for Maternal Mortality Ratio (MMR) showed a decline in Karnataka’s MMR from 83 per lakh live births in 2017-18 to 69 in 2018-20. The State’s Civil Registration System data from 2021-22 to 2023-24 showed a further decline to 64 in 2023-2024. This year, 327 maternal deaths have been reported in Karnataka since April.

Chief Minister Siddaramaiah ordered the suspension of the Karnataka State Drugs Controller, Umesh S., for dereliction of duty. He also directed officials to blacklist Paschim Banga Pharmaceuticals, which had supplied the substandard IV fluids to the Karnataka State Medical Supplies Corporation Limited (KSMSCL). While a criminal case has been registered against the pharmaceuticals company, a departmental inquiry has been ordered against the Managing Director of KSMSCL. An expert committee is to be set up to investigate whether any other maternal deaths occurred in the State where IV fluids supplied by the company was used.

Currently, the particular batch of the solution in question has been withdrawn, and the Ringer’s Lactate fluids supplied to the Ballari district hospital have been sent to private laboratories accredited to the National Accreditation Board for Testing and Calibration Laboratories (NABL) to detect the presence of endotoxins.

The incident has exposed chinks in the drug testing system. Flagging a mismatch in test results conducted by the Central Drugs Laboratory (CDL), Kolkata, and the State, the Karnataka Health Department has written to the Drugs Controller General of India to investigate the Standard Quality (SQ) certification issued by the CDL, Kolkata, to the manufacturer. The State has also sought action against the manufacturer.

In his letter to the Drugs Controller General of India, Principal Secretary (Health) Harsh Gupta pointed out that the batches supplied by the company had been frozen for use in March 2023 by the KSMSCL after two batches were found to be Not of Standard Quality (NSQ) by the government analyst at the Drugs Testing Laboratory, Karnataka. The manufacturer challenged these reports. These were referred to CDL, Kolkata, by the competent court, and the CDL found these to be of SQ. Testing at Karnataka had found that 22 batches failed on various parameters, but few of these samples were found to be SQ in Kolkata.

“Since August 2024, some of the earlier frozen batches which had not yet been tested by the drugs control officers or which had been found to be of SQ by the government analyst had been released by KSMSCL after those were certified to be SQ by NABL empaneled laboratories. KSMSCL has still not released any of such batches found to be NSQ by the Karnataka Drugs Testing Laboratory, even though some of these batches were found to be of SQ by the CDL later,” the letter stated.

However, questions remain. How did this mismatch happen and why did it not warrant a thorough review and a more cautious approach, including a recall of all the 192 batches supplied by the company? This oversight highlights the need for more stringent monitoring and transparency in healthcare product testing.

Meanwhile, there are signs that the incident is being politicised instead of being addressed as a public health concern. With the winter session of the Karnataka Legislature beginning today, the Opposition is expected to bring the government to the mat.