In Karnataka, a worrying mismatch in drug take a look at outcomes

Karnataka Well being Minister Dinesh Gundu Rao on December 7, 2024 interacts with the household of a lady who died lately on the district hospital in Ballari.
| Picture Credit score: The Hindu

The current deaths of 5 girls following caesarean part deliveries on the district hospital in Ballari have raised issues about not simply the standard of maternal care within the north Karnataka district, but in addition public healthcare usually.

Of the 34 girls who delivered by means of C-section between November 9 and November 11 on the Ballari hospital, seven developed issues akin to acute kidney damage and multi-organ dysfunction. 5 of them are useless, although none of them had high-risk pregnancies. An knowledgeable committee from the Rajiv Gandhi College of Well being Sciences, arrange by the federal government to probe the deaths, concluded that the ladies had developed issues after they had been administered a substandard Compound Sodium lactate Injection IP (Ringer’s Lactate answer), an intravenous fluid that medical doctors use to revive hydration and fluid steadiness.

These fatalities occurred regardless of the numerous enchancment in maternal mortality through the years in Karnataka. The Pattern Registration System 2018-20 bulletin for Maternal Mortality Ratio (MMR) confirmed a decline in Karnataka’s MMR from 83 per lakh dwell births in 2017-18 to 69 in 2018-20. The State’s Civil Registration System knowledge from 2021-22 to 2023-24 confirmed an extra decline to 64 in 2023-2024. This 12 months, 327 maternal deaths have been reported in Karnataka since April.

Chief Minister Siddaramaiah ordered the suspension of the Karnataka State Medicine Controller, Umesh S., for dereliction of responsibility. He additionally directed officers to blacklist Paschim Banga Prescribed drugs, which had equipped the substandard IV fluids to the Karnataka State Medical Provides Company Restricted (KSMSCL). Whereas a legal case has been registered in opposition to the prescribed drugs firm, a departmental inquiry has been ordered in opposition to the Managing Director of KSMSCL. An knowledgeable committee is to be set as much as examine whether or not some other maternal deaths occurred within the State the place IV fluids equipped by the corporate was used.

At present, the actual batch of the answer in query has been withdrawn, and the Ringer’s Lactate fluids equipped to the Ballari district hospital have been despatched to personal laboratories accredited to the Nationwide Accreditation Board for Testing and Calibration Laboratories (NABL) to detect the presence of endotoxins.

The incident has uncovered chinks within the drug testing system. Flagging a mismatch in take a look at outcomes performed by the Central Medicine Laboratory (CDL), Kolkata, and the State, the Karnataka Well being Division has written to the Medicine Controller Common of India to analyze the Customary High quality (SQ) certification issued by the CDL, Kolkata, to the producer. The State has additionally sought motion in opposition to the producer.

In his letter to the Medicine Controller Common of India, Principal Secretary (Well being) Harsh Gupta identified that the batches equipped by the corporate had been frozen to be used in March 2023 by the KSMSCL after two batches had been discovered to be Not of Customary High quality (NSQ) by the federal government analyst on the Medicine Testing Laboratory, Karnataka. The producer challenged these studies. These had been referred to CDL, Kolkata, by the competent court docket, and the CDL discovered these to be of SQ. Testing at Karnataka had discovered that 22 batches failed on varied parameters, however few of those samples had been discovered to be SQ in Kolkata.

“Since August 2024, a number of the earlier frozen batches which had not but been examined by the medication management officers or which had been discovered to be of SQ by the federal government analyst had been launched by KSMSCL after these had been licensed to be SQ by NABL empaneled laboratories. KSMSCL has nonetheless not launched any of such batches discovered to be NSQ by the Karnataka Medicine Testing Laboratory, regardless that a few of these batches had been discovered to be of SQ by the CDL later,” the letter said.

Nevertheless, questions stay. How did this mismatch occur and why did it not warrant an intensive overview and a extra cautious strategy, together with a recall of all of the 192 batches equipped by the corporate? This oversight highlights the necessity for extra stringent monitoring and transparency in healthcare product testing.

In the meantime, there are indicators that the incident is being politicised as an alternative of being addressed as a public well being concern. With the winter session of the Karnataka Legislature starting right now, the Opposition is predicted to carry the federal government to the mat.