Ballari maternal deaths: Karnataka Health Dept. writes to Drugs Controller seeking action against manufacturer

Ballari Medical College and Research Centre to which the district hospital is attached.
| Photo Credit: FILE PHOTO

Following the recent maternal deaths in Ballari District Hospital, the Karnataka Health Department has written to the Drugs Controller General of India to investigate the Standard Quality certification issued by the Central Drugs Laboratory, Kolkata, to M/s. Paschim Banga Pharmaceuticals, the manufacturer of Compound Sodium Lactate Injection I.P (Ringer’s Lactate). The State has also sought action against the manufacturer.

Ringer’s Lactate (RL), an intravenous fluid that doctors commonly use to restore hydration and fluid balance in the body, supplied by this manufacturer, was used in the hospital.

Between November 9 and 11, four maternal deaths were reported to have occurred following caesarean section conducted on these three days in the hospital. Out of the 34 such operations during those days, seven women developed complications such as acute kidney injury requiring haemodialysis and multi-organ dysfunction.

Of the seven, four women died, including one on November 26. A confidential review of the deaths by a team of specialists constituted by the Rajiv Gandhi University of Health Sciences revealed that there was no negligence or dereliction of duty by the doctors at the hospital. The report said that all protocols and patient care guidelines have been followed. 

Batches frozen earlier

Pointing out that further investigation into the deaths is underway, Principal Secretary (Health) Harsh Gupta wrote to the Drugs Controller of India on Tuesday (December 3) that the batches supplied by the company had been frozen for use during March 2023, by the Karnataka State Medical Supplies Corporation Ltd. (KSMSCL).

“This was after two batches were found to be ‘Not of Standard Quality’ (NSQ) by the Government Analyst at Drugs Testing Laboratory, Karnataka. Subsequently, the manufacturer challenged some of these NSQ reports and on being referred to the CDL, Kolkata by the competent court, the CDL, Kolkata had found these to be SQ,” the letter stated.

“Based on a letter by KSMSCL, different batches of the said drug were drawn for test and analysis by the Drugs Control officers across Karnataka from the district drug warehouses, out of which 22 batches failed in various parameters including tests for sterility and test for bacterial endotoxins / particulate matter. Few of these NSQ reported samples have also been found to be Standard Quality by the CDL Kolkata later,” the letter stated. 

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

Initiate action

“As the CDL Kolkata comes under the purview of your office, we request you to get the matter investigated at your end and initiate necessary action against the manufacturer and others concerned on priority basis. We also request you to direct the Drugs Controller of West Bengal and your subordinate zonal officers to extend cooperation during investigation at the manufacturing unit by the officers of this State,” the letter added.