The Karnataka government has urged the Drugs Controller General of India (DCGI) to investigate and take action against Paschim Banga Pharmaceuticals, a West Bengal-based pharmaceutical company, amid suspicions that the recent maternal deaths in Ballari could be linked to substandard batches of Ringer’s lactate (RL) solution supplied by the manufacturer.
Four women died at the District Hospital in Ballari between November 9 and 11, following caesarean surgeries performed on them during this period. Of the 34 procedures conducted, seven women developed severe complications, including acute kidney injury requiring haemodialysis and multi-organ dysfunction. As soon as the deaths of the new mothers were reported, the state suspended state Drugs Controller Dr Umesh and also blacklisted the pharma company. An inquiry was also ordered into the deaths.
In a letter dated December 3, Harsh Gupta, Principal Secretary of the Health and Family Welfare Department, highlighted that the RL solution, identified as “Compound Sodium Lactate Injection IP,” was procured by the Karnataka State Medical Supplies Corporation Limited (KSMSCL) and distributed to government hospitals through district drug warehouses.
A confidential review of these deaths, conducted by a team of specialists appointed by the Rajiv Gandhi University of Health Sciences, concluded that there was no negligence or dereliction of duty by the hospital's doctors. The report said that all medical protocols and patient care guidelines had been strictly followed, according to The Hindu.
Earlier in March 2023, KSMSCL had frozen several batches of the RL solution after the Karnataka government analyst declared two batches as ‘Not of Standard Quality’ (NSQ). However, the Central Drugs Laboratory (CDL) in Kolkata later deemed these batches to be of Standard Quality (SQ), following the manufacturer’s appeal in court, the letter said.
The letter said that subsequent inspections by Karnataka Drugs Control officers found 22 batches of the RL solution to have failed quality checks, including sterility, bacterial endotoxins, and particulate matter tests. Despite these findings, some previously frozen batches were released in August after being certified to be of standard quality by NABL-accredited laboratories.
In light of the recent deaths, the state government has again frozen all such batches, citing strong suspicions about their quality.
Harsh Gupta pointed out that CDL Kolkata operates under the DCGI and requested a thorough investigation and appropriate action against the manufacturer and other parties involved. “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 said.