After four maternal deaths were reported in Karnataka, the state government asked DCGI to investigate and take necessary action against the Ringer Lactate manufacturing firm.
Published Dec 04, 2024 | 8:42 AM ⚊ Updated Dec 04, 2024 | 8:42 AM
The use of the suspected IV fluid Ringer Lactate solution has been suspended in all hospitals in the Ballari district. (Wikimedia Commons)
The Karnataka government urged the Drugs Controller General of India (DCGI) to investigate a West Bengal-based pharmaceutical manufacturer suspected of supplying substandard Ringer Lactate (RL) solution.
The reaction came as part of the state government’s intensified response following the tragic deaths of four mothers at the Ballari district hospital in early November.
The deaths, which occurred between 9 and 11 November, have raised serious concerns about the quality of the RL batches administered at the hospital.
On Tuesday, 3 December, in a letter addressed to the DCGI, Karnataka Principal Secretary (Health) Harsh Gupta drew attention to the supply of multiple compound sodium Lactate IP (Ringer’s Lactate IP) batches by Paschim Banga Pharmaceuticals to the Karnataka State Medical Supplies Corporation Limited (KSMSCL).
These solutions were distributed to government hospitals across the state via district drug warehouses.
“The manufacturer, licensed by the Drugs Controller/Licensing Authority of West Bengal and approved by the DCGI, is under suspicion following the recent tragic events in Ballari,” the letter read.
Gupta emphasised the urgent need for action, writing, “You are requested to initiate necessary action against the manufacturer and other concerned parties on a priority basis, with information provided to this office. Additionally, you may direct the Drugs Controller of West Bengal and your subordinate zonal officers to cooperate with the investigation at the manufacturing unit by officers from this state,” the letter read.
The controversy around the RL batches is not new. The letter also mentioned that earlier this year and in March 2023, two batches of the solution were flagged as “Not of Standard Quality” (NSQ) by the Government Analyst at the Drugs Testing Laboratory in Karnataka.
Despite these findings, Paschim Banga Pharmaceuticals contested the reports, leading the matter to be referred to the Central Drugs Laboratory (CDL) in Kolkata. The CDL overruled the NSQ classification and certified the batches as “Standard Quality” (SQ).
Subsequently, testing of various RL batches by Drugs Control Officers across Karnataka revealed that 22 batches failed to meet critical parameters, including sterility, bacterial endotoxins, and particulate matter. However, discrepancies persisted, as some NSQ samples were later found to be SQ by the CDL.
The letter also stated that since August 2024, some of the previously frozen batches, which had not been tested by the Drugs Controller Department or were found to be SQ by the Government Analyst, have been released by KSMSCL after being certified as SQ by NABL-empaneled laboratories.
“Now, all such batches have been frozen by the state after the recent maternal deaths in Ballari, based on a strong suspicion regarding the quality of these batches, as they had been used in the hospital just before the deaths were reported,” Gupta stated in the letter.
Meanwhile, in light of the fatalities, Karnataka Chief Minister Siddaramaiah has taken decisive action by ordering the suspension of the state drugs controller, blacklisting Paschim Banga Pharmaceuticals, and initiating legal proceedings against the company.
The Chief Minister’s Office (CMO) described the measures as necessary to ensure accountability and prevent further loss of life.
The state government also appointed IAS officer K Srinivas who is presently serving as commissioner for the Department of Food Safety and Quality as the administrative head of the Drug Control Department to manage all administrative and financial functions.
While the investigation progresses, families of the deceased are left grappling with their loss, the Karnataka Janarogya Chaluvali (KJC) strongly condemned the government negligence that has led to preventable maternal deaths.
Speaking to South First, Vijay Kumar of KJC highlighted the need for a fact-finding committee.
“Out of 34 caesarean-section delivery cases reported during this period, seven women suffered severe medical complications, and four lives were lost – a horrifying and unacceptable outcome,” a statement from KJC said.
The statement also said, “While the suspension of the batch is a necessary step, it raises serious concerns about the quality control measures in place for medical supplies, as well as the broader systemic failures in public healthcare,”
The KJC demanded immediate accountability and action. It also sought a high-level inquiry to determine the cause of these deaths, including a thorough examination of the IV fluid batch and related medical protocols.
“All parties responsible for negligence, from suppliers to hospital administrators, must be held accountable,” the KJC demanded.
The members also said that comprehensive reforms must be undertaken to ensure stringent quality control of medical supplies, enhanced training for healthcare professionals, and better infrastructure at government hospitals.
Meanwhile, the Health Department has assured transparency in the inquiry, with officials stating that the results will be made public as soon as possible.
Ringer Lactate Solution is a widely used Intravenous (IV) fluid for restoring hydration and electrolyte balance in patients experiencing blood loss, dehydration, or undergoing surgery.
Speaking to South First, Dr Sowmya Sangamesh, a gynaecologist at Gleneagles Hospital in Bengaluru, said RL Solution is one of the safest solutions administered to replenish fluids after significant blood loss due to trauma or surgery, maintain electrolyte levels in patients with imbalances, correct metabolic acidosis and is also extensively used in aggressive volume resuscitation for patients with major burn injuries.
“This solution is used across all ages from infants to senior citizens and is very safe. In Ballari’s case, it should be seen if there was any kind of contamination. Any kind of contamination could lead to deaths,” she explained.
Doctors South First spoke to said that the state government must seek a detailed report on the condition of the women who died and others who developed complications after the use of the RL solution if they suspect that to be the case.
“However, there is no pregnancy that is of zero risk. There is only a low-risk or high-risk pregnancy. One must note that complications in pregnancy could come at any stage of delivery. So, a thorough investigation needs to be done on causes of these maternal deaths in Ballari,” a senior gynaecologist from Bengaluru told South First on condition of anonymity.
(Edited by Muhammed Fazil.)
