In response to the tragic deaths of four expectant mothers who were given below-standard Ringer’s lactate solution—an intravenous fluid typically administered to restore hydration and electrolyte equilibrium—the Karnataka government has decided to suspend Dr. Umesh S., the state’s drugs controller, amid ongoing investigations. The suspension serves as a hold pending further inquiries.
A government-issued statement revealed that the questionable Ringer’s lactate solution had been procured from Paschim Banga Pharmaceutical in West Bengal by the Karnataka State Medical Supplies Corporation Ltd (KSMSCL). Out of 192 batches originally held back due to quality issues, 95 batches underwent testing, with 22 deemed sub-standard and avoided from use. One such unsatisfactory batch had already been dispatched to the Ballari district. The drugs controller’s suspension follows his failure to take legal action against the company upon discovering the quality defects. Additionally, he is accused of neglecting to report on the rest of the batches tested and failing to advise pharmacies against distributing these batches until all quality checks were finalized.
Between November 9 and 11, 2024, the Ballari district hospital documented seven complications among 34 cesarean deliveries, tragically resulting in the loss of four lives. Following these incidents, the implicated batch has been withdrawn throughout the state, with samples sent for additional evaluation, according to a government statement.
Despite receiving a negative quality report indicating substandard results for 22 batches, the drugs controller did not act against the pharmaceutical supplier, which allegedly provided the defective Ringer’s lactate IV fluid. This issue was discussed at a meeting led by the Karnataka chief minister, concluding a clear dereliction of duty by the drugs controller.
Initial findings present a suspicion that the Ringer’s lactate IV fluid contained toxic endotoxins, although this should have been detected and reported within 24 hours. Instead, the drugs controller claimed that testing the Bellari batches would require 15 days, as noted in the communication from the government.
Given these findings, the government has imposed a suspension on Dr. Umesh, the additional drugs controller, who will receive a suspension allowance and must obtain permission before leaving headquarters.
Further investigations have suggested that medical staff within the district hospital adhered to all expected patient care and surgical protocols, indicating that the substandard Ringer’s lactate solution might have played a role in the negative drug reaction.