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Following the death of four pregnant women, who were administered substandard Ringer's lactate solution, an intravenous fluid commonly used to restore hydration and electrolyte balance, the Karnataka government has now issued orders to suspend the state drugs controller Dr Umesh S. The suspension order issued pending inquiry.
The communication from the state government said the concerned Ringer's lactate solution was supplied by West Bengal based Paschim Banga Pharmaceutical to the Karnataka State Medical Supplies Corporation Ltd (KSMSCL). Although 192 batches from this supplier were initially frozen due to quality concerns, 95 batches tested out of which 22 were found sub-standard and not used anywhere. One of these batches went to Ballari district. We are suspending the drugs controller as he should have prosecuted the company after finding quality issues with 22 batches. Also, he did not submit a report on the remaining batches which were tested. Further, he should have issued a circular to all the concerned pharmacies directing them not to supply these batches until testing of all batches are complete.
Between November 9 and 11, 2024, the Ballari district hospital reported seven complications out of 34 caesarean operations, resulting in four fatalities. Following the incidents in Ballari, the specific batch in question has been withdrawn state wide, and samples have been sent for further testing, stated the government communication note.
Further, the drugs controller despite receiving the NSQ (not of standard quality) report which stated that 22 batches were of sub-standard, he failed in taking action against the pharma company which is the drug supply agency.
Prima facie it is proved that the drugs controller has shown dereliction of duty by not taking any action against the pharma company which supplied the poor quality Ringer’s lactate IV fluid resulting in the death of women. This fact was discussed at a meeting held under the chairmanship of the Karnataka chief minister.
Now it is found that Ringer’s lactate IV fluid is suspected to have endotoxin which is poisonous and although it was possible to inspect, test within 24 hours and submit a report. The drugs controller has failed to look into it and instead replied that it requires 15 days time to test the batches that went to Bellari, said the government communication note.
Considering these facts, the government has suspended Dr Umesh, additional drugs controller. He will get a suspension allowance and cannot leave the headquarters without approval.
It is gathered that investigations have indicated that the medical team at the district hospital followed all necessary protocols for patient care and surgical procedures. Hence it is suspected that the use of substandard Ringer's lactate solution might have contributed to the adverse drug reaction.
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