Bengaluru: After five maternal deaths were reported at a hospital in Karnataka ’s Ballari district in November, Health and Family Welfare Minister Dinesh Gundu Rao announced on Tuesday that he would discuss with Chief Minister Siddaramaiah the possibility of conducting either a special investigation team (SIT) or judicial inquiry.
During the Zero Hour at the Legislative Council, Rao admitted a system failure in response to demands from the Opposition BJP and JD(S) for a probe.
The victims, all of whom underwent cesarean surgeries in November, reportedly developed complications linked to the administration of IV fluids suspected to be substandard.
Rao stated that they have blacklisted Paschimbanga Pharmaceutical Company, the manufacturer and supplier of the drugs. He also informed the Drugs Controller General of India to cease manufacturing activities and conduct an investigation.
“The maternal deaths of five women were reported on November 9, 10 and 11. Of the 34 C-section surgeries performed, the deceased women suffered from multiple organ failure and kidney failures. On November 14, an expert committee consisting of doctors from Rajiv Gandhi University of Health Sciences was formed and they submitted the report on 16 November,” he said.
“In the report, they mentioned that the same batch of antibiotic was continued for all patients and intravenous fluid Ringers Lactate (RL) was changed from November 9. The batches were found to be frozen during March 2023 by Karnataka State Medical Supplies Corporation Limited (KSMSCL) based on two batches found to be not of standard quality (NSQ) by the government analyst, drugs testing laboratory, Karnataka,” he added.
“Thereafter, on challenge of some of these NSQ reports by the manufacturer and on being referred to the Central Drugs Laboratory (CDL), Kolkata by the competent court, the CDL, Kolkata found these to be standard quality (SQ).”
Rao said that though the drugs were later used after multiple agencies gave reports of SQ, on October 24 this year, the department gave clearance to use 68 batches of RL. He said that the government was also collecting reports across the state if there were any adverse effects due to the usage of RL.
Rao asserted that there were no lapses by the doctors and staff at the Ballari district hospital; he stated that they are still trying to determine where the mistake actually occurred. “Some competent authorities have given positive reports to the drug manufacturer, but some have not. We need to investigate it deeply. The pharma mafia in the country is massive, and according to the information, they export much better quality to other countries and sell less quality drugs in India. There will be no compromise in the investigation as it is a matter of the lives of innocent people,” he added.
He also said that the government had provided Rs 5 lakh to the families of victims and would continue to help them.
The government suspended Drug Controller Dr Umesh, and a committee headed by the development commissioner was constituted to inquire about possible lapses in the supply of drug samples to empanelled laboratories and the role of KSMSCL officials in the entire episode. He added that a show-cause notice had also been issued to the managing director of KSMSCL.
