The All India Drugs Control Officers’ Confederation (AIDCOC), representing the nation’s drug control officers, has expressed its alarm regarding the suspension of Karnataka’s state drugs controller. This action followed the deaths of four pregnant women from complications allegedly linked to substandard Ringer’s lactate intravenous fluid and was executed without a detailed investigation to ascertain the actual cause.
Earlier this month, the Karnataka state government suspended Dr. Umesh S, the drugs controller, amid reports that four maternal fatalities occurred between November 9th and 11th, 2024, at Bellary’s district hospital. These deaths were speculated to result from improper intravenous fluids produced by Paschim Banga Pharmaceuticals from West Bengal.
AIDCOC has urged state authorities to reverse Dr. Umesh S’s suspension and advocated for a detailed investigation involving both central and regional drug regulators from Karnataka and West Bengal concerning the suspect intravenous fluid.
In a formal statement to the state, AIDCOC criticized the rapid suspension, labeling it unwarranted and unfair. Such actions, the Confederation argues, could create a chilling effect on drug controllers nationwide, who might fear becoming scapegoats in similar situations.
Officials noted that Dr. Umesh S had previously instructed his team to gather samples of the IV fluid, which were flagged as substandard in some instances. Responding to a challenge by the manufacturer, the matter escalated to the Central Drug Laboratory (CDL) in Kolkata. In contrast, certain batches were approved by the Karnataka State Medical Supplies Corporation after independent testing.
“District-level drug control personnel identified batches that were not standard quality after testing them. Yet, despite this red flag, the state medical supplies body continued using these products,” AIDCOC honorary director-general Ravi Udaya Bhaskar commented.
Dr. Umesh S has been diligent in ordering timely checks on samplequality, highlighting that there was no neglect of duty.
Moreover, an in-depth examination of the deaths, alongside the alleged role of the IV fluid, is paramount. Given the fluid’s potential widespread usage across the state, clarity on its impact is vital, particularly as the deaths were isolated to Bellary.
“Since the Central Drugs Standard Control Organization (CDSCO) co-licenses IV fluids, a collective inquiry involving the CDSCO and state drug overseers is necessary,” Ravi Udaya Bhaskar added, asserting that without such an investigation, suspending Dr. Umesh S is baseless.
The state’s health secretary has initiated communication with the Drugs Controller General of India, emphasizing an urgent probe into the matter, with demands for consequential actions against the manufacturer if necessary.
The state’s decision hinged on accusations that Dr. Umesh S failed to prosecute the firm over multiple testing discrepancies, despite some batches meeting required standards.
AIDCOC, however, contended that prosecution wasn’t feasible because the manufacturer contested the results via legal channels.
Highlighting procedural developments, the health secretary noted that in March 2023, batches were frozen due to unsatisfactory testing, yet subsequently deemed standard by CDL after legal challenges to initial findings by the manufacturer.
Since August 2024, even batches previously suspended or test-passable were released post-certification by accredited labs. The secretary assured that those specific NSQ batches were not distributed, underscoring a renewed freeze on products linked to recent events in Bellary.
Permitted under a license from West Bengal, Paschim Banga Pharmaceuticals continues to manufacture these fluids, with CDL oversight aligning with directives from the Drugs Controller General of India.