The Health and Family Welfare Department of Karnataka has urged the Drugs Controller General of India (DCGI) to swiftly investigate and address the issue of substandard Ringer’s lactate IV infusion fluid supplied by Paschim Banga Pharmaceutical, a West Bengal company.
In a formal request, Commissioner Harsh Gupta of the state health and family welfare department emphasized that the DCGI should promptly engage the West Bengal drugs controller and its regional offices to support the investigation of the company’s manufacturing sites by state officers.
According to a letter dispatched to the DCGI, Commissioner Gupta highlighted, “Following our deliberation on December 1, 2024, regarding several consigned Ringer’s lactate IV infusion fluids, or compound sodium lactate injection IP, provided by Paschim Banga Pharmaceutical to the Karnataka State Medical Supplies Corporation Limited (KSMSCL)—the entity responsible for drug distribution in state-run hospitals through district stores. These consignments, identified as substandard, are linked to the tragic deaths of four women.”
Tragic maternal fatalities emerged from Ballari Medical College Hospital and Research Centre, formerly known as Vijayanagar Institute of Medical Sciences (VIMS). The inferior Ringer’s lactate IV fluids administered there are now subject to examination.
Originally in March 2023, KSMSCL halted the problematic batches. Despite a subsequent re-evaluation, where some batches cleared assessments by the Central Drug Laboratory in Kolkata, significant discrepancies remained—as central authorities validated certain samples while condemnations persisted at the local level.
On KSMSCL’s directive, numerous samplings of parallel batches underwent scrutiny by district drug control officers across Karnataka. Discrepancies arose, with failures noted in multiple tests, including evaluations for sterility, bacterial endotoxins, and foreign particulates, although some samples were certified as standard by the Central Drug Laboratory, Kolkata.
Since August 2024, previously immobilized consignments deeming standard quality by the CDL, Kolkata, yet unexamined by local drugs departments, resumed circulation through Karnataka State Medical Supplies Corporation Limited.
Future release of these contested batches has ceased despite standard clearance due to recent fatalities in Ballari, prompting re-imposed restrictions from Karnataka authorities on these waves of concern.
Paschim Banga Pharmaceutical holds the licensure, endorsed by the DCGI’s office, for Ringer’s lactate production under the purview of the West Bengal drugs controller.
Commissioner Gupta concluded by requesting immediate inquiry and appropriate actions from the central body to resolve the evident concerns.