Unauthorised Drug Batch Linked to Maternal Deaths in Ballari

A preliminary investigation by the Lokayukta into the recent deaths of lactating mothers at Ballari Institute of Medical Sciences (BIMS) has revealed that they were given Ringer’s lactate solution from an unauthorised batch. This intravenous fluid, typically used to address dehydration, was identified as batch ’03BF2338′ (manufactured in December 2023 and expiring in November 2026), supplied without proper documentation or approval.

The deaths occurred between November 11 and December 5, affecting women aged 21 to 28, admitted initially to Ballari District Hospital before being referred to BIMS. The batch was not listed among the approved or defrosted supplies, raising suspicions of substandard quality. Additionally, three other batches from the same manufacturer, Paschim Banga Pharmaceutical, had earlier failed quality tests, leading to the company’s blacklisting in March 2024. Despite this, a Technical Advisory Committee unfroze 86 batches in August, but clear directives were lacking.

Further complicating the issue, the district warehouse distributed the unauthorised batch without invoices in October and November. The Lokayukta has now seized samples for testing and expanded the investigation, naming 70 officials, including senior health department representatives, as respondents.

The probe underscores critical lapses in the drug supply chain and regulatory oversight, prompting the Lokayukta to demand explanations by January 16, 2025.

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