The Karnataka government has sought clarity from the Central Drugs Standard Control Organisation following the maternal deaths of pregnant women at Ballari District Hospital, reportedly caused by contaminated IV Ringer’s Lactate solution. Health Department Principal Secretary Harsha Gupta has addressed the issue in a letter to Drugs Controller General Rajeev Singh Raghuvanshi.
Investigations revealed bacterial and fungal contaminants in IV solutions supplied by a West Bengal-based pharmaceutical company. Of 192 batches, 22 were deemed substandard by the state drug control department, prompting an immediate suspension of their use.
However, these batches had earlier passed Central Drug Lab quality tests, causing a regulatory dispute. Samples have been sent back to the central lab in West Bengal for re-analysis, with results expected by December 9.
To safeguard patients, the Health Department blacklisted the affected batches and ordered their withdrawal from all hospitals. Officials stress adherence to tender protocols, as Central Drug Lab approvals remain legally binding.
The incident raises urgent questions about drug safety standards and the need for stringent oversight.
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