Trichy: Drug inspectors from the Central Drugs Standard Control Organisation (CDSCO), along with state drug control officials, conducted an inspection of the Tamil Nadu Medical Services Corporation (TNMSC) warehouse in Trichy on Wednesday and Thursday. This action follows reports of serious adverse cardiac events in patients who were administered Dexamethasone at the Mahatma Gandhi Memorial Government Hospital (MGMGH).
Inspection Details
Sources indicated that the inspection is likely to continue for a few more days as officials examine drug stocks and related records. The investigation was prompted by a letter sent by MGMGH dean S Kumaravel to the director of medical education (DME) on May 29, requesting an analysis of a specific batch of Dexamethasone 8 mg injections supplied through TNMSC.
Adverse Events Reported
In the letter, the dean flagged multiple serious adverse cardiac events suspected to be linked to a particular batch of Dexamethasone injections manufactured by Cotec HealthCare Ltd., Roorkee. According to the hospital, three patients developed severe cardiovascular complications immediately after receiving the drug intravenously. The reported adverse events included ventricular tachyarrhythmias, cardiomyopathy, severe left ventricular dysfunction, hypotension, and refractory cardiogenic shock. Two of the three patients later died, including a nursing student whose death triggered protests.
Official Response
A government source clarified, "The inspection by drug inspectors is a standard operating procedure after a possible adverse drug reaction is reported. It should not be seen as a conclusion on the cause of the incidents. A stop-supply order has been issued, the batch has been recalled, and samples have been sent to a laboratory for testing. The results are awaited."
Further updates on the investigation and laboratory test results are expected in the coming days. Authorities have assured that all necessary measures are being taken to ensure patient safety and determine the root cause of these adverse events.
