The Drug Control Officers India Welfare Association (DCO India), representing both active and retired drug regulation officials nationwide, has called upon the Karnataka government to reassess the suspension of Dr. S Umesh, the state’s drug controller. This action followed reports of four maternal fatalities in Bellary from November 9 to 11.
The association has requested Karnataka’s Chief Minister, Siddaramaiah, to promptly reinstate the drug controller, emphasizing the importance of maintaining justice and morale within the department.
The deceased pregnant women are believed to have died due to being administered subpar Ringer’s lactate solution. This crystalloid fluid, used for replenishing fluids and electrolytes in patients with low blood volume or pressure, was produced by Paschim Banga Pharmaceuticals, a West Bengal-based company, and was supplied by Karnataka State Medical Supplies Corporation Ltd (KSMSCL) through a tender.
DCO India is urging the chief minister to initiate a comprehensive investigation into the incidents, involving both the Central agency (CDSCO) and state DCA, to ascertain the true cause of the deaths. The investigation should extend to the manufacturing site of Paschim Banga Pharmaceuticals in Kolkata.
In correspondence addressed to Chief Minister Siddaramaiah, G Koteeswara Rao, the association president, clarified that Dr. Umesh was not directly involved in the drug procurement or distribution processes. The incidents were isolated to Bellary, with no similar reports from other regions, suggesting that factors other than drug quality alone may be responsible.
Patient adverse reactions led to quality checks, with samples from 97 batches collected, and 22 deemed non-standard quality (NSQ) by a Bengaluru drug testing lab.
On November 13, Bellary’s district surgeon reported allergic reactions to Batch No 03 BF 2338. Samples from this batch are undergoing analysis, with results pending. Further reports of adverse reactions on November 26 prompted more sample testing. An extensive probe into the 22 substandard batches is underway, with prosecution pending reports from Kolkata’s central drug testing laboratory. It is evident that Dr. Umesh had no culpability in this situation.
Reacting to the suspension, Jharkhand’s joint drug controller, Sumanta Kumar Tiwari, shared that his association, representing drug regulators from Northern and Eastern parts of India, also petitioned the chief minister to rescind Dr. Umesh’s suspension.