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The Drug Control Officers India Welfare Association (DCO India), a national body of working and retired drug regulatory officers in the country, has urged the Government of Karnataka to review the suspension order served to the state drug controller, Dr S Umesh, in the aftermath of the report of four maternal deaths that happened in Bellary between November 9 and 11.
The association further wanted the chief minister Siddaramaiah to reinstate the drug controller as early as possible in order to ensure justice and departmental morale.
The cause of the death of four pregnant women is alleged to be due to administration of substandard Ringer’s lactate solution, a crystalloid fluid which is used to replace fluids and electrolytes in patients with low blood volume or low blood pressure, which was manufactured by a West Bengal based company, Paschim Banga Pharmaceuticals, and procured by the Karnataka State Medical Supplies Corporation Ltd (KSMSCL) through tender process.
DCO India has wanted the chief minister to conduct a joint investigation, comprising Central agency (CDSCO) and state DCA, into the incidents to find out the actual cause of the deaths. They said the investigation should be extended to the manufacturing facility of Paschim Banga Pharma in Kolkata, where the company is based.
In a letter sent to the chief minister Siddaramaiah, the president of the association, G Koteeswara Rao has said that the drug controller Dr. Umesh has no direct role in the procurement, distribution and handling of the drugs. The incidents happened in Bellary, but no similar report has come from other parts of the state. This indicates one fact that the cause of death might not be due to mere quality aspects, but were due to various other factors.
Reports of adverse effects in some patients led to a quality assessment of the drugs, accordingly samples from 97 batches were collected, of which 22 batches were declared as substandard (NSQ), by the drug testing laboratory in Bengaluru.
On November 13, the district surgeon of Bellary reported allergic reactions in patients for using Batch No 03 BF 2338. Samples of this batch were sent for analysis and the result is awaited. On November 26, additional reports of adverse reactions from other batches were submitted, and samples were dispatched for testing. A thorough investigation on the 22 substandard batches is going on, and prosecution was planned upon receiving reports from the central drug testing laboratory in Kolkata. In this situation, it is crystal clear that the drug controller is innocent in this matter.
Responding to the suspension order, the joint drug controller of Jharkhand, Sumanta Kumar Tiwari said his association of drug regulators from north and eastern part of the country has also written a letter to the chief minister requesting him to withdraw the suspension order granted to the drug controller Dr S Umesh.
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