The Karnataka authorities on Tuesday requested the Medicine Controller Basic of India (DCGI) to analyze and take crucial motion towards a West Bengal-based producer, amid considerations that current maternal deaths in Ballari district, could possibly be linked to substandard Ringer Lactate resolution provided by the corporate.
Karnataka govt asks DCGI to probe Ringer Lactate agency after maternal deaths (Pic for illustration)
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In a letter, Karnataka Well being Principal Secretary Harsh Gupta, drew the eye of the DCGI to the availability of a number of batches of “Compound Sodium Lactate I P (Ringer’s Lactate I P)” by the West Bengal-based pharmaceutical firm Paschim Banga Prescription drugs to the Karnataka State Medical Provides Company Restricted (KSMSCL) for distribution in authorities hospitals by way of District Drug Warehouses.
The letter emphasised that the producer had been licensed by the Medicine Controller/Licensing Authority of West Bengal, which is accredited by the DCGI.
“…initiate necessary action against the manufacturer and other concerned parties on a priority basis, with information provided to this office. Additionally, you may direct the Drugs Controller of West Bengal and your subordinate zonal officers to cooperate with the investigation at the manufacturing unit by officers from this state,” it said.
Based on the Well being Division, between November 9 and 11, 4 maternal deaths had been reported on the district hospital in Ballari. It was famous that the Ringer Lactate (RL) batches provided by the stated producer had simply been used. The matter is beneath investigation.
The letter additionally talked about that these batches had beforehand been frozen to be used in March 2023 by KSMSCL after two batches had been discovered to be “Not of Standard Quality” (NSQ) by the Authorities Analyst on the Medicine Testing Laboratory in Karnataka.
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Nevertheless, when the producer challenged these NSQ reviews and the matter was referred to the Central Medicine Laboratory (CDL) in Kolkata by the competent courtroom, the CDL discovered the batches to be of Normal High quality (SQ).
Based mostly on a letter from KSMSCL, numerous batches of the drug had been drawn for testing and evaluation by the Medicine Management Officers throughout Karnataka from the District Drug Warehouses. Of those, 22 batches failed in numerous parameters, together with checks for sterility, bacterial endotoxins, and particulate matter. A few of these NSQ samples had been later discovered to be SQ by the CDL.
The letter additional said that since August 2024, a few of the beforehand frozen batches, which had not been examined by the Medicine Controller Division or had been discovered to be SQ by the Authorities Analyst, had been launched by KSMSCL after being licensed as SQ by NABL-empaneled laboratories.
“Now, all such batches have been frozen by the state after the recent maternal deaths in Ballari, based on a strong suspicion regarding the quality of these batches, as they had been used in the hospital just before the deaths were reported,” the letter said.