Bengaluru: The Karnataka government on Tuesday requested the Drugs Controller General of India (DCGI) to investigate and take necessary action against a West Bengal-based manufacturer, amid concerns that recent maternal deaths in Ballari district, could be linked to substandard Ringer Lactate solution supplied by the company.
In a letter, Karnataka Health Principal Secretary Harsh Gupta, drew the attention of the DCGI to the supply of several batches of “Compound Sodium Lactate I P (Ringer’s Lactate I P)” by the West Bengal-based pharmaceutical company Paschim Banga Pharmaceuticals to the Karnataka State Medical Supplies Corporation Limited (KSMSCL) for distribution in government hospitals through District Drug Warehouses.
The letter emphasised that the manufacturer had been licensed by the Drugs Controller/Licensing Authority of West Bengal, which is approved 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 stated.
According to the Health Department, between November 9 and 11, four maternal deaths were reported at the district hospital in Ballari. It was noted that the Ringer Lactate (RL) batches supplied by the said manufacturer had just been used. The matter is under investigation.
Following the deaths, Karnataka Chief Minister Siddaramaiah on Saturday ordered the suspension of the state drugs controller, the blacklisting of Paschim Banga Pharmaceuticals, and the prosecution of the company.
The letter also mentioned that these batches had previously been frozen for use in March 2023 by KSMSCL after two batches were found to be “Not of Standard Quality” (NSQ) by the Government Analyst at the Drugs Testing Laboratory in Karnataka.
However, when the manufacturer challenged these NSQ reports and the matter was referred to the Central Drugs Laboratory (CDL) in Kolkata by the competent court, the CDL found the batches to be of Standard Quality (SQ).
Based on a letter from KSMSCL, various batches of the drug were drawn for testing and analysis by the Drugs Control Officers across Karnataka from the District Drug Warehouses. Of these, 22 batches failed in various parameters, including tests for sterility, bacterial endotoxins, and particulate matter. Some of these NSQ samples were later found to be SQ by the CDL.
The letter further stated that since August 2024, some of the previously frozen batches, which had not been tested by the Drugs Controller Department or were found to be SQ by the Government Analyst, had been released by KSMSCL after being certified 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 stated.
