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The Karnataka health and family welfare department has asked the Drugs Controller General of India (DCGI) to conduct an immediate investigation on the supply of sub-standard Ringer’s lactate IV infusion fluid and initiate action against the West Bengal-based pharma company Paschim Banga Pharmaceutical and others on a priority basis.
The communication from the state health and family welfare commissioner Harsh Gupta stated that the DCGI should in a time-bound manner direct the West Bengal drugs controller and its subordinate zonal offices to extend cooperation during the investigation of all manufacturing facilities by the officers of the state.
In a letter to the DCGI office, state health commissioner Gupta said, “Following our discussion on December 1, 2024 about the supply of the several batches of the Ringer’s lactate IV infusion fluid commonly referred to as the compound sodium lactate injection IP by Paschim Banga Pharmaceutical to the Karnataka State Medical Supplies Corporation Limited (KSMSCL). This is the designated medicine supplier for consumption in government hospitals through district warehouses which are found of not-of-standard quality that led to the fatality of 4 women.”
These maternal fatalities were reported from the Ballari Medical College Hospital and Research Centre, the erstwhile Vijayanagar Institute of Medical Sciences (VIMS). The batches of the IV fluid administered to these patients were of poor quality and now under investigation.
The batches had been earlier frozen in March 2023 by KSMSCL. The two batches were found to be not-of-standard quality by the government analyst at the Drug Test Lab in Karnataka. Thereafter on challenge, some of these NSQ reports by the manufacturer were referred to Central Drug Laboratory, Kolkata by the competent court, which was found to be standard quality.
Based on the letter of KSMSCL, different batches of the same drug were drawn for test and analysis by the drugs control officers across Karnataka from district drug warehouses. It is seen that 22 batches have failed in various parameters including tests for sterility, and bacterial endotoxins besides other particulate matter. But few of these samples have been found to be of standard quality by the Central Drug Laboratory, Kolkata.
Since August 2024, some of the earlier frozen batches which had not been tested by the drugs control department or which had been found to be of standard quality by the CDL, Kolkata was released by Karnataka State Medical Supplies Corporation Limited.
Now the KSMSCL has not released these NSQ batches even though some of these batches were found to be standard quality by CDL, Kolkata. Again, all such batches have been frozen by Karnataka after the recent maternal deaths at Ballari, based on strong suspicion on quality of such batches.
Paschim Banga Pharmaceutical was permitted to manufacture the Ringer’s lactate under license in Form 28D by the West Bengal drugs controller approved by the DCGI office.
Therefore we request you to immediately investigate this issue ad initiate action, stated the Karnataka health commissioner.
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