BENGALURU: The Karnataka Government has written to the Drugs Controller General of India (DCGI), requesting to investigate and initiate action against a West Bengal-based pharmaceutical company, the manufacturer of Ringer’s lactate (RL) solution, amid suspicion that the recent maternal deaths in Ballari might be due to the use of alleged substandard solution from the company.
In a letter dated December 3, the Principal Secretary of the Health and Family Welfare Department, Harsh Gupta, drew the attention of the DCGI towards the supply of several batches of “Compound Sodium Lactate Injection I.P (Ringer’s lactate 1.P)” by West Bengal-based Paschim Banga Pharmaceuticals to the Karnataka State Medical Supplies Corporation Limited (KSMSCL - Govt Supply) for consumption in government hospitals through district drug warehouses.
Between November 9 and 11, four maternal deaths were reported in District Hospital, Ballari, Gupta said, and that RL batches supplied by the said manufacturer had been used and the matter is under investigation.
“The batches had been earlier frozen for use during March 2023 by KSMSCL based on two batches found to be NSQ (Not of Standard Quality) by the government analyst, Drugs Testing Laboratory, Karnataka.
Thereafter, on challenge of some of these NSQ reports by the manufacturer and on being referred to the Central Drugs Laboratory (CDL) in Kolkata by the competent court, the CDL Kolkata had found these to be SQ (Standard Quality),” the letter stated.
“Different batches of the said drug were drawn for test and analysis by the Drugs Control officers across Karnataka from the district drug warehouses, out of which, 22 batches have failed in various parameters including tests for sterility, test for bacterial endotoxins and particulate matter etc. Few of these NSQ reported samples have also been found to be SQ by CDL Kolkata later,” the letter added.
Also, the health secretary said that since August, some of the earlier frozen batches, which were not yet tested by the Drugs Control Department or which had been found to be SQ by the government analyst, had been released by KSMSCL, after those were certified to be SQ by National Accreditation Board for Testing and Calibration Laboratories (NABL)-empanelled laboratories, and added, “Now again, all such batches have been frozen by the state after recent maternal deaths in Ballari, based on a strong suspicion on the quality of such batches as these had come to use in the said hospital just before reporting of the said deaths.”
Stating that the CDL Kolkata comes under the purview of DCGI, the health secretary requested to get the matter investigated and initiate necessary action against the manufacturer and other concerned.