Maternal deaths: Karnataka says central lab cleared ‘substandard’ drug, seeks probe

“Thereafter, on challenge of some of these NSQ reports by the manufacturer and on being referred to the CDL Kolkata by the competent court, the CDL Kolkata had found these to be SQ,” the letter stated. SQ stands for standard quality.

Subsequently, different batches of the drug were tested in Drugs Control Offices across Karnataka, during which 22 batches failed on various parameters, including in tests for sterility and bacterial endotoxins, among others. “Few of these NSQ-reported samples have also been found to be SQ by CDL Kolkata later,” Gupta wrote.

In August 2024, some of the previously frozen batches were released by KSMSCL after being certified as standard quality by laboratories empanelled by the National Accreditation Board for Testing and Calibration Laboratories, the letter noted.

Four women died during Caesarean operations between November 9 and 11 at Ballari District Hospital. A batch of the drug, also known as Ringer’s lactate—a fluid used to replace lost water and electrolytes in the body—is suspected to have been used in the hospital “just before reporting of the said deaths”.

Pointing out that the CDL falls under the purview of the DGCI, Gupta requested the matter to be investigated “at your end and initiate necessary action against the manufacturer and other concerned on a priority basis…” He also sought directions to the drugs controller of West Bengal and subordinate zonal officers of the Central Drugs Standard Control Organisation “to extend cooperation during the investigation at the manufacturing unit by the officers” of Karnataka.