Ballari maternal deaths: Victims were administered solution from unauthorised batch, indicates probe

Bengaluru: At least five lactating mothers who died at the Ballari Institute of Medical Sciences (BIMS) in the last month were given Ringer's lactate solution from an unauthorised, and possibly substandard, batch of drugs, according to a preliminary Lokayukta probe.

The Lokayukta, which on December 6 opened a suo motu investigation into the deaths, found that the women were administered '26.2.9 Ringer’s Lactate IV RL Fluid' from batch '03BF2338' (manufactured in December 2023 and due to expire in November 2026).

Ringer's lactate solution is generally used to treat dehydration after surgery.

Not only was this batch unauthorised but it was also supplied to the Ballari District Hospital without any invoice or indent, the probe found. DH has reviewed the probe documents.

The five women — Kammari Lalitha, 28, died on November 11; Hoogar Nandini, 27, died on November 12; Rojamma, 23, died on November 14; Muskan, 21, died on November 25; Komi Sumaiah, 24, died on December 5 — were admitted first to the Ballari District Hospital and died later in the BIMS. They were administered the IV fluid from batch 03BF2338.

It wasn't immediately clear what batch was administered to T Mahalakshmi, 20, who was admitted to the Primary Health Centre (PHC) in Gudekote on November 24 and moved to the BIMS the same day for further treatment and died on November 27.

Three batches of the solution supplied by private company Paschim Banga Pharmaceutical — 03BF2215, 03BF2252, 03BF2337 — had been found to be of "not standard quality" after tests by the Assistant Drug Controller (Belagavi Circle).

On March 23, 2024, the Karnataka State Medical Supplies Corporation Limited (KSMSCL) had ordered all batches supplied by the company to be frozen and kept aside. The company was blacklisted the same day.

However, on August 17, the KSMSCL's Technical Advisory Committee (TAC) ordered that 86 batches of the solution be unfrozen and used.

Complicating things further, the KSMSCL managing director issued a circular on October 9, stating that "all circulars issued earlier by KSMSCL, including the decision of the TAC dated August 17, are impliedly superseded".

However, neither the KSMSCL nor the Commissioner of Health and Family Welfare Services "authenticated the list of frozen/de-frozen batches", according to the Lokayukta probe.

Despite this, on October 25 and November 8, the district warehouse issued three batches of Ringer’s lactate solution to the Ballari District Hospital without any invoice.

These batches — 03BF2338 (300 bottles), 03BF2239 (150 bottles) and 03BF2340 (50 bottles), all 500ml — were not on the list of de-frozen batches. The victims were administered the solution from batch 03BF2338.

"There are no particulars concerning official communication of frozen and de-frozen list of batches of Ringer’s Lactate (Solution) to the District Warehouse (Ballari)," the probe found.

The Lokayukta police seized a box of 25 bottles from batch 03BF2338 and sent them for further testing.

The preliminary findings have prompted the Lokayukta to launch a full-scale investigation and seek responses from the KSMSL managing director as well as the Commissioner of Health and Family Welfare Services by January 16, 2025.

The Lokayukta police have made 70 respondents in the case, including the principal secretary of the health and family welfare services and medical education departments.