Karnataka Health Minister Dinesh Gundu Rao on Tuesday blamed the country’s “flawed” drug control system for the death of five new mothers in Ballari district last month.
The maternal deaths are suspected to be due to the use of substandard ringer lactate solution supplied by Paschim Banga Pharmaceutical Ltd. The solution is intravenously for hydration and to restore fluid balance in the body.
“The West Bengal-based company that supplied Ringer Lactate IV solution has been blacklisted and banned from producing IV solution until the investigation into the deaths is complete,” said Rao, in his reply in the Legislative Council.
It may be recalled that of the 34 caesarean operations performed at the Ballari district hospital between November 9 and 11, seven led to the patient developing complications like kidney injury and multiple organ failure. Five women died due to complications.
“The state drug controller reported that 22 batches of IV fluid supplied by the West Bengal company were not of good quality. But the Central Drug Lab had reported that four of them were of good quality. We wrote to the Central Drug Controller to take action against the company,” he said.
Rao said that during a joint inspection of the company’s manufacturing facility by the West Bengal drug controllers and the Central Drug Controller, they found there was no quality system of production. “The West Bengal government issued a memo to the company to stop operations and the West Bengal police has blacklisted 9 batches of IV solution which are not of standard quality. This is a good development,” added the minister.
“There are loopholes in the drug control system. The drug lobby is strong in the country. Our central laws also have loopholes,” added Rao.
Elaborating on the steps taken by the state government, Rao said that as soon as the deaths were reported, a team of expert doctors from the Rajiv Gandhi Health University investigated the maternal deaths and submitted a report (on November 16) where they stated there had been no dereliction of duty or negligence on the part of the medical team at the hospital. The team expressed suspicion over the quality of the IV ringer lactate solution administered to the mothers.
The state government blacklisted the company, suspended the state drug controller Dr Umesh for “negligence” in testing the Ringer Lactate solution samples and issued a show-cause notice to the managing director of Karnataka State Medical Supplies Corporation Limited (KSMSCL), which procured IV fluids from the company.
The chief minister announced a compensation of Rs five lakh each to the families of the deceased. However, the KSMSCL has sought higher compensation from the company.
