Karnataka Health Minister Highlights Challenges in Holding Pharmaceutical Companies Responsible for Maternal Deaths

Belagavi, Dec 17 (NationPress) Karnataka Health Minister Dinesh Gundu Rao stated on Tuesday that making pharmaceutical companies accountable has been a challenging task, underlining that this issue needs to be addressed through legislation at the national level.

“I want to emphasize that the laws governing drugs are not robust. There has been no precedent for action against pharmaceutical companies,” the minister remarked during a session in the Legislative Council while discussing the concerning series of maternal fatalities that occurred at the Ballari hospital.

He pointed out that numerous drugs have failed due to inadequate quality, yet holding these companies accountable remains a daunting challenge.

“This matter requires serious national dialogue. If quality medications are not produced, it will have dire consequences for the populace,” Rao asserted.

Substandard medications can lead to deaths and ineffective disease treatment. The majority of drug manufacturing firms are located in states like Himachal Pradesh and Uttarakhand. They receive administrative backing, and to safeguard their reputation, pharmaceutical companies are often granted immunity, as alleged by Rao.

He further claimed that these companies are protected from regulatory frameworks and have legal cover. “Certain manufacturers maintain one quality standard for drugs exported abroad and a different, inferior standard for those supplied in India,” Rao highlighted.

“There should be no disparity in drug quality, regardless of whether they are meant for export or for the underprivileged in India. Quality must not be compromised. The current system fails to ensure this,” the Minister stressed.

He added that the Drug Control Department sent a communication regarding drug quality certification; however, the state laboratory reported otherwise.

“We cannot contest the findings of accredited national laboratories and must acknowledge their reports. The batch of medicines was subjected to five tests before being dispatched to the Ballari hospital,” he mentioned.

He also noted that all laboratories certified the medicine as compliant. However, doubts have emerged concerning the management and operations of nationally accredited labs.

“A team has been assembled to investigate this matter, and a report is pending,” he stated.

Minister Rao insisted that there should not be any attempts to conceal such incidents.

“This represents a systemic failure. Similar occurrences have been seen nationwide. Initial actions are taken, but the issue is later disregarded. This must not happen. It requires discussion at the national level, and systemic deficiencies must be rectified in light of this tragedy,” he urged.

He mentioned that after visits by teams from the state government, the Drug Control of India, and the West Bengal government to the implicated pharmaceutical company, concerns regarding the manufacturing process were raised.

“A production halt notice has been issued to the company, stopping all drug manufacturing operations,” Rao informed.

“Manufacturers should not be permitted to make such errors. The Food Control Department and the Drug Control Department will now be overseen by an IAS officer in the state,” he declared.

“We must not tolerate such incidents in any form. This reflects the current state of our system. In Maharashtra, a company provided antibiotics containing spurious substances,” he reiterated.

“The pharmaceutical lobby in our country is substantial and exerts considerable influence at the central government level. Regulatory laws are not enforced effectively. Our nation needs a framework to ensure the production of only quality drugs. We should strive toward this objective,” Rao asserted.

“The Development Commissioner has been directed to prepare a comprehensive report on the maternal death tragedy. Strict orders have been issued to investigate each case of maternal death in the state, and an audit is currently underway,” he announced.

Discussing the maternal fatalities, Rao elaborated, “The incidents at the Ballari District Hospital occurred on November 9, 10, and 11. A total of 34 cesarean surgeries were conducted, with seven cases turning critical. Tragically, five women died post-delivery, while two recovered and were discharged.”

The government became aware of the incident on November 13, prompting the immediate dispatch of an investigative team. Rao noted that over 2,000 deliveries had taken place at the Ballari hospital previously, with no reported fatalities.

An expert team of doctors visited the hospital on November 14 and submitted a report two days later. The report concluded that local doctors had not exhibited negligence or dereliction of duty and that all due procedures and protocols were adhered to.

Minister Rao emphasized that such occurrences should not be tolerated.

“We must consider the repercussions of a mother’s death in a family due to the negligence of a manufacturer or any other reason,” he remarked.

“We are taking action against laboratories for providing inaccurate reports. Pharmaceutical companies must not distribute substandard medicines. The system must ensure this and prevent companies from jeopardizing lives. Another drug from the same manufacturer has also failed quality tests,” he revealed.

“All necessary actions must be taken against Paschim Banga Pharmaceuticals for supplying substandard medications. We are unaware of how many other companies are functioning similarly. This issue became apparent only due to the series of deaths in Ballari. If deaths occur in various locations, they may go unnoticed due to ineffective reporting mechanisms,” Minister Rao concluded.