Holding pharmaceutical companies accountable has proven difficult: K’taka Health Minister on maternal deaths
Belagavi: Karnataka Health Minister Dinesh Gundu Rao said on Tuesday that holding pharmaceutical companies accountable has proven to be difficult, emphasising that it needs to be tackled through national-level legislation.
“I want to convey that drug-related laws are not strong. There is no history of action being taken against pharmaceutical companies,” said the minister on the floor of the Legislative Council while addressing the series of maternal deaths which occurred at the Ballari hospital.
He highlighted that many drugs have failed due to substandard quality, but holding pharmaceutical companies accountable has proven difficult.
“This issue needs to be seriously discussed at the national level. If quality medicines are not manufactured, it will have serious implications for people,” Rao stated.
Substandard drugs can result in fatalities and ineffective treatment of diseases. Most drug manufacturing companies are based in states like Himachal Pradesh and Uttarakhand. They receive support from the administration, and in order to protect their reputation, pharmaceutical companies are granted immunity, Rao alleged.
He further claimed that pharmaceutical companies are shielded from regulatory laws and protected by the courts. “Some drug manufacturers have one standard for medicines exported to foreign countries and a different, lower standard for medicines distributed in India,” Rao pointed out.
“There should be no differentiation in drug quality, whether they are meant for export or for the poor in India. Quality should not be compromised. The system currently fails to ensure this,” the Minister emphasised.
He added that the Drug Control Department wrote a letter regarding the certification of drug quality, but the state laboratory reported otherwise.
“We cannot dispute the findings of accredited national labs and must accept their reports. The batch of medicines was tested five times before being supplied to the Ballari hospital,” he said
He also pointed out that all laboratories declared the medicine as compliant. However, questions have arisen regarding the management and functioning of nationally accredited labs.
“A team has been formed to investigate this issue, and a report is awaited,” he said.
Minister Rao insisted that there should be no attempt to cover up such cases.
“This is a systemic failure. Similar incidents have occurred nationwide. Initial steps are taken, but the issue is later forgotten. This should not happen. It needs to be discussed at the national level, and systemic flaws must be addressed in light of this tragedy,” he urged.
He said that following visits by teams from the state government, the Drug Control of India, and the West Bengal government to the pharmaceutical company in question, concerns were raised about the manufacturing process.
“A stop-production notice has been issued to the company, halting all drug manufacturing activities,” Rao informed.
“The manufacturer should not be allowed to make such mistakes. The Food Control Department and the Drug Control Department will now be monitored by an IAS officer in the state,” he stated.
“We should not tolerate such incidents in any form. This is the current state of the system in our country. In Maharashtra, a company supplied antibiotics containing spurious powder,” he reiterated.
“The pharmaceutical lobby is huge in our country and has strong influence at the central government level. Regulatory laws are not effectively enforced. Our country needs a system to ensure that only quality drugs are produced. We should strive towards this goal,” Rao asserted.
“The Development Commissioner has been instructed to provide a comprehensive report on the maternal death tragedy. Strict orders have been given to investigate each maternal death case in the state, and a maternal death audit is being conducted,” he announced.
Addressing the maternal deaths, Rao explained, “The incidents in Ballari District Hospital occurred on November 9, 10, and 11. A total of 34 cesarean surgeries were performed, of which seven cases turned critical. Tragically, five women died after delivery, while two recovered and were discharged.”
The incident came to the government’s attention on November 13, prompting the immediate dispatch of a team to investigate. Rao noted that over 2,000 deliveries had been conducted at the Ballari hospital previously, with no reported deaths.
An expert team of doctors visited the hospital on November 14 and submitted a report two days later. The report stated that local doctors had not shown negligence or dereliction of duty and that due procedures and protocols were followed.
Minister Rao emphasised that such incidents should not be tolerated.
“We must consider the consequences of a mother’s death in a family due to the negligence of a manufacturer or any other reason,” he pointed out.
“We are taking action against laboratories for providing false reports. Pharmaceutical companies must not supply substandard medicines. The system must ensure this and prevent companies from risking lives. Another drug from the same company has also failed quality tests,” he revealed.
“All necessary action must be taken against the Paschim Banga Pharmaceuticals company, which supplied substandard medicines. We do not know how many other companies are operating similarly. The issue came to light only because of the series of deaths in Ballari. If deaths occur in different locations, they might go unnoticed due to inefficient reporting mechanisms,” Minister Rao concluded.
