The consultant obstetrician-gynaecologist says there is, at present, a poor system of procuring drugs and medical equipment for the public health system in India.
| Photo Credit: By Special Arrangement
Six women died in Ballari in Karnataka in November following caesarean section deliveries at the government district hospital, raising serious concerns about the quality of maternal health care in the State. All the women died following complications after a substandard intravenous fluid was used to restore hydration and fluid balance. To understand the problem, Frontline spoke to Dr. Shaibya Saldanha, a Bengaluru-based consultant obstetrician-gynaecologist, who has a deep commitment to provide access to respectable healthcare for the vulnerable. Excerpts:
The unfortunate deaths of six young women in Ballari have raised serious concerns about the quality of maternal care in Karnataka. The complications arose after administering a substandard intravenous (IV) fluid, which doctors use to restore hydration and fluid balance, called compound sodium lactate injection IP (Ringer’s Lactate solution). What does this lapse say about the state of public healthcare in Karnataka? Can we see this as an isolated incident or is this part of a larger systemic problem?
There seems to be a poor system of procuring drugs and medical equipment for the public health system in India and we have seen this repeatedly. For example, Ranbaxy [between 2004 and 2013] revealed the serious lapses in the manufacturing of medical drugs for which they paid a settlement of $500 million in the US.
In 2022, 69 children died in Gambia where WHO noted that there were unacceptable levels of diethylene glycol and ethylene glycol as contaminants in cough syrups manufactured in India. In August 2024, CDSCO [Central Drugs Standard Control Organization] reported that paracetamol was among 50 drugs tested that were “not of standard quality” across five to six States in India manufactured by various pharmaceutical companies, with the companies stating that these were probably spurious drugs.
If we go further back in time, 14 patients suffered kidney failure and died at theState-run JJ Hospital in Maharashtra due to the consumption of glycerine laced with a cheap industry-grade adulterant in 1986. It is scary that so many cases like this are still being reported.
Why is the CDSCO in India, the main regulatory body for pharmaceuticals, not doing its job and regulating the manufacture of medical drugs strictly? India has emerged as the headquarters of the low-cost generic drug production market but our quality control is poor and we do not have a strong and robust drug quality control system.
When it comes to these unfortunate deaths in Ballari, the substandard IV fluids were supplied by a company that had already been found to be deficient by the Drugs Testing Laboratory of Karnataka and were referred to the Central Drugs Laboratory in Kolkata. If batches of drugs made by a particular company are tested and some samples are found to be deficient, people like you and me would not purchase tablets from that company till we were sure that the deficiencies had been set right. So why can’t the State Health Department look at every public health user as somebody whose health is valuable?
The manufacturers will certainly put pressure on the drug controlling authority if they are blacklisted and argue their case but, in such instances, the regulatory authorities should diligently follow up, check the company’s manufacturing equipment and verify their drug manufacturing capabilities. There should be random tests done all the time on the quality of medicines; the fact that batches of this IV fluid were already flagged and continued to be administered is unacceptable. This shows that there were lapses in the evaluation and procurement of this batch of IV fluids and the flaw is part of a larger systemic problem.
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Data shows that the maternal mortality ratio (MMR) in Karnataka has declined over the past few years from 83 per lakh live births in 2017-18 to 64 per lakh live births in 2023-2024. The State has witnessed 328 maternal deaths this year from April to the end of November. What does this data tell us about the state of maternal health in Karnataka?
Under the Sustainable Development Goals of the World Health Organization, the aim was to reduce the MMR to below 70 by 2030. Karnataka has done well to bring the MMR to 64 over the past few years. This has happened because of the focus on improving maternal health and antenatal care. The Union Ministry of Health and Family Welfare’s scheme called SUMAN [Surakshit Matritva Aashwasan] ensures that hospitals and labour rooms are monitored for the quality of their care. In Karnataka, the main problem in the past was the lack of specialists (gynaecologists in this case) in district hospitals. This problem was acute in smaller and remote districts where it was difficult to find gynaecologists to be posted there.
However, what the Karnataka government did around a decade ago was to recruit local private doctors on a contractual basis along with an attractive pay package. This policy has been one of the ways that the State has been successful in leading to an improvement in the MMR ratio.
Chief Minister Siddaramaiah announced an ex gratia amount of Rs.5 lakh to the families of the mothers who lost their lives. An inquiry has also been ordered apart from the suspension of the Karnataka State Drugs Controller. But is this enough? What should the Health Department do to ensure that such incidents are not repeated?
In such cases, the biggest aspect to understand is that the amount of money the government pays out as ex gratia is not a deterrent to ensure that precautionary measures are taken in the future. The amount of the ex gratia is something that the government is willing to spend rather than ensure rigorous safety standards, which will cost more. For instance, if a policy is created where for every hospital death due to negligence an amount of Rs. one or two, or more, crores must be paid, that will certainly act as a deterrent. A few lakhs paid to the deceased’s family will not convince any institution to be careful that such instances do not recur in the future. The extra expenses needed to build in permanent safety and quality controls will not be considered necessary.
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Is it significant in any way that all the women who died underwent caesarean section deliveries?
Ringer’s Lactate solution is not just given to women who undergo caesarean section deliveries but is used during other medical and surgical procedures as well, where it is administered to a person who is dehydrated, and while undergoing any operation. The crucial question now is to figure out how many other patients, both non-pregnant women and men, were treated with Ringer’s Lactate solution at the hospital in Ballari and perhaps even across Karnataka. All the patients who were administered this batch of IV fluids must be tracked to ascertain whether any further deaths were caused by this contaminated batch.
It is significant because these six women who died were primarily healthy young women in their 20s and 30s, and none of these were high-risk pregnancies. Yet they died, and their children will have to grow up without their mother. Gandhi once said that the way a country treats its women is an indicator of the country’s development. Maternal deaths are always a red flag as they are an indicator of the state of public healthcare and so the deaths were newsworthy, but every human life has value and access to respectful and quality healthcare is a fundamental right of each person.
