Bengaluru/New Delhi: The Karnataka government will undertake re-testing of all 192 batches of an intravenous fluid after the tragic death of at least four women post-delivery at a Ballari district hospital last month, ThePrint has learnt.
Of the batches tested so far of Ringer Lactate IV fluid procured from West Bengal-based Paschim Banga Pharmaceutical, 22 have failed the test, around 65 have passed it and the remaining are yet to be examined, according to the state health department.
Clinicians ThePrint spoke with explained that Ringer Lactate solution is a common intravenous fluid used in a large number of patients following surgeries in order to replace water and electrolytes.
“Generally, government labs do not have capacity to test that many samples. We had relied on NABL-empanelled private labs for testing. We are now getting the entire batch tested again from our government analyst,” Harsh Gupta, principal secretary in Karnataka’s health & family welfare department, told ThePrint.
The state government has also stopped using around three more IV drugs supplied by the same company across Karnataka, Gupta said.
Between 9 and 11 November, four maternal deaths were reported at a district hospital in Ballari, about 320 km away from Bengaluru.
At the time, Karnataka health minister Dinesh Gundu Rao had said that of the 34 procedures conducted then at the hospital, seven cases suffered severe complications and four women died.
Multiple media reports indicate that two more women have died post-surgery at the Ballari district hospital in the last few days.
Procuring substandard or contaminated drugs is not a problem limited to Karnataka, and the matter has prompted Chief Minister Siddaramaiah to indicate the possibility of a “medicine mafia”. He has also directed that the entire drugs department be restructured on the lines of Tamil Nadu.
In December 2023, Delhi Lt General V.K. Saxena had recommended a CBI inquiry into supply of several drugs, including sodium valproate (anti-epilepsy), cephalexin (used for treatment of lung and urinary tract infections) and dexamethasone (steroid used for life-threatening inflammation in lungs and joints), that failed quality standards.
ThePrint reached out to Paschim Banga Pharma over email for its response on the episode. This copy will be updated if and when a reply is received.
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Karnataka asks for probe
On 3 December, the Karnataka health department shot off a letter to the Drugs Controller General of India, requesting the central agency to investigate and take action against the West Bengal-based drugs supplier.
The health department stated in the letter, which ThePrint has seen, that different batches of the said IV drug from the West Bengal supplier were drawn for test and analysis by drugs control officers across Karnataka from district drug warehouses, of which 22 batches failed in various parameters, including “tests for sterility &/or test for bacterial endotoxins/particulate matter etc”.
The state government is yet to determine the exact cause of the maternal deaths in Ballari, but has said that the one thing that stood out in the procedures was the use of the IV drug from the said supplier.
“The maternal deaths that happened… an audit team by experts revealed that there were no apparent lapses on the part of doctors who performed the (caesarean) surgery, before care or when they saw the complications after care… there were no lapses. There was this incidental finding that this new supply (of IV drug) had just started to be used in the hospital,” Gupta told ThePrint.
In November, Rao had said that over 2,600 caesarean operations had been conducted at the district hospital in Ballari since April this year, with no casualties.
He added that this raised suspicions about the new batch of IV fluid and a probe was ordered into the quality of the newly-procured drug.
In its letter, the health department said that all such batches have been frozen by the state after the deaths in Ballari.
The central drugs controller is, however, yet to respond to Karnataka’s request for a probe and Gupta said he was not aware if it had carried out an investigation or taken action against the West Bengal-based supplier.
Experts weigh in
According to pharmacologists, broadly, drugs that are classified as not of standard quality (NSQ) are those which either fail the quality test or are contaminated by undesired chemicals or have higher than permissible limits of one or more excipients.
Senior pharmacologist Dr Santanu Tripathi explained that NSQ drugs or NSQ formulations refer to those with labelling errors, incorrect ingredient concentrations, or variations in the dissolution profile of active ingredients.
For example, if a product, instead of the required 100 mg of the active pharmaceutical ingredient contains 90 mg on analysis in a statutory laboratory, it shall be called NSQ.
“On the other hand, if a product is contaminated or adulterated, it is called spurious and such medicines carry greater risks. Contaminated drugs often look like a usual batch, but because they contain more dangerous substances, they can affect you differently. This increases the risk of harm, overdose and death,” Tripathi told ThePrint.
Also, a drug may be both NSQ and spurious.
“Ringer Lactate solution or any other drug if declared NSQ does not rule out the possibility of contaminants, which can be serious. However, it is difficult to comment on, without knowing the full result of the quality test, how serious the contamination is and what may be its health effects,” said Tripathi, who has been a member of several panels of the Central Drugs Standard Control Organisation.
Dr Jaydeep Tank, president of the Federation of Obstetric and Gynaecological Societies of India, also said that it was “very difficult to comment on what could have led to these deaths in Karnataka without the full investigative report”.
“I think substandard or not of standard quality Ringer Lactate solution, in case of contamination, can lead to infections that may or may not be fatal,” he added.
It will be crucial to examine details such as time lag between the reported deaths and the administration of the drug, according to the clinicians.
(Edited by Nida Fatima Siddiqui)
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