For the last 20 days, a two-year-old girl from Baddi in Himachal Pradesh is battling for life in an intensive care unit at PGIMER in Chandigarh, where she was admitted after developing renal failure. Her medical report from a few days ago says she is not passing urine due to deranged renal functions and has an altered sensorium (the sensory apparatus of a body, or the ‘seat of sensation’), due to which the “critically sick” child has been put on mechanical ventilation, dialysis and medications.
To find out the cause of her condition, PGI authorities tested the drugs she had been administered by a doctor in Baddi, and a preliminary assessment found diethylene glycol or DEG, a toxic chemical compound known to attack the renal system, in a cough syrup she had consumed.
It’s allegedly the same impurity that was found in a cough syrup produced by the same Sirmaur-based pharmaceutical manufacturer, which is linked to the death of at least nine children in Ramnagar in Jammu earlier this year.
The particular batch of Cofset-AT, the cough syrup in question, has been withdrawn from the market by the drug authorities after they were alerted by the PGI a few days ago, but like the last time, most of the 2,992 bottles from the batch have already been sold across multiple states.
An official of Digital Vision, the manufacturing company, said that only 86 unsold bottles could be recalled from retailers.
In February, drug authorities suspended the licence of Digital Vision and stopped all manufacturing at its unit in Kala Amb in Sirmaur district after PGI officials prima facie found the presence of DEG in Coldbest-PC syrup, which was purportedly consumed by a number of children in Ramnagar who developed adverse effects. Many of them died. The Regional Drugs Testing Laboratory in Chandigarh had found more than 34 per cent DEG in samples of the syrup sent from Jammu and Haryana.
The report was made public by Chief Minister Jai Ram Thakur in the Himachal Pradesh Vidhan Sabha in March, when he also said that the pharma unit owners were booked not only under the Drugs and Cosmetics Act, but also under Section 308 of the IPC dealing with attempt to commit culpable homicide. FIRs were registered in J&K and Haryana, too, and the accused are currently out on bail. They have also challenged the findings of the laboratory.
Last week, Deputy Drugs Controller of India Arvind Kukrety wrote to the HP State Drugs Controller, asking him to alert the field staff for “necessary action” and “to associate this office in investigation of the said manufacturer planned by your office”. He also attached an email from PGI, which said that the 2-year-old kidney patient had consumed a number of drugs, which were tested for the presence of DEG qualitatively using the Gas Chromatography-Mass Spectrometry (GCMS) analysis.
The email said that the girl had been given these oral medications by an area doctor after she developed fever, cough and coryza, but 5-7 days later, her condition worsened and she was diagnosed with acute kidney injury and other complications.
Lab tests found DEG in Cofset AT, and PGI said that earlier, too, they had reported DEG from a syrup made by the same company and marketed by the same Ambala-based firm Orison Pharmaceuticals. “Surprisingly, both these drugs (Cofset and Coldbest) have similar manufacturing and expiry dates,” the email said.
Both the syrup batches were made in September 2019, and the solvent for the batch (believed to contain the impurity) was supplied by a trader from Haryana who had further obtained it from a supplier in Chennai. A police official said that the Covid-19 pandemic had hampered investigations into the previous case, and the police have not been able to establish the original source of DEG so far.
A drug official from Sirmaur said that samples from Cofset AT have been taken from the Digital Vision unit and sent for further testing. Manufacturing at the unit was already suspended, he said, and the police have been intimated about the fresh findings.
Assistant drugs controller, Nahan, Sunny Kaushal said that when the previous case had surfaced in February, 26 different samples from various batches of drugs (besides the September batch of Coldbest-PC syrup) from the unit were procured and tested, but none of them had showed the presence of DEG.
With this fresh detection of DEG, drugs authorities have now seized many more samples, which are being tested, while alerts have been issued to recall the syrup, he said.
‘Not for children’
Parshottam Goyal, the MD of Digital Vision, said that the cough syrup in question was not meant for children. “It’s a prescription drug and only drops should be prescribed to small children, not syrups,” he told the Indian Express.
He asserted that the company had followed all norms during the manufacturing process of both the syrups. “We have challenged the findings of the RDTL laboratory under the Drugs and Cosmetics Act and are pretty sure there is no defect in our drugs. As a precautionary measure, we are assisting the authorities in recalling the syrup. The PGI report is only a qualitative one taken from an open bottle, so it has no legal validity. Only reports from samples taken from our unit with due procedure as per the DCA will be able establish the true facts,” he said.
Meanwhile, in PGI, an anxious father waits outside the ICU. Monu, who works as a mason in Baddi, said that his daughter has not regained consciousness in more than 20 days. “Will there be any action against those responsible for her condition?” he asked.