Toxic cough syrup produced and sold in India may have been the start of a global wave of poisoning. Some of the drug manufacturers could not even prove whether they had tested their products. The parents of the deceased children are still awaiting justice
(Reuters) - In December 2019, Jafar Din's two-month-old son, Irfan, was coughing and running a fever. Dini left their one-room house in the Himalayas and traveled 10 kilometers to the nearest pharmacy, where he bought a bottle of "Coldbest-Pc" syrup. He returned home and gave his son a spoonful of syrup.
A few hours later, Irfan started crying. He didn't even urinate. He was then hospitalized in Jammu city. A week later, he died.
Irfan was one of at least 16 children that authorities in India's northern region of Jammu and Kashmir found to have been poisoned. Twelve of them died after their kidneys and other organs failed, according to police, while four others were left with serious injuries.
Investigations by the police and state inspectors pointed to the drugs produced by the manufacturer "Digital Vision Pharma". The family business is based in the neighboring state of Himachal Pradesh, the center of India's pharmaceutical industry and one of the largest drug manufacturers in Asia.
Government analyzes of the syrups the children took, made by Digital Vision – as well as samples taken from the company's factory and its distributor in early 2020 – found they contained a 34% concentration of the toxin diethylene glycol (DEG ), according to the indictment against the owners of Digital Vision and the investigative report of the Jammu and Kashmir drug regulator.
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The composition of the syrup
This concentration is much higher than the safe levels for DEG, the industrial solvent used in car brake fluid. The World Health Organization (WHO) has announced that the safe limit, based on internationally accepted standards, is no more than 0.10%.
"Digital", on the other hand, said that there was no DEG in its syrup. But the company has not provided any evidence to support this.
The WHO told Reuters that the deaths in Jammu may have been the start of a wave of poisonings from drugs made in India by three other companies that have been linked to the deaths of 141 children in Gambia, Uzbekistan and Cameroon over the past year. . They are part of one of the largest episodes of such poisoning.
In all three cases, the syrups were found to contain high levels of DEG and a related chemical, ethylene glycol (EG). The WHO has added that at least 15 countries may have been selling toxic syrups produced by different companies.
The high number of poisonings has led to criminal investigations, lawsuits and increased regulatory scrutiny in India and abroad. Indian regulators have carried out a wave of inspections this year finding potential violations at around 160 targeted factories.
However, despite intense lobbying on behalf of the children's families in Jammu, no one has yet been found guilty of the cough syrup deaths.
Reuters' analysis of court records and regulatory filings — as well as interviews with two company executives and two regulators — show that the makers of the drugs linked to the child deaths in India, Uzbekistan and The Gambia either did not test their products for toxins. known, or failed to provide sufficient evidence to investigators that they did so - as required by Indian law.
India's health ministry, the prime minister's office and the federal drug regulator, the Central Drug Standards Control Organization (CDSCO), did not respond to requests for comment for this article.
The three drugmakers - Digital Vision, Marion Biotech and Maiden Pharmaceuticals - implicated in the cases in India, Uzbekistan and Gambia have said they bought pharmaceutical-grade chemical ingredients. But Reuters found that these claims were denied or questioned by the chemical suppliers themselves in all three cases.
Reuters reporting also showed how two of the companies were already under scrutiny for poor manufacturing practices.
The news agency also found that Digital Vision and its unit Orison Pharmaceuticals had received at least 16 warnings from drug regulators in the states of Maharashtra and Gujarat about heartburn, antibiotics, antifungals and other drugs before the deaths. in Jammu.
And senior executives of the company linked to the cough syrup deaths in Gambia - Maiden Pharmaceuticals - were released on bail on charges of illegally storing substandard drugs when the African poisonings occurred.
Seven Indian pharmaceutical executives and regulators told Reuters it is common practice among some manufacturers there to substitute cheaper, commercial-grade ingredients when making cough syrups. They declined to identify any of the companies.
Police in Jammu and Kashmir in December charged Digital Vision founder Parshottam Goyal and his sons Manic and Konic with crimes — akin to manslaughter — in connection with the poisonings, according to a charge sheet filed in court in Ramnagar city.
The charges carry a possible sentence of life in prison. The Goyals deny any wrongdoing.
"We will challenge every case brought against us," Goyal told Reuters ahead of an upcoming hearing in the case. Asked about the toxin and the children's deaths, he added that someone might have "planned something" or that the drugs might have been misused. "Who knows what was given to whom," he said.
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Konic Goyal declined to comment; Reuters was unable to reach his brother, Manic. Police investigators did not respond to requests for comment about the case.
A Himachal court upheld Digital's appeal in August 2020 against the state drug regulator's suspension of its manufacturing license five months earlier, noting that only a portion of its syrup, COLDBEST, contained toxins - cargo that was sold in Jammu.
The court banned Digital Vision from manufacturing drugs containing certain ingredients and the case ended without a final verdict on who was to blame for the deaths in Jammu.
Asked by Reuters about the impact of the legal cases, Goyali emphasized that Digital Vision's business was "stabilized" and "expanded." Digital has tripled its capacity to make other drugs, he added, and another company he owns that makes drugs, including antibiotics and eye drops, started exporting them last year.
"The starting point"
The risks posed by DEG and EG are well known. Toxins have killed about 1 children worldwide over the past 80 years, according to Kalle Hoppu, a Finnish pediatric poisons and drugs expert who has worked with the Gambian government to investigate child deaths there.
Cough and cold syrups are made with propylene glycol (PG), a colorless liquid that does not react with other substances, making it an ideal solvent for syrups. It is generally sold in two grades: pharmaceutical and industrial.
Industrial grade PG - widely used in liquid detergent, antifreeze, paints or coatings - is always cheaper than the pharmaceutical version. This is partly because it is not intended for human consumption and may contain more DEG or EG.
Prices for pharmaceutical grade PG in India have risen several times in recent years due to supply chain disruptions, according to ChemAnalyst, a Mumbai-based chemicals market tracker.
A DEG concentration of 34% – the level identified in Digital Vision cough syrup – is likely to make children very ill if they take several doses, putting them at risk of death, explained British consultant nephrologist, Dr. Graham Lipkin.
Initial symptoms include dizziness and vomiting. Without treatment, patients can suffer acute kidney injury. Then other organs can become infected, begin to bleed and fail, he added.
The WHO has said it learned about the 2019 poisonings in Jammu and Kashmir only after it began helping The Gambia investigate its deaths last year. The UN health agency has linked the death of at least 70 children in the West African country to cough syrups produced by Maiden Pharmaceuticals.
Maiden, whose factory is in the northern state of Haryana, denies any wrongdoing. She did not respond to requests for comment for this story.
Rutendo Kuwana, head of the WHO team on substandard and counterfeit drug incidents, said such poisonings tend to cluster together. The agency suspects the high percentage of toxins occurred when someone started using cheaper, toxic ingredients somewhere along the pharmaceutical supply chain.
"(Jammu) is likely to be your starting point for the global wave," Kuwana told Reuters. Further testing and documentation is required to be sure, he added.
continues.
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Translated by: Forca Jashari
