How Indian-made drugs poisoned children with impunity

STORY: Anirudh’s parents try to feed him in hospital about a week before he died of kidney injury in January 2020. The two-year-old had taken toxic cough syrup, his parents said.

He is among at least 12 infants in Jammu and Kashmir poisoned by such syrups, according to Indian police, who point to one Indian manufacturer – Digital Vision Pharma.

Reuters spoke to the families of six of the dead children. Four others were left with severe disabilities, according to police charges filed in December.

Digital Vision says its medicines aren’t to blame.

The parents said their children’s deaths have exposed lax manufacturing standards and a lack of accountability in a country that aims to be the “Pharmacy of the World”.

The World Health Organization says the children in Jammu may have been the first victims of a wave of poisonings by Indian-made medicines, that went on to kill at least 141 other children across the world in 2022 and 2023.

A Reuters examination of court documents and interviews with company executives and regulators reveals how poor manufacturing practices and weak regulation have allowed such tragedies to be repeated.

Jafar Din’s two-month-old son Irfan got sick in December 2019, he said.

He left their single-room house near Jammu in the Himalayan mountains to trek to a pharmacy six miles away,

where he says he bought a bottle of Digital Vision’s medicine ColdBest-PC.

Hours after a dose, Irfan started vomiting. He stopped passing urine and was admitted to hospital.

A week later he was dead.

Like the other parents, Din wants what he calls “strict action.”

“Against the company. The company which made the medicine. They are the real murderers who made the medicine, they are the murderers.”

Digital Vision says there was none of the toxin diethylene glycol or DEG in the syrup. It says someone may have planted something or its medicines may have been misused.

Government tests of the syrup made by Digital Vision Pharma showed it contained a more than 34% concentration of DEG.

That’s according to a police charge-sheet for a criminal case brought against Digital Vision in December.

DEG is usually used in car brake fluid.

The safe limit for DEG is no more than 0.1%, according to the WHO and Indian regulations.

The children’s kidneys and other organs failed, the police charge sheet said.

Anirudh’s mother, Veena Kumari, is a primary school teacher.

Her two-year-old son was an early talker, she says, and a “naughty boy.”

“We miss him every day,” she says.

Anirudh also took ColdBest, then rapidly deteriorated.

A district court in Jammu and Kashmir is hearing the criminal case against Digital Vision’s founder, Parshottam Goyal, and his two sons.

They deny any wrongdoing.

Another court previously barred Digital Vision from making certain cough syrups, but it is making other drugs.

Parshottam Goyal told Reuters it has tripled its production capacity.

Veena Kumari and her family want Digital Vision held to account for their children’s deaths:

“The justice we want from the company is that strict actions should be taken against the company. Penalty and punishment both should be given so that people remember, and no child from any other family meets with the same fate.”

This man helped the families of the dead children get more than $3,500 compensation each – not from Digital Vision but from the state government of Jammu and Kashmir.

Sukesh Khajuria, a home tutor in Jammu city, saw news reports of children dying without explanation and learned the families were largely poor.

He said he persuaded a magistrate to order police to share a drug-inspector’s report, which alleged ColdBest was to blame.

Jammu and Kashmir authorities declined to comment.

An official at another Indian drugmaker, Marion Biotech, told Reuters they never tested for DEG.

“No one does it,” said then operations head Tuhin Bhattacharya.

Marion Biotech’s cough syrups were linked to the deaths of 65 children in Uzbekistan, the health ministry said.

Marion’s owners have denied wrongdoing.

Indian-made drugs were also linked by the World Health Organization to the deaths of infants in Gambia and Cameroon.

The three Indian drugmakers that sold in India, Gambia and Uzbekistan said they had purchased pharmaceutical quality ingredients.

Reuters found these claims were denied or called into question by the chemicals suppliers themselves in all three cases.

Neither Digital Vision nor those other manufacturers could prove they had tested for DEG and other toxins as required by Indian law.

That’s according to Reuters’ examination of Indian court records and regulatory filings and interviews with drug executives.

None of the manufacturers have been punished in India.

Prime Minister Narendra Modi’s government introduced a new rule in June that all cough syrups for export must be checked in government laboratories.

It has not increased testing requirements for those sold in India.

Modi’s office, India’s health ministry and the federal drug regulator did not respond to requests for comment.

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