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Cough syrup India: Lax testing fuelled wave of cough syrup poisonings


In December 2019, Jafar Din’s two-month-old son Irfan was coughing and feverish. Din left their single-room home in the Himalayan mountains and traveled 10 km (6 miles) to the nearest pharmacy, where he bought a bottle of medicine, COLDBEST-PC.

He returned and gave the child a dose.

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Hours later, Irfan started vomiting. He stopped passing urine. He was admitted to hospital in Jammu city. A week later, he died.

Irfan was one of at least 16 children whom authorities in India’s northern region of Jammu and Kashmir found had been poisoned. Twelve died after their kidneys and other organs failed, a police charge sheet showed; four others were left with severe disabilities.
Investigations by police and state drug inspectors pointed to medicines made by one manufacturer, Digital Vision Pharma. The family-owned business is based in the neighbouring state of Himachal Pradesh, a center for India’s pharmaceutical industry and one of Asia’s biggest drug manufacturing hubs. Government analyses of the syrups made by Digital Vision that the children took – 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 charge sheet for an ongoing criminal case against Digital Vision’s owners and an investigative report by Jammu and Kashmir’s drugs regulator, both seen by Reuters. That concentration is far above safe levels for DEG, an industrial solvent used in car brake fluid. The World Health Organization (WHO) says the safe limit, based on internationally accepted standards, is no more than 0.10%. Digital says there was no DEG in its syrup and its medicines are not to blame. The company has provided no evidence to support this.

The WHO told Reuters the Jammu deaths may have been the start of a wave of poisonings, by medicines made in India by three other companies, that have been linked to the deaths of 141 children in Gambia, Uzbekistan and Cameroon over the last year. They are part of one of the largest episodes of such contamination on record.

In all three cases, the syrups were found to contain high levels of DEG and a related chemical, ethylene glycol (EG). The WHO says at least 15 countries may have had tainted syrups on sale, made by various different companies.

The rash of poisonings has led to criminal probes, lawsuits and a surge in regulatory scrutiny in India and abroad. Indian regulators have conducted a wave of inspections this year that found possible violations in nearly nine in 10 of some 160 factories targeted.

Still, despite intense lobbying on behalf of the families of the children in Jammu, no one has yet been found guilty in a court of law for the cough syrup deaths.

A Reuters examination of court records and regulatory filings – as well as interviews with two company executives and two regulators – show that the drugmakers linked to the child deaths in India, Uzbekistan and Gambia either did not test their products for known toxins, or could not prove to investigators that they did so – as required by Indian law.

India’s health ministry, the office of the prime minister and the federal drugs regulator, the Central Drugs Standard Control Organisation (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 said they had purchased pharmaceutical quality chemical ingredients. But Reuters found these claims were denied or called into question by the chemicals suppliers themselves in all three cases. Reuters’ reporting also showed how two of the companies had already come under scrutiny for lax manufacturing practices . The news agency found that Digital Vision and its unit Orison Pharmaceuticals had received at least 16 warnings from the drug regulators of Maharashtra and Gujarat states about substandard heartburn, antibiotic, anti-fungal and other medicines before the Jammu deaths.

And senior executives at the company linked to cough syrup deaths in Gambia – Maiden Pharmaceuticals – were on bail on charges of illegally storing substandard medicines 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 companies.

Police in Jammu and Kashmir in December charged Digital Vision’s founder, Parshottam Goyal, and his sons Manic and Konic with crimes including culpable homicide not amounting to murder – comparable to manslaughter – in connection with the poisonings, according to the charge sheet submitted to a court in Ramnagar town.

The charges carry a possible sentence of up to life in jail. The Goyals deny any wrongdoing.

“We will challenge any case against us,” Goyal told Reuters ahead of the next hearing in the case, due on Sept. 15. Asked about the toxin and the children’s deaths, he said someone may have “planted something” or that medicines may have been misused. “Who knows what was fed to whom,” he said.

Konic Goyal declined to comment; Reuters could not contact his brother, Manic. Police investigators did not respond to requests for comment about the case.

A court in Himachal upheld Digital’s appeal in August 2020 against the suspension of its manufacturing license by the state drugs regulator five months earlier, noting that only one batch of its COLDBEST syrup had been found to contain toxins – the consignment that was sold in Jammu.

The court barred Digital Vision from making drugs containing certain ingredients and the case concluded without a definitive ruling on who was to blame for the Jammu deaths.

Asked by Reuters about the impact of the legal cases, Goyal said Digital Vision’s business had “stabilized” and “expanded.” Digital has tripled its capacity to produce other medicines, he said, and another company he owns that makes medicines, including antibiotics and eye drops, started exporting them last year.


The risks posed by DEG and EG are well known. The toxins have killed nearly 1,000 children worldwide over the last 80 years, according to Kalle Hoppu, a Finnish poisons and pediatric medicines expert, who worked with Gambia’s government to investigate the deaths of children there.

Cough and cold syrups are made with propylene glycol (PG), a colorless, viscous liquid that does not react with other substances, making it an ideal solvent for syrupy medicines. It is generally sold in two grades: pharmaceutical and industrial.

Industrial grade PG – widely used in liquid detergents, 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 jumped 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’s cough syrup – would likely make children sick very quickly if they took several doses, putting them at risk of death – particularly if they had poor access to doctors, said British consultant nephrologist Dr. Graham Lipkin.

Initial symptoms include nausea and vomiting. Without treatment, patients may experience acute kidney injury. Then other organs can become inflamed, start to bleed and fail, he said.

The WHO said it learnt of the 2019 poisonings in Jammu and Kashmir only after it began to help Gambia investigate its deaths last year. The U.N. health agency has linked the deaths of at least 70 children in the West African country to cough syrups made by Maiden Pharmaceuticals.

Maiden, whose factory is in the northern state of Haryana, denies any wrongdoing. It did not respond to requests for comment for this story.

Rutendo Kuwana, the WHO’s team lead for incidents with substandard and falsified medicines, said such poisonings tend to cluster together. The agency suspects the contamination occurred when someone switched in cheaper, toxic ingredients somewhere along the pharmaceutical supply chain.

“It is likely that (Jammu) is your starting point” for the global wave, Kuwana told Reuters. Further testing and paperwork are required to be sure, he said.


Reuters’ examination of the children’s deaths in Jammu shows the difficulties of tracing chemicals within India’s $42 billion-a-year pharmaceutical industry.

Digital told Reuters it produced the suspected batch of COLDBEST in September 2019 using pharmaceutical-grade PG from a supplier, Thakur Enterprises, based in Haryana state.

Thakur confirmed it sold PG to Digital, but said it only supplies industrial grade chemicals.

“All my bills say, in red letters, that all my products are for industrial use only,” said Vibhor Chitkara, who runs Thakur. Neither he nor Digital Vision’s Goyal would provide any documentation to Reuters to support their assertions.

Chitkara said he had bought the PG from another company, Manali Petrochemicals, which is India’s sole PG manufacturer and sells both pharma and industrial grades, according to a spokesperson.

But Manali told Reuters it had not done business with either Thakur or Digital, and called such a claim “entirely incorrect and misleading.” Thakur declined to provide proof of having done business with Manali.

In the case of Marion Biotech, whose cough syrups have been blamed by authorities in Uzbekistan for the wave of poisonings there, Reuters reported in June that its PG supplier Maya Chemtech did not have a license to sell pharmaceutical-grade materials and dealt only in industrial-grade chemicals.

Marion did not respond to requests for comment for this story.

Maiden, meanwhile, told Indian authorities that its PG was made by South Korea’s SKC. But SKC told Reuters it never supplied PG to either Maiden or its stated chemicals supplier, Delhi-based Goel Pharma Chem, the agency reported in May.

Digital Vision told the High Court of Himachal Pradesh in August 2020 – when it was appealing to reopen its factory there – that it had requested tests of its syrup for DEG and EG at a laboratory in New Delhi. But it provided no proof.

The laboratory, Shree Sai Test House, did not respond to Reuters inquiries.

Indian regulations require drug manufacturers to test each batch of raw materials and products for strength, quality and purity. They explicitly require tests for DEG and EG. Violations carry fines or jail sentences up to life if a product is found to cause grievous harm or death. However, there is no nationwide record of punishments for selling or failing to test toxic medicines.

The Himachal High Court ruled in August 2020 that Digital had not proven it bought the PG from a licensed dealer, nor tested it for DEG.

The court nevertheless allowed Digital to resume production of medicines – as long as these do not contain PG.

Though Goyal insisted that his ingredients met pharmaceutical-grade standards – known as pharmacopoeia – he said others’ may not.

“Many pharma companies buy non-pharmacopoeia PG,” he told Reuters, without providing evidence. “Many people don’t even test PG. They think, ‘It’s in a big drum, just add it in.'”


Consumer advocates and lawmakers have lobbied India’s government for more than two decades for improved oversight of its pharmaceuticals industry, one of the world’s largest.

They say supervision remains ineffective partly due to a patchwork of understaffed regulators with no overarching authority, and an array of vague production standards.

There are 37 local-level regulators across India as well as the federal body, CDSCO. Different states often have jurisdiction over different companies in the supply chain.

Although CDSCO is responsible for laying down standards and coordinating state drug control organizations, its role is curtailed by India’s constitution, which allows individual states to have their own laws on drugs.

“So, everybody’s responsibility becomes nobody’s responsibility,” said Kundan Lal Sharma, a former senior Indian health ministry official.

In the Jammu and Kashmir poisonings, the local government said the onus of investigating the products was on the state where Digital Vision’s operations are based – Himachal Pradesh.

But Himachal says finding out how the cough syrups were contaminated is mainly the responsibility of yet another state, Haryana, because that’s where the PG supplier, Thakur Enterprises, is based.

Haryana’s drug regulator did not respond to requests for comment.

A Jammu and Kashmir court ruled in March 2021 that the regional government’s Drugs and Food Control Department should be held accountable because it could have kept the syrups off shelves if it had tested them vigilantly.

The government appealed but India’s highest court upheld the ruling, saying last November that drugs officers had been found “negligent.”

The Supreme Court ordered Jammu and Kashmir to pay the families of the 12 dead children 300,000 rupees ($3,668) each in compensation. But again, it did not rule on who was responsible or order help for those left disabled.

Jammu and Kashmir has paid the compensation. Its drugs controller, Lotika Khajuria, told Reuters that before the deaths it did not inspect medicines or medicine-makers thoroughly, but it will open a new laboratory in September to double its annual testing capacity to 10,000 samples.

“We’re hoping that we will do some justice to the kids,” she said. “Small and medium-scale industries, they never used to test.”


Marion Biotech, based in the Indian state of Uttar Pradesh, produced cough syrups that the health ministry in Uzbekistan linked to the deaths of 65 children there last year.

The syrups shipped to Uzbekistan last year by Marion were made with a toxic industrial-grade ingredient, rather than the legitimate pharmaceutical version, Reuters reported in June.

Tests by an Indian government laboratory in January found 22 samples of Marion-made syrups were “adulterated and spurious,” the country’s drug controller said in March.

The company’s then-head of operations, Tuhin Bhattacharya, told Reuters it had exported cough syrups for more than a decade without testing the PG for impurities like DEG or EG.

“No exporter in India used to test for DEG and EG,” he said. “No one does it.”

Reuters reported in April that government inspectors had found that Maiden Pharmaceuticals also did not test the PG before use.

Authorities in Uttar Pradesh canceled Marion’s license in March and arrested Bhattacharya and two of its chemists. They were released on bail a few days later.

A court barred police from arresting Marion’s owners, Jaya Jain and Sachin Jain, saying police should not have investigated the matter without first bringing it to court. But it allowed drug officials to continue their enquiries.

Drug inspectors from the federal regulator CDSCO are pursuing their investigation into Marion, according to two sources with knowledge of the matter, who declined to be named as they were not authorized to talk to the media.

A lawyer for Marion’s owners declined to comment, and the owners themselves could not be reached.

Bhattacharya said the standards Marion followed were set by the British Pharmacopoeia, or drug standards guidelines, as requested by authorities in Uzbekistan and approved by drug regulators such as CDSCO. Uzbek authorities did not reply to requests for comment.

Bhattacharya said British standards do not explicitly call for propylene glycol to be tested for DEG or EG. “If something has happened, it’s because of the regulation,” he said. “It is not the fault of our technicians.”

A spokesperson for Britain’s Medicines and Healthcare Regulatory Products Agency, which oversees the standard, said that was “not a fair statement.” She cited wider British and international manufacturing guidelines requiring tests that should uncover any toxins and spark further inquiry. However, she added that the agency is working with global regulators to make its requirements more explicit.


Digital’s Goyal told Reuters COLDBEST-PC could not have killed the children in Jammu, because the deaths were concentrated in one region, while his companies supplied 5,575 bottles to eight regions in total.

“Had something been wrong with our product, kids would have died elsewhere too,” said Goyal, 60.

“I am not saying that all those who consumed the medicine would have died, but had it been toxic, it would have killed at least 100 kids.”

Half a dozen experts interviewed by Reuters said Goyal’s argument was not convincing. Several variables could explain the pattern of deaths, they said: For example, any single batch may have used different barrels of the same ingredient. And smaller patients are more vulnerable to DEG poisoning.

“The toxicity depends on the dose and the size of the child,” said Hoppu, the poisons and pediatric medicines expert. “The more doses a child gets, the more likely they are to get kidney damage.”

The seven other regions recalled COLDBEST in February 2020. Federal authorities found toxins in samples sold in four states, according to court and government documents. In Haryana, a sample had 35.87% DEG – the highest of all.

One of the states, Tamil Nadu, told Reuters no deaths had been linked to the syrup but said it was seeking legal action against the company and its owners for selling adulterated drugs.

The others did not respond. Reuters could not determine how many medicines had been sold outside Jammu or if anyone was harmed.


Amid mounting international outcry, Prime Minister Narendra Modi’s government doubled down on testing requirements in June, introducing a new rule that all cough syrups for export must be checked in government laboratories. Health Minister Mansukh Mandaviya said more than 900 cough syrup samples have since been cleared.

Mandaviya told parliament in August that authorities had inspected 162 drug factories since the overseas cough syrup deaths and found possible violations in 143 of them – nearly nine in 10.

The health ministry said in August the inspections of drug factories found an “absence of testing of incoming raw materials.” It gave all companies up to a year to fix that shortcoming and comply with international manufacturing standards set by the WHO. The ministry said fewer than a quarter of India’s 8,500 small drug factories currently meet these.

But India did not increase testing requirements for the domestic market.

Industry executives have complained about the cost of extra tests for exports and asked the government to cover this, according to communications viewed by Reuters.

In June, a national association of small businesses close to Modi’s Bharatiya Janata Party (BJP), called Laghu Udyog Bharati, wrote to the health ministry that inspecting drug factories whose products had been found substandard was a “death sentence” for small companies.

The group later retracted the letter, which the president of its pharmaceutical wing, Rajesh Gupta, told Reuters was inadvertently issued by an official on “emotional grounds.” He declined to identify the official.

“We are not against the government on quality inspections,” Gupta said. “It is the regulator’s right to inspect but it should be done in a friendly way and not in the manner of a raid, which creates fear.”

He also said the deadline for small factories to meet WHO manufacturing standards would lead to the closure of nearly half of them, because they are already heavily indebted. The health ministry did not respond to a request for comment. The WHO declined to comment.

Digital Vision’s Goyal said his company’s sales have now returned to levels seen before 2020, to up to 400 million rupees annually, and he is ramping up exports.

A Goyal-owned company called Vellinton Healthcare is registering to sell drugs in eight countries including Ghana, Ethiopia and Afghanistan. It has exported to countries including Turkmenistan since last year, he said.

“Our vision is mainly export now. There is barely any money in the domestic market,” Goyal said. “Competition is fierce and unhealthy. Quality is not maintained.”

In Jammu, Reuters spoke to the families of six of the dead children. Din took a reporter to the hilly graveyard strewn with boulders where Irfan, his firstborn, is buried. Like the parents of the other five, he said he wants the manufacturers punished.

“I demand strict action against them,” said the 27-year-old father. “It’s been too long already.”


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