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Reuters
- September 22, 2023 10:00
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Toxic cough syrup produced and sold in India may have been the start of a recent 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' investigation into the child deaths in Jammu clearly shows the difficulties of testing chemicals within India's billion-dollar pharmaceutical industry.
Digital told Reuters it produced the COLDBEST syrup ingredient in September 2019 using pharmaceutical-grade PG from Haryana state-based supplier Thakur Enterprises.
"Thakur" has confirmed that it has sold PG to "Digital", but has said that it only supplies companies with industrial-grade chemicals.
"All our invoices show, in red letters, that all the products are for industrial use only", explained Vibhor Chitkara, who runs "Thakuri". Neither he nor Digital Vision's Goyali declined to provide any documents to Reuters to support their claims.
Chitkara has claimed that he had bought the PG from another company, Manali Petrochemicals, which is the sole producer of PG in India and also sells pharmaceutical and industrial products, according to a spokesman.
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But "Manali" stated to Reuters that it had not done business with either "Thakuri" or "Digital", and called the claim "completely incorrect and a fraud". "Thakur" refused to provide evidence that he had done business with "Manali".
In the case of Marion Biotech, whose syrups were targeted by authorities in Uzbekistan for a spate of poisonings there, Reuters reported in June that its PG supplier Maya Chemtech did not have a license to sell pharmaceutical-grade products. and only dealt with industrial grade chemicals.
Marion did not respond to requests for comment for this story.
Maiden, meanwhile, told Indian authorities that its PG was manufactured by South Korea's SKC. But SKC told Reuters it never supplied PG to either Maiden or the chemical's stated supplier, Delhi-based Goel Pharma Chem.
Digital Vision told the Himachal Pradesh High Court in August 2020 - when it was appealing to reopen its factory there - that it had requested testing of its syrup for the toxin DEG and EG at a laboratory in New- Delhi. But he offered no evidence.
The Shree Sai Test House laboratory did not respond to questions from Reuters.
Indian regulations require drug manufacturers to test each batch of raw materials and products for quality and composition. Tests for DEG and EG toxin are explicitly provided for there. Violations are punishable by fines or life imprisonment if any of the products are found to cause serious injury or death. However, there is no nationwide data on penalties for selling or failing to test for toxic drugs.
The Himachal High Court ruled in August 2020 that Digital had not proved that it had purchased the PG from a licensed supplier, nor had it tested for DEG.
The court, however, allowed Digital to resume production of the drugs - as long as they do not contain the PG toxin.
Although Goyal insisted that its ingredients met pharmaceutical grade standards - known as the pharmacopeia - the company claimed that other competitors may not.
"Many pharmaceutical companies buy PG non-pharmacopeia," he told Reuters, without providing evidence. “A lot of people don't even test for PG. They just add it."
"No one is responsible"
Consumer advocates and lawmakers have lobbied India's government for more than two decades for improved oversight of its pharmaceutical industry, one of the largest in the world.
They say oversight remains ineffective, in part, because of a series of understaffed regulators with no overall authority, and a set of unclear production standards.
There are 37 local level regulators across India as well as the federal body, CDSCO. Different countries often have jurisdiction over different companies in the supply chain.
Although CDSCO is responsible for setting standards and coordinating state drug control organizations, its role is limited by the Indian Constitution, which allows individual states to have their own drug laws.
"So everybody's responsibility becomes nobody's responsibility," said Kundan Lal Sharma, a former senior official in India's Ministry of Health.
In the case of the poisonings in Jammu and Kashmir, the local government has reported that the responsibility of investigating the products fell on the state where Digital Vision's operations are based - Himachal Pradesh.
But Himachal has stated that the way to detect the toxin content in cough syrups is primarily the responsibility of another state, Haryana, because PG's supplier, Thakur Enterprises, is based there.
The Haryana drug regulator did not respond to requests for comment.
A court in Jammu and Kashmir ruled in March 2021 that the regional government's Food and Drug Control Department should be held liable because it could have kept the syrups off the shelves if it had tested them more carefully. .
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The government appealed, but India's highest court upheld the decision.
The Supreme Court ordered Jammu and Kashmir to pay the families of the 12 dead children 300 rupees ($3.668) each as compensation. But again it did not decide who was responsible.
Jammu and Kashmir has paid the compensation. Drug inspector Lotika Khajuria told Reuters she had not fully inspected drugs or drug manufacturers before the deaths, but announced she would open a new lab in September to double annual testing capacity to 10 samples.
"We hope that we will bring justice for the children", she added. "Small and medium-sized industries, they never performed tests."
Testing the syrup
Marion Biotech, based in the Indian state of Uttar Pradesh, produced cough syrups that Uzbekistan's Ministry of Health linked to the deaths of 65 children there last year.
Syrups sent to Uzbekistan last year by the Marion company contained a toxic industrial-grade ingredient instead of the legal pharmaceutical version, Reuters reported in June.
Test results from an Indian government laboratory in January revealed that 22 samples of syrups produced by the Marion company were "falsified and fake", the country's drug control body announced in March.
The company's then chief, Tuhin Bhattacharya, told Reuters it had been exporting cough syrups for more than a decade without testing PG for toxins such as DEG or EG.
"No exporter in India was testing for DEG and EG," he added. "No one does that."
Reuters reported in April that Government inspectors had found that Maiden Pharmaceuticals had also failed to test PG before use.
Authorities in Uttar Pradesh canceled the Marion company's license in March and arrested Bhattacharyan and two of the company's chemists. They were released on bail a few days later.
A court stopped the police from arresting Marion's owners Jaya Jain and Sachin Jain, arguing that the police should not have investigated the case without first taking it to court. But it allowed drug officials to continue their work.
Drug inspectors from federal regulator CDSCO are continuing their investigation into the Marion company, according to two sources briefed on the matter, who declined to be named because they were not authorized to speak to the media.
A lawyer for the owners of the "Marion" company refused to comment, and the owners themselves did not respond.
Bhattacharya stated that the standards followed by Marion were determined by the British Pharmacopeia, or drug standards guide, as required by the authorities in Uzbekistan and approved by drug regulators such as CDSCO. Authorities in Uzbekistan did not respond to requests for comment.
Bhattacharya added that British standards do not explicitly require propylene glycol to be tested for DEG or EG. "If something happened, it is because of the regulation", he said. "It is not the fault of our technicians".
A spokeswoman for Britain's Medicines and Healthcare products Regulatory Agency, which oversees the standard, responded by saying it was "not a fair statement". She cited wider British and international manufacturing guidelines, which require testing to detect any toxins and prompt further investigation. However, she added that the agency is working with global regulators to make its requirements clearer.
It continues.
Translated by: Forca Jashari
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The first part:
