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Deaths in Gambia and Uzbek linked to Indian cough syrups: WHO

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NEW DELHI – The World Health Organization on Wednesday warned against two cough medicines made in India, after Uzbekistan’s Ministry of Health linked the syrup to the deaths of at least 18 children.

It is the second WHO medical warning about Indian-made cough syrup after the UN agency acted on the Gambian Ministry of Health’s allegation that Indian medicines caused the deaths of more than 60 children in October.

The case in Uzbekistan was linked to a Marion Biotech facility in Noida, outside Delhi. The Uzbek Ministry of Health said that 18 out of 21 children suffering from respiratory ailments took an excessive amount of the Indian syrup and later died. The ministry added that the drug was withdrawn from the market.

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The WHO statement said the products had excessive levels of diethylene glycol, according to tests carried out by the Uzbek authorities, which was the same compound cited in the Gambian case.

Marion Biotech’s lawyer, Hasan Harris, told local media that the company “regrets the deaths of children in Uzbekistan” and that the Indian government is conducting an inquiry.

The Indian drug alerts are a blow to the reputation of one of the country’s leading industries. India is one of the world’s leading pharmaceutical players, supplying important medicines to many countries, especially in the developing world, including 60% of the world’s vaccines.

In December, Finance Minister Nirmala Sitharaman called India the “pharmacy of the world” – a line echoed by Prime Minister Narendra Modi.

An Indian spokesman said the embassy had contacted the government of Uzbekistan for more details and acknowledged that the Uzbek authorities had taken legal action against local representatives of the company that produces the drug.

After the WHO warning about the drugs in Gambia, however, India’s drugs regulator backtracked and sent a Letter to the WHO saying that the drug samples “were not found contaminated”.

“The statement issued by the WHO in October 2022 has unfortunately been amplified by the global media, which has led to a narrative being constructed internationally targeting the quality of Indian pharmaceuticals. This has negatively affected the image of India’s pharmaceuticals across the world, causing irreparable damage,” said the Letter declared.

The strongly worded letter recalled an earlier spat between the Indian government and the global health agency over India’s death toll from Covid-19.

In contrast to the government’s advocacy of the sector, some public health experts have regularly sounded the alarm about what they contend is inadequate oversight of the rapidly expanding sector. In a recent book, “The Pill of Truth: The Myth of Medicines Regulation in India,” scientist Dinesh Thakur and lawyer Prashant Reddy document how poor standards have affected the quality of Indian medicines.

The authors describe India’s “uniquely depressing” history of incidents involving the same compound in the Gambia and Uzbekistan incidents – diethylene glycol. Poisonings related to the compound led to 84 deaths in the country, the book claims, with the actual number likely to be higher.

“For a country like India, which has earned the nickname ‘pharmacy of the developing world’, these regulatory failures affect not only Indian citizens, but also the citizens of all its trading partners,” says the book. “The Government of India is most interested in supporting the Indian pharmaceutical industry – the only manufacturing success story for India to showcase on the global stage – and to that end will always resist tightening regulatory screws.”

At his Oct. 5 press conference on the Gambia deaths, WHO chief Tedros Adhanom Ghebreyesus said the contaminated products may have also been distributed to other countries. “WHO recommends that all countries detect and remove these products from circulation to prevent further harm to patients.”

Health officials found that children given cough syrup and cold symptoms developed acute kidney problems. After the WHO helped the country investigate, the drugs were linked to an Indian company called Maiden Pharmaceuticals. The company’s association with an exporting body of Indian pharmaceuticals has been suspended.

Srinath Reddy, president of the Public Health Foundation of India, said manufacturers vary across India, some maintaining high standards and others needing investigation.

“While specific cases related to cough syrups need to be fully investigated, it is imperative that regulators weed out manufacturers that fail to meet standards,” he said. “While India’s reputation as a global supplier of medicines is deservedly high, weak links must be removed to ensure it stays that way.”