WHO issues new warning on Indian cough syrup after 18 more child deaths

The World Health Organization emblem on a glass entrance door at the WHO headquarters in Geneva on Feb. 18, 2020. MUST CREDIT: Bloomberg photo by Stefan Wermuth.

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

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

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 The ministry added that the medicine was withdrawn from the market.

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

Marion Biotech 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 alerts over Indian medicines are a blow to the reputation of one of the country’s top industries. India is one of the world’s leading pharmaceutical players supplying key drugs to many countries, particularly in the developing world, including 60 percent of the world’s vaccines.

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

An Indian spokesperson said that the embassy had contacted the Uzbekistan government to seek further details and acknowledged that Uzbek authorities had sought legal action against the local representatives of the company producing the medicine.

After the WHO’s alert over the medicines in Gambia, however, India’s drug regulator pushed back and sent a letter to the WHO saying that samples of the medicines “were not found to have been contaminated.”

“The statement issued by the WHO in October, 2022 was unfortunately amplified by the global media which led to a narrative being built internationally targeting the quality of Indian pharmaceutical products. This has adversely impacted the image of India’s pharmaceutical products across the globe, causing irreparable damage,” the letter stated.

The sharply-worded letter was reminiscent of an earlier spat between the Indian government and the global health agency over the number of deaths in India due to covid-19.

In contrast to the government’s defense of the industry, some public health experts have regularly sounded the alarm over what they maintain is the inadequate oversight of the rapidly expanding sector. In a recent book, “The Truth Pill: The Myth of Drug Regulation in India,” scientist Dinesh Thakur and lawyer Prashant Reddy documented how weak standards have affected the quality of Indian drugs.

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

“For a country like India, which has earned itself the moniker of being ‘the developing world’s pharmacy’, such regulatory failures impact not just Indian citizens but also the citizens of all its trading partners,” the book reads. “The Government of India is more interested in propping up the Indian pharmaceutical industry – the only manufacturing success story for India to showcase on the global stage – and toward this end, it will always resist tightening the regulatory screws.”

In his Oct. 5 news conference about the Gambia deaths, WHO head Tedros Adhanom Ghebreyesus said that the contaminated products may have been distributed to other countries as well. “WHO recommends all countries detect and remove these products from circulation to prevent further harm to patients.”

Health authorities there found that children who were given syrup for cough and cold symptoms developed acute kidney issues. After the WHO helped the country investigate, the medicines were linked to an India-based company called Maiden Pharmaceuticals. The company’s membership with an Indian pharma exporters body was suspended.

Srinath Reddy, the president of the Public Health Foundation of India, said that manufacturers vary in India, with some maintaining high standards and others who need investigation.

“While the specific instances related to the cough syrups need to be fully probed, it is imperative that regulators weed out the manufacturers who do not adhere to standards,” he said. “While India’s reputation as a global supplier of medicines is deservedly high, weak links must be removed to ensure that it remains so.”

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