NEW DELHI (Reuters) – India said it is testing samples of cough syrups made for export by local manufacturer Maiden Pharmaceuticals after the World Health Organization said its products have been linked to the deaths of dozens of children in The Gambia .
The death of 66 children in the West African country could deal a serious blow to India’s image as the “pharmacy of the world”.
The WHO said this week that laboratory analyzes of four Maiden products — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup — have confirmed “unacceptable” levels of diethylene glycol and ethylene glycol, which can be toxic and contain lead to acute kidney injury.
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Diethylene glycol and ethylene glycol are used in antifreeze and brake fluids and other industrial applications, but also in some pharmaceutical products as a cheaper alternative to glycerin, a solvent or thickening agent in many cough syrups.
India’s Health Ministry said samples of all four products that had been exported to The Gambia had been sent to a federal laboratory for testing and the results would “guide further action and bring clarity to the input received/to be received from the WHO.”
She called on the WHO to share its report on “establishing a causal association with death for the medical devices in question.”
WHO spokeswoman Margaret Harris did not directly respond to a Reuters query about when the report could be sent to the Department of Health.
However, she said information from Maiden and India’s director of the Central Drugs and Standard Control Organization indicated that authorities had visited the company’s factories “to investigate this particular incident and the WHO is awaiting the results”.
Anil Vij, the health minister of Haryana state, where Maiden has its factories, warned after the tests of “strict measures if anything is found wrong”.
WHO Director-General Tedros Adhanom Ghebreyesus told reporters on Wednesday that the UN agency is investigating the acute kidney injury deaths with the Indian Medicines Agency and the drug manufacturer.
The agency informed the Drugs Controller General of India of the deaths late last month, prompting the regulator, along with the WHO, to launch an investigation into state agencies.
However, Naresh Kumar Goyal, a director at Maiden, told Reuters the company only found out about the deaths on Thursday morning and is trying to find out details.
“We’re trying to figure out the situation because it just surfaced today,” he said over the phone. “We’re trying to work out with the buyer and all that exactly what happened. We don’t sell anything in India.” He declined to speak further.
Maiden, which began operations in November 1990, only produced and exported the syrup to The Gambia, India’s Health Ministry said. Maiden says on its website that it has two manufacturing facilities in Kundli and Panipat, both near New Delhi in Haryana, and has recently set up another one.
Maiden has an annual production capacity of 2.2 million bottles of syrup, 600 million capsules, 18 million injections, 300,000 tubes of ointment and 1.2 billion tablets.
Maiden says on its website that it sells its products domestically and exports to countries in Asia, Africa and Latin America, although Goyal said they don’t currently sell in India.
The Health Ministry said importing countries usually test such products before allowing their use.
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Reporting by Krishna N. Das in New Delhi; Writing by Shilpa Jamkhandikar; Edited by Robert Birsel, Mark Porter and Edwina Gibbs
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