NEW DELHI, Oct 6 (Reuters) – India said it was testing samples of cough syrups made by local maker Maiden Pharmaceuticals for export after the World Health Organization said their products were linked to the deaths of dozens of children in Gambia.
The death of 66 children in the West African country could deal a major blow to India’s image as the “pharmacy of the world”.
The WHO said this week that laboratory analysis of four Maiden products – Promethazine Oral Solution, Kofexmalin Baby cough syrup, Makoff Baby cough syrup and Magrip N cold syrup – confirmed that diethylene glycol and ethylene glycol, which can be toxic and lead, were “unacceptable”. for acute kidney injury.
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Diethylene glycol and ethylene glycol are used in antifreeze and brake fluids and other industrial applications, as well as in some pharmaceutical products as a cheaper alternative to glycerin, the solubilizing or thickening agent in many cough syrups.
India’s health ministry said samples of all four products exported to Gambia had been sent to a federal laboratory for testing and the results “will guide future course of action and also clarify inputs received/to be received from WHO.”
It asked the WHO to share its report on “establishing a causal link to the death with the medical products in question”.
WHO spokeswoman Margaret Harris did not directly respond to a Reuters query about when the report would be shared with the health ministry.
However, a statement from Maiden and the director of India’s Central Medicines and Standards Control Authority said authorities “have visited the company’s factories to investigate this particular incident and await the findings of the WHO”.
Anil Vij, the health minister of Haryana state, where Maiden has factories, warned of “severe action if anything wrong is found” after the tests.
WHO Director General Tedros Adhanom Ghebreyesus told reporters The UN agency said on Wednesday it was investigating deaths from acute kidney injury with India’s drug regulator and the drug’s maker.
The agency reported the deaths to India’s Drug Controller General late last month, after which the regulator launched an investigation with government authorities along with the WHO.
Girl CEO Naresh Kumar Goyal told Reuters the company only heard about the deaths on Thursday morning and was trying to find out the details.
“We’re trying to figure out the situation because it just came up today,” he said by phone. “We are trying to find out exactly what happened with the buyer. We are not selling anything in India.” I refused to talk further.
The Ministry of Health of India said that Maiden, which started operating in November 1990, only produces and exports the syrup to Gambia. Maiden says on its website that it has two manufacturing plants in Haryana, in Kundli and Panipat, near New Delhi, and has recently set up another plant.
Maiden has an annual production capacity of 2.2 million syrup bottles, 600 million capsules, 18 million injections, 300 thousand ointment tubes and 1.2 billion tablets.
On its website, Maiden sells its products domestically and exports to countries in Asia, Africa and Latin America, although Goyal said they do not currently sell in India.
The Ministry of Health said that importing countries usually test such products before using them.
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Reporting by Krishna N. Das in New Delhi; Written by Shilpa Jamkhandikar; Edited by Robert Birsel, Mark Porter, and Edwina Gibbs
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