India is testing samples of cough syrups produced by Maiden Pharmaceuticals for exports after the World Health Organization said its products were linked to the deaths of dozens of children in Gambia, the country’s health ministry said on Thursday.
The deaths of 66 children in the West African country is a blow to India’s image as a “pharmacy of the world” that supplies medicines to all continents, especially Africa.
The WHO on Wednesday said laboratory analysis of four Maiden products – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup – had confirmed “unacceptable” amounts of diethylene glycol and ethylene glycol, which can be toxic and 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 as a cheaper alternative in some pharmaceutical products.
India’s health ministry said samples of the same batch manufactured by Maiden for all four drugs has been sent for testing to a federal laboratory and the results would “guide further course of action as well as bring clarity on the inputs received/to be received from WHO.”
It asked the WHO to share its report on “establishment of causal relation to death with the medical products in question.”
The WHO did not immediately respond to an emailed request for comment.
Anil Vij, the health minister of Haryana state where Maiden has its factories, warned of “strict action if anything is found wrong” after the tests.
Naresh Kumar Goyal, a Maiden director, told Reuters that it heard about the deaths only on Thursday morning and were trying to find out details.
“We are trying to find out the situation because it cropped up only today,” he said by phone. “We are trying to find out with the buyer and all that what has happened exactly. We are not selling anything in India.” He declined to speak further.
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WHO Director-General Tedros Adhanom Ghebreyesus told reporters on Wednesday that the U.N. agency was investigating the deaths from acute kidney injuries with India’s drug regulator and the drug maker.
The agency informed the Drugs Controller General of India of the deaths late last month after which the regulator launched an investigation with state authorities in tandem with the WHO.
Maiden, which launched its operations in November 1990, manufactured and exported the syrup only to Gambia, the Indian health ministry said. Maiden on its website says it has two manufacturing plants, in Kundli and Panipat, both near New Delhi in Haryana, and has recently set up another one.
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Maiden has an annual production capacity of 2.2 million syrup bottles, 600 million capsules, 18 million injections, 300,000 ointment tubes and 1.2 billion tablets.
Maiden on its website says it sells its products at home and exports to countries in Asia, Africa and Latin America, although Goyal said they were not currently selling in India.
The health ministry said importing countries typically test such products before allowing their use.