NEW DELHI, Oct 6 (Reuters) – India said it is testing samples of cough syrup made by local manufacturer Maiden Pharmaceuticals for export, after the World Health Organization said its products were linked to the deaths of dozens of children in The Gambia.
The deaths of 66 children in the West African country could deal a major blow to India’s “pharmacy of the world” image.
WHO said this week that laboratory analysis of four Maiden products (Promethazine Oral Solution, Kofexmalin Infant Cough Syrup, Makoff Infant Cough Syrup and Magrip N Cold Syrup) confirmed “unacceptable” amounts of diethylene glycol and ethylene glycol, which can be toxic and lead. for acute kidney injury.
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Diethylene glycol and ethylene glycol are used in antifreeze and brake fluids and other industrial applications, but are also used in some pharmaceutical products as a cheaper alternative to glycerin, a solvent or thickening agent in many cough syrups.
The Indian health ministry said samples of the four products exported to Gambia were sent to a federal laboratory for testing, and the results “will clarify inputs from/to be received from WHO as well as guide further steps.”
He asked WHO to share his report on “establishing a causal relationship with the medicinal products in question and death”.
WHO spokesperson Margaret Harris did not directly respond to a Reuters question about when the report could be shared with the health ministry.
However, he said information from Maiden and the director of India’s Central Organization for Pharmaceuticals and Standards Control indicates that officials “visited the company’s factories to investigate this particular incident, and WHO is awaiting the findings”.
Anil Vij, the health minister of Haryana state, where Maiden’s factories are located, warned that “strict action should be taken if anything wrong is found” after the tests.
Tedros Adhanom Ghebreyesus, WHO Director-General told reporters He reported Wednesday that the UN agency is investigating deaths from acute kidney injuries with India’s drug regulator and drug producer.
The agency briefed the General Pharmaceutical Controller of India about the deaths late last month, after which the regulator, along with WHO, launched an investigation with state authorities.
Naresh Kumar Goyal, a Maiden executive, told Reuters, however, that the company only heard of the deaths Thursday morning and is trying to learn the details.
“We’re trying to find out the situation because it just came out today,” he said over the phone. “We’re trying to find out exactly what happened with the buyer. We don’t sell anything in India.” He refused to speak further.
The Indian ministry of health said that Maiden, which started operations in November 1990, only produces and exports the syrup to Gambia. Maiden website says it has two manufacturing plants at 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 syrup bottles, 600 million capsules, 18 million injections, 300,000 ointment tubes and 1.2 billion tablets.
Maiden said on its website that it sells its products domestically and exports to countries in Asia, Africa and Latin America, but Goyal does not currently sell in India.
The health ministry said importing countries often test such products before allowing them to be used.
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Report by Krishna N. Das in New Delhi; Post by Shilpa Jamkhandikar; Editing by Robert Birsel, Mark Porter and Edwina Gibbs
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