JAKARTA - India is awaiting World Health Organization evidence of a link between a cough syrup made by one of the country's companies and the deaths of dozens of children in the Gambia after the UN agency said the drug could cause kidney damage, two Indian officials said Thursday.
The deaths of 66 children in the West African country shocked India as the 'world's pharmacy' that supplies medicines to all continents, especially Africa.
"An urgent investigation into this matter was carried out immediately after receiving the communication from WHO based on available information", said one of the two health ministry staff members who spoke to Reuters on behalf of the ministry, but asked not to be named. identified, as reported on October 6.
"While all necessary steps will be taken in this matter", India is awaiting a report establishing a "causal relationship with death with the medical product in question" and other details from WHO.
Earlier, WHO Director-General Tedros Adhanom Ghebreyesus on Wednesday told reporters the UN agency was investigating deaths from acute kidney injury, with India's drug regulator and New Delhi-based cough syrup manufacturer Maiden Pharmaceuticals.
The UN health agency notified India's Drug Controller of the deaths late last month, after regulators launched an investigation with state authorities, together with the WHO, two sources said.
The WHO said laboratory analysis of Maiden's cough syrup had confirmed "unacceptable" amounts of diethylene glycol and ethylene glycol, which can be toxic and cause acute kidney injury.
Phone calls to the number registered to Maiden, which launched its operations in November 1990, went unanswered as did requests for comment via email. Calls to Drugs Controller General India also went unanswered.
Maiden produces and exports the syrup only to the Gambia, an Indian ministry source said. Maiden says on its website it has two factories, in Kundli and Panipat, both near New Delhi in the state of Haryana, and recently set up another one.
It 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. It is said to sell its products domestically and export to countries in Asia, Africa, and Latin America.
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Two health ministry sources said importing countries usually test the product before allowing its use.
The WHO said Maiden's products, Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup, may have been distributed elsewhere through informal markets but were identified only in The Gambia.
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