NEW DELHI, Oct 6 (Reuters) – India is awaiting more information from the World Health Organization on any links between an Indian-made cough syrup and the deaths of dozens of children in Gambia, two Indian officials 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 cough syrup was made by New Delhi-based Maiden Pharmaceuticals, the WHO said.
“Urgent investigation in the matter has been already taken up … immediately after receiving communication from WHO based on the available information,” said one of two health ministry staff members who spoke to Reuters on behalf of the ministry but did not want to be identified.
“While all required steps will be taken in the matter”, India was awaiting a report establishing “causal relation to death with the medical products in question” and other details from the WHO.
Naresh Kumar Goyal, a Maiden director, told Reuters 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.
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, the two sources said.
The WHO said laboratory analysis of Maiden cough syrup had confirmed “unacceptable” amounts of diethylene glycol and ethylene glycol, which can be toxic and lead to acute kidney injury.
Maiden, which launched its operations in November 1990, manufactured and exported the syrup only to Gambia, the Indian ministry sources said. Maiden says on its website it has two manufacturing plants, in Kundli and Panipat, both near New Delhi in Haryana state, and has 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.
Maiden says on its website it sells its products at home and exports to countries in Asia, Africa and Latin America, though Goyal said they were not currently selling in India.
The two health ministry sources said that importing countries typically test such products before allowing their use.
The WHO said the Maiden 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 it had only been identified in Gambia.
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