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India awaits information from WHO on any link between cough syrup and deaths in Gambia, Health News, ET HealthWorld

New Delhi: India is awaiting more information from the World Health Organization on any link between an Indian-made cough syrup and the deaths of dozens of children in The Gambia, two Indian officials said on Thursday.

The death of 66 children in the West African country is a blow to India’s image as the “pharmacy of the world” which supplies medicines to all continents, especially Africa. The cough syrup was made by New Delhi-based Maiden Pharmaceuticals, the WHO said.

“An urgent investigation into the matter has already been undertaken immediately after receiving a communication from the WHO based on the information available,” said one of the two Health Ministry staff members who spoke to Reuters at name of the ministry but did not want to be identified.

“While all required action will be taken in the matter,” India was awaiting a report establishing “a causal link to the death with the medical products in question” and other details from the WHO.

Naresh Kumar Goyal, a director of Maiden, told Reuters he only heard of the deaths on Thursday morning and was trying to find out details.

“We are trying to find out the situation because it only emerged today,” he said by telephone. “We are trying to find out with the buyer and everything exactly what happened. We are not selling anything in India.”

He refused to speak further.

WHO Director-General Tedros Adhanom Ghebreyesus told reporters on Wednesday that the UN agency was investigating the deaths from acute kidney injury with India’s drug regulator and the drugmaker.

The agency notified India’s drug controller general of the deaths late last month, after which the regulator launched an investigation with state authorities, in collaboration with the WHO, the two said. sources.

The WHO said laboratory analysis of Maiden cough syrup confirmed “unacceptable” amounts of diethylene glycol and ethylene glycol, which can be toxic and lead to acute kidney injury.

Maiden, which started operations in November 1990, manufactured and exported the syrup only to Gambia, Indian ministry sources said. Maiden says on its website that it has two manufacturing plants, in Kundli and Panipat, both near New Delhi in the state of Haryana, and has recently set up another.

It has an annual production capacity of 2.2 million bottles of syrup, 600 million capsules, 18 million injections, 300,000 tubes of ointment and 1.2 billion tablets.

Maiden says on its website that it sells its products in its country and exports to countries in Asia, Africa and Latin America, although Goyal said they do not currently sell in India.

The two Health Ministry sources said importing countries usually test these products before authorizing 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 they have only been identified in Gambia.