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India awaits information from WHO on any link between cough syrup and deaths in Gambia

NEW DELHI, Oct 6 (Reuters) – India is awaiting proof from the World Health Organization of a link between an Indian cough syrup and the deaths of dozens of children in The Gambia after the agency United Nations said the drug could cause kidney damage, 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.

“An urgent investigation into the matter has already been initiated (…) immediately after receiving a communication from the WHO based on the information available,” said one of the two health ministry staff who spoke to Reuters on behalf of the ministry but did not want to be identified.

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“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.

WHO Director-General Tedros Adhanom Ghebreyesus told reporters on Wednesday that the UN agency was investigating deaths from acute kidney injury with India’s drugs regulator and cough syrup maker based in India. New Delhi, Maiden Pharmaceuticals.

The UN health 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 sources said.

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.

Telephone calls to a number listed for Maiden, which launched operations in November 1990, went unanswered, as did an email request for comment. Appeals to India’s Drug Controller General also went unanswered.

Maiden 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. She says she sells her products locally and exports to countries in Asia, Africa and Latin America.

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.

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Reporting by Krishna N. Das in New Delhi; Written by Shilpa Jamkhandikar; Editing by Christopher Cushing, Robert Birsel

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