India vows action, Cough syrup proved to be behind Gambia deaths

NEW DELHI: India is testing samples of cough syrups produced by Maiden Pharmaceuticals after the World Health Organization said its products were linked to the deaths of dozens of children in Gambia, a government official 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.

"Samples have been sent to a central pharmaceutical laboratory for testing," Anil Vij, the health minister of Haryana state where Maiden has its factories, told reporters. "Strict action will be taken if anything is found wrong." The federal health ministry would take all "required steps" in the matter, two officials said, adding that India was awaiting a report establishing "causal relation to death with the medical products in question" 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 India health ministry sources said. The ministry has not issued a statement.

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, 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.