NEW DELHI: India is testing samples of cough syrups produced by Maiden Pharmaceuticals after the World Health Organization WHO said its products are 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 reputation as a pharmacy of the world that supplies medicines to all continents, especially Africa. The WHO said cough syrup was made by New Delhi-based Maiden Pharmaceuticals.
Anil Vij, health minister of Haryana state where Maiden has its factories, told reporters that samples were sent to a central pharmaceutical laboratory for testing. If something is wrong, strict action will be taken. The federal health ministry would take all necessary 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 was trying to find out details.
He said that we are trying to find out the situation because it only came up today, and that we are trying to find out the situation. We are trying to find out about the buyer and all that happened. We are not selling anything in India. He didn't want to speak further.
WHO Director-General Tedros Adhanom Ghebreyesus told reporters on Wednesday that the UN agency was investigating the deaths from acute kidney injuries with India's drug regulator and drug maker.
The Drugs Controller General of India informed the Drugs Controller General of India of the deaths last month, after the regulators launched an investigation with state authorities, in conjunction with the WHO, the two India health ministry sources said.
The ministry hasn't 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.
The Indian ministry sources said that Maiden, which launched its operations in November 1990, only made and exported the syrup to Gambia. Maiden says 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 it sells its products from home and exports to countries in Asia, Africa and Latin America, though Goyal said they were not currently selling in India.
Two health ministry sources said that importing countries usually test such products before allowing their use.
The WHO said that the Maiden products - Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup - may have been distributed through informal markets, but they had only been identified in Gambia.