Samples of cough syrups linked by the World Health Organization to the deaths of dozens of children in the Gambia have been sent for tests, the Health Ministry said on Thursday, underlining that the products were made only for exports and not sold in India.
The ministry said samples of the same batch manufactured by Haryana-based Maiden Pharmaceuticals for all four drugs have been sent for testing to a laboratory and the results would "guide further course of action as well as bring clarity on the inputs received/to be received from WHO."
Asking the WHO to share its report on "establishment of causal relation to death with the medical products in question", the ministry said it was importing countries that typically test such products before allowing their use.
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 WHO on Wednesday said laboratory analysis of four Maiden products - Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup - had confirmed "unacceptable" amounts of diethylene glycol and ethylene glycol, which can be toxic and lead to acute kidney injury.
Diethylene glycol and ethylene glycol are used in antifreeze and brake fluids and other industrial applications but also as a cheaper alternative in some pharmaceutical products.
Anil Vij, the health minister of Haryana, where Maiden has its factories, warned of "strict action if anything is found wrong" after the tests.
Naresh Kumar Goyal, a Maiden director, told news agency Reuters that 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 drugmaker.
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.
Maiden, which launched its operations in November 1990, manufactured and exported the syrup only to the Gambia, the Indian health ministry said. Maiden on its website says it has two manufacturing plants, in Kundli and Panipat, both near New Delhi in Haryana, and has recently set up another one.
Maiden 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 on its website says it sells its products at home and exports to countries in Asia, Africa and Latin America, although Goyal said they were not currently selling in India.
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