Gambia recalls India-made cough syrups linked to 66 child deaths; Indian govt assures strict action against manufacturer

After the World Health Organization (WHO) said four cold and cough syrups produced by New Delhi-based Maiden Pharmaceuticals were linked to the deaths of dozens of children in Gambia, the Indian government started testing the samples of the cough syrups produced by the company.

"Samples have been sent to a central pharmaceutical laboratory for testing," Anil Vij, the health minister of Haryana state where Maiden has its factories, NDTV reported. "Strict action will be taken if anything is found wrong."

The report said citing two officials of the Union Health Ministry that "required steps" will be taken in the matter as soon as a report establishing "causal relation to death with the medical products in question" from the WHO is received.

Naresh Kumar Goyal, a Maiden director, told news agency 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."

Contaminated syrups not sold in India

The Health Ministry said on Thursday that the products were made only for exports and not sold in India, adding that the 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.

For testing, the samples of all four drugs have been taken from the same batch produced by Maiden Pharmaceuticals for export, the ministry said. The results would "guide further course of action as well as bring clarity on the inputs received/to be received from WHO."

It was importing countries that typically test such products before allowing their use, the ministry added.

The four cough syrups -- Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup -- have been named by WHO in its medical alert.

WHO chief Tedros Adhanom Ghebreyesus told reporters that the four cold and cough syrups under probe may "have been potentially linked with acute kidney injuries and 66 deaths among children."

In its medical alert, the UN agency said that laboratory analysis of samples of the products "confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants," adding that those substances are toxic to humans and can be fatal.

The Gambia's health ministry directed hospitals in the country on September 9 to put a halt to using syrup paracetamol, while an investigation was pending, after the death of at least 28 children due to kidney failure, said the report.

The advisory was issued a month after the investigators reported the deaths, it added. No information was provided when the children died, it said.

According to WHO, the information provided by India's Central Drugs Standard Control Organisation indicated that the manufacturer had only supplied the contaminated medications to The Gambia.

  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.