Geneva: The World Health Organization (WHO) issued an alert Wednesday over four cough and cold syrups made by Maiden Pharmaceuticals in India, warning they could be linked to the deaths of 66 children in The Gambia.
The UN health agency also cautioned that the contaminated medications may have been distributed outside of the West African country, with global exposure "possible."
WHO chief Tedros Adhanom Ghebreyesus told reporters that the four cold and cough syrups in question "have been potentially linked with acute kidney injuries and 66 deaths among children."
"The loss of these young lives is beyond heartbreaking for their families."
Tedros said that WHO was also "conducting further investigation with the company and regulatory authorities in India."
According to the medical product alert issued by WHO Wednesday, the four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
"To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products," the alert said, adding that laboratory analysis of samples of the products "confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants."
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.
Symptoms and other details
Those substances are toxic to humans and can be fatal, it said, adding that the toxic effect "can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death."
The Gambia's health ministry asked hospitals last month to stop using a syrup paracetamol, pending the outcome of an investigation, after at least 28 children died of kidney failure.
WHO said that information received from India's Central Drugs Standard Control Organisation indicated that the manufacturer had only supplied the contaminated medications to The Gambia.
"However, the supply of these products through informal or unregulated markets to other countries in Africa, cannot be ruled out," the UN agency said in an email.
"In addition, the manufacturer may have used the same contaminated material in other products and distributed them locally or exported," it warned.
"Global exposure is therefore possible."
Tedros urged caution, calling on all countries to work to "detect and remove these products from circulation to prevent further harm to patients."
The Gambian health ministry's advice on syrup paracetamol was issued on September 9, a month after investigators reported the death of at least 28 children aged five months to four years from acute renal failure.
The investigation had been opened on July 19. No details were given as to when the children died.
India investigating deaths
India is investigating the deaths of dozens of children in Gambia linked to the use of an India-made cough syrup, two federal health ministry sources told Reuters on Thursday.
The sources said the Indian government had asked the WHO to share the report establishing causal relation to death with the cough syrup.
The Central Drugs Standard Control Organisation(CDSCO) took up the matter immediately and further investigation was launched, "CDSCO while responding to WHO within an hour and a half, took up the matter immediately thereafter with the concerned State Regulatory Authority, under whose jurisdiction the drug manufacturing unit is located.
Further, a detailed investigation was launched to ascertain the facts/ details in the matter in collaboration with State Drugs Controller, Haryana (the concerned State Drug Control Authority), said sources.
From the preliminary enquiry, it has been made out that Maiden Pharmaceutical Limited, Sonipat, Haryana is a manufacturer licensed by the State Drug Controller for the products under reference, and holds manufacturing permission for these products. The company has manufactured and exported these products only to The Gambia so far.
India awaits WHO information
"While all required steps will be taken in the matter", India was awaiting a report establishing "causal relation to death with the medical products in question" and other details 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.
'No supply in India'
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 state, 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.
Gambia urgently recalls syrups
Gambia has launched an urgent door-to-door campaign to remove cough and cold syrups blamed for the deaths. Teaming up with the Gambia Red Cross Society, the Ministry of Health has dispatched hundreds of young people to collect the suspect syrups through a house-to-house campaign.
Gambia's Medical Research Council has also issued an alarm.
"Over the last week, we admitted a child with this condition (acute kidney injury) ... and she has unfortunately died. We were able to confirm that she had taken one of the drugs that is suspected to be causing this, prior to her arrival at our clinic. It had been bought at a pharmacy within The Gambia," the council said in a statement.
"The drug has been identified as containing a significant amount of a toxin which damages kidneys irreversibly."