(GIN)—An epidemic of kidney disease among children in Africa has been linked to deadly toxins in cough medicine imported from India.
Doctors say they are seeing dozens of children under the age of 5 with kidney failure—a condition they used to see only once or twice a year—and mothers are demanding justice.
Global health officials have connected the recent deaths of more than 70 children from the Gambia to cough medicine made in India. But before the item could be yanked from the shelves, time had to be spent on testing or screening for bottles wrongly labeled “World Health Organization.”
Four medicines manufactured by Maiden Pharmaceuticals in Kundli-Haryana have been identified as containing toxins by the World Health Organization (WHO), which issued a global alert. But the company got a clean bill of health from India’s drugs controller general, who said the samples tested were not contaminated with the dangerous compounds.
Regulatory documents reviewed by Reuters showed that Maiden’s manufacturing practices had fallen short at least three times. In one, the company was blacklisted for five years for selling substandard and “spurious” (adulterated) medicine. In another, two drugs manufactured by Maiden were found not to meet quality standards. A third incident involved quality violations in drugs sold in Vietnam.
Gambian pediatrician Vivian Muoneke, a graduate of the University of Nigeria, was sure she was seeing an epidemic of child poisoning due to acute kidney injury. It was determined that the cough syrups were contaminated with ethylene glycol (ET) and diethylene glycol (DEG).
“For us, it was psychological torture,” said Muoneke. “If tests for toxins had been done in late July or early August, a sales ban could have saved dozens of children.”
DEG is used in car brake fluid and radiators. Cats and dogs attracted by its sweetness often die after licking it off the ground, said Leo Schep, a New Zealand toxicologist who published a peer-reviewed paper about DEG poisoning.
“It is like putting cyanide in a bottle of paracetamol (acetaminophen in the U.S.),” Schep said.
Pharmaceutical experts have complained for years about lax oversight of drugs made in India, whose industry supplies nearly half of all generic medicines used in Africa.
The Gambian case appears to be the first documented example of DEG poisoning from imported, rather than domestically produced, medicines, experts from Gambia and the U.S. Centers for Disease Control and Prevention said. The tragedy shows the difficulties faced by a poorly resourced country in identifying and removing harmful products, the experts said.
Gambia is one of Africa’s smallest and poorest countries. It has no pharma industry, no means of testing imported drugs, and just over two dozen pharmacists registered for 2.5 million people.
The syrup, manufactured by Maiden Pharmaceuticals, should be held accountable for exporting contaminated medicine, said a Gambian medical committee. Indian officials have rejected their findings, calling WHO “presumptuous” in blaming the syrups for the deaths of some 300 children.
“The issue is not about proof of causation,” said WHO spokesperson Margaret Harris. The toxins found in the syrups “should never be ingested by human beings. This is of the highest priority for us, to see no more child deaths from something that is so preventable.”
There are growing calls for the resignation of Health Minister Dr. Ahmadou Lamin Samateh, along with prosecution of the importers of the drugs into the country.
“…we need justice, because the victims were innocent children,” said Mariam Kuyateh, mother of infant Musa.
The same products are for sale in Cambodia, the Philippines, East Timor, and Senegal.