The death of at least 69 children in The Gambia over the past several months due to consumption of contaminated cough syrups has rattled international health experts.
The children were less than five years in age and many of them were infants. Around the world, parents regularly resort to using syrups bought over-the-counter when their kids have fever, sore throats or coughs.
Doctors no longer recommend cough syrups as medical evidence has found them to be unhelpful in treating underlying causes for cough or fever in children.
“In my practice, I didn’t prescribe cough syrups or suppressants. Generally speaking, the evidence of such cough suppressants being useful for children is very weak. We would prescribe just simple honey and lemon as an alternative,” says Emmanuel Agogo, a Nigeria-based health expert.
“The syrups don’t help in making the child better,” he tells TRT World.
The Gambia, a poor west African country of 2.4 million people, doesn’t have a large medical industry. The syrups were imported from an Indian company Maiden Pharmaceuticals, which had run into quality control issues earlier too.
On October 5, WHO issued a global advisory on the contaminated paediatric medicines.
The four syrups – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup – were all found to contain unacceptable amounts of diethylene glycol (DEG) and ethylene glycol (EG), the health body says.
“From tests conducted here, DEG found in drugs was about 19 percent when it should not be above 0.1 percent,” says Dr. Peter Adebayo Adewuyi, Resident Advisor, Gambia’s Field Epidemiology Training Programme.
“That’s many times the quantity of DEG that should have been there,” he tells TRT World.
For almost a century, DEG–a viscous, sweet chemical–has been known to cause mass poisonings when mixed with medicines. In most of the cases, like what happened in The Gambia, people taking a high dose of DEG suffer kidney failure and die within a few days.
Yet, from time to time the poisonous substance has found its way into medicines in countries ranging from Bangladesh to Haiti and ended up killing scores of unsuspecting patients.
The Food and Drug Administration (FDA), the American regulator whose advisories on medicines are heeded by governments around the world, was, in fact, created in the 1930s as a result of deaths involving DEG.
A solution for deaths
The first well-documented mass poisoning incident involving DEG occurred in 1937 in the US.
An antibacterial drug in liquid form, called Elixir of Sulfanilamide, was sold in the market without any prior testing. Around 105 people, among them 34 children, died within days of taking a few teaspoonfuls of the medicine.
The outcry over the mass deaths forced the government to introduce the Federal Food, Drug and Cosmetic Act of 1938, which allowed the FDA to check medicines and medical equipment before they can be sold to consumers.
Since then hundreds of deaths traced to DEG in medicines have been recorded elsewhere.
DEG is generally used in industrial products such as brake fluids, resins, inks, cosmetics and antifreeze agents.
Some drug companies mistakenly or by design mix DEG as a diluent in liquid medicines to save money in place of costlier medicinal glycerine or polyethene glycol (PEG).
“Criminals can therefore make a profit by obtaining DEG and mislabelling and selling it as PEG or glycerine,” Dr Joel Selanikio, a US-based physician who has worked as a consultant for the World Health Organisation (WHO), tells TRT World.
The syrups are easily available and sold over the counter at local pharmacies.
“We do have a catch-22 situation where there's dwindling access to health services across Africa and the first port of call for most people are pharmacies and chemists. So these people do most of the prescribing,” says Agogo, who is also a 2021 ACDC Kofi Anan Fellow.
The Indian government has assured that the contaminated products were only manufactured for The Gambian market. But WHO warns that some of the bottles might have been smuggled to other countries.
Weak controls
The Haryana-based Maiden Pharmaceuticals, at the centre of The Gambia deaths, is no stranger to controversy.
The company faced a ban in the Indian state of Bihar and was penalised for selling substandard products elsewhere. It’s among 39 drugmakers, that Vietnam has blacklisted, says a Times of India report.
While Maiden says it’s “shocked” over the incident, Indian authorities along with the WHO is investigating how such a dangerous quantity of DEG might have ended up in the syrups.
“Standard equipment used for pharmaceutical quality control, such as mass spectroscopy, can easily detect the difference between DEG and PEG — if it is used correctly,” says Dr Selanikio.
“No reputable company would ever knowingly use DEG, or glycerine that was highly contaminated with DEG. If they are found to have used high levels of DEG, there is most likely to be negligence: very poor quality control that does not detect DEG labelled, for example, as PEG.”
More often it’s weak quality controls at the manufacturing plant where the drug is made than a deliberate ploy that leads to contamination.
The Gambian authorities are also under fire for not running tests on the imported medicines, which are mostly sold over the counter.
Despite repeated attempts, Markieu Janneh Kaira, the Executive Director of Medicines Control Agency, Gambia’s drug regulator, didn’t respond to TRT World’s calls or messages.
The Gambia does not have its own laboratory to run checks on medicines.
“In any case, it’s not practically possible to run quality tests on every drug that’s imported. Not even the US has the resources to do that,” says Dr Adewuyi.
