New Delhi says it found no traces of deadly ethylene glycol and diethylene glycol in Maiden Pharmaceuticals drugs.
Authorities in The Gambia have expressed shock and disbelief after New Delhi absolved an Indian pharmaceutical company whose cough syrups allegedly caused the deaths of 69 children in the African country earlier this year.
“It’s unbelievable,” says Dr. Peter Adebayo Adewuyi, Resident Advisor, Gambia’s Field Epidemiology Training Programme, who has been keeping track of the developments.
“The greatest proof we have of the Indian company’s involvement is that since we withdrew its drugs, we haven’t had a single case,” he tells TRT World.
In October, the UN agency said that its investigators found “unacceptable” levels of diethylene glycol and ethylene glycol, which can be toxic and lead to acute kidney injury, in the products manufactured by Maiden Pharma, a company based in the northern Indian state of Haryana.
The Gambia, a West African country of 2.4 million people, doesn’t have a significant medical industry. The syrups were imported from New Delhi-based Maiden Pharmaceuticals, which had run into quality control issues earlier too.
In a letter to the WHO dated December 13, the Drug Controller General of India, V.G. Somani, said they have run tests of the products of Maiden Pharmaceuticals and haven’t detected any traces of ethylene glycol (EG) or diethylene glycol (DEG).
Maiden Pharmaceuticals is now looking forward to reopening its production plant in Sonipat, a city in northern Indian state Haryana, despite reservations of The Gambian authorities.
“I have full faith in Indian regulatory and judiciary processes. I have not done anything wrong,” Maiden Managing Director Naresh Kumar Goyal told Reuters.
Soon after the reports emerged about the deaths of dozens of children, the WHO analysed the syrups and found EG and DEG in them.
An independent board of enquiry constituted by The Gambian government has come to a similar conclusion, an official said. “A report they prepared has been sent to the government.”
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 DEG and EG, the health body says.
At the time, The Gambian authorities had run tests on these syrups and found DEG content in them at 19 percent when it should not have been above 0.1 percent.
DEG–a viscous, sweet chemical–has been known to cause mass poisonings when mixed with medicines for almost a century. In most cases, like 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, 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.
The syrups are readily available and sold over the counter at local pharmacies.
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.