The SA Health Products Regulatory Authority (SAHPRA) has issued a warning against contaminated baby products linked to the deaths of dozens of babies in The Gambia.
The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup, all produced by Indian company Maiden Pharmaceuticals in New Delhi, reports News24.
SAHPRA CEO Dr Boitumelo Semete-Makokotlela said the regulator would work with law enforcement to remove any of these products on local shelves.
This comes as Indonesia's health authorities today announced that it will investigate cases of acute kidney injury which has caused the deaths of more than 20 children in its capital Jakarta this year.
Indonesia will co-ordinate with investigators from the World Health Organisation (WHO) that have found “unacceptable” levels of diethylene glycol and ethylene glycol, which can be toxic, in the four products made by Maiden Pharmaceuticals, according to a Reuters report in the BusinessLIVE site.
Indonesia’s drug regulator, known as BPOM, said in a statement the syrups weren’t registered in the country.
Its Health Ministry said it was talking to experts from the WHO that are investigating the case in Gambia and it has formed a team with the country’s paediatric association and a Jakarta-based hospital to look into the cases.
It said the illness had infected 40 children across the country so far but didn’t say when the cases were first reported.
The Health Ministry said early findings point to potential intoxication as a cause of the illness, but no definitive cause has been found yet. The ministry said further research was needed.
Indian authorities today said they found 12 violations of good practices at a factory of Maiden and halted production of cough syrups at the plant.
The WHO added the products did not meet quality standards and the pharmaceutical company had failed to assure it of their safety.
It cautioned the products might have been distributed to other countries illegally.
"If you have these substandard products, please do not use them. If you, or someone you know, have used these products, or suffered any adverse reaction or event after use, you are advised to seek immediate medical advice from a qualified healthcare professional and report the incident to the national regulatory authority," said the WHO.
India is still awaiting information from the WHO on any links between the deaths of the children and the cough mixture, officials said last week.
Last month, MedicalBrief ran a Reuters report saying the West African country’s government was investigating the deaths of (at that stage 28) children from kidney failure, with possible links to a paracetamol syrup, but which might also possibly be associated with E.coli bacteria, The Gambia’s health director said at the time.
The numbers have now risen to 66 children, and are a blow to India’s image as a “pharmacy of the world” that supplies medicines to all continents, especially Africa.
“Urgent investigation has already started," said a Gambian Health Ministry employee.
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, said it only heard about the deaths last Thursday and were trying to find out details.
WHO Director-General Tedros Adhanom Ghebreyesus said it was investigating the deaths from acute kidney injuries with India’s drug regulator and the drug maker, and that 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.
Maiden, which launched its operations in November 1990, manufactured and exported the syrup only to The Gambia, the Indian Ministry sources said. The company has two manufacturing plants, both near New Delhi, and has recently set up another one.
It has an annual production capacity of 2.2m syrup bottles, 600m capsules, 18m injections, 300 000 ointment tubes and 1.2bn tablets.
The Health Ministry source said that importing countries typically test such products before allowing their use.
BusinessLIVE – indonesia-probes-coughs-syrups-linked-to-deaths-of-children/
See more from MedicalBrief archives:
Children’s deaths in The Gambia linked to either paracetamol or E.coli
7 African countries sign agreement criminalising fake medicine
Results from 7-country project highlights the need for new vaccines