Families of Indonesian children who died after consuming contaminated cough mixture have demanded restitution at an Indonesian court, which has started hearing their class-action lawsuit against government agencies and pharmaceutical companies.
At least 200 children have died of acute kidney injury in Indonesia since last year and dozens of cases linked to cough syrup have been reported in The Gambia and Uzbekistan.
Al Jazeera reports that authorities have linked two dangerous ingredients – ethylene glycol and diethylene glycol, found in some syrup-based paracetamol medications – to the deaths.
Twenty-five families are now suing 11 parties, including Indonesia’s health and finance ministries, the country’s drugs regulator, and at least eight pharma companies for the children’s deaths and those left with debilitating injuries.
A lawyer representing the families said his clients wanted compensation of up to 3.4bn rupiah ($224 570), and accountability for what happened to their children.
Ethylene glycol and diethylene glycol are typically found in a manufacturing capacity in paints and dyes. They are used in antifreeze, brake fluids and other industrial applications, but also as a cheaper alternative in some pharmaceutical products to glycerine, a solvent or thickening agent in many cough syrups. The substances can also be toxic and lead to acute kidney injury.
Representatives of the finance ministry and five pharmaceutical companies named in the lawsuit did not respond to requests for comment. Another three companies could not be reached. The country’s drugs regulator said it would respect the ongoing legal process, while the health ministry declined to comment, reports Al Jazeera
Authorities in Indonesia have banned a number of cough syrups and mounted legal action against several pharmaceutical companies whose products contained the dangerous ingredients.
In October, the World Health Organisation said the deaths of nearly 70 children in The Gambia from kidney injuries might be linked to the contaminated cough and cold syrups made by an Indian drug manufacturer.
Indian health authorities said later that they had halted all production of New Delhi-based Maiden Pharmaceuticals after a WHO report that its cough and cold syrups exported to The Gambia might be linked to the deaths.
In December, India launched an investigation into the death of 18 children in Uzbekistan after they had also consumed an Indian-manufactured cough syrup. India’s health ministry said the Central Drugs Standard Control Organisation (CDSCO) – the country’s drug regulatory authority – was communicating with its counterpart in Uzbekistan over the incident.
The World Health Organisation subsequently issued a warning against Indian paediatric cough syrups, labelling them “sub-standard” and saying the manufacturers failed to provide safety guarantees.
At the time, both the IndianGgovernment and the company, Maiden Pharmaceuticals, denied the allegations, says the BBC.
In the alert issues on 12 January by the WHO, the two products involved were manufactured by Marion Biotech, which denied the allegations, and said it “does not agree” with the WHO’s findings and that it was co-operating with investigations by the Indian government.
After the deaths were reported in Uzbekistan, India’s Health Ministry suspended production at the company.
Last week, the food safety department in the state of Uttar Pradesh, where Marion Biotech is based, also suspended the company’s production licence.
IThe WHO said an analysis of the two cough syrups – Ambronol and Dok-1 Max – by the quality control laboratories of Uzbekistan’s Health Ministry found unacceptable amounts of diethylene glycol and/or ethylene glycol.
Both are toxic to humans, said the WHO, warning that the products might have marketing authorisations in other countries in the region. “They may also have been distributed, through informal markets, to other countries,” said the agency.
Marion Biotech told the BBC it had followed “approved processes” while manufacturing the syrup and did not agree with findings that “the residue of ethylene glycol was present in the Doc-1 Max Syrup”.
However, the response did not mention the allegations regarding the second
syrup, Ambronol.
The firm also said 20 000 bottles of 100ml each of the Doc-1 Max cough syrup were supplied to “the entire geography of Uzbekistan” but that “fatalities have only been reported in the geographical locality of Samarkand”.
It added that after recalling the syrup, the firm had received around 1 500 bottles, meaning the “balance have been consumed without any side effects”.
It also indicated that there was “something more to the deaths of the children” rather than “simplistically blaming it on the syrup”.
India is known as the “world’s pharmacy” as it produces a third of the world’s medicines, meeting much of the medical needs of developing countries.
But the industry has been under increased scrutiny after cough syrups made by Indian companies have been linked to children’s deaths in other countries.
Al Jazeera article – Indonesia court hearing into children killed by toxic cough syrup (Open access)
BBC article – Marion biotech: WHO alert against use of Indian cough syrups in Uzbekistan (Open access)
See more from MedicalBrief archives:
Probe into Indian cough syrup link to Gambian children’s deaths
Indonesia revokes firms’ licences after 150 deaths from toxic meds
Children’s deaths in The Gambia linked to either paracetamol or E.coli