Why has substandard drugs and ethylene glycol contamination become so common
Summary
Experts said the issue of contamination of drugs is so widespread and difficult to identify because of the contamination in supply chains that are obscure and difficult to track.
Another Indian company has come under the scanner for substandard drugs. Nigerian drug regulator, the Nigerian National Food and Drug Administration, indicated that Mumbai-based SyneCare’s paracetamol drug PARA CLEAR SUSPENSION 125 contains the toxic substance, ethylene glycol. The product failed toxicity tests with the death of five lab animals being recorded. No human fatalities were associated with this event.
Reports of drug contamination in the past
SyneCare’s paracetamol joined the list of other Indian company’s whose drugs are said to contain these toxic substances. In the past, Maiden Pharma’s cough syrups was linked to the death of over 65 children in Gambia, while Marion Biotech’s cough syrup was linked to the death of 18 children in Uzbekistan. The Indian government however refuted allegations on Maiden Pharma.
The World Health Organization (WHO) had also issued an alert on a cough syrup manufactured by Punjab-based QP Pharmachem and marketed by Haryana-based Trillium Pharma.
Many instances of contamination with ethylene glycol and Diethylene glycol (DEG) were reportedly recently. As of January 2023, it was linked to at least seven countries and associated with more than 300 fatalities in three of these countries within a few months.
And, while India might have a number of companies which have been caught in the crossfire due to its large presence in the pharmaceutical industry, it is not just Indian companies linked to supplying drugs laced with these toxic substances.
For example, an alert was issued last year for Indonesian-made syrups which had allegedly poisoned more than 200 children in the country. Meanwhile, Cameroon’s health regulator was investigating the death of six children linked to a cough syrup which was reportedly manufactured by China’s Fraken Group.
Why this issue is so widespread
Experts said the issue is so widespread and difficult to identify because of the contamination in supply chains that are obscure and difficult to track. Pharmaceutical manufacturers generally obtain inputs from external suppliers. These inputs, most often than not, go untested, especially by the lower-quality pharma companies.
One theory also suggest that this contamination is because of the hike in prices of the generally-used safe input propylene glycol in 2021. Following the price rise, it was substituted, by some corrupt parties, with toxic alternatives such as ethylene glycol and diethylene glycol.
Some pharma companies too switched from pharma to chemical suppliers. For example, Indonesian authorities said one of the reasons for the contamination was that a local trader was selling the industrial-grade inputs as pharma-grade.
The fear is that there could be more incidents as one cannot track how much of the supply chain is infiltrated when it comes to both the inputs stored at warehouses to the finished products distributed. However, governments and agencies are becoming more proactive.
The WHO urged all countries to step up surveillance and offered support to those who lack resources. The US drug regulator also issued a guidance on testing high-risk drug components. An example of this pro-activeness was the latest case with SyneCare, in which the oral pain killer paracetamol was tested by Nigeria on behalf of Liberia.
India, too, has been turning the screws and cancelled licenses of 18 pharma companies which were allegedly manufacturing spurious drugs. The country also ordered testing of cough syrups at government labs before exporting them. In some instances, the government asked companies to stop procuring inputs from certain companies that supplied to companies linked to recent incidents.
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