The World Health Organization (WHO), which has issued product alerts for at least three Made-in-India cough and cold medications since October, is investigating more products. While the global agency has not yet expanded the list of medical product alerts, it said this might change as it receives more information.
“To date, this situation has impacted more than 20 products with two countries of origin (India and Indonesia) and more than 15 different manufacturers. All the products are syrup-based (paracetamol syrup, cough syrup, or vitamin syrup),” said Margaret Harris, spokesperson for WHO.
She added that WHO takes all reports of substandard or falsified medical products very seriously. “WHO is aware of media reporting of potentially contaminated syrups in other countries than those listed above.
While investigations are ongoing, WHO has not expanded its list of medical product alerts. This may change as we receive more information,” said Harris.
The WHO director-general issued a call to action in January to implore all member states to increase their surveillance and testing efforts because people are ‘needlessly being put at risk’.
“The world needs to do more to protect its citizens. Our investigations with the impacted countries are ongoing,” Harris said in an emailed response.
Maiden Pharmaceuticals in Haryana was the first to come under WHO scanner for ‘substandard’ cough syrup, and WHO issued a product alert in October last year.
In January, an alert was issued against Marion Biotech of Uttar Pradesh for ‘unacceptable amounts of diethylene glycol and/or ethylene glycol as contaminants’.
In April, a ‘substandard’ batch of Guaifenesin syrup made by Punjab-based QP PharmaChem was identified in the Marshall Islands and Micronesia.
Guaifenesin is an expectorant used to relieve chest congestion and the symptoms of coughing. WHO had said that samples from the Marshall Islands were analysed by quality control laboratories of the Therapeutic Goods Administration of Australia.
“The analysis found that the product contained unacceptable amounts of diethylene glycol and ethylene glycol as contaminants,” it had said.
Harris said that there are historical incidences of product contamination with diethylene glycol or ethylene glycol dating back to the 1930s.
“Diethylene glycol and ethylene glycol are toxic substances and should not be present in human medicines,” she added.
She further added that the recent spate of contaminated medicines began with reports in July–October 2022 in The Gambia, with subsequent reports in Indonesia, Uzbekistan, Micronesia, and the Marshall Islands. These all warrant WHO Medical Product Alerts.
Harris said that alerts are issued when a situation requires action.
“WHO issues such alerts when it has sufficient evidence to demonstrate that a product is contaminated. This is determined by product analysis by the impacted country, the manufacturing country, or the manufacturer. In some cases, countries ask for the help of WHO laboratories to conduct an analysis. WHO relies on the network of member states, their national regulatory agencies, and ministries of health to share information and act on alerts issued by WHO,” she explained.
The role of WHO in this situation is to record the report, assess the public health risk posed by the contaminated product, and communicate the risk to regulators and other stakeholders, as well as the public and patients, in a bid to detect and remove the product from circulation, the agency said.
Union Health Minister Mansukh Mandaviya said earlier this week that India has already started a risk-based assessment of site manufacturing and has a zero-tolerance approach towards any sort of callousness towards quality.
India has also asked for cough syrup batches to be tested by Central Drug Testing Laboratories before exporting.