ISLAMABAD The Drug Regulatory Authority of Pakistan (DRAP) recalled cough syrup and imported raw material used in it on Thursday, The News said, after “poisonous impurities” were found.
According to officials cited in the article, the cough medication tested positive for “poisonous impurities” at the Central Drug Testing Lab (CDL) in Karachi.
According to DRAP officials, a local company imported propylene glycol from Thailand and supplied it to various pharmaceutical companies across the nation for the production of cough syrups, which are in high demand right now due to the country’s influenza and other respiratory illness outbreak.
“We have issued a recall order for Delorvin Syrup and Propylene Glycol, a raw ingredient used to make cough syrup, today.
The cough syrup and the raw material utilized in it were found to contain toxic levels of two deadly contaminants, namely ethylene glycol (EG) and diethylene glycol (EG), during testing, a senior DRAP officer informed The News.
Along with recalling the cough syrup and raw materials used to make it, DRAP officials also started a nationwide probe to find the importer who supplied the raw materials to various pharmaceutical companies and find out which businesses were using the “substandard” raw materials.
According to experts, propylene glycol is used as an excipient or non-active pharmaceutical ingredient in the production of syrups, particularly cough syrups. However, some companies attempt to use industrial-grade propylene glycol, which contains “poisonous levels” of ethylene and diethylene glycol and is therefore unsafe for human consumption.
Since some Indian companies began exporting cough syrups containing toxic impurities, such as EG and DEG, hundreds of children have perished in various countries. A few weeks ago, the World Health Organization (WHO) also discovered cough syrups made by a pharmaceutical company based in Lahore in the Maldives and several other countries.
According to DRAP officials, a pharmaceutical company contacted the drug regulatory body directly to request that the cough syrup be examined for toxins.
In response to a question, a senior representative from DRAP stated that all pharmaceutical companies were required to test all of their raw materials—both active and inactive—for contaminants to ensure patient safety. The official also mentioned that DRAP was initiating “risk-based sampling and testing” for newly imported raw materials. The DRAP official responded that some of the companies would face legal action since they were discovered to have engaged in illegal activities when asked why criminal proceedings were not being initiated against the makers and importers.
In this new case, we believe that an intermediary brought raw materials from a reliable source in Thailand, then mixed them with industrial-grade materials to make them more plentiful and give them to the makers.In addition to recalling the raw material that this middleman imported, we will also file a criminal complaint in the event that further investigation reveals any wrongdoing,” the official stated.
