ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) has recalled a cough syrup and the imported raw material used in it after finding “poisonous impurities”, The News reported on Thursday.
“Poisonous impurities” were detected in the cough syrup during testing at the Central Drug Testing Lab (CDL) Karachi, the publication quoted officials as saying.
The raw material, propylene glycol, was imported by a local firm from Thailand and supplied to various pharmaceutical companies across the country for the production of cough syrups, which are currently in high demand due to the outbreak of influenza and other respiratory diseases in the country, DRAP officials added.
“Today we ordered the recall of Delorvin syrup and propylene glycol, the raw material used in the production of cough syrup. During the testing, the cough syrup and its raw material used poisonous amounts of two deadly impurities i.e. Ethylene Glycol (EG) and Diethylene Glycol (EG), a senior DRAP official told The News.
In addition to the recall of the cough syrup and the raw materials used in the production of the syrup, DRAP officials have launched a nationwide investigation to identify the importer who provided the raw material to various pharmaceutical companies and to identify the companies that used the “substandard” raw material.
Propylene glycol is used as an excipient or inactive pharmaceutical ingredient in the production of syrups, especially cough syrups, experts said, adding that some companies were trying to use industrial propylene glycol, which was unsafe for human consumption because it contained “toxic levels” of ethylene glycol and diethylene glycol.
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Hundreds of children have so far died in many countries after some Indian companies exported cough syrups containing poisonous impurities, including EG and DEG, while a few weeks ago some cough syrups produced by a Lahore-based pharmaceutical company were also exposed by World Health Organization (WHO) in Maldives and some other countries of the world.
The DRAP official claimed that the pharmaceutical firm itself had approached the drug control authority to get the cough syrup tested for poisonous impurities and when the prepared batch of cough syrup and raw material was tested at CDL Karachi, it was found to be substandard and contain poisonous substances. impurities.
When asked, a senior DRAP official said that every pharmaceutical company should have tested all active and inactive ingredients for impurities for patient safety, adding that DRAP was also starting “risk-based sampling and testing” of ingredients. imported into the country. When asked why criminal proceedings were not initiated against manufacturers and importers, the DRAP official said that some companies would be prosecuted because they were found to be involved in criminal activities.
“In this new case, we suspect that some intermediary imported the raw material from an authentic source in Thailand, but later added industrial grade to it to increase its quantity and provided it to manufacturers. Not only are we withdrawing the raw material imported through this middleman, but we also intend to file a criminal complaint if the investigation proves any wrongdoing,” the official added.
