ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) has taken decisive action following the discovery of “poisonous impurities” in cough syrup and its imported raw material.
The hazardous impurities were identified during testing at the Central Drug Testing Lab (CDL) in Karachi, according to officials. The raw material, Propylene Glycol, imported from Thailand by a local firm, was distributed to various pharmaceutical companies across the country for the production of cough syrups.
This move was prompted by the heightened demand for such medications due to the prevalent outbreak of influenza and respiratory illnesses in the country.
The DRAP has initiated a recall of Delorvin Syrup and Propylene Glycol, the implicated raw material. Testing revealed “poisonous amounts” of two lethal impurities, Ethylene Glycol (EG) and Diethylene Glycol (EG), in both the cough syrup and its raw material.
In response, DRAP officials have launched a nationwide investigation to identify the importer responsible for supplying the substandard raw material to various pharmaceutical companies.
Propylene Glycol, typically used as a non-active pharmaceutical ingredient in syrup manufacturing, can pose risks if industrial-grade variants with “poisonous levels” of Ethylene Glycol and Diethylene Glycol are utilized, experts caution.
DRAP officials emphasized that a pharmaceutical firm voluntarily approached the authority to test the cough syrup for impurities. Subsequent testing at CDL Karachi confirmed the substandard quality of the batch, prompting the recall.
Addressing concerns about legal action, a senior DRAP official stated that some companies implicated in criminal activities would face prosecution. The official suspected that a middleman might have imported raw material from a legitimate source in Thailand but later adulterated it with industrial-grade material to increase the quantity.
The DRAP is not only recalling the raw material but also considering criminal proceedings pending the outcome of investigations. The official added that DRAP is introducing “risk-based sampling and testing” for imported raw materials to ensure patient safety.
