ISLAMABAD: The Drug Regulatory Authority of Pakistan (Drap) has issued a directive instructing its regulatory field force to confiscate a batch of allegedly contaminated Propylene Glycol (Batch # 1P03-202308194) reportedly produced by M/s Shinghwa Amperex Technology (Dongying), China, advising the pharmaceutical industry to stop using the raw material imported under this batch due to serious health hazards.
In an advisory, Drap has also urged the therapeutic goods industry, manufacturers of oral liquid preparations, and healthcare professionals to exercise vigilance regarding products manufactured with the aforementioned imported raw material batch.
Elaborating on the risks involved, Drap says that propylene glycol contaminated with diethylene glycol (DEG) and ethylene glycol (EG), when utilized in oral liquid preparations, poses severe health risks. Upon ingestion, EG and DEG can undergo metabolic conversion into toxic substances, impacting the central nervous system and heart functions. Ingestion of such contaminated substances may also lead to kidney damage, potentially resulting in fatal outcomes.
The regulatory field force has been instructed to take immediate action concerning the contaminated batch of propylene glycol and is currently conducting a thorough investigation into the entire supply chain associated with this batch.
Drug manufacturers have been directed to initiate a recall of any finished products manufactured utilizing the same lot of propylene glycol. Furthermore, the regulatory field force has been mandated to seize all oral preparations made with the aforementioned batch of propylene glycol if found in the market.