ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP),Tuesday, directed the regulatory field force to confiscate contaminated Propylne Glycol (Batch # 1P03-202308194) allegedly produced by M/s Shinghwa Amperex Technology (Dongying) China and advised Pakistan’s pharmaceutical industry to stop using the raw material imported under the batch owing to serious health risks.
In an advisory issued here, the DRAP also directed the therapeutic goods industry, manufacturers of oral liquid preparations, and healthcare professionals to remain alert of the products manufactured by the above imported raw material batch.
Explaining the risk statement, the authority said that di-ethylene glycol (DEG) and ethylene glycol (EG) contaminated propylene glycol (PG) when used in oral liquid preparations can lead to serious health risks. When ingested, EG and DEG are converted into toxic metabolites that can affect the central nervous system and heart.
Moreover, it can also cause kidney damage which may lead to fatal consequences.
The regulatory field force has been directed to take necessary action on above mentioned contaminated batch of PG and is investigating the entire supply chain of this batch. The therapeutic goods manufacturer has been instructed to recall any finished products that were manufactured using the same lot of propylene glycol. The regulatory field force has also been instructed to seize all oral preparations that were made using the same batch of propylene glycol if found in the market.
Copyright Business Recorder, 2024
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