ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) has seized a batch of imported pharmaceutical ingredients for having high level of impurities, the reaction to which could be fatal, the regulatory body’s CEO has confirmed.

The acceptable level of impurities in Propylene Glycol (PG) excipient — used in cough syrups — is 1.1 per cent, and any contamination above that level can lead to multiple organ failure.

The batch, imported from Thailand’s Dow Chemical, had an impurity level of 25pc.

The batch was tested at Karachi’s Central Drug Laboratory (CDL) after the importer, M/s MKB Pharmaceuticals (Pvt) Ltd, Peshawar, informed Drap about the impurities.

According to a document issued by Drap, when the impurities, also called ethylene glycol (EG), are ingested, they metabolise into toxins that affect the central nervous system and heart and can cause kidney damage, which can be fatal.

Drap Chief Executive Officer (CEO) Dr Asim Rauf told Dawn that PG is added to Active Pharmaceutical Ingredients (APIs) or raw material to sweeten syrups and is called an excipient instead of API.

“The excipient is used in almost all the cough syrups and syrups given for fever and as pain killers.”

Dr Rauf claimed that the batch of excipients was purchased through a middleman, who is Pakistani.

Drap has reached out to the middleman and sent an e-mail to the Thai company for information about other companies in Pakistan who have been sold the excipient.

“Our team is working to ensure that only safe medicine/syrups reach the patients,” the Drap CEO said, adding that all pharma companies have been directed to get the excipient tested before manufacturing syrups.

Published in Dawn, January 12th, 2024

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