WHO alert over contaminated medicines made in Pakistan 

Dangerous contaminants have been identified in syrup and suspension medicines manufactured by Pharmix Laboratories in Pakistan, leading the World Health Organization (WHO) to issue a medical product alert.

WHO’s Medical Product Alert No. 8/2023 highlights the presence of substandard (contaminated) syrup and suspension medicines across its various regions.

The initial detection occurred in the Maldives and Pakistan, and subsequent findings expanded to include Belize, Fiji, and the Lao People’s Democratic Republic.

Five distinct products—ALERGO Syrup, EMIDONE Suspension, MUCORID Syrup, ULCOFIN Suspension, and ZINCELL Syrup—comprising a total of 23 affected batches, have been linked to the issue.

All these products are produced by Pharmix Laboratories (Pvt.) Ltd in Pakistan.

In November 2023, the Maldives Food and Drug Authority (MFDA) discovered alarming levels of diethylene glycol and ethylene glycol contaminants in five batches of ALERGO syrup.

Diethylene glycol and ethylene glycol ingestion can be fatal, leading to toxic effects such as abdominal pain, vomiting, diarrhea, altered mental state, and acute kidney injury.

Confirmatory testing by the Therapeutic Goods Administration of Australia verified contamination levels surpassing acceptable limits.

In response, the Drug Regulatory Authority of Pakistan (Drap) conducted an inspection of Pharmix Laboratories, expressing concerns about potential contaminants in other products and batches from the same manufacturer.

As a precautionary measure, Drap directed Pharmix Laboratories to halt the production of all oral liquid dosage medicines. On November 16, 2023, Drap issued a Recall Alert for the mentioned five syrup medicines.

Although WHO has not received reports of adverse effects associated with these products, it strongly recommends avoiding the consumption of the affected items.

WHO advises heightened vigilance and testing for oral liquid dosage medicines manufactured by Pharmix Laboratories between December 2021 and December 2022. Regulatory authorities, healthcare professionals, and the public are encouraged to report any adverse reactions or discoveries of substandard products to their national authorities and WHO.

Manufacturers of liquid dosage forms containing substance susceptible to ethylene glycol and diethylene glycol contamination are urged to adhere to Good Manufacturing Practices (GMP) and conduct thorough testing of the same before using them in medicine production.

This alert is the eighth in 2023, following previous warnings on contaminated liquid dosage medicines (Medical Product Alert No. 6/2022, Medical Product Alert No. 7/2022, Medical Product Alert No. 1/2023, Medical Product Alert No. 4/2023, Medical Product Alert No. 5/2023, and Medical Product Alert No. 6/2023).