ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) Thursday said it had closed down the syrup section of a Pakistani pharmaceutical company last month and recalled all its liquid products after World Health Organisation (WHO) alerted that contaminated syrups and suspension medicines had been detected in Maldives, Belize, Fiji, Lao People’s Republic and Pakistan.
“In addition, all the medicines in syrup and suspension form of the pharmaceutical company had been recalled in November 2023 and samples were sent for testing at Central Drug Testing Laboratory (CDL) Karachi following WHO Medical Products Alert last month.
We are expecting the reports from the CDL early next week,” a senior official of the DRAP told The News on Thursday.
Commenting on a WHO Medical Product Alert issued again on Thursday, the DRAP official said strict action would be taken against the company as per existing drug laws if its medicines were found to be adulterated and added that entire pharmaceutical industry had been issued instructions to ensure that hazardous impurities, including Ethylene Glycol and Diethylene Glycol, are not present in any therapeutic product produced by them.
In its medical alert, the WHO said five different syrup and suspension medicines were initially detected in the Maldives and Pakistan and notified to the organisation on November 8, 2023, adding that some of the affected products have also been detected in Belize, Fiji and Lao People’s Democratic Republic.
“The five products are Alergo syrup, Emidone suspension, Mucorid syrup, Ulcofin suspension and Zincell syrup.
A total of 23 batches of these products are affected, the WHO said naming the company.
The WHO medical product alert further said in November 2023, samples of five different batches of Alergo syrup were screened for non-compliance by the quality control laboratory of the Maldives Food and Drug Authority in accordance with the thin layer chromatography test for Diethylene Glycol and Ethylene Glycol for inclusion in The International Pharmacopoeia.
The routine screening detected potentially unacceptable amounts of Diethylene Glycol and Ethylene Glycol as contaminants. Laboratory testing conducted by the Therapeutic Goods Administration of Australia confirmed that all five batches were contaminated with Ethylene Glycol at levels ranging from 0.62 to 0.82% w/w relative to the accepted limit of not more than 0.10% w/w.
The WHO said a follow-on inspection of the company’s laboratory was conducted by the DRAP. DRAP’s review of the manufacturing facility and manufacturing records suggests that Diethylene Glycol/ Ethylene Glycol as contaminants may be present in other products and batches manufactured by the company.
The safety and quality of these products can, therefore, not be guaranteed, the WHO alert added.
As a precautionary measure, the company has been instructed by DRAP to stop production of all oral liquid dosage medicines, and on November 16, DRAP issued a recall alert for five different syrup medicines manufactured by said pharmaceutical company, WHO alert added.
To date, no reports of adverse effects linked to the affected products have been notified to the WHO.
However, the WHO recommends increased vigilance and testing in respect of oral liquid dosage medicines produced by the company between December 2021 and December 2022, the WHO alert added.
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