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CDSCO confirms WHO alert on contaminants in Punjab-made cough syrup

The World Health Organisation (WHO) flagged Punjab Derabassi’s cough syrup in a ‘product alert’ on April 25. It said that the cough syrup is found to be containing unacceptable amounts of toxic contaminants – diethylene glycol and ethylene glycol.

The cough syrup is manufactured by Punjab’s QP Pharmachem Ltd and is marketed by Haryana-based Trillium Pharma.

The Central Drugs Standard Control Organisation (CDSCO) at Baddi in Himachal Pradesh confirmed the presence of toxic contaminants in the cough syrup on Tuesday. A CDSCO official said, “The samples were tested in our Chandigarh laboratory where it was found that diethylene glycol and ethylene glycol were present in more than permitted levels and hence substandard. The investigation will continue and the DCGI has been updated on the matter”.

After the confirmation of the cough syrup as substandard by CDSCO, The Food and Drug Administration (FDA) of Punjab nullified the license of the manufacturer for liquid drugs. Diethylene glycol and ethylene glycol were found in excess amounts in another Indian-made cough syrup that has been blamed for the death of 66 children in Gambia.

The WHO alert was sounded when samples of cough syrup from Micronesia and the Marshall Islands were analyzed by quality control laboratories of the Therapeutic Goods Administration (TGA), Australia.

However, the WHO has not received any information on the adverse effects of the drug in that country.

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What did the WHO say about the manufacturing of syrup?

On April 12, WHO reached out to QP Pharmachem Ltd and contacted Trillium to understand their involvement and the countries where they had distributed the product.

“I will challenge the sample analysis report in the court and also lodge an FIR against the trader-Telpha, who had exported the syrup elsewhere,” said QP Pharmachem managing director Sudhir Pathak.

CDSCO Baddi is expected to issue a show-cause notice on the issue to the manufacturer, and the firm at this point can contest the report. Consequently, another sample analysis of the drug can be conducted at CDSCO Kolkata laboratory, which is the definitive authority for the decision. WHO had cautioned CDSCO about the situation as a routine practice.

The WHO’s official spokesperson said, “We do not have reports of the product being found in other countries. But, if the alert needs to be updated beyond Micronesia and the Marshall Islands, then we will do so,”. “Our correspondence continues and we await details of the actions from CDSCO,” she added.

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