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

Chandigarh: The cough syrup manufactured in Punjab’s Derabassi, which had been flagged in a ‘product alert’ by the World Health Organisation on April 25, has been found to contain unacceptable amounts of toxic contaminants, diethylene glycol and ethylene glycol.

The Central Drugs Standard Control Organisation (CDSCO) at Baddi in Himachal Pradesh on Tuesday confirmed the presence of toxic contaminants in the cough syrup, as was highlighted by WHO a week ago.

“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,” said a CDSCO official.

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

Punjab’s food and drug administration (FDA) has cancelled the manufacturer’s licence for liquid drugs after the CDSCO confirmed the cough syrup was substandard. In fact, 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.

A lot of 18,336 bottles of cough mixture, Guaifenesin syrup TG, manufactured by QP Pharmachem Ltd was exported to Cambodia in 2020.

However, the WHO has not received any information on the adverse effects of the drug in that country. The WHO alert was sounded when samples of the cough syrup from Micronesia and Marshall Islands were analysed by quality control laboratories of Therapeutic Goods Administration (TGA), Australia.

The analysis found that the product contained unacceptable amounts of diethylene glycol and ethylene glycol. WHO reached out to QP Pharmachem Ltd on April 12, 2023 and contacted Trillium to understand their involvement and countries where they had distributed the product.

Alleging that the drug meant only to be exported to Cambodia had somehow been routed to the Islands without approval, QP Pharmachem managing director Sudhir Pathak said, “I will challenge sample analysis report in the court and also lodge an FIR against the trader-Telpha, who had exported the syrup elsewhere.”

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. Accordingly, another sample analysis of the drug can be conducted at CDSCO Kolkata laboratory, which is the final authority for the decision. WHO had alerted CDSCO to the situation as a routine practice.

“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,” said WHO’s official spokesperson. “Our correspondence continues and we await details of the actions from CDSCO,” she added.

Sources in CDSCO pointed out that whenever traders are engaged in the export of drugs, they enjoy huge profit margins and offer low margins to the manufacturer. To cut corners, the manufacturers affect the quality of the drugs, they alleged.