WHO Alerts on Contaminated Indian-Made Cold Syrup, Citing Safety Concerns

Sun Aug 13 2023
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GENEVA: The World Health Organization (WHO) has issued a warning concerning a batch of contaminated common cold syrup, produced by an Indian company, marking the latest instance of the agency’s cautionary notices regarding substandard medications originating from India.

According to the WHO, the identified batch of the syrup, labeled as “Cold Out,” was discovered in Iraq and was manufactured by Fourrts (India) Laboratories for Dabilife Pharma. The syrup was found to contain elevated levels of contaminants diethylene and ethylene glycol, surpassing the acceptable safety limits. Specifically, the batch contained 0.25% of diethylene glycol and 2.1% of ethylene glycol, exceeding the permissible threshold of 0.10%, as outlined in the WHO’s medical product alert.

The WHO’s announcement also highlighted that neither the manufacturer nor the marketer had provided assurances to the organization regarding the safety and quality of the product. At the time of reporting, both companies had not responded to inquiries from Reuters outside of regular business hours.

WHO Advisories Link to Several Indian-Made Syrups

The emergence of this alert concerning Cold Out adds to a series of recent advisories related to tainted cough syrups distributed globally. Notably, several of these scrutinized syrups have been associated with Indian manufacturers.

Cough syrups produced in India have previously been linked to the tragic deaths of at least 89 children in Gambia and Uzbekistan last year. Indian authorities also identified violations at Riemann Labs, whose cough syrup was implicated in the deaths of children in Cameroon.

Regulatory actions were taken by Indian authorities, including the cancellation of the manufacturing license of Marion Biotech, which had exported the syrups to Uzbekistan, and the arrest of certain employees. Meanwhile, Maiden Pharmaceuticals, the company involved in the Gambia situation, contested allegations that their drugs were responsible for the fatalities. Tests conducted by an Indian government laboratory found no presence of toxins in their products.

 

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