WHO issues alert on another contaminated Indian-made cough syrup

The World Health Organization on Monday flagged a batch of contaminated common cold syrup, manufactured by an Indian company, the latest in a series of warnings by the agency about substandard medicines from the country.

The United Nations agency said the batch of the syrup, branded Cold Out, found in Iraq was manufactured by Fourrts (India) Laboratories for Dabilife Pharma, and had higher than acceptable limit of contaminants diethylene and ethylene glycol.

The batch had 0.25% of diethylene glycol and 2.1% of ethylene glycol, when the acceptable safety limit for both is up to 0.10%, WHO said in its medical product alert.

The agency added the manufacturer and the marketer have not provided guarantees to WHO on the safety and quality of the product. The companies did not immediately respond to Reuters’ requests for comments outside of business hours.

The alert about Cold Out is the latest warning issued in recent months about contaminated cough syrups sold worldwide. At least five of the syrups under scrutiny involve Indian manufacturers.

Cough syrups made in India were linked to deaths of at least 89 children in Gambia and Uzbekistan last year. Indian authorities also found violations at Riemann Labs, whose cough syrup were linked to deaths of children in Cameroon.

The Indian regulator had canceled the manufacturing license of Marion Biotech, which had exported the syrups to Uzbekistan, and arrested some of their employees.

The company involved in Gambia, Maiden Pharmaceuticals, has denied that its drugs were responsible for the deaths in the country, and tests by an Indian government laboratory found no toxins in them.

– Reuters