India-made cold syrup flagged for contaminants in WHO's latest warning

A batch of contaminated common cold syrup, manufactured by an Indian company has been flagged by the World Health Organization WHO, the latest in a series of warnings by the United Nations agency about substandard medicines from the country.

On Monday, the WHO said the manufacturer and the marketer have not provided guarantees on the safety and quality of the product.

The United Nations agency said the batch of the syrup, branded Cold Out, and found in Iraq was manufactured by Fourrts (India) Laboratories for Dabilife Pharma. It had higher than acceptable limit of contaminants diethylene and ethylene glycol, chemicals that can be fatal and lead to acute kidney failure in dozens of children.

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 alert about Cold Out is the latest warning issued in recent months about contaminated cough syrups sold worldwide. 

Four types of medicine, made in India, caused the deaths of at least 70 children in Gambia last year, according to the country's presidential commission of inquiry.

According to the World Health Organisation the syrups contained "unacceptable" quantities of diethylene glycol and ethylene glycol; commonly used as antifreeze. 

In October 2022, Gambia recalled a number of medicines following the deaths of the children, including all cough and cold syrups in circulation, as well as all products manufactured by the Indian firm Maiden Pharmaceuticals, where the contaminated syrups came from.

The inquiry concluded that the medicines had not been registered with the medicines control agency prior to being imported, as required by the regulations.

The commissions also noted the urgent need to set up a quality control laboratory to carry out tests on all medicines imported into the country.

The Health Minister pointed to a number of areas for improvement to ensure a better quality health system, such as the creation of a school of pharmacy at the university and stricter control of medicines in circulation.

He also said that the Gambian government was exploring ways of taking legal action against the Indian pharmaceutical laboratory from which the drugs originated, in order to obtain compensation.

Following the health scandal, India shut down the Maiden Pharmaceuticals factory in northern India in October 2022.

A trial on the case is due to open in Gambia in October.