"Test Solvents": Karnataka Tells Drugmakers After WHO Cough Syrup Alert

Karnataka's Drugs Control Department has issued a circular to pharmaceutical companies operating in the state, asking them to follow strict compliance measures with regard to certain solvents used in the manufacture of cough syrups. As a precautionary measure, the manufacturers have been told to sample all the individual containers or pack of solvents.

This fresh directive follows a product alert sounded by the World Health Organisation (WHO), earlier, on four Indian cough syrups, claiming that those had killed 66 children in Gambia.

In its latest circular, the Karnataka Drugs Control Department has asked drug manufacturers to ensure that solvents such as glycerin and propylene glycol are procured from companies in keeping with "pharmacopoeial standards".

The department has also directed drug manufacturers that "certificate of analysis of glycerin and propylene glycol procured in the last one year should be submitted within seven days".

Indian pharma company Maiden Pharmaceuticals, which came under the scanner following the deaths in Gambia, was found to be a repeat offender in India as well. Several drugs manufactured by the pharma company were not found to be up to quality standards by four states of the country. Vietnam had in 2011 banned the company.

Speaking to NDTV, Public health activist Dinesh Thakur had pointed out that the company's medicines had been flagged for quality issues in India.

The WHO had said that laboratory analysis of Maiden cough syrup had confirmed "unacceptable" amounts of diethylene glycol and ethylene glycol, which can be toxic and lead to acute kidney injury.