Banned cough syrup not sold in Maharashtra or Mumbai: FDA

Mumbai: There is no domestic selling and manufacturing of cough syrup made by Maiden Pharmaceutical in the state and city, says Maharashtra Food and Drug Administration (FDA). Moreover, the cough syrups which have been banned by WHO are not being used in any of the city hospitals or not being sold by chemists across Maharashtra.

“We do not play any role in manufacturing or selling Maiden Pharmaceutical cough syrup in Maharashtra. In 2015, Gujarat FDA banned the sale of tablets made by them as they failed quality tests. Moreover, the Central Government also clarified that these products are not sold in India,” said an official from the FDA.

The WHO on Wednesday said laboratory analysis of four Maiden products had confirmed "unacceptable" amounts of diethylene glycol and ethylene glycol, which can be toxic and lead to acute kidney injury. Diethylene glycol and ethylene glycol are used in antifreeze and brake fluids and other industrial applications but also as a cheaper alternative in some pharmaceutical products.

“The State drug controller had given licenses to the said company only for export of these four drugs namely Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup and MaGrip n Cold Syrup. Further, all these four drugs, manufactured only for exports by M/s Maiden Pharmaceuticals Limited, are not licensed for manufacture and sale in India. In effect, none of these four drugs of M/s Maiden Pharmaceuticals is sold domestically in India,” a press release from the Union Health Ministry said on Thursday.

Meanwhile, FDA officials and doctors have urged citizens to not panic with the news of cough syrup as it has not been used for domestic purposes or available in any of the chemists and hospitals. Moreover, they have also urged the citizens to not self-medicate their children or take any syrup without a doctor's prescription.