Cough syrup deaths: CDSCO launches risk-based inspection at manufacturing units of 19 drugs

New Delhi: Central drug regulator, CDSCO, has initiated risk-based inspection at the manufacturing units of 19 drugs, including cough syrups and antibiotics, across six states following reports of child deaths due to the consumption of contaminated cough syrup in Madhya Pradesh, the health ministry said on Saturday.

The inspections by the Central Drugs Standard Control Organisation (CDSCO) began on October 3 with the aim to identify gaps that may have led to drug quality failures and also suggest process improvement to avoid such incidents in future, it said.

Additionally, a multidisciplinary team comprising experts from the National Institute of Virology, the Indian Council of Medical Research, National Environmental Engineering Research Institute, CDSCO and AIIMS-Nagpur, among others, are still analysing the various samples and factors to assess the cause of deaths in and around Chhindwara in Madhya Pradesh, it stated.

The Union Health Ministry on Friday said six drug samples tested by CDSCO and three by the Madhya Pradesh Food and Drugs Administration (MPFDA) were found to be free of Diethylene Glycol (DEG) and Ethylene Glycol (EG) contaminants that are known to cause serious kidney injury.

At the request of the Madhya Pradesh government, the Tamil Nadu Food Safety and Drug Administration Department tested samples of Coldrif Cough Syrup collected from the manufacturing unit of Sresan Pharma in Kanchipuram, Tamil Nadu.

"The results were shared with us late Friday evening... The samples had DEG beyond the permissible limit," the ministry said.

Following this, the Tamil Nadu government banned the sale of the cough syrup and ordered its removal from the market.

"With effect from October 1, the sale of the cough syrup manufactured by the city-based firm has been prohibited across Tamil Nadu," an official said on Friday.

Inspections were also conducted at the pharmaceutical company's manufacturing facility in Sunguvarchathram in neighbouring Kancheepuram district during the last two days, and samples have been collected, he said.