Cough syrup deaths | CDSCO starts risk-based inspection at manufacturing units in six states
New Delhi: Central drug regulator CDSCO has initiated risk-based inspection of drug manufacturing units in six states following collection of 19 samples including that of cough syrups, antipyretics and antibiotics in the wake of child deaths in Madhya
Pradesh and Rajasthan allegedly due to contaminated cough syrups.
The manufacturing units are in Himachal Pradesh, Uttarakhand, Gujarat, Tamil Nadu, Madhya Pradesh and Maharashtra where 19 samples of different drugs were manufactured, sources in the health ministry said.
The inspections by the Central Drugs Standard Control Organisation (CDSCO) began on Friday 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, the ministry 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.
On Friday, the ministry said that six samples that have 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.
Sources from the ministry clarified that the “samples that have been tested so far by CDSCO were not of the two suspected cough syrups one of which is Coldrif that have been under scanner since the deaths”.
“The six drug samples tested by CDSCO which did not show presence of DEG/EG were of other drugs and syrups including antibiotics, antipyretics and Ondansetron, consumed by the children who fell ill in the Chhindwara district of Madhya Pradesh,” a source said.
The analysis of the samples of Coldrif and the other suspected cough syrup by Madhya Pradesh state drug authorities is still underway.
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.
