• Source:JND
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Cough Syrup Row: Following multiple child deaths linked to the consumption of contaminated cough syrups, India’s top drug regulator, the Central Drugs Standard Control Organisation (CDSCO), called for a nationwide audit of all cough syrup manufacturers to ensure product safety and strict compliance with quality standards.

The CDSCO has sought a comprehensive list of all cough syrup manufacturers from each state and is establishing a “robust and proper system” for enhanced audits and surveillance, News18 quoted a senior official as saying.

“We have asked for the list of all manufacturers of cough syrup from the states and union territories. We will begin doing audits of all manufacturers of cough syrup across the country. We are coming up with a proper, robust system for that,” the official said, adding that an official announcement is expected within the next ten days.

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This move comes in response to the recent detection of toxic substance Diethylene Glycol (DEG) in samples from Tamil Nadu and Madhya Pradesh, reigniting scrutiny of India’s pharmaceutical regulatory system following past global incidents involving contaminated Indian-made syrups.

According to CDSCO sources, a joint inspection by the central and state drug authorities in Madhya Pradesh uncovered three syrup samples out of a total of 19, which failed DEG quality checks. “Respifresh, Relife, and Coldrif were found to contain DEG. We divided the samples among ourselves. All six samples tested by us were clear of DEG, but the same evening, Tamil Nadu FDA found DEG. Madhya Pradesh FDA later reported DEG in the same batch,” News18 quoted CDSCO sources as saying.

Following the findings, multiple manufacturers, including Sresan Pharma, have come under strict regulatory scrutiny. Authorities confirmed that Sresan Pharma’s license was granted by the state regulator in 2011 and renewed in 2016, without CDSCO’s oversight.

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“The licence to Sresan was given in 2011 by the state regulator. CDSCO didn’t give the license or renewal. We didn’t know this company existed. We did the audit of the company and found 364 violations, including 38 critical observations. This is an extreme case," the official said.

In light of these findings, the CDSCO recommended that Tamil Nadu’s FDA cancel Sresan Pharma’s license and take criminal action.