Nationwide crackdown on cough syrup makers after toxic scare
India's CDSCO is launching a nationwide audit of all cough syrup manufacturers to combat contamination, including toxic Diethylene Glycol (DEG).
New Delhi: In a decisive move to restore confidence and ensure public safety, India's leading drug regulator, the Central Drugs Standard Control Organisation (CDSCO), is launching a nationwide audit of all cough syrup manufacturers.
This sweeping initiative comes in the wake of recurring cases of contaminated products and intensifying international scrutiny that have cast a shadow over India's pharmaceutical industry.
A senior official revealed that the CDSCO has already tasked all states and union territories with providing a comprehensive list of every cough syrup manufacturer operating within their jurisdiction. The regulator is simultaneously developing a "robust and proper system" to facilitate regular audits and ongoing surveillance across the country. An official announcement detailing this extensive regulatory overhaul is anticipated within the next ten days.
The impetus for this massive crackdown stems from recent alarming discoveries of toxic Diethylene Glycol (DEG) in cough syrup samples originating from Madhya Pradesh and Tamil Nadu. These domestic findings have reignited profound concerns about India’s pharmaceutical oversight, particularly after earlier international incidents linked to Indian-made syrups led to tragic outcomes and significant global condemnation.
According to CDSCO sources, a joint inspection conducted by central and state drug regulators in Madhya Pradesh identified 19 syrup samples for testing. Disturbingly, three of these samples failed quality tests due to the presence of DEG. "Respifresh, Relife, and Coldrif were found to contain DEG," a source confirmed.
The detection unfolded dramatically. "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."
These critical findings have triggered immediate enforcement actions against multiple manufacturers, with Sresan Pharma now under intense regulatory scrutiny. Officials confirmed that Sresan Pharma's manufacturing license was initially issued by the state regulator in 2011 and renewed in 2016, without any involvement from the CDSCO. "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," the official stated, highlighting a significant gap in central oversight.
A subsequent audit of Sresan Pharma uncovered an astonishing 364 violations, including 38 classified as critical observations – a number unprecedented in any previous inspection. Following these egregious findings, the CDSCO has formally recommended that the Tamil Nadu FDA cancel Sresan’s license and initiate comprehensive criminal proceedings against the company.