India Mandates Digital Monitoring of High-Risk Solvents to Ensure the Safety of Cough Syrups.

The Directorate General of Health Services has issued a directive regarding the monitoring of high-risk solvents in the pharmaceutical supply chain due to recent reports of cough syrup contamination with DEG. 

A Digital Monitoring System has been established on the ONDLS (Online National Drugs Licensing System ) portal for this purpose. 

All state and UT drug controllers are requested to direct pharma-grade solvent manufacturers to obtain manufacturing licenses through the ONDLS portal. Manufacturers already holding licenses must register and submit data. 

Solvent manufacturers must also upload batch details, including quantity and vendor information, to the ONDLS portal. Compliance with these directions is mandatory to ensure no non-compliant batches are available in the market.


Table of High-Risk Solvents




News from DrugsControl Media Services: Here


The USFDA has also taken note of issues arising in India and published the following information on its website on October 10, 2025. The FDA's view is more related to assuring US patients that they don’t need to worry about the incidents in India. 


The US FDA’s note is available here.


The vital part of the FDA's note is as follows.

[10/10/2025]  FDA is aware of news reports of devastating, ongoing diethylene glycol (DEG) and ethylene glycol (EG) contamination in children’s cough and cold medicine in India. The agency has confirmed these products have not been shipped to the U.S.


Additionally, the Indian health authority – the Central Drugs Standard Control Organisation –informed FDA these products were not exported from India to any other country.


The agency remains vigilant to prevent contaminated drugs from entering the U.S. and asks manufacturers also to remain vigilant to ensure drugs that are marketed in the U.S. remain of highest quality and are safe.


Contaminated products and other concerns


FDA is aware of the following cough syrups in India contaminated with DEG/EG as identified by India’s Central Drugs Standard Control Organisation. These products have been recalled in India:


• Coldrif, manufactured by Sresan Pharmaceuticals


• Re-Life Syrup, manufactured by Shape Pharma Pvt. Ltd.


• Respifresh-TR, manufactured by Rednex Pharmaceuticals Pvt. Ltd.


According to news reports, there is a fourth cough medicine that is linked to adverse events in children in India. However, India’s testing has not found DEG/EG contamination. This product also was recalled.


• Dextromethorphan Hydrobromide Syrup, manufactured by Kaysons Pharma Ltd.

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