Drug controller recommends cancellation of Srisan Pharma's license after high DEG levels found in cough syrup

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In the wake of the tragic deaths of several children suspected to be linked to the consumption of contaminated cough syrup, central and state drug regulators have swung into action.

sources told CNBC-TV 18 A series of tests conducted over the past few days have confirmed the presence of diethylene glycol (DEG)—a toxic industrial solvent—in some cough syrup samples, leading the Drug Controller General of India, Central Drugs Standard Control Organization (CDSCO), to recommend the cancellation of Sareson Pharma’s manufacturing license.

According to sources, 19 samples have been tested so far by CDSCO, Madhya Pradesh Food and Drugs Administration (MP FDA), and Tamil Nadu Food and Drugs Administration (TN FDA) as officials try to trace the source of the contamination that has raised nationwide alarm.

The first set of test results, sources said, came on October 3, when six samples tested by CDSCO and three by MP FDA were found free of DEG and ethylene glycol (EG). However, the situation changed dramatically later that night when the TN FDA presented test results of Ko Coldrif syrup, manufactured by Srisan Pharma, which revealed 48% DG, hundreds of times the permissible limit of 0.1%.

The next day, on October 4, more samples of Coldrif collected from retail shops and pharmacies in Madhya Pradesh were tested, again confirming the presence of 46%, sources said. By the end of the day, 10 samples had been tested, several of which confirmed the same pattern of contamination in syrups produced by Srisan Pharma.

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Sources further said that on October 5 and 6, additional testing reports from the MP FDA showed that two other products—Refile syrup and Respire TR syrup—contained DEG, even at relatively low levels. Refile syrup showed 0.616% deg and respifresh tr Cyrup showed 1.342% deg, but these were still above the permissible limits.

Based on these findings, sources said CNBC-TV 18 DCGI has written to Tamil Nadu FDA, urging it to immediately cancel the license of Srisan Pharma. Officials have also been told that

The deaths have fueled concerns about quality control lapses in India’s drug supply chain, especially after previous global incidents involving DEG contamination in cough syrups exported from India. Regulatory authorities are now under increasing pressure to ensure strict enforcement of manufacturing standards and prevent further tragedies.

Further action is awaited from both central and state agencies as investigations continue into how the contamination occurred and whether lapses in testing or inspection contributed to the crisis.