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Tamil Nadu FDA finds toxic DEG in Coldrif syrups samples

Published on 04/10/2025 02:26 PM

As part of the ongoing probe into suspected drug-related deaths in Madhya Pradesh, regulators confirmed that fresh testing of Coldrif cough syrup has detected contamination.

The Central Drugs Standard Control Organisation (CDSCO) earlier collected six samples, all of which tested negative for diethylene glycol (DEG) and ethylene glycol (EG). Similarly, the Madhya Pradesh Food and Drug Administration (MPFDA) analysed three of 13 samples, also confirming them to be free of DEG/EG.

However, on the request of the MP government, the Tamil Nadu FDA drew additional samples from the manufacturing site of M/s Sresan Pharma, Kanchipuram. “The results of testing of these samples were shared with us late evening on september 3 2025. The samples are found to contain DEG beyond the permissible limit,” an official statement said.

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Also Read: NSQ Drugs Alert: 143 medicines fail quality test in July, 8 samples found fake

On the other hand, the Union government launched risk-based inspections on October 3 at facilities producing 19 drugs across six states. Officials said the exercise is aimed at identifying systemic gaps that may lead to quality failures and recommending improvements to prevent such incidents in the future.

Meanwhile, a multidisciplinary expert team comprising scientists from NIV, ICMR, NEERI, CDSCO and AIIMS Nagpur continues to analyse samples to establish the cause of recent deaths in and around Chhindwara, Madhya Pradesh.

Also Read: NSQ Drugs Alert: CDSCO identifies 196 medicines that fail quality tests in April 2025

Separately, the CDSCO in its August 2025 update flagged three drugs as spurious and listed 94 others as not of standard quality (NSQ) during routine surveillance. The spurious category included batches of Pan D and Pan 40, commonly prescribed for acid reflux, and diazepam injection used in treating anxiety, alcohol withdrawal, and muscle spasms.

“A drug is considered spurious when manufactured by unauthorised producers using brand names owned by other companies,” the ministry explained. It added that “the matter is under investigation and action will be taken according to the Drugs and Cosmetics Act and rules.”

Officials further noted: “To counter this, rigorous identification and removal of NSQ and spurious drugs from the market is a regular collaborative exercise between central and state regulators.”

Of the 94 drugs listed as NSQ, 32 were identified at central drug laboratories in Kolkata, Mumbai, Hyderabad, Guwahati, and Chandigarh, while the remaining 62 were detected in state drug testing laboratories. The list covered a range of commonly used medicines, including paracetamol, pantoprazole, domperidone, and ambrospas tablets.

The ministry stressed that failures are specific to the tested batches and do not indicate risks to other batches available in the market.

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