• Source:JND

Cough Syrup Row: The Tamil Nadu government has issued a show-cause notice to Kancheepuram-based Sresan Pharmaceuticals, the maker of the controversial cough syrup, Coldrif, linked to the deaths of 14 children in Madhya Pradesh. The notice came amid the probe against Sresan Pharma and the suspension of Coldrif cough syrup sales in 6 states, including Madhya Pradesh, Delhi, Punjab, Rajasthan, Uttar Pradesh and Tamil Nadu.

“As a follow-up action, a memo has been issued asking for an explanation as to why the drug licenses of Sresan Pharmaceuticals should not be completely canceled,” said Tamil Nadu health minister M Subramanian, quoted by Hindustan Times.

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The state’s Food Safety and Drug Administration Department had been alerted after receiving a communication from the Madhya Pradesh State Drug Control Department on October 1. According to officials, a batch of Coldrif syrup (Batch No. SR-13) was found to contain Diethylene Glycol (DEG) at a concentration of 48.6%, far exceeding the permissible limit of 0.1%. 

The contamination represents a serious breach of safety norms under the Drugs and Cosmetics Rules, 1945, prompting the Tamil Nadu authorities to order a complete halt in production on October 3.

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The Tamil Nadu drug control team also inspected the Coldrif manufacturing facility and found more than 350 violations. The report highlighted unhygienic conditions at the plant, with the syrup being manufactured in unclean conditions. 

During the investigation, it was also found that the company was severely lacking in skilled manpower. The investigating team also found toxic substances like propylene glycol and diethylene glycol in high quantities in the syrup. 

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The pharma company has been directed to halt the production and distribution of the contaminated cough syrup. Furthermore, manufacturing units have been sealed while the medicine bottles have been removed from the shelves across medical shops in Tamil Nadu. The state government has also alerted authorities in other states where the coldrif cough syrup has been distributed.

A senior Drug Control official said that the pharma company has been asked to respond to the show-cause notice within two weeks. Meanwhile, further investigations are underway to determine how the toxic compounds entered the production line.