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Madhya Pradesh bans cough syrup ‘linked’ to kids’ deaths, TN samples fail test

Central regulator starts inspection at manufacturing units in 6 states

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The state governments of Madhya Pradesh and Rajasthan have banned the ‘Coldrif’ cough syrup, flowing its suspected link to the deaths of 14 children in the two states. MP officials said samples of the drug were found to contain 48.6 % diethylene glycol, a highly toxic substance.

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Samples of cough syrup collected from a Chennai-based pharmaceutical firm, Sresan Pharma, have been found to be adulterated, officials from the Tamil Nadu Food Safety and Drug Administration Department (FDA) said on Saturday. The Tamil Nadu FDA has asked the firm to stop the production of cough syrup.

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Related news: Cough syrup deaths: Madhya Pradesh doctor who prescribed Coldrif arrested, FIR against manufacturer

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“On request of the Madhya Pradesh Government, the Tamil Nadu Food Safety and Drug Administration Department had taken samples of Coldrif Cough Syrup from manufacturing premises of M/s Sresan Pharma in Kanchipuram, Tamil Nadu.

Earlier, all six samples collected by the Central Drug Standard Control Organisation (CDSCO) were found to be free of DEG/EG. Simultaneously, Madhya Pradesh Food Safety and Drug Administration Department had informed that out of 13 samples collected by their team, three were analysed, which were also found to be free of DEG.

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The results of testing of these samples were shared with us late on October 3. The samples are found to contain diethylene glycol (DEG) beyond the permissible limit,” officials said.

The multidisciplinary team of experts from National Institute of Virology (NIV), Indian Council of Medical Research (ICMR), NEERI, CDSCO and AIIMS-Nagpur are still analysing various samples and factors to assess the cause of deaths in and around Chhindwara in Madhya Pradesh.

Besides, the Central Drugs Standard Control Organisation (CDSCO) has initiated risk-based inspection of drug manufacturing units in six states — Himachal Pradesh, Uttarakhand, Gujarat, Tamil Nadu, Madhya Pradesh and Maharashtra.

The inspections across states, which began on Friday, aim to identify gaps that may have led to drug quality failures and suggest process improvements to avoid such incidents in future, said the Union Health Ministry.

The Kerala Drugs Control department has also suspended the sale of ‘Coldrif’ cough syrup following reports from other states that flagged issues with one of the batches of the Coldrif syrup, Kerala Health Minister Veena George on Saturday said.

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