TN cough syrup found adulterated; MP, Rajasthan-tested samples safe, says Centre

CHENNAI: Test samples of cough syrups from a Tamil Nadu-based company have been found adulterated, a Food Safety and Drug Administration (FSDA) official told PTI on Saturday (October 4). The company has been asked to explain and instructed to halt production at its Sunguvarchathram facility. The syrup has been supplied to Rajasthan, Madhya Pradesh, and Puducherry.

The action follows the Tamil Nadu government’s ban on Coldrif syrup and removal of stocks from the market after suspicion linking it to the deaths of 11 children in Madhya Pradesh and Rajasthan. The sale of the cough syrup manufactured by Sresan Pharmaceuticals has been prohibited in Tamil Nadu with effect from October 1.

At Madhya Pradesh’s request, a high-level team inspected the manufacturing unit in Kancheepuram district last week and collected samples. "Test samples have been found adulterated. We have sought an explanation from the manufacturer. Production is stopped until further orders," the official said, according to PTI.

While the Tamil Nadu samples reportedly contained Diethylene Glycol (DEG) beyond permissible limits, the Union Health Ministry on Friday night said none of the syrup samples tested in Madhya Pradesh contained DEG or Ethylene Glycol (EG), contaminants known to cause serious kidney injury.

A joint team from National Centre for Disease Control (NCDC), National Institute of Virology (NIV), Central Drugs Standard Control Organisation (CDSCO), among others, collected samples on-site. The Madhya Pradesh State Food and Drug Administration also confirmed the absence of DEG/EG in three samples. Blood and CSF tests at NIV, Pune, detected Leptospirosis in one case, the ministry said.

The ministry also clarified that the two child deaths in Rajasthan involved a dextromethorphan-based syrup. The product does not contain Propylene Glycol, a potential source of DEG/EG contamination, it said.

The nine deaths in Madhya Pradesh were attributed to Coldrif, while the two cases in Rajasthan were linked to the consumption of the dextromethorphan-based formulation, which is not recommended for paediatric use.

Meanwhile, the Directorate General of Health Services (DGHS) issued an advisory to all states and Union Territories, directing that cough and cold medications should not be prescribed to children under the age of two years.

Madhya Pradesh bans Coldrif syrup sale

The Madhya Pradesh government on Saturday banned the sale of Coldrif syrup after nine child deaths due to suspected renal failure since September 7. Currently, 13 children, including eight from Chhindwara and Nagpur, are undergoing treatment.

Rajasthan suspends Drug Controller, halts distribution of Kaysons Pharma drugs

On Friday night, the Rajasthan government suspended state drug controller Rajaram Sharma for allegedly influencing the process of determining drug standards.

The Medical and Health Department also stopped the supply of all 19 medicines manufactured by Jaipur-based company Kaysons Pharma. Distribution of all other cough syrups containing Dextromethorphan has also been suspended.

According to the managing director of Rajasthan Medical Services Corporation Ltd (RMSCL), Pukhraj Sen, over 10,000 samples of Kaysons Pharma drugs have been tested since 2012, of which 42 failed the quality standards. 

Also Read: TN bans Coldrif after death of 11 kids, Kancheepuram unit under lens

(With PTI inputs)