Cough syrup case: Marion Biotech licence cancelled

Cough syrup case: Marion Biotech licence cancelled

The UP drug controller has cancelled the licence of Noida-based Marion Biotech that manufactured the alleged contaminated cough syrup linked to the death of 18 children in Uzbekistan. “We have cancelled the licence of Marion Biotech,” Dinesh Tiwari, assistant commissioner (drug), told ET.

The decision to cancel the licence was taken after the Regional Drugs Testing Laboratory (RDTL), Chandigarh, which tested the samples of the cough syrup, found 22 out of 36 were “not of standard quality” or adulterated and spurious.

The UP drugs controller has already ordered Marion Biotech facilities to stop production. Earlier this month, following receipt of the RDTL report, the drugs controller filed a complaint against the Noida drugmaker for sale of adulterated products.

The UP police have arrested three persons in this connection.

Marion holds an export licence from the drugs controller, Uttar Pradesh, to manufacture the Dok-1-Max syrup and tablets.

The UP drug controller and the Central Drugs Standard Control Organisation (CDSCO) have launched a joint probe of Marion Biotech facilities that manufactured the Dok-1-Max cough syrup, after the Uzbekistan health ministry flagged the issue.

The Uzbekistan health ministry has allegedly linked the deaths of 18 children to the Dok-1-Max cough syrup manufactured by Marion Biotech. Uzbekistan had said that a toxic chemical – ethylene glycol – was found in a batch of the cough syrup during laboratory tests.The inspection by teams of CDSCO and UP drug controllers found compliance issues at Marion facilities with respect to schedule M-good manufacturing practices (GMP) in production. TheWHO issued a ‘medical product alert’, referring to two cough syrups Ambronol syrup and DOK-1 Max syrup made by Marion.

(With inputs from health)