Marion Biotech Used Untested Ingredients Procured From Unapproved Vendors

New Delhi : Marion Biotech, the Noida-based pharma company linked to the death of 18 children in Uzbekistan, procured active ingredients used in its cough syrups from an unapproved vendor, investigations have revealed.

According to officials, Marion Biotech has three approved vendors — a Korean firm, a company from Chennai, and another Hapur-based company — that supply ingredients. However, it procured propylene glycol from an unapproved supplier, Delhi’s Maya Chemtech.

“Marion Biotech didn’t procure the excipients used in manufacturing the cough syrups from any of the three approved vendors. The supplier which provided them the excipient for drug production was an unapproved one,” said an official investigating the matter.

“We suspect that the propylene glycol used in the product didn’t conform to standards specified in Indian Pharmacopoeia (I.P.), British Pharmacopoeia (B.P.), and United States Pharmacopeia (U.S.P.),” he added, on condition of anonymity.

It has also been found that the sampling of excipients supplied by the unapproved vendor was not done properly, before using it to manufacture drugs, the official added.

“Due to faulty methods of sampling of ingredients supplied by an unapproved vendor, the firm failed to test the propylene glycol for the presence of diethylene glycol and ethylene glycol,” he added.

Central Drugs Standards and Control Organisation (CDSCO) officials inspected the firm’s manufacturing facility for the third time in a fortnight to collect samples of its Ambronol cough syrup. On Wednesday, the World Health Organisation (WHO) had said that analyses of Ambronol and DOK-1 Max syrups by Uzbekistan’s Ministry of Health had found that both contained unacceptable amounts of diethylene glycol and ethylene glycol. Both the syrups are manufactured by Marion Biotech.

The CDSCO sent four samples of Ambronol yesterday to its testing laboratory in Chandigarh. DOK-1 Max samples have been sent for testing earlier, and those results are awaited.

Asked about the violations found in the Noida plant, the Uttar Pradesh Food Safety and Drug Administration Department (UPFSD) said they had suspended the firm’s licence.

“We await the results from the lab. We will take drastic action if the results show evidence of contamination. We will prosecute them,” the UPFSD official said.

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