Killer Cough Syrup: Marion Biotech used untested ingredients procured from unapproved vendors

Marion Biotech is a manufacturer of Dok1 Max syrup and Tablet for export purpose (Representative Image)

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.

Also Read: Fresh inspection of Marion Biotech plant on after WHO flags 2 cough syrups

“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.

Test result awaited

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.

Also Read: WHO issues alert for 'substandard' Marion Biotech drugs linked to Uzbekistan tragedy

WHO contacts the Indian regulator

The WHO said that it was in touch with the Indian drug regulator on the matter. The WHO had issued a Medical Product Alert for the two contaminated products made by Marion Biotech.

“As a standard practice, the CDSCO has been contacted. We await the results of their investigations that will lead us to have a better understanding of the scope of the risk,” a WHO representative told Moneycontrol in an emailed response.