No evidence of deaths due to our cough syrup, attempt to tarnish India’s image: Marion Biotech

Marion Biotech, the company allegedly linked with the death of children in Uzbekistan, has replied to the drug regulators on the show-cause notice over “violations observed at the company’s manufacturing plant in Noida”.

The Uttar Pradesh Food Safety and Drug Administration (UPFSD) had, on January 10, suspended the licence of the drug maker after it failed to respond within the specified time.

The drug maker in its reply to the regulators has said that the allegations of supplying contaminated drugs was an attempt to “tarnish the image of Marion Biotech and Indian pharma.”

Ambronol and Dok-1 Max syrups are the controversial ones.

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

A copy of the letter has also been sent to the Central Drugs Control and Standard Organisation (CDCSO).

“The management of Marion Biotech has sent its response to the show-cause notice issued by the regulators. They have denied any wrongdoing in a very long response,” said an official who is part of the investigation.

Company contests evidence

According to the official, the founders of Marion Biotech have questioned the method to determine the aetiology of the children’s deaths in Samarkand city of Uzbekistan.

“The company has questioned the reports on the casual linking of children's deaths in Uzbekistan to its cough syrup,” he added.

The official said that Marion Biotech, in its letter, has backed the cough syrups, saying the company followed British Pharmacopoeia standards while manufacturing the syrups.

“The company has said that it is a very old supplier of drugs in Uzbekistan and its drugs were never flagged for adulteration or contamination,” the official said.

Marion Biotech has also said that there were no doctors’ prescription and investigation analysis which indicted them for the deaths of children in Uzbekistan.

Questions investigation findings

The legal team of Marion Biotech, in a five-page letter to the authorities, has also raised objections to the findings of the inspection by regulators. According to the findings, the company had procured active ingredients used in the cough syrups from an unapproved vendor.

In the letter, Marion Biotech has denied procuring raw materials from an unapproved vendor, the official said. The company said excipients used in the syrups were from an approved vendor.

Also read: WHO issues alert for 'substandard' Marion Biotech drugs

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

On the findings of poor hygienic conditions in the plant where drugs were produced, the company has said that it was working towards augmenting the infrastructure in the manufacturing facility.

When asked if the response from Marion Biotech would be of any help for the company to restart drug production in the facility, the official said suspension would not be revoked.

Also read: UP suspends manufacturing license of drug maker Marion Biotech

“We are awaiting the results of cough syrup testing. If they are found to be positive for diethylene glycol or propylene glycol, the founders would be prosecuted,” an official from UPFSD said.

A joint team of central and state drug regulators inspected the Noida-based firm’s manufacturing facility thrice in a fortnight after the World Health Organisation’s medical alert for contaminated drugs manufactured by them.