Regulatory body cancels Marion Biotech’s licence

The Uttar Pradesh Drugs Controlling and Licensing Authority has cancelled the manufacturing licence of Noida-based pharmaceutical company Marion Biotech, whose cough syrup was linked to the death of 18 children in Uzbekistan in December .

“Marion’s licence was cancelled as the company couldn’t respond to the show-cause notice satisfactorily,” said SK Chaurasia, Drugs Licensing Officer, Uttar Pradesh.

“It is the administrative action that has been taken by the state drugs regulator; now the prosecutorial action will follow,” he added.

According to Vaibhav Babbar, drug inspector, Gautam Budh Nagar, the communication regarding the cancellation was received from the state licensing authority over email on Wednesday morning.

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“While the manufacturing licence of the pharma firm was suspended when an inquiry was initiated, it has now been cancelled by the Uttar Pradesh Drugs Controlling and Licensing Authority and a communication regarding the same was shared with us over email on Wednesday. The Noida firm cannot carry out (any) manufacturing now,” he said.

The development comes after the Central Drugs Standard Control Organization (CDSCO) recommended on March 4 that the licence be cancelled.

Marion Biotech’s Dok-1 cough syrups allegedly led to the death of 18 children in Uzbekistan in December 2022, leading to investigations in India amid concerns about the drug’s safety. The syrup was not sold in India.

On March 3, the Gautam Budh Nagar police arrested three employees of the pharma firm that is based in Sector 67. The operations head and two scientists of the company were arrested while a lookout notice has been issued for two of its directors who are absconding.

The arrests followed an FIR that was registered by central and state drug authorities who found the company’s product samples adulterated and not of standard quality. The samples were sent to the government’s regional drug testing laboratory in Chandigarh and 22 of the samples were found to be “not of standard quality” (adulterated and spurious).

Officials from Gautam Budh Nagar drugs control department said the batch of cough syrup imported by Uzbek firm Quramax Medical, was manufactured in May 2021 with an expiry of April 2024.

“During the inspection in December, the company representatives could not produce documents related to the production of ‘Dok-1 max’ cough syrup, prompting the government to order halting of its production immediately,” said Babbar.

After the incident in Uzbekistan, WHO issued a “medical product alert”on December 22, 2022.

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The UN body said in its statement that the samples tested by ministry of health of the Republic of Uzbekistan found that they contained ”unacceptable amounts of diethylene glycol and /or ethylene glycol as contaminants”. It further mentioned that diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal.

This is the second incident globally wherein deaths in children were linked to India-made drugs. WHO on October 5 issued an alert against cough syrups manufactured and exported by Maiden Pharma linking them to deaths of at least 70 children in The Gambia.