The Uttar Pradesh Medication Controlling and Licensing Authority has cancelled the manufacturing licence of Noida-based pharmaceutical firm Marion Biotech, whose cough syrup was linked to the dying of 18 kids in Uzbekistan in December .
“Marion’s licence was cancelled as the corporate couldn’t reply to the show-cause discover satisfactorily,” mentioned SK Chaurasia, Medication Licensing Officer, Uttar Pradesh.
“It’s the administrative motion that has been taken by the state medication regulator; now the prosecutorial motion will comply with,” he added.
In line with Vaibhav Babbar, drug inspector, Gautam Budh Nagar, the communication relating to the cancellation was acquired from the state licensing authority over e mail on Wednesday morning.
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“Whereas the manufacturing licence of the pharma agency was suspended when an inquiry was initiated, it has now been cancelled by the Uttar Pradesh Medication Controlling and Licensing Authority and a communication relating to the identical was shared with us over e mail on Wednesday. The Noida agency can not perform (any) manufacturing now,” he mentioned.
The event comes after the Central Medication Commonplace Management Group (CDSCO) beneficial on March 4 that the licence be cancelled.
Marion Biotech’s Dok-1 cough syrups allegedly led to the dying of 18 kids in Uzbekistan in December 2022, resulting in investigations in India amid considerations concerning the drug’s security. The syrup was not offered in India.
On March 3, the Gautam Budh Nagar police arrested three workers of the pharma agency that’s primarily based in Sector 67. The operations head and two scientists of the corporate have been arrested whereas a lookout discover has been issued for 2 of its administrators who’re absconding.
The arrests adopted an FIR that was registered by central and state drug authorities who discovered the corporate’s product samples adulterated and never of ordinary high quality. The samples have been despatched to the federal government’s regional drug testing laboratory in Chandigarh and 22 of the samples have been discovered to be “not of ordinary high quality” (adulterated and spurious).
Officers from Gautam Budh Nagar medication management division mentioned the batch of cough syrup imported by Uzbek agency Quramax Medical, was manufactured in Could 2021 with an expiry of April 2024.
“In the course of the inspection in December, the corporate representatives couldn’t produce paperwork associated to the manufacturing of ‘Dok-1 max’ cough syrup, prompting the federal government to order halting of its manufacturing instantly,” mentioned Babbar.
After the incident in Uzbekistan, WHO issued a “medical product alert”on December 22, 2022.
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The UN physique mentioned in its assertion that the samples examined by ministry of well being of the Republic of Uzbekistan discovered that they contained ”unacceptable quantities of diethylene glycol and /or ethylene glycol as contaminants”. It additional talked about that diethylene glycol and ethylene glycol are poisonous to people when consumed and might show deadly.
That is the second incident globally whereby deaths in kids have been linked to India-made medication. WHO on October 5 issued an alert towards cough syrups manufactured and exported by Maiden Pharma linking them to deaths of at the least 70 kids in The Gambia.