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Drugs Control Organisation initiates probe after cough syrup linked deaths in Uzbekistan

India initiates probe after cough syrup linked to deaths in Uzbekistan

The health ministry of Uzbekistan has claimed that the children who died had consumed cough syrup 'Doc-1 Max' manufactured by Noida-based Marion Biotech.

The Central Drugs Standard Control Organisation (CDSCO) has initiated a probe in connection with the death of 18 children in Uzbekistan allegedly linked to a cough syrup manufactured by an Indian firm, official sources said on Thursday.
The health ministry of Uzbekistan has claimed that the children who died had consumed cough syrup 'Doc-1 Max' manufactured by Noida-based Marion Biotech.
Hasan Harris, legal representative of Mario Biotech, said the governments of both countries is looking into the matter and inquiring.
"There is no problem from our end and no issue in testing. We have been there for the past ten years. Once the government report will come, we will look into it. For now the manufacturing has stopped," Harris said.
According to the ministry, chemical ethylene glycol was found in a batch of syrup during laboratory tests.
Sources said the Drugs Controller General of India has sought more information regarding the incident from the Uzbek regulator. &nbsp; An inspection jointly conducted by the central drugs regulatory team of north zone and state drugs regulatory team was also taken during which samples of the drugs were also lifted.
Earlier this year, death of 70 children in Gambia was linked to cough syrups manufactured by Haryana-based Maiden Pharmaceuticals following which the Haryana based unit was shut for violation of manufacturing standards. &nbsp;However, later the samples tested in a government laboratory in India were found to be complying with specifications.
Also watch: <a href="https://www.editorji.com/india-news/india-to-get-2-crore-covishield-doses-free-of-cost-know-who-s-providing-covid-19-1672300387174">India to get 2 crore Covishield doses free of cost, know who's providing | Covid-19</a>

Serum India told to halt recruitment for vaccine trials

India's drug regulator has directed Serum Institute of India to suspend recruitment of new volunteers for phase 2 and 3 clinical trials of the Oxford Covid-19 vaccine candidate

India's drug regulator has directed Serum Institute of India to suspend recruitment of new volunteers for phase 2 and 3 clinical trials of the Oxford Covid-19 vaccine candidate. The directive came in the backdrop of pharma giant AstraZeneca pausing the trials in other countries. The DCGI on Friday also directed Serum Institute to increase the safety monitoring of the subjects already vaccinated as part of the trial, and submit the plan and report. The drugmaker&nbsp;had on Thursday hit a pause after AstraZeneca put the trials on hold following an unexplained illness in a volunteer in the UK.

New Delhi, PTI: Drugs Controller General of India (DCGI) has directed Serum Institute of India to suspend till further orders new recruitment in phase 2 and 3 clinical trials of the Oxford Covid-19 vaccine candidate in the backdrop of pharma giant AstraZeneca pausing the trials in other countries.
In an order, a copy of which has been accessed by PTI, DCGI Dr V G Somani on Friday also directed Serum Institute of India (SII) to increase the safety monitoring of the subjects already vaccinated as part of the trial, and submit the plan and report.
Somani also asked the firm to submit clearance from Data and Safety Monitoring Board (DSMB) in the UK as well as in India to obtain clearance from his office (DCGI) prior to resumption of future recruitment in the trial. The central drug regulator DCGI had issued a show-cause notice to SII on September 9 for not informing it about AstraZeneca pausing clinical trials of the vaccine candidate in other countries and also for not submitting casualty analysis of the "reported serious adverse events".
Following which the Pune-based firm, which has partnered with the British-Swedish biopharmaceutical giant AstraZeneca for manufacturing the Oxford vaccine candidate, on Thursday said it is pausing the clinical trials in India.
Earlier this week, AstraZeneca said it had paused the trials because of 'an unexplained illness' in a participant in the study. "We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials," SII said in a statement on Thursday. According to the DCGI's order issued on Friday, the SII in its reply stated that DSMB has noted no safety concerns from the Indian study (part 1-phase-2 study) with the first dose and seven days post vaccination safety data. In its reply, SII also stated that DSMB further recommended "to pause further enrolment into the study until ongoing investigations of SAE reported in the UK study is completed and the sponsor and the UK DSMB are satisfied that it doesn't pose any safety concerns".
"In the view of the above, I Dr V G Somani, Drugs Controller General of India, Central Licensing Authority, after careful examination of your reply and the recommendations of the DSMB in India, in exercise of the powers vested under Rule 30 of the New Drugs and Clinical Trials Rules, 2019, direct to you suspend any new recruitment in the phase 2 and 3 clinical trial till further orders," the order read.
"Increase the safety monitoring of the subjects already vaccinated with the vaccine under trial and submit the plan and report," the order further stated.

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