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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.

Kangana admitted in HC about illegal construction: BMC 

The Brihanmumbai Municipal Corporation in an affidavit filed before the Bombay High Court has said that it undertook demolition of&nbsp;&lsquo;illegal alterations at actor Kangana Ranaut's bungalow&nbsp;with&nbsp;no&nbsp;ulterior motives.

The Brihanmumbai Municipal Corporation in an affidavit filed before the Bombay High Court has said that it undertook demolition of&nbsp;&lsquo;illegal alterations at actor Kangana Ranaut's bungalow&nbsp;with&nbsp;no&nbsp;ulterior motives.&nbsp;In its affidavit, the BMC said, &lsquo;even in the present petition, Kangana has not disputed the fact that she has carried out unlawful alterations and additions. The world&rsquo;s richest civic body said&nbsp;even&nbsp;in her response to a stop-work notice earlier,&nbsp;Kangana&nbsp;did not dispute the allegation of illegal alterations but only made baseless counter-allegations and sought seven days to respond to the notice further.&nbsp;The civic body filed an affidavit in the court a day after Ranaut challenged the demolition at her bungalow in Pali Hill in suburban Bandra.&nbsp;Ranaut's lawyer Rizwan Siddiqui claimed that the BMC had damaged the property, leading to water and electricity connections getting disrupted.&nbsp;

The Brihanmumbai Municipal Corporation in an affidavit filed before the Bombay High Court has said that it undertook demolition of illegal alterations at actor Kangana Ranaut's bungalow&nbsp;with&nbsp;no&nbsp;ulterior motives.&nbsp;
In its affidavit, the BMC said, &lsquo;even in the present petition, Kangana has not disputed the fact that she has carried out unlawful alterations and additions.
The world&rsquo;s richest civic body said&nbsp;even&nbsp;in her response to a stop-work notice earlier,&nbsp;Kangana&nbsp;did not dispute the allegation of illegal alterations but only made baseless counter-allegations and sought seven days to respond to the notice further.&nbsp;
The civic body filed an affidavit in the court a day after Ranaut challenged the demolition at her bungalow in Pali Hill in suburban Bandra.&nbsp;Ranaut's lawyer Rizwan Siddiqui claimed that the BMC had damaged the property, leading to water and electricity connections getting disrupted.&nbsp;&nbsp;

BMC serves show-cause notice to designer Manish Malhotra

After Kangana&nbsp;Ranaut, fashion desinger&nbsp;Manish Malhotra&nbsp;gets BMC&nbsp;notice for his bungalow

The BMC&nbsp;after demolishing a section of&nbsp;Kangana Ranaut's office building at Pali Hill in Mumbai,&nbsp;has now issued a show-cause notice to fashion designer Manish Malhotra&nbsp;for allegedly making "unauthorised alterations" at his office building.
The designer has been issued a notice by the municipal corporation for illegally turning his residential space into a commercial property.
BMC has also sought a reply from him within seven days.

seven days

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