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August 2020
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Sports Minister Rijiju to launch Fit India Freedom Run on Friday        Hoping to get the speed gun up, Starc works on muscular body during COVID lockdown        SpiceJet offers automated customer service and check-in facility on WhatsApp        Sebi issues procedure for exchanges to handle investor complaints against listed cos        Experts warn Spain is losing the 2nd round in virus fight        Bhutan imposes 1st nationwide virus lockdown        Pilot meets Gehlot, handshake signals his return        Over 3 Cr N95 masks, 1.28 Cr PPEs, 10 Cr HCQ tablets given to states, UTs by Centre for free        Bengal govt encourages organ donation: Mamata        PM unveils new tax reforms - faceless tax assessment, taxpayers' charter        Virus outbreak threatens New Zealand's fan-filled stadiums        Lahiri back in action after 5 months, joins Atwal at Wyndham        HAL s Light Combat Helicopters deployed for operations at Leh        Sensex falls over 200 pts in early trade; Nifty below 11,300        Black women, Democrats celebrate Indian-origin Senator Harris' nomination as VP        Joe Biden names Indian-American Senator Kamala Harris as running mate        Biden 'nailed this decision' in picking Harris to be his running mate: Obama        Terrorist gunned down, soldier killed in encounter in J-K's Pulwama        Mulayam Singh Yadav's condition under control: Hospital        COVID-19: 60,963 fresh cases take India's tally to 23,29,638        
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National News
ICMR says following all globally accepted norms to fast-track vaccine; wants to 'cut red tape'
 
New Delhi: As experts cautioned against rushing the process for developing a COVID-19 vaccine after the ICMR stated it plans to launch one by August 15, the apex health research body on Saturday stressed that it is acting in accordance with the globally accepted norms to fast-track vaccine development for diseases of pandemic potential.


The ICMR said that the letter by Director General of ICMR Dr Balram Bhargava to principal investigators of the clinical trial sites was meant to cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants.

Bhargava had on July 2 written to principal investigators of select medical institutions and hospitals to fast-track human clinical trial approvals for the vaccine candidate 'Covaxin' being developed in collaboration with Bharat Biotech.

All other vaccine candidates across the globe have been similarly fast-tracked, it said, adding that the Drugs Controller General of India has accorded permission to conduct phase 1 and 2 (human) clinical trial of 'Covaxin' based on in-depth scrutiny of the available data from pre-clinical studies.

Just as red tape was not allowed to become a hindrance in the fast track approval of new indigenous testing kits or for introducing in the Indian market potential COVID-19 related drugs, the indigenous vaccine development process has also been sought to be insulated from slow file movement, it said.

"The aim is to complete these phases at the earliest, so that population-based trials for efficacy could be initiated without delay," ICMR said in a statement.

After intense characterization and review of all data from BBIL, ICMR said it is supporting the clinical development as the vaccine candidate appears to be promising.

In the larger public health interest, it is important for ICMR to expedite the clinical trials with a promising indigenous vaccine, the statement stated.

Faced with the unprecedented nature of the COVID-19 pandemic, and the consequent dislocation of the normal life, all other vaccine candidates across the globe have been similarly fast-tracked, it said.

"ICMR's process is exactly in accordance with the globally accepted norms to fast-track the vaccine development for diseases of pandemic potential wherein human and animal trials can continue in parallel," it said.

Underlining ICMR was among the world's most reputed organisations in the field of medical research and its track record of facilitating India's globally respected and acknowledged vaccine and drug industry speaks for itself, the research body said trials will be done following the best practices and rigour.

They will be reviewed, as required, by a Data Safety Monitoring Board (DSMB).

"While issues raised in public domain from time-to-time by commentators are welcome, as they form an important part of feedback loop, the best of India's medical professionals and research scientists should not be second guessed for their professionalism or adherence to the highest scientific rigour," the statement stated.

"ICMR is committed to treat the safety and interest of people of India as a topmost priority," it said.

The Indian Council of Medical Research(ICMR) has identified 12 clinical trial sites, including medical institutions and hospitals, and has asked their principal investigators to ensure that the subject enrolment is initiated no later than July 7.

Noting that this was the first indigenous vaccine being developed by India, Bhargava in his letter to principal investigators of the 12 sites said that it is one of the "top priority projects which is being monitored at the top-most level of the government".

"It is envisaged to launch the vaccine for public health use latest by August 15 after completion of all clinical trials....

"You have been chosen as a clinical trial site of the BBV152 COVID vaccine. In view of the public health emergency due to COVID-19 pandemic and urgency to launch the vaccine, you are strictly advised to fast track all approvals related to initiation of the clinical trial and ensure that the subject enrolment is initiated no later than July 7," the letter stated.

The letter further warned that any non-compliance will be viewed very seriously.

"Kindly note non-compliance will be viewed very seriously. Therefore, you are advised to treat this project on highest priority and meet the given timelines without any lapse," the letter stated.


Pilot meets Gehlot, handshake signals his return
Over 3 Cr N95 masks, 1.28 Cr PPEs, 10 Cr HCQ tablets given to states, UTs by Centre for free
Bengal govt encourages organ donation: Mamata
Terrorist gunned down, soldier killed in encounter in J-K's Pulwama
Mulayam Singh Yadav's condition under control: Hospital
COVID-19: 60,963 fresh cases take India's tally to 23,29,638
TN logs 5,834 fresh COVID infections, govt says treatment for non-virus cases unaffected
Former Prez Pranab Mukherjee tests positive for COVID-19
EIA draft must be withdrawn to stop 'environmental destruction': Rahul
62,064 new COVID cases; 1,007 deaths
Def Minister Rajnath Singh announces restrictions on import of 101 defence items
PM to launch financing facility under Agriculture Infrastructure Fund
Border row: India, China hold Major General-level talks on disengagement process
Abhishek Bachchan tests negative COVID-19
Trust for building mosque on five-acre land in Ayodhya in process of setting up office
Pak shells forward areas in Poonch
Centre releases Rs 890 cr as 2nd tranche of package for COVID-19 health system preparedness
Eight COVID-19 patients killed in fire at Ahmedabad hospital
Chemical stored in Chennai safe, to be e-auctioned: Customs
India hits out at China for attempting to raise Kashmir issue at UNSC
ENTERTAINMENT NEWS
My whole life has been a miracle: Rajinikanth
 Mumbai: From starting out as a bus conductor to becoming one of the biggest stars of the: country,  
'Game of Thrones' star Indira Varma tests positive for coronavirus
Coronavirus: Release of Ranveer Singh-starrer '83' put on hold
'Joker' earns Joaquin Phoenix his maiden Oscar
INTERNATIONAL NEWS
Experts warn Spain is losing the 2nd round in virus fight
 Barcelona: Not two months after battling back the coronavirus, Spain's hospitals are beginning to se
Bhutan imposes 1st nationwide virus lockdown
Black women, Democrats celebrate Indian-origin Senator Harris' nomination as VP
Joe Biden names Indian-American Senator Kamala Harris as running mate
KERALA NEWS
Toll in Idukki landslide rises to 52 as three more bodies recovered
 Idukki (Ker): The toll in the landslip in Pettimudi in the high range Idukki district rose to 52 wit
1,417 Covid cases in Kerala; 36 health workers also infected
SIT formed by Kerala police to probe air crash
Kerala logs 1,211 fresh coronavirus cases; aggregate reaches 34,331
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