In strict words, the ICMR said that while issues raised in public domain from time to time by commentators are welcome, '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.'
Claiming that the ICMR is committed to treat the safety and interest of people of India as a topmost priority, it said "Our trials will be done following the best practices and rigour, and will be reviewed, as required, by a Data Safety Monitoring Board (DSMB)."
In its statement, the health research institute said that that it was important to 'promote' indigenous vaccine development while at the same time 'ensure safety, quality, ethics and adherence to all regulatory requirements.'
An inactivated Covid-19 vaccine candidate has been developed by Bharat Biotech International (BBIL), in collaboration with ICMR – National
institute of Virology, Pune. ICMR said that after intense characterisation and review of all data from BBIL, ICMR is supporting the clinical development as the vaccine candidate appears to be promising.
Based on in-depth scrutiny of the available data from pre-clinical studies, the Drugs Controller General of India(DCGI) has accorded permission to conduct phase 1 and 2 clinical trial.
The statement further noted that, "In the larger public health interest, it is important for ICMR to expedite the clinical trials with a promising indigenous vaccine. 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."
However, it is unclear which global vaccine candidate has set a timeline of 40-days from beginning of phase 1 human trials to the launch. Health experts have said that it is unprecedented that a deadline for launch is announced even before the phase 1 trials start.
The ICMR, however, claimed that its 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.' Pre-clinical studies have been completed. Announcing the DCGI nod for phase 1 and 2 human trials, BBIL had said "Expedited through national
regulatory protocols, the company accelerated its objective in completing the comprehensive pre-clinical studies. Results from these studies have been promising and show extensive safety and effective immune responses."