Stating that safety and interest of Indians is the topmost priority, ICMR wrote that "it is also important to promote indigenous vaccine
development while at the same time ensuring safety, quality, ethics and adherence to all regulatory requirements."
The apex body further assured 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."
The expedite approach has been chosen owing to the unprecedented global crisis caused by the spread of Coronavirus.
An inactivated Covid-19 vaccine candidate has been developed by Bharat Biotech International Ltd. in collaboration with ICMR - National Institute of Virology, Pune.
"After intense characterization 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 has accorded permission to conduct phase 1 and 2 clinical trials," the statement read.
The clarification comes in the wake of serious doubts being raised over the August 15 timeline that was mentioned in a letter written by ICMR director general Balram Bhargava to 12 hospitals chosen for carrying out clinical trials of Covid-19 vaccine.
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The deadline was being termed unrealistic and many raised an alarm over the following part of the letter:
“It is envisaged to launch the vaccine for public health use latest by August 15, 2020, after completion of all clinical trials… You are strictly advised to fast-track all approvals related to the initiation of the clinical trial, and ensure that the subject enrolment is initiated no later than July 7, 2020,” Bhargava wrote, followed by, “Kindly note that non-compliance will be viewed very seriously.”
ICMR has defended itself by stating that the nation's best medical professionals and research scientists should not be second-guessed.
"While issues raised in the 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."