A day after experts raised concerns over the Indian Council of Medical Research’s (ICMR) decision to fast-track vaccine development for Covid-19 and set a deadline for August 15, the ICMR has issued a clarification stating that it has decided to fast track the process to cut red-tapeism.
In a statement, the ICMR said the letter sent by DG-ICMR to investigators of the clinical trial sites was “meant to cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants”.
“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,” the ICMR said in its statement.
It said the aim behind this is to complete these phases of vaccine development at the earliest, so that population-based trials for efficacy could be initiated without delay.
The ICMR and Bharat Biotech are jointly developing Covaxin, an indigenous vaccine against Covid-19.
The ICMR ran into a controversy on Friday when a letter written by Director General ICMR Balram Bhargava cgot leaked into the public domain. In the letter, he said human trials for the coronavirus vaccine (Covaxin) should be “fast-tracked” and set a deadline of August 15, which experts said was unrealistic.
The letter said, “It is envisaged to launch the vaccine for public health use latest by August 15, 2020, after completion of the trial.”
It further stated that Bharat Biotech is strictly “advised to fast-track all approvals needed to ensure subject enrolment is initiated no later than July 7”, and that “non-compliance will be taken very seriously”.
Ever since this letter came out in the public domain, public health experts raised ethical and safety concerns over this move to fast-track vaccine development for a disease about which the world is still learning. (Read more about the controvery and what experts said here.)
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