Rohit Shishodia

Faced with criticism over fast track approvals to clinical trials of the Covid vaccine developed by Bharat Biotech International Limited (BBIL) so that vaccines are ready for use by August 15, 2020, the Indian Council of Medical Research has defended its position and said that ICMR’s process is exactly in accordance with globally accepted norms to fact-track vaccine development for diseases of pandemic potential wherein human and animal trials can continue in parallel.

It may be noted that ICMR DG- Prof. Balram Bhargava had directed scientists to fast track all approvals related to initiation of the clinical trial of the vaccine and to ensure that the subject enrollment is initiated no later than July 7, 2020.

This drew criticism from experts who pointed out that the trial had potential risks as the process seemed really rushed and only four reputed government institutes were chosen to conduct it.  

The ICMR has pointed out that the letter 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.

In a press release, the ICMR has stated that 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.

“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 related drugs, the indigenous vaccine development process has also been sought to be insulated from slow file movement. The aim is to complete these phases at the earliest, so that population-based trials for efficacy could be initiated without delay,” said ICMR.

“Our trials will be done following the best practices and rigor, and 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,” it added.