ICMR Claims It's Fast-Tracking COVAXIN to Cut 'Unnecessary Red Tape'

In a new clarificatory note, the nodal medical research agency didn't say why or how the August 15 deadline had been chosen.

New Delhi: After a letter by the Indian Council for Medical Research (ICMR) chief urging medical research centres to produce an ‘Indian vaccine’ by August 15 raised suspicions of politics driving science, the body on Saturday issued a statement saying the vaccine has been fast-tracked by “cutting unnecessary red tape, without bypassing any necessary process”.

On July 2, ICMR’s director general Balram Bhargava had written to 12 select institutions, asking them to commence clinical trials of COVAXIN, a COVID-19 vaccine developed by Bharat Biotech. Though the vaccine was approved for human clinical trials by the Drugs Controller General of India (DCGI), Bhargava’s directive to have the vaccine ready for “public health use” by August 15 raised eyebrows. This deadline was interpreted as giving Prime Minister Narendra Modi an opportunity to win political points by announcing the vaccine to the nation during his Independence Day speech.

Also Read: ICMR’s Rush to Produce ‘Indian Vaccine’ for COVID-19 Suggests Politics is Driving Science

On Saturday, ICMR’s statement said that it had asked institutions to expedite the clinical trials of the ‘promising indigenous vaccine’ in the “larger public health interest”.  “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. 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.

“The letter by [Bhargava] 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,” it adds.

ICMR director general Balram Bhargava. Photo: Screenshot/DD News

The research body said that red tape was “not allowed to become a hindrance” in the fast track approval of new indigenous testing kits or for introducing potential COVID-19 related drugs in the Indian market. Similarly, “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,” the statement says.

However, it’s unclear if by these lines ICMR also intends to justify the circumstances and manner in which it approved the use of hydroxychloroquine as a prophylactic among healthcare workers as an avoidance of red tape.

ICMR also sought to reassure fears by saying that trials will be done following the best practices and rigour. They will be reviewed, as required, by a Data Safety Monitoring Board (DSMB) and issues raised in the public domain will also be welcomed. “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 concludes.

However, the statement chose not to address questions about how or why August 15 was chosen as the deadline.

Also Read: Editorial: ICMR Must Decide if it Is India’s Council for Medical Research or its Master’s Voice

ICMR, which is the nodal agency to handle research on COVID-19 in the country, said that the development of an effective vaccine is a promising tool to save lives. “Though a large number of vaccines are under various stages of development all across the world, 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 statement says.