The ICMR requested docs in 12 hospitals to “fast track” medical trials for the coronavirus vaccine.
New Delhi:
The security and curiosity of Indians is the topmost precedence, the Indian Council of Medical Research (ICMR) stated on Saturday after a memo from the company triggered a backlash for setting August 15 as a goal for creating a coronavirus vaccine, from each medical specialists and the opposition.
A letter despatched out earlier this week by the chief of India’s prime medical analysis company said it “envisaged” launching a novel coronavirus vaccine by Independence Day, prompting accusations by the opposition that the date was set to assist Prime Minister Narendra Modi’s authorities rating political factors.
The letter by ICMR Director-General Balram Bhargava that requested docs in 12 hospitals to “fast track” medical trials also stumped some doctors and researchers, who stated it was unrealistic to set a six-week deadline for a candidate vaccine whose security and efficacy trials haven’t even began.
Defending its message, the ICMR on Saturday stated, “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.”
“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 aim is to complete these phases at the earliest, so that population-based trials for efficacy could be initiated without delay,” it stated.
“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,” the company stated.
The vaccine trials shall be accomplished following the most effective practices and rigour, and shall be reviewed, as required, by a Data Safety Monitoring Board (DSMB), ICMR stated.
“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. ICMR is committed to treat the safety and interest of people of India as a topmost priority,” it added.
Dr Randeep Guleria, director of Delhi’s All India Institute of Medical Sciences (AIIMS) instructed NDTV, “It is unrealistic and even the ICMR is aware of that. The letter was written to speed up processes.”
Dozens of vaccine candidates are at varied levels of improvement around the globe to sort out the coronavirus pandemic. India, a number one producer of vaccines and generic medicines, is anticipated to play a key position on this race.
At least seven vaccines are being researched in India and one, from Bharat Biotech and being developed with the ICMR, and one other from drugmaker Zydus Cadila have been authorised for Phase I and Phase II medical trials this week.
Phase I and Phase II trials sometimes check the security of a drug earlier than it enters Phase III trials that check its efficacy.
Each section can final months, if not years, and though regulators globally have been fast-tracking trials on medicines and vaccines to deal with the novel coronavirus, the timeline given out within the letter could be unprecedented.
“To my knowledge, such an accelerated development pathway has not been done EVER for any kind of vaccine, even for the ones being tried out in other countries,” Anant Bhan, a health care provider and public well being researcher, stated on Twitter.
“Even with accelerated timelines, this seems really rushed, and hence with potential risks, inadequate attention to process.”
Several different well being specialists and political events additionally questioned the launch date proposed within the letter, which was broadly shared on social media.
Asserting that scientific advances can’t be “made to order”, Communist Party of India (Marxist) general secretary Sitaram Yechury on Saturday alleged the ICMR was making an attempt to hurry the vaccine in order that Prime Minister Narendra Modi might make the announcement on Independence Day.
Congress chief Prithviraj Chavan additionally alleged on Saturday that the ICMR’s plans was aimed solely at enabling the prime minister to make an enormous announcement from the Red Fort.