New Delhi: Amid India's indigenous COVID-19 vaccine controversy, country's apex medical research institute, Indian Council of Medical Research (ICMR), on Saturday admitted that red-tapism creates hindrances in the functioning of the Government of India.
Referring to the fast track of COVID-19 vaccine, ICMR said, "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 further said that it is committed to treating the safety and interest of people of India as a topmost priority.
The statement given by ICMR comes a day after it put itself into a vaccine controversy after Director-General Dr Balram Bhargava asked country's 12 clinical trial sites to get ready to bring the COVID-19 vaccine on or before August 15.
The moment, the letter signed by Dr Bhargava came to the fore, scientists, researchers across the country have raised their voice asking how can a pandemic vaccine be developed in 30-40 days.
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The ICMR said that after intense characterization and review of all data from Bharat Biotech International Limited (BBL), ICMR along with National Institute of Virology (NIV), Pune are supporting the clinical development as the vaccine candidate appeared to be promising.
"Based on in-depth scrutiny of the available data from preclinical studies, the Drugs Controller General of India has recorded permission to conduct Phase 1 and 2 clinical trial," the ICMR said.
It said that in the larger public interest, it is important for ICMR to expedite the clinical trials with a promising indigenous vaccine.
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 the disease of pandemic potential where in human and animal trials can we can continue in parallel," the ICMR said.
Now that preclinical studies have been completed successfully, the phase 1 and 2 human trials are to be initiated. "The letter by DG-ICMR to investigators of the clinical trial site was meant to cut unnecessary red tape, without bypassing and necessary process, and speed up recruitment of participants," the ICMR said in a statement.
ICMR is amongst the worlds most reputed organisations in the field of medical research and regulations and its track record of facilitating India's globally respected and acknowledged vaccine and drug industry is well recognised.
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"Our trial will be done following the best practices and rigour and will be reviewed, as required, by a Data Safety Monitoring Board (DSMB). While issues raised in the public domain from time to time by commentators are welcome, as they form an important part of the 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," the ICMR said.
It further said that as the world is battling the COVID-19 pandemic, 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 globe, "it is also important to promote indigenous vaccine development while at the same time ensuring safety, quality, ethics and adherence to all regulatory requirements."
