New Delhi (NVI): The Indian Council of Medical Research has said that its process to develop indigenous Covid-19 vaccine is as per the globally accepted norms and that the August-15 deadline to launch the vaccine has been set to expedite the process in the wake of an emergency health crisis.
The ICMR in a press release yesterday said that it has kept the safety and interest of the people of India as topmost priority in the vaccine development process. The council said that an inactivated Covid-19 vaccine candidate has been developed by Bharat Biotech in collaboration with ICMR- National Institute of Virology, Pune.
“As the entire world is battling the COVID-19 pandemic, 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,” ICMR said in the release.
It said that after intense characterisation and review of all data from BBIL (Bharat Biotech International Ltd), it 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 trials, the Drugs Controller General of India has accorded permission to conduct phase 1 and 2 clinical trial,” it said.
The apex body further stated that it is important to expedite the clinical trials with a promising indigenous vaccine. Defending its stand on the deadline, the body said, “Faced with the unprecedented nature of the Covid-19 pandemic, and the consequent dislocation of the normal life, all other vaccines across the globe have been similarly fast-tracked.”
It said phase 1 and 2 human trials are to be initiated as the preclinical trials have been completed successfully now. The council further stated in the release 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.”
“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 added.
-ARK
