New Delhi: Criticism of its directives to scientists to speed of the human trials of the in the making COVID 19 Vaccine, the ICMR prompted the ICMR to release a statement. The ICMR said that the letter by DG Dr. Balram Bhargawa was intended to cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants for human trials so that these phases can be completed at the earliest. It added that since pre-clinical studies have completed successfully now, phases 1 and 2 human trials are to be initiated.
“In the larger public health 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 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,” ICMR said.
The ICMR said its trials will be done following the best practices and rigour and will be reviewed 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 rigor. ICMR is committed to treating the safety and interest of people of India as a topmost priority,” the statement said.
