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    ICMR says move to fast-track COVID-19 vaccine is in accordance with global norms

    Synopsis

    ICMR said that the letter sent by the DG was meant to cut 'unnecessary red tape'.

    Vaccine maker BBIL received the regulatory nod from the Drug Controller General of India (DCGI) to start human clinical trials for its experimental vaccine last week.
    India’s top health research body on Saturday said that fast tracking of clinical trials of the indigenous Covid-19 vaccine being developed by Bharat Biotech International Ltd is in accordance with the globally accepted norms.

    "In the larger public health interest, it is important for ICMR to expedite clinical trials with a promising indigenous vaccine," said ICMR in a statement, a day after a letter by its Director General seeking to fast track clinical trials so that the vaccine could be launched by Aug 15 stirred a row among medical professionals and healthcare experts.

    However, it said that the letter sent by DG, ICMR was meant to cut “unnecessary red tape”and ICMR was committed to treat the safety and interest of people of India as a topmost priority.

    Justifying its move, ICMR further said that it is important for ICMR to expedite the clinical trials with a 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,” said ICMR in its release dated July 4.

    “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 further said.

    In its letter the ICMR had also instructed the clinical trial sites to enrol the participants by July 7. While questions have been raised on an accelerated approach, ICMR said 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 further added.

    It said that the trials 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 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”.

    Vaccine maker BBIL received the regulatory nod from the Drug Controller General of India (DCGI) to start human clinical trials for its experimental vaccine last week.
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    24 Comments on this Story

    S. SUNDARARAMAN SRINIVASAN34 days ago
    Coincidentally.... 15th August.... the deadline date set by ICMR... FALLS ON INDEPENDENCE DAY.... to enable our Hon. PM to roar like a lion.. in his speech.. as there aren't many topics to touch - Triple talaq ban.. 370 now a problem in itself.. citizen register/CAA a revolt-area... black money retrieval from abroad, a mysterious mole - not a mountain.... millions of jobs promised periodically before 2014 poll now more pronounced by pink slips and shutters down... MIGRANT LABOR can't be a favorable topic on I. Day speech.....? What else to talk with emotional gestures.. ?? Therefore ...............? :-) GOK
    shantanu35 days ago
    This response is a diversion and obfuscation. The issue was that ICMR indicated that a vaccine would be ready by15Aug20, which is not the same as saying that they will fast track the development. A government agency should not be making such false and exaggerated claims as this has implications for other policies and measures with respect to the disease. It’s very distressing to note that ICMR’s pronouncements such as “there is no community transmission” and the vaccine issue seem to be influenced by non-scientific considerations.
    Nasir Ali Zaidi36 days ago
    The situation is abnormal. World over all the governments are anxious for early development of vaccine for treatment of COVID...19 . The only difference is there is no setting of target. The process of developing a vaccine is not like factory production.Secondly the target date is August 15, the independence day when our prime minister will be addressing the nation. Probably he wants to show case this development also major achievement for his leadership.
    The Economic Times