Dr. Purvish Parikh in this article throws light at the important decision by the Indian CDSCO about clinical trials in the background of the COVID-19 pandemic.

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The COVID-19 (SARS-CoV-2) pandemic is affecting almost all the countries in the world. The number of infected cases have almost reached a million. Healthcare facilities and personnel are being roped in to fight the Tsunami of suspected and serious COVID-19 cases.

This means that the 262,366+ ongoing randomized clinical trials globally and the 2500+ ongoing clinical trials in India are taking a backseat. The rigors of clinical trials (ICH-GCP and DCGI/CDSCO requirements) are under threat of being compromised and their data becoming unacceptable to regulatory authorities. Hence innovative solutions must be reached to save the ongoing trials from being “infected” by COVID-19 and prevent them from having a “Serious Adverse Reaction”.

Does the recent CDSCO circular permit ongoing clinical trials to be suspended or terminated?