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Pfizer, Moderna COVID-19 vaccines may soon be available in India

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eMediNexus    03 June 2021

The Drugs Controller General of India (DCGI) has allowed approvals of foreign vaccines in India without specific clinical trials conducted in the country prior to usage. 

DCGI Chief, VG Somani, said in a letter that this will apply to vaccines that have already received approval for restricted use from the US FDA, EMA, UK MHRA, PMDA Japan or have been listed for Emergency Use by the World Health Organization. Somani further stated that post-approval clinical trials and testing every batch by the Central Drugs Laboratory (CDL), Kasauli can be spared for the vaccines which are already in use globally by millions. The specific trials will not be required if the vaccine batch/lot has been certified and released by the National Control Laboratory of the Country of Origin… (ET Healthworld, June 2, 2021)

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