Johnson & Johnson has applied to the drug regulator in India asking for permission to carry out phase-3 clinical trial of its single-dose COVID-19 vaccine and for import license, stated sources.

The company solicited an early meeting of the subject expert committee on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) to decide on its application.

The Central Government had taken a decision last week to fast-track emergency approvals for all foreign-produced COVID-19 vaccines that have received a similar approval by the World Health Organization or regulators in the United States, Europe, Britain or Japan.

Emergency use approval will be given to such vaccines, commanding the need of parallel bridging clinical trial after approval in place of local clinical trial under the provisions of the New Drugs and Clinical Trials Rules 2019, stated the health ministry… (ET Healthworld – PTI, April 20, 2021)