AMN / WEB DESK
India Central Drug Regulator, DCGI will now take decisions on usage of foreign COVID vaccines in the country within three days of their application. The Centre informed this along with issuing regulatory pathway for emergency use authorisation of COVID-19 Vaccines approved by US FDA, EMA, UK MHRA, PMDA Japan are listed in WHO Emergency Use Listing.
The Government had earlier on Tuesday approved a significant fast tracking system for quicker access to foreign COVID-19 vaccines. Central Drugs Standard Control Organisation (CDSCO) in its latest regulatory pathway for granting emergency approval to foreign COVID vaccines has said that such applications will be processed and decision will be taken by DCGI within 3 working days from the date of submission of complete application by the applicant company or pharma organisation. However, it added , the permission for Restricted Use in Emergency situations would be granted with the condition that Vaccines will be used in the country as per the guidelines prescribed under National Covid-19 Vaccination Programme.
The CDSCO has said that the first 100 beneficiaries of such vaccines will be assessed for 7 days for safety outcomes before the vaccine is rolled out for further Vaccination program. It also said that the applicant company shall initiate conduct of post approval bridging clinical trials within 30 days of approval granted to them. The DCGI will review the permission granted for Restricted Use of the Vaccines after receipt of the bridging trial results.