In view of the COVID-19 pandemic and in order to address the emergency situation by increasing the provision of secure and reliable vaccinations, the National Expert Group on Vaccine Administration for Covid-19 found some guidelines on the supply of Covid-19 Vaccine.
The CDSCO will process those proposals for Restricted Use in Emergency Situations on the highest priority through an expedited review/accelerated approval process in accordance with the terms of the New Drugs and Clinical Trial Rules, and the DCGI will assess and make a judgment within three working days of the applicant’s submission of the full application.
Furthermore, a manufacturer proposing to import vaccines into India can submit an application along with a bridging trial procedure, an application for an import registration certificate, an application for an import authorization, and an application for Restricted Use in an Emergency situation to expedite the operation.
Within three working days of the date of acceptance of Restricted Use in Emergency Scenario, CDSCO will process applications for Registration Certificate (registration of oversees production site and substance (in the case of Covid Vaccine) and import license.
Once the Registration Certificate and Import License are granted, the patient would be expected to have each batch of the vaccine checked/published at the Central Drugs Laboratory (CDL), Kasauli until it can be used in accordance with the guidelines recommended under the National Covid-19 vaccination program.
After receiving CDL clearance, the patient can use the Covid-19 vaccine on a limited number of beneficiaries, initially 100, and send protection data to CDSCO.
CDSCO will check the applicant’s protection records which, if considered appropriate, will grant the applicant permission to use the vaccine.
Within 7 days of receiving the request, CDSCO will accept the bridging trial procedure in conjunction with the Subject Expert Committee (SEC).
The applicant will perform the bridging trial within the timeframes stated in the agreed procedure and will send the bridging trial results to CDSCO.
The DCGI can check the approval given for Restricted Use in an Emergency scenario until the bridging trial results are received.
The Covid-19 vaccines that have already been licensed by the DCGI for restricted usage in emergency situations in India and are proposed to be filled at a location within the country separate from the manufacturing site by getting bulk of the approved vaccine, will also be approved by CDSCO dependent on inspection and CDL release.
Furthermore, if such a vaccine is produced in India from the simple drug material level to the fill-finish stage, it would be granted a manufacturing license for stockpiling and CDL release dependent on examination.
eStartIndia will help you getting approval for the import of the COVID Vaccine from the CDSCO department.