Foreign Covid-19 vaccines: Applications for emergency use to be decided in three days
A foreign manufacturer can apply through its Indian subsidiary or through its authorized agent in India
Applications for restricted emergency use of foreign Covid-19 vaccines will be decided by India's national drugs regulator within three working days from the date of submission of complete application by the applicant.
This is part of the regulatory pathways, or guidelines, for foreign Covid-19 vaccines issued by the Ministry of Health and Family Welfare on Thursday.
These are applicable to vaccines approved for restricted use by the United States Food and Drug Administration (FDa), European Medicines Agency (EMA), United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and those named in the World Health Organization’s Emergency Use Listing.
Applications for grant of approval for Restricted Use in Emergency situations will need to be submitted to Central Drugs Control Standards Organisation (CDSCO).
As per the guidelines, an application can be made by the foreign manufacturer through its Indian subsidiary or through its authorized agent in India (in case it does not have an Indian subsidiary).
CDSCO will process such applications for Restricted Use in Emergency Situation and the Drugs Controller General of India (DGCI) will consider and take a decision within three working days from date of submission of complete application by the applicant.
The DCGI will issue permission for Restricted Use in Emergency situation with the following conditions:
· Vaccine shall be used as per the guidelines prescribed under National COVID-19 vaccination programme.
· First 100 beneficiaries of such vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further vaccination programme.
· Applicant shall initiate conduct of post approval bridging clinical trials within 30 days of such approval.
Further, the guidelines said that the applications for Restricted Use in Emergency situations for such vaccines may be accompanied by bridging trial protocol, application for import registration certificate and application for import license.
CDSCO will process applications for Registration Certificate (registration of overseas manufacturing site and product: in this case Covid vaccine) and Import License, within three working days from the date of approval of Restricted Use in Emergency Situation.
As per the existing protocol of CDSCO for batch release of vaccines, each batch of the vaccine will be released by the Central Drugs Laboratory (CDL), Kasauli, before it can be used as per the guidelines prescribed under the National COVID-19 vaccination programme.
The applicant will use COVID vaccine, after receipt of CDL approval, initially only on 100 beneficiaries and submit the safety data to CDSCO.
CDSCO will review the safety data submitted by the applicant, and once found satisfactory, will authorise the applicant to use the vaccine.
The regulatory body will approve the protocol for bridging trial in consultation with the Subject Expert Committee (SEC) within seven days of the receipt of the proposal.
Applicants will conduct the bridging trial within the timelines specified in the approved protocol, and submit data generated in the bridging trial to CDSCO.
After the receipt of the bridging trial results, the DCGI will review the permission granted for Restricted Use in an Emergency situation.