Centre issues regulatory pathways for foreign-produced COVID-19 vaccines

New Delhi [India], April 15 : In view of the rapid surge in coronavirus cases in India, the Central government approved a significant streamlining and fast-tracking of the regulatory system for COVID-19 vaccines approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL).
As per the Ministry of Health and Family Welfare, the government issued the Regulatory Pathway in India for foreign-produced COVID-19 vaccines on Thursday.
The Ministry in the release said that the Central Drugs Standards Control Organization (CDSCO) headed by the Drugs Controller General of India (DCGI) will prepare detailed guidelines specifying regulatory pathway for approval of foreign approved COVID vaccines based on NEGVAC recommendations.
"These guidelines have since been prepared and posted by CDSCO on its website. CDSCO will take steps to widely disseminate these guidelines to the concerned stakeholders. Applicants for grant of approval for restricted use in emergency situation may be submitted to CDSCO. The 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)," the Ministry said.
Further, CDSCO will process such applications for restricted use in emergency situation and DCGI will consider and make a decision within three working days from the date of submission of the complete application by the applicant.
The Ministry said that DCGI will issue permission for restricted use in emergency situation with, inter-alia, the following conditions--"Vaccine shall be used as per the guidelines prescribed under National Covid-19 Vaccination Programme. The first 100 beneficiaries of such vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further vaccination program. The applicant shall initiate the conduct of post-approval bridging clinical trials within 30 days of such approval."
The release said the applications for restricted use in emergency situation for such vaccines may be accompanied by bridging trial protocol, application for the import registration certificate and application for an import license.
"CDSCO will process applications for a 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," it said.
Notably, as per the existing protocol of CDSCO for batch release of vaccines, each batch of the vaccine will be released by Central Drugs Laboratory(CDL), Kasauli before it can be used as per the guidelines prescribed under the National Covid-19 vaccination programme.
The Ministry said that the applicant will use the 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. CDSCO will approve the protocol for the bridging trial in consultation with the Subject Expert Committee (SEC) within seven days of the receipt of the proposal," it added.
It further said that the applicant will conduct the bridging trial within the timelines specified in the approved protocol, and submit data generated in the bridging trial to CDSCO, and after the receipt of the bridging trial results, the DCGI will review the permission granted for restricted use in the emergency situation.