India will take only three working days to clear the applications to import and supply 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). The country's drug regulator Central Drugs Standards Control Organization (CDSCO) headed by the Drugs Controller General of India (DCGI) will issue a detailed guideline specifying the regulatory pathway for such approvals on the basis of recommendations from the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC), headed by Niti Aayog member (health) Dr VK Paul soon.
Union Health Ministry said the decision will facilitate quicker access to such foreign vaccines by India and would encourage imports including import of bulk drug material, optimal utilisation of domestic fill and finish capacity etc., which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability within the country.
The DCGI's permission for Restricted Use in Emergency situation will be conditional. First of all, such vaccines will have to be used as per the guidelines prescribed under National Covid-19 Vaccination Programme. Secondly, the first 100 beneficiaries of such vaccines shall be assessed for 7 days for safety outcomes before it is rolled out for further vaccination programme. The applicant will also be required to initiate conduct of post approval bridging clinical trials within 30 days of such approval.
The applicants for Restricted Use in Emergency situation for such vaccines will have to submit a bridging trial protocol, application for import registration certificate and application for import license at the time of application itself.
CDSCO will process applications for Registration Certificate (registration of oversees manufacturing site and product: in this case Covid vaccine) and Import License, within 3 working days from the date of approval of Restricted Use in Emergency Situation, the ministry said.
The CDSCO will approve the protocol for the bridging trial in consultation with Subject Expert Committee (SEC) within 7 days of the receipt of the proposal. The government will also ask the applicant to conduct the bridging trial within the time lines specified in the approved protocol, and submit data generated in the bridging trial to CDSCO. Based on the bridging trial results, the DCGI will review the permission granted for Restricted Use in Emergency situation.
On April 13, the Centre had approved the streamlining and fast tracking of 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).