India’s drug control will make a decision on applications seeking approval for restricted emergency use of foreign-produced COVID-19 vaccines within three working days from the date of submission, the government said on Thursday.
The move comes at a time when India is fighting a wave in COVID-19 cases with over two lakh cases reported in a single day on Thursday, taking the total number of cases to 1,40,74,564.
The Central Drugs Standard Control Organisation (CDSCO), which is directed by the Drug Controller General of India (DCGI), 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 an emergency situation.
The CDSCO has published complete guidelines defining an administrative pathway for approval of foreign approved COVID-19 vaccines after the central government on Tuesday decided to fast-track emergency approvals for all coronavirus hits that have been given a similar acceptance by the WHO or regulators in the United States, Europe, Britain or Japan.
The Union Health Ministry on Thursday announced administrative pathways for foreign-produced COVID-19 vaccines according to which the CDSCO has provided detailed guidelines specifying regulatory pathway.
Applicants for grant of consent for restricted use in an emergency situation may be submitted to the CDSCO and the application can be made by the foreign manufacturer through its Indian subsidiary or through its authorised agent in India (in case it does not have an Indian subsidiary), the ministry said.
“The CDSCO will process such applications for restricted use in an emergency situation and the DCGI will consider and take a decision within 3 working days from the date of submission of a complete application by the applicant,” it said.
The DCGI will assign authorisation for restricted use in an emergency situation with the condition that the vaccine shall be used as per guidelines prescribed under the National COVID-19 Vaccination Programme.
The first 100 beneficiaries of such vaccines shall be evaluated for 7 days for safety outcomes before it is rolled out for further vaccination program and the applicant shall begin the conduct of post-approval bridging clinical trials within 30 days of such approval.
Requests for restricted use in an emergency situation for such vaccines may be followed by bridging trial protocol, application for an import registration certificate and application for an import license, according to the pathway issued.
As per the present protocol of CDSCO for batch release of vaccines, each batch of the vaccine will be delivered by the Central Drugs Laboratory(CDL), Kasauli before it can be used as per the guidelines prescribed under the National COVID-19 vaccination programme.
As per the guidelines, the applicant will use the COVID-19 vaccine, after receipt of CDL approval, originally only on 100 beneficiaries and submit the safety data to CDSCO.
The CDSCO will evaluate the safety data presented by the applicant, and once found adequate, will allow the applicant to use the vaccine and will allow the protocol for the bridging trial in consultation with the Subject Expert Committee (SEC) within 7 days of the receipt of the proposal.
An applicant will conduct the bridging trial within the timelines stipulated in the accepted protocol, and submit data generated in the bridging trial to CDSCO.
Following the receipt of the bridging trial results, the DCGI will review the permit granted for restricted use in an emergency situation, the guidelines stated.
Certain guidelines have been planned and posted by the CDSCO on its website. The CDSCO will take steps to widely distribute these guidelines to stakeholders.
The government on April 13 had allowed streamlining and fast-tracking of a regulatory system for COVID-19 vaccines approved for restricted use by the US FDA, EMA, UK MHRA, PMDA Japan or which are listed in the WHO Emergency Use Listing (EUL).
The movement will facilitate faster access to such foreign vaccines by India and would encourage imports including import of bulk drug material, optimal utilization 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 ministry said.