Amid a wrenching surge in Covid-19 cases and deaths, the government today issued the regulatory pathway in the country for coronavirus vaccines approved for restricted use by the US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL), the Union Health Ministry said.
The development comes at a time when the country is facing an acute shortage of Covid-19 vaccines as both the Serum Institute and Bharat Biotech are struggling to scale up the production of Covishield and Covaxin, respectively.
The Central Drugs Standard Control Organisation (CDSCO), which is headed 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 issued detailed guidelines specifying regulatory pathway for approval of foreign approved Covid-19 vaccines after the central government on Tuesday decided to fast-track emergency approvals for all coronavirus jabs that have been given a similar nod by the WHO or regulators in the United States, Europe, Britain or Japan.
The Union Health Ministry on Thursday issued regulatory pathways for foreign produced Covid-19 vaccines according to which the CDSCO has prepared detailed guidelines specifying regulatory pathway.
Applicants for grant of approval 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 make a decision within 3 working days from date of submission of a complete application by the applicant," it said.
The DCGI will issue permission 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 assessed for 7 days for safety outcomes before it is rolled out for further vaccination program and the applicant shall initiate conduct of post-approval bridging clinical trials within 30 days of such approval.
Applications for restricted use in an emergency situation for such vaccines may be accompanied by bridging trial protocol, application for an import registration certificate and application for an import license, according to the pathway issued.
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.
According to the guidelines, the applicant will use the Covid-19 vaccine, after receipt of CDL approval, initially only on 100 beneficiaries and submit the safety data to CDSCO.
The CDSCO will review the safety data submitted by the applicant, and once found satisfactory, will authorise the applicant to use the vaccine and will approve 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 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, the guidelines stated.
These guidelines have been prepared and posted by the CDSCO on its website. The CDSCO will take steps to widely disseminate these guidelines to stakeholders.
The government on April 13 had approved streamlining and fast-tracking of the 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 move will facilitate quicker 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.
With PTI inputs
