In a radical reform measure, the Centre on Thursday issued Regulatory Pathway in India for Covid-19 vaccines approved for restricted use in the US, the UK, Japan, or which are listed in the WHO’s emergency use listing.
After comprehensive deliberation, the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC), chaired by Niti Aayog member (Health) Dr. V.K. Paul, issued the Regulatory Pathway for Covid-19 vaccines approval for “restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL)”.
The decision has been taken amid an unprecedented surge in Covid cases in the country with over 2 lakh people were infected on a single day, claiming 1,73,123 lives so far.
The government on April 13, had approved a significant streamlining and fast-tracking of the regulatory system for these foreign-produced vaccines.
This decision aimed at facilitating quicker access to such foreign vaccines by India to encourage imports including bulk drug material, optimal utilization of domestic fill and finish capacity, which will, in turn, provide a fillip to vaccine manufacturing capacity and total vaccine availability within the country.
Considering the step, the Central Drugs Standards Control Organization (CDSCO) headed by the Drugs Controller General of India (DCGI) Thursday explained the pathway that includes preparation for detailed guidelines for approval of foreign approved Covid vaccines based on NEGVAC recommendations.
“These guidelines have since been prepared and posted by CDSCO on its website. The CDSCO will take steps to widely disseminate these guidelines to the concerned stakeholders,” the Ministry said.
Applicants for grant of approval for Restricted Use in the Emergency situation may be submitted to CDSCO, said the Ministry, adding 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 CDSCO will process such applications for restricted use in an 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 DCGI will issue permission for restricted use in an emergency situation with conditions like Vaccine shall be used as per the guidelines prescribed under the national Covid-19 vaccination program.
“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 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.
The 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 an emergency situation.
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 program.
The applicant will use the Covid vaccine, after receipt of CDL approval, initially only on 100 beneficiaries, and submit the safety data to the CDSCO, which will review it.
Once found satisfactory, the Ministry said, the CDSO will authorize the applicant to use the vaccine.
The 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.
“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 move comes as over 11.44 crore Covid vaccine doses have been administered to the people in the countrywide vaccination drive started from January 16.
Presently, two “Made in India” vaccines have been approved for Emergency Use Authorisation (EUA) by national regulator DCGI. These are “Covishield”, developed by Oxford University-AstraZeneca and manufactured by Serum Institute of India (SII), and “Covaxin” developed and manufactured by Bharat Biotech International Ltd (BBIL).
On April 13, India also granted permission for the third Covid-19 vaccine ‘Gam-COVID-Vac’ combined vector vaccine, popularly called Sputnik-V, in emergency situations.
