Union Health Ministry issues regulatory pathways for foreign-produced COVID-19 vaccines

Days after the central government approved fast-tracking of the regulatory system for foreign-produced COVID-19 vaccines, the government on Thursday issued the Regulatory Pathway in India for such COVID-19 Vaccines. The Health Ministry stated that the decision will facilitate quicker access to such foreign COVID-19 vaccines by India and would encourage imports including import of bulk drug material, optimal utilization of domestic fill, and finish capacity. This will provide a fillip to vaccine manufacturing capacity and total vaccine availability within the country, it added. Also Read | All Class 5, 8, 10 students in Punjab to be promoted without exams: CM Pathway for foreign-produced COVID-19 vaccines in India:

• CDSCO shall prepare detailed guidelines specifying regulatory pathways 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 the 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).
• CDSCO will process such applications for Restricted Use in Emergency Situation and
• DCGI will consider and make a decision within 03 working days from the date of submission of a complete application by the applicant.

• DCGI will issue permission for Restricted Use in an Emergency situation with, inter-alia, the following conditions:

1. Vaccine shall be used as per the guidelines prescribed under National Covid-19 Vaccination Programme.
2. The first 100 beneficiaries of such vaccines shall be assessed for 7 days for safety outcomes before it is rolled out for further Vaccination programs.
3. The applicant shall initiate the conduct of post-approval bridging clinical trials within 30 days of such approval.

• Applications for Restricted Use in the Emergency situation for such vaccines may be accompanied by bridging trial protocol, application for an import registration certificate, and application for an import license.
• CDSCO will process applications for Registration Certificate (registration of overseas 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.
• 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 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 CDSCO.
• CDSCO will review the safety data submitted by the applicant, and once found satisfactory, will authorize the applicant to use the vaccine.
• CDSCO 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.
• 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.
• After the receipt of the bridging trial results, the DCGI will review the permission granted for Restricted Use in an Emergency situation.

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