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

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

New Delhi, April 15, 2021

The Union Ministry of Health & Family Welfare has drawn up regulatory pathways for COVID-19 vaccines produced in other countries.

The Government on April 13 had approved a significant streamlining and fast-tracking of the 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).

An official press release said the decision would facilitate quicker access to such vaccines by India and encourage imports including bulk drug material, optimal utilization of domestic fill and finish capacity, and so on.

Vaccine manufacturing capacity and total vaccine availability within the country will also get a boost, it said.

The Central Drugs Standards Control Organization (CDSCO) has prepared detailed guidelines specifying the regulatory pathway for approval of foreign approved COVID vaccines based on NEGVAC recommendations.

These guidelines have been posted by CDSCO on its website. CDSCO will take steps to widely disseminate these guidelines to the concerned stakeholders, the release said.

Applications for the grant of approval for Restricted Use in 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 the Drugs Controller-General of India (DCGI) will consider and make a decision within three working days from the date of submission of a completed application by the applicant.

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

Vaccine shall be used as per the guidelines prescribed under 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 programme.

The applicant shall initiate the conduct of post-approval bridging clinical trials within 30 days of such approval. Applications for Restricted Use in Emergency situation for such vaccines should 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 three working days from the date of approval of Restricted Use in 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 programme.

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 authorise 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 Emergency situation.


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