To grant EUA to foreign vaccines, DCGI will take decision in 3 working days

The union government approved streamlining and fast tracking of regulatory system for vaccines authorised by foreign regulators

Amid record spike in daily coronavirus infections, India's drug regulator will take a decision on applications seeking approval for restricted emergency use of foreign produced vaccineswithin three working days from the date of submission, the government said on Thursday.

The CentralDrug Authority, CDSCO, will process applications for registration certificates (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.

The CDSCO issued detailed guidelines specifying regulatory pathway for approval of foreign approved COVID-19 vaccines after thecentral 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.

"This decision 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," said Ministry of Health and Family Welfare on Thursday.

The ministry on Thursday issued regulatory pathways for foreign produced COVID-19 vaccines according to which the CDSCO has prepared detailed guidelines specifying regulatory pathway for approval of foreign approved COVID-19 vaccines.

The government had on April 13 approved streamlining and fast tracking of regulatory system for COVID-19 vaccines approved for restricted use by the US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL).

On Thursday, India registered its biggest-ever single day spike with 200,739 fresh cases.  Massive 1,037 fatalities were reported during the same period, taking the toll from the deadly infection to 173,152.

The Central Drugs Standards Control Organization (CDSCO) headed by DCGI will follow the below pathway for approval of vaccines:

CDSCO will prepare detailed guidelines specifying regulatory pathway 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 emergency situation can be submitted to CDSCO.

Foreign vaccine makers can apply through their Indian subsidiary or via an authorised agent in India (in case they don't have an Indian subsidiary).

CDSCO will process such applications for restricted use in emergency situation and DCGI will consider and take a decision within 3 working days from date of submission of complete application by the applicant.

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

* Vaccine must be used as per the guidelines prescribed under national vaccination programme.

* First 100 beneficiaries of such vaccines will be assessed for 7 days for safety outcomes before it is rolled out for further Vaccination program.

* Applicant must also initiate conduct of post approval bridging clinical trials within 30 days of such approval.

Emergency approvals for such vaccines maybe accompanied by bridging trial protocol, application for import registration certificate and application for import license.

CDSCO will approve the protocol for the bridging trial in consultation with Subject Expert Committee (SEC) within 7 days of the receipt of the proposal. Applicant will conduct the bridging trial within the time lines 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.